COVID-19 Vaccination

Why do we need to get vaccinated for COVID-19?

With the BIDA (Bawal walang mask, I-sanitize ang mga kamay, Dumistansya ng isang metro, Alamin ang tamang impormasyon) steps and observance of minimum public health standards, vaccination is an important way to protect yourself from getting severe COVID-19.

Can a person decline the vaccination?

Yes. Vaccination is not mandatory and anyone may opt to decline. Refusal to vaccination, however, will subject the vaccinee to a rescheduling process according to the prioritization framework for COVID-19 vaccination. For persons who will refuse vaccination onsite, reason/s for refusal may be documented using the informed consent form.

Note that for Sinovac, in accordance with the Philippine Food and Drug Administration (FDA) and interim National Immunization Technical Advisory Group (iNITAG) recommendations, healthcare frontliners reserve the right to choose and may refuse vaccination without losing his/her slot in the priority list.

When will the COVID-19 vaccine be available?

The government is currently in the initial phase of vaccine rollout with the availability of Sinovac and AstraZeneca vaccines in the country. Likewise, the country is in the advanced stages of negotiations with the COVAX Facility and various other vaccine manufacturers.

Are there enough vaccines for all Filipinos?

The prioritization framework for COVID-19 vaccination based on the WHO Strategic Advisory Group of Experts (SAGE) on Immunization, together with the recommendations of independent bodies of experts including the Interim National Immunization Technical Advisory Group (iNITAG) and the Technical Advisory Group (TAG), was formulated due to the limited global supply of COVID-19 vaccine products. With the guidance of this principle, the Philippine National Deployment and Vaccination Plan formulated strategies and contingencies to ensure the equitable distribution of vaccine products for all Filipinos.

How do we ensure that the public is protected from false advertisements or claims of vaccine availability and distribution?

The Philippine Food and Drug Administration (FDA) is the government’s regulatory body for all medicines in the country. Information regarding products including vaccines may be accessed at the FDA website at https://www.fda.gov.ph/. It shall continuously provide advisories to the public based on their monitoring of products in the market. 

Intensified vaccine information campaigns and risk communication strategies are also presently in place to protect the public from misinformation.

Do potential vaccine recipients need to undergo RT-PCR testing first before getting vaccinated?

RT-PCR testing for COVID-19 is not required prior to vaccine administration.

If a person experienced an anaphylactic reaction from the 1st dose of a specific vaccine brand, can they get another brand? If yes, how long should the interval be?

Based on the Philippine FDA EUA of available vaccines here in the Philippines, occurrence of anaphylactic reaction after the 1st dose of COVID-19 vaccine is not advised for the inoculation of the 2nd dose of that vaccine type. Additionally, interchangeability of vaccine products is not recommended due to limited availability of scientific evidence.

Which healthcare workers can serve as vaccinators (pharmacists, midwives, etc.) and how will they be trained for this?

This will still be finalized with DOH, PRC, and concerned organizations. Details are still being finalized for training, should there be a need for these (i.e. for pharmacists who did not acquire vaccination skills in their undergraduate studies). Healthcare workers will be updated through their respective networks/channels on next steps regarding this.

How will screening be conducted prior to vaccination?

At the screening area, the personnel assigned shall scan the individual's QR or Unique Code before they are clinically assessed for COVID-19 symptoms, comorbidities, and other important clinical information. Contraindications and precautions stated in the EUA issued by the Philippine FDA shall be followed for all vaccines.

Specific health screening (e.g. age, allergy to vaccine components) may be adopted per vaccine and shall be issued in vaccine-specific guidelines. Likewise, health screening shall follow clinical practice guidelines of medical societies, which shall be regularly updated based on best available evidence.

Who will conduct the screening prior to vaccination?

Using both the VIMS Vaccination Post System (VPS) and hard copy of the screening form, health workers shall update the profile of potential vaccine recipients and determine whether or not they are eligible for vaccination.

How long before vaccination should screening be done?

Individuals not belonging to special populations, like those who are immunodeficient or senior citizens with special conditions (i.e. bedridden, in vegetative state, with limited life expectancy), may have their health profiling, provision of informed consent, and screening on the same day of vaccination. Otherwise, they shall first obtain medical clearance from their attending physicians to discuss vaccine-specific risks and benefits.

What sites or areas will be designated as vaccination sites or implementing units for the vaccination program?

”Implementing units”are those allowed to conduct vaccination activities. These are the following: a) hospitals, medical centers, infirmaries, b) rural health units, c) private clinics, and d) health facilities of government agencies.

Are there specific population groups for which vaccination should be conducted in separate sites or at different schedules?

For the following groups, LGUs shall ensure that vaccination is conducted or scheduled either in a separate site/facility stated below or in current LGU vaccination sites but at a separate date from other population:


1. People living with HIV, through HIV treatment hubs, to keep privacy and confidentiality of patients, provided treatment hubs have adequate human resource and capability to conduct the vaccination based on the NVDP
2. People affected with Tuberculosis, through TB-DOTS Centers, provided that assigned health workers and TB patients have adequate and appropriate PPE. Persons with multi-drug resistant tuberculosis (MDR TB), through the Programmatic Management for Drug-resistant Tuberculosis (PMDT) treatment centers/satellite treatment centers, must be strictly vaccinated at a separate place or schedule, ensuring that healthcare workers are equipped with N95 masks and other appropriate PPE.
3. Bed-ridden patients at home and/or in institutions (home for the aged, nursing homes, infirmaries, etc.), wherein LGUs may schedule onsite vaccination teams, ensuring appropriate processes and mechanisms for AEFI referral, such as availability of ambulances. Medical clearance and dialogue with the attending physician is necessary for bed-ridden patients.

How often should post-vaccination monitoring or follow-ups be conducted?

In designing local mechanisms of monitoring, LVOCs shall follow the minimum frequency of prompts or follow-up from the vaccine: one (1) week, two (2) weeks, one (1) month, three (3) months, six (6) months, and twelve (12) months after the date of vaccination. LVOCs may use more frequent intervals of monitoring depending on their capacity and agreements with the vaccination sites.

In designing local mechanisms of monitoring, LVOCs shall follow the minimum frequency of prompts or follow-up from the vaccine: one (1) week, two (2) weeks, one (1) month, three (3) months, six (6) months, and twelve (12) months after the date of vaccination. LVOCs may use more frequent intervals of monitoring depending on their capacity and agreements with the vaccination sites.

Who will be liable for and shoulder expenses related to adverse events following immunization?

The government will have an indemnification fund for all those who will experience adverse effects or events following immunization. In cases of severe AEFIs, costs for hospitalization or management and treatment of the adverse events will be shouldered by the government through PhilHealth. PhilHealth coverage of hospitalization shall be in accordance with the rules and regulations of the National Health Insurance Program.

How can LGUs and private companies enter into a tripartite agreement for the procurement of vaccines? Which office should they coordinate with?

Details on this will be part of the IRR of RA 11525 or An Act Establishing the COVID-19 Vaccination Program Expediting the Vaccine Procurement and Administration Process.

What is/can be considered an AEFI?

An Adverse Event Following Immunization (AEFI) is any of the following that may arise after vaccination:
- unfavourable or unintended sign and/or symptom;
- abnormal laboratory finding; or
- disease that may arise after immunization.

An AEFI may not necessarily be caused by the vaccine.

Where can the public get information that can be easily understood and followed in case of adverse reactions?

LGUs and vaccination sites shall provide post-vaccination reminders and home instructions to all vaccine recipients through handouts or SMS-based reminders that shall include mechanisms to report any adverse event after immunization to the vaccination site or the LGU, initial treatment or management for common adverse events, and contact information or location for consultations or referrals.

Sample post-vaccination reminders are available at bit.ly/RESBAKUNAMaterials

Are vaccines safe for those with existing medical conditions/comorbidities (i.e. diabetes, high blood)?

Patients with comorbidities belong to groups that may have an increased risk of getting severe COVID-19 if infected and would thus benefit from the protection immunization offers. The currently available vaccines in the country may be administered to individuals who have well-controlled comorbidities.

Are the vaccines safe for people with allergies?

Yes, it is safe for persons with an allergy or hypersensitivity to food or medicine, inhalants or environmental allergens, insect bites, or latex to receive the vaccine.

Those allergic to any of the vaccine components should not be administered with the COVID vaccines. Additional precautions must be implemented when administering the vaccine to persons with a previous history of asthma, anaphylaxis, or allergies to food, egg, or medicines. They shall be observed in post-vaccination monitoring areas for 30 minutes.

Can people who had a reaction to another non-COVID vaccine get the COVID vaccine?

Persons who experienced allergic reactions or symptoms, such as rashes/itching, swelling around the eyes, difficulty of breathing, or anaphylaxis (severe allergic reaction), within 6 hours after receiving another non-COVID vaccine should first consult with a doctor.

Can people with asthma or allergic rhinitis get vaccinated?

Yes, people with well-controlled asthma or allergic rhinitis, whether on inhaled corticosteroids or not, may receive the vaccine. Additional precautions will be implemented when administering the vaccine and they shall be observed in post-vaccination monitoring areas for 30 minutes.

Can cancer patients get vaccinated?

Yes, patients with cancer and who are currently, or will be undergoing active chemotherapy may be vaccinated anytime before and/or during their chemotherapy sessions if they have no other contraindications to the vaccine and are able to present a medical clearance from their physician. Cancer survivors diagnosed as recovered do not need a clearance and may get vaccinated.

For those undergoing Hematopoietic Cell Transplantation (HCT) or Cellular Therapy, they should delay vaccination for at least 3 months after transplantation or therapy.

Are the vaccines safe for those who have recovered from COVID-19?

Yes, all individuals who contracted COVID-19 may be vaccinated after recovery or completion of treatment, whether for first or second dose, without restarting the vaccine dose schedule.

For LGUs and private companies entering into a tripartite agreement, is it true that they have to donate 1 vaccine to the national government for every 1 vaccine they procure?

Details on this will be part of the IRR of RA 11525 or An Act Establishing the COVID-19 Vaccination Program Expediting the Vaccine Procurement and Administration Process.

Will the vaccines be available in the pharmacy?

No. Only vaccines which have finished the phase 4 clinical trials are provided a Certificate of Product Registration (CPR) which would allow the vaccines to be commercially available. To date, most of the vaccines are still in Phase 3, hence, the purchase of vaccines must be done through the tripartite agreement with the national government and manufacturers.

What can you do while waiting to get your vaccine?

We urge the public to be more vigilant with the information found online. Let us make it a habit to fact check and verify with reliable sources (DOH Facebook page, DOH website, WHO website, PIA website) regarding new information. Continue observing the minimum public health standards to prevent further transmission of the virus.

COVID-19 Vaccination Prioritization Framework

Who will be vaccinated first?

The priority population groups for COVID-19 immunization are as follows:

Group A:

A1. Frontline workers in health facilities both national and local, public and private, health professionals and non-professionals like students in health and allied professions courses with clinical responsibilities, nursing aides, janitors, barangay health workers, etc.;

A1.1 COVID-19 referral hospitals
A1.2 Hospitals catering to COVID-19 cases
A1.3 Quarantine/isolation facilities
A1.4 Remaining hospitals
A1.5 Government-owned community-based primary care facilities
A1.6 Remaining healthcare facilities (thru LGU)
A1.7 Closed healthcare institutions (such as nursing homes)

A2. Senior citizens;
A3. Adults with comorbidities;
A4. Frontline personnel in essential sectors both public and private, including uniformed personnel, and those working in sectors identified by the IATF that are directly client facing and cannot dutifully meet minimum public health standards; and
A5. Poor population based on National Household Targeting System for Poverty Reduction (NHTS-PR)

Group B:

B1. Teachers, social workers;
B2. Other government workers;
B3. Other essential workers;
B4. Socio-demographic groups at significantly higher risk other than senior citizens and poor population based on NHTS-PR;
B5. Overseas Filipino Workers; and
B6. Other remaining workforce

Group C:

Rest of the Filipino population not otherwise included in preceding groups

Why will the prioritized groups get the vaccine first?

With the initial limited supply, frontline health workers and uniformed personnel are prioritized since they have higher risk of exposure while on duty and to allow them to continue fulfilling their duties in both the public and private sectors. Vulnerable groups such as the elderly and the indigent population, are prioritized guided by the principle of equity.

How will healthcare facilities be further sub-prioritized?

For priority group A1, all workers in a health facility shall be taken as a group. If the incoming supply of vaccines is lower than the population group to be vaccinated, sub-prioritization of facilities or institutions will be done based on (a) historical admission of COVID-19 cases and (b) allocated and occupied COVID-19 beds, in the following order:
 

a. COVID-19 referral hospitals designated by the DOH;

b. Public and private hospitals and infirmaries providing COVID-19 care, as prioritized based on service capability, starting from level 3 hospitals, to level 2 hospitals to level 1 hospitals, and then infirmaries;

c. Among hospitals with a common service capability, the order of priority shall be from facilities owned by the DOH, then facilities owned by LGUs, and then facilities owned by private entities;

d. Isolation and quarantine facilities such as temporary treatment and monitoring facilities and converted facilities (e.g. hotels, schools, etc) that cater to COVID-19 suspect, probable, and confirmed cases, close contacts, and travellers in quarantine;

e. Remaining hospitals including facilities of uniformed services not catering to COVID-19 cases;

f. Government owned primary care based facilities such as Urban Health Centers, Rural Health Units and Barangay Health Stations, birthing homes, and Local Health Offices to include members of BHERTS, contact tracers, social workers;

g. Stand-alone facilities, clinics and diagnostic centers, and other facilities otherwise not specified (e.g. clinics, dialysis centers, dental clinics, and COVID-19 laboratories), dealing with COVID-19 cases, contacts, and specimens for research purposes, screening and case management coordinated through their respective local government units; and

h. Closed institutions and settings such as, but not limited to, nursing homes, orphanages, jails, detention centers, correctional facilities, drug treatment and rehabilitation centers, and Bureau of Corrections.

Sub-prioritization for other priority groups shall be released in succeeding issuances.

Will students from the different medical fields who are practicing in health facilities be included in the priority groups for vaccination?

Yes. Frontline workers in health facilities including non-professionals like students in health and allied professions courses with clinical responsibilities are part of Priority Group A.

Are the non medical personnel who are within the hospital included in the eligible priority groups?

Yes. Frontline workers in health facilities including non-healthcare professionals like ambulance staff, janitors, administrative staff, etc. are part of Priority Group A.

Will there be a prioritization among senior citizens or those in priority group A2?

Yes, prioritization shall be as follows:

A2.1 - Senior citizens living in group settings (e.g. nursing homes, assisted living facilities, convents)
A2.2 - All other senior citizens (including those bed-ridden at home, etc.)

Yes, prioritization shall be as follows:

A2.1 - Senior citizens living in group settings (e.g. nursing homes, assisted living facilities, convents)
A2.2 - All other senior citizens (including those bed-ridden at home, etc.)

Where should senior citizens get masterlisted for vaccination?

For those living in a group home or institution, respective LGUs will coordinate with the institution. All other senior citizens must wait for masterlisting announcements from the LGU. Check social media, posters in public areas, or house-to-house visits for important announcements.

Who should be prioritized among those who belong to priority group A3 or adults with comorbidities?

Filipinos 18-59 years old with any of the following clinically controlled comorbidities will be prioritized. Other disease conditions not included below but belonging to the general category of conditions are also eligible:

1. Chronic Respiratory Disease and Infection - asthma and respiratory allergies; chronic obstructive pulmonary disease; interstitial lung diseases; cystic fibrosis; pulmonary hypertension; pulmonary tuberculosis; chronic bronchitis; histoplasmosis; bronchiectasis
2. Cardiovascular Disease - hypertension; coronary heart diseases; cardiomyopathies; peripheral artery disease; aortic diseases; rheumatic heart disease; congenital heart disease
3. Chronic Kidney Disease
4. Cerebrovascular Disease - stroke and transient ischemic attack
5. Cancer - malignancy
6. Diabetes Mellitus - Type 1 and 2
7. Obesity
8. Chronic Liver Disease - hepatitis; cirrhosis; non-alcoholic fatty liver disease
9. Neurologic Disease - dementia; Alzheimer's disease; Parkinson's disease; epilepsy and seizures; Bell's palsy; Guillan-Barre syndrome; acute spinal cord injury
10. Immunodeficiency State - genetic immunodeficiencies; secondary or acquired (i.e. prolonged use of corticosteroids); HIV infection; solid organ or blood transplant patients
11. Other Diseases - sickle cell disease or thalassemia; Down syndrome

Can persons with other comorbidities also be categorized under priority group A3?

Yes, the group includes all adults with comorbidities. However, with supply coming in batches, we need to prioritize and protect those that are considered as top causes of mortality and morbidity in the Philippines and would therefore have a higher risk of getting severe COVID-19 if infected. Once additional supplies arrive, those with comorbidities not in the list will be scheduled for vaccination.

When is a person's comorbidity considered to be controlled?

Persons with controlled comorbidities are those who have no symptoms of their comorbidity, have stable vital signs (heart rate, respiratory rate, and blood pressure), have had no attacks, admissions, or changes in medication in the past 3 months, and are currently not hospitalized.

Who among those in priority group A3 will need medical clearance prior to vaccination?

Persons with any of the following comorbidities will need a physical or electronic medical clearance from their attending physician:
1. Autoimmune disease
2. Human Immunodeficiency Virus (HIV)
3. Cancer/malignancy, currently undergoing chemotherapy, radiotherapy, or immunotherapy
* Cancer survivors diagnosed as recovered do not need to present clearance and may be vaccinated
4. Transplant patients
5. Undergoing steroid treatment
6. Patients with poor prognosis or bed-ridden

Those persons with other comorbidities not mentioned above do not need a medical clearance before vaccination but should show any proof of comorbidity and undergo screening on vaccination day.

Where can persons with the identified comorbidities get their medical clearance?

Medical clearances can be obtained from attending physicians through teleconsultation, consultation at designated facilities, or Rural Health Units (RHUs) or other primary care centers designated by LGUs. LGUs shall ensure that mechanisms to provide medical clearances to persons in A3 priority group are accessible and available to all who need it.

What can be presented as a valid proof of comorbidity?

Proof of comorbidity may be any of the following: medical certificate from attending physician, prescription for medicines, hospital records (such as discharge summary, medical abstract, surgical records, pathology reports), or any other proof that may indicate eligibility for priority group A3.

Proofs of comorbidity do not need to indicate that the comorbidity is controlled to be eligible for vaccination.

Can Overseas Filipino Workers (OFWs), foreign nationals, or diplomats be included in the priority groups and receive the vaccine?

All Filipinos, including OFWs, and other groups with legal residency status in the Philippines (i.e. foreign nationals, diplomats, etc.) shall be included in the priority group appropriate to their circumstance. For example, said individuals meeting the eligibility criteria for priority group A2 (senior citizens) or A3 (adults with controlled comorbidities) may masterlist with their respective LGUs subject to supply availability.

For government employees and the private sector, will registration be at the LGU of residence or at the LGU of workplace?

All Filipinos shall indicate their interest to be vaccinated through their respective LGUs based on the address of their permanent or current residence or workplace. For other groups under eligible populations, detailed guidelines shall be developed and disseminated accordingly.

What is the required age for vaccination?

This will depend on the vaccine. For those currently available, Sinovac can be given to clinically healthy individuals 18 years old and above, including senior citizens, provided there is careful evaluation of health status and exposure risk to ensure that benefits of vaccination outweigh the risks, especially regarding vaccinees who are hypertensives.

AstraZeneca, Gamaleya Sputnik V, Janssen, and Bharat BioTech can also be given to those 18 years old and above, including senior citizens.

DOH shall develop a Department Memorandum for every COVID vaccine to be deployed in the country and this DM shall indicate the target or recommended age groups per vaccine.

This will depend on the vaccine. For those currently available, Sinovac can be given to clinically healthy individuals 18 to 59 years old, while AstraZeneca can be given to those 18 years old and above, including senior citizens.

DOH shall develop a Department Memorandum for every COVID vaccine to be deployed in the country and this DM shall indicate the target or recommended age groups per vaccine.

Is the vaccine free for priority groups?

The cost of vaccines for priority groups will be shouldered by the Philippine government.

How are the LGUs prioritized in the vaccine deployment program of the government?

Based on DM 2021-0099, otherwise known as, Interim Omnibus Guidelines for the Implementation of the National Vaccine Deployment Plan for COVID-19, sub-prioritization shall be determined by DOH upon recommendation of NITAG conducted within a priority population group through selection of geographic areas if there is insufficient incoming supply of vaccines. Sub-prioritization shall be based on:


a. COVID-19 burden of disease (current active cases, attack rate per 100,000 population in the past 4 weeks, and population density); and


b. Vaccination site and/or LGU readiness, in particular, its supply chain capability, to mount a vaccination campaign

When will vaccines be available for those not part of the priority groups?

The objective is to provide equitable access to safe and effective COVID-19 vaccines to the priority eligible groups or almost 70 million Filipinos by 2021, 60-70% of Filipinos by 2022, and followed by the remaining Filipino population in the next three (3) years.

Will vaccine prices be strictly controlled for populations who are not eligible for free vaccination?

The Government plans to vaccinate all eligible Filipinos for free, starting with 50 to 70 million in 2021. Eligibility would depend on the vaccines available, specifications for their allowable use, as well as scope of use authorized by our Philippine FDA.

Commercialization of vaccines with EUA is not yet allowed under relevant FDA issuances.

Why are children not included in the eligible groups to be vaccinated?

Results from Phase II and Phase III trials of COVID-19 vaccines are currently insufficient for the pediatric age group (<18 yrs old), limiting health experts from formulating any recommendations. Further studies will help in the future inclusion of children for vaccination.

What actions will be taken against those who do not follow the prioritization list and jump the line for vaccination?

Currently, in the guidelines, non-compliance to the prioritization framework may affect considerations for future allocations.

Is the LGU allowed to move on to vaccinating the next priority group without authorization from the DOH? Is vaccinating 90-95 percent of the group's population enough for them to move to the next group?

The LGU should be able to reach its target population based on the masterlist. Prior to moving to the next priority group, it needs to exhaust all means of open calls to the groups currently being vaccinated, and ensure they are well-informed on the availability of COVID-19 vaccines for them. The NVOC will provide information on when to proceed to the next group of eligible population.

Will doctors or healthcare workers who accommodate the clear breach of prioritization protocols be held liable? Aside from reminding people, what other actions is DOH taking to stop this?

LVOCs are accountable for the implementation of the National Vaccine Deployment Plan. As such, the LVOCs should ensure that the prioritization framework is followed by all the vaccination sites within their respective areas. Specific details will follow if there are new information or provisions related to this.

Emergency Use Authorization

What is an Emergency Use Authorization (EUA)?

It is an authorization granted through a risk-based procedure for assessing unregistered (under development) vaccines or drugs during public health emergencies of international concern. It aims to expedite availability of the vaccine or drug to people affected by public health emergencies based on an essential set of available quality, safety and efficacy performance data.

Which applications for EUA have been approved?

As of May 5, 2021, the Philippine FDA has issued an EUA to the Pfizer-BioNTech, AztraZeneca Pharmaceuticals, Sinovac, Gamaleya Sputnik V, Johnson and Johnson’s Janssen, Bharat BioTech’s Covaxin, and Moderna COVID-19 vaccines. The FDA continues to accept applications for EUA.

What is the difference between an EUA and a full market authorization?

The issuance of Emergency Use Authorization is a risk-based procedure for assessing vaccines or drugs that are currently under development for use during public health emergencies of international concern. This aims to expedite access to these vaccines or drugs and will be based on quality, safety and efficacy performance data.

A full market authorization, on the other hand, is granted to fully-developed therapeutics or vaccines. This means that the products have already completed Phase IV clinical trials and have passed the initial registration requirement of 3-year monitored release before being granted a market authorization for general use.

What are the candidate vaccines that can become available once they pass FDA requirements and are granted EUA?

Our current vaccine portfolio consists of eight vaccines - Pfizer-BioNTech, Oxford AstraZeneca, Sinovac CoronaVac, Gamaleya Sputnik V, Bharat BioTech, Moderna, Novavax, and Janssen. As of May 5, 2021, Pfizer, AstraZeneca, Sinovac, Sputnik V, J&J’s Janssen, Bharat BioTech’s Covaxin, and Moderna have been issued an Emergency Use Authorization (EUA) by the Philippine FDA.

What safety monitoring mechanisms are in place for vaccines under an EUA?

The holder of the EUA shall have a comprehensive pharmacovigilance system for their product following the system or protocol for a registered drug and biological product. They shall ensure compliance to the Risk Management Plan (RMP), which contains information on product safety profile and explains the measures to characterize the risk including ongoing, new studies or additional activities. The summary of the RMP shall be published in the FDA website. Any deviation from or changes to the manufacture and changes in label of the product must be notified with the FDA. The pharmacovigilance obligations and post-authorization commitments of the holder of the EUA shall be shared by the national procurer and health program implementers to the fullest extent possible and applicable.

How will the government ensure that no vaccine will be utilized without the EUA or distributed without full market authorization?

The FDA will continuously monitor the vaccines being used in the vaccination program. FDA inspectors shall regularly conduct market surveillance to safeguard from unauthorized use of vaccines.

When is the FDA going to approve the EUA applications of other vaccines?

Decisions on applications for EUA will be given twenty-one (21) days after submission of the application with complete documentary requirements.

Procurement of COVID-19 Vaccines

When will next batches of the COVID-19 vaccines arrive and be deployed?

According to the current projected schedule, we are expecting the following vaccine quantities to arrive in the coming months:
April: 2,000,000 total doses
Sinovac - 1,500,000
Gamaleya - 500,000

May: 4,194,000 total doses
Sinovac - 2,000,000
Gamaleya - 2,000,000
Moderna - 194,000

Which vaccines will be procured by the government?

The government is currently in talks with vaccine manufacturers in order to secure vaccine supply for the Philippines. These include Novavax/Covovax of Serum Institute of India, Pfizer of U.S.A. and Germany, Janssen J&J of U.S.A. and Belgium, Moderna of U.S.A., and Sinovac of China. These vaccines must undergo strict assessment by the Philippine FDA and vaccine experts before they are procured.

What is the basis for selection of vaccines that will be procured and made available by the government?

To guide the choices on which vaccines will be considered for negotiation and procurement, the Vaccine Expert Panel developed a set of criteria for the technical evaluation of the candidate vaccines. The criteria adapts the WHO Criteria for COVID-19 Vaccine Prioritization and WHO Target Product Profiles for COVID-19 Vaccines with additional criteria and considerations suited for local needs:

1. Track record of company in developing and/or manufacturing other vaccines
2. Reliability and stability related to storage requirement
3. Safety based on Phase 1 and 2 of clinical trials
4. Potential efficacy based on Phase II of Clinical Trials
5. Potential efficacy and safety based on Published Phase III Interim Result and/or with EUA
6. Vaccine Implementation

Why does the Philippine Government need to buy different brands of vaccines?

Currently, the Philippines does not have the capacity to develop and manufacture its own vaccines. To ensure adequate supply of COVID-19 vaccines for all Filipinos, the country banks on a combined effort in procuring vaccine doses, participating in Phase 3 clinical trials, and participating in multilateral negotiations such as the COVAX Facility.

Can the private sector directly purchase the vaccines from pharmaceuticals or manufacturers for their employees?

No. Like LGUs, a tripartite agreement involving the National Government, the pharmaceutical company, and the private company is necessary for the procurement of vaccines by the private sector. An Emergency Use Authorization (EUA) is not equivalent to a marketing authorization or a Certificate of Product Registration (CPR). Hence, COVID-19 vaccines are not to be treated as commercial products even if issued with EUA.

Since RA 11525 allows private companies to procure and administer vaccines for their own employees through a tripartite agreement with the government, will these privately procured vaccines be classified and counted under the COVID-19 vaccination program

The private sector can only procure vaccines through a tripartite agreement with the NTF and the Department of Health, as DOH is the EUA holder of these vaccines. Private companies will be advised by the iNITAG on which sector should be prioritized. LIkewise, the private sector needs to partner with a vaccination site that follows the standars described in the NVDP.

Can private companies offer vaccines to dependents of their employees for a fee or should this be given for free as well?

The iNITAG will provide guidance to the private sector if these companies will offer vaccination. These vaccines do not yet have Certificates of Product Registration, thus, these should not be offered commercially. Selling is not allowed.

How much is the cost or what is the price range for each available vaccine?

The Government estimates that it will spend an average composite cost of around PHP 1,300.00 per person for the vaccination program. This includes vaccine cost (assuming a two-dose requirement) and ancillaries.

How cost efficient are the vaccines being procured?

A full-blown cost-effectiveness analysis (CEA) is currently not done for rapid reviews under a pandemic situation due to its emergency nature. A full-blown cost-effectiveness analysis that takes on a societal perspective (i.e., including the economic and social impacts) will be performed once sufficient evidence is available and when full market authorization has been granted.

Given the tremendous impact of COVID-19 to our health, social and economic life, the Health Technology Assessment Unit deems cost-effectiveness is not a priority at this time but will be done once more information on long-term safety and effectiveness of health interventions are available. Cost and resource analysis of implementing the vaccination program shall be done however to inform judgments on whether the vaccines and other health interventions demonstrate reasonable and efficient allocation of resources.

Can LGUs directly purchase the vaccines from pharmaceuticals or manufacturers for their constituents?

No. LGUs cannot procure and roll out COVID-19 vaccines on their own. This must be coordinated with the national government, through the NTF and the DOH in a tripartite agreement involving local governments and pharmaceutical companies. This is meant to align the efforts of LGUs with the vaccine initiative of the National Government which integrates and consolidates all resources and initiatives.

Why can't the government be transparent about the unit acquisition cost or price range of each brand of vaccine?

These agreements are covered by confidentiality agreements so disclosure may be done once the agreements are finalized. The government assures the public that prices will be fair and properly assessed for whichever brands of vaccine will be procured.

Vaccine Doses and Frequency

Can a second dose of a different brand be administered to a vaccinee?

No. The same brand is required to be given for a 2nd dose, to ensure the maximum protection of the vaccinee. The DOH is coordinating with the Local Government Units to ensure allocation of adequate doses of the same Philippine FDA-approved vaccine brand.

How does the government plan to administer vaccines requiring two doses?

The government will make sure that those given with 1st dose will also be given their second dose on time. For example, if we have 50,000 doses available, we will only vaccinate the 25,000 eligible population to make sure that they will be given their second doses accordingly.

What is the interval between the 1st and 2nd dose of COVID vaccine?

Interval of doses varies per vaccine. Vaccines which have already been issued an EUA by the Philippine FDA have the following dosage and frequency:


Sinovac - 2 doses, 4 weeks (28 days) apart
AstraZeneca - 2 doses, 4 to 12 weeks apart
Gamaleya Sputnik V - 2 doses, 3 weeks apart
Janssen - 1 dose
Bharat BioTech - 2 doses, 28 days apa

If the person misses his second dose, how long is the approved interval from the first dose for him to get the second dose?

The US Centers for Disease Control and Prevention (CDC) allow for a 4-day grace period when assessing on-time receipt. People should try to get the second dose during this period or as soon after as possible. However, if the second dose is given later than this, you do not need to restart the vaccine. You still only need to get the second dose. However, it is important to note that the first dose did not protect as many people as were protected after the second dose, so if you are exposed to SARS-CoV-2 during the delay, you may or may not have enough immunity to prevent you from experiencing symptoms.

What should be done in case an individual refuses or misses the second dose of vaccine?

The US Centers for Disease Control and Prevention (CDC) allow for a 4-day grace period when assessing on-time receipt. People should try to get the second dose during this period or as soon after as possible. However, if the second dose is given later than this, you do not need to restart the vaccine. You still only need to get the second dose. However, it is important to note that the first dose did not protect as many people as were protected after the second dose, so if you are exposed to SARS-CoV-2 during the delay, you may or may not have enough immunity to prevent you from experiencing symptoms.

Cold Chain and Logistics

What does “vaccine cold chain” mean?

Vaccine “cold chain” refers to the maintenance of the vaccine’s product quality from the time it is manufactured until the point of administration by ensuring that vaccines are stored and transported within WHO-recommended temperature ranges.

Why is cold chain important?

A vaccine is a biological product. If it gets too hot or too cold, the active ingredients can degrade and become less effective.

Once a dose of vaccine is manufactured, it needs to be transported to immunization programs and clinics and health centers all over the world, and then remain viable until it’s needed.

How will the vaccines be deployed to communities?

From the national central cold storage facility, vaccines will be delivered to the regional hubs - Centers for Health Development (CHDs) and identified provinces and cities with direct flight schedule. From the CHDs, the vaccines will be delivered to provinces and cities, or to pre-identified vaccination sites -  Rural Health Units (RHUs), Main Health Centers, and hospitals within their catchment areas.

Which air and sea ports will be involved in deployment of vaccines to communities?

The DOH will coordinate with the appropriate authorities and with the LGUs to identify which air and sea ports will be involved in delivery of the vaccines. Vaccines allocated for all regions in Visayas and Mindanao, and in selected provinces in Luzon will be delivered by air. The remaining allocation for Luzon will be delivered by refrigerated vans.

Do Local Government Units (LGUs) have to buy freezers?

The LGUs have to coordinate with the local DOH office for the assessment of cold chain capacities. If there is a need based on the assessment, LGUs can augment storage facilities such as freezers and refrigerators.

What are the possible effects of improper vaccine storage and handling?

Improper storage and handling  can reduce or destroy their potency resulting in inadequate or no immune response in the recipient.

What are the temperature requirements for COVID-19 vaccines?

COVID-19 vaccines have different recommended temperature requirements and the deployment plan is ready for the possible requirements of different vaccines:  a) refrigerated (2°C to 8°C, b) frozen (-15°C to -25°C), and c) ultra-cold (-70°C to -80°C).

What is the proper way of handling the vaccines?

Specific guidelines for the implementation of vaccine storage, handling, and transfer shall be in line with the corresponding EUA provisions issued by the Philippine FDA for each vaccine. Cold chain management requirements shall be maintained from manufacturing, storage, and distribution of vaccines to ensure integrity of vaccine compounds.

All vaccines shall be inspected by the DOH Inspection and Acceptance Committee upon arrival at the main warehouse facility prior to distribution to vaccination sites to ensure that the vaccines are of good quality upon arrival, full documentary requirements are present, and recommended storage temperatures are maintained.

Registration and Masterlisting

Why is it necessary to create and maintain a masterlist?

To prepare the country for the COVID-19 vaccination program, a masterlist will: (1) provide basis for identification of target eligible groups for vaccination and identification of priority areas for registration of eligible individuals; (2) ensure uniqueness of individuals in the vaccine administration plan; and (3) provide input to operational planning especially for costing and allocation of resources.

What platform will be used for the masterlist?

The COVID-19 Vaccine Information Management System - Immunization Registry (VIMS-IR) shall be the official platform for masterlisting and pre-registration of individuals for COVID-19 vaccination. The VIMS platform shall also enable use of information and communications technology for scheduling, notification, and vaccination reminders.

Will the COVID-19 VIMS-IR be used to monitor those who have already been vaccinated?

The Vaccine Information Management System - Immunization Registry (VIMS-IR) is used only for masterlisting and as the registry of eligible population. Health facilities and vaccination centers upload their data or linelist of those who were vaccinated to the VIMS - Vaccine Administration System (VAS).

Will the COVID-19 VIMS-IR be centralized in DOH and be connected or aligned across the different LGUs?

DOH will have central access to all of this data including those that are vaccinated. It is stored centrally at DICT. DOH CHDs have been given access to their appropriate data.

Who is included in the masterlisting?

All Filipinos will need to be masterlisted with their full health profile prior to vaccination. But the first phase will involve all frontline health workers in the public and private sector. The schedule of masterlisting will be consistent with the ordering of prioritization in the National Vaccine Deployment Plan.

If I am a frontline health worker who is part of Phase 1 for masterlisting, where do I register or sign-up?

You will need to register through the Human Resource or Administrative Office of the health facility which you belong to.

Will masterlisting be done online? How will those without access to the internet be included?

Health facilities and LGUs may submit required data online through VIMS-IR, any information system linked to VIMS-IR, or physical forms for areas without connectivity. The forms are to be consolidated by the Human Resource Office of the facility and submitted to LGUs for encoding and submission to CHDs.

What information will be collected?

Personal information, such as but not limited to full name, birthday, and PhilHealth Identification Number (PIN), shall be collected to ensure no doubling of identified potential vaccine recipients. Health data will also be collected to help the vaccination team identify and verify which priority group the individual belongs to and assess the person's eligibility for the vaccine.

How will the vaccinees be notified of their vaccination schedule?

The LGU or zones will determine the scheduling for vaccination. The Vaccine Information Management System (VIMS) platform shall be used for scheduling, notifying, and reminding individuals of their scheduled vaccination.

Are there other requirements needed for masterlisting and registration?

All potential vaccine recipients must present any government-issued identification card, such as PRC license, driver's license, UMID, PhilHealth ID, or passport. In case individual does not have a government ID with photo, any other government document, such as cedula, barangay certificate, or birth certificate may be presented.

For government employees and the private sector, will registration be at the LGU of residence or at the LGU of the workplace? What are the steps for registration?

Local government units (LGUs) are in charge of masterlisting or profiling. For other groups under eligible populations, detailed guidelines shall be developed and disseminated accordingly.

What is the correct process for filling up the Quick Substitution List (QSL) - is there a preset list of names or is it free for all?

The QSL should also follow the priority list groupings of eligible populations. Currently, we are completing A1 (frontline health workers), A2 (senior citizens), and A3 (persons with comorbidities). Once all A1 to A3 populations are listed then we proceed to succeeding groups and so on.

Vaccine Efficacy

What is efficacy?

WHO defines efficacy as reduction in disease incidence in a vaccinated group compared to an unvaccinated group under optimal conditions such as in a randomized clinical trial.

For COVID-19 vaccine trials, the primary endpoint  is the occurrence of symptomatic COVID-19 but they are also measuring other endpoints such as severe COVID, hospitalization due to COVID.

Does the vaccine completely prevent an individual from getting and transmitting COVID-19?

No vaccine provides 100% protection from COVID-19. It typically takes a few weeks for the body to build immunity after vaccination. That means it is possible a person could be infected with the virus that causes COVID-19 just before or just after vaccination and still get sick because the vaccine has not had enough time to provide protection.

In addition, efficacy is measured not only by a vaccine's ability to prevent infection, but also in its prevention of severe forms of the disease and of forward transmission. While a vaccinated person  may not be completely prevented from getting infected, s/he will still have a reduced risk of getting severe forms of COVID-19. If more people have this reduced risk, then we can more effectively reduce transmission.

How long will the immunity provided by the vaccine last?

Due to the relatively short observation period for Phase 3 trials, the actual duration of immunity that the vaccines provide is currently unknown. This is still being determined through continuous monitoring of the vaccine recipients in the trials. Until this is established, we must continue practicing minimum public health standards/BIDA behaviors - bawal walang face mask at face shield, i-sanitize ang kamay, dumistansya ng isang metro, at alamin ang tamang impormasyon.

After being vaccinated, can rapid antibody tests be used to determine immune response to the vaccine?

The presence of antibodies can be documented using antibody tests but this is not a requirement post-vaccination and is not recommended based on current evidence particularly for mRNA vaccines.

Do the available vaccines offer protection against the new strains of COVID-19?

Emerging data seems to suggest that the current vaccines protect against the new variants. However, definitive studies are still under way to determine whether the vaccines currently being used will protect against the new variants.

A small in vitro study showed that antibodies from people given the BNT162b2 (Pfizer) vaccine were able to neutralize SARS-CoV-2 variants with the N501Y mutation (this was not the UK variant B.1.1.7, which had more mutations). It seems very likely that the other vaccines will result in the same findings, based on expert opinion.

For individuals who became COVID-19 positive after receiving the first dose of the vaccine, should they restart their vaccine doses to get the full efficacy?

All vaccine recipients who contracted COVID-19 may be vaccinated after recovery or completion of treatment, whether for first or second dose, without restarting the vaccine dose schedule.

If the vaccine will require regular or booster shots, will it be effective and will individuals be adequately immune if they get vaccinated with different brands?

There is currently no evidence on the need for a booster dose/s of the vaccine after the current two-dose vaccine series is complete. The need for and timing of booster doses will be evaluated as further data accumulate.

What is the efficacy rate of each available vaccine?

At this point, only vaccine efficacy (VE) data is available since “effectiveness” depends on many different factors and requires a longer observation period.

1. AstraZeneca COVID-19 Vaccine (ChAdOx1-S [recombinant]): 70.4% (95% CI 54.8 to 80.6%) overall VE against symptomatic COVID-19, 14 days after 2nd dose


2. Sinovac CoronaVac: 65 to 91% (based on Brazil, Indonesia and Turkey Trials)


3. Gamaleya Sputnik V: 91.6% (95% CI 85.6 to 95.2%) overall VE against symptomatic COVID-19, 21 days after 1st dose; 100% (96% CI 94.4 to 100.0%) VE against moderate or severe cases, 21 days after the 1st dose


4. Janssen: 66.9% (95% CI 59.0 to 73.4%) against confirmed moderate to severe/critical COVID-19, 14 days after vaccination; 66.1% (95% CI 55.0 to 74.8%) against confirmed moderate to severe/critical COVID-19, 28 days after vaccination; ~77% effective in preventing severe/critical COVID-19 occurring at least 14 days after vaccination and 85% effective in preventing severe/critical COVID-19 occurring at least 28 days after vaccination


5. Bharat BioTech: 80.6% (95% CI 78.1 to 82.7%) overall VE against PCR-confirmed symptomatic COVID-19, after the 2nd dose


6. Pfizer-BioNTech (BNT162b2): 95% (94.7%, 95% CI 90.3 to 97.6%) against symptomatic COVID-19, 7 days after 2nd dose


7. Moderna (mRNA-1273): 94.1% (95% CI 89.3 to 96.8%%) overall VE against symptomatic COVID-19, at least 14 days after the 2nd dose; 100% VE against severe COVID-19

What are the antibody levels post-vaccination and how soon are these formed?

Clinical trial data show that this varies per individual and that different vaccines have different durations for developing antibodies. Based on available information on reported vaccine efficacy from published Phase III interim results:
1. Pfizer: 7 days after the 2nd dose
2. AstraZeneca: 14 days after the 2nd dose
3. Gamaleya Sputnik V: 21 days after the 1st dose
4. Moderna: 14 days after the 2nd dose

When comparing efficacy of vaccines, do different age groups have varying results based on clinical trials?

There are a lot of factors that can affect vaccine efficacy and age is just one of these factors. Others include:
1. Technology platform used
2. Clinical trial design
3. Health status of clinical trial participants (e.g. presence of comorbidities, HIV-exposure etc. )
4. COVID-19 risk exposure
5. Ethnicity

Hence, when clinical trial results are presented, an overall vaccine efficacy is usually indicated then a vaccine efficacy for the different subgroups (e.g. according to age group, ethnicity) may also be indicated. For the vaccines already approved by Philippine FDA for emergency use, the following are the age groups in which they are allowed to be administered:
1. Pfizer-BioNTech - 16 years old and above
2. AstraZeneca - 18 years old and above
3. Sinovac - 18 years old and above
*Provided that for vaccinees 60 years old and above, there is careful evaluation of health status and exposure risk to ensure that benefits of vaccination outweigh the risks, especially for hypertensives
4. Gameleya Sputnik V - 18 years old and above
5. Janssen - 18 years old and above
6. Bharat BioTech - 18 years old and above

The EUA terms and conditions can be updated as more clinical trial data becomes available from additional age groups or specific population groups.

Clinical/Solidarity Trials

Why do we need to conduct clinical trials?

Every new therapy, vaccine, or diagnostic procedure in medicine should undergo clinical trials which will require participation of volunteers. These provide a scientific basis or guidance for use.

What is a vaccine clinical trial?

These are medical studies that involve people. The main objective is to evaluate how safe and how effective the vaccines under investigation are for humans before licensed for use. Vaccine clinical trials look at the comparison between outcomes in those vaccinated and those who aren’t to see if protection is observed.

How do clinical trials work?

Clinical trials follow a plan called a protocol, which outlines all the components of implementing the study. This plan must be submitted for approval by several groups of technical experts before the study can be conducted.

How are volunteers grouped?

Clinical trials will describe criteria of study sites and potential participants. Volunteers are randomly assigned to a specific study group. Comparison between groups will be done (placebo or comparator vaccine).

Are there regulations for clinical research to protect the participants?

Yes. The Philippine Food and Drug Administration (FDA) is the government agency responsible for regulating conduct of clinical trials in the country.

What will be done to ensure the safety of the participants?

The FDA and partner evaluators follow a rigorous review process for each study to ensure the safety of participants. The review process is done in partnership with the DOST Vaccine Expert Panel, a group of technical experts and scientists, and the Philippine Health Research Ethics Board (PHREB).

Who will monitor vaccine candidates?

An independent Data and Safety Monitoring Committee (DSMC) will be formed to monitor safety of vaccine candidates under WHO Solidarity Trials while the study is ongoing.

What will be done prior to the approval?

A benefit-risk assessment is also done prior to approval. It must be determined that the potential benefits exceed the potential risks. The safety, wellbeing, and health of the study participants are priority.

Are there possible side effects?

Only vaccine candidates observed to have acceptable safety from previous studies can progress across phases of clinical trials. Side effects are possible to occur. These can be mild and localized but there is also a slim possibility that a person will react to the vaccine seriously. For observed side effects, the investigators must determine if side effects are causally-related to the vaccines.

What are the rights of clinical trial participants?

●  Right to know compensation (if any)
●  Right to privacy and confidentiality
●  Right to beliefs
●  Right to documents
●  Right to post-trial care
●  Right to complain
●  Right to ask
●  Right to full disclosure
●  Right to be informed of the risks
●  Right to clear information
●  Right to decide
●  Right to refuse

For a more detailed explanation, please see pages 8 and 9 of the Primer at bit.ly/VaccineTrialsPrimerPH

How are participants for the vaccine trials determined?

The eligible population is specified by study criteria in the identified study sites. All potential participants will first be screened for certain inclusion and exclusion criteria. There may be groups prioritized such as HCWs, frontliners, and contacts of COVID-19 cases.

What is the criteria for eligibility?

Eligibility is based on the results of the following:
● Physical examination
● State of health
● COVID-19 status
● Other diagnostic tests

What is the importance of conducting clinical trials in the Philippines?

The vaccine needs to be tested in the Philippines to make sure that it is safe, produces immunity, and provides protection against COVID-19

Is it possible for different races to have different results?

Yes. Each race has biological or genetic differences that can result in different immune responses that can be discovered through conducting clinical trials.

Why do clinical trials need to be conducted in barangays with high incidence rates?

Clinical trials are normally conducted in areas with a high transmission rate to determine if the vaccine is effective. This is due to the high probability of exposure to the virus.

Are there clinical trials involving children to test the safety and efficacy of vaccines on them?

The Phase 3 trials that are published enrolled patients as young as 16 (Pfizer) to 18 (Moderna) years old. Trials are underway to look at the vaccines’ safety and efficacy in children.

How much of the population is needed for clinical trials to deem the vaccines being tested as "safe"?

Clinical trials have several stages:
Phase 1: The candidate  vaccine is given to a small number (10-100) of healthy adults with the primary aim of assessing safety
Phase 2: If the candidate vaccine is found safe in Phase 1, it will be given to 100-1000 participants to determine how effectively it stimulates immune response and if there are any side effects
Phase 3: If the vaccine is found to be safe and effective in Phase 2, it will be given to thousands of people (as much as ~30K) to determine if it protects a large population from the disease and whether there are any uncommon or serious side effects.

Even for vaccines that will eventually be given approval, monitoring of people who are vaccinated will still be done as there are very rare (i.e. 1 in 100,000 or 1 in 500,000 people) side effects that large clinical trials may not capture or the clinical trials may not have included groups who may have higher risk of side effects than those who participated in the trials (e.g. pregnant women, older population).

Where can healthcare workers volunteer to be vaccinators for the WHO Solidarity Trials?

You may contact Dr. Zen Zordilla (Project Manager) through email at zdzordilla@up.edu.ph or landline of the PGH Infectious Disease Section at (02)8-5251062.

Will the available and candidate vaccines go through Phase 4 clinical trials?

Once granted a certificate of product registration or marketing approval by National Regulatory Authorities, all candidate vaccines will undergo Phase IV clinical trial or post-marketing surveillance intended to understand the benefits and risks of the approved vaccine over time.

It may be noted that in the Philippines, the Universal Healthcare Law requires the completion of Phase IV clinical trials before the  government can procure vaccines.  However, as the country is now in a state of pandemic, this provision is waived temporarily for COVID-19 vaccine candidates and treatments in line with the implementation of the Bayanihan to Heal as One Act.

How do placebo-controlled clinical trials plan to handle the subjects assigned to the placebo group after treatment unmasking?

This may vary depending on the protocol of the clinical trial, the sponsor, and the requirements of Ethics Review Boards  in a country. After unmasking and if the candidate vaccine was found to be effective, those in the placebo arm may request to be vaccinated.

What is the status of ongoing clinical trials for other candidate vaccines?

There are 263 COVID-19 candidate vaccines under development as of 12 March 2021 based on the WHO Draft landscape of COVID-19 candidate vaccines. Of these, 81 are under clinical development with 28 candidates in Phase 3, 28 candidates in Phase 2, 21 candidates in Phase 1 and 4 candidates in Phase 4 clinical trials.

As of 15 March 2021, the Philippine FDA has approved the conduct of the following clinical trials in the Philippines:
1. Janssen - Philippine FDA released approval to conduct clinical trials on 28 December 2020
2. Clover Biopharmaceuticals - Philippine FDA released approval to conduct clinical trials on 08 January 2021
3. Sinovac - Philippine FDA approved CT application on 15 January 2021

As of March 15, 2021, the Philippine FDA has not received new applications for clinical trials of COVID-19 vaccine candidates.

Which vaccines are being considered or are for use in the WHO Solidarity Trial?

Candidate vaccines being considered for use in the Solidarity Trials have not yet been disclosed by the WHO.

What is the timeline for the WHO Solidarity Trials?

The approved duration of the implementation of the WHO SVT in the Philippines is from  01 October 2020 to 31 March 2022 (1.5 years). This duration includes the preparatory work of the Philippine team, approximately 3 months of actual vaccination, 2 months of analysis, and 6 to 18 months of follow-ups.

Do individuals who have received vaccines through participation in clinical trials abroad have to undergo quarantine when traveling to the Philippines?

Yes, the minimum public health standards and other existing quarantine procedures or guidelines still have to be followed since the efficacy and effectiveness of the vaccines administered in clinical trials are not yet assured and the participants may have received placebo treatments.

Since clinical trials are only about to begin in the Philippines, does this mean that the vaccines which are being procured by the government cannot yet claim their efficacy, or are the upcoming clinical trials for vaccine brands other than those availabl

For COVID-19 vaccines with EUA approval from the Philippine FDA, this means the vaccines were found to be safe and effective for the age groups and conditions that the EUA approval provides for.

It should be noted, however, that clinical trials are still ongoing even for vaccine brands which have been granted with an EUA by the Philippine FDA and are being acquired by the government (e.g. Pfizer, AstraZeneca, Sinovac, etc.) since their Phase 3 results have not yet been completed. The analysis of their efficacy has been based on partial/interim Phase 3 clinical trial results, which in this state of a public health emergency will suffice to apply for and be issued with an EUA.

Vaccine developers that applied to have clinical trials in the Philippines have specific objectives for conducting these studies, such as to assess the vaccine in a specific age group or populations not included in initial trials or a different dosing schedule.

All EUA approvals granted, whether locally or in other countries, may be updated as more clinical trial data becomes available.

Will participants or volunteers eventually be informed whether they received a placebo or an actual vaccine during the clinical trials?

It is possible that they may not be informed because the clinical trials are double blind randomized in nature and the ones analyzing the study are also not aware of what was administered to the participants. Unblinding will only happen when the clinical trial is over, unless a serious adverse event happens, in which case the researchers will decide on whether to unblind the affected participant/s to determine if the reaction was caused by or attributable to the vaccine or not. It is therefore a case to case basis. However, the ethics committee believes that it is the right of those in the placebo group to eventually be given a vaccine proven to be effective once the trial is finished.

Is participation in the WHO Solidarity Trials mandatory for chosen LGUs?

No. Eligible LGUs will be chosen based on criteria given by the WHO, but we will still rely on their cooperation and it will be their decision whether to join the Solidarity Trials or not. Of course, we highly encourage chosen LGUs to participate in this global effort, especially since the Philippines is recognized as one of the best contributors to clinical trials because our country has very good scientists and organizations managing the trials and making sure participants are safe.

How can clinical trial investigators ensure that participants fully comprehend the study procedures before joining?

It is a standard step in clinical trials that clinical trial investigators explain to potential participants what the study is all about and what are possible risks and benefits in a language they understand. To further ensure that participants fully  comprehend the study procedures, It would be helpful to use a guide with diagrams or pictures when inviting participants to explain the procedures to them. After which, investigators can validate the potential participants' understanding by asking some follow up questions. If potential participants answer incorrectly, investigators must correct them and explain again.

Will the rollout of the national vaccination program coincide with clinical trials or WHO Solidarity Trials in some areas?

It is possible. However, it should be noted that WHO-SVT is a community-based trial with target participants of generally healthy adults aged 18-59 years old,  while the first two priority groups for the national vaccination program are health care workers and senior citizens. On this note, the possibility of coinciding is minimal. Further, the DOH, DOST, and the Vaccine Cluster of the National Task Force for COVID-19 are closely coordinating to ensure there are no overlaps.

How will LGUs be protected from liabilities to participants of clinical or solidarity trials in the event they experience serious adverse reactions?

Aside from the informed consent which participants sign upon agreement to join the trials, an indemnification fund has also been set up by WHO for use in cases where a participant experiences a severe adverse reaction proven to be directly caused by the vaccine being studied. The fund will cover all expenses related to the management and treatment of the adverse reaction, as well as compensation for any potential loss of earning capacity. However, regardless of whether the adverse reaction was caused by the vaccine or not, participants who experience such will be treated and managed appropriately and emergency care will be provided by the trial sponsor.

What is the difference between an independent clinical trial and the WHO Solidarity Trial?

These are the main differences between the 2 types of trials:


1. FDA-approved independent clinical trials for Janssen, Clover, and Sinovac to be conducted in the country are funded by their respective vaccine manufacturers or pharmaceutical companies. The WHO Solidarity Trial is funded by the Philippine Government through DOST and DOH. There are no guidelines from WHO yet regarding which vaccines will be used and studied in the Solidarity Trials.


2. Independent clinical trials are conducted in specific hospitals or communities in which hospitals have an extension or presence. Trial sites are fixed and researchers will require the permission of the Ethics Review Board if they wish to move to a different site. The WHO Solidarity Trial, on the other hand, is more adaptive and can move among different barangays depending on the COVID-19 caseload of an area, which serves as the eligibility criteria of the trial.

Do we have available data on AEFIs reported per ethnicity (specifically Asians or SE Asians) based on the clinical trials conducted?

These details are not currently available. However, most vaccines have been tested largely among Caucasians (around 80%), Asians make up around 4% of the trial populations but it is not specified which country/ies they are from. While there are also some published studies which have some Asian subjects in their study population, it is not really a good representation and is still a minority. This is why it is also good to support the local solidarity trials for vaccines, so that we have a study based on the Filipino population.

Communications

Why was the COVID-19 Vaccine developed at an unprecedented speed?

COLLABORATION.
Continuous dialogue between regulatory experts and developers provided early advise on safety and efficacy

PRIORITIZATION.
Government, academe and developers shifted their resources to focus on this singular goal, (e.g. adding more people)

RESOURCE MOBILIZATION.
Developers were incentivized by commitments of governments to purchase when found to be safe and effective.

What is immunogenicity?

“Immunogenicity” refers to the ability of any antigen or vaccine to trigger the body’s immune response, and is related to the body’s natural biological responses and defenses against viral infections.

How do vaccines prevent disease?

Vaccines mimic the virus or bacteria that causes disease and triggers the body’s creation of antibodies. These antibodies will provide protection once a person is infected with the actual disease-causing virus or bacteria.

How do vaccines differ?

Vaccines differ in their composition and how they trigger the immune response to create antibodies. These antibodies protect the body from microorganisms and serve as protection once a person gets infected with disease. Vaccines can be inactivated, weakened or killed copies of the whole or part of the virus or bacteria, or genetic product (like mRNA vaccines) that creates protein copies without causing disease.

How can people be assured that the vaccines' effectiveness is greater than the risks or possible long-term effects, especially when they know that clinical trials and evaluations were done as quickly as possible?

Vaccines are some of the most rigorously tested medical products today, and the COVID-19 vaccines are no different. The fact that the COVID-19 vaccines are available for use less than a year since the virus was discovered was not because corners were cut in the conduct of the clinical trials.

Instead, the technology used to make the vaccines are the result of years of basic science research and experience with other outbreaks, as well as the continuous advancement in science and technology. All the vaccines which underwent Phase 3 clinical trials have undergone rigorous evaluation and examination by independent safety monitoring boards and have been scrutinized by the strictest regulatory agencies in the world.

The vaccines with published Phase 3 trials show remarkable efficacy and impressive safety profiles. Most side effects are mild and self-limiting and very rare reports of severe adverse events. It must be noted that the results of these Phase 3 trials are “interim” because these safety and efficacy data are short term. The Phase 3 studies will continue on to completion in 1-2 years and it’s only then when we will have the full picture of its long term capability to provide protection.

Having said this, in the setting of a raging pandemic where people at highest risk for contracting the disease must be protected immediately, the interim Phase 3 results and the resulting Emergency Use Authorizations from the various regulatory agencies worldwide are reliable markers that should rebalance the risk-benefit assessment towards receiving the vaccines.

Can the results of the assessments conducted by the Vaccines Expert Panel based on the parameters for selection be discussed and made public?

There are various levels of evaluation done pertaining to COVID-19 vaccines:

Application for Clinical Trial
The DOST Vaccine Expert Panel conducts technical evaluation of the candidate vaccines that have applied for clinical trials in the Philippine FDA. Their evaluation cannot be made public as they are under a Confidentiality Disclose Agreement. Details about the clinical trials which can be disclosed are determined by the FDA.

Application for EUA and Use in the Philippine COVID-19 Vaccination Program
For COVID-19 vaccines submitted to the FDA for EUA application, the FDA assigns the evaluation of the safety and efficacy data to their Experts Panel. Provided that there is parallel submission of data to HTAC, the Council may start its assessment, particularly for COVID-19 vaccines that have been requested by the end-user for review. The HTAC evaluation framework considers important factors such as the vaccine’s safety, efficacy, responsiveness to magnitude and severity, affordability and viability, household financial impact, social impact, and responsiveness to equity.

If DOH-HTAC grants a positive recommendation, the vaccine can be considered for procurement and use in the Philippine COVID-19 Vaccination Program. After HTAC’s approval, NITAG will then assess as to which population groups the vaccine should be prioritized for.

Recommendations of the HTAC and NITAG are made available at the DOH website, while all completed HTAC assessments may be accessed via the HTAC website (hta.doh.gov.ph).

How can healthcare workers properly educate patients and disseminate accurate information on the COVID-19 vaccination program without making them doubt the efficacy of the vaccine or increasing vaccine hesitancy?

Healthcare workers must inform patients of the benefits they will receive from getting vaccinated versus developing the immunity from the natural disease. Emphasize that prevention is always better than cure.

How should those who refuse to take the vaccine offered to them be approached or communicated to?

In communicating to people about getting a vaccine against COVID-19, you may encounter some people who have concerns or hesitations about vaccination. Remember to personalize your message to the specific issue and the specific situation of the person:

1. Find out about their specific concerns. Ask questions and listen intently to their response.

2. Show empathy. Tell them that you understand that they have concerns about the vaccine or they have their reasons for choosing not to get vaccinated. But, you would like to offer them additional information so that they will have more confidence about getting vaccinated.

3. If needed, tap the support of influencers, trusted people in the community or their trusted loved ones to convince them to get vaccinated.

4. You can also share the positive experiences of getting vaccinated.

5. You can share with them resources on where to get updated on information about COVID-19 vaccines.

What is the government doing to control the spread and proliferation of false information about vaccines?

We continuously update information through our official channels. We also encourage the public to verify information they encounter and report any misinformation or rumors through the KIRA chatbot. In addition, we engage communities through our champions, starting with our healthcare workers and moving across the different priority groups. We need the joint efforts of all stakeholders in communicating the science and evidence behind the vaccine deployment.

An expected challenge in convincing the eligible population to consent to the vaccination are news about deaths and serious side effects related to the vaccine. What can be done to manage this information?

DOH, FDA, and NTF continue to reassure the public that stringent monitoring processes are in place with regard to data regarding AEFIs. The DOH and FDA continue to encourage all health workers to get vaccinated especially now that we are seeing a surge in COVID-19 cases. Millions of people around the world have received the vaccine, and evidence continues to show that the benefit of vaccination outweighs the risk of severe disease and death caused by COVID-19.

Will there be parallel information dissemination activities to be conducted in communities to minimize fear of getting the vaccine?

Yes, aside from the information dissemination activities at the national level, there is expected to be parallel social mobilization and community engagement activities at the local level to be spearheaded by the local government units.

Is there a guide or some best practices that can be shared on how to deal with people spreading misinformation and fake news about COVID-19 on our official Facebook pages?

nowing the right information is crucial in making an informed decision. It is highly encouraged to make fact-checking a habit. Verify with legitimate sources such as the DOH Facebook Page and Website. For any fake news encountered online, kindly report through the DOH’s KIRA Chatbot which can be accessed through Viber or Messenger.

Are there available paraphernalia or manuals that healthcare workers can use in counselling vaccine hesitant patients?

Various IEC materials are available to assist healthcare workers in addressing queries and concerns of vaccine-hesitant patients. Healthcare workers may access the materials uploaded on Google Drive through http://bit.ly/COVID19VaxMaterials4Partners. Please keep checking this Drive as we will continue to update and develop more materials in the future.

Are there templates or educational slides that can be used to advocate for COVID-19 vaccination?

The Department of Health has set up a Google Drive that is accessible through the following link: bit.ly/COVIDVaccinesPHChampionsKit. It provides for the policies/issuances related to COVID-19 vaccination, guidelines & tools, and IEC materials including video recordings of presentations and AVPs that can be used to advocate for COVID-19 vaccination.