DOH, FDA ASSURE VACCINE SAFETY; SECRETARY DUQUE VACCINATED AS PROOF OF SAFETY

Press Release | 23 April 2021

As the Philippines rolls out the National Vaccine Deployment Program (NVDP) to cover more individuals under the identified priority groups, local incidents of adverse events after vaccination have also been reported. However, the Department of Health (DOH) and the Philippine Food and Drug Administration (FDA) today assured the public that COVID-19 vaccines are safe and effective in preventing hospitalization and deaths from the disease, and that the benefits of vaccination far outweigh its risks.

During the regular Adverse Events Following Immunization (AEFI) presser, the DOH and FDA reported that as of April 10—with the country as of said date having vaccinated 1 million individuals—almost all cases of AEFI were vaccinees who experienced very mild side effects, and only 1.5% of the total AEFIs were serious. Additionally, the DOH and FDA reported that all reported serious AEFIs were later found to be coincidental and totally unrelated to the vaccine after careful and thorough causality assessment conducted by the National AEFI Council (NAEFIC)—an INDEPENDENT expert body organized to investigate reports of AEFI.

“From the start of our vaccination period to April 10, only 1.5% of the total AEFIs were serious cases. This means that for every 1,000,000 vaccinated, less than 0.04% may experience serious AEFI cases. But it does not necessarily mean that the vaccine causes the events. This risk is much lower than the fatality of the COVID-19 infection in our country which has a 1.69% fatality rate,” FDA Director General Rolando Enrique Domingo said.

Meanwhile, the DOH and FDA assured that common side effects of vaccines such as headache, fever, pain in the injection site, malaise, fatigue, muscle pain, and increased blood pressure are normal signs that one’s body is developing protection against COVID-19. The agencies likewise guaranteed that all reported adverse events were properly attended to, and reiterated that comprehensive screening prior to vaccination and sufficient monitoring after, are all in place to ensure total minimization of the risk of side effects, despite the risk already being extremely minimal.

“Part of the preparations that the DOH and the entire vaccine cluster put in place during our preparations was making sure that any adverse event will be monitored and managed sufficiently. All vaccination sites have holding stations where vaccinated individuals are closely monitored for any adverse reaction to the vaccine. The government also set up an indemnification fund to ensure the welfare of patients who will experience serious adverse events,” Health Secretary Francisco T. Duque III said.

To further assure vaccine safety and reiterate the importance of vaccines in the fight against the pandemic, Secretary Duque—after waiting for his turn to get vaccinated—also received his first jab of the CoronaVac vaccine as part of the Priority Group A2 (senior citizens).

In his message, Sec. Duque underscored that vaccines are safe and effective, and stressed that the DOH is relentless in communicating the value of vaccination, convincing more people to get vaccinated, reiterating that the continuous rollout of COVID-19 vaccines will save countless lives.

Sec. Duque further emphasized that with the global shortage of COVID-19 vaccine supplies, available vaccines are all the more valuable and should not be wasted. Despite challenges in securing adequate vaccine supplies, Sec. Duque assured the public that the government, through Secretary Carlito Galvez and the vaccine cluster, is doing everything to secure sufficient vaccine doses to cover 70 million Filipinos.

The Secretary also thanked the vaccinators and the members of the National Immunization Program (NIP) and the different local government units across the country who continue to afford the protection of vaccines to communities and families.

“As I receive my dose of the COVID-19 vaccine today, I invite everyone to do the same, and choose to be protected. Let us all take part in protecting public health, and let us be in unison in spreading one message: that vaccines are safe, and vaccines are effective,” Sec. Duque concluded.