Abundance of caution: Vaccine safety key to public acceptance

THE Department of Health (DoH) announced last April 8 that it has “adopted the rec­ommendation of the Food and Drug Administration (FDA) to temporarily suspend the use of AstraZeneca vaccines for indi­viduals aged below 60-years-old, following recent reports of rare cases of blood clots with low platelets detected in some individuals inoculated with the vaccine.”

This action followed the April 7 issuance by the COVID-19 sub­committee of the World Health Organization (WHO) Global Ad­visory Committee on Vaccine Safety (GACVS).

It is important to know, under­stand, and appreciate the salient points of the WHO and DOH issu­ances, especially at this time that the rollout of COVID-19 vaccines has begun and there are millions of Filipinos waiting for their turn to be immunized while the strictest quarantine measures are being enforced.

First, this is a temporary pause, out of an abundance of caution, while the GACVS and other simi­lar scientific bodies continue their studies on results of the use of AstraZeneca vaccines.

Second, the noted incidents of blood clots tallied by the WHO are “very rare, with low numbers reported among the almost 200 million individuals who have re­ceived the AstraZeneca COVID-19 vaccine around the world.” For its part, the European Medicines Agency, the European Union’s counterpart to the United States’ Food and Drug Administration, cited 169 cases of blood clots out of 34 million Astra Zeneca vac­cine doses administered.

Third, other countries – such as Austria, France, Germany, Canada, and Thailand – have also temporarily suspended the use of AstraZeneca vaccines while more conclusive assessment of the implications of the blood clots and other possible side ef­fects is being awaited.

Fourth, the DOH and the FDA state that “to date, the National Adverse Events Following Immu­nization Committee (NAEFIC) has not received any local reports of such side effects” of the use of AstraZeneca (AZ) vaccines on Filipinos. A total of 525,600 AZ vaccines have been received by the country through the COVAX global facility together with two million doses of Sinovac vac­cines from China.

Above the welter of conflict­ing, misleading, and unveri­fied reports swirling in social media – most of which are fake news – it is important to heed the WHO’s latest advisory: “The administration of vaccines is based on a risk versus benefit analysis. In extensive vaccina­tion campaigns, it is normal for countries to identify potential adverse events following im­munization. This does not nec­essarily mean that the events are linked to vaccination itself, but they must be investigated to ensure that any safety concerns are addressed quickly. Vaccines, like all medicines, can have side effects.”

Dr. Rolando Enrique Domingo, FDA Director General, empha­sized: “This temporary suspen­sion does not mean that the vaccine is unsafe or ineffective – it just means that we are tak­ing precautionary measures to ensure the safety of every Fili­pino. We continue to underscore that the benefits of vaccination continue to outweigh the risks and we urge everyone to get vac­cinated when it’s their turn.”