FDA chief says initial data show no incidence of blood clots in those given AstraZeneca shots

FDA chief Domingo says he’s still waiting for full data on around 500k who have been given AstraZeneca shots

 

(Eagle News) — The head of the Food and Drug Administration (FDA) said that there were no observed incidence of blood clots among the half a million who had been administered with the AstraZeneca vaccines in the country.

FDA Director General Eric Domingo said that so far there had been no reported incidents of blood clotting among those given the AstraZeneca shots.

In an Eagle News Service interview over NET25 Program “Balitalakayan” on Tuesday, April 13, Domingo said that so far, around 500,000 had been immunized with the Oxford-AstraZeneca vaccine, but that the adverse Events Following Immunization (AEFI) committee of the Department of Health has not yet given any report of such incidents.

But Domingo stressed that they are still waiting for the full and more complete report.

Sa ngayon, hinihintay natin lahat ng data. Yung Adverse Event Following Immunization (AEFI) Committee, ang national committee na yan, nagbigay naman na sila ng kaunting datos, pero ang sabi nila wala pa naman silang nakita,” he said in the Balitalakayan interview.

After mga kalahating milyon na rin ang nabakunahan natin ng AstraZeneca, at sabi nga nila, wala naman silang nakita na blood clotting events.”

-FDA to release new guidance based on vaccine expert panel recommendation-

Domingo said that FDA is also waiting for the recommendation from the Philippine Vaccine Expert Panel regarding AstraZeneca, although the World Health Organization (WHO) had already given its recommendation.

The World Health Organization (WHO), on April 7,  issued its interim statement regarding AstraZeneca.  It said further “specialized studies are needed to fully understand the potential relationship between vaccination and possible risk factors.”

But WHO said that “based on current information, a causal relationship between the vaccine and the occurrence of blood clots with low platelets is considered plausible but is not confirmed.”

(FILES) In this file photo taken on November 17, 2020 An illustration picture shows vials with Covid-19 Vaccine stickers attached and syringes, with the logo of the University of Oxford and its partner British pharmaceutical company AstraZeneca, on November 17, 2020. – The UK medicines regulator said on April 2, 2021 it has so far identified 30 cases of blood clots in people who received AstraZeneca’s Covid vaccine in the UK, but stressed that the benefits of the vaccination outweigh this “very small” risk. (Photo by JUSTIN TALLIS / AFP)

On April 8, the FDA asked the DOH to suspend the use of AstraZeneca for those below 60 following recent reports in various countries about “rare cases of blood clots with low platelets detected in some individuals inoculated with the vaccine.”

So far, the 525,600 doses of AstraZeneca delivered in the country have been distributed as first doses, and none will be reserved for second dose since the period between doses for vaccinees is recommended at 12 weeks or longer based on studies for AstraZeneca’s better efficacy.

President Rodrigo Duterte views one of the crates containing the doses of AstraZeneca vaccines which arrived in the country on Thursday night, March 4, 2021 (Screenshot of PCOO video/Courtesy PCOO)

Unlike AstraZeneca, the second dose of Sinovac, on the other hand, should be given 28 days after the first dose.

Domingo said that the next batch of AstraZeneca delivery could happen by end of April or May, which gives vaccine experts here more time to analyze the vaccine.

So by this week, we hope na makakapaglabas na tayo ng bagong guidance kung paano ito gagamitin, and yung what to watch out for,” he told Eagle News Service’s Balitakayan.

-Benefits still outweigh risks-

But Domingo is very positive that the AstraZeneca doses are still safe to use for the population.

This is because although there had been observed instances in other countries on reported rare blood clot after the vaccine administration, its “benefits still outweigh the risks.”

“But definitely, of course magagamit po natin ito kasi nakita naman talaga sa buong mundo na natin na bagama’t mayroon mga rare na ganitong instances, yung benefit pa rin generally greatly outweigh the risk,” the FDA chief said.

So far, the AstraZeneca vaccines in the country are being used for the elderly, as had been recommended by WHO.

Earlier this week, the European Medicine Agency (EMA) said blood clots should be listed as a “very rare” side effect of the AstraZeneca vaccine, but added that benefits continued to outweigh risks

The announcement came after EMA examined 86 blood clotting cases, 18 of which were fatal, out of around 25 million people in Europe who received the AstraZeneca vaccine. Most of the cases were in women aged under 60.

In response to the findings, Italy — which initially recommended the AstraZeneca vaccine for those in the 18-55 age group — restricted its use to those aged 60 and above.

Similar action was taken in other European countries.

-Rare side-effects hard to predict-

Domingo called such rare occurrences as “idiosyncratic reactions” or side-effects which are very hard to predict.

May mga very rare side-effects na hindi mo ma-predict kung sino ang magkakaroon ng ganoon na reaction, doon sa gamot. And this is probably one kind of reaction na very very rare, pero very difficult to predict,” he said.

Domingo said that the public should still continue to have confidence in these vaccines against COVID-19, as millions had already been vaccinated with these shots around the world, and such side effects were very very few, and its benefits still outweigh the risk.

“Definitely, it’s still to the best interest of the country na mabakunahan na po lahat sa lalong madaling panahon,” he said.

(Eagle News Service)