FDA OKs use of AstraZeneca COVID-19 vaccine after check on clotting concerns

Jamaine Punzalan, ABS-CBN News

Posted at Apr 15 2021 04:59 PM | Updated as of Apr 15 2021 10:55 PM

FDA OKs use of AstraZeneca COVID-19 vaccine after check on clotting concerns 1
Health workers inoculate their fellow health workers with the AstraZeneca COVID-19 vaccine at the Ospital ng Maynila on March 9, 2021. Jonathan Cellona, ABS-CBN News

MANILA (UPDATED) — The Philippines' drug regulator on Thursday recommended the resumption of use of Britain's AstraZeneca COVID-19 vaccine for the country's inoculation program after looking into reports that it had caused very rare blood clots abroad. 

The Food and Drug Administration last week recommended that the use of AstraZeneca be limited to people over 60 years old, which the Department of Health heeded. 

However, the FDA has received "unanimous" recommendations from the World Health Organization and local experts that AstraZeneca's "benefit outweighs the known and the potential risks," said the agency's director general Eric Domingo. 
The FDA did not find reports of blood clots in the Philippines, he added.

"Mas malaki pa rin ang benepisyo kung gagamitin ang bakuna, Domingo said in a press briefing. 

(The benefit is bigger if we use the vaccine.)

He said he wrote to Health Secretary Francisco Duque III to recommend "that we should continue using the vaccine." 

Video courtesy of PTV

The Philippines has received 525,600 AstraZeneca doses, almost all of which have been administered, said Domingo. The country's next delivery of the UK-developed vaccine might arrive in May, he said last week. 

It is one of only two vaccine brands currently available in the Philippines, the other being China's Sinovac. 


In an interview with ABS-CBN's Teleradyo, Dr. Nina Gloriani, head of the government's vaccine expert panel, said that while there is a possible causality for the reported blood clotting, its risk could be considered "minimal." 

Gloriani added that the said serious adverse event was found to have possible links with AstraZeneca's jabs, based on their review of the vaccine with the European Medicines Agency and the WHO. 

"Tiningnan 'yung mga kaso. May causality ba, mayroong bang asosasyon sa vaccine? Mayroon naman kasi silang nakita na possible link," she explained. 

(If you will look at the cases, whether there is a causality, and whether the blood clots are associated with the vaccine... They saw a possible link.) 

"Pero kung isusumatutal mo yung risk ng clot na yun at ito ay maaaring kasama dun sa mga may risk factors although di clearly defined, ang risk ay 4 per million doses. Apat na ganoong kaso ng clots sa 1 million... mababa," she added. 

(But if you will look at the risk of the clot, which can be gotten by those with the risk factors although not clearly defined, the risk of clotting is 4 per a million doses. It has low chance.) 

Among the worst hit by the pandemic in Asia, the Philippines aims to vaccinate up to 70 million people or two-thirds of its population this year. 


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More than a dozen countries have at one time suspended use of the AstraZeneca vaccine, which has been given to tens of millions in Europe. But most have resumed, with some, including France, the Netherlands and Germany, recommending a minimum age.

European Union health ministers failed to agree on common guidance on the use of the shot, despite calls for coordination across member states to combat public hesitancy over a vaccine set to be a key component of many vaccination programs. 

The European Medicines Agency (EMA) received reports of 169 cases of the rare brain blood clot by early April, after 34 million doses had been administered in the European Economic Area. The EEA comprises the 27 EU countries plus Iceland, Norway and Liechtenstein.

But experts say that, even if a causal link is proven, the risks of getting a serious clot are vanishingly small compared to the risks from possible COVID-19 infection, which can cause similar clots along with other serious symptoms.

The shot has faced questions since late last year, when the drugmaker and Oxford University published trial data with two different efficacy readings as a result of a dosing error.

Among possible causes for the rare cerebral sinous vein clots being investigated are that the vaccine triggers an unusual antibody in rare cases or a possible link with birth control pills. But there is no definitive evidence.

Many experts say it is not clear whether or why AstraZeneca's vaccine would cause a problem not shared by other vaccines that target a similar part of the virus.

— With a report from Reuters