FDA asks DOH to suspend AstraZeneca use for those below 60 after report on “rare” blood clot links abroad

Screenshot of PCOO Laging Handa press briefing on Thursday, April 8, 2021


(Eagle News) – The Food and Drug Administration (FDA) has asked the Department of Health (DOH) to suspend the use of the remaining AstraZeneca doses in the country for those aged 60 and below following reports of “very rare” blood clot instances following the vaccine administration abroad.

FDA Director General Eric Domingo said that he had already gotten in touch witth the DOH regarding this.

He said that out of 200 million recipients of the AstraZeneca vaccine, only 16 had “very rare” instances of blood clots and change in number of platelets that were being probed as connected to the vaccine, citing a report from the European Medicines Agency.

“We asked DOH kung mayroon pa pong natitirang AstraZeneca vaccine, siguro ay huwag muna nating gamitin sa people below 60 years old until we get clearer evidence and clearer guidance from the WHO at sa ating pong mga experts,” FDA chief Domingo said on Thursday, April 8, in a Laging Handa press briefing.

Wala na po tayong AstraZeneca vaccines at this time. Dahil talagang naubos natin ito, may mangilan-ngilan na lang daw,” he said.

-Further study on AstraZeneca evidence needed –

Domingo said that the next delivery of AstraZeneca vaccines could come next month.

“That would give us time to further study the evidence or kung magkakaroon tayo ng panibagong guidance sa paggamit ng AstraZeneca vaccines,” he said.

Domingo also assured those who already received the AstraZeneca jabs that they should not worry since the benefits of getting the vaccines outweigh the risks.

“I want to emphasize that this temporary suspension does not mean that the vaccine is safe or ineffective. It just means that we are taking precautionary measures to ensure the safety of every Filipino,” he said in a statement.

“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,” he said.

Before this, the FDA had set in its guidelines that the AstraZeneca jabs can be given to the elderly citing the World Health Organization recommendation.  But late afternoon on Wednesday, April 7, FDA also gave the green light to Sinovac vaccine, Coronovac, for use in the elderly following the recommendation of the Philippine vaccine expert panel which cited its good performance and safety.

Vials with the AstraZeneca COVID-19 vaccine against the novel coronavirus are pictured at the vaccination center in Nuremberg, southern Germany, on March 18, 2021. – Germany on March 15 halted the use of AstraZeneca’s coronavirus vaccine after reported blood clotting incidents in Europe, saying that a closer look was necessary. (Photo by Christof STACHE / AFP)

The European Medicines Agency (EMA) said Wednesday that blood clots should be listed as a “very rare” side effect, encouraging countries to continue its use.

The announcement came after the 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.

But EMA chief Emer Cooke said no particular risk factor had been identified and the clots may be linked to an immune response to the vaccine.

Domingo said the FDA is aware of this recommendation by the EMA “to list blood clots as very rare side effects of the AstraZeneca vaccine.”

“While we have not seen such incidents in the country, the FDA has recommended to temporarily suspend the use of the vaccine for persons below 60 years old as we await results of the review being done by our local experts, as well as the official guidance of the WHO,” he said.

(wih a report from Agence France Presse)