DOH: Rare blood clot cases to be included in evaluation of J&J COVID-19 vaccine

The Philippines’ evaluation of Johnson & Johnson’s application for emergency use authorization (EUA) of its COVID-19 vaccine will also cover reports of rare blood clots among individuals abroad who got the jab, a health official said Wednesday.

Health Undersecretary Maria Rosario Vergeire said vaccine manufacturers have a responsibility to report such incidents to the Food and Drug Administration (FDA), the local regulatory authority that they are seeking approval from.

“Of course, lahat ng ating na-re-receive na ebidensya kasama po ‘yan sa pag-aaral ng ating VEP (Vaccine Expert Panel) at saka ng FDA pero more than anything, ‘yung submission ng manufacturers mismo,” Vergeire said during an online briefing.

(Of course, all the evidence we receive will be included in the studies of our VEP and FDA but more than anything, what matters are the submissions of manufacturers themselves.)

Janssen, the pharmaceutical arm of American firm Johnson & Johnson, filed an EUA application for its single-dose COVID-19 vaccine

In the United States, health agencies recommended on Tuesday an immediate pause in the use of the Johnson & Johnson vaccine after six recipients developed a rare disorder involving blood clots. 

The DOH and FDA said no blood clot cases have been recorded so far out of more than 1 million people who have received the Sinovac and AstraZeneca vaccines in the Philippines. 

As a precautionary measure, however, the FDA temporarily suspended the use of the AstraZeneca jab on people younger than 60 due to blood clot concerns. — RSJ, GMA News