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Manila Bulletin devider Philippines devider National devider FDA explains EUA grant to Janssen's COVID-19 vaccine despite blood clot concerns

FDA explains EUA grant to Janssen's COVID-19 vaccine despite blood clot concerns

Published Apr 20, 2021 12:51 pm

The Food and Drug Administration (FDA) on Tuesday, April 20, defended its decision to allow the emergency use of a coronavirus disease (COVID-19) vaccine developed by Johnson & Johnson amid concerns of potential blood clotting.

FDA Director General Eric Domingo
(RTVM / FILE PHOTO)

The FDA has granted the emergency use authorization (EUA) to the single-dose COVID-19 vaccine of Johnson & Johnson’s Janssen, as well as the Covaxin developed by India's Bharat Biotech, on Monday, April 19.

“Ang ating (Our) requirement for approval, we should be able to see that the benefit outweighs the risk,” FDA Director General Eric Domingo said in a public press briefing on Tuesday.

Domingo said the Johnson & Johnson’s vaccine has been approved in 40 countries and has an emergency use listing with the World Health Organization (WHO).

The granting of the EUA came amid reports overseas of blood clotting possibly linked to the COVID-19 jab, with some countries even suspending the rollout of the vaccine due to potential blood clot risks.

The FDA chief said there were seven cases of possible blood clotting events currently being studied in the United States, out of the 7 million people inoculated with the vaccine in the US.

“Even if it is found later to be connected to the vaccine, ‘yung one per 1 million na adverse event ay mas matimbang pa rin yung 1 million na maaari nating protektahan kung nabakunahan sila (the one per 1 million adverse event outweighs the 1 million that we can protect if they are vaccinated),” Domingo said.

“So we have to really weigh the benefit compared to the risk,” he added.

Domingo said a safeguard should be in place once the country starts using the single-dose vaccine in its vaccination program.

“Kailangan po clear sa atin kung ano yung mga sintomas at signs na kailangan banatanay para kung magkaroon man ng pagbaba ng platelet ay madetect po agad at tsaka ma gamot (It is necessary to make clear what are the symptoms and signs that need to be monitored so that if there is a decrease in platelet count, it will be detected and treated immediately),” he said.

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