FDA grants EUA to Janssen, Covaxin COVID-19 vaccines

Up to 6 brands of COVID-19 vaccines can be used in the Philippines after the approved the emergency use authorization (EUA) of 2 more vaccines.

The Food and Drug Administration (FDA) said on Tuesday that it has already given the EUA the Janssen vaccine of American company Johnson & Johnson and of Bharat Biotech from India.

Prior to that, the EUA had previously granted to Pfizer, AstraZeneca, Sputnik V, and Sinovac.

But FDA Director-General Eric Domingo clarified that for now, the authorization given to is conditional.

“May isang papel pa po sila na kailangan i-submit sa amin bago mag-import ng bakuna,” said Domingo.

In order for Janssen to be rolled out, the Department of Health (DOH) must issue guidelines.

This is due to the ongoing investigation by the FDA in America regarding reports of alleged clotting or blood clots.

“They are investigating kasi parang 1 for every million na nabakunahan, mayroon silang ini-investigate na possible clotting na adverse event. So we told the DOH na bago i-roll out ito, kailangan gumawa ng very clear guidelines,” said Domingo.

FDA grants EUA to Janssen, COVID-19 vaccines

According to the DOH, although there have been recorded adverse events after vaccination, most of them are non-serious.

Adverse events observed in Sinovac recipients include increased pressure, headache, the pain at the injection site, dizziness, and rashes.

At AstraZeneca, fever, headache, pain at the injection site, chills, and weakness were observed.

Experts have previously said that it is common to have such a feeling after vaccination, and it is often mild and disappears as well.

Despite this, all reported adverse events are still closely monitored.

At present, there are no pending applications for the EUA for other vaccines.

Sinopharm has not yet submitted an application from China while it is possible that will apply in the third quarter of the year.

Although the Philippines is still waiting for Moderna’s vaccine application, Philippine Ambassador to the United States Jose Manuel Romualdez said the arrival of the Moderna vaccines can be expected in June.

“Ikinonfirm sa akin ng Moderna na they will start delivery starting June 15. That is the target date. It would start increasing in the succeeding months… they will complete the 20 million before the end of the year,” said Romualdez.