COVID-19 vaccines Janssen, Clover now under FDA evaluation -DOH

At least two COVID-19 vaccines are being evaluated by the Food and Drug (FDA) administration for emergency use authorization, the Department of Health said Friday.

Health Undersecretary Rosario Vergeire announced that Janssen—the COVID-19 vaccine developed by Johnson and Johnson—has already secured approval from the Vaccine Experts panel and the Ethics Review Board alongside that of Clover, a Chinese firm.

“Janssen has recently secured positive recommendation from the Vaccine Experts Panel (VEP) after getting one from Ethics Board. Ibig sabihin nito papasok na sila sa proseso ng FDA,” Vergeire said in an online forum.

The VEP under DOST reviews the Phase 1 and 2 clinical trials of the candidate vaccine, while the Ethics Board evaluates the selection for participants for human clinical trials, among other safeguards that the vaccine manufacturer provided for the participants.

The evaluation of VEP and Ethics Board are done simultaneously.

A COVID-19 vaccine must be approved by the VEP and Ethics Board before it can be evaluated by the FDA.

Chinese firm Sinovac has secured VEP approval but is yet to get a nod from the Ethics Board.

British firm AstraZeneca, on the other hand, already secured approval from Ethics Board but is yet to get the same from VEP.

Vergeire, however, noted that vaccine approval on the part of FDA will not come in haste.

“Hindi po ito agad agad dahil kailangan po nain masigurado na safe at effective ito,” Vergeire added.

A COVID-19 vaccine must be approved by the FDA before it can be administered in the Philippines.

Only COVID-19 vaccines made by American firms Pfizer-BioNTech, Moderna and British firm AstraZeneca have been proven at least 90% effective after human trials so far.

COVID-19 vaccines of Pfizer-BioNTech and Moderna, however, need a -70 to -80 degrees Celsius ultra low freezer for storage to ensure the vaccines’ effectivity—a challenge for countries with limited resources like the Philippines.

Health Secretary Francisco Duque III said on Monday that the Philippine government does not have ultra low freezer storage at the moment.

The Philippines has recorded 445,540 COVID-19 cases so far. Of this number, 409,058 recovered while 8,701 died.

The number of active COVID-19 cases is at 27,781. -MDM, GMA News