FDA eyes full authorization of COVID vaccines 'early next year': chief

ABS-CBN News

Posted at Nov 18 2021 09:08 AM | Updated as of Nov 18 2021 09:09 AM

A health worker shows the vial of the Comirnaty COVID19 vaccine of Pfizer BioNTech during its first rollout inside the Makati Medical Center on May 12, 2021. The city government of Makati received 5,000 doses of Comirnaty COVID19 vaccine from the COVAX global facility led by the World Health Organization and targets to initially inoculate 500 citizens belonging to A1(health workers), A2 (senior citizens), and A3 (persons with comorbidities) categories. George Calvelo, ABS-CBN News
A health worker shows the vial of the Comirnaty COVID19 vaccine of Pfizer BioNTech during its first rollout inside the Makati Medical Center on May 12, 2021. The city government of Makati received 5,000 doses of Comirnaty COVID19 vaccine from the COVAX global facility led by the World Health Organization and targets to initially inoculate 500 citizens belonging to A1(health workers), A2 (senior citizens), and A3 (persons with comorbidities) categories. George Calvelo, ABS-CBN News

MANILA - Several COVID-19 vaccines could soon be sold in drugstores as early as the first quarter of 2022 once given full approval by Food and Drug Administration, its chief said Thursday.

"My prediction is early next year, by the first quarter, not only Pfizer maybe several of the existing vaccines will get full approval for marketing authorization," FDA Director General Eric Domingo said on ANC.

According to Johns Hopkins Medcine, full approval is granted when the FDA has amassed enough scientific evidence to support use of the COVID-19 vaccines, showing that the benefits of the vaccine are greater than its risks, and that the vaccines can be manufactured reliably, safely and with consistent quality.

The FDA has so far granted emergency use authorization to nine vaccine brands, which include Pfizer-BioNTech (Comirnaty), AstraZeneca, Sinovac (CoronaVac), Gamaleya Institute (Sputnik V), Johnson & Johnson (Janssen), Bharat Biotech (Covaxin), Moderna, Sinopharm, and Novovax (Covovax). 

Under an EUA, only government can procure the vaccines while private firms may buy it through a tripartite agreement.

The United States granted Pfizer full authorization in August. Pfizer has yet to apply for full approval in the Philippines, said Domingo. 

"We did ask them and they said they were completing their documents and requirements...It's not going to take long but they haven’t applied yet. It’s probably because the company is not yet ready to supply, baka nagkoconcentrate sila sa one market at this time (maybe they're concentrating on one market at this time)."

The FDA has also granted an EUA to investigational drug ronapreve for COVID-19 treatment, Domingo said. Another drug, molnupiravir, can be accessed through hospitals with compassionate use permit, he added.