FDA sees full authorization of COVID-19 vaccines in early 2022

The Food and Drug Administration (FDA) on Thursday said COVID-19 vaccines may have full authorization by early next year, a development that could pave the way for the doses to be sold commercially.

"My prediction is siguro (maybe) 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 Dr. Eric Domingo said on ANC.

Pfizer is already seeking the US authorization of its experimental antiviral COVID-19 pill that cuts the chance of hospitalization or death for adults at risk of severe disease by 89% in a clinical trial.

So far, the FDA has only approved the emergency use authorization (EUA) to vaccine brands Pfizer-BioNTech, AstraZeneca, Sinovac, Gamaleya Institute, Johnson & Johnson, Bharat Biotech, Moderna, Sinopharm, and Novovax.

"They haven’t applied anywhere else other than the US at this time," Domingo said of Pfizer.

"We did ask them and they said they were completing all of their documents and requirements. If they do apply here, it’s not going to take long. However, they haven’t applied yet. It’s probably because the company is not yet ready to supply at baka nagko-concentrate sila sa one market at this time," he added.

Anti-viral drugs

Domingo also said that Merck & Co Inc (MSD) has applied for emergency use authorization (EUA) in the Philippines for its antiviral medicine molnupiravir.

“Right now, it is available here. People can access it to the hospitals that have compassionate special permit for it. Although last week," Domingo said.

The FDA has granted the EUA for antibody treatment for another antiviral drug ronapreve in October. According to the FDA, this drug can be used for the treatment of mild to moderate COVID-19 cases for recipients aged 12 years and older weighing at least 40 kilograms. —KBK, GMA News