MANILA, Philippines — The country’s Food and Drug Administration might give emergency authorization to leading coronavirus vaccine candidates in January at the earliest, its chief said Thursday.
This, if drugmakers developing COVID-19 vaccines apply for an emergency use authorization (EUA) with the local FDA anytime soon.
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“Pag nag-apply sila sa atin maaaring first few weeks of January, meron na tayong maibigay na EUA at mapaaga nang kaunti, magkaroon ng chance na mga March, magkaroon na ng bakuna dito sa Pilipinas,” FDA Director General Eric Domingo said in a Palace briefing.
(If they submit their application, it’s possible that we can already issue EUA by the first few weeks of January. Perhaps, there may already be a vaccine here in the Philippines by March.)
President Rodrigo Duterte signed Tuesday an executive order giving the FDA the power to issue EUA for COVID-19 vaccines and treatments, shortening the process of regulatory approval from the usual six months to as fast as 21 days.
EUA applicants in the Philippines should have an equivalent emergency authorization from countries where they were developed, counterpart regulatory body or the World Health Organization.
If applicants present all the necessary documents, the review on the vaccine's safety and efficacy will be completed within 21 to 28 days.
Process
In a separate briefing hosted by the Department of Health, Domingo said EUA applications will be submitted to the local FDA.
The agency’s Center for Drugs Regulation and Research will assess the quality of the vaccine candidate, while an expert panel will conduct a review on safety and efficacy data of COVID-19 vaccines or drugs.
Domingo also said the FDA, along with DOH’s Epidemiology Bureau, will set up a “very strong” post authorization monitoring to track the effects of the vaccine or drug on the public once it is administered.
“We’d like to assure the public that we’ll take it very seriously, that we’ll make sure the benefits will outweigh the risks more than anything before we even consider giving EUA to any vaccine and of course, it will come with a lot of condiitons to make sure that we safeguard the safety of the public,” Domingo said.
China is allowing the emergency use of vaccine candidates from Sinovac and Sinopharm. The United Kingdom gave emergency authorization to Pfizer’s coronavirus vaccine, leaping ahead of the United States. Moderna, another vaccine frontrunner, also applied for EUA from the US FDA.
Domingo said these four vaccine developers along with AstraZeneca might be the first to request emergency use in the Philippines.
If granted, an emergency authorization will only be valid within the duration of public health emergency due to COVID-19. The FDA may also revisit or revoke the EUA “to protect the general public health and safety.”
With over 430,000 COVID-19 cases and 8,000 deaths, the Philippines is scrambling to obtain vaccine supplies to help end one of Southeast Asia’s worst outbreaks.
The country, through the efforts of around 30 private companies, has so far secured 2.6 million doses of COVID-19 vaccine developed by Astrazeneca. The British-Swedish developer said the average efficacy of its vaccine candidate was 70%. — with report from Xave Gregorio