FDA says might approve coronavirus vaccine's emergency use in January

Jamaine Punzalan, ABS-CBN News

Posted at Dec 03 2020 02:46 PM

A person gets a dose of the coronavirus disease (COVID-19) vaccination of BioNTech and Pfizer in this undated handout photo, as Britain became the first western country to approve a COVID-19 vaccine, in Mainz, Germany. BioNTech SE 2020, all rights reserved/Reuters

MANILA — The Food and Drug Administration (FDA) said Thursday it might clear a coronavirus vaccine candidate for emergency use in January at the earliest.

With President Rodrigo Duterte's authorization, the FDA can issue an emergency use authorization (EUA) in 21 to 28 days after the application of a vaccine maker, said the agency's Director General Eric Domingo. The regulatory body is normally required to verify a drug for 6 months before allowing its use.
Applicants should have an equivalent EUA from the country where they were developed, the World Health Organization, or a "stringent" regulatory authority, said Domingo.

"Maaari pong by first few weeks of January, mayroon na rin po tayong maibigay na emergency use authorization," he told reporters.

"Baka mapaaga nang kaunti, baka magkaroon ng chance na mga March, magkaroon na ng bakuna dito sa Pilipinas," added.

(It is possible that by the first few weeks of January, we can already issue an emergency use authorization. Perhaps in March, there may already be a vaccine here in the Philippines.)

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China is already allowing the use of its COVID-19 vaccines Sinovac and Sinopharm. The UK on Wednesday approved the emergency use of the Pfizer vaccine, while the US is expected to do the same for Moderna and Pfizer.

These 4 vaccine brands might be the first to apply for emergency use in the Philippines, said Domingo.
The Philippines, which has the second most number of confirmed coronavirus cases and deaths in Southeast Asia, based on the Johns Hopkins University COVID-19 tally, is racing to lock in vaccine supplies.

It has so far secured 2.6 million COVID-19 vaccine shots from British drugmaker AstraZeneca, which still has to be approved by regulators.

As of Dec. 2, the country has 434,357 cumulative total of confirmed coronavirus infections, of which, 26,916 are active cases, while 8,436 resulted to deaths and the remaining 399,005 are recoveries.

The country's first case was confirmed on Jan. 30 in a Chinese woman who arrived from Wuhan City, China where the disease is believed to have first emerged late last year.


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