WHO emergency listing of Pfizer vaccine can speed up review process — health chief
MANILA, Philippines — The move of the World Health Organization to grant emergency validation to Pfizer’s coronavirus vaccine could help expedite the evaluation being done by local regulators, Health Secretary Francisco Duque III said.
The Pfizer/BioNTech vaccine was the first to receive WHO’s “emergency validation” since the novel coronavirus emerged in China a year ago. The United Nations health agency said its emergency use listing paves the way for regulators to quickly approve the import and distribution of the vaccine.
“The one from the WHO is a welcome addition to the regulatory approvals and therefore that should be a lot easier for the local [Food and Drug Administration], our own FDA, to already review all the documents and assess the risk benefit ratio of the said candidate vaccine,” DOH Secretary Francisco Duque III said in a briefing Friday.
FDA Director General Eric Domingo called the WHO emergency use listing “very significant.”
“Our experts are currently evaluating the documents submitted by Pfizer as outlined in our guidelines. I will issue a decision on the application as soon as all the regulatory requirements and procedures are completed,” he said.
Pfizer submitted an application for the emergency use authorization of its COVID-19 vaccine on December 23. An EUA shortens the process of regulatory approval from the usual six months to as fast as 21 days.
Preliminary data showed that the vaccine candidate of New York-based Pfizer and German company BioNTech was more than 90% effective. The United Kingdom was the first to launch a vaccination drive with the Pfizer/BioNTech vaccine last December, with the United States, Canada and EU nations following suit.
The WHO review found that the “benefits of using the vaccine to address COVID-19 offset potential risks.”
The Philippines, however, has yet to secure a deal with Pfizer for vaccine doses. Duque was previously criticized for allegedly botching the vaccine supply deal with the American firm.
Pfizer vaccines are required to be kept in ultra-low temperature freezers around minus 70 degrees Celsius, an infrastructure which the country’s does not have yet. — Gaea Katreena Cabico with report from Agence France-Presse
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