DOH: Next step for AstraZeneca is application for emergency use
MANILA, Philippines — After its withdrawal of application for the conduct of COVID-19 shots clinical trials in the country, the next step for British vaccine developer AstraZeneca for its vaccines to be able to be used in the Philippines is an application for emergency use authorization, according to the Department of Health (DOH).
Health Undersecretary Maria Rosario Vergeire said Monday that the government is currently negotiating with the firm regarding its vaccines.
“We are already having negotiations with AstraZeneca. So their next step would be the application for an emergency use authorization here in the country if ever and also with the other countries. So ito pong FDA (Food and Drug Administration) process na natin ang kanilang pag-a-applyan (This is the FDA process they have to undergo),” she said in a virtual media forum.
FDA director-general Eric Domingo earlier said AstraZeneca told the agency that they already have enough data for the trials.
Vergeire explained there are two “pathways” for COVID-19 vaccine applications—one for the conduct of clinical trials and one for being available in the Philippine market.
“So itong gagawin ng AstraZeneca, papasok na sa merkado ng Pilipinas so they have to go through the regulatory process like FDA process, the health technology assessment council if the government will procure from them para sila ay magkaroon ng approval and we can use their product,” she explained.
(What AstraZeneca will do now is to enter the Philippine market, so they have to go through the regulatory process like the FDA process, health technology assessment council if the government will procure from them, so that they can secure approval and we can use their product.)
President Rodrigo Duterte earlier allowed the FDA to grant EUA for COVID-19 vaccines, which will shorten the process of approving the vaccines from the usual six months to 21 days.
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