Emergency use approval still needed for donated COVID-19 jabs — FDA
MANILA, Philippines — Local regulators said Wednesday that donated COVID-19 vaccines such as Beijing's pledge of half a million shots to Manila, would still need emergency approval before it is allowed for use at home.
The Food and Drug Administration had said that the health department could accept donated jabs by other countries after China over the weekend said it would turn in 500,000 doses to the Philippines, under an administration that has fostered close ties with it.
"Let it be stressed that the approval of the donated product does not mean free use thereof," the agency said. "FDA's authorization is limited to the donated lot and carries conditions for use depending on the nature of the donated product."
Regulators added that it is the DOH that would have to apply for EUA for the donated vaccines, where "it shall assume full responsibility for the said health product."
"Only after authorization of the FDA may the DOH distribute the products to the intended beneficiaries," it said.
Such pronouncement came a day after senators were alarmed over the move which Minority Leader Franklin Drilon said is "a very dangerous proposition" that could hurt further Filipinos' trust in vaccines.
"The public's confidence in the vaccination process will never be enhanced by such confusing statements," he said. "We must reiterate that only 47% of our people would want to be vaccinated."
Drilon was referring to findings by Pulse Asia that nearly a majority of the population were unwilling to be inoculated once the jabs are available, with most of them concerned that the vaccines may not be safe.
It remains unclear as to what brand of vaccine China would be giving to the Philippines, but the country of origin of the coronavirus has so far developed two: the state-owned Sinopharm and Sinovac, whose low efficacy results had spurred concern among Filipinos, including lawmakers.
To date, it is only Pfizer that has been cleared for EUA, with the Sinovac still awaiting approval. This would mean that even if the 500,000 shots arrive in the country, it would still have to wait for EUA before it is given.
FDA Director General Eric Domingo in yesterday's briefing had been asked if the agency is facing pressure to approve Chinese-made jabs following Beijing's pledge.
He said authorities can receive the donations, but stressed that these must be used "under the supervision" of the DOH, who in turn, had said as well that it would wait for the EUA before accepting any.
President Rodrigo Duterte had made public his trust for vaccines developed by China and Russia, two nations which he had pivoted the Philippines to in his years in office.
He went as far as to claim that all vaccines are the same, despite drugmakers reporting different efficacy rates. His administration has also come under public scrutiny for its seeming preference for Chinese-made jabs, despite its 50% efficacy rate and its overall price still uncertain, due to officials' refusal to disclose the information.
The national government has so far secured two official deals for COVID-19 vaccine supplies in the Philippines, one with Chinese pharmaceutical company Sinovac and another with the Serum Institute of India.
Watch this space for bite-sized developments on the vaccines in the Philippines. (Main image by Markus Spiske via Unsplash)
Health Officer-in-Charge Maria Rosario Vergeire says the general population may now get their second booster jab.
"We're just waiting for the release of implementing guidelines, then we'll start rolling out our second booster for the general population," she says. — Gaea Katreena Cabico
Amid questions on vaccines being administered, the Department of Health assures the public all doses are safe and effective as the “process of extending shelf life goes through thorough stability studies.”
“The government ensures that every vaccine that is injected with an extended shelf life has gone through studies, and is still safe and effective against COVID-19,” it adds.
Government must increase vaccination capacity across the Philippines in anticipation of a surge of COVID-19 cases caused by the Omicron variant of the corona virus, Sen. Risa Hontiveros says.
She says local government units and the private sector can work together to put up more vaccination centers and deploy more vaccination teams to get more people inoculated against COVID-19.
"The active COVID cases have nearly doubled in three days. The positivity rate is almost four times the ceiling set by the World Health Organization. Huwag na nating hintayin na sobrang lumala pa ang sitwasyon bago tayo gumawa ng paraan para mapabilis ang ating pagbabakuna."
FDA chief Eric Domingo says that its agency has given emergency approval for the use of the Pfizer-BioNTech COVID-19 vaccine for children ages 5 to 11.
The United States immunized around 900,000 children aged five-to-11 against Covid in the first week the Pfizer vaccine was authorized for them, a White House official says Wednesday.
Roughly 700,000 more have made appointments at pharmacies, White House Covid coordinator Jeff Zients tells reporters.
"The program is just getting up to full strength," he says, adding most of the shots were given in the last couple of days alone. — AFP
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