FDA clarifies donated vaccines require authorization, evaluation
Marje Pelayo • January 21, 2021 • 220
MANILA, Philippines — The Food and Drug Administration (FDA) issued a statement on Wednesday (January 21) clarifying that donated COVID-19 vaccines still require FDA authorization in the form of Emergency Use Authorization (EUA) prior to use.
The statement came after some senators in a recent Senate hearing, raised concerns on the issue of donated vaccines from China.
The FDA said, “Entities which intend to donate vaccines to the government are required to coordinate with the Department of Health (DOH) which will facilitate the acceptance and processing of the donation.”
The agency further noted that the proposed donations will be evaluated by the DOH in consideration to the need of beneficiaries, reliability of the source shelf life and other relevant criteria.
“Only after authorization of the FDA may the DOH distribute the products to the intended beneficiaries,” FDA said.
FDA stressed that “the approval of the donated product does not mean free use thereof. FDA’s authorization is limited to the donated lot and carries conditions for use depending on the nature of the donated product.”
The DOH is also mandated to take full responsibility for the use of the donated vaccines, given that the product has been granted EUA by the FDA which ensures its safety, quality and efficacy. MNP/Raymund David
MANILA, Philippines – President Rodrigo Duterte will wait for China-state-owned Sinopharm’s COVID-19 vaccine to secure an emergency use authorization (EUA) from the country’s Food and Drug Administration (FDA) before receiving a dose, his spokesperson said Tuesday.
Presidential Spokesperson Harry Roque made the announcement after the FDA confirmed that it has received Sinopharm’s application for an EUA that was filed on Monday afternoon.
“Mag-aantay po si president ng EUA dahil nabalita ko nga kahapon, mayroon na pong nag-apply ng EUA for the Sinopharm,” Roque said in a press briefing.
Securing an EUA from the FDA is part of the process for a vaccine to be legally used in the country.
The FDA earlier approved a compassionate use license for 10,000 doses of Sinopharm vaccines for the members of the Presidential Security Group.
The agency, however, clarified that the issuance of such a permit is not tantamount to a stamp of approval.
Duterte earlier expressed a preference for Sinopharm developed COVID-19 vaccines. – RRD (with details from Correspondent Rosalie Coz)
MANILA, Philippines – Senator Sherwin Gatchalian on Tuesday said he has volunteered to receive the COVID-19 vaccine shot developed by Chinese firm Sinovac Biotech in a bid to address vaccine hesitancy.
In a statement, Gatchalian said he is willing to be inoculated with Sinovac’s CoronaVac if allowed under the government’s prioritization framework for the nationwide immunization campaign.
“Alam ko may prioritization tayo ngayon. Kung hindi naman lalabag dito, I would volunteer to be vaccinated by Sinovac. This is to show to the public our support to the vaccination program,” Gatchalian said.
The senator said he sent word to vaccine czar Sec. Carlito Galvez Jr. over the weekend of his willingness to participate in the national vaccination program.
This is also to disprove the notion that some politicians want to be vaccinated with the brand of their choice and with an efficacy rate higher than CoronaVac, he added.
“What’s more important to me is the seal of approval of the Food and Drug Administration (FDA). If it’s approved by the FDA, which went through tedious analysis prior to the grant of authorization for emergency use, I’m okay with it,” he said.
“I’m okay with any brand of anti-COVID-19 vaccine. I’m not brand conscious. I put my trust in the FDA,” he added.
The FDA earlier said that Sinovac’s CoronaVac is not recommended for healthcare workers frequently exposed to COVID-19 patients due to its low efficacy rate of 50.4%, based on trials conducted in Brazil.
The FDA, however, clarified that health workers can still choose to receive the vaccine as it only made a recommendation on which groups it is not suited for.
The Philippine government on Monday rolled out its immunization program after COVID-19 vaccines donated by China arrived in the Philippines on Sunday.
The Department of Health said that more than 700 frontline workers, and government officials received the vaccine on the first day of immunization.
Prior to Monday’s immunization drive, a survey conducted from January 26 to February 1, 2021 by the OCTA Research Group showed that only 19% of Filipinos are willing to have themselves vaccinated while 46% would not want to be inoculated and 35% are still undecided.
Gatchalian, however, expressed optimism that the figures will change in the coming days.
“Maraming hesitant dahil bago itong vaccine. Kaya importante dito ang confidence building na dapat pangunahan ng mga opisyal ng gobyerno, well-known personalities, at kahit mga elected officials kagaya ng ginawa ni Indonesian President Joko Widodo at Hong Kong Chief Executive Carrie Lam,” he said.
MANILA, Philippines – Health Secretary Francisco Duque III will not be receiving the CoronaVac vaccine developed by Chinese firm Sinovac Biotech, the Department of Health (DOH) said.
“FTD (Francisco T Duque III) will not be vaccinated with SINOVAC as EUA provisions exclude 60 and above,” the DOH said in a message to reporters.
“He also underscores that we will follow the prioritization framework, and will ensure that limited doses will go to the HCWs first,” it added.
Duque, 64, earlier said he is willing to receive Sinovac COVID-19 vaccine but the age bracket recommended by the Food and Drug Administration (FDA) might become an issue.
The FDA said the Sinovac jabs are only recommended to be administered to people aged 18 to 59 years old as it showed a higher efficacy rate in the said group based on clinical trials conducted in Indonesia and Turkey.
Duque led the rollout of the government’s COVID-19 vaccination drive for healthcare workers and other frontliners on Monday after the donated 600,000 Sinovac vaccines from China arrived in the country on Sunday. – RRD (with details from Correspondent Aiko Miguel)
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