EUA on Pfizer vaccine won’t be revoked yet despite Norway deaths, DOH says

Robie de Guzman   •   January 18, 2021   •   333

MANILA, Philippines — The emergency use authorization (EUA) issued last week by the Food and Drug Administration (FDA) to drug-maker Pfizer-BioNTech for its COVID-19 vaccine will not be revoked yet pending an investigation into claims that it caused the death of some elderly people in Norway, the Department of Health (DOH) said Monday.

Health Undersecretary Maria Rosario Vergeire said Norwegian authorities are still looking into reports that 23 individuals aged 75 to 80 with underlying health conditions died after getting inoculated with COVID-19 vaccine developed by Pfizer-BioNTech.

Vergeire also said that studies need to be done on the matter.

“Pfizer has to submit a report to the Philippine Food And Drug Administration regarding this matter. Once we evaluate the report, base sa kanilang conclusion, that’s the time FDA can decide on the EUA of Pfizer. For now,” Vergeire said.

“Hanggang wala pang sufficient evidence that it was caused by vaccines, status quo tayo on this EUA given to Pfizer,” she added.

The FDA granted EUA to Pfizer last January 14, the first out of four applications it received so far. Other applications are AstraZeneca, China’s Sinovac, and Russia’s Gamaleya Institute.

FDA Director-General Eric Domingo said they are still awaiting a report from Norwegian authorities and that they will “revise the conditions of the EUA as needed,” before starting vaccinations as part of the agency’s protocols on the use of vaccines.

Health authorities also reiterated that COVID-19 vaccines will go through stringent evaluation before it can be approved for use in the country.

“Aside from the safety, and the efficacy na meron ang mga bakuna na papasok, titingnan din nila iyon pong social impact nito, titingnan nila ang affordability and titingnan nila sa response ng equity,” Vergeire said.

“They will be evaluating and then they give their recommendation to the Secretary. Kapag positive ang recommendation, we can procure the specific vaccine,” she added. – RRD (with details from Correspondent Aiko Miguel)

Duterte to wait for FDA approval before using Sinopharm vax – Palace

Robie de Guzman   •   March 2, 2021

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)

Gatchalian volunteers to be inoculated with Sinovac vaccines

Robie de Guzman   •   March 2, 2021

Senator Sherwin Gatchalian

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.

12,000 doses of CoronaVac arrive in Davao City; vaccination rollout to start on Friday

Maris Federez   •   March 2, 2021

DAVAO CITY, Philippines Aboard the flag carrier Philippine Airlines (PAL), 12,000 doses (placed in 20 boxes) of Sinovac Biotech’s CoronaVac vaccines arrived at the Davao International Airport on Tuesday, March 2, at 6:45 in the morning.

The 12,000 doses of CoronaVac are allocated for the vaccination of more than 8,000 frontliners, most of whom are healthcare workers (HCW).

However, the vaccines were brought to the Department of Health (DOH) Regional office, instead of the Southern Philippines Medical Center (SPMC) as originally planned.

The DOH said this is because Sinovac vaccines are not as temperature-sensitive as that of Pfizer vaccines which the SPMC storage facility was designed and constructed for.

CoronaVac can be stored in a storage facility with a +2 to +8˚Celsius temperature, as compared to that of Pfizer vaccines which require a -70˚Celsius temperature.

The DOH said they did not encounter any problems in the transportation of the vaccines from the airport to the DOH office.

The health department also reported that the vaccination rollout among frontliners will begin on Friday, with a target of 150 HWCs.

Based on the DOH priority list, 3,000 HCWs from the SPMC will be inoculated first, to be followed by those from private hospitals.

SPMC OIC Dr. Ricardo Audan, Davao City COVID-19 focal person Dr. Ashley Lopez, and DOH Regional Director Annabelle Yumang volunteered to receive the vaccines first to set an example to their colleagues. —/mbmf (with details from Davao Correspondent, Marisol Montaño)

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