India’s Bharat Biotech applies for EUA in Phl for COVID-19 vaccines

Aileen Cerrudo   •   January 21, 2021   •   262

MANILA, Philippines — Indian biotechnology company Bharat Biotech has applied for Emergency Use Authorization (EUA) in the country for its COVID-19 vaccine.

The Food and Drug Administration, in a message, has confirmed that Bharat Biotech submitted their application for Covaxin on Wednesday (January 20) and pre-evaluation is already ongoing.

“They submitted an application this morning and pre-evaluation is going on,” according to FDA Director-General Eric Domingo.

Meanwhile, in a statement, the biotech company said that Covaxin is ideal for tropical countries because storage temperature only needs to be set by two to eight degrees celsius.

Bharat Biotech also said the Philippines is among the list of priority countries that will receive Covaxin supply.

“The Philippines is among the list of priority countries that Bharat Biotech will allocate supplies of Covaxin to. It was announced earlier this week that the Indian government has issued a letter of comfort covering this,” the company said in a statement.

Other companies seeking EUA in the country include Astrazeneca, Gamaleya Research Institute, and Sinovac Biotech. -AAC (with reports from 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.

Health chief Duque won’t be inoculated with Sinovac COVID-19 jab – DOH

Robie de Guzman   •   March 1, 2021

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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