FDA raises vaccine hopes

‘Doses may be ready for distribution by March at the earliest’

A vaccine against COVID-19 may be available in the Philippines by as early as March 2021 following recent developments abroad, Food and Drug Administration (FDA) Director-General Eric Domingo said Thursday.

Domingo made the projection at a Palace briefing a day after the UK approved the Pfizer-BioNTech COVID-19 vaccine for use.

Domingo said there is information that the US FDA is also gearing toward the issuance of emergency use authorization for the COVID-19 vaccines developed by Pfizer and Moderna within two weeks.

He said if the drug companies applied here in January, they could be given emergency use authorization, a move that would improve the chances of having a vaccine ready for distribution by March.

He said this could even be as early as January, but this would depend on how soon the companies could ramp up production and when they would be able to allocate doses for the Philippines.

Domingo said if companies applied for an EUA, the FDA would be able to render a decision within 21 to 28 days.

He added that the Pfizer-BioNTech vaccine stands a good chance of securing an EUA in the Philippines if it applies for one.

He said the FDA’s counterpart in the United Kingdom, which granted an EUA to the Pfizer-BioNTech vaccine, was a stringent regulatory authority that had thoroughly examined all the data.

Still, he said his agency would want information on the vaccine’s stability in a tropical environment.

He said they would also want to know if there were enough Asians or Filipinos among their test subjects to gauge the drug’s safety and efficacy on different ethnic groups.

In a separate interview, Dr. Jaime Montoya of the Philippine Council for Health Research and Development (PCHRD) said FDA approval of a drug or vaccine can be expected in 40 days or less now that it is allowed to issue an EUA.

He added that the process will also be faster for drugs or vaccines that have been given EUA in other countries.

On Wednesday, Malacañang announced that President Rodrigo Duterte, through Executive Order 121, has allowed the FDA to issue an EUA for COVID-19 drugs and vaccines.

The Philippines hopes to acquire vaccines developed by the United States, China, Russia, and the United Kingdom.

Domingo said the government would not force people to be vaccinated against COVID-19, and said persons would only be inoculated after full disclosure of the vaccine’s potential risks and potential benefits.

“You can’t be forced into it and this is not compulsory,” Domingo said in Filipino.

But to allay fears about the vaccines, which are seen to help turn the tide of the global pandemic, Domingo assured the public they would not compromise their safety.

“We would like to assure the public we take it very seriously. We will make sure that the benefits will outweigh the risk more than anything before giving the emergency use authorization for any vaccine,” he said.

To bolster public confidence, the Department of Health (DOH) is set to hold an education campaign about the vaccines to allow the public to make an informed decision, Domingo said.

The Department of Health (DOH), meanwhile, said it will identify the priority areas where COVID-19 vaccines developed by British firm AstraZeneca and Oxford University will be administered, the agency said.

“Since this would be a tripartite agreement and the EUA (emergency use authorization) will be issued by the [Philippine] government, the allocation framework that the companies would follow would be the one prescribed by the Department of Health,” the DOH said.

Earlier, the government and private companies signed an agreement with AstraZeneca for the acquisition of 2.6 million doses of the drug manufacturer’s COVID-19 vaccines.

Under the deal, 50 percent of the vaccines will be distributed to areas identified by the DOH.

The remaining half will be given to geographical areas or sectors identified by the private firms that purchased the vaccine.

The Palace said Thursday that the President will attend a virtual session of the 31st special session of the United Nations General Assembly (UNGA) on the COVID-19 pandemic from Dec. 3 to 4.

Presidential spokesman Harry Roque said the President is expected to deliver the Philippine statement on Dec. 3, New York time.

“The President will further amplify his call for global solidarity in addressing the challenges posed by the COVID-19 pandemic,” Malacañang said in a statement.

The President is particularly concerned about “universal access to anti-COVID-19 technologies and products and the need for global efforts to ensure availability of safe and effective vaccines to peoples of developing nations,” Roque said.

Earlier, the President said access to COVID-19 vaccines “must not be denied nor withheld.”

“It should be made available to all, rich and poor nations alike, as a matter of policy,” he said during the general debate of the UNGA’s 75th session last September.

Topics: Vaccine , COVID-19 , Rodrigo Duterte , Food and Drug Administration , Eric Domingo , AstraZeneca , Department of Health , Pfizer-BioNTech
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