US moves toward approval of Pfizer’s Covid-19 vaccine

Washington, Dec 10 (efe-epa).- A panel that advises the US Food and Drug Administration recommended Thursday that the FDA issue an emergency use authorization for the Covid-19 vaccine developed by pharmaceutical giant Pfizer Inc. in collaboration with BioNTech.

Meeting a day after the United States suffered its largest one-day death toll from the pandemic, the FDA’s Vaccines and Related Biological Products Advisory Committee voted 17-4 in favor of the non-binding recommendation.

One member abstained.

“Our plan is to take their recommendations into account for our decision-making and make a decision shortly thereafter,” FDA Commissioner Dr. Stephen Hahn said earlier Thursday on NBC’s “TODAY” show.

“It really depends upon the complexity of the issues discussed, but we intend to act quickly,” he said.

If the FDA approves the Pfizer drug, a Centers for Disease Control and Prevention (CDC) panel will begin a review of the medication with an eye toward making a decision on Sunday.

Federal officials say that within 48 hours of final approval from both the FDA and CDC, 6.4 million doses of the BNT162b2 vaccine will leave warehouses and the first injections are expected to be administered early next week.

The United Kingdom, Bahrain, Canada and Saudi Arabia have already approved the vaccine.

Pfizer, which is based in the US, and Germany’s BioNTech said that data from Phase 3 clinical trials involving nearly 44,000 people worldwide showed BNT162b2 to be 95 percent effective at preventing infection with the coronavirus.

“Tens of millions of people have been affected globally and over 1.5 million people have already died,” Pfizer senior vice president and head of vaccine research and development Kathrin Jensen said during Thursday’s committee hearing.

Wednesday’s 3,055 fatalities pushed the US death toll from Covid-19 to a world-leading 290,000, while the number of confirmed cases stands at 15.5 million.

“No one is safe from this disease and certain groups, such as health care workers and first responders, the elderly with underlying diseases, are at particularly high risk. We need a safe and efficacious vaccine to stem this devastating pandemic while also deploying other prevention strategies such as infection control including mask wearing and social distancing,” Jensen said.

But Nissa Shaffi, of the National Consumers League, cited reports from the UK about adverse reactions to the Pfizer vaccine among people with severe allergies.

Those incidents spurred regulators in the UK to caution people with severe allergies against getting the shot for now.

“We call on the FDA to heed these warnings and to continue to sustain its robust interagency collaboration towards the evaluation, approval and distribution of the Covd-19 vaccine. Consumers will rely on ongoing guidance from public health agencies regarding potential adverse events from the vaccine,” Shaffi said.

A member of the panel, Children’s Hospital of Philadelphia vaccinologist Paul Offit, stressed the need to determine whether the vaccine is safe for people suffering from severe allergies.

“This issue is not going to die until we have better data,” he said. “I’m talking about perception more than reality. With those two statements out there, that people with severe allergic reactions shouldn’t get the vaccine, we just really need to offer people some solace.”

Observers have pointed out that the handling requirements for the Pfizer/BioNTech drug, which must be maintained at a temperature of minus 70C (minus 94F), could represent a challenge for less-developed countries.

But Pfizer, the world’s second-biggest pharmaceutical firm, said it was “confident in its vast experience, expertise and existing cold-chain infrastructure to distribute the vaccine around the world.”

Pfizer and BioNTech said they have the capacity “to supply up to 50 million vaccine doses globally in 2020 and up to 1.3 billion doses by the end of 2021.”

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