What did the FDA say regarding the Pfizer/BioNTech vaccine?

The FDA’s authorisation for emergency use of the first Covid-19 vaccine is a significant milestone in battling this devastating pandemic that has affected so many families in the United States and around the world. Says the head of the FDA agency, Stephen Hahn. He has said that the authorisation came after “an open and transparent review process” that ensured the vaccine met the “FDA’s rigorous, scientific standards for safety, effectiveness, and manufacturing quality”.

On Thursday, medical experts advising the FDA recommended the emergency-use authorisation. A 23-member panel concluded the vaccine’s benefits outweighed its risks. Emergency use, the FDA said, was not the same as full approval, which would require Pfizer to file a separate application to secure. US media reported that Mr Hahn had earlier been told to approve the vaccine for emergency use by Friday or quit. Mr Hahn, however, said the reports were “untrue” and stressed that the agency had not compromised safety in its testing.

The Pfizer/BioNTech vaccine was the first coronavirus jab to show promising results in the latter stages of its testing process. It is a new type called an mRNA vaccine that uses a tiny fragment of genetic code from the pandemic virus to teach the body how to fight Covid-19 and build immunity. “The vaccine contains a small piece of the Covid-19 virus’s mRNA that instructs cells in the body to make the virus’s distinctive ‘spike’ protein,” the FDA said.

“When a person receives this vaccine, their body produces copies of the spike protein, which does not cause disease, but triggers the immune system to learn to react defensively, producing an immune response against Covid-19.” The vaccine is given as two injections, 21 days apart, with the second dose being a booster. Immunity begins to kick in after the first dose but reaches its full effect seven days after the second dose.

The vaccine must be stored, at ultra-low temperatures, which makes distribution difficult. Special shipping containers that use dry ice, will be used to transport frozen vials direct to the point of vaccination, Pfizer says. The pharmaceutical company has agreed to a deal to supply the US with 100 million doses of the vaccine by March. An additional 200 million doses of a second vaccine, developed by Moderna and the National Institutes of Health, will be provided by June.

Daniel Carpenter, a political scientist at Harvard University, said it was unprecedented to go from the discovery of disease to the development of a vaccine in 11 months. The shortest timeline previously was for the mumps vaccine, which took four years. Most vaccines are produced, for ailments that have been around for a long time, after years of research often marked by failures and disappointments. In the case of AIDS, there still is no vaccine, nearly four decades after HIV was identified.

Pfizer and its Germany-based partner, BioNTech, harnessed a fast, flexible genetic technology that had been in development for decades but never deployed in an approved medical product. It was used to build a vaccine that surpassed all expectations by being 95 percent effective at preventing disease in a clinical trial with tens of thousands of participants. However, the most commonly reported side effects of the vaccine, which typically lasted several days, were pain at the injection site, tiredness, headache, muscle pain, chills, joint pain, and fever. Of note, more people experienced these side effects after the second dose than after the first dose, so the FDA warns that it is important for vaccination providers and recipients to expect that there may be some side effects after either dose, but even more so after the second dose. The vaccine has already been approved in Britain, Canada, Saudi Arabia and Bahrain.

By Jumana Jabeer

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