Pfizer’s COVID-19 vaccine first to get approval from US regulators for mass distribution

Pfizer’s COVID-19 vaccine, which the company claims to be 95 per cent effective, is the first to receive approval from US regulators for mass distribution. Initially, the vaccine will be available in limited quantities, with initial doses earmarked for frontline healthcare workers and high-risk patients.

Stephen M Hahn, FDA Commissioner, in an official statement said the FDA’s authoritization for emergency use of the first COVID-19 vaccine is a significant milestone in battling this devastating pandemic that has affect so many families in the United States and across the world. “Today’s action follows an open and transparent review process that included input from independent scientific and public health experts, and a thorough evaluation by the agency’s career scientists to ensure this vaccine met FDA’s rigorous, scientific standards for safety, effectiveness, and manufacturing quality needed to support emergency use authoritization.”

Ugur Sahin, BioNTech CEO, told CNN that the most important result is that the company expects that the vaccinated people will have a much lower risk of hospitalization. “We will not have a direct impact on the pandemic spread in the next few months since we need of course to reach a large proportion of the population to reduce the speed of the outbreak,” he explained. “Pfizer has only been able to produce a few million doses for the US so far, so it will not immediately affect the pandemic.” Sahin predicts that after more people get vaccinated, the effects will kick in.

“It could start depending on how fast we can do the roll out and depending also when other companies join us. It could happen at the beginning of March, middle of March, end of March to see the first effects. And I hope that with the Spring season, we will have by nature a lower rate of infections,” he said. Sahin added that the combination of both might help everyone have a better summer than the present situation.

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It should be noted that the FDA’s decision came hours after an advisory panel, comprising of outside medical experts, voted 17-4 to endorse Pfize’s vaccine for mass distribution. The expert panel recommended the vaccine despite concerns regarding instances of allergic reactions in some patients, and lack of available data on how the vaccine affects patients aged 16 and 17. Sahin explained that people with a known anaphylactic reaction are known to be at risk for vaccination with any type of vaccine. “So this is not a big surprise and there must be precautions. And one of the most important precautions is really that vaccination happens under the control of a physician,” he said.

Sahin highlighted that the safety data shows that this is a vaccine like any other anti-viral vaccine with a benign safety profile, mild and moderate side effects. The typical side effects are pain at the injection site, fever and headache in a proportion of participants. Overall, he said that its a “safe and highly effective” vaccine.