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Pfizer Seeks Emergency Approval For COVID-19 Vaccine From US Regulators

New York: Pfizer on Friday announced that it is moving ahead with its request of asking the US regulators to allow emergency use of its Covid-19 vaccine. Pfizer’s vaccine has shown 95 per cent efficacy in a totality of two data sets released in the last 10 days.

Unless some nasty surprises turn up, Pfizer’s action on Friday could be the first step towards vaccinating the most vulnerable Americans by December end.

Pfizer and another US company, Moderna, have broken all vaccine development speed records in their race for a cure over the last nine months.

US regulators are standing by for the approval process while coronavirus cases are surging to record levels across all the 50 states.

The Vaccines and Related Biological Products Advisory Committee in the US Food and Drug Administration is a key player in how this process rolls along.

Pfizer’s submission also includes safety data on approximately 100 children aged 12-15 years.

“Our work to deliver a safe and effective vaccine has never been more urgent,” Pfizer CEO Albert Bourla said in a statement.

Pfizer and BioNTech expect to produce a total of 50 million vaccine doses in 2020 and up to 1.3 billion doses in 2021. US regulators hope to have 20 million vaccine doses each from Moderna and Pfizer available for distribution in late December.

Earlier on Wednesday, Pfizer and its German partner BioNTech released a second batch of interim results on Wednesday, saying their coronavirus vaccine candidate is 95 per cent effective and also protects the most vulnerable people in older age groups from the risk of falling prey to the virus.

“Primary efficacy analysis demonstrates BNT162b2 to be 95 per cent effective against Covid-19 beginning 28 days after the first dose; 170 confirmed cases of Covid-19 were evaluated, with 162 observed in the placebo group versus 8 in the vaccine group,” the company said.

(With IANS Inputs)

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