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Pfizer And BioNTech SE To Seek Emergency Use Approval From US FDA For Covid-19 Vaccine
representative image (Source: @pfizer/Twitter)
Pfizer, an American pharma multinational, announced today that it is moving ahead with its request of asking the United States (US) regulators to allow the emergency use of its Covid-19 vaccine.
The company announced that it will submit a request today to the US Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of their mRNA vaccine candidate, BNT162b2 against the novel coronavirus.
The vaccine showed 95 per cent efficacy over a diverse group of people in a totality of two data sets released in the last 10 days. Pfizer's submission also includes safety data on approximately 100 children aged 12-15 years.
The BNT162b2 vaccine candidate is developed by Pfizer in collaboration with BioNTech SE. It is currently not approved for distribution anywhere in the world.
If everything runs smoothly, Pfizer's action today could become the first step towards vaccinating the most vulnerable Americans by December end.
Another US company, Moderna, along with Pfizer, has broken all vaccine development speed records in their race for a cure over the last nine months.
The US regulators are standing by for the approval process while coronavirus cases are surging to record levels across all the 50 states.
“Our work to deliver a safe and effective vaccine has never been more urgent, as we continue to see an alarming rise in the number of cases of COVID-19 globally. Filing in the U.S. represents a critical milestone in our journey to deliver a COVID-19 vaccine to the world and we now have a more complete picture of both the efficacy and safety profile of our vaccine, giving us confidence in its potential,” said Dr Albert Bourla, Pfizer Chairman and CEO.
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.
With inputs from IANS
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