Published 16:35 IST, November 21st 2020
Pfizer-BioNTech apply for Emergency Use Authorisation for their COVID-19 vaccine
American biotech firm Pfizer and its German partner BioNTech, on November 20, applied to seek approval to roll out their coronavirus vaccine early.
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American biotech firm Pfizer and its German partner BioNTech, on November 20, applied to seek approval to roll out their coronavirus vaccine early. In the aftermath of their Phase 3 trials, the companies announced that their vaccine candidate- BNT162b2 showed 95 per cent effectiveness against the deadly COVID-19 infection. However, it still requires approval from the US Food and Drug Administration (FDA) to begin mass production and distribution.
Read: Storage Of Pfizer's COVID Vaccine Challenge For Most Nations; India Examining Possibilities: Govt
Commenting on the request for emergency use authorization, the FDA asserted that its vaccines committee would meet on December 10 to discuss the same. However, it was still unsure how long it would take the review committee to give a go-ahead to the vaccine.
"The FDA recognizes that transparency and dialogue are critical for the public to have confidence in COVID-19 vaccines. I want to assure the American people that the FDA's process and evaluation of the data for a potential Covid-19 vaccine will be as open and transparent as possible, “ the organization's head Stephen Hahn said in a statement.
Pfizer-BioNtech announce 95 per cent efficiency
Pfizer and BioNTech, on November 18 announced that its COVID-19 vaccine candidate - BNT162b2 - has met all of the primary efficacy endpoints. Concluding from the analysis, the biotech firm stated that its vaccine candidate has shown an efficacy rate of 95 per cent in participants with and without prior COVID infection. However, the efficacy reduced by a per cent in adults over the age of 65 years. The analysis by Pfizer and BioNTech is based on 170 participants.
The companies have also announced that it has achieved the safety milestone required by the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA). Based on the safety and efficacy data collected, the firms intend to submit a request within days to the FDA for a EUA. The announcement comes just two days after Moderna reported that its vaccine candidate had shown nearly 95% efficacy rate.
16:37 IST, November 21st 2020