KOLKATA (India) — US-based pharma giant Pfizer and German partner BioNTech’s novel coronavirus vaccine became the first in the world on Friday to advance for emergency use authorization at a major nation like the US.
Pfizer’s EUA application is being seen as a major milestone towards stemming the growth of the virus that originated in Wuhan, China later last year.
The submission, as speculated would come soon, came after large scale clinical trials showed the mRNA-based vaccine dubbed BNT162b2 is capable of delivering a very high degree of protection against the SARS-CoV-2 virus that causes COVID-19.
Pfizer’s vaccine is based on a technology that has no track records of approval in the past, but researchers have pointed out that it has a high-efficiency rate.
The latest analysis of Pfizer’s vaccine candidate found the vaccine efficacy rate has improved from the previous 90% to 95% in participants without or without prior exposure to SARS-CoV-2 infection when both the cases were measured from 7-days after the second dose.
The vaccine dubbed — BNT162b2 — came after 170 participants of the trial were observed, of whom 162 COVID-19 cases were recorded in the placebo group, while only 8 cases were recorded in the BNT162b2 group, Pfizer said earlier.
Results were consistent across the spectrum of race, gender, and ethnicity demographics, but the efficacy of the vaccine dropped a tiny bit of 1% when it came to adults over 65-years-old and more.
“Filing (the EUA) 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, in a joint statement from the two companies.
Over 200 vaccine candidates are racing to develop a novel coronavirus vaccine, which is being seen as a critical requirement to return to ‘normal’ after nearly a year of being amid a pandmeic.
The coronavirus 2019 pandemic has pushed the world’s healthcare system on its toes, crippling some, while exposing the flaws in other cases.
Never have been ever a vaccine developed by the global governments at such record speed, then it has been the case for the novel coronavirus, WHO said earlier.
Both the pharma giants have earlier, and this time round have expressed their plans to move forward for emergency use authorization in other nations around the world.
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US Food and Drug Administration said it will hold an advisory meeting on December 10th, but the agency declined to comment on the time-frame it will take for the vaccine approval, Reuters reported.
Nonetheless, Pfizer and its partner have predicted if things go as intended, frontline workers in the US and elderly people would be able to receive the vaccine by Mid-December.
Moderna Inc. is expected to be the next company to apply for emergency use authorization with the US government after large-scale trial data showed their vaccine candidate was 94.5 percent effective.
Two other significant vaccines under development come from the British pharma-giant AstraZeneca who is developing Oxford University’s vaccine. And the other is from American-pharma giant Johnson & Johnson.
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