US FDA allows Pfizer-BioNTech Covid-19 vaccine for emergency use

December 12, 2020 08:53 PM AEDT | By Kunal Sawhney
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  • The US FDA has allowed an emergency use of Pfizer-BioNTech Covid-19 vaccine.
  • With the approval, the vaccine doses are expected to be administered in less than 24 hours.


The US Food and Drug Administration (FDA) on Friday gave a go-ahead to Pfizer-BioNTech COVID-19 Vaccine for emergency use in the US. The FDA in a statement said that it is determined that Pfizer-BioNTech’s vaccine has met its statutory criteria and therefore is fit to be used in the US, which is one of the worst impacted by the pandemic.


The vaccine, which can be administered to people aged 16 and older, is made up of a small piece of the SARS-CoV-2 virus's mRNA that helps cells within the body to make the virus's distinctive "spike" protein.


US approves first Covid-19 vaccine


The vaccine came at a very crucial time for the US, where over 294,000 people have lost their lives to the Covid-19. The approval of the Pfizer vaccine comes after a couple of other pharmaceutical companies have filed an application for EUA including the Massachusetts-headquartered biotechnology company Moderna.


According to the prescribed statutory criteria of the FDA, the coronavirus vaccine made by Pfizer and BioNTech exhibits efficacious results. FDa noted that the Pfizer-BioNTech vaccine shot “may be effective in preventing” Covid-19 (SARS CoV-2) disease as the totality of the data provided by the companies furnishes clear evidence of vaccine’s efficacy.


The “known and potential benefits” of the Pfizer-BioNTech coronavirus vaccine certainly outweigh the “known and potential risks” associated with the vaccine, thereby supporting the vaccine usage in the country, FDA noted.

(Image Source: ©Kalkine Group 2020)


The vaccine has already been approved in the UK, Canada, Mexico, Bahrain and Saudi Arabia.


The FDA has further explained that the genetic material, messenger RNA (mRNA), that is present in the vaccine, instructs the cells in the body to make the virus’s distinctive “spike” protein.


The human body produces multiple copies of the “spike protein” after receiving the vaccine dose that helps the body in producing an immune response against the SARS-CoV-2 virus triggering the immune system to react defensively.


Also Read | Pfizer vaccine update: People with serious allergies told to avoid the shot


Cases continue to rise


Though the vaccine approval has given a new lease of life to Americans, experts have warned that the worst days are yet to come for the US. According to data provided by Johns Hopkins University, the US has seen 210,201 new Covid-19 cases daily on an average over the past week. This spike is the highest ever since the infections were reported in the country.


The global health emergency has killed 294,000 people in the country with the total cases mounting to 15,474,800, as per the data from Centers for Disease Control and Prevention.


Significant milestone


FDA Commissioner Stephen M. Hahn has termed it as a “significant milestone” after the FDA officials voted in majority to authorise the emergency use of the Pfizer’s COVID-19 vaccine.


The drug regulator of the United Kingdom, Medicines and Healthcare Products Regulatory Agency (MHRA) has been the first regulatory body in the world to grant an emergency use of Pfizer-BioNTech coronavirus vaccine. Britain has already started the process of vaccinating the people across the country after the country received the first batch of vaccine shots that contained 800,000 doses.


What is an EUA


The FDA’s granting an EUA is entirely different from the FDA approval of a vaccine. Typically, a vaccine or a drug receives a go-ahead on the emergency use in the coronavirus pandemic-like emergency situations when the potential benefits-to-risks assessment is favourable.


Even after receiving the nod, the companies are suggested to continue the trials to increase the efficacy and minimise the potential risks and adverse effects associated with the vaccine. The extended clinical trials can assist the vaccine makers in obtaining an FDA approval.





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