Pfizer, BioNTech apply for EUA of COVID-19 vaccine, seek FDA nod

  • November 21, 2020 03:05 PM AEDT
  • Team Kalkine
    Team Kalkine
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Pfizer, BioNTech apply for EUA of COVID-19 vaccine, seek FDA nod

Summary

  • Pfizer and BioNTech have submitted a request to US FDA for EUA of COVID-19 vaccine, BNT162b2.
  • The FDA’s scientists would now assess the COVID-19 vaccine data. The external panel of independent experts would also examine the vaccine data.
  • There would then be a public safety meeting, and Pfizer and BioNTech would present data related to the safety and effectiveness of the vaccine to VRBPAC.

 On 20 November 2020, Pfizer and BioNTech have submitted a request to the US FDA for an Emergency Use Authorization (EUA) of their COVID-19 vaccine, BNT162b2. After the FDA green light, the vaccine could be used for high-risk populations in the US by December 2020 end.

The FDA scientists will review the COVID-19 vaccine data collected to date. Also, as per the guidance from the FDA, the evidence would further be examined by an external panel of independent experts. It would be followed by a public safety meeting where both the companies Pfizer and BioNTech would present on the vaccine’s safety and effectiveness.

The discussion will be held at Vaccines and Related Biological Products Advisory Committee, where Pfizer and BioNTech would answer the questions raised by the committee members.

Vaccines and Related Biological Products Advisory Committee (VRBPAC) has a key role in the process to approve the vaccine candidate for emergency usage. VRBPAC would be providing recommendation to the FDA on whether the approval to be given to the vaccine candidate or not and the FDA would take the final decision.

Pfizer and BioNTech have submitted data from 170 confirmed COVID-19 cases accrued in Phase 3 trial and safety data from a randomized subset of minimum 8,000 participants who were 18 years and above. Further, Pfizer and BioNTech also have data on ~ 19,000 trial participants who have been monitored for a median of 2 months post the second and final dose of the COVID-19 vaccine along with the manufacturing processes.

Who will be the first receivers of the COVID-19 vaccine?

The economy and healthcare market is quite upbeat post the vaccine updates from Pfizer and BioNTech followed by another positive update related to Moderna’s COVID-19.

Once FDA approves the COVID-19 vaccine developed by Pfizer and BioNTech, the vaccine would then be rolled out in phases to be distributed in the public. The priority would be healthcare workers followed by older people or people with major health conditions followed by other essential workers.

According to the interim plans of CDC, after the health workers, essential federal workers would be the next set of Americans to get the COVID-19 vaccine. Five federal agencies have started communicating to their employees that they would be able to get the COVID-19 vaccine prepared by Pfizer and BioNTech and Moderna within 8 weeks post FDA’s clearance of the vaccines.

Diplomats at the State Department with age 70 years and above plus the vulnerable population group may also be considered for the early vaccination.

Agencies as per CDC’s list to get doses directly from the Federal Government:

  • The Bureau of Prisons
  • Department of Defense
  • Department of State
  • Indian Health Service
  • Veterans Health Administration

INTRESTING READ:  Pfizer-BioNTech Vaccine 95% Effective In Preventing COVID-19, Ready For Regulators

 

 


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