FDA Advisory Panel Recommends Emergency Use Approval for Pfizer/BioNTech COVID-19 Vaccine

Strategic Insights -

The FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) has recommended emergency use approval for Pfizer/BioNTech's COVID-19 vaccine, paving the way for its immunization in the US. This comes after a 90-year-old British woman became the first person outside of a trial setting to receive the vaccine on Tuesday. The UK has procured over 800,000 doses of the vaccine, with a total of 20 million doses expected to be supplied through 2021, enough to immunize nearly a third of the UK's population.

Key Takeaways:

  • The FDA's VRBPAC has recommended emergency use approval for Pfizer/BioNTech's COVID-19 vaccine, which is expected to be authorized by the FDA.
  • The vaccine has shown over 94% effectiveness in adults over 65 years of age, with trials indicating that about 60 individuals out of 1,000 may still be infected despite vaccination.
  • The vaccine is administered in two doses of 30 μg each, given 21 days apart, and takes several weeks after the second dose to become effective.
  • The vaccine works by instructing the body's cells to create copies of the SARS-CoV-2 virus's spike protein, triggering an immune system response and producing antibodies to fight the infection.
  • Immunized individuals still need to follow social distancing guidelines and wear masks, as scientists are unsure if they can still transmit the virus to others.
  • Pfizer/BioNTech has initiated rolling submissions for the vaccine in several countries, including Australia, Canada, Europe, and Japan, and expects to produce over 50 million doses in 2020 and up to 1.3 billion doses by the end of 2021.

Statistics:

  • The vaccine has been shown to be over 94% effective in adults over 65 years of age.
  • Trials indicate that approximately 60 individuals out of 1,000 may still be infected despite vaccination.
  • The vaccine is administered in two doses of 30 μg each, given 21 days apart.
  • Pfizer/BioNTech expects to produce over 50 million doses of the vaccine in 2020 and up to 1.3 billion doses by the end of 2021.
  • The UK has procured over 800,000 doses of the vaccine, with a total of 20 million doses expected to be supplied through 2021.

Sources:

  • The New York Times
  • FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC)
  • Research published in the journal Nature in 2018