Pfizer and BioNTech found its COVID-19 is 95% effective in the last trial run, “meeting all primary efficacy endpoints.”

The vaccine also showed signs of safety and met all the requirements for the FDA to approve its use as soon as possible.

From Pfizer:

  • Primary efficacy analysis demonstrates BNT162b2 to be 95% effective against COVID-19 beginning 28 days after the first dose;170 confirmed cases of COVID-19 were evaluated, with 162 observed in the placebo group versus 8 in the vaccine group
  • Efficacy was consistent across age, gender, race and ethnicity demographics; observed efficacy in adults over 65 years of age was over 94%
  • Safety data milestone required by U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) has been achieved
  • Data demonstrate vaccine was well tolerated across all populations with over 43,000 participants enrolled; no serious safety concerns observed; the only Grade 3 adverse event greater than 2% in frequency was fatigue at 3.8% and headache at 2.0%
  • Companies plan to submit within days to the FDA for EUA and share data with other regulatory agencies around the globe
  • The companies expect to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses by the end of 2021
  • Pfizer is confident in its vast experience, expertise and existing cold-chain infrastructure to distribute the vaccine around the world

There are four Pfizer facilities that take part in manufacturing and distribution: St. Louis, Andover, Kalamazoo, and Puurs, Belgium.

The global supply will come from BioNTech’s German sites.

Moderna announced on Monday that its COVID-19 vaccine is 94.5% effective. It has one advantage over the Pfizer vaccine:

A key advantage of Moderna’s vaccine is that it does not need ultra-cold storage like Pfizer’s, making it easier to distribute. Moderna expects it to be stable at standard refrigerator temperatures of 2 to 8 degrees Celsius (36 to 48°F) for 30 days and it can be stored for up to 6 months at -20 degrees Celsius.

Pfizer’s vaccine must be shipped and stored at minus 70 degrees Celsius, the sort of temperature typical of an Antarctic winter. At standard refrigerator temperatures, it can be stored for up to five days.

RELEASE BOTH NOW.

 

 
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