Pfizer / BioN Tech vaccine, what we know

https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-conclude-phase-3-study-covid-19-vaccine

HTTPS://WWW.BUSINESSWIRE.COM/NEWS/HOME/20201118005595/EN/

PFIZER AND BIONTECH CONCLUDE PHASE 3 STUDY OF COVID-19 VACCINE CANDIDATE, MEETING ALL PRIMARY EFFICACY ENDPOINTS

Wednesday, November 18, 2020 - 06:59am 

Phase 3, 27th July

Primary efficacy analysis, 95% effective

(p less than 0.0001), 9, 999 out of 10,000

high rate of protection against COVID-19 can be achieved very fast after the first 30 µg dose

beginning 28 days after the first dose

170 confirmed case

10 severe cases

N = 41,135

42% of global participants and 30% of U.S. participants have racially and ethnically diverse backgrounds

41% of global and 45% of U.S. participants are 56-85 years of age

Placebo group

162 infections

9 severe cases

Vaccine group

8 infections

1 severe case

Efficacy was consistent across age, gender, race and ethnicity demographics

Observed efficacy in adults over 65 years of age was over 94%

Two month safety test

Safety data milestone required by U.S. Food and Drug Administration (FDA) for Emergency Use 

Authorization (EUA) has been achieved

Side effects

FDA adverse events rules

https://www.fda.gov/media/73679/download

Well tolerated across all populations

No serious safety concerns observed

Mostly less than 2%

Grade 3 adverse event 

Fatigue 3.8% 

Headache 2.0%

Plan to submit within days to the FDA for EUA and share data with other regulatory agencies around the globe

expect to produce globally up to 50 million vaccine doses in 2020

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

Manufacturing

Germany 

Belgium

3 US sites

Logistics

Specially designed, temperature-controlled thermal shippers

Utilizing dry ice

Maintain temperature conditions of -70°C±10°C

They can be used be as temporary storage units for 15 days by refilling with dry ice

UK
40 million doses, 10 million by end of the year