Question: On 20 November 2020; Pfizer Inc. and BioNTech announced they are going to submit a request for Emergency Use of their COVID-19 vaccine. To which of the following country BioNTech belongs?
a) Japan
b) Germany
c) India
d) USA
Answer: (b)
Related Facts:-
- On 20 November2020; Pfizer Inc. and BioNTech announced they are going to submit a request for Emergency Use of their COVID-19 vaccine.
- These companies are applying for it to US Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of their mRNA vaccine candidate, BNT162b2.
- This authorization will potentially enable use of the vaccine in high-risk populations in the U.S. by the middle to end of December 2020.
- The submission is based on a vaccine efficacy rate of 95% (p<0.0001) demonstrated in the companies’ Phase 3 clinical study.
- Phase 3 clinical studies were done in participants without prior SARS-CoV-2 infection (first primary objective) and also in participants with and without prior SARS-CoV-2 infection (second primary objective).
- In each case it has been measured from 7 days after the second dose.
- The first primary objective analysis was based on 170 confirmed cases of COVID-19.
- This submission also is supported by solicited safety data from a randomized subset of approximately 8,000 participants ≥18 years of age.
- It has also taken unsolicited safety data from approximately 38,000 trial participants who have been followed for a median of two months following the second dose of the vaccine candidate.
- The submission also includes solicited safety data on approximately 100 children 12-15 years of age.
- Approximately 42% of global participants and 30% of U.S. participants in the Phase 3 study have racially and ethnically diverse backgrounds.
- It should be known that 41% of global and 45% of U.S. participants are 56-85 years of age.
- Most importantly till date, the Data Monitoring Committee (DMC) for the study has not reported any serious safety concerns related to the vaccine.
- Companies said that filing in the U.S. represents a critical milestone in our journey to deliver a COVID-19 vaccine to the world.
- Companies informed, they now have a more complete picture of both the efficacy and safety profile about this vaccine.
By – Rajesh Tripathi