Health Canada authorises emergency use of Pfizer’s COVID-19 vaccine
Canada becomes the third country to approve Pfizer and BioNTech’s mRNA COVID-19 vaccine BNT162b2 for emergency use - after UK and Bahrain.
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Canada becomes the third country to approve Pfizer and BioNTech’s mRNA COVID-19 vaccine BNT162b2 for emergency use - after UK and Bahrain.
Pfizer spokesperson reveals supply chain challenges and late clinical trial results contributed to its COVID-19 vaccine production target for 2020 being halved.
A 90-year old woman is the first person to receive BNT162b2, the Pfizer and BioNTech COVID-19 vaccine, outside of clinical trials.
The UK's MHRA has given temporary emergency authorisation to Pfizer and BioNTech's COVID-19 vaccine, making it the first in the world to receive approval.
If the Conditional Marketing Authorization application is approved, the COVID-19 vaccine BNT162b2 could be used in the EU by the end of 2020.
Both the UK and US have said that, if approved, the Pfizer and BioNTech COVID-19 vaccine could be administered to people as early as December.
The companies suggest if the Emergency Use Authorization (EUA) is approved, high-risk patients in the US could begin receiving the BNT162b2 vaccine by the end of December 2020.
The concluded Phase III study of BNT162b2 met all primary efficacy endpoints, with a consistent 95 percent efficacy across all patient populations.
Subject to regulatory approval, EU member states will be supplied with the potentially highly effective BNT162b2 COVID-19 vaccine candidate.
The COVID-19 vaccine candidate BNT162b2, made by Pfizer and BioNTech, has demonstrated over 90 percent efficacy in its first interim analysis during its Phase III trial.
The rolling review of BNT162b2 will allow the committee for human medicines (CHMP) to reach a faster decision on a future marketing authorisation application.
The companies and European Commission will soon enter contract negotiations for the supply of their investigational COVID-19 vaccine candidate BNT162b2.
The BNT162b2 mRNA-based vaccine produced by Pfizer and BioNTech will enter Phase have II/III clinical trials to test its safety and efficacy against COVID-19.
The COVID-19 vaccine candidate, BNT162b1, has been approved for clinical trial registration by China's National Medical Products Administration (NMPA).
Two investigational SARS-CoV-2 vaccine candidates, BNT162b1 and BNT162b2, currently in clinical trials have been granted Fast Track designation by the FDA.