Pfizer, BioNTech covid vaccine (BNT162b2) has received following marketing authorization* approval till date.
- Saudi Arabia
*Most of the approvals are emergency use authorization, not a full marketing authorization.
Quick look into approval status
Temporary authorization for emergency use by MHRA on 2 December after a rolling review of vaccine data.
On 4 December, Bahrain became the second country to approve BNT162b2, according to a statement from the country’s National Health Regulatory Authority.
Vaccine was authorized by Health Canada on 9 December after a rolling review.
Authorization for Emergency Use granted by COFEPRIS on 11 December.
USFDA has authorized this vaccine for use in people 16 years and older under an Emergency Use Authorization on 11 December. BNT162b2 received FDA Fast Track designation in July. Pfizer plans to seek full FDA approval in April 2021.
Interim authorization was granted to BNT162b2 by HSA for individuals 16 years and older under the under the PSAR regulatory pathway.
The Public Health Institute of Chile has authorized BNT162b2 for emergency use in the country on 16 Decembe
The country of Oman has authorized the vaccine for use in individuals 16 years and older.
Pfizer and BioNTech’s vaccine has been authorized for use in the country by Saudi Arabia’s drug regulator.
The ministry of health in Kuwait has authorized BNT162b2 for emergency use.
Conditionally authorized after receiving a recommendation by the EMA’s Committee for Medicinal Products for Human Use earlier in the day.
BNT162b2 received provisional determination from TGA, which is the first step on the road for approval for the vaccine in the country.
Pfizer has applied for an EUA for BNT162b2 with DCGI in India.
Pfizer has applied for approval of the BNT162b2 vaccine with the Ministry of Health, Labour and Welfare of Japan.
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