Pharma News

Keep updating your pharma knowledge
29 Dec 2020

Pfizer, BioNTech covid vaccine approval tilldate

Posted By

Pfizer, BioNTech covid vaccine (BNT162b2) has received following marketing authorization* approval till date.

  1. UK
  2. Bahrain
  3. Canada
  4. Mexico
  5. US
  6. Singapore
  7. Oman
  8. Saudi Arabia
  9. Kuwait
  10. EU

*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.

Saudi Arabia

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.


  1. Covid-19 vaccine information portal by Biontech >>
  2. RAPS vaccine development and commercialization tracker >>
  3. Pfizer and BioNTech vaccine announcement >>

Leave a Reply

The reCAPTCHA verification period has expired. Please reload the page.

Upskill Your Pharma Knowledge

Explore Next Gen Learning

Case Studies & Caselets | Simulation Based Learning | E-Lectures | Online Self Competency Assessments

Thank You for Subscription!