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29 Dec 2020

Pfizer, BioNTech covid vaccine approval tilldate

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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

UK

Temporary authorization for emergency use by MHRA on 2 December after a rolling review of vaccine data.

Bahrain

On 4 December, Bahrain became the second country to approve BNT162b2, according to a statement from the country’s National Health Regulatory Authority.

Canada

Vaccine was authorized by Health Canada on 9 December after a rolling review.

Mexico

Authorization for Emergency Use granted by COFEPRIS on 11 December.

USA

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.

Singapore

Interim authorization was granted to BNT162b2 by HSA for individuals 16 years and older under the under the PSAR regulatory pathway.

Chile

The Public Health Institute of Chile has authorized BNT162b2 for emergency use in the country on 16 Decembe

Oman

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.

Kuwait

The ministry of health in Kuwait has authorized BNT162b2 for emergency use.

EU

Conditionally authorized after receiving a recommendation by the EMA’s Committee for Medicinal Products for Human Use earlier in the day.

Australia

BNT162b2 received provisional determination from TGA, which is the first step on the road for approval for the vaccine in the country.

India

Pfizer has applied for an EUA for BNT162b2 with DCGI in India.

Japan

Pfizer has applied for approval of the BNT162b2 vaccine with the Ministry of Health, Labour and Welfare of Japan.

Reference: 

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

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