Pfizer seeks emergency authorisation for its Covid-19 vaccine in India

Pharmaceutical giant Pfizer has become the first company to apply for an Emergency Use Authorisation (EAU) for its Covid-19 vaccine in India, days after it received such an approval from the UK where the vaccination campaign is expected to roll out shortly.

The company has also sought a waiver from the Drugs Controller General of India for the mandatory clinical trial requirement, which two other imported vaccines, Sputnik (Russian) and Covishield – made by the Pune-based Serum Institute using the same master seed used in the AstraZeneca-Oxford University vaccine – are carrying out at the moment.

While Pfizer has decided on not to sell its vaccine in the private market, it is unclear at the moment whether the Union Health Ministry would buy this vaccine priced at $ 19.5 a dose (nearly Rs 1,450 per dose) in the US market. Moreover, storage and transportation of the vaccine pose a huge logistical challenge because of its ultra-low cooling needs.

A company official said it would not sell any vaccine in the private market and would supply the vaccine only through government contracts after receiving regulatory approval.

"Pfizer India has submitted an application on December 4 to the DCGI seeking the EUA for its Covid-19 vaccine. The firm has submitted the EUA application for grant of permission to import and market the vaccine (BNT162b2) in India," said an official.

The UK on Wednesday became the first country to approve the Pfizer/BioNTech vaccine against Covid-19 with the UK regulator Medicines and Healthcare products Regulatory Agency granting a temporary authorisation for its emergency use.

The British regulator said the jab, which claims to offer up to 95% protection against the pandemic virus is safe for a roll-out.

The vaccine comes with a huge logistical challenge as it needs to be stored at minus 70 degrees Celsius temperature,

The company offers three options as resolve the problem - (1) an ultra low-temperature freezer that is commercially available and can extend the shelf life of the vaccine up to six months (2) a Pfizer-designed special temperature-controlled thermal shippers that can maintain the temperature range of -70 degrees Celsius to +10 degrees Celsius for 10 days without opening and (3) refrigeration units at hospitals where the vaccine can be stored for five days at a temperature of 2-8 degrees Celsius.

The thermal shipper uses dry ice (solidified carbon dioxide) for cooling. Once it is opened, the vaccine has to be used within 30 days with recharging of dry ice after every five days.

While five vaccines are under various stages of clinical evaluation in India, three more are under an advanced stage of development with the involvement of the Indian pharmaceutical industry. India had earlier indicated to follow a smart vaccination strategy under which only a selected group of people would be vaccinated with the aim of breaking the chain of transmission rather than following a universal vaccination policy.