Pfizer Pulls Application For COVID Jab Approval In India After Country Requested Local Trials

By RED VOICE MEDIA - February 13, 2022

NEW DEHLI, INDIA – After failing to fulfill India’s pharmaceutical regulator’s requirement for a local safety and immunogenicity study, Pfizer reportedly withdrew its application for emergency-use authorization of its COVID jab in the country, per a company statement delivered on February 4th.


As a result of the decision, Pfizer’s COVID shot will not be available for purchase in the foreseeable future in neither India nor China, two of the most populated nations in the world. Apparently both countries have gone a different route when it pertains to their breed of COVID jabs being administered.


The backstory on Pfizer pulling out of trying to break into the India market is a unique one, as the company had apparently sought to bypass standard procedures that other COVID jab developers had to adhere to when being placed on the market in India.


Other companies who have foreign-developed COVID jabs participate in small-scale studies of their products in India, whereas Pfizer sought an exemption from such said typical practice by touting their trials that were conducted in countries like the United States and Germany.


However, that clearly didn’t assuage health officials in India.

The country’s drug regulator noted on their website that they couldn’t recommend Pfizer’s COVID jab due to there being ongoing research about side effects – a.k.a., adverse events and reactions – from the company’s jab abroad.


On February 2nd, Pfizer had a meeting with India’s Central Drugs Standard Control Organization which whatever was conveyed during such meeting clearly resulted in the decision two days later to pull out of getting their COVID shot approved for emergency use in the country.


Pfizer released a statement pertaining to the matter, saying they’ll “continue to engage” with officials in India “and re-submit” the application once they’re able to fulfill their requests.


“Based on the deliberations at the meeting and our understanding of additional information that the regulator may need, the company has decided to withdraw its application at this time. Pfizer will continue to engage with the authority and re-submit its approval request with additional information as it becomes available in the near future.”


The company has been pushing to get their COVID shot authorized in India since late 2021, but the country’s government opted to approve two different shots coming from Oxford University/AstraZeneca and another produced by India-based entity Bharat Biotech.

5 views0 comments

Recent Posts