This comes after the country asked for local trials, due to there being ongoing research about side effects – a.k.a., adverse events and reactions…
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“After failing to fulfil 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,” local reports have written.
“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 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.”
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 an India-based entity Bharat Biotech.