Pfizer’s Covid-19 vaccine may not meet India "immediate" Requirements
|Pfizer’s Covid-19 vaccine may not meet India "immediate" Requirements|
Pfizer India has become the first pharmaceutical firm to seek from the Drugs Controller General of India (DCGI) an emergency-use authorisation for its Covid-19 vaccine in the country.
"The firm has submitted the EUA application in Form CT-18 for grant of permission to import and market Pfizer-BioNTech's Covid-19 mRNA vaccine BNT162b2 in the country," the source said, citing the application.
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 (MHRA) granting a temporary authorisation for its emergency use.
The Covid vaccine developed by American pharma giant Pfizer, which was cleared by the United Kingdom Wednesday and will be rolled out to the public early next week, is unlikely to be available in India at this time - NDTV notes.
The Pfizer vaccine (which has been cleared by the UK) reported an efficacy rate of over 90 per cent. Another global vaccine candidate - developed by Moderna Inc., which has also not sought permission to hold clinical trials in India - reported 94.1 per cent.
In India, the second worst-hit country, 95 lakh cases have been reported so far, of which around 4.28 lakh are active cases and over 1.38 lakh are deaths linked to the virus.
India May Not Get Pfizer Covid Vaccine
The Pfizer-BioNTech vaccine needs a minus 70 degrees Celsius cold chain requirement and is not being tested in India. So it isn’t very high on New Delhi’s watchlist but its approval and rollout in the UK are of much more than academic interest, according NDTV.
For the vaccine to be considered for use here, the Indian subsidiary of Pfizer will have to approach the regulator and share the data it has submitted to the UK regulator. “They can then ask for an approval and, accordingly, the regulator will take a decision,” an official told The Indian Express.
V K Paul, who chairs the high-level National Expert Group on Vaccine Administration, had spelled out India’s strategy with respect to such candidates — like Pfizer and Moderna — which have shown positive results in Phase 3 abroad but are not being tested here.
“We know that doses of this vaccine (Pfizer) will not be available in huge quantities… If this vaccine candidate has to come, and if we require it, we are preparing ourselves…we have parallel plans,” Paul had said to Express.
India’s current strategy, specifically keeping in mind its largescale requirement, is based on expected supplies of five vaccine candidates currently in clinical trials here: Astrazeneca-Oxford, Zydus Cadilla, Biological E, Dr Reddy’s and Bharat Biotech.
Five vaccines are in advanced phases of clinical trials in India with the Serum Institute of India conducting phase-3 trial of the Oxford-Astrazeneca Covid-19 vaccine, while the indigenously developed vaccine by Bharat Biotech in collaboration with ICMR has already started the phase-3 clinical trial.
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