Vaccine highly effective against strain found in India: Pfizer seeks India's approval
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US pharmaceuticals major Pfizer on Wednesday sought a fast-track approval for its COVID-19 vaccine and told the Indian authorities that its jab has proven to be highly effective against the SARS-CoV-2 variant prevalent in India and on people of Indian ethnicity or nationality.
According to sources, Pfizer has also said that its vaccine is suitable for everyone aged 12 years or above and that the vaccine can be stored for a month at 2-8 degrees Celsius, sources said on Wednesday.
Pfizer claimed that its recent data points confirm the high effectiveness of BNT612b2 (as the Pfizer-BioNTech vaccine is technically known) 2-dose regimen against SARS-CoV-2 variants, and among individuals of Indian ethnicity.
The American pharma giant is currently in talks with the government to roll out five crore doses between July and October - if it receives significant regulatory relaxations, including indemnification, or protection from compensation claims in case of adverse events.
Pfizer seeks indemnity and liability protections in all of their agreements consistent with applicable local laws and has one with 116 countries in the world. Indemnification clauses are often included in contracts with governments for the supply of necessary vaccines during any public health emergency.
According to PTI, sources told the Indian government it should "rely on the 44 authorisations, including WHO approval (to) facilitate emergency use authorisation..."
The company, however, is open to considering surveillance of the first 100 subjects to get its vaccine.
The company, however, is open to considering surveillance of the first 100 subjects to get its vaccine.
In a series of meetings between Indian authorities and the company's top brass, Pfizer has sought a firm pre-order along with advance payment for supplying Covid-19 vaccines to India on the same lines as other countries which have opted to procure vaccines from the company, sources familiar with the details told Economic Times.
