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Pfizer Wants India to Apply for Covid-19 Vaccine Before Seeking Approval | India News

NEW DELHI: Pfizer Inc will continue its request for India to approve its Covid-19 vaccine if the government agrees to buy injections, the US drugmaker told Reuters on Monday, even as global supplies dwindle.
Pfizer was the first company to apply for emergency use authorization (USA) for a Covid-19 vaccine in India, but the government approved two much cheaper injections this month: one from Oxford University / AstraZeneca and one developed in-house. by Bharat Biotech with the Indian Council of Medical Research.
India’s Central Medicines Control Organization (CDSCO) says Pfizer officials did not attend the meetings after the company’s application was submitted in early December. The regulator has also refused to accept the company’s application for approval without a small local test on the safety and immunogenicity of the vaccine for Indians, Reuters reported.
Pfizer says its app is backed by data from a global study showing a 95% overall efficacy rate with no serious vaccine-related safety concerns. It also says that, based on the same data, the vaccine developed with German partner BioNTech has been approved in Britain, the United States, the European Union and Canada.
“The data collected has been endorsed by various regulatory agencies (including the most evolved ones) and has given the US [based on] … that data, ”the firm said in an email response to questions, including India’s demand for a local test.
“Given our exclusive priority to government supply, we await confirmation from the government on the necessary supplies, [on the] base [of] what we will carry forward the regulatory process, as we have done throughout the world, “he added.
Last week, government officials in some EU countries said Pfizer had cut their deliveries in half, causing frustration and hampering vaccination campaigns.
Indian officials have had talks with both Pfizer and its American rival Moderna Inc about how to make their injections in India, given its large pharmaceutical capacity.
However, India, the world’s largest vaccine maker, says it relies primarily on vaccines already approved or tested at home to run its mass immunization campaign that began on January 16.
Pfizer said its current focus was to distribute the vaccine worldwide using manufacturing capacity in the United States and Europe.
“Once the pandemic supply phase is over and we enter a regular supply phase, Pfizer will evaluate any additional opportunities available,” he said.
When asked why he did not attend the meetings called by the CDSCO, Pfizer said its officials had not received enough notice.
“Company representatives have not been able to participate in previous meetings due to extremely brief notices of a few hours or less and time zone limitations,” the company said.
“We remain committed to working with the government of India to make this vaccine available to the government of the country.”

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