By Krishna N. Das
NEW DELHI (Reuters) – Pfizer Inc will follow its request for India to approve its COVID-19 vaccine if the government commits to buying vaccines, the American drugmaker told Reuters on Monday, despite the global tightening.
Pfizer was the first company to seek emergency use authorization (USA) for a COVID-19 vaccine in India, but this month the government approved two much cheaper vaccines – one from Oxford University / AstraZeneca and one developed at home by Bharat. Biotech with the Indian Medical Research Council.
India’s Central Drug Control Organization (CDSCO) says Pfizer employees did not attend meetings after the company’s order was placed in early December. The regulator also refused to accept the company’s request for approval without a small local trial on vaccine safety and immunogenicity for Indians, Reuters reported.
Pfizer says its application is supported by data from a global study showing an overall 95% effectiveness rate with no serious vaccine-related safety concerns. He also says that, based on the same data, the vaccine developed with the German partner BioNTech was approved in Great Britain, United States, European Union and Canada.
“The data collected was endorsed by several regulatory agencies (including the most evolved ones) and gave the USA [based on] … that data, “the company said in an e-mail response to questions, including about India’s demand for a local test.
“Given our exclusive priority for government supplies, we expect confirmation from the government about the necessary supplies [on the] base [of] that we will take the regulatory process forward, as we have done all over the world, “he added.
Last week, government officials in some EU countries said Pfizer halved deliveries to them, causing frustration and hampering vaccination campaigns.
Indian officials have argued with both Pfizer and its American rival Moderna Inc about how to make their vaccines in India, given their large pharmaceutical capacity.
However, India, the world’s largest vaccine maker, says it relies mainly on vaccines that have already been approved or tested at home to carry out its massive immunization campaign that began on January 16.
Pfizer said its current focus is to distribute the vaccine worldwide using manufacturing capacity in the United States and Europe.
“As soon as the pandemic supply phase is over and we enter the regular supply phase, Pfizer will assess all additional opportunities available,” the document said.
Asked why they did not attend the meetings called by CDSCO, Pfizer said its employees were not given enough notice.
“Company representatives were unable to attend previous meetings due to extremely short notices of a few hours or less and time zone limitations,” said the company.
“We remain committed to engaging with the government of India to make this vaccine available for use by the government of the country.”
(Reporting by Krishna N. Das. Mark Potter edition)