Pfizer says its application is supported by data from a global study that shows an overall efficacy rate of 95% with no vaccine-related, serious 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) and they have given EUA [based on] ... that data," the firm said in an emailed response to questions, including on India's demand for a local trial.
"Given our exclusive priority to government supply, we look forward to a confirmation from the government on necessary supplies, [on the] basis [of] which we will take the regulatory process forward, as we have done across the world," it added.
Last week, government officials in some EU countries said Pfizer had slashed in half deliveries to them, causing frustration and hampering vaccination drives.
Indian officials have had discussions with both Pfizer and its U.S. rival Moderna Inc about making their shots in India, given its large pharmaceutical capacity.
However, India, the world's biggest vaccine maker, says it is mainly relying on shots already approved or tested at home to run its massive immunisation campaign that began on Jan. 16.
Pfizer said its current focus was on distributing the vaccine around the world using manufacturing capacity in the United States and Europe.
"Once the pandemic supply phase is over and we enter a phase of regular supplies, Pfizer will evaluate all additional opportunities available," it said.
Asked why it did not attend meetings called by the CDSCO, Pfizer said its officials had not been given enough notice.
"The company representatives have been unable to participate in previous meetings due to extremely short notices of a few hours or less and time-zone limitations," the company said.
"We remain committed to engaging with the Government of India to make this vaccine available for use by the government in the country."
Business Standard has always strived hard to provide up-to-date information and commentary on developments that are of interest to you and have wider political and economic implications for the country and the world. Your encouragement and constant feedback on how to improve our offering have only made our resolve and commitment to these ideals stronger. Even during these difficult times arising out of Covid-19, we continue to remain committed to keeping you informed and updated with credible news, authoritative views and incisive commentary on topical issues of relevance.
We, however, have a request.
As we battle the economic impact of the pandemic, we need your support even more, so that we can continue to offer you more quality content. Our subscription model has seen an encouraging response from many of you, who have subscribed to our online content. More subscription to our online content can only help us achieve the goals of offering you even better and more relevant content. We believe in free, fair and credible journalism. Your support through more subscriptions can help us practise the journalism to which we are committed.
Support quality journalism and subscribe to Business Standard.