Pharma major Pfizer has withdrawn its application for an emergency-use authorisation of its coronavirus vaccine in India, the company said on Friday, as details of its meetings with drug regulators showed that it had been pressed for more data in order to address some concerns.
Pfizer was the first company to seek an approval when it approached the central drugs standard control organization (CDSCO) on December 7, days after its shot became the first tested dose to be approved anywhere in the world. But the application was pending, with several adjournments in the interim even as the regulator cleared two others that applied much later.
“Pfizer will continue to engage with the authority and resubmit its approval request with additional information as it becomes available in the near future. Pfizer remains committed to making its vaccine available for use by the Government in India and to pursuing the requisite pathway for emergency use authorisation that enables the availability of this vaccine for any future deployment,” the company said in a statement.
The decision appeared to come after the CDSCO’s subject expert committee (SEC) did not recommend granting approval for want of more data in a meeting on February 3. “The committee noted that that the incidents of palsy, anaphylaxis and severe adverse events have been reported during post marketing and the causality of the events with the vaccine is being investigated. Further, the firm has not proposed any plan to generate safety and immunogenicity data in Indian population. After detailed deliberation, the committee has not recommended for grant of permission for emergency use in the country at this stage,” according to the minutes of February 3 meeting made public by CDSCO.
{{/usCountry}}The decision appeared to come after the CDSCO’s subject expert committee (SEC) did not recommend granting approval for want of more data in a meeting on February 3. “The committee noted that that the incidents of palsy, anaphylaxis and severe adverse events have been reported during post marketing and the causality of the events with the vaccine is being investigated. Further, the firm has not proposed any plan to generate safety and immunogenicity data in Indian population. After detailed deliberation, the committee has not recommended for grant of permission for emergency use in the country at this stage,” according to the minutes of February 3 meeting made public by CDSCO.
{{/usCountry}}An official in CDSCO, in the know of things, confirmed the development, and said that the main point of contention was that the company wanted waiver of local trials.
“Their data is robust but it is always good to know how the product will work or behave in the local population, for which the regulatory authorities ask for bridging studies. So far, no foreign product has been allowed for import and to be marketed in India without a local study. It doesn’t have to be a large study, just a small study. But it is important,” said one of the officials requesting, not to be identified.
Pfizer-BioNTech’s is a two-dose mRNA vaccine to be given 21 days apart and requires superfreezing temperatures to store and move, a factor that many see as making it a difficult option for India.