iNDICA NEWS BUREAU-
On Friday, January 5, the US pharmaceutical major Pfizer decided to take a step back and withdrew its application for Emergency Use Authorization (EUA) of its COVID-19 vaccine in India.
The reason for this withdrawal is cited as failing to meet the drug regulator’s demand for a local safety and immunogenicity study.
Pfizer was the first pharmaceutical firm to seek an emergency use authorization from the Drugs Controller General of India (DCGI) for its COVID-19 vaccine in the country after it secured such clearance in the UK and Bahrain.
However, on its website, the drug regulator said its experts did not recommend the vaccine because of side effects reported abroad were still being investigated. It also said Pfizer had not proposed any plan to generate safety and immunogenicity data in India.
“In pursuance of the Emergency Use Authorization of its COVID-19 vaccine, Pfizer participated in the Subject Expert Committee meeting of the Drug Regulatory Authority of India on February 3. Based on the deliberations at the meeting and our understanding of additional information that the regulator may need, the company has decided to withdraw its application at this time,” a company spokesperson said in a statement.
The decision basically means that Pfizer vaccine Comirnaty will not be available India and China, for the moment.
Indian health officials say they generally ask for so-called bridging trials to determine if a vaccine is safe and generates an immune response in its citizens. There are, however, provisions under India’s rules to waive such trials in certain conditions.
Pfizer will continue to engage with the authority and resubmit its approval request with additional information as it becomes available in the near future, the statement said.
“Pfizer remains committed to making its vaccine available for use by the Government in India and to pursuing the requisite pathway for emergency use authorization that enables the availability of this vaccine for any future deployment,” the spokesperson said.
Pfizer in its application submitted to the drug regulator in December 2020, had sought permission to import the vaccine for sale and distribution in India, besides waiver of clinical trials on Indian population in accordance with the special provisions under the New Drugs and Clinical Trials Rules, 2019, official sources had told reports.