A day after the Indian subsidiary of pharma giant Pfizer sought emergency use authorisation for its Covid-19 vaccine candidate, the Drug Controller General of India (DCGI) has placed it before a committee of experts to examine the data of its clinical trial conducted abroad, The Indian Express has learnt.
Pfizer has become the first vaccine manufacturer to have sought fast-track approvals for commercial use of its vaccine.
However, top government sources underlined that the regulatory process of emergency authorisation approvals for vaccine candidates being tested in India, specifically the one being developed by Oxford-AstraZeneca at Serum Institute of India and ICMR-Bharat Biotech’s Covaxin vaccine candidate, are set to take place in the next few days.
“The Prime Minister has already said that a vaccine tested here will be ready in the next few weeks after regulatory approvals,” sources said.
On Pfizer, sources confirmed that DCGI has now forwarded the application submitted by Pfizer India to the Subject Expert Committee for detailed scrutiny of the clinical trials data. The SEC, which consists of a panel of experts, will be giving its recommendations to the regulator, on the basis of which a decision will be taken, sources said.
On December 2, UK became the first country to grant temporary authorisation for the emergency use of Pfizer’s mRNA vaccine (BNT162b2) against Covid-19. “The request by Pfizer has been placed before the subject expert committee late Saturday evening. The company submits the safety, efficacy, and immunogenicity data, and also informs whether the data is complete or incomplete. The SEC examines this data, can hold virtual meetings or can seek further clarifications,” sources said.
Eye on Indian candidate
Pfizer has become the first firm to seek emergency authorisation approval for its Covid-19 vaccine candidate. However, the Prime Minister has reiterated that an Indian vaccine candidate will be ready in the next few weeks, a clear indication that the Indian regulator will soon be fast-tracking the process of granting approvals to vaccines tested in India.
In its application, Pfizer has sought permission to import its vaccine and also to waive the need for clinical trials on the Indian population under relevant provisions of the New Drugs and Clinical Trial Rules, 209. Sources said the waiver sought by the firm will be “scrutinised by the SEC”.
On Sunday, UK’s National Health Service said people aged 80 and above as well as care home workers will be the first to receive the vaccine, along with NHS workers.
On November 20, Pfizer said it had requested the US Food and Drug Administration for emergency use authorisation for their vaccine candidate. The US regulator is scheduled to meet on December 10 to take decision on granting approvals to Pfizer.
Pfizer has said that the final efficacy analysis of their ongoing Phase 3 clinical trial indicates an efficacy rate of 95 per cent in volunteers without prior SARS-CoV-2 infection. “Efficacy was consistent across age, gender, race, and ethnicity demographics. The observed efficacy in adults over 65 years of age was over 94%,” the company has said.