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Why India’s expert panel rejected Pfizer plea for emergency use nod to its Covid vaccine

The Drug Controller General of India has in the past rejected several applications from other drugmakers, including Dr Reddy Laboratory and Natco Pharma.

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New Delhi: The Narendra Modi government’s expert panel has rejected drugmaker Pfizer’s application seeking emergency nod for its Covid-19 vaccine after the company insisted on waiver of clinical trial in India, ThePrint has learnt.

The American pharma giant Friday announced its decision to withdraw the application, a day after participating in the expert panel meeting to seek an emergency nod. 

According to the minutes of the meeting of the Subject Expert Committee (SEC) and two official sources, the company wasn’t keen on conducting the “bridging trials” in India and had requested for waiving off clinical trials despite some side-effects being reported in various countries.

Bridging trial is a supplementary trial performed in a new region or country to get more clinical data on efficacy, safety and dose regimen.

“The firm presented its proposal for emergency use authorisation of Covid-19 mRNA Vaccine BNT162b before the committee. The committee noted that incidents of palsy, anaphylaxis and other SAEs (serious adverse events) have been reported during post-marketing and the causality of the events with the vaccine is being investigated,” read the minutes of the meeting, dated 3 February, uploaded on the Central Drugs Standard Control Organisation’s (CDSCO) website. 

The SEC advises the apex drug regulator, Drug Controller General of India (DCGI), on applications seeking approvals for new drugs, vaccines and clinical trials. The DCGI heads the CDSCO, the health ministry arm that regulates the quality of drugs and vaccines in India. 

The minutes also noted that “the firm has not proposed any plan to generate safety and immunogenicity data in Indian population”.

Following the discussion, “after detailed deliberation, the committee has not recommended for grant of permission for emergency use in the country at this stage”, it stated.

Also read: Why a ‘mucosal’ Covid vaccine has a better shot at ending the pandemic

Pfizer argued to use global data for approval  

According to a source who is part of the SEC panel, conducting local trials was deemed necessary as the company did not have “enough data on trial participants of Indian ethnicity”.

The company, according to SEC and CDSCO sources, had argued that the panel should consider the data submitted by them, which showed safety and efficacy in global trials such as in the US, the UK and other countries.

“We had asked for data on participants of Indian origin for considering their request of waiver, but they were unable to provide the same. The request, hence, was deemed unfit due to lack of complete data,” said a source from CDSCO. 

“Moreover, the company did not express any interest in conducting bridging trials in India, which were earlier conducted by Serum Institute of India for receiving approval for Astra-Zeneca & Oxford University vaccine where global data was also present.”

ThePrint reached Pfizer through email for an official comment on this but received no response until the time of publishing this report.

Earlier, announcing its decision to withdraw application for emergency use of its vaccine in India, the company said in a statement: “In pursuance of the Emergency Use Authorisation of its COVID-19 vaccine, Pfizer participated in the Subject Expert Committee meeting of the Drug Regulatory Authority of India on February 3.”

It added: “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.”

No approvals without local clinical trials 

The drug regulator has rejected several applications from other drugmakers on the same ground.

It recently turned down Dr Reddy Laboratory’s request for approving Olokizumab. The drug is manufactured by Russian drugmaker R-Pharm to treat rheumatoid arthritis drug, which the company is now trying to repurpose for Covid-19.

It also rejected the request of Natco Pharma, which sought emergency use of Baricitinib tablets for Covid, and recommended that “the firm should conduct the Phase III clinical trial”.

Also read: Covid vaccine Sputnik V has 91.6% efficacy, Lancet report says. Makers expecting India nod


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