Regulatory panel rejects Pfizer’s application for EUA on safety concerns
3 min read 05 Feb 2021, 04:00 PM ISTAccording to Pfizer’s own global trial, four of the roughly 40,000 participants had suffered Bell’s palsy, a temporary facial paralysis, after they received the mRNA vaccine.
PremiumNEW DELHI : A subject expert committee at India’s drug regulator, Central Drugs Standard Control Organization (CDSCO), on Wednesday rejected the proposal from Pfizer Ltd seeking emergency licensure for its covid-19 messenger RNA vaccine over concerns about the vaccine’s safety and lack of clinical trials.
“The committee noted that incidents of palsy, anaphylaxis and other SAE’s 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," the minutes of a SEC meeting on Wednesday showed, adding that the committee did not recommended granting permission for the vaccine’s emergency use “at this stage".
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According to Pfizer’s own global trial, four of the roughly 40,000 participants had suffered Bell’s palsy, a temporary facial paralysis, after they received the mRNA vaccine. Various news reports have said that there have been incidents of anaphylaxis—a severe allergic reaction—as well as some other serious side-effects.
Recommendation from the SEC is crucial for a company as only after that, the Drugs Controller General of India (DCGI) V.G. Somani, who heads CDSCO, gives his clearance for a proposal, be it for emergency licensure, conducting clinical trial or change in protocols during a trial.
Pfizer on Friday said that it has withdrawn its application for emergency licensure in India for now after the SEC’s decision on Wednesday.
“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. 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 spokesperson said.
The company said that it remains committed to making its mRNA vaccine, which it developed with German firm BioNTech, available for use by the Indian government. The US-based company only wants to provide the vaccine to the government and is not keen on supplying it in the private market.
Pfizer had approached the Drugs Controller General of India V.G. Somani for emergency authorisation of its messenger RNA vaccine in December along with Bharat Biotech International and Serum Institute for India.
While, Bharat Biotech and Serum Institute had received the nod for Covaxin and Covishield from Somani on 3 January and began vaccination 13 days later, Pfizer had so far not made its presentation to the SEC.
The government also has not shown much interest in using the Pfizer vaccine in India due to its high cost and requirement of -70 degree Celsius ultra-low temperature freezers.
Pfizer's mRNA vaccine costs $19.5 per dose in the US. While it has said it will provide the vaccine at a lower cost in India, expectation is it will still be more expensive than Serum Institute's Covishield that costs ₹200 per dose, a little less $3, for the Indian government. Bharat Biotech has priced Covaxin at ₹295 ($4 per dose).
Further, Pfizer's trial in the US and other countries had a very low representation of Asians.
Only 4.3% of the 40,000-odd participants in its global phase 3 trial were Asian, while the efficacy rate for the diverse ethnic group was 74.4%. In contrast, the company’s overall efficacy was 95% for a cohort, which comprised 83% whites, according to the documents published by the US FDA.
Ethinicity and regional variations have an impact on vaccine efficacy, and despite the lack of data on Indians, the company had sought a waiver on local clinical trial in the form of a phase 2 and 3 bridging study, similar to what Serum Institute of India did for Covishield and Dr Reddy’s Laboratories is doing for Sputnik V vaccine.
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