Home >News >India >India defers nod to SII, Bharat Bio vaccines

An expert panel advising the drug regulator on covid-19 vaccines on Wednesday said it needs more time to analyse clinical trial data submitted by Serum Institute of India (SII) and Bharat Biotech International in support of their applications for emergency licences.

The panel met on a day the UK regulator gave emergency authorization to AstraZeneca’s vaccine. Serum Institute is seeking emergency use licence for a version of the British drugmaker’s vaccine.

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The subject expert committee, an independent panel of experts set up by Drugs Controller General of India (DCGI) V.G. Somani to vet vaccine proposals, will next meet on Friday and may also take up the proposal from Pfizer, the government said.

Pfizer has sought an emergency licence for import of the vaccine into India, as well as a waiver on clinical trials in India.

“The analysis of the additional data and information is going on. SEC will convene again on 1 January 2021 (Friday)," the health ministry said.

Typically, the DCGI clears a proposal for approval or emergency licence only when it is recommended by the SEC.

The deferment is particularly significant for Serum Institute’s vaccine candidate Covishield.

Serum Institute’s proposal was taken up after the UK Medicines and Healthcare products Regulatory Agency gave emergency authorization to the vaccine jointly developed by AstraZeneca and Oxford University for immunizing people who are 18 years or older. The authorization is for two full doses administered with an interval of between four and 12 weeks, AstraZeneca said.

Speaking at an event on Monday, Serum Institute chief executive officer (CEO) Adar Poonawalla said that the vaccine is expected to get an emergency-use licence from the Indian regulator by early January.

Serum Institute had submitted its proposal earlier this month. The expert committee asked it to submit updated data after the UK regulator gave its approval to AstraZeneca’s original version.

“This is great and encouraging news. We will wait for the final approval from Indian regulators," Poonawalla said after the UK authorization to AstraZeneca.

A comment from Poonawalla on the expert panel’s decision was not immediately available at the time of publishing.

AstraZeneca signed a pact with Serum Institute earlier this year, where the Indian firm would contract manufacture and supply 1 billion doses of the vaccine for low-and-middle-income countries, with a commitment to provide 400 million doses before the end of 2020.

Including its pact with other manufacturers globally, AstraZeneca has a manufacturing capacity of up to three billion doses of the vaccine in 2021.

The AstraZeneca-Serum vaccine is one of the most significant so far in the global fight against covid-19 as it will be priced at as little as $3 per dose. The two messenger RNA (mRNA) vaccines by US firms Pfizer and Moderna that were recently authorized in the US are charging at least six times the amount.

Also, unlike the mRNA vaccines that require sub-zero temperatures, AstraZeneca-Serum vaccine can be stored at 2-8 degrees Celsius.

“It has been shown to be effective, well-tolerated, simple to administer and is supplied by AstraZeneca at no profit," AstraZeneca chief executive officer Pascal Soriot said.

To be sure, AstraZeneca’s vaccine sparked a controversy after it claimed that a dosing error increased the effectiveness of the vaccine. Soriot admitted in an interview with Britain’s Sunday Times newspaper earlier this week: “We would have preferred a simpler set of results."

AstraZeneca’s clinical trials for its vaccine in the UK and Brazil included two separate dosing regimens. A lower dosage gave a greater efficacy of 90% while two full doses a month apart gave a 62% efficacy.

Researchers were unable to explain why the lower dosing regimen—a half dose followed by a full dose one month later—was more effective, calling it “serendipity".

Serum Institute conducted its own phase 2 and 3 bridging study in India using two full doses, which had shown a 62% efficacy in AstraZeneca’s trial. Bridging studies look at safety and immune response to prove that the version being contract manufactured is the same as the original.

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