BackSEC seeks more time to analyse data on Covishield, Covaxin; next meet on Friday
Serum Institute's proposal taken up on day when UK MHRA gives emergency authorisation to AstraZeneca vaccineAstraZeneca-Serum vaccine is one of the most significant so far in the global fight against covid-19 as it will be priced as little as $3 per dose
PremiumOn a day when the UK regulator gave an emergency authorisation to AstraZeneca's covid-19 vaccine, an subject expert committee in India on Wednesday sought more time to analyse the additional data given by Serum Institute of India and Bharat Biotech International while seeking emergency licensure for their covid-19 vaccines, the health ministry said in a statement on Wednesday.
The SEC, an independent panel of experts set up by the Drug Controller General of India V.G. Somani to vet these proposals, will next meet in Friday, and may also take up the proposal by Pfizer, which had sough more time, the government said. Pfizer had sought an emergency licensure 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 1st January 2021 (Friday)," the health ministry said.
Usually, the DCGI clears a proposal for approval or emergency licensure only when it is recommended by the SEC.
The deferment of decision on the two companies' porposals to Friday is especially significant for Serum Institute, whose proposal was taken after the UK Medicines and Healthcare products Regulatory Agency (MHRA) had given an emergency authorisation to AstraZeneca’s covid-19 vaccine for immunising people that are 18 years or older. The authorisation recommends two full doses administered with an interval of between four and 12 weeks, the Anglo-Swedish firm said.
Covishield is Serum Institute’s version of the vaccine originally co-developed by AstraZeneca and the University of Oxford.
Serum Institute had submitted its proposal for emergency licensure for the vaccine earlier this month, but an independent expert committee set up by the DCGI to vet the submissions had asked the company to return with updated data and after an approval was given by the UK MHRA to AstraZeneca for the original version. The original version was co-developed by AstraZeneca and the University of Oxford, with AstraZeneca having the commercial rights.
“This is a great and encouraging news. We will wait for the final approval from Indian regulators," Serum Institute chief executive officer Adar Poonawalla said after the UK MHRA authorisation to AstraZeneca.
AstraZeneca had 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 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 globally 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 as little as $3 per dose, compared to the two messenger RNA vaccines by US firms Pfizer and Moderna, which were recently authorised in the US, that 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 degree 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.
A comment from Serum Institute CEO Adar Poonawalla on the SEC's decision was not immediately available at the time of publishing.
Efficacy results of AstraZeneca’s vaccine, which it has co-developed with Oxford University, sparked a controversy after it claimed that a dosing error increased the effectiveness of the vaccine. Soriot admitted that 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. Instead, the researchers said they had stumbled upon it by accident and called the superior results “serendipity".
Serum Institute, the contract manufacturer of the vaccine, conducted its own phase 2 and 3 bridging study in India using two full doses, which showed 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.
Poonawalla on Monday also said the vaccine is expected to get an emergency-use licence from the UK Medicines and Healthcare products Regulatory Agency and the Indian regulator by early January.
The company has manufactured 40-50 million doses so far and would sell these shots primarily in India initially.
The company is manufacturing 50-60 million doses of Covishield a month and will increase its capacity to 100 million doses by March after commissioning its third plant. Poonawalla said he expects a shortage of vaccines in the first six months, but after that, as more vaccine manufacturers’ products are launched, the supply-demand mismatch will ease.
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