New Delhi, Dec 30: On 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 first doses are being released Wednesday and vaccination will start Monday. AstraZeneca says it aims to supply millions of doses in the first quarter.
The vaccine should be capable of fighting the new variant of the coronavirus responsible for a surge of cases in the UK, according to AstraZeneca CEO Pascal Soriot
“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.
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.