The United Kingdom drug regulator cleared the Oxford-AstraZeneca vaccine for use on Wednesday, making it very likely that Covishield, the variant of the vaccine being tested and manufactured under licence by Pune-based Serum Institute of India (SII), will become the first vaccine to be approved for use in this country. A final decision on the clearance is likely to come by the end of this week.
Following the nod for the vaccine in the UK, a subject expert committee (SEC) of the Indian regulator was considering a request from SII for similar approval in India under emergency circumstances, a senior government official said.
Hyderabad-based Bharat Biotech, which has developed Covaxin, its own candidate vaccine against the novel coronavirus, was learnt to have also made a presentation before the independent expert committee on Wednesday to push for emergency approval.
The SEC was unable to come to a decision on the matter by Wednesday evening, and has decided to reconvene in the new year to finish its deliberations on the two applications. Sources close to the development told The Indian Express that the SEC has sought additional information from the companies related to their candidates.
“From SII, [they] have asked for information like a fact sheet of information about the vaccine for the general public, and product information that will be included like a package insert. The MHRA had also given its approval to AstraZeneca with some conditions, so [the SEC] wants to know what these conditions are,” said one of the sources on condition of anonymity.
India is heavily invested in the Oxford-AstraZeneca and Bharat Biotech vaccines, both of which are being manufactured in large volumes here. Covishield and Covaxin don’t require super-cold storage temperatures, and are likely to be significantly cheaper than the mRNA options.
“From Bharat Biotech, [they] have sought updated information [on their ongoing] trials,” the source added.
The SEC was also supposed to take up a request by the Indian arm of the American drug giant Pfizer to waive clinical trials for its mRNA vaccine candidate, which has not been tested in India. However, the company has requested for more time, the government said.
“Further time was requested on behalf of Pfizer. The additional data and information presented by SII and Bharat Biotech Pvt Ltd was perused and analysed by the SEC,” the Ministry of Health and Family Welfare said in an official release. “The analysis of the additional data and information is going on. SEC will convene again on 1st January 2021 (Friday),” it said.
AZD1222, the candidate on which Covishield is based, received the approval of the UK Medicines and Healthcare products Regulatory Agency (MHRA) for “emergency” use on people aged 18 years and above. According to AstraZeneca, which developed the vaccine with the University of Oxford, the approval recommends two doses administered at an interval of 4 to 12 weeks.
“Additional safety and efficacy data for the vaccine will continue to accumulate from ongoing clinical trials…AstraZeneca is also seeking Emergency Use Listing from the World Health Organisation for an accelerated pathway to vaccine availability in low- and middle-income countries,” the Swedish-British firm said in a statement on Wednesday.
SII CEO Adar Poonawalla described the UK clearance for the vaccine as “great and encouraging news”. He said, “We will wait for the final approval from Indian regulators.”
A recommendation by the SEC in favour of approving Covishield based on data submitted by SII and the approval of AZD1222 by the UK MHRA, will pave the way for the Drug Controller General of India (DCGI), Dr V G Somani, to grant approval to the vaccine candidate in India.
Poonawalla had said in a virtual press conference on Monday that the firm expected the regulator’s approval for its variant of AZD1222 to come “in a few days” — and that the vaccine should, therefore, be licensed in the country by January. The firm has manufactured over 40 million doses of Covishield so far, and plans to ramp up its capacity to 100 million a month by the end of February.
SII had approached the Central Drugs Standard Control Organisation (CDSCO) earlier this month seeking approval for Covishield despite not having completed its phase 2/3 clinical trials of the candidate here. Its application was based on data from global trials on the efficacy of the AZD1222 candidate — that is, its ability to bring down the number of symptomatic Covid-19 cases. SII had supplemented this data with interim safety data from its trial on 1,600 participants in India.
On December 9, the SEC looking into the application had told SII that it needed to submit additional late-stage safety and efficacy data from its ongoing trial. SII had submitted this additional data within two weeks.
Bharat Biotech, which had only submitted interim safety and immunogenicity data from phase 1 and 2 trials of Covaxin, was also told to submit additional data, especially from its ongoing phase 3 trial.