An expert committee under the country’s top drug regulator recommended on Friday that Covishield, the Indian version of the Covid-19 vaccine developed by the University of Oxford and AstraZeneca, should be approved with certain conditions, The Indian Express has learnt.
The recommendation is enormously significant, as it paves the way for India to get its first vaccine against the novel coronavirus that has killed almost 1.5 lakh and sickened more than 1 crore Indians.
The recommendation of the Subject Expert Committee (SEC) has come two days after regulators in the United Kingdom approved the use of the Oxford-AstraZeneca vaccine among the British public. The expert body in India was at the time considering an application for clearance for Covishield, which is being tested and manufactured under licence by Serum Institute of India (SII).
The SEC had on Wednesday sought additional information from the Pune-headquartered firm, including a fact sheet of information about the vaccine for the general public.
It had also asked for details of the product that would be included in the package insert, as well as the specific conditions that the UK Medicines and Healthcare products Regulatory Agency (MHRA) had imposed on AstraZeneca while granting emergency authorisation for its candidate, known as AZD1222.
The SEC, which reconvened on Friday to make a decision on SII’s application, recommended that the Central Drugs Standard Control Organisation (CDSCO) should grant approval to Covishield despite the candidate not having completed phase 2/3 clinical trials in India, a source close to the development told The Indian Express. The panel has recommended the approval of two full doses of the vaccine that should be administered around 4-6 weeks apart, the source said.
While details of the panel’s meeting were not public by press time on Friday, The Indian Express has learnt that the approval has been recommended on condition that SII submits details of any adverse events arising from the administration of the vaccine to the drug regulator every 15 days. The fact sheet sought by the committee on Wednesday is also to be made available for those being vaccinated, according to the source.
“The company should continue with the trial that is going on. Every 15 days, they should report any adverse events (to CDSCO),” the source said on condition of anonymity.
If the Drug Controller General of India (DCGI) greenlights this, SII will be able to supply Covishield to the government for mass vaccination before it completes these trials.
AZD1222, on which Covishield is based, received the approval of the UK MHRA for “emergency” use on people aged 18 years and above. According to AstraZeneca, the approval recommends two doses administered at an interval of 4 to 12 weeks.
The SEC on Friday also told Hyderabad-headquartered Bharat Biotech to expedite recruitment of volunteers for ongoing late stage human clinical trials of its Covid-19 vaccine candidate, Covaxin, the source said. The committee had asked the company to submit an interim analysis of the efficacy of the vaccine candidate – its ability to bring down the number of symptomatic Covid-19 cases.
“The efficacy trial (of Covaxin) is still going on…they (Bharat Biotech) have to come back at the earliest (with this interim analysis),” the source said.
Bharat Biotech is presenting its case for similar approval for Covaxin, as it too, has not finished late stage human trials on over 25,000 participants across the country. The firm had initially submitted only interim safety and immunogenicity data from early-stage clinical trials, and had been asked by the SEC on Wednesday to submit additional, updated trial information for consideration.
While it is unclear how soon DCGI Dr V G Somani will take the final call on approving Covishield, regulatory processes during the pandemic, especially for Covid-19 medicines and vaccines, have been fast-tracked considering the urgency of the situation.
Expert meetings and approvals for such products do not take more than five days, a senior government official close to the development had earlier told The Indian Express.
SII CEO Adar Poonawalla had said at a virtual press conference on Monday that the firm expected the regulator’s approval for Covishield to come “in a few days” — and that the vaccine should, therefore, be licensed in the country in January.
SII has manufactured over 40 million doses of Covishield so far, and currently has a capacity to make around 50-60 million doses a month. It expects to ramp up this capacity to around 100 million a month by the end of February.
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