A committee of experts from 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 under certain conditions, The Indian Express has learned.
The recommendation is hugely significant as it paves the way for India to get its first vaccine against the new coronavirus that has killed nearly 1.5 lakh and sickened more than 1 crore of Indians.
The recommendation of the Subject Matter Expert Committee (SEC) came two days after UK regulators approved the use of the Oxford-AstraZeneca vaccine among the British public. The Indian body of experts was at the time considering an application for authorization for Covishield, which is being tested and manufactured under license by the Serum Institute of India (SII).
On Wednesday, the SEC had sought additional information from the Pune-based firm, including a fact sheet on the vaccine for the general public.
It had also asked for details of the product that would be included in the prospectus, as well as the specific conditions that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) had imposed on AstraZeneca when granting emergency clearance for its candidate, known as AZD1222. .
Preparation for the Covid-19 vaccination test at a clinic in New Delhi on Friday. (Express Photo by Praveen Khanna)
The SEC, which met again on Friday to make a decision on the SII application, recommended that the Central Standard Drug Control Organization (CDSCO) grant approval to Covishield even though the candidate has not completed clinical trials. phase 2/3 in India, a source close to told The Indian Express the development. The panel recommended approval of two full doses of the vaccine to be administered 4-6 weeks apart, the source said.
While details of the panel meeting were not public as of press time Friday, The Indian Express learned that approval was recommended on the condition that the SII submit details of any adverse events arising from the administration of the vaccine to the drug regulator every 15 days. . The fact sheet requested by the committee on Wednesday will also be available to those who get vaccinated, according to the source.
“The company should continue with the test that is being carried out. Every 15 days, they must report any adverse event (to CDSCO), ”said the source on condition of anonymity.
If the Comptroller General of Drugs of India (DCGI) approves this, the SII will be able to supply Covishield to the government for a mass vaccination before it completes these trials.
AZD1222, on which Covishield is based, was approved by the UK MHRA for ’emergency’ use in people aged 18 years and over. According to AstraZeneca, the approval recommends two doses given 4 to 12 weeks apart.
On Friday, the SEC also told Hyderabad-based Bharat Biotech to accelerate the recruitment of volunteers for ongoing advanced-stage human clinical trials of its Covid-19 vaccine candidate, Covaxin, the source said. The committee had asked the company to present an interim analysis of the efficacy of the candidate vaccine, its ability to reduce the number of symptomatic cases of Covid-19.
“The (Covaxin) efficacy test is still ongoing … they (Bharat Biotech) have to come back as soon as possible (with this interim analysis),” the source said.
Bharat Biotech is making its case for a similar approval for Covaxin, as it has also not completed late-stage human trials on more than 25,000 participants nationwide. Initially, the firm had submitted only interim safety and immunogenicity data from early-stage clinical trials, and the SEC had asked it on Wednesday to submit additional and updated trial information for its consideration.
While it is unclear how soon DCGI Dr. VG Somani will take the last call to approve Covishield, regulatory processes during the pandemic, especially for Covid-19 drugs and vaccines, have been sped up considering the urgency of the situation.
Expert meetings and approvals for such products take no more than five days, a senior government official close to development previously told The Indian Express.
SII CEO Adar Poonawalla had said in a virtual press conference on Monday that the company expected regulator approval for Covishield to come “in a few days” and that therefore the vaccine should be licensed in the country in January.
SII has manufactured more than 40 million doses of Covishield so far and currently has a capacity to produce between 50 and 60 million doses per month. It expects to increase this capacity to around 100 million a month by the end of February.
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