The central government’s Subject Expert Committee (SEC) on Friday rejected the Serum Institute of India’s (SII) request to approve the third dose of Covishield, sources told CNN-News18. The SEC, at a meeting, reviewed the SII’s application — which was submitted earlier this month before the Drugs Controller General of India (DGCI) — and decided against recommending a third Covishield dose. The panel has sought additional data from the SII on the need to add the third shot in the current vaccine format, sources added.
The SII had sought the approval to administer the third dose of its vaccine, citing adequate stock of the jab and rising demand for booster shots amid the emergence of new coronavirus variants.
Prakash Kumar Singh, Director, Government and Regulatory Affairs at SII, had at the time cited that the UK’s Medicines and Healthcare products Regulatory Agency has already approved the booster dose of AstraZeneca ChAdOx1 nCoV-19 vaccine. “People of our country, as well as citizens of other countries who have already been fully vaccinated with two doses of Covishield, are also continuously requesting our firm for booster dose,” Singh had stated in an application submitted before the DGCI.
At the meeting today, the SEC also did not consider a request made by pharma company Biological E for clinical trials of an additional dose of Corbevax for those inoculated with either Covishield or Covaxin. The Hyderabad-based company had in October issued a statement saying that several studies have suggested that antibodies may decline even among vaccinated individuals and many countries have already started administering or are mulling booster doses. The company had stated that it, therefore, wants to examine the safety of its single-dose vaccine, Corbevax, among inoculated individuals.
Corbevax, the third made-in-India jab against coronavirus, is a recombinant protein subunit vaccine, which is made by using a specific part of the SARS-CoV-2 virus — the spike protein on the virus’s surface. The other two indigenous vaccines are Bharat Biotech’s Covaxin and Zydus Cadila’s ZyCoV-D.
India has not yet come up with a policy for administering the additional third dose to its people even as several countries have already begun administering booster shots to its citizens. Recently, at a meeting of a department-related standing committee for health and family welfare, Indian Council of Medical Research chief Dr Balram Bhargava said that the additional dose should be taken not before nine months of taking the second dose. He also said the central government is not calling it the ‘booster dose’ and what it should be called is the ‘third dose’.
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