In a big boost to India’s fight against coronavirus, an expert panel of the central drug authority on Wednesday cleared Covaxin and Covishield for full use, a year after the vaccines were given emergency approval.
While the vaccines are already available at hospitals and clinics registered with the government portal CoWIN, they will soon be on sale in the market under certain conditions.
The development comes as the government deliberates over the booster dose policy. Precautionary third doses of vaccines — announced by Prime Minister Narendra Modi last month — are now being given to health and frontline workers and adults above 60 years of age, dealing with illnesses. The recommended period, however, between the second and the third dose is currently nine months.
Wednesday’s recommendation by the expert panel of the Central Drugs Standard Control Organisation (CDSCO) has been sent to the top drug regulator DCGI.
The vaccines won’t be available over the counter and registration on CoWIN will be necessary, sources say.
SEC of CDSCO has recommended for upgrade of covishield and covaxin status from restricted use in emergency situations to grant of new drug permission with conditions In adult population ,DCGI will evaluate the recommendations and give its decision.
— CDSCO_INDIA_INFO (@CDSCO_INDIA_INF) January 19, 2022
“SEC of CDSCO has recommended for the upgrade of Covishield and Covaxin status from restricted use in emergency situations to grant of new drug permission with conditions in the adult population, DCGI will evaluate the recommendations and give its decision,” the regulatory body tweeted.
A few weeks back, the Serum Institute of India had urged the centre to give market approval to its Covishield, underlining that over a billion doses of the vaccine have been given worldwide and it’s safe. Covishield accounts for nearly 90 per cent of vaccinations in the country.
Sources say 300 million doses of the vaccine are presently stocked with the SII.
Bharat Biotech too had sought a similar prescription-based nod for the homegrown Covaxin.
With over 158 crore doses given so far in India, a market approval means that booster shots would soon be available for those in need, apart from the frontline workers and senior citizens, which may lead to big changes in the centre’s policy.
A key question that remains, however, is if the interval between the second and third dose can be brought down to six months – the usual interval period being followed in many parts of the world as the antibody count starts depleting after that.
Also, as per the government policy, a mix-and-match of vaccines is not an option for now.
This morning, India logged 2.82 lakh fresh cases – over 18 lakh cases have been registered in the last one week in an Omicron-driven surge. The big cities, however, are now witnessing a drop in daily cases.