The drug regulator’s subject expert committee (SEC) on Covid vaccines is likely to again meet next week if the two companies come up with the requisite data.
At present, the Drugs Controller General of India (DCGI) has granted marketing approval to the two vaccines – Covaxin and Covishield – with certain conditions for restricted use, which indicates the jabs can be administered only under the government’s vaccination programme and cannot be sold in the retail market. The conditions have been imposed because the vaccines were given accelerated approval based on limited clinical trial data in an emergency pandemic situation.
“Permission for marketing the vaccine in the retail market cannot be given to Covid vaccines as long as the pandemic situation exists. Allowing sale in retail market will create multiple challenges in monitoring its production, availability and administration. Besides, how are we going to issue vaccination certificates if vaccines are available in open market,” a senior official told TOI.
Currently, Covid vaccines are not available in open retail market in any country. Also, there are other conditions imposed such as the companies are required to submit safety data every 15 days. Also, a large spectrum of side-effects, including anxiety are covered under adverse events following immunisation that these companies are required to track and report to the regulator on a regular basis.
While a total of over 156 crore doses of vaccines – majority comprises Covishield (86%) and Covaxin(13%) – have been administered so far, it is possible that some of the conditions can be removed.
The SEC have asked the companies for six months safety data to consider waiving certain conditions.
The SII has also been asked to submit data related to neurological effects due to Covishield, an official said.