New Delhi: Covid Vaccine will not be available on the retail market in the near future, even when the Regulator Expert Committee has requested Bharat Biotech and Serum Institute of India (SII) to submit some additional data for covaxin and covishield, based on what will be considered to release conditions certain which is part of the current regulatory approval given to two jabs, the official source said.
The subject committee of the drug regulator (SEC) on the Covid vaccine is likely to meet again next week if the two companies produce data needed.
At present, the controller of the Indian Medicine (DCGI) has provided marketing approval to two vaccines – Covaxin and Covishield – with certain conditions for limited use, which shows Jab can only be sold under the government vaccination program and cannot be sold in the retail market.
Conditions have been put in place because vaccines are given accelerated approval based on limited clinical trial data in the emergency pandemic situation.
“Permit to market vaccines in the retail market cannot be given to the Covid vaccine during the pandemic situation there.
Allowing sales in the retail market will create many challenges in monitoring production, availability and administration.
In addition, how we will issue a vaccination certificate if the vaccine is available on the market Open, “said a senior official to Ti.
At present, covid vaccines are not available in the retail market open in any country.
Also, there are other conditions imposed such as companies required to send safety data every 15 days.
Also, the large spectrum of side effects, including anxiety covered in bad events after immunization that these companies are required to track and report to regulators regularly.
While a total of more than 156 doses of crore vaccines – the majority consist of covishield (86%) and covaxin (13%) – has been provided so far, it is possible that some conditions can be removed.
The SEC has asked the company for six months of data security to consider ruling out certain conditions.
SII was also asked to submit data related to the neurological effects because of the covishield, the official said.