Updated: January 20, 2022 7:34:53 am
The subject expert panel on Covid-19 vaccines on Wednesday recommended to regulator Central Drugs Standard Control Organisation (CDSCO) to grant Serum Institute of India’s Covishield and Bharat Biotech’s Covaxin full market authorisation with conditions for the adult population. The recommendations will be evaluated and a decision will be taken, the regulator said.
Since January last year, Covishield and Covaxin have been available under Emergency Use Authorisation (EUA). The EUA route, which in India is termed as restricted use in emergency situations, is invoked in public health emergencies like a pandemic, provided that the regulator, based on initial data from phase 3 of clinical trials, determines that the potential benefits of the vaccine, when used to prevent Covid-19, outweigh its potential risks.
Scientifically, Wednesday’s recommendations mean that the two vaccines now meet the high standard of safety, effectiveness and manufacturing quality that the Drugs and Cosmetic Act required of a new vaccine.
“The subject expert committee 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 the adult population. DCGI will evaluate the recommendations and give its decision,” the drug regulator said in a tweet.
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In August last year, Pfizer’s mRNA vaccine, received the full FDA approval for individuals 16 years and older.
The expert panel’s recommendations are based on long-term followup data of Covishield and Covaxin, which show significant efficacy in preventing the severe infection as well as safety profile of the vaccines.
As on Wednesday, 137 crore doses of Covishield and 21.75 crore doses of Covaxin have been administered across the country.
Currently, the two vaccines can be administered only under the government’s vaccination drive – and all the vials manufactured are tracked by the government. Under the present conditions of the EUA, these vaccines cannot be sold in the retail market.
On Wednesday, the regulator said the expert panel’s recommendations are based on certain conditions. Therefore, the key question, that currently remains unanswered, is if full licensure would result in the two manufacturers selling the vaccines in the retail market.
Since vaccination certificates are generated after every dose, it is likely that the government will continue to monitor and track these two vaccines, even if they are available in open market. Therefore, it is unlikely that these two vaccines will be made available in the over the counter purchase at the chemists.
Second, after these vaccines are administered, the beneficiaries are monitored by trained health professionals – and adverse events following immunisation are captured on the government’s CoWin platform, on real-time basis. The new conditions are likely to have more detailed recommendations of AEFI monitoring. The regulator is also likely to impose post-marketing surveillance conditions, which are imposed on various approved drugs.
Third, it is also likely that the two manufacturers will have to continue to follow government guidelines on the precautionary third dose, which is limited to three priority groups – the elderly population with comorbidities, healthcare workers and frontline workers.
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