IT Correspondent
Mumbai, Jan 20:
The subject expert committee of Central Drugs Standard Control Organisation (CDSCO) on Covid-19 vaccines on Wednesday recommended to the CDSCO to grant Pune based Serum Institute of India’s “Covishield” and Hyderabad based 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 CDSCO said.
Since January last year, Covishield and Covaxin are 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 III of clinical trials, determines that potential benefits of the vaccine, when used to prevent Covid-19, outweigh its potential risks.
“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. Drug Controller General of India (DCGI) will evaluate the recommendations and give its decision,” the CDSCO said in a tweet.
The expert committee based its recommendation on the facts that over two third of the population has been vaccinated using these two vaccines and their efficacy has been proved in India and abroad.
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.
On Wednesday, CDSCO said the panel’s recommendations are based on certain conditions. Therefore, the key question that remains unanswered is whether full licensure would result in the two manufacturers selling the vaccines in retail market.
Since vaccination certificates are generated after every dose, it is likely the government will continue to track these vaccines, even if they are available in open market. Therefore, it is unlikely that these two vaccines will be made available in over the counter purchase at the chemists. Second, beneficiaries of these vaccines are monitored by trained health professionals – and adverse events are captured on government’s CoWin platform on real-time basis. The new conditions are likely to have more detailed recommendations of Adverse Events Following Immunization (AEFI) monitoring.
