There is still some time till Serum Institute of India’s Covishield and Bharat Biotech’s Covaxin get full marketing authorisation from India’s drug regulator.
According to government sources, the review process is underway and experts are studying the data in detail. Moreover, the vaccine makers are keen to start selling the vaccines in retail pharmacies once they get full marketing approval. The Centre, however, is unlikely to allow that until the pandemic ends.
“The review process is on and will continue. It takes time to study and analyse the huge amounts of data generated and submitted,” said the source who is close to the development.
The subject expert committee advising the drug regulator met on Friday for a review meeting. Now that the vaccines have been administered to billions of people, there is enough real-world data on immunogenicity, efficacy, and adverse events.
“The analysis of this real-world data will give us the confidence to approve the vaccines as safe and immunogenic. The vaccine makers want to sell at retail pharmacies if a full authorisation is given. That, however, seems unlikely as we are still in a pandemic situation, and Covid-19 vaccine administration would continue through the Co-WIN platform,” said another government official.
This could imply that even after a full marketing authorisation comes based on the data submitted by companies, the government would continue to retain controls over the administration of Covid-19 vaccines. “If it starts to sell in the open pharmacies, there is no way to know who has taken a shot, when, and of which vaccine. The situation could spiral out of control. People may take more shots than is allowed,” said the source cited above.
At present, both the vaccines have a restricted emergency use authorisation.
Legal experts feel if a full marketing authorisation comes, nothing much really changes on the ground. “This would mean they have cleared the efficacy tests under the Drugs and Cosmetics Act. Nothing much changes on the ground,” said Ashish Prasad, partner, litigation, and dispute resolution practice of Economic Laws Practice (ELP).
The vaccines are sold in private hospitals and are also exported commercially to other countries.
SII CEO Adar Poonwalla had tweeted they had applied for a full marketing authorization on December 31. In response to the application, the Central Drugs Standard Control Organisation had sought more details, which were subsequently submitted last week. Bharat Biotech, too, is undergoing a similar review process for its Covid-19 vaccine Covaxin.
During the pandemic, regulators worldwide had done rolling reviews of clinical trial data. The approvals (restricted emergency use or emergency use authorisation) were granted based on the data from phase 1 and 2 trials and interim data from phase 3 trials. At that time, there was no data on long-term efficacy or immunogenicity.
Accelerated reviews of clinical trial data do not mean the trials have been rushed. The trials on subjects have taken their usual time, the doses being given at stipulated intervals. The recruitment of subjects has been a faster process and the regulator has been reviewing the data from these trials from time to time.
This interim reviewing of data did not happen earlier. The regulator would review the data once the trial was completed and the sponsor analysed and presented the data.
Companies themselves also conduct what is called phase 4 trials or post-marketing studies of their vaccines.