Covid vaccines get full market authorisation

The Drugs Controller General of India DCGI granted full market authorisation to Covid- 19 vaccines Covaxin and Covishield under certain conditions, according to the Union health minister Mansukh Mandaviya on Thursday. The decision came nearly a week after the Subject Expert Committee SEC of the Central Drug Standard Control Organisation CDSCO recommended an upgrade of Covishield and Covaxin status from restricted use in emergency situations to grant new drug permission with conditions in the adult population.

The permission for COVAXIN and Covishield has been changed from restricted use in emergency situations to normal new drug permission in the adult population with certain conditions, according to the CDSCO INDIA INF. Mandaviya said that the conditions include the provision of programmatic settings, including registration on the CoWin platform, and the ability to submit safety data on a six-monthly basis.

The approval of the drug controller was granted under the New Drugs and Clinical Trials Rules, 2019 according to the government officials. The SEC recommended full market authoring for Covaxin and Covishield under certain conditions on January 19th. SII and Bharat Biotech, the manufacturers of Covishield and Covaxin, both of which were administered under the national Covid 19 immunisation programme under emergency use authorisation, had separately applied for full market authorisation.

In India, supplies of COVISHIELD vaccine have exceeded 1.25 billion doses. Adar Poonawalla, CEO of SII, recently tweeted that the government of India now has enough data for full market authorisation, and that SerumInstIndia has applied to CDSCO INDIA INF DCGI and MoHFW INDIA for this permission.

What does full market authorisation mean?

The CDSCO granting full market authoring means that vaccines are fit to meet the requirements of safety, effectiveness and manufacturing quality under the Drugs and Cosmetic Act, 1940, for a new vaccine. Senior officials in the union health ministry said that the panel granted the authorisation after long-term follow-up of clinical trial data of the vaccines in terms of safety and efficacy in preventing severe Covid- 19. The vaccine is safe and effective for most people who have received it, and the government grants full market authoring. The authorities also review full data of quality, safety and effectiveness from phase 1, 2 and 3 trials before granting full market approval.

Hyderabad-based Bharat Biotech s Covaxin and Covishield, developed by Oxford-AstraZeneca and manufactured by Pune-based Serum Institute of India s SII under a licence, would now be available for sale in the retail market. The emergency use authoring was an interim approval after evaluating the evidence that the vaccines were safe and effective. The EUA allowed the vaccines to be used in the general public under government supervision.

The sale of both vaccines was regulated by the government and could only be administered under the Covid 19 immunisation drive, with all the doses sold and tracked via government. The manufacturers can't sell their vaccines in the retail market with EUA status.

After full market authorisation, the vaccines will be available across medical distribution channels. The vaccines may be available in the near future for the clinics and hospitals registered with the CoWin platform. There is a possibility of getting booster shots, which is only available for those over 60 years of age with comorbidities and healthcare and frontline workers.

What are the conditions for full market authorisation?

The government would continue to conduct post-marketing surveillance. The vaccine manufacturers will have to submit the data from clinical trials to the regulator on a regular basis, along with the real-world usage data. The documentation of each Covid 19 vaccine dose that is administered in the country won't be allowed over the counter sales of the vaccine because of the fact that the government won't allow over the counter sales of these vaccines.

The government officials said that even after granting full market authorisation, it has decided to limit the prices of these vaccines, which are the drivers of the Covis 19 immunisation program.

The National Pharmaceutical Pricing Authority NPPA is working to capping their prices so that they can still be affordable to people in the retail market.

Covaxin is currently priced at Rs 1,200 per shot, but Covishield is charged at Rs 780 in private vaccination centres, including Rs 150 as a service charge. The centres may be allowed to charge a service charge of 150 rupees per dose of both vaccines, according to sources in the union health ministry.