When the drug regulator granted Serum Institute of India’s (SII) Covishield and Bharat Biotech’s Covaxin Covid-19 vaccines “conditional market authorisation” (CMA) for the country’s adult population yesterday, many news consumers wondered what the jargon meant. Well, since January 2021, the two vaccines have been available under “Emergency Use Authorisation” (EUA), under which 140.89 crore doses of Covishield and 22.95 crore doses of Covaxin have so far been administered. As the term suggests, the EUA is pressed into service in public health emergencies like the pandemic — under the condition that the regulator, based on initial data from phase 3 of clinical trials, is convinced about the potential benefits of the vaccine, which must outweigh its potential risks.
For a year, the SII and Bharat Biotech kept submitting rolling data related to product efficacy and safety in batches as they became available. Because of the fact that, by now, the two vaccines have begun conforming to the high standards of safety, effectiveness and manufacturing quality that the Drugs and Cosmetics Act, 1940, asks of a new vaccine, the availability of the two vaccines have been upgraded to CMA. Yet, this is not full market authorisation.
The European Medicines Agency (EMA), which is the European Union agency tasked with the evaluation and supervision of medicinal products, grants CMA if four key criteria are met:
- the benefit-risk balance of the vaccine is positive
- it is likely that the applicant will be able to provide comprehensive data post-authorisation
- the vaccine fulfills an unmet medical need, and
- the benefit of the immediate availability of the vaccine to patients is greater than the risk inherent in non-availability of additional data
A CMA remains valid for a year. It can be renewed annually, the EMA says.
CMA: India vs world
The Union Ministry of Health and Family Welfare says that CMA is a new category of authorisation that has emerged during the Covid-19 pandemic. “The approval pathways through this route are fast-tracked with certain conditions to enhance the access to certain pharmaceuticals for meeting the emerging needs of drugs or vaccines,” the ministry said.
The CMA for Covishield and Covaxin will be similar to the CMA that, say, the US Food and Drug Administration (FDA) has granted to Pfizer’s mRNA Covid-19 vaccine, or the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK has granted to AstraZeneca’s Covid-19 vaccine.
Whatever be the jargon, how does it matter to you? A drug or vaccine that has received full or general market authorisation — which Covishield and Covaxin have not — is available in pharmacies or chemist shops for purchase either as an over-the-counter product or against a doctor’s prescription. Therefore, you cannot yet buy Covishield and Covaxin from regular pharmacies as retail products even when you have a prescription.
The vaccines will, however, be available to private hospitals and private clinics that can now procure the doses against required documentation and payment, government sources said. As and when a private hospital or clinic administers a dose, it will have to register it on CoWin, the government’s digital vaccination platform.
Not the same as a mass booster dose
Government channels will supply Covishield and Covaxin under “programmatic setting” to health centres for people whom the government deems eligible for the precautionary dose — frontline workers, healthcare workers and the elderly population with comorbidities. These people will, as of now, be eligible for the booster dose. Hospitals can administer the third dose to others only after the government amends its policy.
The CMA is still different from the existing EUA for the vaccines insofar as regulatory requirements on monitoring the safety of the vaccines are concerned. The CMA is more relaxed than the EUA. To the ordinary citizen, the two terms do not mean much. Under the EUA, manufacturers have to submit safety and efficacy data every 15 days or a month. Under the CMA, the health ministry says, they have to submit the data every six months.
The ministry says that while an adverse event following immunisation (AEFI) and an adverse event of special interest (AESI) will still be monitored, the SII and Bharat Biotech will have to submit AEFI and AESI data with due analysis on a six-monthly basis or as and when available, whichever is earlier as per the New Drugs and Clinical Trial Rules, 2019. This implies that hospitals continue to have all AEFI monitoring systems in place. They will have to still systematically record and report adverse events to the vaccine manufacturer.