Explained: What does ‘conditional market authorisation’ for Covishield and Covaxin mean?

Since January last year, 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 been administered so far.

Not every vaccine is granted EUA before it receives full approval. The EUA route, referred to in India as restricted use in emergency situations, is invoked in public health emergencies like the pandemic — provided 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.

For a year, Serum Institute and Bharat Biotech have been submitting rolling data related to product efficacy and safety in batches, as they have become available.

However, since the two vaccines now meet the high standards of safety, effectiveness, and manufacturing quality that the Drugs and Cosmetics Act, 1940 requires of a new vaccine, they have been upgraded to “conditional market authorisation”.

This, however, is still not full market authorisation, sources in the government said.

Do international regulators also grant conditional market authorisation?

The European Medicines Agency (EMA), the European Union agency tasked with the evaluation and supervision of medicinal products, grants conditional marketing authorisation 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.

Such an approval is valid for one year, and can be renewed annually, the EMA says.

How does India’s conditional market authorisation differ from full market authorisation?

The Union Health Ministry said on Thursday that conditional market authorisation 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 conditional market authorisation for Covishield and Covaxin will be similar to the conditional market authorisation that, say, the United States 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 United Kingdom has granted to AstraZeneca’s Covid-19 vaccine.

A health worker shows empty vials of Covishield vaccine at a vaccination centre in Jammu. (PTI Photo)

What will change for ordinary recipients of the two vaccines with the grant of conditional market authorisation?

Not much.

A drug or vaccine that has received full or general market authorisation would be available in pharmacies or chemist shops for purchase — either as an over-the-counter product, or against a doctor’s prescription.

However, Covishield and Covaxin will still not be available in regular pharmacies, and you will not be able to buy them as a retail product, with or without a prescription.

The vaccines will be available for private hospitals and private clinics to procure though, against required documentation and payment, government sources said.

However, the sources said, as and when a private hospital or clinic administers a dose, it will still have to capture it on CoWin, the government’s digital vaccination platform.

Will the grant of conditional market authorisation open up the ‘precautionary’ booster dose to all double-vaccinated people?

No. The two vaccines will be supplied under “programmatic setting”, which means only those whom the government has made eligible for the precautionary dose — frontline workers, healthcare workers, and the elderly population with comorbidities — can access the third dose.

Hospitals will be able to administer the third dose of Covishield or Covaxin to others only after the government makes a change in its policy.

How then is this stage of conditional market authorisation different from the existing EUA for the vaccines?

For individual recipients of the vaccines, not much changes. But conditional market authorisation relaxes somewhat the regulatory requirements on monitoring the safety of the vaccines.

Under EUA, manufacturers have to submit safety and efficacy data every 15 days or a month. Under the conditional market authorisation, the Health Ministry said, they have to submit the data every six months.

Also, the ministry said, while adverse event following immunisation (AEFI) and adverse event of special interest (AESI) shall continue to be monitored, the two companies 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 means hospitals will need to still have all AEFI monitoring systems in place, and will have to continue to systematically record and report adverse events to the vaccine manufacturer.

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