Conditional market approval for Covaxin, Covishield

The Drug regulator in India has granted conditional market approval for the COVISHIELD and COVAXIN vaccines. This means that the private hospitals shall administer the vaccines. However, the vaccines will not be available in retail medical stores.

What is conditional market authorisation?

The Serum Institute vaccine COVISHELD and Bharat Biotech’s COVAXIN were administered in the country under Emergency Use Authorisation. The EUA means restricted use of the medicine. The outcome of the medicine is not yet proved. But the medicine shall still be used during unavoidable situations like that of the pandemic. The two vaccines have now met high standards of safety and quality as listed under the Drugs and Cosmetics Act, 1940. Thus they are now being given the conditional market authorization. This is not full market authorization. The culture of conditional market authorization merged during the pandemic.

What do the international regulators say about this?

The European Union Medical Agency grants conditional marketing authorization under certain conditions. They are as follows:

  • Benefit – Risk balance of the medicine should be positive
  • The applicant of the medicine should provide enough sate after authorisation
  • The medicine should be available immediately

The approval of these medicines is valid only for a year. The conditional market authorization to be provided by India is to be the same as that provided by USFDA and the EU. USFDA has provided CUA to mRNA vaccine of Pfizer. The UK has granted the CUA to the vaccine of Astrazeneca.

Is CUA open to booster doses?

No. The GoI has launched programme setting to implement the CUA. This means only that government decided eligible will receive the third dose. This includes health care workers, frontline workers, and elderly population.

How is CUA different from EUA?

Under the EUA, the manufacturers had to submit the efficacy and safety data of the vaccine once in 15 days. Under CUA, they have to submit this once in six months.

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