Highlights

  • DGCI to take final call on full approval
  • US FDA gave the first full regulatory approval to Pfizer vaccine in August

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EJ Explains: What is regular market approval vs emergency use approval for vaccines

An expert panel of India's central drug authority recommended regular market approval to Covid vaccines Covishield and Covaxin. 

The subject expert committee (SEC) of India's central drug authority has recommended granting regular market approval to Covid vaccines Covishield and Covaxin. The vaccines currently have emergency use authorisation only.

Central Drugs Standard Control Organisation (CDSCO) took to Twitter to confirm that its "SEC has recommended for upgrade of Covishield and Covaxin status from restricted use in emergency situations to grant of new drug permission with conditions in the adult population, DCGI will evaluate the recommendations and give its decision.

What is the difference?

An EUA is granted based on review of data by the medical authorities to merely seek it's effectiveness in combating a disease.

Only after review of a larger set of data based on a wider set of parameters such as safety, effectiveness and also involves site/facility visits by the medical authorities.

So what changes, Why do drug makers want full approval?

Under regular (or full) market approval the vaccine would be available even at chemists associated with hospitals and not just centres approved by the government right now.

Which means that if you wanted a booster shot you would be able to get the vaccine from a hospital chemist and have your doctor administer it for you.

Also a full market approval gives security for production and supply as an EUA can be withdrawn at any point for a particular drug. But withdrawal/recall of an 'approved' drug is not common.

Also insurance typically doesn’t pay for products under an EUA so that also weighs on the medication.

Do any global vaccines have full approval or are they also on
EUAs?

On August 23, 2021, the US FDA gave the first full regulatory approval for a Covid vaccine to Pfizer-BioNTech’s Comirnaty for individuals 16 years and older


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