COVID-19 vaccine: Here's why Indian government passed Covaxin before phase 3 trials
Phase 3 efficacy of COVID-19 vaccine candidates has been reviewed by drug regulators worldwide before passing the vaccine for mass distribution. Bharat Biotech's Covaxin is an exception, as it is currently in its phase 3 trials and was approved by the Government of India to use it for emergency purposes. There is no interim efficacy study, and only data regarding immunogenicity and not vaccine effectiveness are present by the Phase-1 or two preprints. The acceptance of the vaccine even for emergency use or even to use it as a back-up vaccine is very odd. The Indian government has declared that Serum's Covishield will be used as the main vaccine and Bharat Biotech's Covaxin is a backup, in case of a surge in cases.
Serum Institute spoke about providing the vaccine to the Indian Government at USD 3 per dose while offering Covishield at three times the prices in private markets. Cost of Bharat Biotech's Covaxin has not been disclosed yet, but some media reports indicate that it could cost around USD 1 per dose. Even if we consider, the Government of India takes the vaccine from Bharat Biotech at the rate of USD 1, it would still cost them over USD 2.6 billion to vaccinate the entire population. GOI has not yet signed a big agreement with either of the vaccine generators. In the future, if Bharat Biotech's Covaxin can prove its effectiveness, subsequent vaccines would have to compete for both in value and efficacy.
The approval of two vaccines by Indian drug regulators on almost the same date (Covishield on January 1, Covaxin on January 3) indicates India's effort to find alternatives which will allow the vaccine manufacturers to compete on pricing. In order to sign quantity contracts with GOI, Serum Institute will need to give better discounts before alternatives arise.
Probable reasons why GOI permitted Covaxin for emergency use:
1) Covaxin is India's first indigenous COVID-19 vaccine. This will promote the Make in India sentiment.
2) To make sure Serum doesn't have a monopoly over the Indian market, Covaxin has been approved to maintain fair competition between the two vaccines.
By July 2021, the government plans to vaccinate people who are more prone to the virus, that's 25 per cent of the overall populations. However, these numbers may take until the end of 2021. It is projected that in 2021, India will have adequate doses of the vaccine to cover 78 per cent of the population, without taking Moderna and Pfizer doses into account. Given the high price of vaccines, the private sector is expected to contribute only a small amount.