US Decision To Not Give Emergency Authorisation To Bharat Biotech’s Covaxin Has Nothing To Do With Its Efficacy

“A vaccine that has been administered in India to the tune of 29 million doses has been denied emergency-use approval in the US,” reads a caption by a news portal on Twitter, on the subject of the United States (US) denying emergency-use authorisation to Bharat Biotech's Covaxin.

The implication is that the vaccine is somehow inferior in quality, and the fact that 29 million doses have been administered should be a cause of concern.

Such sensational headlines, without delving into the reality of the matter, can prove costly at a time when vaccine hesitancy is a real challenge around the globe.

Right now, no coronavirus vaccine is fully approved by the US Food and Drug Administration (FDA). The vaccines in use have been granted emergency-use authorisation (EUA).

The truth is that the US government didn’t “deny” EUA to Covaxin, the inactivated whole virus vaccine developed by Bharat Biotech, but said it wasn’t giving EUA to Ocugen, Bharat Biotech’s American partner, which hasn’t even submitted an EUA application yet.

The US has decided not to give EUA simply because it has enough vaccines to immunise its population. It is no longer in a situation where it needs to fast-track approvals of Covid-19 vaccines.

Through its "Operation Warp Speed" initiative, the country had invested $18 billion in the development of various Covid-19 vaccines for its population last year. So, it has already granted EUAs to the vaccines of Pfizer-BioNTech and Moderna-NIAID, as well as Johnson & Johnson (all are American pharma giants).

The EUA, by definition, applies to an emergency situation, when it makes sense to fast-track authorisation, compromising on the more stringent requirements of the regular procedure.

Since the US has enough vaccines, there is no such emergency.

The US FDA recommended Ocugen to go the Biologics Licence Application (BLA) route with data from an additional clinical trial. The BLA is a "full approval" mechanism of the FDA for drugs and vaccines. However, this will delay Covaxin’s launch in the US. A full authorisation will mean that the vaccine’s approval may take up to a year.

Bharat Biotech, in response to the FDA's recommendation, said that with herd immunity and a significant percentage of the population vaccinated, the pandemic is slowing in the the US, and the regulator had earlier communicated that no new EUAs will be approved for Covid-19 vaccines.

Reportedly, no vaccine manufactured or developed in India has ever received the EUA or full licensure from the US FDA. Covaxin, so far, has received EUAs in 14 countries, with the process underway in more than 50.

The pharma lobby in the US is strong and wields considerable influence. The US government is accused of making it difficult for outsiders to compete with them.

The AstraZeneca vaccine (a British-Swedish company), which has been approved for use in the United Kingdom and several European Union countries, hasn’t received the EUA in the US yet.

This is the case when the AstraZeneca shot is already approved for use in around 80 countries and is much cheaper than rival vaccines, as well as easier to transport and store.

Early last month, the Wall Street Journal reported that AstraZeneca may skip the emergency-use authorisation route in the US and instead pursue a full-fledged licence.

Covaxin has been tested in phases one through three of human clinical trials in India. Bharat Biotech claims that the vaccine’s efficacy is around 78 per cent.

Reportedly, published data from the phase 3 clinical trial of the vaccine, which involved over 25,000 participants, is expected to reach a preprint server in July after it is submitted to India's Central Drugs Standard Control Organisation. Peer review of this information is expected to take another two to four months.

NITI Aayog member (Health) V K Paul said on 11 June that the phase 3 publication of Covaxin will come in seven to eight days, and that this is beyond the data shared with the Drugs Controller General of India.