Govt Approves Bharat Biotech COVID Vaccine 'Covaxin' Without Efficacy Data, Controversy Erupts

India has approved two COVID-19 vaccines on Sunday for a emergency use. However, a massive controversy broke out soon after the government's announcement on the permission accorded to Hyderabad-based Bharat Biotech¡¯s home-grown vaccine 'Covaxin'.

Experts suggest the nod was given without any efficacy data in violation of standard clinical practice.

"Absolutely no efficacy data"

Some independent scientists said while the data from Phase 1 and Phase 2 trials looks encouraging, they raised questions over the process of approval when efficacy data from the vaccine's Phase 3 trial had not come in.

Covaxin Covid-19 vaccine by Bharat BioTech

Dr Gagandeep Kang, vaccine scientist and Christian Medical College professor, said she is completely confused and has never seen anything like this before, when asked about approval nod to Covaxin.

She said that there is absolutely no efficacy data that has been presented or published by Bharat Biotech. "In fact, it is impossible for them to have it given that that the vaccine required two doses. The Phase 3 trial started only in November," she added.

Phase-3 trial not completed

Not just doctors and subject experts expressed worry over the approval, but some politicians also raised concerns over the matter.

My analysis of the paper released by #BharatBiotech researchers & the Press Statement by the Drugs Controller General of India (DCGI) on Restricted Emergency approval of 1out of 3 COVID-19 virus vaccine from Bharat Biotech: A thread...

¡ª Dr Sumaiya Shaikh (@Neurophysik) January 3, 2021

Congress leaders raised concern over the grant of permission for the restricted use of Covaxin without its phase 3 trials. Congress leaders asked the government to explain why mandatory protocols and verification of data has been dispensed with and warned the approval was "premature".

As per submissions made before the expert panel, phase 3 trials have not been completed and therefore, the data on safety and efficacy has not been reviewed, which is a mandatory requirement, Congress leader Anand Sharma said.

This is all we are saying. Of course we will be proud if the vaccine turns out to work effectively. But offering it before Phase3 clinical trials have proven efficacy is a violation of every scientific protocol &unheard of in the world. Jingoism is no substitute for common sense. https://t.co/aRlU8TvYHT

¡ª Shashi Tharoor (@ShashiTharoor) January 4, 2021

"The Health Ministry needs to give cogent reasons for dispensing with the mandatory protocols and requirements in this case, since it involves the health and safety of those frontline workers who will be vaccinated under the restricted category," Anand Sharma was quoted as saying by PTI.

"The DCGI statement is puzzling and the government must reveal the final data of global efficacy trials and the final trials in UK which has been shared officially by UK's MHRA following a government to government agreement signed between the two countries which should be put in the public domain to avoid any confusion on the proven efficacy of the vaccine," he added.

Congress MP Shashi Tharoor also expressed apprehensions over approval to Covaxin, saying it has not yet had phase 3 trials.

"The Covaxin has not yet had Phase 3 trials. Approval was premature and could be dangerous.

@drharshvardhan should please clarify. Its use should be avoided till full trials are over. India can start with the AstraZeneca vaccine in the meantime," Shashi Tharoor said.