India's Drug Controller Clears Indigenous COVID Vaccines, Refuses To Take Questions On Transparency, Efficacy

Two vaccines for coronavirus, Oxford Institute's Covishield, which is being developed by Serum Institute and Bharat Biotech's Covaxin, received emergency approval from the country's drug regulator on Sunday, December 3. However, this major development has received mixed reactions.

"We'll never approve anything if there is slightest of safety concern. The vaccines are 110 per cent safe. Some side effects like mild fever, pain and allergy are common for every vaccine," Drug Controller General of India VG Somani said.

On January 3, Somani announced that his office had approved the Serum Institute and Bharat Biotech COVID-19 vaccine candidates for "restricted" emergency use in India. However, after the event, Somani refused to take questions pertaining to the hasty approval of the vaccines and the transparency in the process. Most questions were not taken up due to 'paucity of time'.

Bharat Biotech's and Serum Institute's phase 3 trials are yet to conclude, however, the vaccines have been approved for "emergency use". Congress leader Shashi Tharoor took to Twitter asking why the vaccines are being offered before the Phase 3 clinical trials have proven efficacy. The leader called it a violation of every scientific protocol.

Several opposition leaders, activists and journalists have called the approval of the Hyderabad-based Bharat Biotech's vaccine "puzzling, premature, and dangerous". Neither the company nor the country's drug regulator has revealed its efficacy results, FirstPost reported.

Activist Prashant Bhushan said that PM Modi and the vaccine manufacturers should take the vaccine "before subjecting our people to it" as they claimed that it was "110 percent safe".

"On what basis was this approval given when Bharat Biotech has NOT shown enough data proving safety & efficacy?" Activist Saket Gokhale asked.

Dr Somani claims the vaccine candidates is "110% safe", however, the government and the drug controller has failed to furnish the source of this figure.

Questions have also been raised on the limited details available about Bharat Biotech's phase 1 and 2 clinical trials in the public domain. The drug controller said that the data was too huge to be shared and none of the countries had revealed it.

Queries related to what are the possible side-effects of the vaccines have also not been answered. Out of the multiple vaccine candidates available, it is still unclear how will the authorities or the government choose the one that will be administered to everyone.

Bharat Biotech in a statement last year had said that its vaccine candidate, Covaxin, will be nearly 60% effective. The calculation of this estimate also remains unknown.

In November last year, a participant of a Serum Institute trial for its vaccine candidate, Covishield, sued the company for Rs 5 crore alleging that he developed a neurological complication after getting the vaccine in early October. The institute then warned against counter-sue for defamation. However, the DCGI gave no clarification as to whether the complication was related to the trial or not.

The vaccine candidates have been approved for restricted use, but the criteria for restricted or emergency use is still not defined.

British drug-maker AstraZeneca has been under the scanner for the administration of its vaccine candidate during clinical trials in the UK and Brazil. Serum Institute's Covishield is derived from this candidate and it is still unclear if the same concerns carry over to Covishield as well.

Questions related to who would be a part of the vaccination criteria and will those with comorbidities be a part of the process also remain answered.

The DCGI claims that crores had been awarded as compensation to trial participants. However, there was no mention of the duration over which this compensation was awarded.

Experts have also questioned if there wasn't a new strain of Coronavirus, would the drug authority still be in a hurry to approve the vaccine?

As the premature nod to the vaccines comes under the scanner, the drug controller has failed to answer some critical questions related to a pandemic that has infected over 10.3 million people in India.

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