Market approval for Covishield, Covaxin likely to come with riders

Will the vaccines be freely available with chemists?

The subject expert committee’s recommendation for regular market approval to Covishield and Covaxin, if accepted by the regulator, could be subject to some conditions, the government has indicated. 

There is lack of clarity at present on whether the market authorisation for the vaccines means these would be available at chemist shops for the general public to buy and if the vaccine makers would be allowed to sell them freely. 

Health Secretary Rajesh Bhushan said, “Whether the approval would be with certain conditions will be known in the future. Once that decision is taken, these questions will be answered.” 

Experts said, in principle, such an approval would mean that the vaccine manufacturers can sell in the open market with some price control, but this may not be how things will roll out for the two Covid vaccines, which are currently available only under emergency use authorisation. 

“Since these are vaccines and not drugs, there may be extra approvals or conditions. Given a choice, many would go for extra shots, but that might not be in their best interest. It has to be regulated,” said Sakthivel Selvaraj, director, Health Economics, Financing and Policy at Public Health Foundation of India. 

The other option could be to make it available only through a doctor’s prescription or authorise its sale only to doctors who would then decide who gets these shots based on clinical assessment. For example, a 59-year-old currently not eligible for a booster shot could be prescribed one by a doctor, depending upon comorbidities and other health conditions. 

“This is done in case of cancer drugs as well. The doctor -- and not the patient -- would have to get the drug from authorised dealers or vaccine makers. This would mean full authorisation but not market licensure,” Jacob John, senior virologist and former head of the departments of clinical virology and microbiology at Christian Medical College, Vellore said. 

And will vaccine makers be liable for any adverse reaction if market approval comes through? 

Experts said this is not clear. A senior pharma expert said, “There have been adverse reactions but the companies have not been held liable yet.” 

Others such as John believe a market approval would mean the company is not liable and the answerability lies with the doctor or the patient. 

Another question that experts such as John have raised is on the safety of Covishield and the data that the subject expert committee has relied on to decide that the vaccine is safe. He said no one has explained this data fully. “The reporting of adverse effects following immunisation in India is not streamlined,” John said. “The data has not been robust or shared in detail.”