Emergency approval for vaccine should come by Dec-Jan: AIIMS director

Randeep Guleria say data showed that in the short term the vaccine is safe

India may get emergency-use authorisation for a coronavirus vaccine from regulators by the end of December or early January, with several candidates now in the final stage of trials, Dr Randeep Guleria, director, All India Institute of Medical Science said on Thursday. 

Speaking to ANI, Guleria said that the data showed that in the short term the vaccine is safe. “There is good data available that the vaccines are very safe. Safety and efficacy of vaccines not compromised at all. Around 70,000-80,000 volunteers have been given vaccines in trials with no significant serious adverse effects seen.”

Russia was the first in the world to give emergency approval in August to its vaccine Sputnik V, even before crucial Phase-3 trials were conducted. Russian President Vladimir Putin has ordered his government to start large-scale vaccinations against Covid-19 next week.

Britain is the first country in the West to roll out a Covid vaccine, granting an emergency licence to the antidote developed by American pharma major Pfizer along with Germany’s BioNtech. The country is expecting delivery of 800,000 doses in the next few days. 

Serum Institute of India is expected to apply to the Indian drug regulator this month for emergency-use authorisation of the Oxford-AstraZeneca vaccine.  

Health ministry has also said that the government does not plan to  vaccinate the entire country but a critical mass, enough to stop the chain of transmission. 

Emergency use authorisation is an accelerated process which permits the regulator to grant permission under an emergency, such use is different from regular market authorisation. The latter takes more time and requires more data on safety and efficacy to be shared with the regulator.

A decision to allow such use is based on whether the information and documentation submitted provide sufficient evidence regarding quality, safety and efficacy and a risk-benefit analysis. The Drug Controller General of India under the provisions of the Drugs and Cosmetics Act can allow such approval for a public health emergency. It can also be withdrawn if it leads to adverse results in patients.

Guleria said, “We have seen a decline in the current wave and I hope this will continue if we are able to follow good Covid-19 appropriate behaviour. We are close to having a big change related to the pandemic if we manage this behaviour for the next three months.” 

The AIIMS chief also backed SII in the controversy over an adverse event in a Chennai based volunteer. He said that the finding was incidental rather than related to the vaccine. “When we vaccinate a large number of people, some of them may have some other disease which may not be related to the vaccine.”