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 It can also be withdrawn if it leads to adverse results in patients.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.”
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.”