No Shortcuts In Fast Vaccine Approval: Niti Aayog Member

Pune, 6 Dec 2020:

Niti Aayog member (health) Vinod Paul, who also heads the National Expert Group on Vaccine Implementation for Covid19, said the country would follow all scientific and regulatory norms once a vaccine company sought emergency use authorisation.

“The procedure for issuing the license will follow a framework based on scientific principles. The country has outstanding standing in this regard. Our drugs and vaccines are used to save lives the world over because of their impeccable quality,” said Paul.

He said once a vaccine maker decides to file for emergency permit, all available data on safety, immunogenicity and efficacy will scrutinized by independent experts. Once cleared, the vaccination programme can start within a matter of days, he added.

“The procedure will be based on deep and objective scrutiny of available scientific data from the trials. There is no room for any shortcuts,” Paul told TOI.

There are about five vaccine candidates against Covid currently in different stages in India. Pune-based Serum Institute of India, which is making the AstraZeneca-Oxford vaccine, said it will apply for an emergency use nod in two weeks.

The phase 3 trial of the India-made shot from Bharat Biotech and the ICMR is underway. A candidate by Zydus Cadila has completed its phase 2 clinical trial while pharma major Dr Reddy’s Labs has started combined phase 2 and 3 clinical trials of the Russian-made Sputnik V in India. Another domestic firm, Biological E, has also started early phase 1 and 2 human trials.

An approved vaccine will be first given to about one crore health workers from both the public and private sectors. They will be followed by another two crore frontline workers, which also includes police units. The Times Of India