Three Covid-19 vaccines under active consideration of EUA: Central government

The central government has three Covid-19 vaccine candidates under active consideration for emergency use authorisation (EUA). Pfizer, Serum Institute of India (SII) and Bharat Biotech have approached the Drug Controller General of India (DCGI) for emergency authorisation for their Covid-19 vaccines.

New Delhi: The central government on Tuesday made it clear that three Covid-19 vaccine candidates are under active consideration to get emergency use authorisation (EUA) from the apex drug regulator.

"Three Covid-19 vaccines are under active consideration. It is going for all the three vaccines to get "temporary authorisation" from the drug regulator or any one of them will get it," said Dr VK Paul, chairman of the National Task Force on Vaccine Administration in New Delhi.

Pfizer, Serum Institute of India (SII) and Bharat Biotech have approached the Drug Controller General of India (DCGI) for emergency authorisation for their Covid-19 vaccines.

He said that India as one of the largest manufacturers of vaccines, "is also looking into the other factors so that once a vaccine is produced in the country, it can be sent to other countries as well."

Supporting the statement made by Dr Paul, Union Health Secretary Rajesh Bhusan said that the DCGI has a specific framework under specific situation where it can issue emergency authorisation of vaccine.

"Under the New Drugs Clinical Trial Rule, 2019, the drug regulator can go for emergency approval in a certain situation," said Bhushan.

The statement given by Bhushan assumes significance following the fact that the DCGI had recently said that no foreign drugs in India will be allowed for manufacturing and marketing without going for human clinical trials. Under the present scenario, Pfizer is one such Pharma giant whose vaccine has not yet gone for any kind of human trial on the Indian population.

On the other hand, Covid-19 vaccine candidates of SII and Bharat Biotech are currently undergoing Phase 3 clinical trials.

Substantiating the fact, Dr Balram Bhargava, Director General of Indian Council of Medical Research (ICMR) said that all other countries have certain emergency procedures set under which they can issue emergency use authorisation for a new vaccine.

"It's, however, the regulator who needs to be satisfied with risk-benefit ratio before giving any authorisation," said Dr Bhargava.

Health Secretary Bhushan said that as many as eight Covid-19 vaccine candidates are in race in India.

He informed that SII's Covishield, Bharat Biotech's COVAXIN, Cadila Healthcare Limited's ZyCoV-D, Dr Reddy's Sputnik V, Novavax and SII's NVX-CoV2373, Biological E Limited's Recombinant Protein antigen-based vaccine, Genova's HGCO 19 and Bharat Biotech's Inactivated rabies vector platform are under review of the drug regulator.

"There are multiple vaccine candidates in different stages of development, some may get licensed in next few weeks," said Bhushan.

He said that the vaccine will be required 2-3 doses and 3-4 weeks apart. "Even after vaccination, Covid precautions must be undertaken," said Bhushan.

He informed that the government has set up a vaccine task force (VTF) in April to provide guidance for focussed research on Coronavirus vaccine and other science and technology issue.

"Subsequently, National Expert Group on Vaccine Administration for Covid-19 was set up in August for prioritisation of vaccine population groups, procurement and inventory management, vaccine selection and vaccine delivery and tracking mechanism," said Bhushan.

The Health Secretary has informed that the state steering committee and state task force for vaccine administration will have its meeting on December 8. This will be followed by district task force meeting by December 12 and Block task force meeting on December 15.

Referring to the cold chain infrastructure augmentation, Bhushan said that presently cold chain system consists of 85,634 pieces of equipment for storage of vaccine at about 28,947 cold chain points across the country.

"Current cold chain is capable of storing an additional quantity of Covid-19 vaccine required for first 3 crore i.e. health care workers and frontline workers," said Bhushan.

The health secretary informed that around 2.39 lakh vaccinators (ANMs) across the country provide vaccination under the Universal Immunisation Programme (UIP).

"Out of this only 1.54 lakh ANMs will be used for Covid vaccinations across India," said Bhushan.