Three COVID-19 vaccines under consideration, may get emergency use approval in next few weeks, says Centre

India's drug regulator is actively considering licensing at least three vaccines for emergency use in the next few weeks, the government said Tuesday in a briefing on the situation in the country.

These three vaccines include Hyderabad-based pharmaceutical firm Bharat Biotech's COVAXIN, Pune-based Serum Institute of India's Covieshield (developed from AstraZeneca and Oxford vaccine candidate), and US pharmaceutical giant Pfizer's mRNA vaccine. The UK began inoculating its high-risk citizens with the Pfizer vaccine on Tuesday.

Over the last four days, the Indian arm of Pfizer, Serum Institute of India, and Bharat Biotech have applied to the Drugs Controller General of India (DCGI) seeking emergency use authorisation for their potential vaccines.

As per news agency ANI, NITI Aayog member Dr VK Paul said: "Three vaccine candidates are under consideration of the regulator for licensing. Very active consideration is going on. There is hope that early licensure is possible in respect of all of them or any one of them."

Three vaccine candidates are under consideration of the regulator for licensing. Very active consideration is going on. There is hope that early licensure is possible in respect of all of them or any one of them: Dr VK Paul, Member (Health), NITI Aayog pic.twitter.com/EVMMjqCgGk

— ANI (@ANI) December 8, 2020

Elaborating further, Health Secretary Rajesh Bhushan said, "To summarise, three vaccine are in pre-clinical stages, six are in clinical trials. So there are multiple vaccine candidates in multiple stages of development and some of them may get licensed in the next few weeks. But we cannot foretell at this moment in time as licensure is the domain of the national regulator," said Bhushan.

News agency PTI had reported official sources as saying on Monday night that an expert committee of the Central Drugs Standard Control Organisation (CDSCO) will meet on Wednesday to review applications of Pfizer, Serum Institute of India and Bharat Biotech seeking emergency use authorisation for their vaccine candidates.

"DCGI has already started processing the applications. The subject expert committee (SEC) on at CDSCO will deliberate on the applications by Pfizer, Serum Institute of India and Bharat Biotech seeking emergency use authorisation for their vaccines on 9 December," a source told PTI.

After evaluation, the SEC will give its recommendations to the DCGI on whether emergency use approval (EUA) for the vaccine candidates should be granted or not, the source said.

During the briefing on Tuesday, the health secretary further said that the vaccines require two to three doses — while the majority require two doses, one may possibly need three doses — and every dose will have to be given with a gap of three to four weeks.

Bhushan, however, warned that precautions must be taken even after vaccination. "It doesn't mean that we let down our guard if a vaccine comes or if one is administered a vaccine. COVID appropriate behavior has to be followed" he said.

The health secretary gave information about the preparation undertaken by the government for the vaccine, including the constitution of a Vaccine Task Force, the National Expert Group on Vaccine Administration for .

The health secretary maintained that every single Indian who needs to be vaccinated will be administered a vaccine and added that the NEGVAC has recommended prioritising healthcare workers (1 crore), frontline workers (2 crores), and those above the age of 50 (about 27 crore) for vaccine administration.

NEGVAC's recommendation on prioritised population groups- healthcare providers & workers in healthcare setting, personnel from state & central police, armed forces, home guards,civil defence& disaster management volunteers&municipal workers & persons above 50 yrs: Health Ministry pic.twitter.com/GDvdsjiqFS

— ANI (@ANI) December 8, 2020

The health ministry said that the current cold chain facilities are capable of storing an additional quantity of vaccine for the first lot of 3 crore recipients, which includes healthcare and frontline workers.

As per a report in the Hindustan Times, the health ministry also said that the anti- vaccination drive will have a minimal impact on routine health services including routine immunisation.

It informed that of the 2.38 lakh auxiliary nurse-midwives (ANMs) who provide vaccination under the universal immunisation programme, only 1.54 lakh ANMs will be involved in the inoculation, reported PTI.

With inputs from agencies