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

Over the last four days, 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 COVID-19 vaccines

FP Staff December 08, 2020 19:21:20 IST
Three COVID-19 vaccines under consideration, may get emergency use approval in next few weeks, says Centre

Illustration of vials of COVID-19 vaccine. Image: Igor Golovniov/SOPA Images

India's drug regulator is actively considering licensing at least three COVID-19 vaccines for emergency use in the next few weeks, the government said Tuesday in a briefing on the COVID-19 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 COVID-19 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."

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 COVID-19 vaccine candidates.

"DCGI has already started processing the applications. The subject expert committee (SEC) on COVID-19 at CDSCO will deliberate on the applications by Pfizer, Serum Institute of India and Bharat Biotech seeking emergency use authorisation for their COVID-19 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 COVID-19 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 COVID-19 .

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.

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- Coronavirus 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 COVID-19 inoculation, reported PTI.

The report stated that preparation for the roll-out of the vaccine is being carried out by the Centre in collaboration with states and Union Territories. “ COVID-19 vaccination cannot just be a state or the Centre’s responsibility. It has to be people’s participation,” the report quoted Bhushan as saying.

 The total coronavirus cases in India mounted to 97,03,770  on Tuesday with 26,567 new infections while the toll rose to 1,40,958 with 385 new fatalities, as per the health ministry's morning update.

With inputs from agencies

 

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