Sputnik V gets the green light in India as infections hit record high
PFIZER AND OTHER FOREIGN VACCINES APPROVED ABROAD WILL ALSO BE USED
INDIA has authorised the emergency use of Russia’s Sputnik V Covid-19 vaccine and will fast-track approval for other shots already passed by other major countries, authorities said on Tuesday (13), as infection rates soared to a new record high.
The government has faced mounting calls to approve more vaccines during the Covid surge and a slower-than-expected mass inoculation drive. Sputnik V is the third drug to be approved by India after Oxford-AstraZeneca’s Covishield and Covaxin, which was developed by Indian firm Bharat Biotech.
An SEC expert panel said the Russian vaccine should be authorised “in emergency situations” and this has been accepted, the health ministry said in a statement. Sputnik V, backed by the Russian Direct Investment Fund (RDIF), already has production agreements in India to produce 852 million doses.
RDIF chief executive Kirill Dmitriev said the approval was a “major milestone” after “extensive cooperation” on clinical trials of the shot in India.
Dmitriev told Indian broadcaster NDTV that the first doses could be ready by late April or May, with ramped up production by June. “We believe by June, we will really be at good production capacity in India and will become a very meaningful player in vaccination programme in India,” he added.
GV Prasad, co-chair of pharmaceutical company Dr Reddy’s Laboratories, said his firm was “very pleased to obtain the emergency use authorisation”.
“With the rising cases in India, vaccination is the most effective tool in our battle against Covid-19,” he added.
The health ministry also said it would expedite the approval of vaccines not made in India – unlike the first three – to “expand the basket of vaccines for domestic use and hasten the pace and coverage of vaccination”.
The jabs will need to have already been granted emergency-use authorisation by regulators, such as the US Food and Drug Administration, the European Medicine Agency and others in Britain and Japan or the World Health Organisation, the ministry said.
A requirement for pre-approval clinical trials would be replaced by post-authorisation trials. Vinod K Paul, a member of the government advisory body NITI Aayog, said during a health ministry briefing that “we hope and invite vaccine makers like Pfizer, Moderna, Johnson and Johnson and others” to apply for licences “at the earliest possible” opportunity.
Pfizer said on Tuesday that it would work towards bringing its Covid-19 vaccine it developed with Germany’s BioNTech to India after the government eased import rules, after withdrawing its application in February.
“We have noted the recent announcement with regard to the regulatory pathway for global vaccines,” a Pfizer spokesperson said in an email.
“We remain committed to continuing our engagement with the government towards making the Pfizer and BioNTech vaccine available for use in the government’s immunisation program.”
India on Monday (12) reported more than 161,000 new cases – the seventh-consecutive day that more than 100,000 infections have been recorded.
Local authorities have imposed night curfews and clamped down on movement and activities. In Mumbai, authorities have ordered the construction of three more 2,000-bed field hospitals in the next six weeks. The number of beds for Covid-19 patients has also been ramped up in New Delhi.