While J&J is keen to enter India and has recently held preliminary discussions to apply for emergency use authorisation, Pfizer withdrew from the race in February due to regulatory issues.
The rollout of vaccines from Pfizer and J&J could take a few months as the companies are yet to decide their strategies, sources told TOI, adding Pfizer could face issues due to limited manufacturing capacity. At present, vaccinations are on full throttle in the US and Pfizer has already committed its supply to exports and to GAVI, the Vaccine Alliance, a UN initiative.
The US has administered nearly 100 million doses of the Pfizer vaccine till now, according to the Centers for Disease Control and Prevention. The company will deliver 200 million doses by May-end and reach 300 million by July. Brazil, Colombia, Mexico, the Philippines, South Africa and Ukraine are set to be among the main recipients of the Pfizer vaccine between April and June, according to GAVI.
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“We have noted the recent announcement with regard to the regulatory pathway for global vaccines. 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 in the country,” a Pfizer spokesperson said.
Experts say Pfizer could have first-mover advantage since it was the first to apply for emergency authorisation last year, in December, but provided it has enough doses for India. The company had withdrawn in February after the government had decided against recommending it in the absence of data from local clinical trials.
It is understood that the government’s decision on Tuesday came as a big surprise; both companies have said they would take a few days to firm up plans.
In the case of J&J, the US drugs major initiated talks with the Centre recently to start a bridging clinical study of the Janssen Covid-19 vaccine, but it now may get a leg up from the government’s decision on Tuesday. J&J had announced a tie-up with Hyderabad-based Biological E in August last year.
India, with the largest manufacturing capacity of vaccines globally, is, ironically, facing a major shortage of vaccines, with several states facing delays and running out of stock over the last few days. It has administered over 10 crore doses till now but needs to ramp up due to surging Covid-19 cases.
Also, trials of a vaccine by another US company, Novavax, started in India in March, with the aim of launching by September. Tuesday’s government decision could also fast-track this vaccine.
Meanwhile, the mRNA vaccine from US firm Moderna will be months away, with the company still in early talks with the Council of Scientific and Industrial Research for a possible tie-up, according to news reports.