With a bid to vaccinate all citizens by December 2021, India will produce 216 crore doses of COVID-19 vaccines between August-December, the Centre said on Thursday, 13 May. As India deals with an acute shortage of doses, Niti Aayog’s VK Paul on Thursday said that “there should be no doubt that vaccine will be available for all as we move forward”.
These vaccines include 75 crore doses of Covidshield, 55 crore doses of Covaxin, 30 crore doses of Bio E Sub vaccine, 20 crore SII- NOVAVAX, 10 crore BB Nasal vaccine, and 0.6 crores of Genova mNRA vaccine.
“Any vaccine that is approved by the FDA or WHO can come to India. The import license will be granted within one to two days. No import license is pending,” Paul said while addressing the media, adding that the Ministry of External Affairs (MEA) and other relevant bodies have been in touch with manufacturers like Pfizer, Moderna, and Johnson & Johnson from the beginning.
However, these manufacturers have spoken of vaccine availability in India only by the Q3 (July-September), Paul said.
Current Status of the Availability/Trials of These Vaccines
After the completion of Phase I/II trials that began in November 2020, Hyderabad-based pharmaceutical company Biological E Limited (BE) received the approval to start the Phase III clinical trial from the Central Drugs Standard Control Organisation (CDSCO) - Subject Expert Committee (SEC) late last month.
The Phase III clinical study will reportedly be conducted in 15 sites across India in about 1,268 healthy subjects in the age range of 18 to 80 years, after successful Phase II trials in about 360 subjects in the age group.
Meanwhile, the United States is looking at joint production of Johnson and Johnson’s vaccine in India in association with Serum Institute, Charge d’Affaires of the US Embassy, Daniel B Smith said on Tuesday, 11 May.
As of 5 May, SII started a Phase II/III observer-blinded, randomized, active-controlled trial of Novavax with 1,600 participants over the age of 18 across 15 centers, the launch of which has been delayed due to the issue of export of raw material from the US. It will be called Covavax in India.
According to The Economic Times, its worldwide launch will get pushed beyond Q3 2021 (July to September).