Facing accusations of delay in placing orders for vaccines, the government has defended its vaccine procurement policy saying it has been pursuing Pfizer, Johnson & Johnson and Moderna since mid-2020 for the earliest possible imports. “Buying vaccines internationally is not similar to buying ‘off-the-shelf’ items,” the government said in a statement titled ‘Myths & Facts on India’s Vaccination Process’.
The statement said no application of any foreign manufacturer for approval is pending with the drugs controller.
The statement said the Central government has proactively eased the entry of vaccines approved by USFDA, EMA, UK’s MHRA and Japan’s PMDA, and WHO’s Emergency Use Listing into India in April.
“These vaccines will not need to undergo prior bridging trials. The provision has now been further amended to waive off the trial requirement altogether for the well-established vaccines manufactured in other countries,” it said.
US pharma giant Pfizer has already said it is ready to offer five crore doses — 1 crore in July, 1 crore in August, 2 crore in September and 1 crore in October –for supply to India in 2021 and that it will deal only with Government of India and payment for vaccines will have to be made by GOI to Pfizer India.
“Yes, we are engaged with Pfizer because they have indicated availability of a certain amount of, a certain volume of vaccines in coming months, possibly starting in July,” Niti Aayog (health) member VK Paul said.
“We are examining the request (for indemnity) and we will take a decision in the larger interest of people and on merit. This is under discussion but there is no decision as of now,” he further added.
According to a report in PTI, Moderna is expecting to launch a single-dose COVID-19 vaccine in India next year and is in talks with Cipla among other Indian firms. But it has conveyed to Indian authorities that it does not have surplus vaccines to share in 2021. It is learnt that Cipla has already evinced interest in procuring 5 crore doses from Moderna for 2022 and has requested confirmation from the central government in respect of stability in regulatory requirements/policy regime. The Health Ministry has also been asked to take an early decision on Cipla’s request regarding support required by them for procurement of Moderna vaccines.
Johnson & Johnson
According to a report in PTI, India is exploring ways to secure Johnson and Johnson’s vaccines for the Indian market as the US company is not likely to export its jabs to other countries in the near future. One billion doses of the J&J vaccine will be manufactured in India by Hyderabad’s Biological E under the Quad Vaccine Partnership, but those will not be for the domestic market.
Sputnik Light Single-dose
The government is hopeful of a speedy launch of single-dose COVID-19 vaccine Sputnik Light in India and all stakeholders, including the Russian manufacturer and its Indian partners, have been directed to fast-track the application and regulatory approval procedures for the jab to boost the country’s vaccination drive, PTI reported citing sources. An application seeking regulatory approval for Sputnik Light is expected to be filed in the next couple of weeks and it could become the first single-dose vaccine to be launched in India.
Currently, India has been inoculating its people with Covishield produced locally at the Serum Institute of India (SII), Covaxin made by local firm Bharat Biotech and has begun rolling out Russia’s Sputnik V. India launched the world’s largest vaccination drive in mid-January.
Never miss a story! Stay connected and informed with Mint.
our App Now!!