Indian drugmaker gets approval to distribute partner’s vaccine, clearing the way for India’s first mRNA vaccine to be imported.
Indian drugmaker Cipla Ltd has received regulatory approval to distribute partner Moderna Inc’s COVID-19 vaccine in the country, a senior government official said, clearing the way for India’s first mRNA shot to be imported.
Moderna’s vaccine will be the fourth shot authorised for use in India, after AstraZeneca and partner Serum Institute of India’s Covishield, Bharat Biotech’s Covaxin and Sputnik V developed by Russia’s Gamaleya Institute.
“Our vaccine basket is now richer by this addition,” government official Vinod Kumar Paul said at a news briefing on Tuesday, adding the government remained in talks with Pfizer over the drugmaker’s vaccine.
After a fall in coronavirus cases from a devastating second wave last month, India has doubled down its efforts to vaccinate its 940 million adults amid fears of a third wave of infections.
The country has administered 61 million doses in the last two weeks starting from June 12, more than the number of people who signed up for shots during the period, indicating an improvement in supplies after widespread shortages.
The government officials did not provide any further details on the partnership between Moderna and Cipla and how the vaccine, which is based on messenger RNA technology, will be imported.
“I want to thank the government of India for this authorisation, which marks an important step forward in the global fight against the pandemic,” Moderna’s Chief Executive Officer Stéphane Bancel said.
Cipla is supporting Moderna with the regulatory approval and the import of vaccines to be donated to India, the company said in an email, adding that “at this stage, there is no definitive agreement on commercial supplies”.
India had in May scrapped local trials for “well-established” foreign coronavirus vaccines to accelerate its vaccination rollout and the officials confirmed that the vaccine developed by Moderna will not require so-called bridging trials.
Earlier in the day, Johnson & Johnson said it was in talks with the Indian government to explore ways to speed up the delivery of its single-shot COVID-19 vaccine.
Anant Bhan, a senior researcher in health and bioethics, said the Moderna vaccine – which needs to be stored at minus 20 degrees Celsius (minus four Fahrenheit) – was unlikely to be for mass use due to its cold-chain requirements and higher price tag.
Rival jabs such as the Covishield vaccine – which is the main shot used in India – can be kept at normal refrigerator temperatures of between two and eight degrees Celsius (36-46 Fahrenheit).
“It’s primarily going to be used in the private health sector largely present in the cities. There, they can manage and build to meet some of its storage requirements,” Bhan told AFP news agency.
“It is a welcome decision but the question is also what it means in terms of access, number of doses and price point. We will have to wait and watch for that.”
So far, India has administered 331.1 million doses, more than the overall shots administered in the United States. The country’s vaccination rate proportionate to the number of the population, however, is much lower than for many other countries.
Moderna’s two-dose vaccine has been widely used in several regions, including the US and Europe, but may face some cost and distribution hurdles in India as the shot requires cold storage.
“Moderna is coming in ready-to-inject form as there is no manufacturing base” in India, Paul said. “But we also hope, going into the future, Moderna should produce this vaccine on Indian soil.”