On Tuesday, India approved a fourth COVID-19 vaccine, with Cipla receiving permission from the Drugs Controller General of India (DCGI) to import Moderna's COVID-19 vaccine for restricted emergency use. With the permission, the vaccine by the US-based company could be imported and start getting used in country's vaccination programme. The company will only have to provide safety assessment data of the first 100 beneficiaries before mass rollout. But it might be some time yet before the vaccine available to Indians as a whole.
At present there is no timeframe for the availability of the vaccine for the Indian population. While it is likely that some doses will be donated to India in the near future, there is no definitive agreement yet on commercial supply.
"Cipla Limited is supporting Moderna, Inc. with the regulatory approval and importation of vaccines to be donated to India. At this stage, there is no definitive agreement on commercial supplies," the company said in a statement.
In separate communications, Moderna had on June 27 informed DCGI that the US government has agreed to donate a certain number of doses of its COVID-19 vaccine through COVAX to India for use here and sought an approval from the Central Drugs Standard Control Organisation.
It is an mRNA vaccine that had been 94.1% effective at preventing laboratory-confirmed COVID-19 infection in people who received two doses and had no evidence of being previously infected during clinical trials. A recent study published in Nature had indicated that the Pfizer and Moderna COVID-19 vaccines provided “persistent” and lasting protection for years and individuals might not ultimately require booster shots.
According to the US Center for Disease Control and Prevention, it is suitable for people aged 18 and above. It is a two dose vaccine, that is being administered in the US with a 28 day gap between doses. With dosage gaps varying from country to country for other vaccines, it is not yet clear whether this timeframe will be exactly followed in India.
While this is an mRNA vaccine, it is the first of its kind in India. Russia's Sputnik V and Covishield are both adenovirus vector vaccines while Covaxin is an inactivated virus-based jab.
The company on Tuesday said that its vaccine showed promise in a lab setting against coronavirus mutations, including the highly contagious Delta variant. The results came from vitro neutralisation studies of sera from eight participants one week after they received the second dose of the Moderna COVID-19 vaccine.
The vaccine showed favourable reaction against the Beta variant which was first identified in South Africa, the Kappa and Delta variants first identified in India, the Eta variant first identified in Nigeria and the A.23.1 and A.VOI.V2 variants first identified in Uganda and Angola respectively. The data has been submitted as a preprint and is yet to be peer-reviewed.
The Moderna vaccine is being used in much of the western world including the USA. The vaccine features on the WHO’s Emergency Use Listing and has been assessed and authorised for use across the EU by the European Medicines Agency.
