US Moderna's Covid vaccine approved for use in India

India approved the import of US pharmaceutical major Moderna’s mRNA technology-based coronavirus disease (Covid-19) vaccine.

US Moderna's Covid vaccine approved for use in India

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• The story: India approved the import of US pharmaceutical major Moderna’s mRNA technology-based coronavirus disease (Covid-19) vaccine. This is the first international vaccine against the infectious disease approved by India.
• Cipla in picture: On behalf of Moderna, Indian pharmaceutical company Cipla Ltd applied to the country’s drugs regulator, the Drugs Controller General of India (DCGI), for grant of approval to import the vaccine to India. This is the first internationally developed vaccine for which now such permission exists today. Moderna is donating an unspecified number of doses to India through the World Health Organization (WHO) and Gavi’s COVAX mechanism; Cipla is facilitating this, and the approvals are part of the process.
• Not just donations: The approval was not limited to donations, but Cipla has been given a licence to import, and it is applicable to the Moderna vaccine import in general, under which they are also allowed to distribute it here; since it is still under emergency use authorization retail sale of the product is not allowed.
• Indemnity: Cipla was considering spending up to $1 billion to import 50 million doses of the vaccine. Cipla has also sought indemnity for the Moderna vaccine, much like other international vaccine makers negotiating their entry into India. The government is yet to take a call on indemnity for any foreign vaccine maker.
• Format: Moderna is coming in the ready-to-inject form. There is no manufacturing base as of now, like in case of Sputnik V, but it is hoped that in the future, Moderna will produce this vaccine on Indian soil. The vaccine, mRNA-1273, manufactured by Moderna TX, Inc., is a two-dose vaccine with the shots to be given 28 days apart.
• mRNA magic: The messenger RNA vaccines, also called mRNA vaccines, are a new vaccine technology platform. The vaccine can be stored for up to seven months between -25 and -15 degrees Celsius; and its medium-term storage temperature is -20 degrees. In normal cold chains, where the temperature is between 2 and 8 degrees Celsius, an unopened vial can stay effective for 30 days. The mRNA vaccines teach human cells how to make a protein, or even just a piece of a protein of the virus, triggering an immune response inside human bodies. The benefit of mRNA vaccines, like all vaccines, is that those vaccinated gain protection without ever having to risk the serious consequences of getting sick with Covid-19.

 

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