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American biotech company Moderna’s mRNA Covid-19 vaccine has been added to the World Health Organisation’s basket of vaccines for emergency use.
The WHO said, Moderna’s vaccine (mRNA 1273) has been listed for emergency use, making it the fifth to receive such validation from the WHO.
Others that have made the cut include Pfizer’s mRNA vaccine, the AstraZeneca-Oxford University vaccine from two different suppliers, including Serum Institute of India, and the one-dose Johnson and Johnson vaccine.
Logistics concerns
The WHO emergency listing paves the way for countries without the regulatory infrastructure to expedite their own approval process to import and administer the mRNA vaccine. But mRNA also comes with added logistics concerns, given the extreme temperatures required to transport and distribute it.
Moderna appears to have addressed this issue. The WHO note explained, although the vaccine is provided as a frozen suspension at –25 ºC to –15 ºC in a multidose vial, vials can be stored refrigerated at 2–8 °C for up to 30 days prior to withdrawal of the first dose, meaning that ultra-cold chain equipment may not always be necessary to deploy the vaccine.
This would be a significant feature in different climatic regions and in low and middle-income countries that may not have the infrastructure to store and distribute.
In the recent past, Moderna chief has indicated that their capacities are occupied in servicing existing contracts. Hence it remains to be seen how the WHO listing may facilitate a roll-out outside of the US and Europe. And whether it would involve a tech-transfer.
No presence in India
India has from Saturday opened up the pathway to bring foreign vaccines into the country with fast-track approvals. Moderna has no presence or alliance in India, and there is little clarity on its India plans.
WHO’s listing process assesses the quality, safety and efficacy of Covid-19 vaccines and is a prerequisite for the COVAX facility vaccine supply.
The vaccine has already been reviewed by WHO’s Strategic Advisory Group of Experts on Immunization (SAGE), which makes recommendations for vaccines’ use in populations (recommended age groups, intervals between shots, advice for specific groups such as pregnant and lactating women). And SAGE recommended the vaccine for all age groups 18 and above.
The US Food and Drug Administration had issued an emergency use authorisation on the Moderna vaccine in December 2020 and a marketing authorisation valid throughout the EU was granted by the European Medicines Agency in January 2021.
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