Moderna, a pharmaceutical and biotechnology company has informed that the US government has also committed to send a set number of doses of the Moderna vaccine to India via COVAX.
Official sources indicated on that India’s medicines authority may soon issue Moderna’s COVID-19 vaccine restricted emergency use authorization.
Moderna also announced that the US government has consented to provide a set number of doses of the Moderna COVID-19 vaccine to the Indian government through COVAX, and that the vaccinations have been approved by the Central Drugs Standard Control Organization (CDSCO).
Cipla, a Mumbai-based pharmaceutical company, has requested import and marketing authorization for these vaccines on behalf of the US pharmaceutical giant.
According to the sources, a decision will be made soon because the CDSCO is in favour of it.
Cipla filed an application seeking permission to import the COVID-19 vaccine, citing DCGI notices that stated that if the vaccine is approved by the USFDA for EUA, the vaccine can be granted marketing authorization without a bridging trial and that safety data of the first 100 vaccine recipients must be submitted before the vaccine is rolled out in immunizable persons.
It’s unclear how many dosages Moderna will donate to India, or whether they’ll be delivered via government or private means.