The Drugs Controller General of India (DCGI) gave nod to Cipla for import of Moderns' COVID-19 vaccine. The Union Health Ministry on Tuesday said that new drug permission has been granted to Moderna which is the first internationally developed vaccine. However it said that Moderna has been given permission for restricted use only.
Moderna's vaccine will be the fourth COVID-19 jab to be available in India after Covishield, Covaxin and Sputnik.
Mumbai-based pharmaceutical multinational Cipla, on behalf of the US pharma major Moderna, had requested for import and marketing authorisation of its COVID-19 vaccines.
The company had sought Drugs Controller General of India (DCGI) nod for importing Moderna's coronavirus vaccine, sources informed to ANI According to sources, Cipla had filed an application recently seeking permission for import of Moderna COVID-19 vaccine referring to DCGI notices dated April 15 and June 1 stating that if the vaccine is approved by the USFDA for EUA, the vaccine can be granted marketing authorisation without trial and assessment of safety data first 100 beneficiaries of vaccines shall be submitted before rolling out in immunization programme.
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. Much like Pfizer, Moderna's jab is also an mRNA vaccine with high efficacy. The vaccine had been shown to have an efficacy of over 94% in clinical trials, starting 14 days after the first dose.
According to the Centers for Disease Control and Prevention in the US (where the Moderna vaccine has been used for several months now), is a two shot jab that is recommended for adults. The doses are given 28 days apart, and an individual is considered fully vaccinated two weeks after the second shot.
Moderna's method to protect against Covid-19 relies on messenger RNA (mRNA) to program cells to generate immunity to the coronavirus. The vaccine has shown more than 90 per cent efficacy in clinical trials in protecting against COVID-19.