Pfizer has reportedly submitted an application to the Drugs Controller General of India (DCGI) for an emergency use authorisation (EUA) for its Covid-19 vaccine in India.
Pfizer is the first company to seek approval from India’s drug regulator, CNN-News18 reported.
NDTV quoted VK Paul, who is advising the Indian government on Covid-19 matters, as saying: “We welcome interest from Pfizer to seek emergency licensure in our country.”
Paul added that typically DCGI may take up to 90 days to decide on such applications and give approval. However, a decision on Pfizer’s vaccine could be made much faster.
Last month, Paul said that Pfizer and its rival Moderna’s vaccines may not be available in the country in huge quantities soon.
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In a similar move, the Serum Institute of India (SII) sought an EUA from the DCGI for its Oxford Covid-19 vaccine, Covishield, in the country citing unmet medical needs, PTI quoted official sources as saying.
Co-sponsored by Indian Council of Medical Research (ICMR), the Phase III trial of the vaccine is taking place in different parts of the country by the SII.
Furthermore, AstraZeneca and Oxford are conducting clinical studies of Covishield in the UK and Brazil.
Under the application, results from four clinical studies, two in the UK and one each in Brazil and India, showed that Covishield was highly efficacious against symptomatic and severe Covid-19 infections.
The news agency quoted a source citing the application as saying: “In terms of safety, Covishield was well tolerated with respect to solicited adverse events and was not associated with an increased number of SAEs and deaths.”
Moreover, the SII submitted 12 batches of the vaccine to the Central Drugs Laboratory (CDL) in Kasauli for testing purpose.