FDA rejects emergency use authorisation for Covaxin in a setback for India-made jab

Hyderabad: In a setback to Bharat Biotech’s COVID-19 vaccine Covaxin, the US Food and Drug Administration has “recommended” Ocugen Inc, the US partner of the Indian vaccine maker, to go for Biologics Licence Application (BLA) route with additional data, nixinghopes of Emergency Use Authorisation. Ocugen in a statement on Thursday announced that as recommended by … Read more

Bharat Biotech applies for emergency use authorization of Covaxin in Philippines

New Delhi: As part of the globalization of India-developed COVID-19 vaccine, India’s Bharat Biotech has applied for “Emergency use authorization” (EUA) in the Philippines. EUA was filed earlier this month in the country and is the first international regulatory filing for Bharat Biotech’s COVAXIN. Once approved by the local regulator, India is expected to donate … Read more

COVID-19 | Dr Reddy’s eyes March launch of Sputnik V vaccine under Emergency Use Authorisation

‘We are dosing patients and we expect to complete the dosing as part of the phase 3 (trials) by February,’ said the company Dr Reddy’s Laboratories, which is conducting Phase 3 trials of Russia’s COVID-19 vaccine Sputnik V, believes the jab is expected to be launched in India through Emergency Use Authorisation, a senior official … Read more