Serum Institute of India's application for emergency use authorisation will be considered by the expert panel today. This development comes hours after the UK government accepted the recommendation from the Medicines and Healthcare Regulatory Agency (MHRA) to authorise Oxford University-AstraZeneca's Covid-19 vaccine, named Covishield, for emergency use. Serum Institute is conducting the trials for Covishield in India and is the manufacturer for the same.
Speculations are rife that the COVID-19 vaccine would be approved for emergency use authorisation. The subject expert committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) had sought safety and immunogenicity data from the clinical evaluations abroad before granting approval for emergency use in India. The SEC had recommended that the firm should submit an updated safety data of phase 2 and 3 clinical trials in the country, immunogenicity data from the clinical trial in the UK and India, along with the outcome of the assessment of the UK Medicines and Healthcare products Regulatory Agency (MHRA) for grant of emergency use authorisation.
While Bharat Biotech and Pfizer had also applied for emergency use authorisation, Oxford-AstraZeneca's candidate has been touted to be the first one to get the nod.
The COVID-19 SEC had sought additional safety and efficacy data from SII and Bharat Biotech for their coronavirus vaccines after deliberating on their applications. Serum Institute is reported to have furnished the additional data. Pfizer eventually sought more time to make a presentation before the committee.
Meanwhile, Serum CEO Adar Poonawalla has said, "You'll be hearing some good news from the UK very soon... It would be a 90-95% effective vaccine if you just keep a two-to-three months' gap between dose 1 and dose 2. They will make that public with documentation."
Once the vaccine is approved, Serum will have to get the World Health Organisation's (WHO) pre-qualification to export the vaccine to other countries which might take a month. This would eventually be beneficial for India as the country would get the first batch of about 40-50 million doses of the vaccine that's been developed at the Pune plant.