Covid vaccine approval panel in India deadlock, to meet again on January 1
London, Dec. 31, 2020 (AltAfrica)-The Indian approval panel- independent expert committee advising the Drugs Controller General of India (DCGI) on Covid-19 vaccines met in New Delhi on Wednesday but fail to reach an agreement over paucity of data submitted by vaccine manufacturers
The deadlock in India came same day the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) gave emergency authorisation for AstraZeneca-Oxford University’s vaccine candidate
The Subject Expert Committee (SEC) of the DCGI (approval panel) said the analysis of additional data and information provided by Bharat Biotech and Serum Institute of India (SII) is still going on. It will meet again on Friday, an official statement said.
The statement added that the SEC met to consider the Emergency Use Authorisation request of Pfizer, SII and Bharat Biotech. Further time was requested on behalf of Pfizer. The SEC perused the additional data presented by SII and Bharat Biotech, and this process is still going on. The SEC will convene again on Friday.
The British approval for the AZ-Oxford vaccine just ahead of the New Year comes as good news for those awaiting the vaccine in India.
In India, the vaccine, branded as Covishield, is being produced and marketed by Pune-based SII, which is said to have stockpiled 50 million doses ahead of the DCGI approval. SII CEO Adar Poonawala said the firm would be able to supply 300 million doses by July.
AZ, in a statement, said it released the first doses of the vaccine in the UK on Wednesday, making it possible to commence vaccination in early 2021. This is the second vaccine to get emergency approval in the UK after the Pfizer-BioNTech mRNA vaccine. In the US, vaccines of both Pfizer and Moderna have received the green signal.
The authorisation provided in the UK is for the active immunisation of individuals 18 years or older. It recommends two doses administered with an interval of four to 12 weeks. “This regimen was shown in clinical trials to be safe and effective at preventing symptomatic Covid-19, with no severe cases and no hospitalisation of more than 14 days after the second dose,” a note from the British company said.
Covishield is said to be more suitable for the Indian market in terms of storage and distribution. SII is expected to produce and market the vaccine in India as well as other low- and middle-income countries.
Though a trial participant in Chennai claimed that he suffered acute encephalopathy after receiving the Covishield shot, the company rejected the charge.
Pascal Soriot, CEO of AZ, said the vaccine has been shown to be effective, well-tolerated and simple to administer. It is “supplied by AstraZeneca at no profit.”