After UK approval, India panel ponders data of SII, Bharat Biotech for Covid-19 vaccine, nod likely next week

Hours after Britain approved the Oxford University-AstraZeneca COVID-19 vaccine, India’s expert panel met on Wednesday to review the data before submitting its final recommendation for approval. The entire process is likely to take a week and the announcement is likely to be known next week.

The Subject Expert Committee of the Central Drug Standard Control Organization (CDSCO) apparently pondered the data presented before it on Wednesday. The vaccine Covishield by SSI (Oxford-AstraZeneca) is a non- replicating viral vector vaccine with viruses that have been modified to act as delivery systems carrying the viral antigens to the body’s immune cells. Chimpanzee adenovirus is the vector used to deliver in this vaccine.

Once the application of Serum Institute of India for the same vaccine manufactured in India for emergency use authorization is approved, rollout will begin in a week’s period making India the second country to give EUA to the vaccine. Along with SII, Hyderabad-based Bharat Biotech had also applied for Emergency Use Authorization for its Covaxin and made its presentation on Wednesday before the experts panel.

Amid fears of new strain spreading rapidly, the UK became the first country in the world to approve the vaccine called Covishield, following a recommendation from the Medicines and Healthcare products Regulatory Agency (MHRA). Withthis, the rollout of mass vaccination is expected to begin in the first week of January in both the countries.

Vaccine-fda

Vaccine-fda

Soon after the UK approval, AstraZeneca said in a statement that first doses of the vaccine will be released to begin the vaccinations drive and that the company hopes to supply millions of doses in the first quarter of 2021 as part of its deal with the UK government to supply up to 100 million doses in total. In India, SII is ready with 50 million doses of the vaccine already.

Earlier this month, the CDSCO had asked SII to submit the outcome of the assessment of UK-MHRA before granting emergency use authorization, updated safety data of the Phase II/III clinical trials and immunogenicity data from the clinical trial in UK and India.

Vaccination Drive

The central government plans to vaccinate nearly 30 crore people in the first phase, covering about one crore healthcare workers, about 2 crore frontline and essential staff besides 7 crore elderly, mostly above the age of 50 years with comorbidities.

SII CEO Adar Poonawalla on Monday said 40-50 million doses of COVID-19 vaccine have already been stockpiled, the rollout will be the New Year gift to the country that had witnessed severe health and financial crisis throughout the year 2020.  Together with Bharat Biotech, the two firms can produce 65 million doses of the vaccine per month.

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