New year begins on a happy note as India’s expert panel clears Oxford vaccine, Covishield
Oxford vaccine: India has moved one step closer to getting its Covid-19 vaccine rollout approved as the expert panel has cleared use of Covishield, the Oxford-AstraZeneca vaccine being developed by Pune based Serum Institute of India. On Friday, the expert panel at DCGI (Drugs Controller General of India) gave its recommendation for EUA (emergency use authorization) of Covishield. The final approval by DCGI for marketing and use of vaccine may follow soon.
The SEC’s (Subject Expert Committee) recommendation followed two days after the UK regulators approved the public use of Oxford-AstraZeneca vaccine. SEC has mentioned that it is seeking additional information from SII which includes a fact sheet of vaccine information for the general public. SEC has also asked the company to provide product details that would be included in package insert along with specific conditions asked by MHRA (UK Medicines and Healthcare products Regulatory Agency) for approval of Oxford Vaccine.
After the final approval by DCGI, the first round of shots will be given to healthcare workers. This will commence one of the largest vaccination drive in the country aiming to inoculate the “priority population” of 30 crore by July in India. It is likely that sanitation workers and pharmacists too will be added to the list. The first shots will be administered in next 7-10 days post DCGI’s approval, which is expected soon.
Prime Minister Narendra Modi said on Thursday that efforts are in line to ensure that vaccines are made available to the target population quickly, marking the year 2021 begin with hope to finally have cure of the coronavirus pandemic.
On Friday, SEC extended that CDSCO (Central Drugs Standard Control Orgamisation) must grant its approval for Covishield use. It is to be noted that the vaccine candidate has not yet completed phase 2/3 of clinical trials in India. Like the dosage recommendation by UK’s MHRA, panel has recommended two full doses approval of the vaccine which must be administered 4-6 weeks apart.
The recommendation has come with certain conditions. The SII is required to submit any and all adverse events from vaccine administration to the regulator every 15 days.
Post DCGI approval, Covishield will be supplied to government for mass vaccination even before it completes the ongoing trials. The trials however, must be continued by the SII.
So far, the Serum Institute has manufactured 40 million doses of Covishield. Currently the SII has capacity to manufacture 50-60 million doses of vaccine per month, and expects to increase it to nearly 100 million a month by February end.