Oxford COVID-19 vaccine 'Covishield' gets expert panel's nod in India

The Serum Institute of India, the world's largest vaccine manufacturer, has tied up with AstraZeneca to manufacture 'Covishield'.

SII had applied to the Drugs Controller General of India (DCGI) for EUA for Oxford COVID-19 vaccine on December 6. (Representational Photo | AP)

An expert panel on COVID-19 from the Central Drugs Standard Control Organisation (CDSCO) has approved the emergency use of the Oxford vaccine 'Covishield' in the country on Friday.

The vaccine is being manufactured by Pune-based Serum Institute of India (SII).

#JustIn: The expert committee of @CDSCO_INDIA_INF on #Covid19 recommends approval of @AstraZeneca- @UniofOxford vaccine in India.@NewIndianXpress

— Sumi Dutta (@SumiSukanya) January 1, 2021

The official confirmation of the approval from the government however is yet to follow.

The SEC will make suitable recommendations to the Drugs Controller General of India (DCGI), which will take the final decision on clearing the vaccine for use in India.

All states are set to conduct a COVID-19 vaccination dry run on Saturday (January 2). The dry run is proposed to be conducted in all state capitals, while some states will also include districts that are situated in difficult terrain or have poor logistical support.

The Serum Institute of India, the world's largest vaccine manufacturer, has tied up with AstraZeneca to manufacture Covishield.

Responding to queries from The New Indian Express, the Serum Institute of India had earlier confirmed that it has already produced 40 million doses under an at-risk manufacturing and stockpiling license from the Drugs Controller General of India and will be manufacturing up to 100 million doses by February 2021.

“We have already started manufacturing in small batches and hope to reach about 400 million doses by June-July 2021,” it said. 

Nearly 1 crore healthcare workers—which include doctors, nurses, paramedical staffers and others working in hospitals across the country—are set to be the first beneficiaries of the government-run vaccination drive.

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) on Wednesday had approved the COVID-19 vaccine developed by scientists at Oxford University and produced by AstraZeneca for human use.

Officials also hinted that EUA granted to the Covishield means that its safety and efficacy will be continued to be monitored after administration of shots and at least 10 % of all beneficiaries—in every state—will be diligently followed up, like it happens in clinical trials, for monitoring any adverse events.

SII has said that it has stockpiled about 50 million doses of Covishield—enough to vaccine about 2.5 crore people as it is given in two dose regimens—much of which will be supplied within India. Once the Drugs Controller General of India, approves the vaccine, weekly manufacture will begin at a faster rate, the firm had said.

What happens next

•  The National Expert Group on Vaccine Administration on Covid-19 will likely meet on Saturday and will share specific details with SII on how many vials per state are to be sent
•  Special cargo planes with cold boxes storage space and refrigerated vans may start ferrying vials of the vaccine from Pune
• The company, under the supervision of the Union and state governments, will be responsible for transportation of the vaccine
• From state capitals, vials will be distributed to district headquarter before they reach inoculation centres
• The initial lots of the vaccine will be sent  to government hospitals, public health centres or large private hospitals where healthcare and frontline workers will be inoculated
• Polling booths, wedding and community halls, and mobile vans could then be converted into temporary vaccination centres where those above 50 and people with serious comorbidities will be vaccinated against Covid-19.

(With inputs from Sumi Sukanya Dutta in Delhi)