COVISHIELD GETS EXPERT PANEL NOD, BUT BHARAT BIOTECH WILL HAVE TO WAIT

Covishield, the novel coronavirus vaccine developed by the University of Oxford and drug manufacturer AstraZeneca, has become the first vaccine to secure recommendation for emergency use approval in India. The recommendation was made by a government-appointed expert panel on Friday. However, the Drugs Controller General of India (DCGI) will take a final call on the matter.

On Friday, an expert panel in the Central Drugs Standard Control Organisation (CDSCO) held a meeting to deliberate on the issue of granting emergency use authorisation. The meeting was held to examine the applications submitted by the Serum Institute of India (SII) for the Oxford Covid-19 vaccine and Bharat Biotech’s Covaxin.

The SII is making the vaccine Covishield, developed by Oxford University and AstraZeneca, while Bharat Biotech has partnered with the Indian Council of Medical Research (ICMR) for its Covaxin.

As per information, SII’s Covishield has submitted its data which has been found to be satisfactory, but Bharat Biotech’s Covaxin will need about three weeks more before submitting data from its trials.

In an exclusive interview, AIIMS Director Dr Randeep Guleria spoke about the steps involved in securing emergency authorisation for the Covid-19 vaccine in India. He also provided more insights on the vaccine programme in the interview with The Daily Guardian. Excerpts:

Q: How can people get the vaccine?

A: The important thing that we must understand is that we will never have doses for everyone in the beginning. The government has prioritised who should be given the vaccine first. The three broad groups that have been prioritised are healthcare workers, frontline workers and people above 50 years of age with comorbidities. This has been done keeping in mind that our aim is to decrease deaths and break the chain of people who are getting infected to stop transmission.

The total number will be 30 crore. Listing of healthcare workers has been done and data has been uploaded on the COWIN software. After registration on the app, contact numbers will also be added, on the basis of which, a person will be informed about the place and time of vaccination via SMS. It will be easy in the case of healthcare workers, which will be coordinated with the help of hospitals. The Home Ministry has also made a list of frontline workers. For the third stage, on the basis of ID cards, which give details about age, information will be uploaded on COWIN so people can be informed about vaccination via SMS.

Q: Who is going to pay for the vaccine? Is it free of cost?

A: Currently, the cost of the vaccine will be supported by the government as a part of their initiative.

Q: Do you think old people who cannot come out of their homes should get doorstep facility?

A: One has to consider not only old people, but also those who come with comorbidities. We should be careful about such high risk groups. Some kind of strategy will need to be planned and it will evolve gradually. Some backup facilities need to be prepared.

Q: On what basis has Covishield been given EUA?

A: The large amount of data which they have published from Brazil and the UK, looking at its efficacy and safety. Now, the issue has been about what data is available for the Indian population. Serum Institute has done studies in India on smaller numbers and shown that data from that study is comparable and equal, both in terms of safety and efficacy.

Q: How much time will Covaxin take before receiving EUA?

A: They will take more time to prove efficacy. DCGI can give approval after two to three weeks.

Q: How many doses are required for the AstraZeneca vaccine to be effective?

A: Only two doses are required. The UK has said that it can be given in 28 days to 12 weeks of time. They changed their criteria because cases were increasing rapidly. We should make some arrangements to avoid confusion.