COVID Vaccine: Knowledgeable panel for conditional nod to Serum-Oxford; meet on with Bharat Biotech

The subject expert committee of the Central Drugs Standard Control Organisation (CDSCO), it is reliably learnt, has recommended on Friday, 1 January, that the Serum Institute of India’s Covishield vaccine be given the Emergency Use Authorisation (EUA in quick speak) by the Drug Controller General of India with conditions. The EUA has apparently been recommended along with some implementation-related conditions, details of which are still not available.

However, nothing has been communicated officially to the company as yet. But it is learnt that the Serum presentation was well received and that this was followed by the presentation by Bharat Biotech, which was still in progress at the time of writing this.

The Covishield vaccine presentation, often also referred to as the Oxford-AstraZeneca vaccine, was a little over a three-hour-long online meeting where the company officials made the presentation. This was after the expert panel had already studied the documents and the data already shared by the company before the meeting on Friday.

The Serum Institute vaccine is one among the three vaccines awaiting Emergency Use Authorisation approval (the other two being Bharat Biotech and Pfizer). The other two also may well get the approval, feel some of the experts in the vaccine industry.

Typically, these presentations involve a team of about 6 to 7 technical people led by the medical director or the person in charge of clinical trials from the company making a presentation to the subject expert committee. At the meet, all the clinical data is presented and the team will need to respond to any questions that the expert committee may have – be it around production, quality or regulatory affairs.

This is significant because it is only this recommendation that will lead to the issuance of a licence by the DCGI for emergency use of the vaccine. Serum is also working on other vaccine candidates that are in the pipeline but it is only Covishield that was under discussion on Friday, 1 January.

Currently, Serum has stockpiled 50 million doses of the Covishield vaccine and is making 10 million doses a month, and apparently, it is gearing up to make 50 to 60 million doses per month from this month and ramp it up to about 100 million doses by April this year. This may look big when seen as an absolute number but very small still when seem from the overall demand. India alone will need 2.5 billion doses if all are to be vaccinated. Of course, there are other companies too that will be pitching in. Globally, the demand is around 17 billion doses (there are two doses that typically get administered).

In the case of Serum, it has apparently committed 50 per cent of total production for the Indian market. The rest will be for global demand. Currently, India is talking of 300 million or 30 crore people to be vaccinated first. GAVI – the vaccine alliance globally has already talked of 300 million doses from Serum. Of this, it has already placed an order for 100 million doses.

What is really not clear is the amount to be ordered by the Indian government or whether an order for the vaccines has already been placed with the companies. This is important because the government has already started dry runs to ensure smooth implementation of the vaccine delivery programme. Therefore, by now, there should have been some clarity on the number of doses that the government is procuring.