Serum waits for India’s green signal for COVID-19 vaccine use

Serum Institute of India, which is also manufacturing the Oxford-AstraZeneca coronavirus vaccine in India, said that it expected the government to approve the shot for emergency use in a few days.

The company has already made 40 million to 50 million doses of the vaccine and will be able to ramp up capacity to around 100 million a month by March when a new facility comes online.

"We have 40-50 million doses of Covishield stockpiled. Once we get regulatory approvals in a few days, it'll be down to the government to decide how much they can take and how fast," Serum Chief Executive Adar Poonawalla said.

"All data on Oxford-AstraZeneca COVID19 vaccine submitted in India and UK. There are no concerns, regulators are closely reviewing documents and data," informed Serum CEO. Poonawalla also told the reporters that India is a part of 'COVAX' and hence, the company will keep giving 50% of everything we make to India and to COVAX at the same time. However, he added that since India was a large population, the company will "probably end up giving the majority of those 50 million doses to India first."

He also said that Serum will be producing around 300 million doses by July 2021.

Further Poonawalla said, "You will be hearing some good news from the UK very soon."

"By January, we should have the AstraZeneca/Oxford vaccine licensed."

Talking about the Covid vaccination drive which has kickstarted in many countries across the world including the UK, US and European nations, Poonawalla said that the first six months of 2021 will see a shortage globally and "nobody can help that."

"But we will see easing off by August-September 2021 as other vaccine manufactures will also be able to supply," he added.

Currently, three COVID-19 vaccines candidates of Bharat Biotech, Serum Institute of India and Pfizer are under active consideration of India's drug regulator and there is hope that early licensure is possible for all or any of them, according to the Union health ministry.

On the availability of the AstraZeneca-Oxford vaccine, Serum's Poonawalla had earlier said that based on the trial results in India and the UK, and if approvals from regulatory bodies are in place in time, "then we can expect the vaccine to be available in India by January 2021 (only if it is proven immunogenic and efficacious)".

Stating about the price of the vaccine, he said, "We want the vaccine to be affordable and accessible to all. The Government of India will receive it at a far more affordable price of USD 3-4, since they will be buying in a larger volume. The priority is going to be India and the GAVI countries, after which only, the private market will open up where the pricing would be USD 6-8 per dose".

AstraZeneca’s chief executive, Pascal Soriot, said that new data will show the vaccine is as effective as the Pfizer and Moderna jabs that have already been approved, protecting 95 per cent of patients, and is “100 percent effective" in preventing severe illness requiring hospital treatment.

He said that it "should be" effective against the new highly transmissible variant of the deadly virus, which put England under complete lockdown again after its rapid spread was detected.

The Oxford vaccine, which also has a tie-up with the Serum Institute of India, is expected to win approval in the UK before Thursday, speeding up the provision of the jab to the most vulnerable groups.