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Serum Institute of India (SII) has started ‘at-risk’ production of Covovax vaccine, two persons aware of the development said, expecting regulators to grant emergency licence for the promising protein subunit vaccine.

The Pune-based vaccine maker had been struggling to start production of Covovax, its version of Novavax’s covid-19 vaccine, due to the lack of raw materials following the invocation of the Defence Production Act by the US government in February that restricted export of all covid-19 vaccines and their raw materials.

“They have started producing Covovax at risk on a small scale using some raw materials it had. Until they are able to secure more raw materials from the US, they will not be able to scale it up further. Discussions with the US government about it is ongoing," said one of the two persons cited above, both of whom spoke under condition of anonymity.

Covovax and its innovator version by Novavax have not received authorization in any country yet. Novavax has initiated rolling review of its data with regulators in Europe, UK, Canada, Australia, among other countries, and plans to apply for emergency use authorization (EUA) in July-September. SII is considering applying for expedited authorization under the Indian government’s revised norms if Novavax secures the EUA in either the UK or Europe.

Novavax’s trials in the UK showed that the vaccine has 96.4% efficacy against the original strain of SARS-CoV-2 virus and 86.3% efficacy against the B.1.1.7 variant that was first discovered in the UK. The vaccine’s efficacy was 55.4% in another trial in South Africa, where the B.1.351 variant that is known to escape the immune response of vaccines was dominant.

Adding to the robust efficacy data from the two trials is the fact that protein subunit vaccines are considered by many experts as one of the safest vaccine platforms, making it one of the most promising candidates.

Novavax has advance purchase agreements in place with multiple countries, including Japan and South Korea, while the two companies also have an advance order of 1.1 billion doses from Gavi, the Vaccine Alliance for the Covax facility, starting from the July-September quarter.

About 750 million doses will be provided by the Serum Institute.

The Indian government has projected that it can procure 200 million doses between August and December, even though it has not placed any advance orders yet.

SII will also be scaling up its Covishield capacity to provide around 90 million doses in June and will increase it further to provide around 100 million doses or more in July, the person said. So far, the company was manufacturing around 60-70 million doses a month.

Like Covovax, the Indian government had not placed advance orders for Covishield until the vaccine had got a restricted EUA in India in January.

Currently, SII is servicing an order of 110 million doses worth 1,732.50 crore that has to be supplied by July.

Meanwhile, the country is struggling with an acute shortage of vaccines, especially after the government opened up vaccination for all adults starting 1 May.

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