The new vaccine approval norms in the country are unlikely to speed up the launch of new Covid-19 vaccines from Serum Institute of India (SII). SII has a long pipeline, but none of them has got the Emergency Use Authorisation (EUA) that would have ensured a faster launch in India.
Apart from the Covishield vaccine deal with AstraZeneca-Oxford, SII has tied up with Novavax for manufacturing Covid-19 vaccines in India. However, Novavax has not got EUA for its vaccine in any of the regulated markets such as the US, the EU, the UK, Japan or the WHO. Novavax expects to file for authorisation in the UK and the US by the second quarter of 2021 and the company is on track to get EUA in the next few months.
Novavax’s NVX-CoV2373 is in Phase II and III trials. The NVX-CoV2373 is currently being evaluated in trials in the UK, US, Mexico, South Africa, India and Australia. This vaccine is scheduled for a September 2021 launch in India.
Serum has partnered with USA-based biotechnology company, Codagenix Inc, for global manufacturing and supply of another Covid-19 vaccine. Codagenix and SII have started dosing in Phase 1 Trial of COVI-VAC, a single dose, intranasal, live attenuated vaccine for Covid-19. According to Codagenix CEO, J. Robert Coleman, COVI-VAC had the potential to provide a broader immune response in comparison to other Covid-19 vaccines and it would prove critical as new variants of SARS-CoV-2 have emerged. COVI-VAC is a single dose, a needle-free vaccine that needs only a standard freezer or fridge.
SII has another agreement with UK-based SpyBiotech and has started Phase I/II trials. SpyBiotech has signed an exclusive global licensing agreement with SII for the development of a novel virus-like-particle vaccine targeting Covid-19. SpyBiotech has exclusive rights from the University of Oxford to apply, commercialise and sub-license the technology for vaccine development. They will be combining SpyBiotech’s protein ‘superglue’ technology with the known safety and immunogenicity of the Serum Institute’s Hepatitis B surface antigen virus-like particle for an effective Covid-19 vaccine.
Serum has been working on five vaccine candidates against Covid-19. Two of which are Serum’s candidates and the company hopes to announce the availability of their vaccines by the end of 2021. SII is also conducting Phase-III trials of the recombinant BCG vaccine shots to improve the innate ability to fight the virus and reduce the severity of Covid-19 in India. This is considered a safe vaccine as it is given to newborn babies and has been selling in more than 100 countries worldwide for decades.
The SpyBiotech vaccine is expected towards the end of this year while Codagenix could be launched early next year. All these vaccines have to be approved by international regulators so cannot be fast-tracked into India.
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