Govt keen on Covovax trials for children soon

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Bhawani Singh
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The government is keen on Serum Institute of India starting a trial of Covovax covid-19 vaccine in children soon keeping in mind their susceptibility of the disease, NITI Aayog member health Vinod K. Paul said. Covovax is Serum Institute’s version of the protein subunit vaccine developed by US-based firm Novavax.

“As you know, they (Serum Institute) are conducting a bridging trial already, which is in advanced stages of completion… We hope they will complete the trial on schedule, and also hoping that they would also start in good time trials in children,” Paul said, adding that it is time to start the trial in paediatric population without delay.

Paul’s comments come a day after Novavax reported an efficacy of 90.4% in the interim analysis from its phase 3 trial on 29,960 participants in US and Mexico.

Novavax also showed that the vaccine had an efficacy of 100% in preventing people from getting moderate and severe disease.

The trial was conducted at a time when the B.1.1.7 ‘alpha’ variant, first discovered in the UK, was dominant in the US, indicating that the vaccine provides strong protection against mutant variants.

Earlier interim data for the vaccine from the phase 3 trial in UK showed that the vaccine had an efficacy of 96% against the original strain of the novel coronavirus.

Serum Institute of India started “at-risk” production of the vaccine in small quantities last month. The production is “at-risk” because of the significant financial risk taken by the company to start manufacturing even before the vaccine secure emergency use authorisation anywhere in the world.

Novavax plans to apply for authorisations with regulators in UK, US, European Union, among other countries, in July-September, with Serum Institute also planning to complete its trial in India around that time before seeking authorisation from the Drugs Controller General of India.

The vaccine is key to meeting India and other developing countries’ vaccine requirements. India expects about 200 million doses of Covovax between August and December, while Novavax and Serum Institute together plan to provide 1.1 billion doses to the Covax facility, which is aimed at providing equitable access to the covid-19 vaccines.

Novovax president and chief executive officer (CEO) Stanley C. Erck on Monday said that the company will initially focus on distributing its vaccines to low-and middle-income countries, including India. This is because most developed countries like US, UK, Canada, France and Germany no longer require vaccines in large quantities anymore after administering jabs from Pfizer, Moderna, AstraZeneca and Johnson & Johnson to most of their population.

On the other hand, India continues to face a severe vaccine crunch and has been able to vaccinate less than 20% of its population with at least one dose despite administering over 260 million doses so far. Less than 4% of the country’s total population is fully vaccinated.

In such a scenario, the government is scurrying to secure vaccines, and last month had also signed its first advance purchase agreement for a yet-to-be-authorised vaccine with Biological E.

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