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Explained: Will India trails Novavax vaccine from October 2020?


New Delhi, Sep 19: In what comes as a recent development, the India trials of a vaccine candidate being developed by American company Novavax is likely to begin in late October, the government said in Lok Sabha on Friday.


It can be seen that the Novavax vaccine candidate is currently undergoing phase-2 clinical trials in South Africa. Global phase-3 trials are expected to begin next month. In India, Novavax has entered into an agreement with Pune-based Serum Institute of India for production of 100 million doses of the vaccine.

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Addressing the Parliament, Health Minister Dr Harsh Vardhan said, "ICMR and SII (Serum Institute of India) have partnered for clinical development of a glycol-protein sub-unit nanoparticle adjuvanted vaccine developed by Novavax from USA. The trial will be initiated in the second half of October after the vaccine is manufactured by Serum Institute. The trial is led by ICMR-National AIDS Research Institute."

However, this would be the second vaccine candidate whose clinical trials have been planned in India. Serum is already testing a vaccine candidate developed by AstraZeneca and Oxford University in combined phase-2 and phase-3 trials. The trials had to be briefly paused after one of the trial participants in England had reported severe illness. But it has resumed now.

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Besides these, two vaccine candidates developed by Indian companies, Bharat Biotech and Zydus Cadila, are currently undergoing combined phase-1 and phase-2 trials.

On Thursday, Moderna released a 135-page document, giving details about ongoing phase-3 trials of its coronavirus candidate vaccine releasing the full roadmap of how the trials are being conducted.

The documents contain information about the criteria used for selecting trial participants, how they are being monitored and the evidence that will be used to assess whether the vaccine is effective.

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In its document, Moderna has said it expected to know about the effectiveness of its vaccine by December. Pfizer has earlier said that it expects effectiveness data to be available by the end of October.

Presently, both the vaccine candidates are undergoing phase-3 trials in the United States and are expected to be among the first vaccines to be ready and made available for public use.

As on September 18 as many as 182 vaccine candidates are in pre-clinical or clinical trials. 36 of them in clinical trials. Nine in final stages, phase-III of human trials. It can be seen that at least eight candidate vaccines being developed in India. Two of these have entered phase -II trials after completing phase-I.

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