September 19, 2020 10:34:48 am
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. It is expected that at least 50 per cent of this would be meant for supplies within India.
“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,” Health Minister Harsh Vardhan said in Parliament.
This is 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.
Besides these, two vaccine candidates developed by Indian companies, Bharat Biotech and Zydus Cadila, are currently undergoing combined phase-1 and phase-2 trials.
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After Moderna, now Pfizer releases detailed information about its vaccine trials
After Moderna released a 135-page document on Thursday giving details about ongoing phase-3 trials of its coronavirus candidate vaccine, Pfizer has now come out with similar information, releasing the full roadmap of how the trials are being conducted.
The two 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.
Such information is usually shared by companies only after trials are over, but the move by these two developers seem to have been prompted by a persistent scepticism about coronavirus vaccines because of the speed with which they are being developed.
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.
Both the vaccine candidates are undergoing phase-3 trials in the United States right now, and are expected to be among the first vaccines to be ready and made available for public use.
Hunt for coronavirus vaccine: The story so far
As on September 18
- 182 vaccine candidates in pre-clinical or clinical trials
- 36 of them in clinical trials
- Nine in final stages, phase-III of human trials
- At least eight candidate vaccines being developed in India. Two of these have entered phase -II trials after completing phase-I.
The ones most talked about:
* AstraZeneca/Oxford University
* Johnson & Johnson
* Russian vaccine, developed by Gamaleya Insttiute in Moscow
* Three Chinese vaccines that have been approved for use in China without phase-3 trials being completed. One of them has been given emergency use authorisation in UAE
(As on September 18; source: WHO Coronavirus vaccine landscape of September 18, 2020)
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