Questions over India’s Covaxin side effects, ethical violations Quartz 1/12/2021
A shadow is lurking over the trial process of India’s homegrown Covid-19 vaccine.
Covaxin, the novel coronavirus vaccine co-developed by Bharat Biotech and the Indian Council for Medical Research, has been accused by some trial participants of sidestepping procedures and not making adverse events public. It has denied these charges, but trial volunteers want the government to intervene and halt the phase 3 human trials.
Bharat Biotech began courting controversy on On Jan. 4, when scientists expressed grave concerns over the hasty approval given to Covaxin. Now, its trial participants in Madhya Pradesh’s Bhopal allege that they were not informed that the jab would be given to them as part of a clinical trial. Covaxin’s third phase of human trials has 25,800 participants across the country.
Saint-Herblain , January 12, 2021 – Valneva SE, a specialty vaccine company focused on prevention of infectious diseases with significant unmet medical need, today announced it is in advanced. | January 16, 2021
French
Saint-Herblain (France), January 12, 2021 – Valneva SE, a specialty vaccine company focused on prevention of infectious diseases with significant unmet medical need, today announced it is in advanced discussions with the European Commission (EC) for the supply of up to 60 million doses of its COVID-19 vaccine, VLA2001. VLA2001 is currently the only inactivated vaccine candidate in clinical trials against COVID-19 in Europe.
Valneva’s vaccine candidate is based on a proven approach and will leverage the Company’s existing manufacturing platform being used for its US Food and Drug Administration (FDA) and European Medicines Agency (EMA) approved Japanese encephalitis vaccine. VLA2001 entered Phase 1/2 clinical studies in December 2020
The European Commission had held discussions with French pharma company, Valneva, with a view to securing up to 60 million doses of its inactivated virus COVID-19 vaccine, VLA2001.