AstraZeneca Plc has resumed the us trial of its experimental COVID-19 vaccine after approval by regulators, and Johnson & Johnson is preparing to resume its trial on Monday or Tuesday, the companies said on Friday.
The interruption raised concerns about the prospects of one of the fastest-moving shots and highlighted the hurdles researchers face when developing a vaccine.
AstraZeneca's U.S. trial was paused since September 6 after the UK-based biopharma giant had announced that the phase 3 testing of its COVID-19 vaccine has been put on hold due to a suspected serious adverse reaction in a participant in the United Kingdom.
Bharat Biotech plans to test over 20,000 volunteers across 12-14 states in India, Sai Prasad, executive director, Bharat Biotech International Ltd, told The Indian Express.
In July, the DCGI had given permission to Bharat Biotech to conduct Phase 1 and 2 clinical trials of its COVID-19 vaccine. "That is for the full efficacy results", Prasad added.
Addressing a review meeting with officials of the Uttar Pradesh government, Vardhan said, "Appropriate measures are being taken to combat COVID-19".
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Such temporary halts of drug and vaccine testing are relatively common: In research involving thousands of participants, some are likely to fall ill.
India's Ingenuously developed COVID-19 Vaccine, Covaxin is all set to enter the third phase.
Speaking to Hindustan Times, Prasad said, "The DCGI has asked us to change a few details in the protocol".
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The Pune-based Serum Institute of India, which has partnered with AstraZeneca for manufacturing the Oxford COVID-19 vaccine candidate, is also conducting Phase 2 and 3 human clinical trials of the candidate in India.
Covishield is a front-runner and is expected to be ready by March 2021.
Pfizer's vaccine is administered in two different doses and falls apart unless it is kept in a deep freeze, meaning that the vaccine will have to be chilled to minus 80 degrees Celsius up to when it is given to people.
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