Over 1,100 People For Clinical Trials Of India's First Covid Vaccine

Henrietta Brewer
July 7, 2020

Earlier, the Government dropped a hint of August 15th release for the vaccine. The Indian Academy of Sciences calls the timeline "unreasonable and without precedent".

Development of the other vaccine candidate has been done by Indian pharmaceutical company Zydus Cadila.

Emergent BioSolutions Inc EBS.N said on Monday it signed a five-year contract to make the drug substance used in Johnson & Johnson's JNJ.N COVID-19 vaccine candidate, adding to a series of deals likely to put it at the heart of future global vaccine production.

The Indian Council of Medical Research (ICMR) had claimed it aims to launch the indigenous COVID-19 vaccine by August 15.

"The vaccine is being derived from a strain of SARS-CoV-2 isolated by ICMR-National Institute of Virology, Pune".

The hospitals were asked to start enrolling participants "no later than July 7" and the vaccine was described as "one of the top priority projects which is being monitored at the topmost level of the government". The ministry had also said that vaccine would be introduced by 2021. "In my knowledge, such an accelerated development pathway has never ever been done for any kind of vaccine", says Anant Bhan, an independent ethics and policy researcher and past president of the International Association of Bioethics.

New Delhi: There is no coordination between the Indian Council of Medical Research (ICMR) and the Ministry of Science and Technology regarding the corona vaccine. The proposed age groups for the trials are 18-55 years for Phase I and 12-65 years for Phase II. This letter was written to keep the vaccine process at a slow pace.

BBIL refused to comment on ICMR's August 15 deadline.

On Saturday, ICMR did some backpedaling and issued a statement saying the vaccine has been fast-tracked by "cutting unnecessary red tape, without bypassing any necessary process".

India is eagerly awaiting a COVID-19 vaccine. It just surpassed Russian Federation as the country with the third-highest number of cases, after the United States and Brazil. There were 24,000 confirmed new cases on Sunday; the national tally stands at 697,413 cases and 19,693 deaths. Meanwhile, Soumya Swaminathan, chief scientist at the World Health Organization, said there will be one or more safe and efficacious vaccines by next year.

"While there is an unquestioned urgent need, vaccine development for use in humans requires scientifically executed clinical trials in a phased manner", the IASc said. "First of all timelines for vaccines differ from vaccine to vaccine and can not be predicted".

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