India's First COVID-19 Vaccine Gets DGCI Nod for Human Clinical Trials

India Coronavirus Vaccine Update

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Globally, more than a dozen shots are undergoing human testing.

For the World Health Organization (WHO), however, the victor is clear - AZD1222 from the University of Oxford and AstraZeneca.

Meanwhile, South Korea's health authorities called yesterday for citizens to stagger vacation schedules ahead of the holiday season and avoid gatherings at workplaces and religious facilities, as infections from small clusters continued to persist.

Coronavirus Vaccine Antibody
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Identifying a key target, the FDA advised that they would expect a COVID-19 vaccine to prevent disease or decrease its severity in at least 50% of individuals who are vaccinated. Phase 3 trials must comprise thousands of volunteers, but China does not have patients and carriers to examine vaccines' effectiveness. Among them, there are about 10 or so, which are in a relatively advanced stage of development. It is also being trialled in Britain, South Africa and Brazil.

In a vaccine tracker created by the Regulatory Affairs Professionals Society (RAPS), there are at least 36 vaccines now under clinical trials and pre-clinical stages, as of June 25. It means that these specialists began with a viral vector, in this case, it should be a common adenovirus strain-a virus strain that causes mild upper respiratory symptoms developing into the disease.

After the success of phase II trials, CNBG moved on to launch the phase III tests - which will allow a vaccine into the market if it succeeds. The packaging, labelling, storage and distribution of Catalent's vaccine will take place when Moderna's vaccine reaches late-stage clinical trials. Catalent is already in partnership with Johnson and Johnson as well as AstraZeneca.

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The bioresearch facility said that it had since finished the larger second phase fo the trial, ensuring safety and efficacy.

The company also came up with a vaccine for H1N1 or Swine Flu epidemic several years ago. "This includes the different technologies such as DNA, RNA, protein and viral vectored vaccines being developed by commercial vaccine manufacturers and other entities", the statement reads.

Thailand is also preparing for humans trails.

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FDA commissioner, Stephen Hahn, acknowledged that the expedited regulatory process that could see a COVID-19 vaccine rapidly approved necessitated reassurance to the public that the agency's decision-making process was "based on the science and the available data".

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