US FDA comes out with guidance for COVID-19 vaccine approval

Discussing COVID-19 Vaccine Updates From AstraZeneca Moderna BioNTech Sanofi

It was developed after the National Institute of Virology, Pune isolated a strain of the SARS-CoV-2 and transferred it to the company.

The Phase 1 and 2 clinical trials of the CanSino's vaccine candidate showed it has the potential to prevent diseases caused by the coronavirus, which has killed half a million people globally, but its commercial success can not be guaranteed, the company said. The collaboration with ICMR and NIV was instrumental. Precisely, there are almost 150 vaccine candidates under development now, of which 17 are undergoing human trials.

Central Drugs Standard Control Organisation has granted approval to Bharat Biotech India to conduct human clinical trials for "Covaxin" which is scheduled to start across India in July.

The vaccine has shown promising results in preclinical studies, demonstrating extensive safety and effective immune responses.

Apart from Bharat Biotech, Zydus Cadilla is working on two vaccines, while Biological E, Indian Immunologicals, and Mynvax are developing a vaccine each.

Several companies such as Moderna Inc, Pfizer Inc and AstraZeneca Plc are in the race to develop a vaccine.

China’s army gives limited approval to potential Covid-19 vaccine

Bharat Biotech's COVID-19 vaccine has been approved for human trials, making it India's first domestic candidate to get the green light from the government's drug regulator as cases surge in a country with more than 1.3 billion people.

Companies may pour hundreds of millions of dollars into development, pre-clinical (or lab) trials only to have their shots fail in early clinical trials.

"Our ongoing research and expertise in forecasting epidemics has enabled us to successfully manufacture a vaccine for the H1N1 pandemic", said Suchitra Ella, joint managing director of the company.

Worldwide, around 10 other candidate vaccines, including one in Britain and one in China, are already in human clinical trials while around 100 other candidates are under various stages of development.

About a third of Americans said in a recent Reuters/Ipsos poll that they would be less inclined to receive a coronavirus vaccine if President Trump said it was safe.

The US Food and Drug Administration on Tuesday released guidance for approving a coronavirus vaccine, saying the vaccine has to prevent or decrease disease severity in at least 50% of people who are inoculated.



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