Health

Moderna’ Stock Rises 12% as Covid-19 Vaccine Advances to Trial on 30,000 People

Moderna announced on Monday that it had started the first phase III study of a vaccine in the US. The first phase study is a large scale trial that comes last before a new product is submitted for regulatory approval.

Early in July, 45 patients tested in the early-stage trial in which the vaccine candidates produced neutralizing antibodies, which scientists believe is important for building immunity against the virus.

“The newly released data puts us on a positive path towards a larger phase three trials with which we hope to demonstrate the safety and efficacy,” Moderna Chief Medical Officer Tal Zak told CNBC.

Although US scientists warned that the phase one study was small, with just 45 individuals who were all healthy, the results may differ for the other population, especially those with underlying health conditions.

“I believe we have an ethical obligation to advance this vaccine as fast as possible given the unmet need on one hand and given what science enables us to do on the other,” Zak responded to critics “I think it is incumbent upon us to do this in a manner that’s responsible, judicious and accounts for emerging understanding of the safety profile and I think we’re doing that by ensuring that our phase three is a large phase three.”

The trial is being conducted in collaboration with the US National Institutes of Health in the US, under the US federal government’s Operation Warp Speed public-private partnership.

“Having a vaccine by the end of 2020 was a stretch goal but the right goal for the American people,” said Francis Collins, the NIH director.

In its phase III trial, Moderna and the NIH will test whether it can prevent symptomatic COVID-19 disease. They will also look at how effective it is in preventing all COVID-19 infections, even those without symptoms, and what impact it has on people needing hospitalisation.

Since the pandemic started in the United States, there are no Food and Drug Administration (FDA) approved vaccines for the coronavirus, which has infected about 13 million people worldwide and killed at least 649,662 people as of today, Monday, 27 July,  according to data compiled by Johns Hopkins University.

While there is no FDA approved vaccine yet, Moderna has moved fast because it uses a novel technology based on messenger ribonucleic acid, which transcribes the genetic code of a virus inside a human cell to teach the immune system to recognise it. But the FDA has not approved a vaccine using this technology.

Other Biotech companies like Pfizer and its German Partner may also start their Phase III trial this month, July while others in Operation Warp Speed including John & Johnson and Novavax hope to begin their phase three trials from September. In the United Kingdom, AstraZeneca, a global biopharmaceutical company has partnered with the University of Oxford, and has begun a trial designed to blend the phase II and phase III stages at sites in the UK, South Africa and Brazil, and is expected to start at the US sites shortly.

Meanwhile, because of Moderna’s potential coronavirus vaccine has generated a promising immune response in an early stage human trial, the company’s stock surged by 12 percent last week.

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