First US Phase III trial for COVID-19 vaccine begins

[Karlston]

First US Phase III trial for COVID-19 vaccine begins

Shares rise after 30,000 participants get their Phase III jabs.

Enlarge / A research associate works at the Moderna Therapeutics Inc. lab in Cambridge, Massachusetts.

Bloomberg/Getty Images

132 with 81 posters participating

Moderna has given the first doses of its experimental COVID-19 vaccine to participants in what will be a 30,000-person trial, as the United States moved into a new phase of the race to develop a vaccine by the start of next year.

 

The Boston-based biotech said on Monday that it had begun the first Phase III study of a vaccine in the US, a large-scale trial that is usually the last before a new product is submitted for regulatory approval.

 

The company’s shares were up as much as 10.6 percent before paring some of their gains.

 

Its trial is being conducted in conjunction with the US National Institutes of Health at sites across the US, under the federal government’s Operation Warp Speed public-private partnership. Francis Collins, the NIH director, said having a vaccine by the end of 2020 was a “stretch goal” but the “right goal for the American people.”

 

Stéphane Bancel, Moderna’s chief executive, told CNBC that he estimated the vaccine had a 75 percent chance of meeting the Food and Drug Administration’s requirement of being 50 percent effective.

 

“We look forward to this trial demonstrating the potential of our vaccine to prevent COVID-19, so that we can defeat this pandemic,” he said in a statement.

 

Moderna took just 42 days from receiving the genetic sequence of SARS-CoV-2, the virus behind COVID-19, to produce a vaccine for testing. Results from its earliest trial showed all 45 participants produced antibodies, and it expects efficacy data from its Phase II trial to be available in late August or September.

 

The company was able to move 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 recognize it. But a vaccine using this technology has not yet been approved by the FDA.

 

Pfizer and its German partner BioNTech may also start their Phase III trial this month, while others in Operation Warp Speed including Johnson & Johnson and Novavax hope to begin their phase three trials in the autumn. AstraZeneca, which is partnering with the University of Oxford, has begun a trial designed to blend the Phase II and Phase III stages at sites in the UK, South Africa, and Brazil, and the company is expected to start at US sites shortly.

 

In its Phase III trial, Moderna and the NIH will be testing 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 hospitalization.

 

The trial will be conducted at more than 100 sites chosen to reflect a range of demographics and to ensure they include the most vulnerable populations. Mr. Bancel told CNBC that one-third of all participants would be over-65s, who are both more likely to develop severe disease and have immune systems that are less likely to respond robustly to a vaccine.

 

Anthony Fauci, director of the National Institutes of Allergy and Infectious Diseases, said the early-stage testing had indicated the vaccine was safe and generating an immune response in recipients.

 

“Although face coverings, physical distancing and proper isolation and quarantine of infected individuals and contacts can help us mitigate SARS-CoV-2 spread, we urgently need a safe and effective preventive vaccine to ultimately control this pandemic,” he said.

 

 

First US Phase III trial for COVID-19 vaccine begins