© Reuters. FILE PHOTO: This picture shows small bottles marked with a "Vaccine COVID-19" sticker and a medical syringe
By Julie Steenhuysen
CHICAGO (Reuters) – The United States is planning massive testing efforts with more than 100,000 volunteers and about half a dozen of the most promising vaccine candidates to deliver a safe and effective vaccine candidate led by scientists by the end of 2020, Reuters said.
The project will shorten the normally 10-year development and testing of vaccines to a few months. This is evidence of the urgency to stop a pandemic that has infected more than 5 million people, killed over 335,000, and affected the economy worldwide.
To get there, leading vaccine manufacturers have agreed to share data and make their clinical trial networks available to competitors if their own candidate fails, the scientists said.
Candidates who demonstrate safety in small early studies will be tested in large studies with 20,000 to 30,000 subjects for each vaccine, which are expected to start in July.
Between 100,000 and 150,000 people could participate in the studies, said Dr. Larry Corey, a vaccine expert at the Fred Hutchinson Cancer Center in Seattle, who helps design the studies. "If you don't see a security issue, just keep going," said Dr. Francis Collins, director of the National Institutes of Health (NIH), told Reuters. The vaccination efforts are part of a public-private partnership called Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) that was announced last month.
The effort fits into the research and development arm of Operation Warp Speed, the White House program that was announced last week to accelerate the development of coronavirus vaccines. Vaccines intended for use in healthy people are usually tested in sequential steps, starting with animal testing.
Human testing begins with a small safety study on healthy volunteers, followed by a larger study to find the right dose and get an early overview of its effectiveness. The final phase consists of extensive tests on thousands of people. Only then would a vaccine developer commit to making millions of doses. In the coronavirus era, many of these steps will overlap, particularly the middle and late stage studies, Collins and Corey said.
The approach is risky because certain security issues may only arise in large-scale studies. According to a Reuters / Ipsos survey, Americans are concerned about the speed of vaccination efforts. A highly effective vaccine could be tested in just six months if there is a big difference in benefit between the vaccine and placebo groups, said Corey. Trials for a modestly effective vaccine can take nine to 12 months.
The U.S. government has committed billions of dollars to help manufacturers manufacture vaccine doses that may never prove successful.
THE SHORT LIST
To get the quickest answer, vaccines are being tested in healthcare workers and communities where the virus is still spreading to show whether they have reduced new cases of COVID-19. Washington, DC, which has yet to peak its outbreak, is a likely test site. Trials could be done abroad, including in Africa, where the virus has just spread, Collins said.
The government plans to use its own study networks, including the Department of Veterans Affairs 100 health facilities, for potential volunteer students, while drug manufacturers will recruit from their clinical research networks.
A Moderna (NASDAQ 🙂 Inc vaccine, developed in collaboration with the NIH, will be the first to participate in large-scale testing in July, and a vaccine from the University of Oxford and AstraZeneca (NYSE 🙂 Plc may be added, said Collins.
The U.S. government said Thursday it would spend $ 1.2 billion to get 300 million doses of the Oxford vaccine. "What we could try is to operate these two side by side, but with a control arm, which would include 10,000 healthy people who received a sham vaccine," Collins said. Moderna's candidate is already in the middle of human trials. Vaccines from Johnson & Johnson, Sanofi (PA 🙂 and Merck & Co are a month or two behind the frontrunners and could "be added during the summer" after Collins was tested on humans at an early stage, Collins said.
Merck has made no specific announcements about its vaccination program and declined to comment.
Collins would not name any other candidates on the US shortlist of 14, but said that they would have to complete the early safety tests by summer to enter the larger tests. Studies need to investigate whether the vaccines cause an improvement in the disease – a potentially dangerous side effect in which the vaccine makes the disease worse instead of preventing it in some people. Animal studies with vaccines designed to fight a close relative of the virus that causes COVID-19 have been reported to improve the disease. "If there are improvements, that's a big stop sign for everything," said Dr. Anthony Fauci, director of the National Institutes for Allergy and Infectious Diseases at the NIH.
"If all the cards fall in the right place and all the stars are aligned, you could definitely get a vaccine by December or January," said Fauci.