..- United States plans evidence from half a dozen of the most promising vaccine projects for the coronavirus in more than 100,000 volunteers, in an effort to achieve safe and effective immunization by the end of 2020, the scientists who run the program told ..
The project will compress what they are typically 10 years of development and vaccine tests in months, which testifies to the urgency of stop the pandemic It has infected more than 5 million people, killed more than 335,000, and has hit economies around the world.
To achieve this, the main vaccine manufacturers have agreed share information and clinical trial networks with its competitors in the event its own candidate fails, the scientists said.
Candidates who demonstrate safety in small initial studies will be tested in huge trials of 20,000 to 30,000 subjects for each vaccine, scheduled to start in July.
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Between 100,000 and 150,000 people could enroll in the studiessaid Dr. Larry Corey, a vaccine expert at the Fred Hutchinson Cancer Center in Seattle, who is helping to design the tests.
“SIf you don’t see a security problem, you just keep going“, said to . Dr. Francis Collins, director of the National Institutes of Health (NIH). The vaccine effort is part of a public-private partnership called Acceleration of Therapeutic Interventions and Vaccines COVID-19 (ACTIV), which was announced last month.
The effort fits into the research and development arm of the “Operation Speed of Light“The White House program announced last week to accelerate the development of the coronavirus vaccine.
Vaccines, which are intended to be used in healthy people, are typically tested in successive stages, beginning with animal testing.
Human testing begins with a small safety trial in healthy volunteers, followed by a larger study to find the correct dose and get an early measure of effectiveness. The final stage consists of large-scale testing on thousands of people. Only then does a vaccine developer commit to making millions of doses.
Because of the coronavirus, many of those steps will overlap, in particular the rehearsals of the middle stage and the final stage, Collins and Corey said.
The approach has its risks, since certain security problems can only appear in large-scale trials. Americans are concerned about the speed of the vaccine campaign, according to a . / Ipsos poll.
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A highly effective vaccine could be tested in as little as six months if there is a big difference between the benefit for the immunized group and that of the placebo, Corey said. For a modestly efficient, Trials could last from nine to twelve months.
The United States government has pledged billions of dollars to help manufacturers produce doses of vaccines that may never be successful.
For the fastest response, vaccines will be tested in healthcare workers and in communities. where the virus is still spreading to show if they reduced new Covid-19 cases.
Washington D.C., which has not reached the peak of the outbreak, is a likely test site. Trials can be carried out abroad, including in Africa, where the virus just started spreadingCollins said.
The government plans leverage your own trial networks, including 100 health care facilities of the Department of Veterans Affairs, to search for potential volunteers for the study, while drug makers will recruit from their clinical research networks.
A Modern vaccine Inc, developed in association with the NIH, will be the first to enter large-scale testing in July, and it may be added one from the British University of Oxford and AstraZeneca PlcCollins said.
“What we could try to do is run those two together, but with a control group“Which would also include 10,000 healthy individuals receiving a bogus vaccine, Collins said.
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The Moderna candidate is already proceeding with human trials at the intermediate stage. Vaccines Johnson & Johnson, Sanofi and Merck & Co They are a month or two behind the first and “could be added in the course of the summer (boreal)” after the first human tests, according to Collins.
Collins did not mention other candidates on the shortlist of 14 shortlisted, but said they need to finish the safety tests early this summer in order to enter the larger trials.