Around 138,600 Americans have signed up as volunteers to test COVID-19 vaccines. At this time, when some Americans are concerned about the safety of the vaccine, this was an encouraging action from the side of Americans. Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases said, “That’s why we’re optimistic that we’re going to be able to get the trials enrolled in an expeditious way. I think we can do what we need to do.”
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Tens Of Thousands Have Signed Up To Test COVID-19 Vaccines
National Institutes of Health launched a clinical trial network of more than 100 clinical trial sites at hospitals and medical clinics in the United States and across the world which will take on the unprecedented challenge of testing COVID-19 vaccines and other preventive treatments, federal officials announced Wednesday. More volunteers are still required.
In the initial stages of vaccine tests, 30,000 volunteers each are required for four companies that plan to launch Phase 3 clinical trials of their potential vaccines by early fall. At least 120,000 volunteers are required for the Moderna, Pfizer BioNTech, AstraZeneca, and Inovio trials.
Barry Bloom, an immunologist and vaccine expert who is a professor of public health at the Harvard Chan School of Public Health said, “I would say it’s very encouraging at this stage.”
It doesn’t just require volunteers but staff and physicians experienced in running clinical trials
For conducting tests, it doesn’t just require volunteers but also a robust complement of clinics, hospitals, and medical centers around the nation with staff and physicians experienced in running clinical trials. So NIH launched the COVID-19 prevention trials network on July 8 with a website where volunteers can signup.
The Food and Drug Administration says it wants the vaccine candidates to be tested in populations most affected by COVID-19, including ethnic and racial minorities, pregnant women, the elderly, and people with underlying medical conditions that can worsen COVID-19. Experts involved in these trials said that the guidelines for these trials are really clear and they will be scientifically rigorous and there are no shortcuts. The vaccine will be experimenting with humans in three phases of the test.
These phases of clinical trials will come only after months of other tests that first begin in cells and then moves on to animals.
Only if all these experiments go well with animal tests does the process move to humans? Phase 1 trial is to determine any immediate adverse effects of the vaccine. This is done by conducting tests in a small number of healthy people.
Phase 2 trials expand safety testing and determines dosing. So several dose levels will be tested. This phase of the trial also looks to see if the vaccine causes an immune response in the subject. Phase 3 trials begin only if the vaccine doesn’t cause immediate adverse effects and appear to provoke an immune response. This phase is to see if the vaccine actually protects the subjects against getting COVID-19 or, if they do get it, does this vaccine causes the illness to be less severe.
