With the novel coronavirus continuing to disrupt millions of lives in the United States and countless other countries around the world, it’s no surprise that vaccine manufacturers have reported unprecedented interest in volunteers keen to enroll in key phase 3 clinical trials . Both Pfizer (with partner BioNTech) and Moderna are each looking for 30,000 employees to review their vaccine candidates. These groups will ultimately provide data on how effective the vaccines are in reducing the risk of coronavirus infection. (The Oxford vaccine, made in partnership with AstraZeneca, is recruiting subjects in South Africa, the UK and Brazil.) Based on these studies, we may know by this year whether one or more vaccines can help prevent infections and the slower the pandemic.
Participating in a vaccine study does not guarantee immunity to the novel coronavirus ̵
1. Who can participate in a coronavirus vaccine study?
According to Meridian Clinical Research, which is helping organize the Phase 3 clinical trial for the Moderna vaccine, volunteers must be at least 18 years of age with no known history of coronavirus infection. The study organizers could also weigh factors such as: B. an essential employee, regular contact with the public or underlying diseases such as diabetes or high blood pressure. The studies actively encourage Black, Latin American, and Native American participants, as well as older volunteers, to evaluate the vaccine’s effectiveness in groups most affected by the virus.
The most important factor at this point may be the locations of the registration authorities. Meridian is currently recruiting subjects through nine offices in six states: Georgia, Louisiana, Maryland, Nebraska, New York, and South Dakota. Moderna uses several organizers and will operate 89 locations. Pfizer is looking for topics in 39 federal states.
2. How do volunteers register?
Meridian Clinical Research is providing volunteers for the Moderna study through its website. Pfizer also invites people to submit their inquiries online. To find a study near you, you can also visit coronaviruspreventionnetwork.org, a website operated by the National Institutes of Health (NIH). Potential volunteers fill in some basic information in a short questionnaire. If a representative is eligible, they will do their best to gather more information and set up registration.
3. What happens if someone is admitted to a trial?
Individuals eligible to participate in a study will be scheduled for an office visit for a basic physical exam and blood test. You will also receive a COVID-19 test. The participant will then be injected with either a working vaccine or a placebo and monitored for side effects before being sent home. Both the Moderna and Pfizer vaccines are two doses, so subjects will have to return for the second dose – usually in three to four weeks.
4. Are participants guaranteed to receive an experimental coronavirus vaccine?
No. These Phase 3 clinical trials are randomized, double-blind, placebo-controlled studies, meaning that half of the participants will receive a placebo to create a control group. The results of this group will be compared to those who received the working vaccine. Neither the subjects nor those who give the injection will know whether the injection had a working vaccine or the placebo, which is typically a harmless saline solution.
Even if the subject receives the vaccine, there is no assurance that it will provide protection against coronavirus. This is what the clinical study wants to find out.
5. What are the participants obliged to do?
Subjects are asked to undertake follow-up examinations to assess their health and report any adverse effects. In the Pfizer study, volunteers will return a total of six times over a two-year period – including the first two visits to administer the shot. You may also be asked to keep a private online diary of symptoms.
6. Are volunteers paid?
Generally yes. As with many clinical trials, the organizers pay up to $ 2000 for subjects who have completed the two-year observation period. The Pfizer study also reimburses study-related costs such as parking fees, meals, and other travel expenses.
7. Are these attempts safe?
At the start of a phase 3 study, a vaccine has already gone through the first two phases, which focus on its safety at different doses. In fact, a vaccine can start from phase 3 and be given to thousands of people because of its promising safety profile in earlier stages. No serious adverse events were reported with the Moderna vaccine, which appears safe. The Pfizer vaccine has also shown safety, although fatigue, headache, chills, or pain at the injection site have been observed with both vaccines.
However, it is important to know that a serious reaction cannot be ruled out. At least one participant in a previous Moderna study developed a fever of 103 degrees 12 hours after receiving a second dose and sought medical attention.
8. Is it possible to infect coronavirus from the vaccine?
No. No live virus is used for either vaccine. Both the Moderna and Pfizer vaccines use a synthetic version of the virus’ messenger RNA, or mRNA, to induce human cells to produce protein from the virus that allows the immune system to build a defense. The vaccination cannot infect anyone.
9. What happens if someone gets sick during a trial?
At no point is anyone involved in a phase 3 study that is intentionally infected with COVID-19. (This approach, known as the “challenge attempt,” is a hotly debated one among scientists.) If a vaccine subject falls ill, they will likely fall under their insurance plan. If the subject is not insured and is harmed in any way as a result of the vaccine, they may receive financial reimbursement for medical expenses. Because these guidelines can vary, it is important that volunteers obtain this information in advance from the study organizers and their own insurance company.
10. When will researchers have an answer as to whether the vaccines are working?
Estimates vary widely as to when data will be available to show how well the vaccines are working in protecting subjects from COVID-19 infection. The trials must enroll participants who meet the approval guidelines, give a starting dose, wait several weeks for a second dose, and then wait to see who in the vaccine and placebo groups gets infected. For example, in order to be able to assess the effectiveness of the vaccine to 60 percent, about 150 infections would have to be documented out of 30,000 people. Moderna believes an answer could come by November or December. Pfizer anticipates information may be available by October. The Food and Drug Administration has already stated that a vaccine must be at least 50 percent effective in order to be approved.