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COVID-19 Phase 3 Vaccine Trials Give People a Chance to Be Heroes

Would you like to be a hero? You may be able to do so, at least if you are willing to travel a moderate distance.

The list of heroes in the age of COVID-19 already is a long one, including front-line medical workers – physicians, nurses, nursing assistants, technicians and hospital housekeeping staff. Then there are the first responders – police, firefighters and first aid squad members. Toss in essential workers such as those who have toiled away in supermarkets, the people who work at meat packing plants (and have paid a huge price for their efforts) and truck drivers who have kept America fed during this crisis. Don’t forget bus drivers and subway conductors who got other essential workers to their jobs during the spring shutdowns, or the public works employees who hauled away your garbage. There have been so many heroes, such as the volunteers working at food banks or neighbors delivering food to the aging neighbor next door, that some almost are sure to slip through this count.

But now new heroes are emerging who may be the greatest of all as the world battles COVID-19. We’re talking about the folks who are volunteering to receive the numerous experimental vaccines that are being developed around the globe.

The biggest test so far in the United States kicked off on Monday when a Phase 3 clinical trial of a vaccine developed by the Massachusetts-based ModernaTX Inc. in a collaboration with the Biomedical Advanced Research and Development Authority and the National Institute of Allergy and Infectious Diseases (NIAID, headed by Dr. Anthony Fauci), was launched. It has been reported that the first volunteer, who received her shot in Savannah, Ga. just before 7 a.m., was Dawn Baker, a local television anchor.

Some 30,000 volunteers will be needed to determine if the mRNA-1273 vaccine is safe and effective. They’ll be getting their shots and be followed up on at 89 study locations across the country.

Two of the 89 study locations are in New Jersey: the Hackensack University Medical Center in Hackensack and the Rutgers New Jersey Medical School in Newark. Another fairly close option can be found at the University of Pennsylvania’s Perelman School of Medicine’s Center for Resuscitation Science.

Be warned, though, that if you want to volunteer, you will have to meet a long list of requirements and commit for quite some time.

High Risk People

Are Being Sought

According to the clinicaltrials.gov website, all participants must be 18 years of age or older. And they must be out and about.

“Participants who are at high risk of SARS-CoV-2 (the virus that causes COVID-19 disease) infection, defined as adults whose locations or circumstances put them at appreciable risk of exposure to SARS-CoV-2 and COVID-19,” reads the study’s very first inclusion criteria.

People who are accepted for the study must understand and agree to comply with the study procedures and be able to comply with such procedures based on the assessment of the investigator.

Female participants of non-childbearing potential may be enrolled in the study. But female participants of childbearing potential must have a negative pregnancy test at screening and on the day of the first dose. Those woman must also have practiced “adequate contraception” or abstained from “all activities that could result in pregnancy” for at least 28 days prior to the first dose and agree to continue adequate contraception through three months following the second dose on day 29. Women of childbearing potential must also not be currently breastfeeding.

Male participants engaging in “activity that could result in pregnancy of sexual partners must agree to practice adequate contraception and refrain from sperm donation from the time of the first dose and through three months after the second dose.”

Healthy adults or adults with pre-existing medical conditions such as lung disease or diabetes, who are in stable condition – defined as “disease not requiring significant change in therapy or hospitalization for worsening disease during the three months before enrollment” – can participate in the study. In fact, older individuals, people with pre-existing conditions, essential workers with a lot of contact with the public, and minorities or other people who live in neighborhoods with high rates of coronavirus disease are being sought for the study because they are especially vulnerable to COVID-19. In other words, the study is looking for volunteers who have a high risk of being affected to better figure out if the vaccine works.

There is an even longer list of exclusion criteria. Individuals who are acutely ill or have a body temperature of 100.4 degrees Fahrenheit or higher 72 hours prior to or at screening will be excluded. So will women who are pregnant or breastfeeding, and people with a known history of SARS-CoV-2 infections or prior administration of an investigational coronavirus vaccine (such as SARS or MERS); a demonstrated inability to comply with the study procedures; a history of anaphylaxis, urticaria, or other significant adverse reaction requiring medical intervention after receipt of a vaccine; a bleeding disorder; or having donated 450 milliliters of blood products within 28 days prior to screening, etc. (the entire list can be found at clinicaltrials.gov).

If You Pass,

What To Expect?

If you think you are qualified to participate in the study (or studies, as you shall see later), understand it is a fairly rigorous commitment.

According to coronaviruspreventionnetwork.org, the website a potential volunteer can register with, most studies require coming into the research site for 10 or more visits over one to two years. Every study involves getting injections or infusions. Remember, this is a double-blind study to avoid bias, meaning half of the participants will receive the vaccine while the other half will receive a placebo, a sterile saline solution, with neither the participants nor the people conducting the study knowing who is receiving each. So volunteers may not actually receive the vaccine.

According the the National Institutes of Health, volunteers will receive two intramuscular injections approximately 28 days apart. Investigators will closely monitor participant safety, calling participants after each vaccination to discuss any symptoms. Participants will be provided with a diary to record symptoms and a thermometer for temperature readings.

Any participant suspected of having COVID-19 will be asked to provide a nasal swab for testing within 72 hours. If the test is positive for SARS-CoV-2 infection, the participant will be followed closely and referred for medical care if symptoms worsen. Participants will be asked to provide a daily assessment of symptoms through resolution and have saliva sampled periodically, so investigators can test for SARS-CoV-2 infection.

So, are people involved in such a study at danger of contracting COVID-19 via the vaccine or suffering serious side effects? Probably not. Results from Phase 1 testing of the Moderna vaccine, published in the New England Journal of Medicine a few weeks ago, said the vaccine was considered “promising” as it triggered an immune response with mostly mild side effects, such as a brief fever, chills, and pain at the injection site.

If you are going to volunteer for a vaccine study, you are obviously taking some risk. That’s what would make you a hero.

More Studies

Are Coming

According to published reports, some 200,000 people have already registered as volunteers for COVID-19 vaccine studies. But if you want to volunteer and qualify for such studies, you still may not be shut out.

The government-funded COVID-19 Prevention Network expects new Phase 3 studies of other leading coronavirus vaccine candidates – each with 30,000 volunteers — to commence each month throughout the fall. Candidates include large pharmaceutical companies such as Johnson & Johnson, Pfizer Inc. and Novavax, plus a final U.S. study of the “Oxford Shot,” a vaccine designed by researchers at Britain’s Oxford University.

Four other Phase 3 trials have already commenced throughout the world, three by Chinese companies and the aforementioned collaboration between Oxford University and the private company AstraZeneca.

The easiest way to become involved with coronavirus vaccine studies is to visit the coronaviruspreventionnetwork.org website. The preliminary survey will take only about 10 minutes.

— Rick Mellerup

rickmellerup@thesandpaper.net


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