Service of Need to Know: If You’re in the Covid Trial Placebo Group, Do You Get a Vaccine ASAP?

December 7th, 2020

Categories: Drug Trials, Medical, Medical Tests, Medicine, Pandemic, Safety

Photo: newatlas.com

I admire anyone who volunteers to test a potentially lifesaving drug. I was curious as to why piling on $billions from the US Government and Bill Gates Foundation, among many, helped speed up discovery of a vaccine by over three years. I guess it’s because the human guinea pigs are paid and to have the numbers injected to ensure efficacy and safety at $250 or more a pop requires deep pockets on the spot.

Carl Zimmer and Noah Weiland pose a dilemma in their New York Times article, “Many Trial Volunteers Got Placebo Vaccines. Do They Now Deserve the Real Ones?”  Seems it’s not an easy “yes” or “no.”   The tens of thousands injected with the placebo who thought they’d get a real shot in the arm after the vaccine was approved may wait as long as two years they reported.

Photo: savethestudent.org

Some scientists think these volunteers “should be moved toward the front of the line in exchange for [her] service for the greater good.” Last week “18 leading vaccine experts — including a top regulator at the Food and Drug Administration — argued that vaccinating placebo groups early would be disastrous for the integrity of the trials. If all of the volunteers who received placebo shots were to suddenly get vaccinated, scientists would no longer be able to compare the health of those who were vaccinated with those who were not.”

As background they explain that “It’s vital that neither the volunteers nor the staff running the trial know who is randomly assigned to get the vaccine or the placebo. This ‘blinding,’ as it’s called, eliminates the chance that people will behave differently depending on which treatment they get, potentially skewing the trial’s results.”

Pfizer “said it would propose to the F.D.A. that volunteers who got the placebo could get the real vaccine.” Richard Peto, a medical statistician at the University of Oxford and his colleagues argue that “once a placebo group disappears from a clinical trial, the chance to collect rigorous data about a coronavirus vaccine will vanish.”

Researchers claim they need to keep secret the placebo group to learn about how long the vaccine protects the recipients, how many get sick in subsequent months as compared to the placebo group.

Dr. Anthony Fauci Photo: businessinsider.com

Zimmer and Weiland reported that “If the companies were to encourage unblinding their trials, that could also harm their chances of receiving the F.D.A.’s full stamp of approval — a license. And allowing a trial to continue may also be good for their bottom line, because knowing when immunity from a vaccine begins to wane will dictate how frequently people will need their product.”

Dr. Anthony Fauci had a great solution: everyone gets an injection in reverse: Those who received the vaccine get a placebo and vice versa. Secret is preserved.

Assuming that there are fixed costs to discovering a vaccine and putting it through its approval paces, why else, other than the cost of assembling and paying sufficient numbers of human volunteer guinea pigs, would money be the answer to the record breaking time it took for discovery? Why wasn’t money used before to attack such pestilence as polio, cholera and AIDS? Do you know anyone who has volunteered to take a drug during a trial period? Do you agree that Dr. Fauci’s compromise, while costly, would be the solution to protecting the volunteers who received the placebo? Are you planning to be vaccinated?

Photo: theconversation.com

 

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3 Responses to “Service of Need to Know: If You’re in the Covid Trial Placebo Group, Do You Get a Vaccine ASAP?”

  1. BC Said:

    What are my / our options? We can wait to get sick, or we can take the
    Vaccine-not much discussion about the longevity of the vaccine
    (Tetanus toxoid requires a booster every 10 yrs). We have no idea about
    the time span for protection. Flu shot every year!?!? Will COVID mutate?
    Health care workers and other front line folks will get the vaccine first, so
    the average person will have time to see how it works in them re:
    side effects.

    Luckily, we are not in the trial placebo group

  2. Jeanne Byington Said:

    BC,

    I read that the second injection has made some people feel sick for six hours, a small price to pay in return for protection against the virus. I, too, plan to get the vaccine. I saw a request on Facebook by CVS Drugstore asking for people with appropriate backgrounds to submit resumes to work on the program.

    When I see the lines of people waiting for Covid tests outside of urgent care clinics all over Manhattan in all kinds of weather I am concerned about how so many will get vaccinated without catching something while waiting for the anti covid injection!

  3. Lucrezia Said:

    When the mumps vaccine first came out, the children’s pediatrician said he would first await results, since he did not want his patients to be “Guinea Pigs.” The same theory applies here. Kudos to those who choose to act that part. Society needs a break!

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