Why Requiring Placebo-Controlled Trials For New Vaccines Could Harm Americans
HOLLYWOOD, FLORIDA - AUGUST 07: Lisa Taylor receives a COVID-19 vaccination from RN Jose Muniz as ... More she takes part in a vaccine study at Research Centers of America on August 07, 2020 in Hollywood, Florida. (Photo by)
Vaccines, a polarizing issue for many Americans, will trigger more alarms in the near future with a new requirement for their future development and distribution. Robert F. Kennedy Jr. and the Trump administration plan to require all new vaccines to be tested against an inert substance in placebo-controlled trials before they are widely distributed to the public.
While the move may be very well-intended and will enhance transparency to the American public, there could be many unintended or intended consequences that could harm millions of Americans. Here's how.
Andrew Nixon, a spokesman for Robert Kennedy Jr., said 'except for the COVID vaccine, none of the vaccines on the CDC's childhood recommended schedule was tested against an inert placebo, meaning we know very little about the actual risk profiles of these products.'
This, in fact, is not true and is part of the basis for this new requirement for vaccine testing. As an example, several placebo-controlled trials have been performed testing the efficacy and side-effect profile for the MMR vaccine that combats measles, mumps and rubella. A study published back in 1966 in Pediatrics compared the MMR vaccine with placebo among more than 4,700 children. In the study, measles was diagnosed in 504 children, 430 of whom were in the placebo group. More recently just last year in The Lancet, a placebo-controlled trial was performed in over 6,500 5-7 month old infants and was found to be safe, without any severe adverse events related to the vaccine itself.
The basis for this new policy on vaccine testing is based in part on vaccine misinformation. Kennedy himself has a history of promoting vaccine misinformation, having repeatedly claimed vaccines cause autism, an assertion that has been widely debunked by science and data. This type of rhetoric will undoubtedly contribute to public skepticism on vaccines and undermine confidence in vaccine programs in America. Vaccine hesitancy is already on the rise and has contributed significantly to the nearly 900 cases of measles this year alone, mostly in unvaccinated individuals.
Measles infections are entirely preventable with vaccines and one shot offers 93% protection against the virus, while two shots offer 97% protection. Instead of promoting MMR vaccine usage with clear messaging to the general public, the Trump administration casts doubts on vaccines asserting that childhood vaccines have not been thoroughly tested. This will only fuel vaccine hesitancy. This will harm and continue to harm Americans, who are already suffering from the measles outbreak because parents refuse to vaccinate their children.
Imagine giving some Americans a vaccine that is known to prevent illness and death, and withholding it from other Americans when a deadly disease is circulating in the environment. This is precisely what could happen in the near future with future iterations of the COVID vaccine.
The updated COVID vaccines could be considered a 'new' vaccine because it is updated yearly to match the strains that are circulating at the time of introduction. If the COVID vaccine needs to be tested in placebo-controlled trials, some Americans in the placebo group would be deprived of receiving an already well-tested vaccine that has been shown to save lives. Modest estimates show that the COVID vaccine prevented more than 14 million deaths. Withholding a life-saving vaccine would be unethical and would do more harm than good. The type of testing that the HHS is proposing for vaccines should only be done when no effective vaccine is available or none has ever been tested.
Testing a critical life-saving COVID vaccine could delay availability of the vaccine for people that need it most. Testing requires time, sometimes months to years to ensure all data is collected and side-effect profiles are reviewed. If that is the case, rolling out a vaccine like the COVID vaccine could be delayed, which would be a devastating problem if that occurred during peak season in the late fall and winter for the over 22 million Americans with weakened immune systems that need it.
Those with weakened immune systems cannot adequately mount an appropriate immune response when exposed to different diseases. Without the vaccine, these 22 million Americans could get sick, hospitalized and even die. The COVID-19 virus is still very much a threat. As an example, during the week of April 19, 183 Americans died from COVID.
Although the Trump administration may have good intentions in testing new vaccines for greater safety and transparency, the harm done by unintended consequences could be devastating.
I am reminded of a famous saying of the Prophet Muhammad, the last prophet in the Islamic religion, who states, 'indeed actions are judged by intentions.' Intentions are only part of the equation, the rest are actions, and actions speak louder than words.
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