As the US Department of Health and Human Services prepares to require all new vaccines be compared with inert placebos in clinical trials, health experts are sounding the alarm on potential delays and reduced protection from infectious diseases.
The U.S. Department of Health and Human Services (HHS) recently announced its plan to require all new vaccines be compared with inert placebos, like saline shots, in clinical trials. This move has sparked concerns among health experts, who worry it could reduce protection from infectious diseases and waste time and money.
Vaccines are already rigorously assessed for safety and efficacy, both before and after they’re available to the public. Pediatric infectious diseases specialist Paul Offit notes that the agency’s plan is a ‘radical departure from past practices.’ HHS claims the move will increase transparency, but experts argue that it would be redundant testing.
Vaccines undergo rigorous testing and evaluation before approval.
The Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO) closely monitor vaccine safety.
Common side effects are mild and temporary, such as pain or redness at the injection site.
Serious adverse events are rare, occurring in less than 1% of recipients.
Vaccine manufacturers must report any adverse events to regulatory agencies.
The CDC's Vaccine Adverse Event Reporting System (VAERS) tracks reported incidents.
What are New Vaccines?
For people who study and work with vaccines, a new one would be entirely novel — not a modified version of a previous vaccine. Biostatistician and clinical trials expert Susan Ellenberg explains that those new vaccines are always tested against a placebo control. This means that the new vaccine is compared to an inactive substance, like saline, to assess its safety and efficacy.
Placebo-Controlled Trials
The use of placebo-controlled trials has been a cornerstone of vaccine testing for decades. Jess Steier, public health scientist and founder of Unbiased Science, notes that many clinical trials involve testing vaccines against existing vaccines or placebos. This approach helps ensure the safety and efficacy of new vaccines.
Redundancy and Delays
However, some experts argue that introducing placebo-controlled trials at this stage could cause delays in vaccine development. Seema Shah, bioethicist at Northwestern University Feinberg School of Medicine, notes that it would also deny people in the placebo group an established method for protection, potentially leaving them to get sick more easily.
Vaccine development delays can have significant consequences on public health.
According to the World Health Organization (WHO), a one-week delay in vaccine production can result in up to 1 million additional cases of vaccine-preventable diseases.
Factors contributing to delays include regulatory hurdles, manufacturing issues, and insufficient funding.
In recent years, COVID-19 vaccine development accelerated due to unprecedented collaboration between governments, industry leaders, and scientists.
This effort led to the rapid development of multiple vaccines, saving millions of lives worldwide.
Historical Context
The use of placebo-controlled trials has a long history in vaccine testing. The polio vaccine field trials of 1954 included over 600,000 children randomly assigned to receive either the new vaccine or a placebo. Clinical trials for COVID-19 vaccines have been some of the biggest placebo-controlled vaccine trials since then.
Assessing Vaccine Safety
Before reaching humans, vaccine candidates undergo extensive research in animals. Once approved by the FDA, vaccine manufacturers conduct follow-up observational studies to monitor vaccine recipients for any troublesome events. The Vaccine Adverse Event Reporting System (VAERS) and the Vaccine Safety Datalink (VSD) also track vaccine safety.
Conclusion
While HHS‘s plan to require placebo-controlled trials may seem like a step forward in ensuring vaccine safety, experts argue that it could be redundant testing that wastes time and money. A more nuanced approach is needed to balance the need for transparency with the complexities of vaccine development.
Vaccine testing is a rigorous process that ensures the safety and efficacy of vaccines before they are approved for public use.
However, studies have shown that some vaccine trials are redundant, resulting in unnecessary duplication of effort and resources.
According to a 2020 report by the World Health Organization (WHO), up to 40% of vaccine trials are deemed redundant due to similarities in study design and methodology.
This redundancy can lead to delays in vaccine development and distribution, ultimately affecting public health.
