Doctors must be honest with parents about unknown risks of COVID-19 emergency vaccine

The Food and Drug Administration's momentous announcement last week that the Pfizer-BioNTech vaccine will be made authorized under emergency use for children ages 5-11 was followed Tuesday afternoon by the Centers for Disease Control and Prevention's decision to recommend the vaccine's use for children. For some parents, this is blissful news, and for others, the announcement may raise questions or concerns.

Of course, when it comes to children in America, we all want to do what is absolutely best for their health. We all want to minimize the harms and suffering of children, as well as harms to those who love them and care for them. We want to do what is best for kids in the short term, as well as what is best for them in the long term.

With that in mind, it is absolutely essential that we communicate about this vaccine in an informative and nuanced way and, for the moment, resist uninformative persuasion. This means we should use language that empowers parents to take part in a shared decision-making discussion to determine whether vaccination is right for their kid in this moment or, if not now, potentially some moment in the future.

Small studies can't tell the full story

It is vital that medical practitioners don't exaggerate or embellish what is known in this moment. Applying pressure or force is not appropriate at this time. Trying to convince someone should take a backseat to trying to inform them, and accepting their decision. A review of the evidence to date helps explain why.

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Emergency use authorization was granted in this age group on the basis of a pivotal trial that is ongoing but has a relatively small sample size (4,700 children). This sample size is too small to document new or known adverse side effects (called safety signals) that have been noted at other ages and at other doses.

For instance, myocarditis, an inflammation of the heart muscle that can reduce the heart's ability to pump or beat correctly, occurs in about 1 per 5,000 cases of vaccinated boys ages 12-15. If myocarditis occurs in boys ages 5-11 at the same rate as in boys 12-15, a study of this size would not be able to document that. We are flying blind on a side effect that parents need to be informed about.

Finally, the trial was not designed or able to assess whether vaccinating kids of this age, at this dose, slows asymptomatic disease or spread of SARS-CoV-2 to other household members, or for adults who care for these kids outside of the home. That limitation must be acknowledged.

The FDA emergency authorization was also supported by its modeling data that makes a compelling case for vaccination of kids. The model estimates how many kids could be hospitalized with the virus, and compares these results against myocarditis that might occur. But in several scenarios outlined by the model, the FDA had to assume the rate of excess myocarditis for an entirely different age group, children 12 to 17, because the rate for children ages 5 to 11 is unknown.

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Although the FDA's overall modelling favors vaccination, in one scenario, the model even predicted boys, as well as boys and girls considered together, may experience "more excess hospitalization and ICU stays due to vaccine-related myocarditis" compared with the number of hospitalizations and intensive care unit stays due to COVID-19.

The FDA conducted these models to show vaccination is worth it. But when the assumptions are coming from other data sources and have some possibility of being over- or underestimates, we need to acknowledge the model's limitations.

Experts: It's OK to wait

Looking at this regulatory decision, it is fair to say that there is residual uncertainty, or the uncertainty that remains after the best possible analysis.

Most likely, vaccinating will end up being a benefit to kids. At the same time, there is a small chance that at least some groups of kids vaccinated may experience adverse events and guidance might be revised for them. Impact on the broader trajectory of the pandemic is highly speculatory because transmission from vaccinated children has not been measured.

Finally, it must be noted that Moderna, maker of the other mRNA vaccine, announced Oct. 31 that it will delay submitting for emergency use authorization for kids ages 6 to 11, while the FDA investigates myocarditis among adolescents.

For these reasons, drug safety experts wisely note that it is OK to wait. Here's Dr. Walid Gelad, an assistant professor at the University of Pittsburgh School of Medicine:

Should health care providers acknowledge the idea that it is OK to wait? I say: They must.

One might argue that even suggesting this option could discourage vaccination. However, if we are not honest about the residual uncertainty of the regulatory decision, we risk causing disappointment, anger and possibly harm in the rare scenario that vaccine guidance is revised in some manner.

Two reasonable, loving options

Moreover, waiting does offer alternative benefits. Waiting allows current passive collection systems (for example, unsolicited contributions to the Vaccine Adverse Event Reporting System, which is co-managed by the FDA and CDC) to detect vaccine adverse events, and could help clarify whether myocarditis is going to occur and if so, how often.

Dr. Stefan Baral, an associate professor at the Johns Hopkins Bloomberg School of Public Health, puts it this way:

Ending this pandemic, and doing what's best for children, is of absolute importance. Based on available data so far, it is reasonable for a parent to decide that moving forward with vaccination is the right thing in this moment. It is also reasonable for a parent to decide to sit back and wait a bit for additional safety data to accumulate.

Health care providers must acknowledge the residual uncertainty as we talk about the vaccine in the news media and with patients. This is the right thing to do. But also, pre-COVID, vaccination had already grown into an increasingly divisive issue, which threatens our efforts with routine, well-established vaccines. If the profession of medicine errs, in even a small way, we run the risk of pouring gasoline on this fire.

Everything is on the line – the health of American kids, the fate of the pandemic, but perhaps also the fate of all vaccination programs – and we don’t know it all. This is not the time for uninformative persuasion; it is the time for listening, counseling and being comfortable when parents choose yes, but also when they decide to wait a little bit longer.

Dr. Vinay Prasad is a hematologist-oncologist and associate professor in the Department of Epidemiology and Biostatistics at the University of California, San Francisco. He runs the VK Prasad Laboratory at UCSF, which studies cancer drugs, health policy, clinical trials and better decision-making. Follow him on Twitter: @VPrasadMDMPH

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This article originally appeared on USA TODAY: FDA, CDC approve COVID-19 vaccine for kids 5-11, despite unknown risks