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Posted this morning, it is speaking to some of the things we have discussed in various threads... Doctors must be honest with parents about unknown risks of COVID-19 emergency vaccine. (Note that I did not include the plethora of links. That is something you will have to click on the original article to explore for yourself.)
Yep. Just another 'obscure opinion' in a non-peer reviewed publication. Nothing to see there. Except, the author isn't just another hack, but qualified to express his opinion, which he also happens to document (again, I didn't include the links) and links to other, qualified individuals who share that 'obscure opinion.' How is he qualified...
That link takes you to a page which includes yet another link to his 311 publications, the majority of which are in peer-reviewed journals or on more than credible sites hosted by actual science organizations.
Yep. I get it. So, he's published a lot. (I know a number of professors from "publish or perish" departments who produce good stuff and schlock to keep their numbers up.) It doesn't mean his is the only opinion or that there aren't contrary opinions by actual experts. But, as I've stated before, if there weren't a diversity of opinions, there wouldn't be anything to discuss and the matter would be largely 'settled' already.
...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.
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...
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...
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...
...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...
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.
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...
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...
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...
...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...
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.
Yep. I get it. So, he's published a lot. (I know a number of professors from "publish or perish" departments who produce good stuff and schlock to keep their numbers up.) It doesn't mean his is the only opinion or that there aren't contrary opinions by actual experts. But, as I've stated before, if there weren't a diversity of opinions, there wouldn't be anything to discuss and the matter would be largely 'settled' already.
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