A Bay Area Sutter accidentally gave 14 children too much COVID vaccine. UCSF experts say not to freak out (too much). – SFGate

But two UCSF experts said not to worry too much about this particular incident, which prompted Sutter to issue a public statement following intense backlash, as the dosage the children received had previously been tested in studies, did not lead to significantly worse symptoms in these studies and will not result in any long-term risks. 

“I understand where the panic is coming from,” said UCSF infectious diseases expert Dr. Peter Chin-Hong. “There are real symptoms probably happening but it’s also … the feeling of uncertainty and not sure of what’s happening to your kid with something that wasn’t standard or wasn’t supposed to happen and parents don’t know the data and the way the trials are set up.”

Some background: When the Pfizer COVID-19 vaccine doses are provided to hospitals, clinics and pharmacies, they are provided a “multiple dose vial.” But the key for the children’s vaccine, which comes with a special orange cap and is intended to provide 10 vaccinations per vial, is that each vial of the Pfizer shot must be diluted with 1.3 milliliters of sodium chloride solution to reach the proper dosage of 10 micrograms in 0.2 milliliters of vaccine fluid.

(The Moderna or Johnson & Johnson vaccines, neither of which have received an emergency use authorization for children five to 11, do not need to be diluted.)

At the Sutter urgent care clinic in Antioch, the vials received too little diluent, a Sutter spokesperson told SFGATE, meaning that the vaccine was improperly diluted. In effect, the people who administered the vaccine set up a 0.2 milliliter injection of COVID-19 vaccine, but because that injection was improperly diluted, each one carried 20 micrograms of vaccine instead of the recommended 10.

Both Chin-Hong and fellow infectious diseases expert Dr. Monica Gandhi told SFGATE that this incident is proof that health care providers — in the Bay Area and beyond — should be more careful, especially when immunizing children because of the newness of the shot.

“That just kind of gives a lesson for the health care system that when something’s new, and they’re not used to it, that they should be careful about following the instructions,” Gandhi said.

Chin-Hong concurred. “This is by far the vast exception rather than the rule,” he said. “And it turns out that in this case, luckily, we know what to predict based on the dose.”

But the symptoms of receiving a vaccine with an improper dosage, according to the U.S. Centers for Disease Control and Prevention, are largely just slightly more intense symptoms of what most vaccine recipients already experience.

“According to the CDC, patients who receive vaccine with an incorrect diluent volume may experience more arm soreness, fatigue, headache, or a fever in response to the dose given,” a Sutter spokesperson told SFGATE.

And crucially, both Chin-Hong and Gandhi pointed out, initial testing for the Pfizer vaccine gave children between ages five and 11 doses higher than the initial 10 microgram shot — some of them even received a full, adult dose of 30 micrograms.

In this “dose escalation study,” only a few of the recipients of the 30 microgram dose experienced “severe” redness or other symptoms.

Further, the recipients of the 10 and 20 microgram doses experienced similar rates of fever, headache, fatigue and other symptoms in these trials. And none, Gandhi said, will experience any “long-term harms or risks.”

What it does, Chin-Hong said, is ensure that doctors and other people responsible for immunizing children can “stop at the lowest dose we can get away with to give the same immune response.”

“No, there are unlikely to be any harms at all for giving a 20 microgram dose to a younger child, just because that was the dose that they started out studying,” Gandhi said.

And more importantly, Gandhi said, the controversy of this incident should illuminate the significance of proper dilution for health care providers and create awareness for the issue in the Bay Area and elsewhere in the country.

What the controversy shouldn’t do, Gandhi said, is discourage anyone from getting vaccinated.

“These kinds of things can be amplified when it’s really a small problem that reminds everyone in health care to be really careful,” Gandhi said.

“The safety of our patients is our top priority, and we immediately reviewed our processes to help make sure this doesn’t happen again,” said the Sutter spokesperson in a statement.