GAITHERSBURG, Md. — Nearly 100 students at South Lake Elementary School were recently given the wrong dose of Pfizer's COVID-19 vaccine at a school clinic. The parents of 98 students vaccinated at the school on Nov. 10 were notified on Nov. 15 that their child received an over-diluted dosage.
According to Montgomery County's Health and Human Services Director Dr. Raymond Crowel, a staff member was following protocol and diluting the Pfizer vaccine with a saline solution, but mixed in too much saline. The error was caught three days after the children were vaccinated and the staff immediately notified officials, according to a department press release.
"I am personally regretful and sorry that this happened to this set of families," Montgomery County HHS Director Dr. Raymond Crowel said. "We are working to correct the mistake that was made. We'll give some sense that they can trust the system and trust the vaccine to deliver those doses."
Health experts stressed that there are no known side effects in getting a lower-than-recommended dosage.
"We want to reassure that what's happened is no way a reflection on the problems with the vaccine itself," Crowel said. "The vaccine is safe."
After consulting with county health officials as well as Pfizer, the guidance was to revaccinate the affected children as soon as possible. An additional clinic will be held at South Lake Elementary School on Wednesday, Nov. 17.
“We are confident that this is an isolated situation and staff have already received additional training on reconstituting and administering pediatric doses," said Dr. James Bridgers, acting County health officer.
Bridgers added that county staff will receive weekly updates on clinical guidance for giving pediatric vaccines.
The CDC has guidance online as to what patients should do if they are under-dosed. Their recommendation is to repeat the dose immediately if the individual received too little vaccine, either due to too little volume or incorrect dilution.
While both adults and children get two shots, the doses are different. For adults, it’s 30 micrograms and for children, it is 10 micrograms.
“In some cases, if you give someone a dose that’s too high, you may have a more robust response than you need to and that can lead more likely to side effects,” said Dr. Allison Agwu, a pediatric infectious diseases expert from Johns Hopkins University.
According to the FDA, when your child sits down to get the shot, the vial holding the vaccine should have an orange cap and a label with an orange border. Adult doses come with a purple cap and label with a purple border.
“Kids have such a robust immune system and their ability to respond to that stimulus is so great, they found they can use a lower dose, which is optimistic,” said Dr. Aaron Milstone, a pediatric infectious diseases expert from Johns Hopkins University.
Thus far, more than 19,000 pediatric doses of the COVD-19 vaccine have been given out at county-sponsored clinics, pharmacies and by local physicians. According to county officials, Montgomery County has the highest number of pediatric vaccinations in Maryland.
A similar situation occurred at an Ashburn CVS, who confirmed that three patients received vaccinations mixed with excess diluent, which reduced the efficacy. A CVS spokesperson said the incident was reported to HHS’s Vaccine Adverse Event Reporting System (VAERS) to help prevent this from occurring again.
Ted Pharmacy in Aldie, Virginia was also recently stripped of its ability to give COVID-19 vaccines, after giving diluted versions of the adult vaccine to112 children on Nov. 10.
"Should an investigation reveal there is probable cause to believe a law or regulation was broken an Informal Conference or a Formal Hearing before the board may be held for consideration of possible disciplinary action," a Board of Pharmacy spokesperson said in a statement.
Examples of disciplinary action include issuance of a reprimand, advisory letter, monetary penalty, requirements to obtain additional continuing education, probation with terms and conditions, suspension and revocation of license.
Any parent or guardian who thinks their child may have been given the wrong vaccine dosage should contact their pediatrician or health care provider to figure out the next steps.