FDA Issues Alert on Wrong COVID Vaccine Doses for Children
“We are advising healthcare providers who administer the Moderna COVID-19 vaccine to individuals six months through 11 years of age to ensure that the correct volume of the vaccine is withdrawn from the vial so that the correct dose is administered to the vaccine recipient,” the FDA alert said.
The FDA said it has since revised a fact sheet for health care providers on the mRNA vaccine to “further clarify that 0.25 mL should be withdrawn from the vial and that the vial and any excess volume should then be discarded.”
The agency added it has “become aware that some healthcare providers may not recognize that the single dose vial of Moderna COVID-19 Vaccine (2023-2024 Formula) for use in individuals six months through 11 years of age contains notably more than 0.25 mL of the vaccine. Some healthcare providers may be withdrawing the entire contents of the vial to administer to an individual. However, the volume of a single dose … is only 0.25 mL.”
It came after a 5-year-old girl in North Carolina accidentally received a double dose of a COVID-19 vaccine, according to the child’s mother.
The unnamed mother told WRAL-TV that the girl recently received the shot but was called by the doctor’s office, who told her that “we made a mistake” when they gave the girl the vaccine.
“We gave her a double dose instead of a single dose,” she said. The woman did not say what brand of vaccine was given to her daughter, although the FDA has approved the mRNA shots made by Pfizer and Moderna for kids.
It’s not clear if the FDA issued the health alert in response to that specific reported incident in North Carolina.
Last year, the World Health Organization (WHO) issued a statement that the U.N. health body was “aware of an increasing number of reports regarding COVID-19 immunization errors in children,” including “the use of adult dose in children [and] use in inappropriate age groups,” among other errors.
In late 2021, more than a dozen children were given an incorrect COVID-19 vaccine dosage in Antioch, California, according to local reports. Some children received double the amount they were supposed to.
In a more striking example, some 110 children aged 5 to 11 were given the wrong dose of a COVID-19 vaccine at a pharmacy in Loudon County, Virginia, in November 2021. The county’s health officer at the time said that the pharmacy that administered the shots incorrectly attempted to use the adult vaccine to provide to children by cutting the doses into thirds.
The Epoch Times has contacted the FDA for comment on Friday.
Uptake Still Low
While the FDA and CDC both essentially signed off on the latest booster shots made by Moderna, Pfizer, and Novavax in September, recent data has signaled that uptake appears to be relatively slow.
About 15 million people in the United States, including children and adults eligible to get the vaccine, have received the latest shot as of Oct. 27, figures from the Department of Health and Human Services (HHS) show. That amounts to more than 4.5 percent of the American population.
“As of Oct. 27, more than 15 million Americans have received the updated COVID-19 vaccine, and over 19 million vaccines have shipped to pharmacies and other locations, with 91 percent of Americans 12 years and older living within 5 miles of a vaccination site,” an HHS spokesman said in a statement.
By Oct. 26 of last year, approximately 23 million people had received the initial updated booster shot, according to CDC data. The 2022 fall vaccination campaign started around 10 days earlier than the 2023 season. In all, about 56.5 million people, or 17 percent of the U.S. population, got last year’s booster.
Moderna is now working to “increase a sense of urgency to get vaccinated” by encouraging medical providers to recommend the COVID-19 shot, executives said in a Thursday call with investors. It would also run more ads.
“Our assumption is everyone who has gotten their booster in 2023 will at least get their booster also in 2024 and beyond,” Moderna chief customer officer Arpa Garay said during the call.
Shares of Moderna closed 6 percent lower on Thursday. So far in 2023, Pfizer’s stock has plunged about 39 percent, and Moderna’s has dropped 56 percent.
As for Pfizer, the firm confirmed to local media outlets this week that it would shut down two plants in North Carolina amid a widespread cost-cutting initiative.
Source: Epoch Times
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