Today the Centers for Disease Control and Prevention (CDC) said it is now applying individual-based decision-making to COVID-19 vaccination instead of making routine recommendations on use.
The CDC also recommended that toddlers receive the varicella (chickenpox) vaccine as a standalone immunization rather than in combination with measles, mumps, and rubella vaccination.
"Informed consent is back," said Acting Director of the CDC and Deputy Secretary of Health and Human Services (HHS) Jim O’Neill in an HHS press release. "CDC's 2022 blanket recommendation for perpetual COVID-19 boosters deterred health care providers from talking about the risks and benefits of vaccination for the individual patient or parent. That changes today."
Now, all Americans are tasked with consulting with their healthcare providers to decide if they should get a seasonal COVID-19 booster.
The changes follow recommendations made by the CDC's Advisory Committee on Immunization Practices (ACIP) last month, and are meant to place "shared clinical decision making" at the forefront of vaccine administration.
Decision called 'misleading'
On X, former director of the National Center for Immunization and Respiratory Diseases, Demetre Daskalakis, MD, MPH, said the announcement was misleading.
Vaccinators may require proof of a discussion with a clinical before vaccination.
All vaccines come with shared deciding making between patients and clinicians, he said. But under the new CDC recommendation, "Vaccinators may require proof of a discussion with a clinical before vaccination. In many states that means getting a prescription with a diagnosis code before a vaccine will be administered. This means that pharmacists, in some states, aren't given the authority to share in decision making."
Daskalakis added, "All vaccination involves discussion. The acting director is showing his lack of experience in the clinical or policy space and is purposefully trying to say, 'finally clinicians have to talk to their patients.' "
The HHS press release said the COVID-19 vaccines will continue to be covered by both private and public insurers.
Chickenpox vaccine already given separately to 85%
The recommendation for standalone varicella vaccination comes after ACIP was presented evidence by the CDC Immunization Safety Office showing that 12- to 23-month-old toddlers had an increased risk of febrile seizure 7 to 10 days after vaccination for the combined measles, mumps, rubella, and varicella vaccine compared to those given immunization for chickenpox separately.
According to the HHS, the combination vaccine doubles the risk of febrile seizures without conferring additional protection from varicella.
The combined vaccine was licensed in 2005 to promote increased vaccine uptake, but currently only 15% of US parents choose it for children ages 12 to 15 months.
"I commend the doctors and public health experts of ACIP for educating Americans about important vaccine safety signals," O'Neill said. "I also thank President Trump for his leadership in making sure we protect children from unintended side effects during routine immunization."
NY state extends executive order for pharmacists
In related developments, yesterday New York Governor Kathy Hochul signed an extension to an executive order allowing pharmacists in the state to administer COVID-19 vaccines for an additional 30 days without a prescription under a standing order.
"I will sign as many extensions of this executive order as I need to," Hochul said. "We will always let science lead the way—not politics."
