The CDC’s Advisory Committee on Immunization Practices met Thursday and Friday to revise the nation’s child and adult vaccine schedules. Normally these meetings are careful, evidence-based discussions among experts.
This time, the tone was different with performative statements, repeated mistakes, and ideological posturing in contrast with the usually academic atmosphere. CDC staff presentations remained clear and grounded, laying out the risks, benefits, and data with precision. Despite the wacky language the panelists used at the meeting, their decisions were surprisingly modest. Let’s start with what they did on the COVID booster.
COVID Vaccine
ACIP thankfully voted down a motion to require prescriptions for all adults (the chair broke the 6-6 tie). However, they dropped the earlier broad, universal recommendations. The COVID booster now falls on what’s called “shared clinical decision-making” for everybody 6 months old and up.
From CDC:
“Shared clinical decision-making recommendations are intended to be flexible. The decision to vaccinate may be based on the individual’s characteristics, values, and preferences; the provider’s clinical discretion; and the characteristics of the vaccine. There is no default assumption that the vaccine should be administered to all persons in a particular age group or risk group.”
Here are the exact motions that the committee voted on for COVID. Pay particular attention to votes 2 and 4:
Vote 1. It is the sense of the committee that the CDC engages in an effort to promote more consistent and comprehensive informed consent processes, and as part of that considers adding language accessible to patients and medical providers to describe at least the six risks and uncertainties included in the Work Group Chair presentation. Passed (Yes 11, NO 1)
Vote 2. It is the sense of the committee that state and jurisdictions should require a prescription for the administration of COVID-19 vaccination. Failed to Pass (Yes – 6, No – 6) – the chair broke the tie by voting NO.
Vote 3. It is the sense of the committee that in conversations with patients before COVID-19 vaccination, authorized healthcare providers discuss the risks and benefits of the vaccination for the individual patient. The discussion should consider known risk factors for severe outcomes from COVID-19, such as age, prior infections, immunosuppression, and certain comorbidities identified by the CDC, and include a discussion of the potential benefits and risks of vaccination and related uncertainties especially those outlined in the vaccine information statement, as part of informed consent. Passed (Yes – 12, NO – 0)
Vote 4. The pediatric and adult immunization schedules for administration of FDA-approved COVID-19 vaccines should be updated as follows:
- Adults 65 and older: Vaccination based on individual-based decision making – also known as shared clinical decision making.
- Individuals 6 months to 64 years: Vaccination based on individual-based decision-making – with an emphasis that the benefit of vaccination is most favorable for individuals who are at an increased risk, according to the CDC list of COVID-19 risk factors. Passed (Yes -12, No – 0)
I think this means that people 65 and over should be able to get the vaccine in pharmacies relatively easy. They won’t need a prescription. The ‘shared clinical decision-making’ criteria doesn’t mean there needs to be a doctor actually advising the patient – although some pharmacies may choose to require that – but it’s not something that’s required to meet the recommendation standard.
I think this also means people under 65 are still eligible, but the emphasis is on weighing individual risk factors with a healthcare provider. However, there’s no prescription needed, and there’s nothing in the language of shared clinical decision-making standard to suggest the person needs a doctor’s note or assessment. The ACIP was silent regarding pregnancy, but I think pregnant women can get it as a regular adult with ‘shared clinical decision-making’.
As for coverage by health plans – I think today’s decision means health plans should generally cover the vaccine and there is no prescription needed.
Now, that doesn’t mean that pharmacies and health plans won’t take a restrictive view of the ACIP recommendations and voluntarily limit who they vaccinate. With ACIP no longer urging universal use, insurers may be less likely to cover shots for healthy younger adults, and some pharmacies might hesitate to offer them without clear state guidance.
Also, last week Governor Hobbs issued an Executive Order to clear up the confusion and smooth the vaccination road. A key element of that EO was the directive for the ADHS to issue a Standing Order authorizing the vaccine – essentially a blanket prescription, allowing pharmacies to vaccinate anyone who wants the shot.
That Standing Order, which has been issued by former US Surgeon General Richard Carmona, should go a long way toward giving pharmacies comfort about administering the vaccine. Here’s a link to Dr Carmona’s Standing Order
MMRV Vaccine
ACIP voted to withdraw its recommendation for use of the combined MMRV vaccine in children under 4. Research has shown that this shot slightly increases the risk of febrile seizures compared with giving the measles-mumps-rubella (MMR) and varicella (chickenpox) vaccines separately. While the combined shot is still a choice if parents prefer, ACIP now recommends separate administration.
This decision will also affect reimbursement. Some health insurers, like Blue Cross Blue Shield of Arizona, had been pushing pediatricians to use the combined MMRV to avoid paying separately for two shots. With the new guidance, insurers will likely need to cover the MMR and varicella vaccines individually. Families who previously opted for the convenience of the MMRV may see reduced or ended coverage for that choice – but families should still be able to get their kids vaccinated with no co-pay or deductible.
Hepatitis B Vaccine Recommendation
The committee ultimately decided not to delay the Hep B vaccine birth dose until one month of age if the mother tests negative for the virus. The committee discussed the post market surveillance that showed that the vaccine has a very low (about one severe allergic reaction per 2–3 million doses),
Had they made the change, the decision would have put infants at risk, especially if a mother’s Hep B status is unknown or if she is positive. The stakes are high: nine in ten babies who contract Hep B develop lifelong chronic infection, compared with only one in ten adults. It also may have caused health systems to interpret it as permission to drop the Hep B birth dose from standard newborn care meaning babies of unscreened or even positive moms might not get the vaccine at birth.
The birth dose of Hep B will be on a future agenda – as many members were ‘concerned’ about the Hep B vaccine’s safety based on anecdotal evidence of higher rates of irritability and fussiness in babies, despite CDC studies showing no increased risk of neurological issues.
