ARTICLE

CDC’s ACIP recap: Things they didn’t say

March 6, 2024 – Last week the CDC’s Advisory Committee on Immunization Practices (ACIP) gathered for their regularly scheduled February meeting. The ACIP traditionally meets three times per year in February, June, and October. COVID upended that, with 10 meetings in 2020, 17 in 2021, 11 in 2022, and seven in 2023.¹ The ACIP started this year with a notable eight vacancies on the panel, so for this meeting, members of the federal government stepped in as voting members. Topics included the expected: shots for COVID, flu, polio, pneumococcal, and meningococcal, alongside discussions revisiting guidance for diphtheria, tetanus, and pertussis, and newly-licensed, fast-tracked chikungunya vaccines.

Four votes were taken; each passed easily. The first added another recommended 2023-2024 version of the COVID shot for those over 65. The committee spent over 30 minutes discussing whether the recommendation language would be more effective at getting shots in arms if the CDC says people “should” get the shot versus “may” get the shot. The difference is, if the CDC says people “may” get a shot, it sounds more like permission and would create discussion with providers about individual patient needs, while “should” more clearly supports their end goal of directing one-size-fits-all medicine. In the end, push came to shove and the crew decided “shared decision making” was too weak and confusing and went with “should.” Is it curious that the ACIP spent a hefty chunk of time debating the subtleties of persuasive language? Were there other topics that that went ignored?

The committee also voted to update Vaccines for Children (VFC) guidelines for combination vaccines containing tetanus, diphtheria, and pertussis. This is significant because VFC earmarks taxpayer money to supply free vaccines to poor children only if the vaccine is specifically added to the list. But these combo shots have been given to children since the 1970s. What changed? The stated reason for doing this was because an unnamed maker of the only DT vaccine (who happens to be Sanofi), discontinued manufacturing.² The DT vaccine was recommended for children who had a reaction to the pertussis component of DTaP, or people who showed up in the ER for potential tetanus exposure. DT will be replaced with Td, also manufactured by Sanofi, and containing less diphtheria toxoid than DT. (For a review of the alphabet soup of this combo shot, check out our article “Shining a light on Pertussis, the vaccine that opened the courthouse doors.”)

Strangely, the group voted to add Td, manufactured by MassBiologics, to the VFC resolution to authorize taxpayer dollars for free vaccines despite acknowledging the company’s very recent decision to discontinue manufacture of the product. There was no discussion about why either product was being discontinued, but Sanofi cited “minimal demand” in a letter to customers,³ and the maker of TdVax revealed the FDA was investigating some of its lots in 2022.⁴ One member of the committee, Dr. Chan, did not vote because he disclosed an active collaboration with MassBiologics. What does this curious vote mean for Americans? Moving forward, children who have a reaction to DTaP may be able to access Td (with lower doses of diphtheria toxin than DT) as long as there are no supply shortages, however, people going to the ER with a wound will most likely not be able to access a shot that does not include pertussis. Our article “Shining a light on tetanus: The case of the rusty nail and the anti-fertility vaccine” explains why doctors push the Dtap shot when they see open wounds.

Two further votes sailed through for the first-ever chikungunya vaccine to be recommended for lab workers and anyone traveling to a country where there is an increased risk of the mosquito-borne illness. Chikungunya commonly causes fever and joint pain and, according to the WHO, most people fully recover and have lifelong immunity.⁵ Serious or long-term illness occurs typically only in the very old or very young and those with complications. Unfortunately, the FDA’s press release announcing licensure in November 2023 makes one wonder if the cure is worse than the illness itself for the healthy traveler or lab worker:

The FDA’s announcement further explains that the vaccine was granted “Accelerated Approval,” based on whether a product may be effective. There’s no mention of safety requirements, and the press release admits that adverse reactions did not happen in the placebo group, and that it is unknown whether the vaccine will cause adverse effects in newborns. The FDA is relying on the manufacturer to do postmarket surveillance to gather safety data. In other words, we’ll figure out how safe this is after we sell it and see what happens.

There’s no information on the safety or efficacy for mom or baby, because it’s general practice not to test vaccines on pregnant women. There’s also no “human data” on whether vaccine virus or antibodies are present in breast milk after vaccination. Two pregnant women who were inadvertently included in clinical trials both had miscarriages after the vaccine was administered (none in the placebo group did), and the miscarriages were not attributed to the shot.

Regardless, the ACIP did not exclude or add precautions to their recommendation for pregnant women.

As you can see, there was a lot missing from the meeting discussion. Here are just a few of the things left unsaid during the COVID discussions:

Data about hospitalization for COVID in children wasn’t given, though there was a full presentation on adult hospitalization.
Public attitudes about the shot, and top concerns were presented in the context of addressing why people haven’t gotten all the shots, and notably absent was any discussion of people’s concerns, which included serious or mild side effects, and whether the shot worked at all.
COVID vaccine safety presentations still did not address the safety signal from VAERS data and deaths.
Efficacy data presented did not include inquiry into “negative efficacy,” meaning questions of whether those vaccinated are more likely to get COVID.
Why efficacy data was discontinued after a very short 119 days.
Economic analysis also didn’t include the possibility of breakthrough infections in estimating years of life and money saved.
“Available data” addressing the acknowledged signal for stroke associated with the shot was “inconsistent,” with the claim “most” results didn’t show an association…which leaves one wondering if there are studies that have shown those results which were not disclosed or discussed.
There was no discussion about why they recommend a 2^nd 2023-2024 shot for those over 65 at four months rather than the typical 2 month wait between shots.
There were references to differences in opinion among Working Group members regarding the 2^nd shot recommendation, but full disclosure of those differences was absent.
There were comments about returning to strain recommendations at least yearly, but no discussion on why we need new strains every year.

Here are some things they DID say about the COVID shots:

“I totally acknowledge that lots of people don’t want it…anything we can do to lower the barrier of getting a vaccine in someone’s arm is just wonderful.”
“We know efficacy wanes.”
“98% of people have natural or vaccine immunity.”
[There are] “lots of questions, probably unanswerable.”

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