Welcome to our biweekly sequence in partnership with CIDRAP on the College of Minnesota.
I (Izzy) am scripting this whereas consuming espresso from my favourite Shakespearean insults mug, which seems like the precise companion for a publish about language. Shakespeare understood {that a} well-chosen phrase has the ability to harm, flatter, or utterly change how we see one thing.
Juliet’s well-known line “What’s in a reputation? That which we name a rose / By every other title would scent as candy” is a beautiful sentiment, and it holds some fact. The rose doesn’t change. However what we anticipate of it and whether or not we belief it shift alongside the label. Phrases are greater than a ornament. They inform us what to anticipate and what to do subsequent.
That concept was on my thoughts on September 23, when the U.S. Division of Well being and Human Providers (HHS) up to date their Interim Scientific Issues for Use of COVID-19 Vaccines. HHS oversees the Facilities for Illness Management and Prevention (CDC), and this steerage is written for clinicians and public well being officers to make use of when sufferers ask about vaccination. Final week, we in contrast it with the Could 1, 2025, model phrase for phrase, however a social media publish solely suits a lot. So first, a fast run-through of this version’s coverage updates, then a deep dive. Let’s focus on…
The PDF model of as we speak’s replace is right here. Learn previous installments right here and as we speak’s replace on the Unbiased Science Substack right here.
The State of U.S. Vaccine Coverage, in Transient
HHS launched a vaccine harm initiative, a U.S.-funded hepatitis B vaccine trial in newborns drew extra pushback, and New York declared a measles emergency. There have been additionally updates within the courts and in Florida.
HHS launches a vaccine harm initiative, which incorporates paying docs for Vaccine Adversarial Occasion Reporting System (VAERS) experiences
On October 8, HHS introduced:
A Nationwide Institutes of Well being (NIH) clinic to check and deal with individuals who expertise well being issues after vaccinationA Facilities for Medicare and Medicaid Providers (CMS) proposal to pay physicians for submitting experiences to VAERSA requirement that digital well being information seize vaccine-related antagonistic occasionsA CDC contract to replace VAERS
Right here’s the gist: We ALL need vaccine security, and we have already got monitoring methods with a monitor report of catching uncommon uncomfortable side effects (it’s how a uncommon clotting dysfunction was linked to the Johnson & Johnson COVID-19 vaccine in 2021), so implying in any other case is deceptive. Anybody can submit a VAERS report, and a report alone doesn’t present {that a} vaccine induced something. With out analysis into these experiences, extra submissions might be mistaken for proof of extra hurt. HHS Secretary Robert F. Kennedy Jr. mentioned HHS should not “dismiss or gaslight” households who report vaccine accidents. Taking them significantly means investigating what truly induced their signs. The CMS piece continues to be a proposal, and we’ll remember to flag it if and when it opens for public remark.
If the purpose is to assist injured households, essentially the most direct repair is the compensation backlog, during which claims take two to a few years, and none of those actions tackle it. We’re additionally fearful concerning the Vaccine Harm Desk, which HHS can change with out Congressional enter. When a listed harm happens inside a set time window after receipt of a selected vaccine, causation is mostly presumed. Most childhood vaccines are given within the first few years of life, which can be when autism is usually recognized, so relying on how vast that window is about, an enormous variety of households may develop into eligible for compensation over a hyperlink that many years of analysis (and vaccine court docket itself) have discovered no proof for. That would drain the compensation fund and push producers out of the market, as lawsuits did within the Eighties. For extra data, learn our October 10 piece.
Guinea-Bissau says it hasn’t licensed a U.S.-funded trial that will delay hepatitis B vaccine for some newborns
Dealing with a September 30 deadline to spend funds, CDC officers pulled $1.6 million for a trial in Guinea-Bissau from funds Congress designated for international well being safety (cash that would have gone towards the Ebola outbreak within the Democratic Republic of Congo), Rolling Stone experiences. The trial would enroll 14,000 newborns. Half would get the hepatitis B vaccine at delivery, and half would wait till 6 weeks, the nation’s present schedule. Greater than 12% of adults there have persistent hepatitis B, and about 90% of infants contaminated at delivery develop persistent an infection.
One core requirement for a randomized trial is medical equipoise, which means actual uncertainty about which choice is best for contributors. The researchers wish to research broader outcomes like total deaths, however there’s no credible uncertainty {that a} well timed delivery dose protects newborns from hepatitis B (it prevents 70% to 95% of mother-to-baby transmission). They argue that no child would get fewer vaccines than the nationwide schedule offers. Guinea-Bissau already plans so as to add the delivery dose by 2028, and in February, the World Well being Group referred to as the trial unethical, noting that restricted assets can’t justify withholding confirmed care in a research. The Hepatitis B Basis and the African Hepatitis B Advocacy Coalition have additionally denounced it.
On September 30, an ethics committee on the College of Southern Denmark voted 5 to 4 to affirm the trial. Two members instructed Rolling Stone that the expiring funds rushed deliberations and that the vote was scheduled earlier than all members may attend, and a minimum of 4 members have since resigned. The dean gave closing approval on October 7, although the trial can’t start with out Guinea-Bissau’s authorization. On October 13, Guinea-Bissau’s well being minister mentioned the federal government by no means licensed it and that it could want additional overview.
An appeals court docket heard the federal government’s problem to the ruling that paused Kennedy’s vaccine advisory committee
The ACIP (Advisory Committee on Immunization Practices) is the panel of outdoor consultants that advises CDC on who ought to get which vaccines. Its suggestions form insurance coverage protection and the vaccines out there by means of Vaccines for Kids. In June 2025, Kennedy fired all 17 members and changed them along with his personal picks, a number of of whom had publicly questioned vaccine security. The American Academy of Pediatrics (AAP) and different medical teams sued in AAP v. Kennedy. They argue that the brand new committee lacks the steadiness and experience federal regulation requires and that Kennedy modified the childhood vaccine schedule with out following correct course of. In March, a federal district court docket paused each the rebuilt ACIP’s appointments and votes and Kennedy’s modifications to the childhood vaccine schedule whereas the case continues.
The federal government appealed solely the ACIP half, and the First Circuit heard arguments on October 6. The schedule pause stays in place both method. If the court docket lifts the ACIP pause, HHS may return to utilizing the rebuilt committee to make new suggestions. The ruling doesn’t cease Kennedy from appointing new members, so long as the committee meets these authorized necessities. We’ll cowl the choice when it comes.
Florida drops a proposed vaccine exemption however nonetheless plans to finish 4 college vaccine necessities
On September 30, Florida’s well being division dropped a proposed new vaccine exemption that will have let mother and father decide their youngsters out of college vaccines based mostly on “sincerely held ethical or moral beliefs,” leaving the prevailing medical and spiritual exemptions in place. It nonetheless plans to finish college and childcare necessities for the hepatitis B, chickenpox, Haemophilus influenzae sort b (Hib), and pneumococcal vaccines, which might stay out there however not be required. As a result of these necessities are set by company rule, the division can drop them with out the Legislature’s enter. Docs, mother and father, and a 7-year-old most cancers survivor testified towards the plan at an October 8 listening to. Feedback are open till October 19 at vaccinerule@flhealth.gov.
New York declares a measles emergency
On October 5, New York declared a measles catastrophe emergency, the primary since circumstances started rising in 2025. The state has 108 circumstances to this point this yr, principally in rural communities with low vaccination charges. The order quickly lets extra forms of well being professionals give the measles, mumps, and rubella (MMR) vaccine.
Pennsylvania has reported 1,222 circumstances this yr, and a sixth measles-associated loss of life there was reported October 12. In November, the Pan American Well being Group will determine whether or not the USA retains its measles elimination standing. In the meantime, a brand new Annenberg ballot discovered that solely 31% of adults know Kennedy recommends the MMR vaccine.
The federal vaccine-finder web site isn’t working
Vaccines.gov presently rejects each ZIP code as invalid. Vaccinefinder.org nonetheless works, as do pharmacy web sites and your clinician’s workplace.
What’s in a Title? CDC’s September 2026 COVID-19 Vaccine Steerage
A be aware earlier than we start: CDC stays dwelling to many devoted public well being professionals, and this evaluation isn’t a critique of their work.
A clinician who learn the Could 2025 COVID-19 pointers and the September 2026 steerage could come away with completely different impressions. The current modifications shift the emphasis of the steerage from advantages to dangers. Statements that the advantages of vaccination outweigh the dangers have been faraway from key sections, whereas package-insert language about “unknown” threat and a brand new listing of significant antagonistic occasions have been added. An unbiased overview by CIDRAP’s Vaccine Integrity Challenge (VIP), printed in JAMA on September 2, included 155 new research and located no new security issues.
Why so many updates?
CDC’s COVID-19 steerage has modified a number of instances prior to now two years, tied to the authorized battle over who units the vaccine suggestions we lined within the beforehand talked about transient. The Could 1, 2025, model predates Kennedy’s Could 27 directive, and the September 23, 2026, model got here after the federal court docket stayed lots of the modifications that adopted. The timeline reveals the place every model falls, which helps clarify why they learn so otherwise.
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Key dates in CDC’s COVID-19 vaccine steerage and AAP v. Kennedy, created by Unbiased Science.
ACIP, Advisory Committee on Immunization Practices; CDC, Facilities for Illness Management and Prevention; MMWR, Morbidity and Mortality Weekly Report; VAERS, Vaccine Adversarial Occasion Reporting System.
What stayed the identical?
The grownup advice is the clearest line within the new steerage: “A 2026-2027 COVID-19 vaccine is advisable for all adults ages 18 years and older in the USA for the prevention of COVID-19.” As in Could 2025, all adults are advisable to get vaccinated.
The brand new model provides notes marking some advisable makes use of as “off-label,” as a result of the U.S. Meals and Drug Administration (FDA) authorised the vaccines for fewer individuals and fewer doses than the steerage recommends. FDA authorised this season’s vaccines for adults 65 and older and for adults below 65 with a minimum of one high-risk situation, so vaccinating wholesome adults below 65 is off-label. For adults 65 and older, the steerage recommends two doses six months aside, whereas noting that “giving a couple of dose of COVID-19 vaccine to adults ages 65 years and older is off-label use.” The time period “off-label” can sound alarming, however off-label use is authorized and customary. Right here, it merely means the advice goes additional than the label.
What the proof reveals: Up to date vaccines reduce the danger of COVID-19 hospitalization by about half in adults 65 and older and in adults 18 by means of 64, in line with the
overview. The American Academy of Household Physicians (AAFP) additionally recommends a COVID-19 vaccine for all adults, particularly these 65 and older, these at increased threat, and people by no means vaccinated.
What occurred to the being pregnant part?
The being pregnant part reveals the shift most clearly. Listed below are the 2 variations aspect by aspect:
The part highlighted in purple was eliminated completely. The purple spotlight reads like a brand new instruction, although discussing dangers and advantages has all the time been a part of prenatal care.
FDA, Meals and Drug Administration.
Rather than the Could 2025 language, the steerage quotes the being pregnant and lactation components of the package deal inserts for every of this season’s 4 COVID-19 vaccines. A package deal insert is a regulatory label, and utilizing it as an alternative of an proof abstract places “unknown” and “dangers” entrance and middle.
Instance package deal insert for the Comirnaty COVID-19 vaccine that was added to the CDC’s steerage.
The brand new model not addresses people who find themselves making an attempt to get pregnant. It additionally drops the Could recommendation that acetaminophen (Tylenol) may be provided for fever after vaccination throughout being pregnant, since fever throughout being pregnant has been linked to issues.
Pregnant ladies are nonetheless lined by the advice for all adults. However the steerage not consists of any abstract of the proof.
Till very lately, CDC’s web page for the general public nonetheless mentioned that “the advantages of receiving a COVID-19 vaccine outweigh potential dangers of vaccination throughout being pregnant.” That web page, up to date as lately as October 8, now redirects to the clinician steerage.
Latest research have discovered:
Maternal vaccination was related to about half as many COVID-related hospital visits in infants’ first two months.Maternal vaccination lowered COVID-related emergency and pressing care encounters amongst pregnant ladies by 58%.In about 140,000 pregnancies in Quebec, Canada, vaccination didn’t increase the danger of stillbirth, preterm delivery, or small dimension for gestational age.In 527,564 infants, first-trimester mRNA vaccination was not related to main delivery defects.
The American School of Obstetricians and Gynecologists (ACOG) recommends a COVID-19 vaccine for people who find themselves contemplating being pregnant, pregnant, lately pregnant, or breastfeeding. The AAFP additionally recommends vaccination throughout any trimester and through lactation.
Why does ‘least favorable’ matter for youths?
In Could 2025, the steerage mentioned: “COVID-19 vaccination is advisable for everybody ages 6 months and older in the USA for the prevention of COVID-19.”
The September 2026 steerage modified that for youngsters:
On this steerage, “least favorable” covers kids of all ages, together with infants and toddlers. As with adults, the steerage additionally marks vaccinating wholesome kids as off-label, as a result of FDA authorised the vaccines just for kids with a minimum of one situation that raises their threat of extreme COVID-19.
What the proof reveals:
Many kids hospitalized for COVID-19 are infants and toddlers, and the AAP’s technical report notes that extreme illness occurred “in in any other case wholesome younger kids.” From October 2022 by means of April 2024, kids 6 by means of 23 months accounted for about 45% of COVID-19 hospitalizations amongst vaccine-eligible kids, and greater than half of them had no underlying medical situation.The 2024-25 vaccines reduce COVID-19 emergency and pressing care visits by about three-quarters in younger kids and by greater than half in older kids and youths.
Off-label doesn’t suggest unsafe. VIP’s overview of latest research discovered no new security issues.
The AAP recommends vaccination for all kids 6 by means of 23 months and says any youngster whose mum or dad or guardian desires them protected must be provided the vaccine.
What about myocarditis?
The myocarditis sections within the two variations are fairly related. Each describe myocarditis and pericarditis after vaccination as uncommon. Each additionally say that vaccine recipients, particularly males ages 12 by means of 39, must be instructed about this uncommon threat and about “the advantage of COVID-19 vaccination in lowering the danger of extreme outcomes from COVID-19.”
What’s gone is the conclusion that the advantages of vaccination outweigh this uncommon threat. In Could 2025, the steerage mentioned ACIP and CDC “decided that the advantages of COVID-19 vaccination (eg, prevention of COVID-19 and its extreme outcomes) outweigh the uncommon threat of myocarditis and pericarditis in all populations advisable for vaccination.” That sentence is not within the September 2026 model.
What the proof reveals:
The brand new steerage presents figures exhibiting that myocarditis was 10 instances extra widespread after having COVID-19 than after vaccination (0.05% vs 0.005%) in a research of greater than 4 million individuals ages 16 by means of 25. However these figures seem solely in a desk footnote on one other web page, not within the myocarditis part. The AAP report finds that vaccine-associated myocarditis has been uncommon, concentrated in adolescent males after the second dose of the first sequence, and usually milder and that the majority younger individuals who had it absolutely recovered. Charges have additionally been decrease with newer vaccine formulations. The VIP unbiased overview discovered no research exhibiting elevated myocarditis charges amongst individuals vaccinated after 2022, when CDC started advising an extended interval between the primary and second doses.
What’s new on the CDC’s security listing?
The September 2026 security web page provides an inventory titled, “Severe Adversarial Occasions (Confirmed Causal or Robust Sign).” The Could 2025 model didn’t have this listing.
CDC, Facilities for Illness Management and Prevention; CISA, Scientific Immunization Security Evaluation; VAERS, Vaccine Adversarial Occasion Reporting System; VSD, Vaccine Security Datalink.
Some entries, like anaphylaxis and myocarditis, are established dangers. Febrile seizures are completely different: CDC’s personal paragraph on them modified. In Could 2025, it mentioned, “CDC postmarketing security surveillance for mRNA COVID-19 vaccines has not recognized a security concern for febrile seizure in kids ages 6 months–5 years.” That sentence is now gone.
What the proof reveals: The AAP report reviewed the febrile seizure information, together with an FDA sign in younger kids after the unique vaccines. A follow-up research discovered about three further circumstances per 100,000 Moderna doses and no vital improve after Pfizer’s. AAP concludes that “the out there proof doesn’t assist a constant febrile seizure security sign.” The identical report discovered no security sign for Guillain-Barre syndrome (GBS) or for blood clots after mRNA vaccination in kids and youths. Lastly, febrile seizures can occur with any fever in younger kids and normally trigger no lasting hurt.
Do small phrases actually matter?
Among the modifications are solely a phrase or two, which makes them straightforward to skim previous. Giving COVID-19 vaccine on the identical go to as different vaccines (and alongside the antibodies that shield infants from RSV) went from “advisable” to “acceptable.” “CDC recommends that folks keep updated with COVID-19 vaccination” was eliminated. A brand new line says “COVID-19 vaccination is just not assured to forestall an infection with or unfold of SARS-CoV-2.” That is true for vaccines typically, however the principle good thing about COVID-19 vaccines has all the time been stopping extreme sickness and hospitalization.
What will we do with this?
We won’t say why these edits have been made, and we can’t guess. What we are able to say is that the proof supporting these vaccines has grown, whereas key statements about their advantages have disappeared from the steerage.
The steerage nonetheless recommends vaccination for all adults, and the medical societies that look after these sufferers have expanded their suggestions. ACOG recommends vaccination earlier than, throughout, and after being pregnant, the AAP recommends it for younger kids and older kids at increased threat, and the AAFP recommends it for all adults. Every based mostly its suggestions, a minimum of partly, on the VIP’s 2026-27 overview, which any clinician can use.
Lastly, we wish to take a second to honor the inimitable Helen Branswell, STAT’s infectious illness reporter, who died October 13 at 69. She spent greater than 20 years explaining extreme acute respiratory syndrome (SARS), flu, polio, Ebola, and COVID-19 to the general public, and he or she by no means hyped a menace past what the proof confirmed. The day earlier than she died, she was nonetheless sharing new information on maternal RSV vaccine uptake together with her colleagues from the hospital. It is a monumental loss for the general public well being group. We have been all higher knowledgeable due to her work, and we’ll miss her dearly.
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