The Childhood Vaccine Schedule May Soon Change. Here’s What to Know

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Robert F. Kennedy Jr.’s vaccine advisory committee voted to stop recommending the combination vaccine protecting against measles, mumps, rubella, and chickenpox for children under the age of 4, indefinitely postponed a vote on the hepatitis B vaccine schedule, and moved away from a broad recommendation for the COVID-19 vaccine during a chaotic two-day meeting.[time-brightcove not-tgx=”true”]On Thursday, in a vote of 8 to 3 with one abstention, the Advisory Committee on Immunization Practices (ACIP) recommended that children under the age of 4 no longer receive the MMRV shot, but get the MMR and varicella (chickenpox) vaccines separately. The committee was meant to vote on whether it would continue to recommend that all newborns should receive the hepatitis B vaccine, but decided on Friday to postpone that vote to a later date. On Friday afternoon, the committee rejected a proposal that would have recommended that state and local jurisdictions require a prescription for the COVID-19 vaccine, but diverged from previous guidance on who should get the shot.ACIP is a panel of experts that provides vaccine recommendations to the Centers for Disease Control and Prevention (CDC). The committee members were recently appointed by the health secretary, after he removed all the previous members of the committee this summer. Many of the new panelists have expressed skepticism of vaccines or lack experience in the subject, sparking backlash from the medical and science communities, which have released their own immunization recommendations that conflict in important ways with the ACIP advice.Public health experts have widely credited the shots protecting against MMRV, hepatitis B, and COVID-19 for lowering the prevalence of diseases, but several ACIP members cast doubt over the safety and efficacy of the vaccines this week. At multiple points during the meetings, external experts, including those from well-established medical organizations such as the American Medical Association and the American Academy of Pediatrics, criticized the recent changes to the ACIP meeting processes. These experts, who historically served as liaison members to ACIP, were removed from ACIP’s working groups, where they provided their expertise in analyzing and vetting data on vaccines and presenting summaries of that research to the larger ACIP committee.Here’s what to know about the new recommendations.What is the new recommendation for the MMRV vaccine?Until now, the CDC has recommended the combination measles, mumps, and rubella (MMR) vaccine or MMRV, which includes the varicella vaccine against chickenpox, and leaves the choice up to families and their physicians. Either vaccine can be given in two doses: first, to children aged 12-15 months, and second to children aged 4 through 6 years. On Thursday, ACIP recommended against the combined MMRV vaccine for children under the age of 4; guidelines for the separate MMR vaccine and varicella vaccine, though, remain the same.In a move that appeared at odds with that decision, ACIP also decided on Thursday to have the Vaccines for Children (VFC) program continue to cover the cost of the MMRV vaccine for children under the age of 4, in a vote of 8 to 1. The VFC program provides vaccines to about half of all children in the U.S. for free or at a lower cost. The vote sparked confusion among the committee members, and three ACIP members abstained—one of whom stated that he was doing so because he didn’t understand what he was voting for.“I’m going to abstain because I’m not quite sure what I’m voting for here,” Dr. Cody Meissner, a pediatrician at Dartmouth Geisel School of Medicine who is among the more experienced vaccine experts, having served on the Food and Drug Administration’s vaccine expert committee during the approval of the COVID-19 vaccines, said during the meeting. “I don’t want discrepancy between the children who get their vaccine from VFC and the children who don’t get their vaccine through VFC. That’s not right.”When the committee reconvened on Friday, the members took up the VFC vote again, and this time, the panel reversed their decision, with 9 voting yes and 3 abstaining, bringing the coverage in line with the ACIP’s new recommendation so the VFC program would not cover the MMRV shot for children under the age of 4. The separate MMR and varicella shots, though, will continue to be covered under the program.CDC officials presented data at Thursday’s meeting indicating that the MMRV vaccine carries a slightly increased risk of fever-related seizures in children aged 12-23 months, compared to the MMR vaccine. While some ACIP members expressed concerns over this potential side effect, other experts emphasized that these types of seizures can happen with many childhood illnesses, not just the MMRV vaccine, and frequently resolve on their own without long-term consequences.The majority of children—roughly 85%—get separate MMR and chickenpox shots; only about 15% get the combination MMRV vaccine, according to CDC data presented at the meeting. Still, many external experts in attendance at Thursday’s meeting criticized the proposed change in ACIP’s recommendation, saying that it would limit parents’ options and sow confusion among the public.“What we’re saying is we don’t trust parents to make a decision,” Meissner said. “If a parent wants to get a single dose, why are we taking away that option?”Dr. Jason Goldman, an internal medicine physician and president of the American College of Physicians who is a liaison to ACIP, voiced his objection to the change during Thursday’s meeting, saying that it doesn’t take into account the perspective of “actual practicing clinicians and how we deal with vaccine hesitancy and how we talk to our patients.” He expressed concern that changing the recommendation would “give license” to insurance companies to stop covering the cost of the MMRV vaccine in children under the age of 4.“I would argue that this recommendation is going to create more confusion among the public,” Goldman said. “You are taking away the choice of parents to have informed consent and discussion with their physician on what they want to do for the health and benefit of their children.” “I urge this committee not to change the recommendations if they truly want to give the power to the parents to decide what is best for their child and allow them to make the choice in consultation with their physician,” he continued.What did ACIP vote on for the hepatitis B vaccine?After a heated debate between ACIP members and other experts, the committee decided to table a vote on possible changes to the hepatitis B vaccine schedule.The controversy centered around when the first dose of the hepatitis B vaccine, which protects against a highly infectious disease that can cause damage to the liver, is given. Currently, the CDC recommends that the vaccine is provided in three doses: the first, at birth; the second, between 1-2 months of age; and the third, between 6-18 months of age. ACIP discussed changing the recommendation so that the first dose of the vaccine would not be given until a child is at least one month old, unless the newborn’s mother is known to be infected with hepatitis B.CDC scientists presented data at Thursday’s meeting that demonstrated the safety and efficacy of the hepatitis B vaccine beginning with the first dose, emphasizing that the sooner the vaccine is administered after birth, the greater its effectiveness in preventing mother-to-child transmission of the disease. Scientists also pointed out that infants can be at risk of exposure to hepatitis B even if their mother tests negative for the disease—for instance, if the infant lives with someone who has chronic hepatitis B.“A universal birth dose provides a critical safety net for infants who may have unrecognized exposure to [hepatitis B] infection during pregnancy or early childhood, which can result in catastrophic outcomes,” Adam Langer, a CDC official, said during the meeting. “The sooner that an infant starts the hepatitis B vaccine series, the sooner that the baby will be protected against these early childhood exposures.”Public health experts have called the hepatitis B vaccine a significant public health intervention, crediting it for drastically reducing the number of cases of mother-to-child transmission in the country.Some external experts questioned why the timing of the doses was being discussed again, after it has been part of the routine childhood immunization schedule, if no strong data indicates that the birth dose is linked to safety concerns. Still, some ACIP members cast doubt on the safety of the vaccine, suggesting that only babies whose mothers have tested positive for hepatitis B should be vaccinated at birth.But Meissner said it’s “very hard” to identify people who are at a higher risk of exposure and infection to the disease; for instance, people who are homeless or participate in sex work may have inconsistent access to health care. Other experts also pointed out that many people aren’t aware that they have hepatitis B.“I think we’ve learned with many vaccines that the more we try and define a target group to vaccinate, the less successful we are,” Meissner said. “The optimal approach seems to be to have a standard recommendation.”Dr. Evelyn Griffin, an ACIP member and ob-gyn who has previously questioned the safety and effectiveness of COVID-19 shots, said that pregnant people can be tested for hepatitis B in the facility where they give birth, and that those results can be received very quickly, within a matter of hours. But several experts argued that may not always be possible—for instance, not all pregnant people give birth in a hospital, or labs may be backed up and so test results may not be received quickly.“In a perfect world, we would know everybody that has hep B; they would all be under care, labs at a birthing hospital would all be done quickly, easily, and transparently,” Dr. Grant Paulsen, who is a liaison to ACIP from the Pediatric Infectious Diseases Society, said during the meeting. “Unfortunately, we live in an imperfect world and have to decide public policy based on what’s best for everyone, not just the anecdotes of my hospital or yours.”What did ACIP vote on for the COVID-19 vaccine?After a lengthy and heated discussion over the COVID-19 vaccine, ACIP decided on Friday not to recommend that state and local jurisdictions require a prescription to get the COVID-19 vaccine. The committee was divided, with 6 members voting yes and 6 voting no, and the decision ultimately went to the committee chair, Martin Kulldorff, who voted no.Both external experts and ACIP members expressed concerns that requiring a prescription would create additional barriers for people seeking the COVID-19 shot, particularly for people who live in rural areas, are uninsured or underinsured, or may not otherwise have consistent access to a health care provider.“It has always been clear that vaccines are a primary prevention public health strategy,” Dr. Amy Middleman, a liaison to ACIP from the Society for Adolescent Health and Medicine, said during the meeting. She argued that requiring a prescription for the shots would “overwhelm” doctors’ offices. “It’s alarming to me that for a primary prevention strategy, we [would] actually [be] adding access concerns and barriers, rather than diminishing them.”The committee voted unanimously to update the current immunization schedules for COVID-19 shots: for adults 65 and older, ACIP recommends that vaccination should be based on individual-based decision making; and for people between the ages of 6 months and 64 years, ACIP recommends that vaccination be based on individual-based decision-making, but “with an emphasis that the risk-benefit of the vaccination is most favorable for individuals who are at an increased risk for severe COVID-19 disease and lowest for individuals who are not at an increased risk.”This change is at odds with most professional medical organizations, which continue to recommend yearly COVID-19 shots for people aged 6 months and older.Currently, the CDC recommends the vaccine for most adults ages 18 and older, and that parents of children between the ages of 6 months and 17 years make the decision in consultation with their doctors. At the moment, it is unclear how ACIP’s new recommendation would affect people’s access to the shots, but it could complicate access depending on individual state policies.Kennedy’s vaccine policy changesThe CDC director can either accept or reject ACIP’s recommendations. The acting director of the agency, Jim O’Neill, was recently tapped to replace Susan Monarez, who was the CDC director for less than a month before she was fired. She testified before a Senate committee on Wednesday that Kennedy pressured her to pre-approve every ACIP recommendation—orders that she said were “inconsistent with my oath of office.” She said that she refused to comply, which led to her firing.ACIP’s new recommendations are the latest in a series of changes to the country’s immunization policy, led by Kennedy.Kennedy, a prominent vaccine skeptic, said in May that the CDC would no longer recommend COVID-19 shots for pregnant women and healthy children. Multiple respected medical associations, including the American Academy of Pediatrics and the American College of Obstetricians and Gynecologists, released their own guidance that diverged from federal recommendations. Last month, the Food and Drug Administration (FDA) said that this year’s COVID-19 vaccines would only be approved for people ages 65 and older, or people who are at an increased risk of developing severe cases of the virus. Previously, the shots were recommended for everyone older than 6 months.