| |  | The Lead Brief | A federal panel of vaccine advisers will meet on Dec. 4 to talk about issues related to vaccine safety, updates to the childhood and adolescent immunization schedule, and potential new recommendations on hepatitis B vaccines, according to a new regulatory filing. The Advisory Committee on Immunization Practices, or ACIP, makes recommendations to the Centers for Disease Control and Prevention about standards for vaccine use and inclusion in federal programs — which can ultimately impact insurance coverage and reimbursement. → It’s been a flash point in public health policy during the Trump administration. Health Secretary Robert F. Kennedy Jr. fired the previous members of the panel and replaced them with his own hand-selected picks, including some who have expressed vaccine-skeptical views. The panel last met in September and made its first recommendations to change to the childhood vaccination schedule. Why it matters: Even incremental recommendations from ACIP can have big implications for the health system — including providers, insurance companies, government programs and vaccine makers — and public health overall. What to watch: Although the announcement doesn’t get into specifics about how the ACIP plans to tackle vaccine safety, the childhood vaccination schedule or hepatitis B shots, there have been signals from the administration and the panel’s previous two-day meeting in September that provide guidance on what to watch out for. Here are the top three items: HEPATITIS B The panel will likely return to a discussion on whether to recommend a delay in hepatitis B vaccines for newborns, and could vote on new recommendations. During the ACIP’s last set of meetings in September, the panel appeared poised to eliminate a 34-year-old recommendation to provide hepatitis B vaccination to babies upon birth — but tabled the vote in order to take more time. Delaying the shot has drawn widespread condemnation from medical associations and some doctors on the panel. The virus is a leading risk factor for liver disease and cancer later in life. Sen. Bill Cassidy (R-Louisiana), a physician who leads the Senate’s health panel, has emphasized the safety of hepatitis B vaccines for newborns and said an ACIP recommendation to delay the shot for a month — unless mothers test positive for the disease — could “put access at risk.” ALUMINUM Both Trump and Kennedy have criticized the use of aluminum in vaccines, questioning the safety of the ingredient. “We want no aluminum in the vaccine,” Trump said during a White House briefing in October, despite no evidence showing the ingredient leads to developmental disorders or other illnesses. Several vaccines — including the shots meant to protect against hepatitis B and diphtheria, tetanus and pertussis that are given to children — include aluminum salts as an ingredient used to jump-start the body’s immune response. Last month, the CDC formed a working group to study the childhood vaccine schedule, including investigating the safety of certain vaccine ingredients such as aluminum. The ingredient has been used in vaccines for several decades and has been repeatedly evaluated as a part of vaccines in clinical trials. A large-scale study of more than 1 million Danish children found no links between the ingredient and autism or other chronic illnesses. Removing aluminum from vaccines would essentially require vaccine manufacturers to completely remake their products, including finding a new adjuvant that’s just as effective and putting them through new testing — an effort that would likely take years and hundreds of millions of dollars. SEPARATING MMR The Trump administration has also been advocating to break up the combined measles-mumps-rubella shot given to children into three shots — arguing, without evidence, that it’s safer to space them out. “It seems to be that when you mix them, there could be a problem,” Trump said in September. Acting CDC Director Jim O’Neill posted on social media last month calling for vaccine manufacturers to develop the three separate shots. The combination measles, mumps and rubella vaccine has been around since 1971, and serves to reduce the number of shots children receive. Separating them out — in addition to being untested — would also likely decrease adherence to the entire schedule, scientists say, and therefore increase disease. Many large-scale studies have shown there is no connection between the combination vaccines and autism. There are no individual shots for measles, mumps and rubella on the market in the U.S. A directive to separate them would also require pharmaceutical companies to develop entirely new vaccines, prompting years of research, development and testing, according to Jesse Goodman, a physician and former head of the federal office that oversees vaccine approvals. → In September, the ACIP voted to stop recommending a dose of a combined measles, mumps, rubella and varicella (better known as chicken pox) vaccine before a child turns four. Instead, the panel recommended that kids get a combination measles, mumps and rubella vaccine and a separate chicken pox shot. | 
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