By Michael Erman and Mariam Sunny
ATLANTA (Reuters) -A revamped panel of U.S. vaccine advisers appointed by Health Secretary Robert F. Kennedy Jr. on Friday decided not to go ahead with a vote to delay the first hepatitis B vaccine dose for newborns, giving a temporary win to doctors, public health experts and patient advocates who decried the move.
It was not clear how the committee, which advises the Centers for Disease Control and Prevention on U.S. vaccination schedules, would proceed on the issue going forward. It attributed the delay to inconsistencies in the proposed policies.
The CDC has since 1991 recommended that all babies receive the shot at birth, which has led to a dramatic decrease in rates of the disease. The committee late Wednesday disclosed it would vote on the shot to be given at one month instead of at birth, sparking an outcry from medical experts and patient advocates who warned infants would be vulnerable to disease.
The decision followed the panel's Thursday vote recommending against giving the combined measles-mumps-rubella-varicella shot to children under four, citing a small increase in seizure risk that was not seen in children who receive separate doses. On Friday, the panel re-voted to align the U.S. government's childhood vaccine program with their recommendations.
SENATOR CASSIDY HAD WARNED AMERICANS
Republican Senator Bill Cassidy, a medical doctor who specializes in liver disease, had last week warned that if the committee were to change the hepatitis B recommendation, Americans should not follow their advice.
He made the comments after a HELP committee hearing during which ousted CDC Director Susan Monarez discussed her August firing and said that she had been told that she was expected to approve all committee recommendations. Kennedy had told her that the schedule for children's vaccines would change, she said.
Fiona Havers, a former CDC official who stepped down earlier this year, said she thought the committee would try to revisit the issue.
"I think that this was a temporary setback for Kennedy’s agenda. It was clear that there was no scientific basis to move forward with a vote to change the long-standing recommendations," Havers said.
Kennedy has been moving at breakneck speed to rewrite U.S. vaccination policy, including dropping recommendations for COVID for pregnant women and children, directing states on limits to their vaccine mandates and cutting funding for mRNA-based research.
COMMITTEE MEMBERS DEBATE TWO OR THREE MONTHS
While many committee members appeared to support making a change to the hepatitis B recommendation during the Thursday discussion, early Friday some raised new concerns about data CDC presented. Some suggested changing the vote to recommend the first vaccine at 2 to 3 months. During Thursday's discussion, it was not clear how the one month criterion had been chosen.
Dr. Catherine Troisi, infectious disease epidemiologist at UTHealth Houston, said the U.S. birth-dose policy drove a 97% decline in acute hepatitis B among Americans under 19.
The panel voted to recommend universal hepatitis B testing for all pregnant women, a move they said they hoped would increase rates. Testing is already recommended by medical groups and covered by insurance.
PANEL CONSIDERS CHANGES TO COVID VACCINE RECOMMENDATIONS
The votes came as the Advisory Committee on Immunization Practices (ACIP) reconvened for a second day of meetings that have highlighted deep divisions over the future of the U.S. immunization schedules under Kennedy, who has long promoted claims about vaccine harms that run contrary to scientific evidence.
The panel is also considering updates to COVID-19 vaccine guidance. The panel, reconstituted this year by Kennedy, includes several members who have previously raised concerns about routine vaccines or advocated against COVID shots. Five of the members began their terms on Monday.
Members of the working group for COVID, Dr. Wafik El-Deiry and Charlotte Kuperwasser, raised several potential safety issues in mRNA vaccines that they believe need more study.
These include impurities in the vaccines, immune changes spurred by the vaccines, and the persistence of the spike protein in tissue after the vaccines have been given. Much of the evidence presented was from small lab studies and published in little-known journals.
Pfizer, which partners with Germany's BioNTech; Moderna and Sanofi, which partners with Novavax, all defended the safety and effectiveness of their vaccines.
Moderna scientist Bishoy Ruscala argued that "well controlled" studies shared with the FDA have refuted concerns raised by the work group that vaccine-derived spike protein or mRNA remains in the body long term.
Pfizer's head of vaccines medical affairs Dr. Paul Barmer, said global regulatory assessments since 2020 consistently showed its benefits outweigh risks.
The CDC presented data suggesting COVID-19 vaccination provided additional protection against emergency department visits in children and adults, and hospitalizations and critical illness in adults 65 and older. It said U.S. hospitalization rates from COVID have been highest for adults 65 and older and infants under 6 months.
(Reporting by Mrinalika Roy in Bengaluru, Mariam Sunny and Michael Erman; Editing by Sriraj Kalluvila, Caroline Humer and Nick Zieminski)