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Unclear when committee will reconvene on hepatitis B

change

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Panel will later vote on COVID-19 vaccine update

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Drugmakers defend safety, efficacy of their vaccines

(Adds outside comment in paragraphs 6-10; Covid presentations

in 16-21)

By Michael Erman and Mariam Sunny

ATLANTA, Sept 19 (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 ( PFE ), which partners with Germany's BioNTech

; Moderna ( MRNA ) and Sanofi, which

partners with Novavax ( NVAX ), all

defended the safety

and effectiveness of their vaccines.

Moderna ( MRNA ) 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 ( PFE ) 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.