Two votes focused on new recommendations for communicating potential risks or uncertainties about COVID-19 vaccines to patients.

First, members voted 11-1 to recommend that the CDC update their language regarding potential risks.

Second, members voted unanimously to recommend that health care providers communicate risks with their patients on an individual level.

ACIP's recommendations must be reviewed and approved by the CDC director to become official guidance, but CDC directors have almost always accepted the recommendations.

Shortly after the final vote, the meeting was adjourned.

The committee voted against requiring a prescription for COVID-19 vaccination. With a vote of 6 yes and 6 no, the decision went to the ACIP chair, who voted no.

COVID workgroup member Henry Bernstein previously shared an opposing view on requiring a prescription, saying the need would "create unnecessary steps to receiving a vaccine, and do not effectively target" high-risk groups.

Ahead of the vote, Dr. Cody Meissner said he was "strongly opposed" to a prescription requirement. 

ACIP member and epidemiologist Catherine M. Stein, who has previously been openly critical of the U.S. response to COVID-19, also raised concerns. 

"I believe the segment of the population that is underinsured has lack of access to health care, they're going to be unable to get a prescription, and those are the people that are at highest risk for a lot of these comorbid conditions," she said.

In a unanimous vote, ACIP members voted that the CDC drop its recommendation that most adults ages 18 and older get a COVID-19 vaccine.

The panel instead recommended that individuals decide for themselves whether to get the vaccine.

The updated recommendations would include the following:

• Adults 65 and older: Vaccination based on individual-based decision-making, also known as shared clinical decision making
• Individuals 6 months to 64 years: Vaccination based on individual-based decision-making — with an emphasis that the risk-benefit of 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, according to the CDC list of COVID-19 risk factors.

Currently, the CDC recommends a 2024-2025 COVID-19 vaccine for most adults ages 18 and older.

For children ages 6 months to 17 years, the CDC says parents should discuss the benefits of vaccination with a health care provider.

Last month, the American Academy of Pediatrics recommended that all infants and toddlers aged 6 to 23 months receive the COVID vaccine. The group cited data showing that children under 2 have the highest COVID hospitalization rates among pediatric age groups, and that more than half of those hospitalized had no underlying conditions.

ACIP member and COVID workgroup chair Retsef Levi shared the four recommendations the committee will vote on about the COVID-19 vaccine.

First, the workgroup recommends the CDC "engages in an effort to promote more consistent and comprehensive informed consent processes, and as part of that considers adding language accessible to patients and medical providers to describe at least the six risks and uncertainties included in the WG (workgroup) chair presentation."

The second vote will focus on the recommendation that state and local jurisdictions should "require a prescription for the administration of a COVID-19 vaccination."

In a presentation that countered the majority views of the workgroup, workgroup member Henry Bernstein said the need of a prescription will "create unnecessary steps to receiving a vaccine, and do not effectively target" high-risk groups. 

The third vote will focus on health care providers discussing the risks and benefits of the vaccination for the individual patient. 

And the fourth vote will focus on updates to the pediatric and adult immunization schedules for FDA-approved COVID-19 vaccines. The workgroup suggests the following:

• Adults 65 and older: Vaccination based on individual-based decision making, also known as shared clinical decision making
• Individuals 6 months to 64 years: Vaccination based on individual-based decision-making — with an emphasis that risk-benefit of 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, according to the CDC list of COVID-19 risk factors.

The COVID workgroup's recommended actions, presented by ACIP member Retsef Levi, include more communication to patients of the risks and uncertainties related to COVID vaccines as well as the development and enhancement of national efforts to diagnose and care for those injured by vaccines.

Vaccine injury was a topic discussed earlier this month at the presentation of Health and Human Services Secretary Robert F. Kennedy Jr.'s "Make Our Children Healthy Again Strategy" report. In response to a question on vaccine injury reporting, Kennedy didn't specify exactly how he plans to change how they're currently investigated, but said "we're changing the system."

While he called injuries caused by medications "rare," he said those who suffer deserve better care and consideration.

Levi said they are not planning on a vote on vaccines taken during pregnancy Friday, and called for more data in this area for future discussion.

Dr. Sandra Fryhofer, an internal medicine doctor and ACIP liaison for nearly 20 years, said the topic of COVID vaccines among babies was personal, with two grandchildren on the way.

"Babies 6 months old or too young to be vaccinated, they're at highest risk, and maternal vaccination can lower that risk. So please make these vaccines available to protect these little babies," she said.

Fryhofer also said she was surprised the workgroups — who she said she was previously part of until medical organizations were recently cut from the process — presented such preliminary research at this level. She pointed out they supported more research into mRNA vaccines despite the administration cutting such research. 

"As we all know, on August 5, HHS delivered a death blow to mRNA vaccine development by canceling $500 million in contracts for mRNA vaccines. HHS terminated 22 grants supporting refinement and development of mRNA vaccines, and canceling these research grants leaves us highly vulnerable to the next pandemic. It also puts development of mRNA-based cancer treatments at risk," she said.

ACIP member and RFK Jr. ally Dr. Robert W. Malone and Dr. Cody Meissner, a pediatrics professor who previously served as a member of the Food and Drug Administration's vaccines panel, got into a small debate over whether there's evidence of COVID protection from vaccines.

"Are there any well-defined, characterized correlates of protection for COVID, yes or no?" Malone asked. "The answer is no. … You really have no right to assert what your feelings or opinions are about whether or not there's a correlation between any of these outcomes, these adaptive immune responses and protection."

Meissner argued against that, saying there is "pretty well-defined" data.

"I will send you a paper that was in the New England Journal of Medicine a couple years ago that derived a result based on all of the vaccine trials," he told Malone.

Prior research has shown COVID vaccinations are highly effective at preventing severe illness, hospitalizations and deaths from the virus.

During the discussion section of the meeting, Dr. Kirk Milhoan, an ACIP member and a pediatric cardiologist based in Hawaii, noted his prior career in medicine with a doctorate in pharmacology as he brought up his issues with vaccine manufacturers. 

"I'm shocked at the lack of pharmacological rigor in dosing — dose timing, dose accumulation, how long that dose lasts," he said. 

In response, Dr. Tracy Beth Høeg, senior adviser for clinical sciences at the FDA, said the data provided by the manufacturers to the agency was "within the regulatory limits."

In addition to presentations from CDC officials, COVID-19 workgroup members also shared presentations about potential safety concerns of the COVID-19 vaccine.

Dr. Wafik El-Deiry, the associate dean for oncologic sciences at Brown University's Warren Alpert Medical School, and Dr. Charlotte Kuperwasser, professor in the Department of Developmental, Molecular and Chemical Biology at Tufts University's School of Medicine, presented on safety uncertainties on mRNA COVID vaccines, the type used by Moderna and Pfizer.

Their presentation argued more research and safety monitoring is needed on the longer-term effects of mRNA vaccines.

"There are COVID vaccine safety concerns that stem from unexpected biological activities of mRNA gene therapy platforms, raising questions about potential pathogenic mechanisms and human subjects research protections," El-Deiry said. He shared a list of recommendations to continue research in the areas presented.

Public health officials have credited mRNA technology with creating COVID vaccines quickly and saving millions of lives.

Bruce Carlton, a professor of pediatrics in the Faculty of Medicine at the University of British Columbia, presented on research he began on COVID-19 vaccine-induced myocarditis, which is an inflammation of the heart muscle.

"This grant was canceled with 48 hours notice in March, but I had a chance to do some initial work," he said. He added, "This is all very preliminary."

After the tabled hep B vote, some liaison members from top medical organizations shared their agreement for holding off on making changes to the current recommendations. Some also urged more transparency in how decisions will be made on future potential recommendation changes.

"I would urge the committee to use the methodical scientific method to weigh the risks and benefits appropriately," said Dr. Amy Middleman, a liaison for the Society for Adolescent Health and Medicine. She added, "This is important for all vaccine decisions, and this is what I think some of us are really concerned about in terms of the absence of it."

ACIP member Retsef Levi said he appreciated the desire to keep scientific methods but took issue with the liaison member's comments.

"I have to say that one thing that puzzles me is that many of the speakers that push for the scientific approach are speaking very confidently in the absence of the gold standard evidence of robust long-term clinical trials against placebo," Levi added, who has been pushing for more research beyond what the CDC has presented during the meetings. 

When ACIP chair Kulldorff began to move on from the hep B discussion, Dr. Jason Goldman, president of the American College of Physicians, chimed in asking for more explanation and to call out the committee for muting him.

"That is disrespectful. You want debate and discussion, but you're muting people and silencing them," Goldman said. "Please provide to the public so they can have trust, faith and confidence in vaccination as to what process we are going to be using to properly vet and discuss all future vaccines. … Tell the public how you are going to be analyzing all of these vaccine decisions so we can have confidence in this committee."

Kulldorff responded that he previously responded to that comment already before moving on to the next agenda matter.

Members voted unanimously in favor of having all pregnant women tested for hepatitis B infection.

The test is covered by all insurance plans, an HHS spokesperson noted in a statement to CBS News. They said the goal is to encourage testing in pregnancy to assure that women with hepatitis B and their newborns can be properly cared for to reduce transmission of the virus from mother to child.  

But after much discussion, the ACIP members voted to table the second vote — with 11 yes and 1 no — to a later time. The vote was meant to focus on whether to change the pediatric vaccine schedule of the universal birth dose for children of mothers who test negative for hepatitis B.

"I think there is going to be some debate as to whether any evidence at all was presented for what's being recommended," ACIP member and RFK Jr. ally Dr. Robert W. Malone said. "I believe that there's enough ambiguity here and enough remaining discussion about safety, effectiveness and timing that I believe that a vote today is premature."

It is unclear when the tabled vote will take place.

After kicking off Friday's meeting with a roll call of members and liaisons, ACIP chair Martin Kulldorff said there was discussion on "what to do" about two conflicting votes that took place the day prior.

During Thursday's meeting, after much confusion among the members over the vote on vaccine coverage under the Vaccines for Children program, which helps certain groups pay for immunizations, the majority voted no. This meant coverage would stay as is for covering both the combined MMRV and two separate MMR+V vaccines for those under age 4 — even though the committee had previously voted against recommending the combined MMRV shot for this age group.

In Friday's meeting, the vote changed to 9 yes and 3 abstentions.

"I just want to stress that what all this means is that every child, including every child in the vaccine program — the Vaccines for Children program — will have access to be vaccinated against measles" mumps, rubella and chickenpox, Kulldorff said.

On the topic of hepatitis B, the panel is reviewing two different potential recommendation changes. 

The language for the first proposed change was presented as: "All pregnant women should be tested for hepatitis B infection."

The second proposed change would say that if the mother tests negative for hepatitis B:

• The first dose of the hepatitis B vaccine is not given until the child is at least one month old.
• Infants may receive a dose of hepatitis B vaccine before one month according to individual based decision-making. (Also referred to as shared clinical decision-making.)

Ahead of the meetings this week, CDC insiders said they expected the panel to consider potentially narrowing of the list of conditions that would classify someone as being at high risk for severe COVID. That shift could mean fewer people would be recommended for vaccination, even if they might still benefit.

Dr. Lakshmi Panagiotakopoulos, a prior ACIP working group lead who resigned from the CDC earlier this year, warned that limiting recommendations could send the wrong signal, saying, "People may interpret a narrower recommendation as meaning the vaccine doesn't work, when in fact it's still highly protective against severe disease."

The possible exclusion of healthy pregnant women and healthy infants from the high-risk category is also drawing attention. Pregnancy and early infancy have long been recognized as periods of elevated vulnerability, and experts worry that dropping these groups from the recommendation would not only reduce their protection but would erode public confidence in maternal and pediatric vaccination.

Last month, the American Academy of Pediatrics (AAP) recommended that all infants and toddlers aged 6 to 23 months receive the COVID vaccine. The group cited data showing that children under 2 have the highest COVID hospitalization rates among pediatric age groups, and that more than half of those hospitalized had no underlying conditions.

The Society for Maternal-Fetal Medicine, the national organization representing high-risk pregnancy experts, has reaffirmed its recommendation that all pregnant and breastfeeding women receive the COVID vaccine.

Read more here.

The Advisory Committee on Immunization Practices' Thursday session focused on hepatitis B and the combined measles, mumps, rubella and varicella (MMRV) vaccines. 

The committee voted to change its recommendation on the MMRV vaccine, saying "the combined MMRV vaccine is not recommended" before age 4. Instead, the group recommends children in this age group receive a separate measles-mumps-rubella vaccine and varicella vaccine, or MMR+V.

After completing presentations and discussions on the hepatitis B topics, the vote on that was pushed to Friday.

Read more here.

After presentations Thursday on the potential risks and benefits of hepatitis B vaccination at birth, some members of the advisory committee clashed on what the data meant for the vote they will be taking. 

Dr. Cody Meissner, a pediatrics professor who previously served as a member of the Food and Drug Administration's vaccines panel, called the vaccine "safe" with "no evidence of harm."

If the recommendation changes, he said, it would "increase the risk of harm based on no evidence of benefit, because there will be fewer children who will get the full hepatitis B vaccine series."

"This an absolutely safe vaccine," he said. "I'm not sure what we're gaining by avoiding that first dose within 12 to 24 hours after birth."

Member Vicky Pebsworth, a regional director of the National Association of Catholic Nurses, disagreed, saying "there are gaps in what we know and understand about the effects of hepatitis B, particularly on very young infants, and I think that the conclusion that it is safe is perhaps premature."

In a presentation Thursday on the hepatitis B vaccine, Dr. Adam Langer with the CDC outlined how changing the current recommendation could put more children at risk. The vaccine is currently recommended for newborns at birth.

Some argue the vaccine isn't needed if a baby's mother isn't infected. But Langer listed a number of situations where unvaccinated infants could be at risk even if their mother tested negative for the disease when they were born:

• They live with a person who has chronic hepatitis B, not necessarily their mother.
• Someone who has an infection comes to visit their home.
• They go to daycare or other places where even "minuscule amounts of infectious blood or fluids might be present."

"About half of people with HBV infection are unaware of their infection so they could unknowingly expose infants that are in their care," he said.

The only potential benefit to rescinding the current recommendation is a potential reduction in rare cases of adverse effects from the birth dose vaccine, according to the presentation.

"When they do occur, these adverse events tend to be mild. The worst adverse event you could imagine, anaphylaxis, has been very rarely reported at only 1.1 cases per 1 million vaccine doses administered," Langer said. 

The panel is considering whether to support changes to the CDC's recommendations for hepatitis B vaccination.

The CDC currently recommends the first dose of hep B vaccine for newborns within 24 hours after birth. Universal infant vaccination became the norm in 1991 after data showed too many cases of hepatitis B among pregnant women were missed during prenatal care.

Medical experts say a universal birth dose acts as a safety net, protecting infants whose parent's infection might have been missed. Before birth-dose policies, the U.S. saw an estimated 1,000 preventable infections in newborns each year. 

Proposed changes to the timeline would suggest delaying the first shot for one month if the mother tests negative, though families could choose to get it sooner.

Infection with hepatitis B can lead to serious health problems later in life, including liver damage, cirrhosis and liver cancer.

After firing all 17 of the committee's previous members in June, HHS Secretary Robert F. Kennedy Jr. named eight new advisers to the ACIP, one of whom later withdrew. They include several allies he has worked with closely over the years and some who have a history as vaccine critics. 

Kennedy appointed the new members directly, breaking with the past practice of agency officials vetting potential experts before sending them to the secretary for approval.

Then earlier this week, five more members were announced. The latest additions include some who have questioned established medical research on immunizations and the COVID-19 pandemic.