A federal court has put a temporary hold on the government's order for Juul to stop selling its electronic cigarettes.

Juul filed the emergency motion so it can appeal the sales ban from the Food and Drug Administration. The U.S. Court of Appeals in Washington granted the request later Friday. A day earlier, the FDA said Juul must stop selling its vaping device and its cartridges. The agency said Juul didn't give it enough information to evaluate the potential health risks of its e-cigarettes.

In its court filing, the company disagreed, saying it provided enough.

To stay on the market, companies must show that their e-cigarettes benefit public health. In practice, that means proving that adult smokers who use them are likely to quit or reduce their smoking, while teens are unlikely to get hooked on them.

July 13 is the deadline for the Food and Drug Administration’s approval process on synthetic nicotine products.

Any marketed product sold in U.S. stores, such as Puff Bars or other vaping products, will become illegal if they do not meet the requirements of the FDA’s health and safety standards.

“Today, young people see vaping as cool. It was the kids who never would have smoked, and if you don’t get your arms around that fast, you’ll have another 30-year problem,” said Matt Myers, president of the Campaign for Tobacco-Free Kids.

In 2020, the FDA outlawed the sale of flavored tobacco products due to the number of kids it was enticing. According to a 2020 study from the Centers for Disease Control and Prevention, as many as 3 million high school students, or 19.6%, vape regularly, and 550,000 or 4.7% of middle schoolers do as well.

The law meant companies such as Juul, which controlled as much as 70% of the U.S. vaping market at the time, could only sell tobacco-flavored and mentholated tobacco products. Myers says the law was written in such a way that it allowed for loopholes. However, as other companies began creating synthetic nicotine that used no tobacco, which is why to this day, dozens of flavored vaping products are sold in convenience stores and gas stations nationwide.

“We’re really at a critical juncture both for e-cigarettes and in regard to youth cigarette use,” said Myers. “If the FDA follows through and removes from the market all of the flavored products that appeal to kids, we can reverse the youth e-cigarette epidemic in a relatively short period of time.”

The FDA does not have a clear list of vaping companies that have applied for approval and has not revealed if any have received it.

Advocates say what happens next weighs on if and how the FDA enforces its policy after July 13.

U.S. officials granted full approval to a closely watched Alzheimer’s drug on Thursday, clearing the way for Medicare and other insurance plans to begin covering the treatment for people with the brain-robbing disease.

The Food and Drug Administration endorsed the IV drug, Leqembi, for patients with mild dementia and other symptoms caused by early Alzheimer's disease. It’s the first medicine that’s been convincingly shown to modestly slow the cognitive decline caused by Alzheimer's.

Japanese drugmaker Eisai received conditional approval from the FDA in January based on early results suggesting Leqembi worked by clearing a sticky brain plaque linked to the disease.

The FDA confirmed those results by reviewing data from a larger, 1,800-patient study in which the drug slowed memory and thinking decline by about five months in those who got the treatment, compared to those who got a dummy drug.

“This confirmatory study verified that it is a safe and effective treatment for patients with Alzheimer’s disease," said FDA's neurology drug director, Teresa Buracchio, in a statement.

The drug's prescribing information will carry the most serious type of warning, indicating that Leqembi can cause brain swelling and bleeding, side effects that can be dangerous in rare cases. The label notes that those problems are seen with other plaque-targeting Alzheimer's drugs.

The process of converting a drug to full FDA approval usually attracts little attention. But Alzheimer’s patients and advocates have been lobbying the federal government for months after Medicare officials announced last year they wouldn’t pay for routine use of drugs like Leqembi until they receive FDA’s full approval.

There were concerns that the cost of new plaque-targeting Alzheimer's drugs like Leqembi could overwhelm the program's finances, which provide care for 60 million seniors. Leqembi is priced at about $26,500 for a year’s supply of IVs every two weeks.

The vast majority of Americans with Alzheimer’s get their health coverage through Medicare. And private insurers have followed its lead by withholding coverage for Leqembi and a similar drug, Aduhelm, until they receive FDA's full endorsement. An FDA decision on full approval for Aduhelm is still years away.

Medicare administrator, Chiquita Brooks-LaSure, said in a statement Thursday the program will begin paying for the drug now that it has full FDA approval. But the government is also setting extra requirements, including enrollment in a federal registry to track the drug's real-world safety and effectiveness.

Video below: How your diet possibly contributes as a risk factor for Alzheimer's

Medicare “will cover this medication broadly while continuing to gather data that will help us understand how the drug works,” Brooks-LaSure said.

Some Medicare patients could be responsible for paying the standard 20% of the cost of Leqembi, though the amount will vary depending on their plans and other coverage details.

Hospitals and medical clinics have also cautioned that it may take time to get people started on the drug.

Doctors need to confirm that patients have the brain plaque targeted by Leqembi before prescribing it. Nurses need to be trained to administer the drug and patients must be monitored with repeated brain scans to check for swelling or bleeding. The imaging and administration services carry extra costs for hospitals beyond the drug itself.

Eisai has told investors that about 100,000 Americans could be diagnosed and eligible to receive Leqembi by 2026. The drug is co-marketed with Cambridge, Massachusetts-based Biogen.

“We want to ensure that appropriate patients only are the ones that get this product,” said Alexander Scott, a vice president with Eisai.

Eisai studied the drug in people with early or mild disease who were evaluated using a scale measuring memory, thinking and other basic skills. After 18 months, those who got Leqembi declined more slowly — a difference of less than half a point on the scale — than participants who received a dummy infusion. Some Alzheimer's experts say that delay is likely too subtle for patients or their families to notice.

But federal health advisers said the difference could still be meaningful and recommended that FDA fully approve the drug at a public meeting in June.

WASHINGTON (AP) — The Food and Drug Administration acknowledged Tuesday that its response to the U.S. infant formula shortage was slowed by delays in processing a whistleblower complaint and test samples from the nation’s largest formula factory.

A 10-page report from the agency offers its first formal account of the factors that led to the ongoing shortage, which has forced the U.S. to airlift millions of pounds of powdered formula from overseas.

The review zeroed in on several key problems at the agency, including outdated data-sharing systems, inadequate staffing and training among its food inspectors, and poor visibility into formula supply chains and manufacturing procedures.

“For things that are critical to the public health, if you don’t have some understanding of how all the pieces fit together, then when you get into a crisis or a shortage you have a real problem,” FDA Commissioner Robert Califf told The Associated Press in an interview. “To a large extent that’s what happened here.”

Califf said the FDA will seek new authority to compel companies to turn over key information.

One consumer advocate said the evaluation doesn't go far enough to fix the problems.

“This internal evaluation treats the symptoms of the disease rather than offering a cure,” Scott Faber of the Environmental Working Group said in a statement. “Nothing in this evaluation addresses the fragmented leadership structure that led to critical communication failures.”

The FDA report was overseen by a senior official who interviewed dozens of agency staffers. It comes nearly eight months after the FDA shuttered Abbott's Michigan plant due to safety concerns, quickly slashing domestic production within the highly concentrated formula industry.

A company whistleblower had tried to warn the FDA of problems at the plant in September 2021, but government inspectors didn't investigate the complaints until February after four infants became sick, resulting in two deaths. The FDA is still investigating links between those illnesses and the formula.

The FDA previously told Congress that top agency officials didn't learn about the complaint until February because of mail delays and a failure to escalate the Abbott employee's allegations. The new report stated that FDA's “inadequate processes and lack of clarity related to whistleblower complaints,” may have delayed getting inspectors to the plant.

“Whistleblower complaints come into the agency in many different ways, from many different sources,” said Dr. Steven Solomon, an FDA veterinary medicine official who oversaw the review. “One of the actions we’ve already taken is to make sure that however they come into the agency, they get triaged and escalated to the right leadership levels.”

FDA inspectors collected bacterial samples from the plant for testing, but shipping issues by “third party delivery companies” delayed the results, according to the report. The FDA also faced challenges ramping up its testing capacity for cronobacter, a rare but potentially deadly bacteria repeatedly linked to outbreaks in baby formula.

The FDA also noted that it had to reschedule its initial inspection of the Abbott plant due to cases of COVID-19 among company staff. That delay came on top of earlier missed inspections because the agency pulled its inspectors from the field during the pandemic.

The report concluded by listing new resources that Congress would need to authorize to improve infant formula inspections and standards, including:

— Increased funding and hiring authority to recruit experts to FDA's food division;

— Improved information technology to share data on FDA inspections, consumer complaints and testing results;

— New authority to compel manufacturers to turn over samples and records on manufacturing supply chains, manufacturing quality and safety.

U.S. inventories of baby formula have been improving, hitting in-stock rates above 80% last week, according to IRI, a market research firm. That's up from a low of 69% in mid-July. The U.S. has imported the equivalent of more than 80 million bottles of formula since May, according to White House figures, and the Biden administration is working to help foreign manufacturers stay on the market long term to diversify supply.

Califf has commissioned a separate external review of FDA's food division citing “fundamental questions about the structure, function, funding and leadership” of the program. That review is being led by former FDA commissioner Dr. Jane Henney, who led the agency during the final years of the Clinton administration.

A salmonella outbreak that was linked to Gold Medal flour is over, the U.S. Centers for Disease Control and Prevention said Wednesday. However, consumers should still make sure they don't have any recalled bags of flour at home.In late April, General Mills recalled certain 2-, 5- and 10-pound bags of Gold Medal Bleached and Unbleached All-Purpose Flour with use-by dates of March 27 and 28, 2024. The CDC says data showed that some Gold Medal flour was contaminated with Salmonella infantis bacteria that was responsible for at least 14 infections in 13 states. Nearly all of the patients interviewed reported eating raw dough or batter, and all of those who recalled the flour brand identified Gold Medal.A U.S. Food and Drug Administration investigation identified a single production facility for the flour that the sick people used, and an inspection of the General Mills facility in Kansas City, Missouri, turned up a sample with the outbreak strain of the bacteria."Although this outbreak investigation has ended, CDC advises you to throw away or return any bags of recalled flour and to wash any containers used to store recalled flour with warm water and soap," the CDC says.Salmonella infection typically causes diarrhea, fever and stomach cramps six hours to six days after consuming the bacteria. Most people recover without treatment in four to seven days, and because they aren't tested for salmonella, the true number of infections in the outbreak is most likely higher than what was reported, the CDC says. Some people – kids under 5, adults over 65 and those with weakened immune systems – may have more severe illness that requires medical treatment or hospitalization.Most flour is raw and hasn't been treated to kill germs that cause food poisoning, according to the CDC. Salmonella bacteria dies when it is cooked or baked, but people can get sick when eating or tasting foods that include raw flour. Raw dough used for crafts and play clay also pose a risk.The CDC advises baking or cooking any foods made with any brand of raw flour before eating. Thoroughly wash hands, bowls, utensils and surfaces after using raw flour. If making play dough at home, use heat-treated flour.

Researchers are on the cusp of rolling out a new vaccine to combat the respiratory syncytial virus amid an increase in cases in recent months.RSV has become the second leading cause of hospitalization, and tens of thousands of people a year die from it. Children under 2 and adults older than 60 are most at risk for serious disease, and a vaccine has been elusive -- until now."It will be a huge, huge breakthrough for us to have an RSV vaccine available," said Dr. James Campbell, professor of pediatrics and the University of Maryland School of Medicine.RELATED: Sinai pediatrician describes ICU availability amid increase in RSV casesModerna released preliminary results of their vaccine for RSV that shows it's more than 80% effective at preventing serious disease in people older than 60. The company is preparing to submit the vaccine to the Food and Drug Administration for approval, which follows submissions from Pfizer and GlaxoSmithKline late last year."The Pfizer vaccine, they also relayed results on giving that same vaccine to pregnant women, and then what happens is the antibodies the woman makes, gets passed through the placenta into the baby, and they showed very good protection in the first three months of life," Campbell said.Clinical trials are underway on a vaccine for babies and young children, who are among the high-risk groups for developing complications and dying from RSV.RELATED: Maryland hospitals concerned over surge of children with RSVThese would be the first RSV vaccines approved, which would be a feat because researchers have been working on them since the 1960s. Moderna's version uses the mRNA technology made famous by its COVID-19 vaccine."The reason why they could move so quickly on the COVID vaccine was because they had already been studying this RSV vaccine that we're just learning about now, and they used that same technology, and a lot of the tricks they found from that, in order to develop the COVID vaccine," Campbell said.RSV video playlist below:Campbell cautioned the results in the RSV vaccine study are preliminary and are not yet peer-reviewed, so while promising, he's waiting for the full details."That doesn't take away that this is really exciting news, but I think everyone should be waiting to see what the final, all the data show for this vaccine and the other RSV vaccines," Campbell said.Campbell said researchers are hopeful that some of these vaccines will be approved in time for RSV season in the fall.LINK: Maryland Department of Health website for RSV

A federal judge in Texas on Friday ordered a hold on U.S. approval of the abortion medication mifepristone, throwing into question access to the nation’s most common method of abortion in a ruling that waved aside decades of scientific approval.

The immediate impact of the ruling by U.S. District Judge Matthew J. Kacsmaryk, which does not go into immediate effect, was unclear.

The abortion drug has been widely used in the U.S. since 2000 and there is essentially no precedent for a lone judge overruling the medical decisions of the Food and Drug Administration. Mifepristone is one of two drugs used for medication abortion in the United States, along with misoprostol, which is also used to treat other medical conditions.

Kacsmaryk, a Trump administration appointee in Amarillo, Texas, signed an injunction directing the FDA to stay mifepristone’s approval while a lawsuit challenging the safety and approval of the drug continues. His 67-page order gave the government seven days to appeal.

“Simply put, FDA stonewalled judicial review — until now,” Kacsmaryk wrote.

He didn’t go as far as the plaintiffs wanted by withdrawing or suspending the approval of the chemical abortion drug and removing it from the list of approved drugs. But he put a “stay” or hold on approval of the drug.

Federal lawyers representing the FDA are expected to swiftly appeal.

Clinics and doctors that prescribe the two-drug combination have said that if mifepristone were pulled from the market, they would switch to using only the second drug, misoprostol. That single-drug approach has a slightly lower rate of effectiveness in ending pregnancies, but it is widely used in countries where mifepristone is illegal or unavailable.

Mifepristone is part of a two-drug regimen that has long been the standard for medication abortion in the U.S. Clinics and doctors that prescribe the combination say they plan to switch to using only misoprostol. The single-drug approach is slightly less effective at ending pregnancies.

The lawsuit was filed by the Alliance Defending Freedom, which was also involved in the Mississippi case that led to Roe v. Wade being overturned. At the core of the lawsuit is the allegation that the FDA’s initial approval of mifepristone was flawed because it did not adequately review its safety risks.

Courts have long deferred to the FDA on issues of drug safety and effectiveness. But the agency’s authority faces new challenges in a post-Roe legal environment in which abortions are banned or unavailable in 14 states, while 16 states have laws specifically targeting abortion medications.

A growing number of state legislatures are considering bans on cosmetics and other consumer products that contain a group of synthetic, potentially harmful chemicals known as PFAS.In Vermont, the state Senate gave final approval this week to legislation that would prohibit manufacturers and suppliers from selling or distributing any cosmetics or menstrual products in the state that have perfluoroalkyl and polyfluoroalkyl substances, as well as a number of other chemicals.The products include shampoo, makeup, deodorant, sunscreen, hair dyes and more, said state Sen. Terry Williams, a Republican, and member of the Senate Committee on Health and Welfare.“Many known toxic chemicals are used in or found as contaminants in personal care products, including PFAS, lead and formaldehyde," Williams said in reporting the bill to Senate colleagues.California, Colorado and Maryland passed similar restrictions on cosmetics that go into effect in 2025. Other proposals are under consideration in Washington and Oregon while bills have also been introduced in Illinois, Rhode Island and Georgia.According to the U.S. Environmental Protection Agency, studies have linked PFAS exposure to increased cancer risk, developmental delays in children, damage to organs such as the liver and thyroid, increased cholesterol levels and reduced immune functions, especially among young children.Like in Colorado and California, the proposed Vermont crackdown on PFAS — known as “forever chemicals” for their persistence in the environment — goes beyond cosmetics. The bill, which now must be considered by the Vermont House, would extend the ban to apparel, including outdoor apparel for severe wet conditions, athletic turf, clothing, ski wax and textiles, including upholstery, draperies, towels and bedding that intentionally contain PFAS. The bill has been referred to a House committee and the chairwoman said Friday that she's not sure if the panel will get to it this session. The legislation gives various timelines for the phaseouts."We must stop importing dangerous chemicals like PFAS into our state so we can prevent the harms they are causing up and down the supply chain — from their production and use to their disposal,” Lauren Hierl, executive director of Vermont Conservation Voters, said in a statement.In March, the Environmental Protection Agency proposed the first federal limits on the chemicals in drinking water, saying the protection will save thousands of lives and prevent serious illnesses, including cancer. The chemicals had been used since the 1940s in consumer products and industry, including in nonstick pans, food packaging and firefighting foam. Their use is now mostly phased out in the U.S., but some still remain. Pressure is also growing to remove PFAS from food packaging.A study by University of Notre Dame researchers released in 2021 found that more than half the cosmetics sold in the United States and Canada were awash with a toxic industrial compound associated with serious health conditions.Researchers tested more than 230 commonly used cosmetics and found that 56% of foundations and eye products, 48% of lip products and 47% of mascaras contained fluorine — an indicator of PFAS.The U.S. Food and Drug Administration says on its website that there have been few studies of the presence of PFAS in cosmetics, and the ones published found the concentration is at very low levels.The Personal Care Products Council, which represents the cosmetics industry, says in 2020 it supported California legislation to phase out certain ingredients, including 13 PFAS in cosmetics, and identical legislative language in Maryland the following year. The group called for states to pass uniform laws to avoid confusion.As for bans on apparel containing the chemicals, the American Apparel & Footwear Association supports the bill passed unanimously in the Vermont Senate and appreciates that amendments were made to align with phase-out timelines in existing PFAS restrictions in California and New York, said Chelsea Murtha, AAFA’s director of sustainability, in a statement.The Outdoor Industry Association, based on Colorado, said overall it supports the Vermont bill, also noted the current version more closely matches the timeline for compliance with California's.“We are also appreciative of the exemption for outdoor apparel severe wet conditions until 2028, as our industry is diligently working to move toward non-regrettable alternatives that will not compromise consumer safety or the quality of the product,” said association President Kent Ebersole in a statement.

The U.S. Food and Drug Administration issued a warning on Friday to consumers and health providers to discontinue using and discard recalled Pilot COVID-19 at-home tests made by SD Biosensor, Inc. over "significant concerns" of bacterial contamination.

SD Biosensor is recalling all impacted tests, which were distributed by Roche Diagnostics to various retailers to stop the spread of COVID-19 infections.

Throw out any Pilot tests from the affected lot numbers and do not pour the liquid solution down the drain, the FDA said.

"Direct contact with the contaminated liquid solution may pose safety concerns and the bacterial contamination could impact the performance of the test," the FDA said in a news release.

The FDA said the tests may be contaminated with bacteria such as enterococcus, enterobacter, klebsiella and serratia species and cause infection. Bacterial infections may cause illness in people with weakened immune systems.

If the liquid comes into contact with skin or eyes, flush with large amounts of water and get medical attention if irritation persists. Signs and symptoms of bacterial infection can include fever, discharge, or red eyes.

Some 500,000 tests were distributed to CVS Health, as well as about 16,000 tests to Amazon, the FDA said, and the agency is working with Roche Diagnostics to determine how many tests were sold to consumers.

The FDA notes that none of the impacted lots were distributed through any federal testing programs.

"If you received your tests through the COVID.gov/tests distribution or as part of other federal testing programs, they are not subject to this safety communication or product recall," the release said.

Your smartphone will now have the ability to deliver doses of insulin after the US Food and Drug Administration clears it.

On Thursday, Tandem Diabetes Care announced that the FDA had approved it to deliver insulin through its mobile app, t:connect.

“This FDA clearance further validates our commitment to innovation and the diabetes community by providing one of the most requested feature enhancements,” said John Sheridan, president and CEO of Tandem Diabetes Care, in a press release. “With the improvements in diabetes management provided by Tandem’s Control-IQ technology, giving a meal bolus is now the most common reason a person interacts with their pump, and the ability to do so using a smartphone app offers a convenient and discrete solution.”

The company said it would be offered in the United States for no additional cost to new t:slim X2 insulin pump customers.

"The updated t:connect mobile app is designed to offer t:slim X2 insulin pump users the ability to program and cancel bolus insulin requests through the convenience of their compatible smartphone," the company said.

WASHINGTON —

U.S. health officials warned parents on Thursday not to use three popular powdered infant formulas manufactured at an Abbott plant in Michigan that investigators recently linked to bacterial contamination.

The Food and Drug Administration said it is investigating four reports of infants who were hospitalized after consuming the formula, including one who died. The agency said one of the cases involved salmonella and three involved Cronobacter sakazakiim, a rare but dangerous germ that can cause blood infections and other serious complications.

Abbott, one of the country's largest infant formula makers, said it is recalling all potentially affected products manufactured at the facility. The recall affects certain lots of Similac, Alimentum and EleCare with expiration dates of April 1, 2022, or later. The product was distributed throughout the U.S. and overseas, the company said in a statement.

FDA staff are now inspecting Abbott's plant in Sturgis, Michigan, where environmental samples tested positive for the Cronobacter bacteria. Inspectors have also uncovered potential manufacturing problems, and past records showing the destruction of formula due to bacterial contamination.

"We're working diligently with our partners to investigate complaints related to these products, which we recognize include infant formula produced at this facility, while we work to resolve this safety concern as quickly as possible," said FDA Deputy Commissioner Frank Yiannas.

The FDA said it is working with federal and local authorities in Minnesota, Ohio and Texas— the states where the infant infections were reported.

Abbott could not specify how many units the recall includes, but brands like Similac are among the best-selling formulas in the U.S. and overseas.

"We value the trust parents place in us for high quality and safe nutrition and we'll do whatever it takes to keep that trust and resolve this situation," a company spokeswoman said in a statement.

Abbott said parents can identify the recalled products by examining the number on the bottom of each container. The affected formulas have a number starting with 22 through 37, contain K8, SH, or Z2 and have an expiration date of April 1, 2022, or later. The company has also set up a website where parents can check if their products have been recalled: https://www.similacrecall.com/us/en/home.html.

The company said its own testing of the finished product didn't detect any contamination. The recall does not affect liquid infant formulas or any other Abbott products.

___

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute's Department of Science Education. The AP is solely responsible for all content.

The COVID-19 vaccine for kids under five is on hold again.

On Friday, the FDA said it was delaying an advisory committee meeting to review the vaccine for children six months and up.

New data from Pfizer indicates while the vaccine appears safe, it may not work well enough to meet FDA standards.

“What we see, particularly among two- to five-year-olds, the data is not so compelling in terms of it being effective," said Eyal Oren, who runs the public health program at San Diego State University. "Meaning two doses did not promote an effective or strong immuno-response in these kids."

He says FDA officials say they want to wait on a decision until there is data available about a third dose of the vaccine.

Some doctors hope a vaccine is approved soon because kids are still sick.

“The younger the child, they could have difficulty breathing as that mucus gets in the lungs," said Dr. Joe Perno, the vice president of medical affairs at Johns Hopkins All Children’s Hospital. "So breathing problems where they’re breathing fast, where it’s sucking in around their ribs, they’re panting, those types of things. Those are come see us in the emergency room right away."

He says it’s important to note how safe the vaccine has been in other age groups.

“There are over eight million kids in the U.S. alone that have received at least one dose of the vaccine over the age of five, and the safety profile is astronomical," said Perno.

The FDA hasn't said when it would review this topic again, but Pfizer said it would have data on the third dose available in April.

The Food and Drug Administration (FDA) announced Friday that it has issued emergency use authorization (EUA) for Eli Lilly's new monoclonal antibody treatment.

Clinical trials have shown the treatment to be effective against the COVID-19 omicron variant.

“Today’s action makes available another monoclonal antibody that shows activity against omicron, at a time when we are seeking to further increase supply,” said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research. “This authorization is an important step in meeting the need for more tools to treat patients as new variants of the virus continue to emerge.” 

According to the Center's for Disease Control, omicron is the dominant variant in the U.S.

The EUA covers treatment for patients with mild to moderate COVID-19 who are at high risk of hospitalization or death.

It can be used on children as young as 12 if they weigh at least 88 pounds, the FDA says.

Prior to the authorization, the U.S. agreed to purchase 600,000 doses. They are to be delivered no later than March 31, Eli Lilly said.

WASHINGTON —

Federal health regulators on Friday delayed next week's public meeting to review Pfizer’s COVID-19 vaccine for children under 5, saying they want to see more data.

The surprise announcement by the Food and Drug Administration raises questions about how soon youngsters could get the shots. The FDA's outside experts were set to evaluate the first data on COVID-19 vaccinations in toddlers and babies.

The FDA said Pfizer has new data available from its ongoing vaccine study — and the agency needs more time to evaluate it.

The expert panel had been scheduled to meet Tuesday to determine if children under 5 should start getting extra-low doses of Pfizer’s vaccine before it’s clear if they’ll need two shots or three.

The nation’s 18 million children under 5 are the only age group not yet eligible for vaccination. The FDA had pushed Pfizer and its partner BioNTech to apply for authorization of its extra-low doses for tots before final study data was in, as the hugely contagious omicron variant took a toll on children.

This is a developing story and will be updated.

The U.S. is expanding COVID-19 boosters as it confronts the omicron surge, with the Food and Drug Administration allowing extra Pfizer shots for children as young as 12.

Boosters already are recommended for everyone 16 and older, and federal regulators on Monday decided they’re also warranted for 12- to 15-year-olds once enough time has passed since their last dose.

But the move, coming as classes restart after the holidays, isn’t the final step. The Centers for Disease Control and Prevention must decide whether to recommend boosters for the younger teens. Dr. Rochelle Walensky, the CDC’s director, is expected to rule later this week.

The FDA also said everyone 12 and older eligible for a booster can get one as early as five months after their last dose rather than six months.

Vaccines still offer strong protection against serious illness from any type of COVID-19. But health authorities are urging everyone who’s eligible to get a booster dose for their best chance at avoiding milder breakthrough infections from the highly contagious omicron mutant.

Children tend to suffer less serious illness from COVID-19 than adults. But child hospitalizations are rising during the omicron wave — most of them unvaccinated.

The vaccine made by Pfizer and its partner BioNTech is the only U.S. option for children of any age. About 13.5 million 12- to 17-year-olds — just over half that age group — have received two Pfizer shots, according to the CDC.

For families hoping to keep their children as protected as possible, the booster age limit raised questions.

The older teens, 16- and 17-year-olds, became eligible for boosters in early December. But original vaccinations opened for the younger teens, those 12 to 15, back in May. That means those first in line in the spring, potentially millions, are about as many months past their last dose as the slightly older teens.

As for even younger children, kid-size doses for 5- to 11-year-olds rolled out more recently, in November — and experts say healthy youngsters should be protected after their second dose for a while. But the FDA also said Monday that if children that young have severely weakened immune systems, they will be allowed a third dose 28 days after their second. That’s the same third-dose timing already recommended for immune-compromised teens and adults.

Pfizer is studying its vaccine, in even smaller doses, for children younger than 5.

The U.S. Food and Drug Administration has approved the first injectable medication for pre-exposure prophylaxis (PrEP) to lower the risk of getting HIV through sex, it announced Monday.Apretude is approved for adults and teens who are at risk of getting HIV through sex and who weigh at least 77 pounds. It's given first as two shots a month apart, and every two months afterward.PrEP was previously available only in the form of pills, Truvada and Descovy."Today's approval adds an important tool in the effort to end the HIV epidemic by providing the first option to prevent HIV that does not involve taking a daily pill," said Dr. Debra Birnkrant, director of the Division of Antivirals in the FDA's Center for Drug Evaluation and Research.Approval of the new drug "will be critical to addressing the HIV epidemic in the U.S., including helping high-risk individuals and certain groups where adherence to daily medication has been a major challenge or not a realistic option," Birnkrant added.An estimated 34,800 new cases of HIV were diagnosed in 2019, the latest year for which federal statistics are available. That's down from 37,800 in 2015. Data from the Centers for Disease Control and Prevention show that in 2020, PrEP was recommended for about 1.2 million people, but only a quarter got a prescription for it.Two double-blind clinical trials comparing Apretude with Truvada found significantly lower HIV risk in people getting the injection, the FDA noted. The risk was 69% lower in the first trial, of HIV-negative cisgender men and transgender women who have sex with men, and 90% lower in the second trial, which involved cisgender women.Research also found that Apretude was more likely than Truvada to cause side effects such as injection site reactions, headache, fatigue, back pain, myalgia and rash.Because of a risk of drug-resistant HIV variants, Apretude is only for people who test negative for HIV immediately before starting the drug and before each injection. The label also includes warnings about hypersensitivity reactions, liver damage and depressive disorders.

Newborns and younger pediatric patients who have tested positive for COVID-19 can now receive monoclonal antibody treatments that were previously authorized for those 12 and older.

The Food and Drug Administration announced Friday that it had revised its emergency use authorization for bamlanivimab and etesevimab.

The FDA says the monoclonal antibodies can now be used for “treatment of mild to moderate COVID-19 in all younger pediatric patients, including newborns, who have a positive COVID-19 test and are at high risk for progression to severe COVID-19, including hospitalization or death.”

The FDA cautions that the treatment is not a substitute for vaccination.

“Vaccines remain our best tool in the fight against the virus, and there is a COVID-19 vaccine authorized for children 5 years of age and above,” said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research.

The FDA says it expanded the emergency use authorization following a clinical trial of 125 pediatric patients that showed the monoclonal antibodies were safe and effective.

CINCINNATI —

There's another potential game-changer in the fight against this pandemic.

Pfizer has now applied for Food and Drug Administration emergency authorization for its COVID-19 antiviral pill.

The pill is made for people who have already been diagnosed with COVID-19, are unvaccinated and at a high risk for becoming severely ill.

The pill would be sold under the brand name Paxlovid, and if granted, could be available in just weeks.

In a clinical trial with adults 18 and up, Pfizer found its antiviral pill cuts hospitalization and death risks by nearly 90 percent when taken within three days of onset symptoms.

Most COVID-19 treatments right now require an IV or injection.

Great Britain authorized Merck's COVID-19 pill earlier this month, and it's pending approval here in the United States.

The US government is expected to cover the cost for both medications, estimated to be around $700 per treatment.

Side effects of this pill were mild to moderate according to Pfizer.

Both Pfizer's pill and Merck's pill attack the coronavirus by interfering with the ability to replicate itself.

CINCINNATI — A rash and joint pain may have saved Lily McBreen's life by getting her to the doctor in time for a breast cancer diagnosis. Although many other survivors choose implants after their mastectomies, she's adamant that she won't. Having almost lost her life once, she's worried the side effects of receiving breast implants could endanger it again.

“After breast cancer your biggest motivation is to survive and you know that to survive you have to become healthy and whole again," she said. "So the idea of putting something in your body that’s potentially going to make you sick again is something you’re not going to be willing, or want to do."

McBreen was diagnosed with fibromyalgia a few years ago. When she noticed rash and joint swelling in her wrists, she went to her doctor, who sent her to a rheumatologist to perform a full body scan. That’s when she saw it: a lump inside her breast. She was diagnosed with stage two breast cancer.

“I just started spinning mentally," said McBreen, a registered nurse. "I really honestly can’t verbalize. I just started bawling."

She started chemo within a week of the diagnosis and had her last round on her birthday in November.

“That’s either a gift or not a gift,” she said.

That was followed by a bilateral mastectomy a month later. Then came another big decision: Should she get breast implants?

“By now, I heard people tell plenty of just anecdotal accounts of implant syndrome,” she said.

It’s why she elected to instead have a flap surgery, which uses the patient's own tissue to reconstruct the breast.

“I wanted to avoid the rheumatological symptoms that have been out in the news for so many decades," she said. "There has been so many accounts of women complaining of problems with them."

Those symptoms, which women are calling “breast implant illness,” are among the many reasons the United States Food and Drug Administration could soon take extreme measures when it comes to educating the public about implants.

FDA investigates breast implants

In March 2019, at an FDA conference about breast implants, women, doctors and surgeons shared harrowing stories of complications connected to receiving implants after a mastectomy.

“I experienced extreme exhaustion, rapid weight gain, paralyzing brain fog,” Julie Elliot testified.

“I was completely bedridden, waiting to die,” said Terry Diaz, who described herself as a breast implant survivor. “I couldn’t even walk up a flight of stairs.”

The women said their implants caused these issues. Others experienced an even more serious complication: A rare form of cancer called breast implant-associated anaplastic large cell lymphoma, or BIA-ALCL, in which lymphoma develops in the tissue around the implant.

“Life as I knew it ceased to exist,” Terry McGregor, a BIA-ALCL survivor, told the FDA panel. “Four years ago, I was diagnosed with ALCL from breast implants that were six years old. My diagnosis was stage four. The joy of life was cut short by a profit-driven, man-made cancer."

The FDA released more findings about BIA-ALCL in July, months after the conference. According to U.S. and global medical device reports, there have been 573 reports of BIA-ALCL. Thirty-three patients died.

Of those cases, the FDA said a majority are linked to a single pharmaceutical manufacturer, Allergan, and its textured BIOCELL implants. The company recalled the implants on July 24.

“Patient safety is a priority for Allergan," the company said in a news release announcing the recall. "Patients are advised to speak with their plastic surgeon about the risks and benefits of their implant type should they have any concerns.”

In October, the FDA proposed adding a black box warning to all breast implants warning patients about the potential side effects of breast implant illness and BIA-ALCL.

Spencer Platt

Women file class-action lawsuit against Allergan

By January 2020, women from 37 different states had signed onto a class-action lawsuit against Allergan, including one woman from Ohio and another from Kentucky.

The lawsuit, which was filed by Berger Montague PC, Sauder Schelkopf LLC and Mazie Slater Katz and Freeman LLC, accuses the company of negligence and claims it knowingly withheld information that the recalled implants were linked to cancer.

The lawsuit seeks to cover the cost associated with removing and replacing the patients' implants.

As part of the recall, Allergan said in a press release that the company would “provide Allergan smooth device replacements for free … As part of this program, Allergan will not provide surgical fee assistance to revision patients.”

“Our clients and the many women who have contacted us should not have to deal with the anxiety of living with a recalled breast implant," said plaintiffs’ attorneys Joe Sauder and Matt Schelkopf. "We look forward to fighting on their behalf in seeking a resolution that provides them with peace of mind.”

In a statement to WCPO, the company said it has followed FDA regulations and acted transparently: “Allergan has a demonstrated history of dedication to the health and safety of patients and a strong record of compliance with U.S. Food and Drug Administration (FDA) regulations and requirements. Allergan has followed FDA regulatory reporting procedures and acted transparently with patients about textured breast implants.

"We paid close attention to reports of a link between textured breast implants and BIA-ALCL, shared reports of patient complaints with regulators, and worked with the FDA to determine that a BIOCELL textured implant product recall was an appropriate step. We’ve worked hard to keep patients and surgeons informed about the recall and continue to encourage a full dialogue between patients and their doctors about the benefits and risks of breast implants."

Doctors say implants are safe, for the most part

Several doctors in our region told WCPO that breast implants are safe — for the most part.

“Breast implants are one of the most-studied medical tools because we’ve had so many of them for so long,” said Dr. Neil Kundu, chief of plastic surgery at Mercy Health. “The real key is to make sure that there’s a good dialogue and expectations and understanding are made.”

Kundu said that when discussing BIA-ALCL, the numbers need to be put into context.

“We’ve had hundreds and thousands of breast implants," he said. "And these implants have been in for decades, and of the hundreds of thousands of implants, the FDA has only seen 530 some unique cases of this ALCL."

Kundu also noted that he rarely uses textured implants, which are most commonly linked to ALCL. Still, a handful of his patients have come in to have their implants removed because of the recent news.

“I’ve had three patients that I’ve removed implants on for concern of this," he said. Kundu explained that the numbers aren't higher "because not every patient needs to have them removed."

He believes the black box warning is key for education, which is necessary for anyone choosing to undergo a surgery.

“Breast implants are safe,” he said. "The most important thing is education, and before having any procedure, or any implanted device go into your body, you should have a thorough understanding of what the device does and the risk and benefits of every device that you have.”

University of Cincinnati assistant professor of plastic surgery Ryan Gobble echoed that sentiment.

“I think the idea is more transparency is better," he said. "And that making sure patients know that there are real risks associated with using implants."

As for women specifically choosing implants after surviving breast cancer, Mercy Health breast surgical oncologist Amy Moldem said the decision — and discussion — should be no different.

“I think we would offer the same implants, whether or not it’s an augmentation versus a reconstruction,” she said. “I think the important thing is that we educate them. We can educate them that there is a black box warning when we do their consent but also relay that fact that this disease has never been associated with the implants that we’re going to use.”

Draft warning includes a patient check list

Currently,the black box warning exists only as a draft while the FDA continues to consider its implementation.

The draft warning outlines three main concerns.

First, “breast implants are not considered life time devices" and women may require more surgery if complications occur.

It also states that implants have been associated with BIA-ALCL.

“This cancer occurs more commonly in patients with textured breast implants than smooth implants, although rates are not well defined," the warning reads. "Some patients have died from BIA-ALCL.”

Finally, it describes how some patients have reported a variety of symptoms, including “joint paint, muscle aches, confusion, chronic fatigue, autoimmune disease and others.”

The FDA is also proposing a patient decision checklist, which would include situations in which the device should not be used, considerations for a successful breast implant candidate, risks of surgery, the importance of using an appropriate physician, the risk of BIA-ALCL and other symptoms and discussion of other options.

Still, some have said these proposals don’t go far enough, including Diana Zuckerman who is President of the National Center for Health Research. The center initiated the Breast Implant Working Group, which is made up of six experts including patient advocates and plastic surgeons.

“The FDA’s draft Black Box warning is too vaguely worded on BIA-ALCL and breast implant illness, and includes jargon that will not be understood by all patients,” the working group said in a statement. “The FDA draft Black Box states that 'breast implants have been associated with the development of a cancer of the immune system called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).' Association implies correlation rather than causation. In fact, the evidence is clear that breast implants can cause BIA-ALCL.”

FDA recommends a black box warning on all breast implants

What’s next?

It’s unclear when or if the FDA will decide on implementing the black box warning. The agency declined an interview with WCPO.

However, McBreen, who is now breast-cancer-free, has a warning of her own she is standing by.

“That black box warning means, ‘Hey, this could be really deadly. Take it seriously,’” she said.

And to women considering implants?

"Her health is so much more important," McBreen said. "And lymphoma is no joke. There isn’t one (cancer) that is a walk in the park.”

Around the country, some parents are growing concerned over a product occasionally dubbed weed light or diet weed. Experts say delta-8 THC is in a legal gray area and can cause negative health effects, sister station WGAL investigated. Delta-8 THC products are being sold online and in stores in different forms. "It can come in Rice Krispies treats, gummies, candies, a whole litany of edibles," said Michael Reisinger, who runs American Shaman in Lancaster, Pennsylvania.Reisinger said his customers, who must be 21 or older, are using it for things like sleep, relaxation and pain relief."The same thing that they’re looking and turning to CBD for, delta-8 can help with the same relief," he said.Delta-8 THC is a psychoactive substance found in very low levels in the hemp plant. But CBD can be synthesized into high levels of delta-8 and added to products.The 2018 Farm Bill legalized hemp and hemp products as long as they have less than 0.3% of delta-9 THC, the compound in marijuana that causes a high. But the bill doesn't address delta-8."It lives in that gray area," attorney Bill Roark said.Roark, who teaches cannabis law and regulation, said people may believe delta-8 is legal because it is derived from hemp. "I don't think anyone can say that the intent of the Farm Bill was to find another way to create a legalized psychoactive drug," he said.The Food and Drug Administration recently issued a warning that some delta-8 THC products can have serious health risks. It said there have been adverse event reports in the last year involving 22 patients. They experienced vomiting, hallucinations and other issues."You don't know what you're getting. You're getting an adulterated hemp material and so it really needs to be buyer beware," said Dr. Kent Vrana, a pharmacologist with the Penn State College of Medicine.When Reisinger was asked whether people are using delta-8 THC to get high, he said, "Not in our experience. I can't say for every single person. Nine times out of 10, there's not a psychoactive element that's hit. While there's the potential, we want to be more safe than sorry."Nineteen states have regulated, restricted or banned the sale of delta-8 THC products, which include Alaska, Arizona, Arkansas, Colorado, Connecticut, Delaware, Kentucky, Idaho, Iowa, Michigan, Mississippi, Montana, New York, North Dakota, Rhode Island, Texas, Utah, Vermont, and Washington.Watch the video above for more on this story.

CINCINNATI —

The U.S. Food and Drug Administration's advisory panel has voted to allow emergency use authorization of Pfizer's shot in kids ages 5 to 11.

Shots could start in a matter of days if the FDA and Centers for Disease Control and Prevention go ahead with committee recommendations. Of the 18 voting members, it was unanimous with 17 yes votes and one abstention.

"Based on the totality of the evidence, the benefits do outweigh the risks,” NCIRD Chief Medical Officer Amanda Cohn said.

The FDA panel recommends Pfizer’s two shots 21-days apart, at one-third the dose given to other Americans. Pfizer's data shows its vaccine is more than 90% effective at preventing severe symptomatic infections. Dr. Chris Peltier with Pediatric Associates of Mt. Carmel and is the president of the Ohio chapter of the American Association of Pediatricians, says it has been a long wait.

“In a word, relief. We've been waiting on this for a while now. So, this is a huge group of patients 5 to 11-year-olds that have not been able to have access to the vaccine which means they are at risk for getting COVID,” Peltier said.

While the vaccine has been shown to cause rare cases of a mild inflammation of the heart in some older teens and young adults, there were no documented cases in the study of 5 to 11-years-old. Doctors say the risk is higher from getting COVID-19 along with other impacts in day-to-day life.

“In addition and probably on a bigger scale, even though kids aren't getting as sick from COVID, if they're getting COVID they're having to miss school,” Peltier said.

A recent poll shows only a third of parents plan to get their children vaccinated right away. That's worrying for many doctors who say vaccinating elementary-aged kids will be key in getting the pandemic under control for good. Peltier says the orders are already on standby for our area.

“Actually, through the state of Ohio, the Ohio Department of Health, many pediatricians, including my practice, we have already placed our first order for the vaccine," he said.

Peltier, not only recommends getting the vaccine, but says to go ahead and call your pediatrician to see if they'll have it available. If they don't, he says to check around for vaccine clinics which are already being worked on.

It's now up to the FDA to decide whether to follow the advisory committee's recommendation. A CDC committee will meet next week to also decide on vaccine approval.

If that panel recommends emergency use authorization and the CDC director follows with a thumbs up, shots could start as early as the end of next week.

U.S. regulators on Wednesday signed off on extending COVID-19 boosters to Americans who got the Moderna or Johnson & Johnson vaccine and said anyone eligible for an extra dose can get a brand different from the one they received initially.

The Food and Drug Administration's decisions mark a big step toward expanding the U.S. booster campaign, which began with extra doses of the Pfizer vaccine last month. But before more people roll up their sleeves, the Centers for Disease Control and Prevention will consult an expert panel Thursday before finalizing official recommendations for who should get boosters and when.

The latest moves would expand by tens of millions the number of Americans eligible for boosters and formally allow "mixing and matching" of shots — making it simpler to get another dose, especially for people who had a side effect from one brand but still want the proven protection of vaccination.

Specifically, the FDA authorized a third Moderna shot for seniors and others at high risk from COVID-19 because of their health problems, jobs or living conditions — six months after their last shot. One big change: Moderna's booster will be half the dose that's used for the first two shots, based on company data showing that was plenty to rev up immunity again.

For J&J's single-shot vaccine, the FDA said all U.S. recipients, no matter their age, could get a second dose at least two months following their initial vaccination.

The FDA rulings differ because the vaccines are made differently, with different dosing schedules — and the J&J vaccine has consistently shown a lower level of effectiveness than either of the two-shot Moderna and Pfizer vaccines.

As for mixing and matching, the FDA said it's OK to use any brand for the booster regardless of which vaccination people got first. The interchangeability of the shots is expected to speed the booster campaign, particularly in nursing homes and other institutional settings where residents have received different shots over time.

The decision was based on preliminary results from a government study of different booster combinations that showed an extra dose of any type revs up levels of virus-fighting antibodies. That study also showed recipients of the single-dose J&J vaccination had a far bigger response if they got a full-strength Moderna booster or a Pfizer booster rather than a second J&J shot. That study didn't test the half-dose Moderna booster.

Health authorities stress that the priority still is getting first shots to about 65 million eligible Americans who remain unvaccinated. But the booster campaign is meant to shore up protection against the virus amid signs that vaccine effectiveness is waning against mild infections, even though all three brands continue to protect against hospitalization and death.

"The available data suggest waning immunity in some populations who are fully vaccinated," FDA acting commissioner Dr. Janet Woodcock said in a statement Wednesday. "The availability of these authorized boosters is important for continued protection against COVID-19 disease."

The Moderna booster decision essentially matches FDA's ruling that high-risk groups are eligible for the Pfizer vaccine, which is made with the same technology.

FDA recommended that everyone who'd gotten the single-shot J&J vaccine get a booster since it has consistently shown lower protection than its two-shot rivals. And several independent FDA advisers who backed the booster decision suggested J&J's vaccine should have originally been designed to require two doses.

Experts continue to debate the rationale of the booster campaign. Some warn that the U.S. government hasn't clearly articulated the goals of boosters given that the shots continue to head off the worst effects of COVID-19, and wonder if the aim is to tamp down on virus spread by curbing, at least temporarily, milder infections.

Those questions are likely to come up Thursday as an influential panel convened by the CDC offers more specifics on who should get boosters and when. Their recommendations are subject to approval by the CDC director.

The vast majority of the nearly 190 million Americans who are fully vaccinated against COVID-19 have received the Pfizer or Moderna options, while about 15 million have received the J&J vaccine.

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AP Writer Mike Stobbe contributed to this story from New York.

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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute's Department of Science Education. The AP is solely responsible for all content.

For the first time in history, the FDA authorized three e-cigarette products: the Vuse Solo device and its pods.

The agency says the company that makes the Vuse Solo gave them data that shows it can be helpful to cigarette smokers.

In an email, the FDA said, "the potential benefit to smokers who switch completely or significantly reduce their cigarette use would outweigh the risk to youth."

Gregory Conley is the American Vaping Association president.

“After years of debate, you now have the FDA, which is our chief regulatory arm for things that we ingest - The FDA is saying that this particular product is appropriate for the protection of public health,” Conley said.

He says electronic cigarettes, which have been sold in the U.S. since 2006, are an essential step in the fight to help smokers quit tobacco cigarettes.

Last year, the FDA also took steps to keep vape products out of kids' hands, sending warning letters to 10 companies telling them to pull their flavored e-cigarette and e-liquid products because they appeal to young people.

Hasmeena Kathuria, MD, is an associate professor of medicine at Boston University and the director of the tobacco treatment center.

“Inhaling anything directly into the lungs is not a good idea,” Kathuria said.

She says she’s glad the FDA is acting on its promise to regulate these products. Nonetheless, the U.S. Surgeon General's office says since 2014, E-cigarettes have been the most commonly used tobacco product by American kids, and Kathuria says that's concerning.

“We think all e-cigarettes should not be allowed on the market because of – one, the youth epidemic of nicotine addiction, two, we know that there's FDA approved medications for smoking cessation that have that are regulated, that we know are safe, that we know that, that there are effective,” Kathuria said.

Knowing e-cigarettes aren't leaving the market anytime soon, the FDA will make these authorizations and marketing decisions on a case-by-case basis.

The agency says it hopes to get to a place where every vape product is “appropriate for the protection of the public health.”

 

Vaccine advisers to the Food and Drug Administration are meeting Thursday morning to discuss whether to authorize boosters of Moderna's coronavirus vaccine for some adults.

It's the first portion of a two-day Vaccines and Related Biological Products Advisory Committee meeting that will also include a vote on boosters for the Johnson & Johnson vaccine and a presentation on mix-and-match vaccines. Thursday's agenda focuses on Moderna boosters, and includes a presentation by Moderna, and another by the FDA, which will provide its assessment of Moderna's booster data.

Moderna is requesting authorization for a 50-microgram booster dose — half the size of the 100-microgram doses used in the primary series of the two-dose vaccine — at least six months after the second dose, and only for certain groups: people age 65 and older; people ages 18 to 64 who are at high risk of severe COVID-19; and people ages 18 to 64 whose exposure to the coronavirus in their settings or jobs put them at risk for COVID-19 complications or severe illness.

Moderna's request mirrors the groups authorized to receive a booster dose of Pfizer's mRNA vaccine. Third doses of the Moderna and Pfizer COVID-19 vaccines are already authorized for some immunocompromised people.

On Thursday, the committee will hear from Dr. Peter Marks, the director of FDA's Center for Biologics Evaluation and Research who recently took over as acting director of the agency's Office of Vaccines Research and Review as two of its senior leaders prepared to depart the agency.

Israeli researchers will also brief VRBPAC on booster data from there; most people in Israel received the Pfizer COVID-19, and boosters for vaccinated people began weeks before the United States authorized Pfizer boosters. The presenters, Dr. Sharon Alroy-Preiss, director of public health services at Israel's Ministry of Health and Ron Milo, a professor at Israel's Weizmann Institute, spoke in support of Pfizer's booster application last month.

The meeting, which will be streamed online, is scheduled to last until 4:45 p.m. ET. A two-hour period for discussion and voting is scheduled to begin at 2:45 p.m. ET.

The FDA's committee of independent advisers typically discusses and makes recommendations to the agency around vaccine authorizations and approvals, and the agency then makes the final decision about whether to OK a vaccine. If the FDA gives emergency use authorization to Moderna boosters, vaccine advisers to the U.S. Centers for Disease Control and Prevention will meet to discuss which groups to recommend them to. Typically, shots can be administered once the CDC director signs off on the recommendation.

CDC's Advisory Committee on Immunization Practices is already scheduled to meet to discuss boosters from 10 a.m. to 5 p.m. ET Oct. 20-21.