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US approves 1st vaccine for RSV after decades of attempts

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WASHINGTON (AP) — The U.S. approved the first vaccine for RSV on Wednesday, shots to protect older adults against a respiratory virus that’s most notorious for attacking babies but endangers their grandparents, too.

The Food and Drug Administration decision makes GSK’s shot, called Arexvy, the first of several potential vaccines in the pipeline for RSV to be licensed anywhere.

The move sets the stage for adults 60 and older to get vaccinated this fall — but first, the Centers for Disease Control and Prevention must decide if every senior really needs RSV protection or only those considered at high risk from the respiratory syncytial virus. CDC’s advisers will debate that question in June.

After decades of failure in the quest for an RSV vaccine, doctors are anxious to finally have something to offer — especially after a virus surge that strained hospitals last fall.

“This is a great first step … to protect older persons from serious RSV disease,” said Dr. William Schaffner, medical director of the National Foundation for Infectious Diseases, who wasn’t involved with its development. Next, “we’re going to be working our way down the age ladder” for what’s expected to be a string of new protections.

The FDA is considering competitor Pfizer’s similar vaccine for older adults. Pfizer also is seeking approval to vaccinate pregnant women, so their babies are born with some of mom’s protection.

There isn’t a vaccine for kids yet but high-risk infants often get monthly doses of a protective drug during RSV season — and European regulators recently approved the first one-dose option. The FDA also is considering whether to approve Sanofi and AstraZeneca’s one-shot medicine.

“This is a very exciting time with multiple potential RSV solutions coming out after years of really nothing,” said Dr. Phil Dormitzer, chief of vaccine research and development for GSK, formerly known as GlaxoSmithKline.

RSV is a cold-like nuisance for most people but it can be life-threatening for the very young, the elderly and people with certain high-risk health problems. It can impede babies’ breathing by inflaming their tiny airways, or creep deep into seniors’ lungs to cause pneumonia.

In the U.S., about 58,000 children younger than 5 are hospitalized for RSV each year and several hundred die. Among older adults, as many as 177,000 are hospitalized with RSV and up to 14,000 die annually.

Why has it taken so long to come up with a vaccine? The field suffered a major setback in the 1960s when an experimental shot worsened infections in children. Scientists finally figured out a better way to develop these vaccines — although modern candidates still were first tested with adults.

GSK’s new vaccine for older adults trains the immune system to recognize a protein on RSV’s surface, and contains an ingredient called an adjuvant to further rev up that immune reaction.

In an international study of about 25,000 people 60 and older, one dose of the vaccine was nearly 83% effective at preventing RSV lung infections, and reduced the risk of severe infections by 94%.

To see how long protection lasts, GSK is tracking study participants for three years, comparing some who get just one vaccination during that time and others given a yearly booster.

Shot reactions were typical of vaccinations, such as muscle pain and fatigue.

There was a hint of a rare but serious risk — one case of Guillain-Barre syndrome, which can cause usually temporary paralysis, and two cases of a type of brain and spinal cord inflammation. The FDA said it was requiring the company to continue studying if there really is a link to the vaccine.

If the CDC ultimately recommends the vaccination for some or even all seniors, it will add another shot for the fall along with their yearly flu vaccine – and maybe another COVID-19 booster.

“We’ll have to educate the population that this virus that not everyone has heard about is actually an important threat to their health in the wintertime,” said Schaffner, an infectious disease expert at Vanderbilt University. ___

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North Florida News

Gov. Ron DeSantis Names Alex Peraza to Miami-Dade Judicial Nominating Commission

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TALLAHASSEE, Fla. (FNN)Ron DeSantis announced Friday the appointment of Alex Peraza to the Eleventh Judicial Circuit Judicial Nominating Commission, which serves Miami-Dade County.

Peraza, of Coral Gables, is a partner at Diamond Kaplan & Rothstein, P.A., a law firm based in South Florida.

The Judicial Nominating Commission is responsible for reviewing and recommending qualified candidates for judicial appointments within the circuit.

Peraza earned his bachelor’s degree from the University of Miami and his juris doctor from the University of Florida. His appointment term will run through July 1, 2027.

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Florida

Advocates Oppose Florida Medicaid Work Reporting Bill, Cite “Deathbed Exemption” and Coverage Gap Risks

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TALLAHASSEE, Fla. (FNN) — A Florida Senate committee on Monday advanced SB 1758, legislation that would impose Medicaid work reporting requirements in a state that has not expanded Medicaid under the Affordable Care Act. Advocates say the proposal would push thousands of low-income Floridians into the state’s existing coverage gap and create new administrative barriers for people with serious illnesses.

The bill goes beyond the recently passed federal measure, H.R. 1 — known as the One Big Beautiful Bill Act — which exempts non-expansion states from federal Medicaid work reporting requirements. Critics argue Florida lawmakers are moving forward despite that exemption.

Bill Would Add Work Reporting and “Deathbed Exemption”

SB 1758 would require certain Medicaid recipients to document at least 80 hours per month of work or qualifying activities to maintain coverage. The bill includes exemptions, including a recently added provision that would exempt terminally ill parents only if they can prove a life expectancy of six months or less.

Sadaf Knight, CEO of Florida Policy Institute, said the amendment would require a single mother who is terminally ill and earning less than $8,000 a year to meet monthly work reporting requirements unless she can demonstrate a six-month prognosis.

“It is hard to grasp how we arrived at a policy that effectively asks someone facing the end of their life to prove they are dying quickly enough to keep their Medicaid,” Knight said.

Opponents say the proposal would increase administrative costs while stripping coverage from residents who are already working or unable to work due to caregiving responsibilities or medical conditions.

Advocates Warn of Coverage Gap, Legal and Fiscal Risks

Florida is one of 10 states that has not expanded Medicaid, leaving an estimated 260,000 residents in the coverage gap — earning too much to qualify for traditional Medicaid but too little to receive federal marketplace subsidies.

More than two dozen organizations signed a letter urging members of the Senate Appropriations Committee to reject the bill. Signatories include the American Cancer Society Cancer Action Network, American Heart Association, American Lung Association, Southern Poverty Law Center, UnidosUS, The AIDS Institute, Florida Policy Institute, Florida Voices for Health and 1199SEIU.

Melanie Williams of Florida Health Justice Project called the bill “fiscally reckless,” noting that the state has already spent $1 million defending wrongful Medicaid terminations in federal court and that the Department of Children and Families has reported budget constraints in addressing court-mandated changes.

Rachel Klein of The AIDS Institute said federal law prohibits non-expansion states from implementing Medicaid work requirements and warned the measure could face legal challenges. Others argued the costs of building a new reporting system would outweigh any potential savings.

Advocates say the Legislature should focus instead on expanding access to affordable coverage amid rising health care costs and expiring enhanced premium tax credits.

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Florida

Bracy Davis, Rosenwald File Bill to Fix My Safe Florida Home Program Application Barriers

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TALLAHASSEE, Fla. (FNN) — Senator LaVon Bracy Davis and Representative Mitch Rosenwald have filed legislation aimed at expanding access to the My Safe Florida Home Program by allowing homeowners to reapply when applications were previously deemed abandoned or withdrawn due to errors or omissions.

The measure, SB 1148/HB 1045, would modify program rules to permit subsequent applications when the original filing was rejected because of compliance-related mistakes, provided there is good cause and the applicant corrects the issue in a timely manner.

Expanding Access to Homeowner Assistance
The My Safe Florida Home Program is a state initiative that provides eligible Florida homeowners with inspections and grant funding to help strengthen their homes against storms while reducing insurance costs. The program is administered by the Florida Department of Financial Services.

Current rules allow for reapplication if an application was denied or withdrawn due to errors or omissions. However, the proposed legislation would also allow reapplication when an application was deemed abandoned or withdrawn because of similar compliance-related issues.

Addressing Bureaucratic Barriers
“At a time when Florida’s families are struggling with rising insurance costs, we cannot allow bureaucratic technicalities to block access to affordability tools,” said Bracy Davis, a Democrat from Ocoee.

The bill responds to concerns from homeowners who were unable to submit a new application after their original submission was closed due to misunderstandings or reasonable mistakes regarding program requirements.

Focus on Seniors and Low-Income Homeowners
Rosenwald, a Democrat from Oakland Park, said the legislation is intended to help vulnerable homeowners who rely on the program for financial relief.

“This program can be a lifeline for seniors and low-income homeowners,” Rosenwald said. “In response to Floridians reporting that they were blocked from submitting a new application because of a misunderstanding or reasonable mistake concerning program compliance, I filed this glitch bill.”

If approved, the legislation would ensure more homeowners have access to financial assistance aimed at strengthening homes and improving insurance affordability across Florida.

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