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The FDA Approves A Breakthrough Vaccine 50 Years In The Making

On Wednesday, the Food and Drug Administration approved the first vaccine that protects against respiratory syncytial virus, otherwise known as RSV.

This is a big moment in the fight against a major scourge. Researchers have been working to create an RSV vaccine for more than half a century. And it's not an exaggeration to say RSV vaccines could save hundreds of thousands of lives each year on a global scale.

RSV generally causes cold symptoms, but can also lead to severe lung inflammation or infection in very young and very old people. Each year, it causes up to 160,000 hospitalizations and 10,000 deaths among older Americans, and as many as 55,000 adult deaths globally. People with heart and lung disease and weakened immune systems are at the highest risk for severe RSV disease.

RSV season usually starts in the autumn and is worst in the winter. The vaccine, known as Arexvy, was approved for adults 60 and over, will likely be recommended by the CDC in June and available in time for people to receive it this fall, according to reporting in the New York Times.

Young babies, especially newborns born prematurely, are also at high risk for bad disease due to RSV: Annually, the virus causes up to 80,000 hospitalizations and 300 deaths in American children under 5, and leads to 2 million outpatient visits. The virus also leads to an estimated 120,000 infant deaths worldwide each year.

Right now, this news does not impact pediatric populations. But there's hope on the horizon: Several vaccines that would protect babies and children — and a number of other adult vaccines — are currently either under FDA review or at earlier stages of development.

RSV was a major contributor to the "tripledemic" that flooded hospitals last winter. As these vaccines come to market, they could dramatically change the face of cold and flu season for the better.

For now, here's what you need to know.

The vaccine is highly effective and has generally mild side effects

Arexvy, which is made by drug manufacturer GSK, is one of two adult RSV vaccines the FDA reviewed at a March 1 meeting. In trials, the vaccine reduced the risk of lower respiratory tract illness in adults over 60 by nearly 83 percent, and the risk of severe illness by 94 percent.

The vaccine, which is given as a single injection, is built using the kind of conventional technology that preceded mRNA technology used to create many Covid-19 vaccines. It's built using a chunk of the RSV virus and a couple of additional molecules. The result is called a recombinant vaccine because it combines pieces of a virus with other products that stimulate the immune system. Other vaccines built with this technology include the ones used to prevent whooping cough, meningitis, and shingles.

Side effects related to the vaccine were generally mild and resolved within one to two days. The most common side effect was mild to moderate pain at the injection site, and a smaller number of people reported fatigue after the injection.

The FDA will monitor for severe side effects

For the most part, the Arexvy vaccine appears to be safe. However, the FDA has its eye on a few uncommon side effects that it will watch for carefully as more and more people get the vaccine. Although these were very rare among people who took part in the vaccine trials, they're severe enough to merit close monitoring.

In one trial, where each group had 12,500 participants, 10 Arexvy recipients and four people who got a placebo had atrial fibrillation, an irregular and rapid heart rhythm that can lead clots to form in the heart. (The condition is extremely common among older adults and sometimes reverses itself; it's treatable with blood thinners when it does not.) One participant in this trial developed Guillain-Barré syndrome, a condition in which the immune system attacks nerve cells, leading to weakness and sometimes paralysis.

In another trial with 2,500 people each in the Arexvy and placebo groups, two people who received the vaccine developed an inflammatory condition affecting the brain and spinal cord, one of whom died.

The FDA is requiring GSK to monitor for the incidence of all these conditions among people who get the vaccine going forward.

As ever, the question for the agency is whether the vaccine's side effect risks are greater than RSV risks. Time will help answer that question.

This is a huge win!

People first began trying to develop an RSV vaccine in the 1960s. Why did it take so long to make it work?

RSV's surface proteins are shape-shifters, taking different forms depending on whether they've invaded — or fused to — a human cell. To complicate matters, their pre-fusion shape is wildly unstable. That meant that for a long time, researchers' only option was to use the protein's post-fusion shapes as targets for new vaccines.

As a result, for years, RSV vaccines could only recognize viral particles after they'd invaded cells — too late to make much of a difference. To make a better vaccine, scientists really needed a clear picture of what those surface proteins looked like before cell invasion.

In 2013, structural biologist Jason McLellan, now at the University of Texas at Austin, figured out how to get that picture: He worked out a way to stabilize a surface protein in its pre-fusion form, then described it in great detail. That discovery meant researchers could now create vaccines that targeted an earlier stage of RSV infection — and they did.

Arexvy is just the first downstream result of this discovery to be approved by the FDA, and more will likely follow soon. Pfizer's RSV vaccine for adults will probably be approved later this month; Moderna has said it's expecting its adult vaccine to be authorized in the first half of this year; and multiple companies are working on vaccines to protect babies and toddlers under 2.

Overall, we're in for a lot more good news about RSV vaccines in the near future.

First-ever RSV Vaccine Approved By FDA For Adults 60 And Over

The Food and Drug Administration (FDA) has approved the first respiratory syncytial virus (RSV) vaccine for use in the U.S., the public health agency announced on Wednesday.

The drug, called Arexvy, is approved for use by people 60 years and older to prevent RSV, which is a lower respiratory tract disease.

"Older adults, in particular those with underlying health conditions, such as heart or lung disease or weakened immune systems, are at high risk for severe disease caused by RSV," said Dr. Peter Marks, PhD, director of the FDA's Center for Biologics Evaluation and Research in Silver Spring, Maryland, in the FDA's announcement. 

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"Today's approval of the first RSV vaccine is an important public health achievement to prevent a disease which can be life-threatening and reflects the FDA's continued commitment to facilitating the development of safe and effective vaccines for use in the United States," he continued.

The Food and Drug Administration (FDA) has approved the first respiratory syncytial virus (RSV) vaccine for use in the U.S. (iStock)

A common respiratory virus that is highly contagious, RSV generally causes mild, cold-like symptoms that usually last a week or two, according to the Centers for Disease Control and Prevention (CDC).

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For people in some high-risk groups, including older adults and babies, the virus can cause more serious conditions.

In older adults, RSV infections can lead to lung infection or pneumonia, and also could cause complications in those who have asthma, heart disease, weak immune systems or chronic obstructive pulmonary disease (COPD), per the CDC.

The drug, called Arexvy (not pictured), is approved for use by people 60 years and older to prevent RSV, which is a lower respiratory tract disease. (iStock)

Around 60,000-160,000 older adults are hospitalized in the U.S. With RSV each year — and between 6,000-1,000 die from the virus, the CDC states.

The FDA conducted an "an ongoing, randomized, placebo-controlled clinical study" to ensure Arexvy's safety and effectiveness of a single dose for people 60 years and older, according to the announcement.

Of the 25,000 study participants, half received the vaccine and half received a placebo.

"The vaccine significantly reduced the risk of developing RSV-associated LRTD (lower respiratory tract infection) by 82.6% and reduced the risk of developing severe RSV-associated LRTD by 94.1%," the FDA said.

"To put that in perspective, there were seven RSV cases in the vaccine group and 40 cases in the placebo group," Dr. Shana Johnson, a physical medicine and rehabilitation physician in Scottsdale, Arizona, told Fox News Digital. "Reducing severe disease, such as hospitalizations and death, are the critical benefits."

In older adults, RSV infections can lead to lung infection or pneumonia, and also could cause complications in those who have asthma, heart disease, weakened immune systems or chronic obstructive pulmonary disease (COPD). (iStock)

The most common side effects reported in the study were injection site pain, muscle pain, fatigue, joint pain/stiffness and headache.

The FDA also ran two smaller studies that included about 2,500 people 60 years of age and older. 

In one of those studies, in which participants received both Arexvy and an influenza vaccine, two people developed acute disseminated encephalomyelitis (ADEM) — a rare type of inflammation that affects the brain and spinal cord — within seven and 22 days of inoculation.

Around 60,000-160,000 older adults are hospitalized in the U.S. With RSV each year.

In the other study, one person developed Guillain-Barré syndrome, a rare immune disorder that causes muscle weakness and sometimes paralysis, nine days after getting inoculated with Arexvy.

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"Based on safety data from the two smaller studies, the FDA is requiring the company to do a post-marketing study to check for the risks of the immune-mediated complications of Guillain-Barré and ADEM, which are rare but catastrophic complications if they occur to an individual," Johnson explained.

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"The company has also committed to assessing for an increased rate of atrial fibrillation (an abnormal heart rhythm)," Johnson added.

Melissa Rudy is health editor and a member of the lifestyle team at Fox News Digital. 

R.S.V. Vaccine Approved For Older Adults

Why It Matters: R.S.V. Can be lethal

The F.D.A. Estimates that R.S.V. Is associated with 6,000 to 10,000 deaths each year in adults 65 and older and at least 60,000 hospitalizations in that age group. It is a leading killer of children worldwide.

This winter, R.S.V. Contributed to the "tripledemic" also involving flu and Covid cases that swamped children's hospitals and some I.C.U. Wards.

Announcing the approval, Dr. Peter Marks, the agency's vaccine division chief, said: "Older adults, in particular those with underlying health conditions, such as heart or lung disease or weakened immune systems, are at high risk for severe disease caused by R.S.V."

Background: Benefits and risks of the shots

On March 1, an F.D.A. Advisory panel reviewed data from trials for two R.S.V. Vaccines aimed at older adults, one from GSK and one from Pfizer. The panel recommended that the agency approve both.

The GSK vaccine was nearly 83 percent effective in preventing lower respiratory tract illness in adults 60 and older in a study of about 25,000 patients, according to data published in The New England Journal of Medicine. The virus can lead to pneumonia, which is far more worrisome for the elderly.

Pfizer's R.S.V. Vaccine for older adults is also expected to receive F.D.A. Approval this month. In a large study of that shot, it was found to be nearly 67 percent effective in preventing R.S.V.-related illness.

The Pfizer and GSK vaccines were even more effective in treating older and sicker patients.

The advisers did learn of some rare side effects from the vaccine trials. In the days after the shots were given, two recipients of the Pfizer vaccine and one recipient of the GSK shot developed cases of Guillain-Barré, a condition where the immune system attacks the nervous system, according to data presented to the F.D.A. Panel.

Once the shots become available to the public, the agency said it would require GSK to monitor the incidence of Guillain-Barré and another rare condition that was possibly related to the shot.

Moderna is also developing an R.S.V. Vaccine for this age group, and said it expected authorization in the first half of this year. A trial of 37,000 older adults showed 82 percent efficacy of its shot, the company said, with "no safety concerns identified" though analyses were continuing.

AstraZeneca and Sanofi are seeking F.D.A. Approval of a monoclonal antibody treatment to protect infants and toddlers up to 2 years old from R.S.V. Infections. Findings of a major study showed the therapy reduced confirmed illnesses by 75 percent after one shot, according to AstraZeneca.

Pfizer has applied for separate approval of an R.S.V. Vaccine to be given in the later stages of pregnancy to protect young infants.

What's Next: When will the shots be available?

It will still be months before the adult vaccine is publicly available in the United States.

The Centers for Disease Control and Prevention is expected to follow the F.D.A.'s approval, most likely issuing its recommendation in June.

GSK said its vaccine would then be available in the fall at U.S. Pharmacies, clinics and other health care settings.

GSK executives have said that supplies of the vaccine, which is manufactured mainly at a plant in Belgium, should be readily available. For Medicare patients with Part D drug coverage, there would be no out-of-pocket expense, Alison Hunt, a GSK spokeswoman, said. But the company has not released a price, although insurers typically cover much of the cost of many vaccines.

Last week, the European Medicines Agency recommended approval of GSK's vaccine for adults 60 and older. The company said it hoped the shots would also be approved later for use in Japan and China.

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