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RSV Vaccines Are Finally Here after Decades of False Starts

After a decades-long search, vaccines for RSV are finally here. Scientists have been working on the shots since soon after the virus was discovered in 1956. But some disastrous clinical trials in the 1960s and dozens of other failed attempts stymied progress for many years. Now not just one but two RSV vaccines for older adults have been approved by the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention. As of this writing, a vaccine given to pregnant people, designed to protect infants after birth, was on track to be approved by the end of the summer. The breakthrough leading to these developments happened once researchers solved a 50-year-old mystery about…

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Featured

 RSV Vaccine Labeling Updated With Guillain-Barré Syndrome Warning

Findings from this self-controlled case series showed an increased risk of GBS during the 42 days following vaccination with Abrysvo (9 excess cases per million doses; incidence rate ratio [GBS cases in the risk window/control window], 2.02 [95% CI, 0.93-4.40]) and Arexvy (7 excess cases per million doses; incidence rate ratio, 2.46 [95% CI, 1.19-5.08]). Results of this study, coupled with clinical trial data and reports to the Vaccine Adverse Event Reporting System (VAERS), suggest an increased risk of GBS with these vaccines, though a causal relationship could not be established due to insufficient evidence. According to the FDA, the benefits of vaccination with Abrysvo and Arexvy continue to outweigh the potential risks.

Previously Featured

Do Early R.S.V. Vaccine Trials Have a Henrietta Lacks Story?

The new vaccines have been thoroughly tested in accordance with today’s clinical trial standards. But this breakthrough has a history, one tangled up in questions of medical ethics and racial exploitation.

FDA Approves the First RSV Vaccine for Pregnant Women

The shot becomes the second RSV vaccine, and third new intervention against the disease this year. In May, the FDA approved the Abrysvo vaccine for preventing RSV in people 60 years and older. The same vaccine is now approved for pregnant people in their third trimester. And in July, the agency approved nirsevimab, an antibody-based injection that protects babies immediately after birth from RSV.

FDA’s approval of the world’s first vaccine against RSV will offer a new tool in an old fight – 4 questions answered

A vaccine against RSV has been in the works for decades. One problem that has plagued vaccine manufacturers is the difficulty of identifying an antigen – the piece of the virus that the vaccine targets – that doesn’t change, or shape-shift. The F protein of the RSV virus is notorious for changing its shape once it fuses with a host’s cell.

Moderna says RSV vaccine worked, setting stage for competition with GSK and Pfizer

Moderna’s vaccine against the respiratory syncytial virus, or RSV, reduced the rate of lower respiratory disease in people over 60 in a Phase 3 trial, the company said Tuesday. The result will increase competition in a soon-to-be crowded market. The drug giants Pfizer and GlaxoSmithKline have already presented results for their RSV vaccines in older individuals, and have been preparing for what could be a brisk marketing battle.

New RSV vaccines are coming. This is very, very good news.

The vaccines, along with other preventative treatments, could change cold season as we know it.

Pfizer's RSV vaccine to protect babies gets greenlight from FDA

Given during the third trimester of pregnancy, Pfizer's new shot – Abrysvo – protects infants from lower respiratory tract disease caused by RSV, or respiratory syncytial virus, through their first six months of life.

Respiratory Syncytial Virus Vaccines

The goal of RSV vaccination is not to prevent RSV infection but, rather, to prevent RSV-associated LRI. Efficacy studies of candidate vaccines will have to be designed with this goal in mind.

Should You Get the New RSV Vaccine?

The RSV vaccines work by introducing an inactivated RSV protein into the body, where it fuses to host cells and stimulates the immune system to recognize the actual RSV virus if/when it encounters it and help prevent severe disease.

The FDA approves a breakthrough vaccine 50 years in the making

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.

What to Know About the New R.S.V. Immunizations

New vaccines for older adults and pregnant women, and an antibody therapy for infants, provide options for preventing severe infection.

Resources

Abrysvo

ABRYSVO is a vaccine indicated for: the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in people 60 years of age and older pregnant individuals at 32 through 36 weeks gestational age for the prevention of LRTD and severe LRTD caused by RSV in infants from birth through 6 months of age

Arexvy

AREXVY is the first FDA-approved vaccine for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus in people aged 60 years and older.

Beyfortus

Beyfortus is a prescription medicine used to help prevent a serious lung disease caused by Respiratory Syncytial Virus (RSV) in: Newborns and babies under 1 year of age born during or entering their first RSV season. Children up to 24 months of age who remain at risk of severe RSV disease through their second RSV season.

RSV and Me

Even the best-laid plans could be cut short by RSV. While you may not have heard of it yet, RSV is not a new virus and may be more of a health concern than you think—even if you’re healthy. If you’re aged 60 or over, you can get RSV. But don’t worry, by coming here you’ve taken a savvy first step toward learning about RSV so you can be informed. Let’s dive in..

CDC

Vaccines are available to protect older adults from severe RSV. Monoclonal antibody products are available to protect infants and young children from severe RSV.