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.

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.