– RSV is a common virus that causes respiratory infections, particularly in young children and older adults. It is a leading cause of hospitalization among older adults in the United States.

– The Pfizer-BioNTech vaccine is designed to prevent RSV in adults aged 60 and older, who are at high risk of severe disease and hospitalization. The vaccine uses messenger RNA (mRNA) technology, the same technology used in Pfizer-BioNTech’s COVID-19 vaccine.

– The FDA advisory committee voted unanimously to recommend the vaccine, citing data from a Phase 2 trial that showed the vaccine was well-tolerated and generated an immune response against RSV.

– The recommendation is a positive step towards the development of the first vaccine against RSV. However, it is not a final approval, and the FDA will still need to review and approve the vaccine before it can be made available to the public.

– The Pfizer-BioNTech RSV vaccine is part of a larger effort to develop vaccines for respiratory viruses, including COVID-19. mRNA technology has shown promise in developing vaccines quickly and effectively, and could be a key tool in fighting future pandemics.

In a recent development, the US Food and Drug Administration (FDA) advisory committee voted in favor of recommending the country’s first vaccine against Respiratory syncytial virus (RSV) for older people. The vaccine, which is developed by Pfizer, is aimed at people aged 60 years and older. The vote was based on the vaccine’s efficacy and showed a reduction of up to 86% in the risk of contracting RSV. The FDA now has to approve the vaccine, which may take a few months. If approved, the Centers for Disease Control and Prevention must also recommend the shot before it becomes available to the public.

RSV is a viral infection that causes lower respiratory illness and can lead to serious complications such as bronchiolitis or pneumonia. Older people and infants are at higher risk of severe outcomes, and it is estimated that RSV kills over 10,000 people aged 65 or older and around 300 children under 5 every year in the US. In addition, there has been a recent spike in RSV cases among infants, which has overwhelmed children’s hospitals.
The Pfizer vaccine is not the only RSV vaccine being evaluated by the FDA. The advisory committee is also set to evaluate a similar vaccine for older adults from GlaxoSmithKline, which has shown promising results in clinical trials, with an 83% reduction in symptomatic illness and a 94% reduction in severe illness in people aged 60 and up.
The development of RSV vaccines is essential in reducing the burden of disease and associated hospitalizations, particularly among vulnerable populations. Several companies are racing to secure FDA approval for RSV vaccines, with Moderna and Bavarian Nordic among those with vaccines in development.

Despite the positive outcome of the Pfizer vaccine vote, concerns were raised by some committee members about its safety profile. The most common side effects of the vaccine among older people were fatigue, headache, pain at the injection site, and muscle pain. Additionally, there were concerns about a potential association with Guillain-Barré syndrome(https://en.wikipedia.org/wiki/Guillain–Barré_syndrome), a rare neurological disorder that damages nerve cells and causes muscle weakness or paralysis. One man in the Pfizer trial developed Guillain-Barré after receiving the vaccine, and a woman developed Miller Fisher syndrome(https://rarediseases.org/rare-diseases/miller-fisher-syndrome/ )a rare nerve disease related to Guillain-Barré.

In conclusion, the positive vote for the Pfizer RSV vaccine is a significant step towards protecting vulnerable populations from this serious viral infection. With other vaccines in development and the ongoing evaluation of the safety and efficacy of the Pfizer and GlaxoSmithKline vaccines, there is hope for reducing the burden of disease caused by RSV.

———

#RSVvaccine #Pfizer #FDA #advisorycommittee #elderly #respiratoryillness #GuillainBarreSyndrome #vaccines