Pfizer's RSV vaccine receives FDA breakthrough therapy designation for "medical masks" to prevent lower respiratory tract diseases in the elderly

April 1, 2022 / eMedClub News / -- On March 25, 2022, Pfizer announced that its respiratory syncytial virus (RSV) vaccine candidate, RSVpreF, received a U.
S.
Food and Drug Administration (FDA) breakthrough Sexual therapy designation for the prevention of lower respiratory tract disease caused by RSV in people 60 years of age or older
.

The FDA's decision was driven primarily by positive results from a proof-of-concept, Phase 2a study evaluating the safety, immunogenicity and efficacy of a single dose of 120 μg RSVpreF in a human virus challenge model in healthy adults aged 18 to 50 years
.

RSV Respiratory syncytial virus (RSV) is a common virus that can cause respiratory symptoms
.

Infections caused by RSV include upper respiratory tract infections (colds), bronchiolitis (infections of the pulmonary passages), and pneumonia
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In most healthy children and adults, RSV causes cold symptoms for about a week
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But for the young, the elderly, people with weakened immune systems, and those with underlying lung or heart disease, it can be very serious and even life-threatening
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How to get infected with respiratory syncytial virus? Respiratory syncytial virus (RSV) spreads easily from person to person
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When an infected person coughs or sneezes, virus-laden droplets are spread through the air
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You can also get RSV by touching something that an infected person has touched, such as a doorknob or a toy, and then touching your eyes, nose, or mouth
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Viruses can survive for hours on hard surfaces
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People infected with RSV are usually contagious within 3 to 8 days of showing symptoms, but some infants and individuals with weakened immune systems can continue to transmit even after they appear to have recovered, the Centers for Disease Control and Prevention (CDC) said.
virus for up to 4 weeks
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What are the symptoms of RSV? Symptoms of RSV tend to appear 4 to 6 days after infection
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Most children and adults over 6 months of age contract RSV, with symptoms similar to the common cold: runny nose, stuffy nose, mild headache, sore throat, cough, fever, fatigue
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Symptoms usually last 3 to 7 days, although a cough can last for several weeks
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The CDC notes that babies don't always show these symptoms
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In infants younger than 6 months, the only symptoms of RSV infection may be irritability, decreased activity and appetite, and apnea (pauses in breathing)
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In early March, Pfizer announced that RSVpreF received Breakthrough Therapy Designation from the U.
S.
Food and Drug Administration (FDA) for the prevention of RSV-related lower respiratory tract disease in infants from birth to six months of age through active immunization of pregnant women
.

The FDA designation was driven by the results of a Phase 2b proof-of-concept study (NCT04032093) of RSVpreF, which evaluated the safety, tolerability and immunogenicity of RSVpreF in vaccinated pregnant women and their infants aged 18 to 49 years
.

This follows the FDA's November 2018 decision to grant RSVpreF Fast Track status
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Existing modalities for prevention and treatment of RSV Currently, standard treatment for RSV is limited to supportive care such as oxygen, nasal congestion relievers, nutrition and hydration, and the use of bronchodilators, epinephrine, and steroids
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Ribavirin, a broad-spectrum antiviral drug not specifically targeting RSV, is not recommended by major clinical practice guidelines in the United States and China due to concerns about its potential toxicity, limited and unpredictable efficacy, and its association with nebulized administration With the associated inconvenience and high costs, a patient can cost an average of $29,000 per day
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There are currently no existing RSV drugs approved specifically for RSV pediatric patients in China
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Interferon is an off-label broad-spectrum drug used in China to treat children with RSV bronchiolitis and pneumonia
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About Pfizer Pfizer's investigational RSV vaccine candidate builds on basic science discoveries, including those from the National Institutes of Health (NIH), that detail the crystal structure of pre-fusion F, which RSV uses for A key form of the viral fusion protein (F) that attacks human cells
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Research from the National Institutes of Health has shown that specific antibodies in the prefusion form are highly effective at blocking viral infection, suggesting that prefusion F-based vaccines may offer the best protection against RSV
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Following this important discovery, Pfizer tested numerous versions of the viral protein and identified those that elicited strong antiviral immune responses in preclinical evaluations
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The vaccine candidate consists of two preF proteins selected to optimize protection against RSV A and
B.

References: 1.
https:// Xuanhu Medical Heart "Respiratory Syncytial Virus" - a list of recent popular activities - ▼On April 12, diversified genetic modification helps CAR-T therapy to release application potential