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RSV Nose Drops Vaccine Gets FDA Fast Track Tag

Respiratory syncytial virus

Respiratory syncytial virus ( National Institute of Allergy and Infectious Diseases, NIH)

2 Nov. 2022. A vaccine designed from engineered live viruses and taken as nose drops to prevent respiratory syncytial virus received a Food and Drug Administration fast-track designation. Codagenix Inc. in Farmingdale, New York is developing the experimental vaccine CodaVax-RSV for children age five years and younger, the most common population segment to get RSV infections.

RSV is a common respiratory virus affecting young children and older adults that in most cases results in only mild and temporary symptoms similar to the common cold. Some infants and young children, however, can develop more serious complications from RSV, such as bronchiolitis — inflamed small airways in the lungs — and pneumonia, requiring hospitalization. Centers for Disease Control and Prevention says each year RSV causes 2.1 million outpatient visits among children under the age of five years, leading to 58,000 to 80,000 hospitalizations and up to 300 deaths. Among older adults, age 65 and over, RSV is responsible for 120,000 hospitalizations each year, leading to as many as 10,000 deaths.

Codagenix develops vaccines for infectious diseases and as cancer therapies, as well as for animal health. The company’s technology for infectious diseases such as RSV starts with live viruses, then applies techniques driven by synthetic biology and machine learning algorithms to attenuate or weaken the virus’s infectious properties. Those techniques, says Codagenix, involve removing hundreds of key genetic components from the viral DNA, while retaining enough of the original live virus to generate an immune response.

Trial with young children set to begin

The company says its infectious disease technology alters the the microbe further to stabilize the remaining viral elements, making it possible to produce vaccines administered without injections and, in some cases, shipped and stored without refrigeration, as needed by conventional vaccines. Codagenix’s lead product is CoviLiv, an attenuated virus vaccine given as a nasal spray to prevent SARS-CoV-2 infections, needing only conventional refrigeration. CoviLiv is being tested as a Covid-19 booster vaccine.

Codagenix is set to begin an early-stage clinical trial of CodaVax-RSV among 36 healthy children age five and younger with or without RSV antibodies in their blood. Participants are randomly assigned to receive two doses of CodaVax-RSV nose drops or a placebo, 28 days apart. Parents will take the children’s temperature and record other symptoms in a diary, with telephone follow-up periodically over the test period. The study team is looking primarily for adverse reactions of any severity for up to two months, as well as neutralizing antibodies in blood sample of participants after a month.

FDA assigns its fast track designation to speed development and review of new drugs, biologics, or diagnostics addressing serious unmet medical needs. Fast-track designees are eligible for more frequent interactions with FDA and expedited agency reviews. New medical products need to show evidence of superior effectiveness or fewer adverse effects, or address emerging public health needs. Children’s hospitals in many parts of the U.S. are now experiencing a spike in new RSV admissions, in some cases filling up available hospital beds.

“Unlike previous live-attenuated RSV vaccine candidates,” says Codagenix co-founder and CEO J. Robert Coleman in a company statement, “CodaVax-RSV is extremely stable due to genetic edits that prevent wild-type reversion. This stability, combined with easy intranasal administration, broad systemic and mucosal immunity and preclinical efficacy in animal models, and clinically demonstrated safety, culminate in a promising profile that we look forward to investigating further in a Phase 1 study in healthy infants and toddlers.”

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