Biotech's RSV vaccine gets FDA 'fast track' status
Steffen Mueller, president and chief scientific officer for Codagenix, working in a lab. Credit: Newsday/John Paraskevas
The RSV vaccine candidate of a Long Island biotech has won "fast track" designation from the Food and Drug Administration, the company said Wednesday.
Codagenix Inc., based in Farmingdale, said it expects to launch a phase 1 trial of its CodaVax-RSV candidate for healthy children aged six months to five years early next year.
The FDA grants fast-track status in an effort to hasten the development of drugs that could fill an unmet medical need.
In a statement, J. Robert Coleman, Codagenix co-founder and chief executive, said that the vaccine, delivered through nose drops, has shown effectiveness in animal studies and could help prevent spread of the virus through airways.
In the United States, there are no vaccines approved for respiratory syncytial virus.
Its cold-like symptoms typically are mild. Still, in severe cases, RSV leads to an estimated 100-300 deaths annually among children younger than 5 and 6,000 to 10,000 among adults 65 and older, according to the Centers for Disease Control and Prevention. A Codagenix spokesman said the company's clinical trials are focused only on children for now.
Earlier this week, Pfizer Inc. announced positive data from a phase 3 clinical trial for an RSV vaccine given to expectant mothers that also protects their newborns.
Data showed the Pfizer vaccine prevented hospitalization or assisted breathing from birth to six months in about 70% of infants. That RSV vaccine received breakthrough therapy designation from the FDA in March. A breakthrough therapy designation is designed to speed development of a drug whose early clinical data indicates a "clear advantage" over existing treatment.
Pfizer said the vaccine also is being tested on adults aged 60 or older.
An RSV vaccine for adults also is under development by London drugmaker GSK plc.
The World Health Organization has begun giving volunteers doses of a Codagenix serum as part of a global campaign to develop next-generation COVID-19 vaccines.
Codagenix, a startup founded on research developed at Stony Brook University, is backed by venture capital firms, including Topspin Partners, Euclidean Capital and Adjuvant Capital.
RSV symptoms
Symptoms of RSV include nasal congestion, runny nose, decreased appetite, cough, sneezing, fever, headache;
Severe cases can lead to pneumonia or bronchiolitis, inflammation of passages leading to the lungs; those symptoms can include fever, cough, wheezing, labored breathing and bluish skin color (lack of oxygen);
Symptoms in infants can include: shallow, rapid breathing; labored breathing, cough, lethargy;
Seasonal patterns
Historically, RSV cases have spiked from late December to mid-February, though the CDC said that the COVID-19 pandemic disrupted some seasonal trends.
What to do
Cases are usually mild and require only home care;
Stay at home if you don't feel well (People with RSV are usually contagious for three to eight days, though some may carry the virus longer.)
Cover your mouth and nose when you sneeze or cough; wash your hands.
Children only should return to day care or school a minimum of 24 hours after their fever has returned to normal (without medication).
Sources: Mayo Clinic, Centers for Disease Control and Prevention
Ken Schachter covers corporate news, including technology and aerospace, and other business topics for Newsday. He has also worked at The Miami Herald and The Jerusalem Post.
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