Pfizer plans to test around 30,000 people aged 60 and up around the world.
Pfizer announced on Thursday that its vaccine for the respiratory syncytial virus, or RSV, has entered the third phase of adult clinical trials, nearly two weeks after the Food and Drug Administration (FDA) fully authorized Pfizer’s SARS-CoV-2 or COVID-19 vaccine.
RENOIR (RSV vaccine Efficacy study in Older adults Immunized against RSV disease) is a phase 3 clinical trial that evaluates the efficacy, immunogenicity, and safety of a single dose of Pfizer’s respiratory syncytial virus vaccine candidate in adults 60 years and older. According to Pfizer, RENOIR will test around 30,000 people over the age of 60 around the world.
RSV is a common respiratory virus that is often confused with COVID-19 due to similar symptoms. Most children had an RSV infection by the age of two, according to the CDC. RSV can be dangerous for infants and the elderly, and most adults recover in one to two weeks.
“RSV is a significant cause of severe respiratory disease in older adults, and it can cause disability and death. There is an important unmet medical need for an effective vaccine that can help protect older adults against this highly-contagious disease. The start of this Phase 3 study is an important step forward towards our goal of comprehensive immunization against RSV disease, which includes developing a potential first vaccine to help prevent RSV disease in adults as well as the ongoing efforts to help protect infants through maternal immunization, subject to regulatory approval of the candidate vaccine.”Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research & Development at Pfizer Inc.
The Respiratory Syncytial Virus Burden
RSV (respiratory syncytial virus) is a widespread and common cause of acute respiratory illness. The virus infects the lungs and airways and is highly contagious. Infections affect people of all ages and can feel like a common cold to most young adults, but they can be life-threatening to infants, the immunocompromised, and the elderly.
In older adults, as well as those with chronic heart or lung disease or a weakened immune system, the risk of serious infection increases.
More than 177,000 older adults over the age of 65 are hospitalized in the US each year, with 14,000 of them dying from RSV.
RSV OR COVID-19? Watch out for these symptoms
RSV is the most common cause of bronchiolitis and pneumonia in children under the age of one year. RSV symptoms include, but are not limited to, runny nose, loss of appetite, coughing, sneezing, fever, and wheezing.
There has been an unusual increase in RSV cases this summer. Cases of RSV and other respiratory viruses typically increase in the fall and peak in the winter. According to Pfizer, RSV affects about 177,000 older adults over the age of 65, with 14,000 cases resulting in death, making the vaccine all the more important given how dangerous it can be for infants and the elderly.