an experimental vaccine from
Moderna Ltd.
significantly reduced the risk of viral respiratory disease It’s the latest promising sign in pharmaceutical companies’ efforts to combat the deadly RSV virus among older adults participating in large clinical trials.
Citing results, the Cambridge, Massachusetts-based company announced Tuesday that it will apply for U.S. regulatory approval to market a vaccine against RSV within the next few months. RS virus. If regulators approve a vaccine, it could be available by early 2024, the company said.
Moderna’s RSV vaccine was 83.7% effective against lower respiratory tract disease caused by RSV in the study, the company said. To assess efficacy, Moderna counted cases with at least two symptoms, such as cough, fever, and difficulty breathing, in addition to his confirmed RSV infection.
Moderna’s vaccine was 82.4% effective in preventing severe RSV cases with three or more symptoms, the company said.
“We have demonstrated that a highly effective vaccine can be developed against a highly unmet need for a viral infection,” said Stephen Hoge, President of Moderna.
This result is the latest in an experimental RSV vaccine.Also developed shot that is
sequencer,
Pfizer Ltd.
When
in the meantime,
Sanofi SA
When
PLC co-developed an antibody-based drug used to prevent RSV in infants. They have applied for FDA approval of the drug and expect a decision in the third quarter of 2023.
RSV can lead to: serious health problems Pneumonia and dyspnea in infants and the elderly.one of the viruses behind the surge Hospitalizations and emergency room visits in recent months in the United States, along with flu and Covid-19.
According to the Centers for Disease Control and Prevention, approximately 58,000 children under the age of five and 177,000 adults over the age of 65 are hospitalized each year due to RSV infection. While most children survive, RSV kills up to 500 children and about 14,000 seniors annually in the United States.
Unlike influenza and Covid-19, there is no licensed vaccine against RSV. For years, efforts to find a safe and effective vaccine have been unsuccessful, but a breakthrough in research a decade ago at the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases has helped pharmaceutical companies to do better. The way has been opened to find promising candidates.
Researchers have found that using specific methods to target proteins on the surface of viruses can be effective in triggering the desired immune response.
Moderna’s Phase 3 trial, which began early last year, has enrolled approximately 37,000 people aged 60 and older in 22 countries, including the United States. About half received her dose of Moderna’s RSV vaccine and the rest received a placebo.
In an interim analysis, researchers detected 64 cases of RSV with at least 2 symptoms in all study subjects after receiving vaccine or placebo. Of these, 55 were those who received a placebo and 9 were those who received the Moderna vaccine, indicating that the vaccine was effective in reducing the risk of disease.
The company is also tracking the effectiveness of its vaccine against mild infections with fewer than two symptoms, but has not published results on the effectiveness of these measures. and will be presented at a medical conference.
“We want to focus on the more serious forms of the disease that we believe are actually causing the majority of the burden, both in terms of cost and distress,” said Dr. Hoge.
He said vaccine efficacy appears to last for at least six months and could be longer until follow-up analysis. Dr. Hoge said he envisions receiving the RSV vaccine once a year.
People in the study experienced adverse events such as injection site pain, fatigue, and headaches.
Pfizer and GSK have applied for Food and Drug Administration approval of their respective RSV vaccines for adults over the age of 60, with an FDA decision expected in May. Any FDA approval will be the first approval of an RSV vaccine.
GSK’s RSV vaccine was approximately 82.6% effective against lower respiratory tract disease and 94.1% effective against severe disease in the study. In another study, Pfizer’s RSV Vaccine It was 66.7% effective for lower respiratory tract disease with at least 2 symptoms and 85.7% effective for more severe cases with at least 3 symptoms.
Johnson & Johnson is analyzing the results of a large RSV vaccine study and preparing to submit shots for regulatory approval.
Moderna is also researching RSV vaccines for adults and children under the age of 60.
Write to Peter Loftus at [email protected]
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