An experimental vaccine from
Moderna Inc.
significantly reduced the risk of a viral respiratory disease among older adults in a large clinical trial, the latest promising sign in drugmakers’ efforts to fight the deadly RSV virus.
Based on the results, the Cambridge, Mass., company said Tuesday it would apply in the coming months for U.S. regulatory approval to sell its vaccine against RSV, which stands for respiratory syncytial virus. If regulators approve, it could become available by early 2024, the company said.
Moderna’s RSV vaccine was 83.7% effective against lower-respiratory diseases caused by RSV in the study, the company said. To assess efficacy, Moderna counted cases of confirmed RSV infections plus at least two symptoms, such as cough, fever or difficulty breathing.
Moderna’s vaccine was 82.4% effective at preventing severe RSV cases with three or more symptoms present, the company said.
“We really have demonstrated now against a high-unmet need viral infection that we can develop a highly effective vaccine,” Moderna President
Stephen Hoge
said.
The results are the latest for an experimental RSV vaccine. Also developing shots are
GSK
PLC,
Pfizer Inc.,
and
Johnson & Johnson.
Meantime,
Sanofi SA
and
AstraZeneca
PLC have co-developed an antibody-based drug to be used for the prevention of RSV in infants. They applied for FDA approval of the drug and expect a decision in the third quarter of 2023.
RSV can lead to serious health problems such as pneumonia and difficulty breathing for infants and older adults. It is one of the viruses behind a surge in hospitalizations and visits to emergency rooms in recent months in the U.S., along with influenza and Covid-19.
Each year RSV infections result in about 58,000 hospitalizations of children under 5 years old and 177,000 hospitalizations of adults 65 and older, according to the Centers for Disease Control and Prevention. While most children survive, RSV kills up to 500 children in the U.S. each year and about 14,000 older adults each year—a toll that approaches that of influenza.
Unlike flu and Covid-19, there is no approved vaccine against RSV. For many years, efforts to find a safe and effective vaccine failed, but a research breakthrough a decade ago at the U.S. National Institute of Allergy and Infectious Diseases vaccine-research center cleared the way for drugmakers to find more promising candidates.
The researchers found that using a certain method to target a protein on the surface of the virus could be effective at triggering the desired immune response.
Moderna’s Phase 3 trial, which started early last year, enrolled about 37,000 people ages 60 and older in 22 countries including the U.S. About half were given a single dose of Moderna’s RSV vaccine and the other half received a placebo.
In an interim analysis, researchers detected 64 cases of RSV with at least two symptoms among all study subjects after getting the vaccine or placebo. Of these, 55 cases were in people who received the placebo, while nine occurred among people who received the Moderna vaccine, indicating the vaccine was effective at reducing the risk of disease.
The company also is tracking the vaccine’s effectiveness against milder infections, with fewer than two symptoms, but didn’t release efficacy results for those measures. Moderna plans to publish the full study results and present them at a coming medical conference.
“We want to focus on a more severe form of the disease that we think really does drive a majority of the burden, both in cost and suffering,” Mr. Hoge said.
He said the vaccine’s efficacy appeared to hold up for at least six months, and could be longer pending follow-up analyses. Moderna envisions the RSV vaccine as a once-yearly shot ahead of typical RSV season in the fall and winter in the Northern Hemisphere, Mr. Hoge said.
People in the study experienced some adverse events including injection-site pain, fatigue and headache.
Pfizer and GSK have applied for Food and Drug Administration approval of their respective RSV vaccines in adults 60 and older, and expect FDA decisions in May. An FDA approval of either would be the first approval of an RSV vaccine.
GSK’s RSV vaccine was about 82.6% effective against lower-respiratory tract disease in a study, and 94.1% effective against severe cases. In a separate study, Pfizer’s RSV vaccine was 66.7% effective against lower respiratory tract illness with at least two symptoms, and 85.7% effective against more severe cases, with at least three symptoms.
Moderna also is studying its RSV vaccine in adults younger than 60 years and in children.
Write to Peter Loftus at Peter.Loftus@wsj.com
Copyright ©2022 Dow Jones & Company, Inc. All Rights Reserved. 87990cbe856818d5eddac44c7b1cdeb8
An experimental vaccine from
Moderna Inc.
significantly reduced the risk of a viral respiratory disease among older adults in a large clinical trial, the latest promising sign in drugmakers’ efforts to fight the deadly RSV virus.
Based on the results, the Cambridge, Mass., company said Tuesday it would apply in the coming months for U.S. regulatory approval to sell its vaccine against RSV, which stands for respiratory syncytial virus. If regulators approve, it could become available by early 2024, the company said.
Moderna’s RSV vaccine was 83.7% effective against lower-respiratory diseases caused by RSV in the study, the company said. To assess efficacy, Moderna counted cases of confirmed RSV infections plus at least two symptoms, such as cough, fever or difficulty breathing.
Moderna’s vaccine was 82.4% effective at preventing severe RSV cases with three or more symptoms present, the company said.
“We really have demonstrated now against a high-unmet need viral infection that we can develop a highly effective vaccine,” Moderna President
Stephen Hoge
said.
The results are the latest for an experimental RSV vaccine. Also developing shots are
GSK
PLC,
Pfizer Inc.,
and
Johnson & Johnson.
Meantime,
Sanofi SA
and
AstraZeneca
PLC have co-developed an antibody-based drug to be used for the prevention of RSV in infants. They applied for FDA approval of the drug and expect a decision in the third quarter of 2023.
RSV can lead to serious health problems such as pneumonia and difficulty breathing for infants and older adults. It is one of the viruses behind a surge in hospitalizations and visits to emergency rooms in recent months in the U.S., along with influenza and Covid-19.
Each year RSV infections result in about 58,000 hospitalizations of children under 5 years old and 177,000 hospitalizations of adults 65 and older, according to the Centers for Disease Control and Prevention. While most children survive, RSV kills up to 500 children in the U.S. each year and about 14,000 older adults each year—a toll that approaches that of influenza.
Unlike flu and Covid-19, there is no approved vaccine against RSV. For many years, efforts to find a safe and effective vaccine failed, but a research breakthrough a decade ago at the U.S. National Institute of Allergy and Infectious Diseases vaccine-research center cleared the way for drugmakers to find more promising candidates.
The researchers found that using a certain method to target a protein on the surface of the virus could be effective at triggering the desired immune response.
Moderna’s Phase 3 trial, which started early last year, enrolled about 37,000 people ages 60 and older in 22 countries including the U.S. About half were given a single dose of Moderna’s RSV vaccine and the other half received a placebo.
In an interim analysis, researchers detected 64 cases of RSV with at least two symptoms among all study subjects after getting the vaccine or placebo. Of these, 55 cases were in people who received the placebo, while nine occurred among people who received the Moderna vaccine, indicating the vaccine was effective at reducing the risk of disease.
The company also is tracking the vaccine’s effectiveness against milder infections, with fewer than two symptoms, but didn’t release efficacy results for those measures. Moderna plans to publish the full study results and present them at a coming medical conference.
“We want to focus on a more severe form of the disease that we think really does drive a majority of the burden, both in cost and suffering,” Mr. Hoge said.
He said the vaccine’s efficacy appeared to hold up for at least six months, and could be longer pending follow-up analyses. Moderna envisions the RSV vaccine as a once-yearly shot ahead of typical RSV season in the fall and winter in the Northern Hemisphere, Mr. Hoge said.
People in the study experienced some adverse events including injection-site pain, fatigue and headache.
Pfizer and GSK have applied for Food and Drug Administration approval of their respective RSV vaccines in adults 60 and older, and expect FDA decisions in May. An FDA approval of either would be the first approval of an RSV vaccine.
GSK’s RSV vaccine was about 82.6% effective against lower-respiratory tract disease in a study, and 94.1% effective against severe cases. In a separate study, Pfizer’s RSV vaccine was 66.7% effective against lower respiratory tract illness with at least two symptoms, and 85.7% effective against more severe cases, with at least three symptoms.
Moderna also is studying its RSV vaccine in adults younger than 60 years and in children.
Write to Peter Loftus at Peter.Loftus@wsj.com
Copyright ©2022 Dow Jones & Company, Inc. All Rights Reserved. 87990cbe856818d5eddac44c7b1cdeb8