Health
Pfizer RSV Vaccine Clinical Trial Shows Protection for Infants and the Elderly
- A new study finds that an RSV vaccine appears to be effective in protecting newborns from severe disease.
- Results showed that this vaccine is effective against severe RSV-associated lower respiratory tract diseases such as pneumonia and bronchiolitis in infants from birth to 6 months of age.
- Bronchiolitis is inflammation of the small airways that enter the lungs.
The Pfizer respiratory syncytial virus (RSV) vaccine protected infants and the elderly from disease caused by the virus, according to preliminary results from two Pfizer-funded trials.
In one trial, the results were published on April 5th. New England Journal of Medicinethe vaccine was given late in pregnancy.
Results showed that this vaccine is effective against severe RSV-associated lower respiratory tract diseases such as pneumonia and bronchiolitis in infants from birth to 6 months of age.
Bronchiolitis is inflammation of the small airways that enter the lungs.
“By giving pregnant women this vaccine, they produce antibodies that cross the placenta and protect their infant in the first few months of life. Colleen CunninghamA professor of pediatrics at the University of California, Irvine, who was not involved in the trial, told Healthline.
The vaccine was 82% effective at 90 days of age and 69% effective at 6 months of age.
Cunningham said this decline in efficacy is expected because antibody levels in infants decline over time.
However, “this strategy [of vaccinating a pregnant mother] It is expected to be very helpful in the first few months of life,” she said.
Researchers identified no safety concerns in vaccinated infants or women.
Pfizer is Asked The Food and Drug Administration approves an RSV vaccine for pregnant women to protect infants. The company said it expects to make a decision by August 2023.
FDA too review Application from AstraZeneca for monoclonal antibody therapy designed to protect children up to 2 years of age from RSV.
In another company-funded trial, the Pfizer RSV vaccine was 67% to 86% effective against RSV-related lower respiratory tract disease, including acute bronchitis and pneumonia, in adults 60 years and older.
It was also 62% effective against RSV-related acute respiratory illness.
Results on April 5th, New England Journal of Medicine.
The researchers identified no safety concerns in this age group, and the incidence of adverse events was similar between vaccinated and inactive placebo groups.
The results show that three serious adverse events observed in vaccinees were thought to be vaccine-related.
The first was a delayed allergic reaction.the other two were consistent
If these vaccines are approved by the FDA, the FDA and Centers for Disease Control and Prevention will continue to monitor their safety.
Pfizer is demand FDA approval of RSV vaccine for adults over age 60.
In March, the FDA’s Vaccines Advisory Committee voted Favor approval of RSV vaccine candidates for the elderly from GlaxoSmithKline (GSK) and Pfizer.
If authorities approve these vaccines, they could be the first RSV vaccines approved in the world.
Johnson & Johnson’s vaccine division, Janssen, announced In March, it was due to complete research into an RSV vaccine candidate.
Bavarian Nordic based in Denmark expect Here are the results of a clinical trial of an RSV vaccine for the elderly that took place in the middle of this year.
RSV is widespread and highly contagious. Most children get RSV by the time he is 2 years old.
But people of all ages can be infected multiple times in their lifetime, the agency said.
RSV usually causes a mild infection in most people, causing cold-like symptoms such as runny nose, cough, sneezing, fever and loss of appetite.
However, in infants younger than 6 months and older adults, RSV can be severe enough to lead to hospitalization and death.
RSV causes up to 80,000 hospitalizations and up to 300 deaths in children under the age of five each year in the United States. National Infectious Diseases Foundation.
Additionally, RSV causes up to 160,000 hospitalizations and up to 10,000 deaths in adults over the age of 65, the foundation reports.
There is currently no specific treatment for RSV infection. Treatment includes managing symptoms and providing supportive care.
Doctor David DeemartHe is Professor of Medicine and Microbiology, Immunology, and Tropical Medicine at The George Washington University School of Medicine and Health Sciences, Washington, DC.
“Newborns and infants bear the brunt of this respiratory infection in terms of severity, especially those born prematurely,” Diemart, who was not involved in the trial, told Healthline.
“Vaccinating pregnant women is a proven and safe way to give babies high levels of antibodies that protect them from invading viruses and other disease-causing organisms,” he said. I got
diemert said George Washington University Vaccine Research Unit is about to begin recruiting 18- to 60-year-olds for a Phase 3 clinical trial of Pfizer’s RSV vaccine.
The trial focuses on adults in this age group who are at high risk of developing severe illness from the RSV virus because of comorbid conditions such as asthma, diabetes, or chronic kidney disease.
Researchers will also enroll immunocompromised adults of all ages.
“This study will examine the safety of the vaccine in these populations,” said Diemart. [will] Also, make sure that the immune response generated by the vaccine is similar to what has been seen in other successful studies done so far.”
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