Respiratory syncytial virus – virus vaccines under investigation
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Vaccine comes from Pfizer Shows potential to protect adults ages 18 to 59, who are at higher risk of contracting the virus Serious illness The company said on Tuesday that the drug was derived from respiratory syncytial virus in a late-stage clinical trial.
Preliminary data suggests Pfizer’s Abrysvo vaccine could help protect a wider range of people from RSV infection. The vaccine is currently approved in the United States, Europe, Japan and other countries for adults 60 and older and expectant mothers because they can pass protection to their fetuses.
However, there is no RSV vaccine approved globally for use in young, high-risk adults.
RSV reason Thousands Elderly Americans and hundreds of infants are hospitalized and die every year. The virus can also cause severe illness in younger people with weakened immune systems or chronic medical conditions such as asthma and diabetes.
Pfizer said nearly 10% of U.S. adults ages 18 to 49 have chronic medical conditions that put them at risk for severe RSV illness. For people aged 50 to 64, that number rises to about 24%.
“I think about my own family and friends who have asthma or have had asthma since childhood,” Dr. Iona Munjal, Pfizer’s executive director of clinical vaccine development, told CNBC. “These are populations that are at risk for RSV every winter… Over and over again. There is no lasting immunity without vaccination.”
Munjal added that targeting high-risk adults ages 18 to 59 is the “next logical step” following efforts to reduce the incidence of RSV disease in older populations.
The data comes as Pfizer attempts to win more RSV market share after falling behind GSK last year. GSK’s RSV vaccine for adults aged 60 and over had sales of about 1.2 billion pounds ($1.5 billion) last year. Meanwhile, Pfizer’s shots will generate about $890 million in 2023 revenue.
Pfizer said it plans to submit the data to regulators and apply to expand approval of Abrysvo to people 18 and older. The company did not provide any details on the timeline for these plans.
Pfizer also intends to present final results from the trial at an upcoming scientific meeting and submit them for publication in a peer-reviewed journal.
Initial Safety and Effectiveness Data
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Pfizer said on Tuesday that its vaccine met the primary goals of its Phase 3 trial of efficacy and safety in high-risk adults ages 50 to 59.
The company specifically released data from a substudy that examined nearly 700 patients who were at high risk for severe RSV due to underlying medical conditions. Pfizer expects to release data from another substudy of about 200 patients with weakened immune systems later this year, Munjal told CNBC.
Results showed that the drugmaker’s single-dose injection triggered an immune response against RSV A and RSV B, the two main subtypes of the virus.
Immune responses were similar to those observed in adults 60 years and older.Early and late stages A study of more than 30,000 older adults found that Pfizer’s vaccine maintained protection against RSV during two full seasons of RSV circulation.
“People 18 to 60 years old are seeing similar levels of antibodies after vaccination as people 60 and older,” Munjal told CNBC. She later added that this “leads you to believe that in both groups, they are actually The response to the vaccine is the same and therefore likely to have similar efficacy.”
Within a month of participants receiving the Pfizer shot, protective antibody levels against RSV A and RSV B increased fourfold compared to before vaccination.
The company said the vaccine was well tolerated by patients in the trial. Pfizer added that safety data in high-risk adults aged 18 to 59 years were consistent with results in adults aged 60 years and older.
GlaxoSmithKline (GSK) released late-stage trial data in October showing its vaccine protected adults aged 50 to 59.
Food and Drug Administration February indeed GlaxoSmithKline (GSK) has received “priority review” for its application to expand approval of its drug Arexvy to a new age group. This designation expedites the review process for certain drugs that treat serious conditions.
The FDA is expected to decide on June 7 whether to approve GlaxoSmithKline’s RSV vaccine for use in adults ages 50 to 59.