U.S. drug regulators have approved a drug aimed at preventing a respiratory disease in babies and toddlers. The U.S. Food and Drug Administration (FDA) on July 17 cleared Beyfortus, a monoclonal antibody that prevents respiratory syncytial virus (RSV), a lower respiratory tract disease. Children up to 24 months of age can now receive the drug,…
FDA Approves Drug Aimed at Preventing Respiratory Disease in Babies and Toddlers
CDC Panel Divided on Recommending RSV Vaccine for All Older Adults
June 23, 2023
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The U.S. Centers for Disease Control and Prevention’s (CDC) panel of experts voted on Wednesday against recommending the RSV vaccine for all older adults. Instead, the Advisory Committee on Immunization Practices (ACIP) concluded that anyone aged 60 and older “may” consider receiving a single dose of either Pfizer’s or GSK’s new RSV vaccine and that the…
CDC Advisers Recommend Use of GSK, Pfizer RSV Vaccines for Adults Aged 65 and Over
An advisory committee to the Centers for Disease Control and Prevention (CDC) on June 21 voted to recommend that adults aged 65 and over receive one of the newly approved vaccines for respiratory syncytial virus (RSV). The CDC’s Advisory Committee on Immunization Practices voted 9–5 in favor of recommending two different RSV vaccines—GlaxoSmithKline (GSK) and Pfizer’s…
FDA Panel Unanimously Endorses New RSV Antibody Drug for Infants
A panel of outside advisers to the U.S. Food and Drug Administration (FDA) voted in favor of approving a preventative antibody treatment for respiratory syncytial virus (RSV) for in newborns and infants. The unanimous vote by 21 members of the FDA’s Antimicrobial Drugs Advisory Committee (AMDAC) on Thursday brings the monoclonal antibody, nirsevimab, closer to final approval by the FDA. All on…
Parents Urged to Be on Winter Alert for RSV
Parents are advised to look out for signs of breathing problems in young children over winter, with a report highlighting the deadly risks from a mostly unknown seasonal virus. The report found RSV, or respiratory syncytial virus, is responsible for the hospitalisation of about 12,000 babies under 12 months each year. That number climbs to…
FDA Approves Pfizer’s RSV Vaccine for Older Adults
The Food and Drug Administration (FDA) has approved Pfizer’s vaccine, Abrysvo, which protects adults 60 and older from the respiratory syncytial virus (RSV), Pfizer announced on Wednesday. The approval makes Abrysvo the second RSV vaccine available for the common virus. On May 3, the agency approved GSK’s Arexvy, the world’s first RSV vaccine for adults…
FDA Advisers Back Maternal RSV Vaccine as Pfizer Says Safety Concerns Can be Studied Post-Approval
Advisers to the U.S. Food and Drug Administration (FDA) voiced support on May 18 for Pfizer’s maternal RSV vaccine even after several expressed concerns over premature births. Outside experts on the Vaccines and Related Biological Products Advisory Committee unanimously said data from two trials run by Pfizer were sufficient to support the vaccine being effective at…
After Decades of Set Back, First Ever RSV Approved: A Closer Look
The U.S. Food and Drug Administration (FDA) approved the first-ever respiratory syncytial virus (RSV) vaccine for adults aged 60 and over on Wednesday, almost 60 years after the first RSV vaccine trial was called off due to two vaccine-induced deaths. The vaccine is called Arexvy and was developed by GSK, formerly GlaxoSmithKline. According to the…
Pfizer Data Says RSV Vaccine 82 Percent Effective in Newborns When Given to Pregnant Mothers
An experimental vaccine targeting respiratory syncytial virus (RSV) was found to be nearly 82 percent effective for infants when administered to pregnant mothers, said data published by Pfizer on Wednesday. Final data from the study was published in the New England Journal of Medicine. The paper also said that the shot is 86 percent effective in…
FDA Panel Endorses GSK Vaccine for RSV in Older Adults, a Day After Recommending Pfizer’s Vaccine
A committee of outside advisers to the U.S. Food and Drug Administration (FDA) recommended a vaccine from GlaxoSmithKline (GSK) against the respiratory syncytial virus (RSV) for adults over age 60. The vote from the Vaccines and Related Biological Products Advisory Committee (VRBPAC) for GSK’s Arexvy (RSVPreF3-AS01) vaccine comes a day after the 12 members voted to endorse Pfizer’s vaccine candidate, Abrysvo…
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