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9.22.23 – Pfizer Broadens Portfolio of Respiratory Vaccines Recommended by CDC Advisory Committee with ABRYSVO for RSV

Pfizer Inc. (NYSE: PFE) shared today it has broadened its portfolio of respiratory vaccines recommended by the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) following a favorable vote for ABRYSVO™ [Respiratory Syncytial Virus Vaccine], the company’s bivalent RSV prefusion F (RSVpreF) vaccine, as a maternal immunization. This is the first-ever fall in which eligible individuals can receive Pfizer vaccines to help protect against RSV, COVID-19, and pneumococcal pneumonia.

  •  ABRYSVO recommended by CDC Advisory Committee for pregnant persons 32 through 36 weeks gestation to help protect infants from respiratory syncytial virus (RSV) from birth through first six months of life
  • RSV maternal immunization recommendation adds to Pfizer’s respiratory vaccines offerings already available to help protect against RSV in older adults, COVID-19, and pneumococcal pneumonia in adults

9.12.23 – Pfizer, Moderna score FDA nods for next round of seasonal COVID-19 vaccines

Out with the old and in with the new: Monday, the US FDA approved retooled mRNA shots against COVID-19 from Pfizer-BioNTech and Moderna simultaneously bidding adieu to the companies’ bivalent shots in the US. The FDA has approved Pfizer-BioNTech and Moderna’s separate vaccine formulations that are more closely targeted to current variants of the disease, the agency said in a release. The vaccines have been updated to include a monovalent component aimed at omicron variant XBB.15, according to the companies and the FDA. Meanwhile, Novavax’s revised shot is still pending regulatory approval. 

8.31.23 – GSK’s RSV Arexvy: RSV Vaccines Remains Effective Against Distinct Viral Variants

GSK’s Arexvy vaccine for respiratory syncytial virus (RSV) — the first to be approved for older adults — can remain effective against a range of variants and produces strong antibody responses against distinct viral strains, according to a new study. The study results, published in the journal Science Translational Medicine, indicate that the vaccine could offer enduring protection against both contemporary RSV and future variants, especially when combined with vaccine adjuvants.

8.28.23 – US CDC Advisory Committee unanimously recommends routine use of Beyfortus (nirsevimab) to protect infants against RSV

CDC is recommending a new immunization starting this fall to help protect all infants under 8 months and some older babies at increased risk of severe illness caused by respiratory syncytial virus (RSV).

Today, CDC director Mandy Cohen, MD, MPH, adopted the CDC Advisory Committee on Immunization Practices’ (ACIP) recommendation for the use of nirsevimab, trade name BeyfortusTM, a long-acting monoclonal antibody product, which has been shown to reduce the risk of both hospitalizations and healthcare visits for RSV in infants by about 80 percent.

8.22.23 – FDA Approves Pfizer’s Abrysvo for Pregnancy to Protect Babies

Already with an approval in hand for older adults, Pfizer’s Abrysvo has become the first vaccine for pregnant women to protect their newborns against respiratory syncytial virus (RSV). The FDA has signed off on Abrysvo for women who have been pregnant for 32-36 weeks. The shot affords protection to babies for the first six months of their lives. 

8.1.23 – Quest Launches Blood Test for Alzheimer’s Disease

Advances in drug treatment for Alzheimer’s disease have opened doors for diagnostics, and Quest is the latest to walk through. The clinical testing giants has put forward a blood test designed to help gauge a person’s level of beta amyloid – one of the hallmarks of neurodegenerative condition – and it’s now making it available directly to consumers. 

6.25.23 – FDA Advisory Committee Recommends a Monovalent COVID booster

FDA Advisory committee, which decided unanimously that COVID vaccines this fall should not provide coverage against the original, wild-type coronavirus and that protection is only needed against an XBB strain. The advisory committee recommendation is consistent with a directive last month from the World Health Organization, which has recommended that the new COVID-19 boosters target XBB subvariants. 

6.15.23 – FDA Advisory Committee unanimously recommends Nirsevimab as first immunization against RSV for all infants 

About RSV: RSV is a very contagious virus that can lead to serious respiratory illness for infants, according to the Centers for Disease Control and Prevention (CDC). RSV symptoms can include runny nose, coughing, sneezing, fever, decrease in appetite, and wheezing.1 Two out of three infants are infected with RSV during their first year of life and almost all infants are infected by their second birthday.1,2 In the U.S., RSV is the leading cause of hospitalization in infants under 12 months, averaging 16 times higher than the annual rate for influenza.3,4 Approximately 75% of infants hospitalized for RSV are born healthy and at term with no underlying conditions.5 Each year in the U.S., there are an estimated 590,000 RSV disease cases in infants under one requiring medical care, including physician office, urgent care, emergency room visits and hospitalizations.6

5.19.23 – U.S. FDA Approves Prevnar 20, Pfizer’s 20 Valent Pneumococcal Conjugate Vaccine For Infants And Children

Pfizer Inc. announced on April 27th that the U.S. Food and Drug Administration (FDA) has approved PREVNAR 20®(20-valent Pneumococcal Conjugate Vaccine) for the prevention of invasive pneumococcal disease (IPD) caused by the 20 Streptococcus pneumoniae (pneumococcal) serotypes contained in the vaccine in infants and children six weeks through 17 years of age, and for the prevention of otitis media in infants six weeks through five years of age caused by the original seven serotypes contained in PREVNAR®.

“Today’s FDA approval of our vaccine, PREVNAR 20, now offers parents the ability to help protect their children against 20 pneumococcal serotypes in circulation, which represent the majority of pneumococcal disease in U.S. infants and children,”1,2 said Annaliesa Anderson, Ph.D., Senior Vice President and Chief Scientific Officer, Vaccine Research and Development, Pfizer. “This important PREVNAR 20 approval builds on more than 20 years of real-world impact with PREVNAR and PREVNAR 13, safety data, and effectiveness; highlighting Pfizer’s leadership in developing groundbreaking pneumococcal conjugate vaccines to help protect infants and their families from life threatening infections. We are grateful to the families and clinical investigators who participated in this research and our colleagues who have worked tirelessly to develop this breakthrough vaccine.”