VRBPAC

CSL Seqirus is Fully Prepared to Implement the FDA's Vaccines and Related Biological Products Advisory Committee Trivalent Influenza Vaccines Strain Selection for the 2024/25 U.S. Season

Retrieved on: 
Wednesday, March 6, 2024
FDA, Food, CSL, Influenza, Vaccine, Season, COVID-19, VRBPAC, WHO, Epidemiology, Environment, Public

CSL Seqirus worked closely with the FDA during 2023 to align on a path forward and is fully prepared to transition its complete portfolio of seasonal influenza vaccines in the U.S. market from quadrivalent to trivalent formulations for the 2024/25 influenza season.

Key Points: 
  • CSL Seqirus worked closely with the FDA during 2023 to align on a path forward and is fully prepared to transition its complete portfolio of seasonal influenza vaccines in the U.S. market from quadrivalent to trivalent formulations for the 2024/25 influenza season.
  • CSL Seqirus completed its transition plan for the 2024/2025 season by December 2023 and regulatory and manufacturing teams are on track to convert the full U.S. portfolio.
  • As a result of this effort, CSL Seqirus received FDA approval on March 4, 2024 for all of its U.S. trivalent influenza vaccines.
  • "This strain consistency across hemispheres will support both speed and efficiency, as CSL Seqirus has experience manufacturing these recommended strains," said Dave Ross, Vice President, North America Commercial Operations, CSL Seqirus.

Pfizer and BioNTech Receive U.S. FDA Approval for 2023-2024 COVID-19 Vaccine

Retrieved on: 
Monday, September 11, 2023
Science, Biotechnology, Research, Pharmaceutical, Health, FDA, COVID-19, Infectious Diseases, EUA, BioNTech, SARS-CoV-2, Vaccine, Heart, US Foods, Inc., Pirola, Omicron, Civil service commission, Tell, Vaccination, Face, Pharmacy, PFE, Coronavirus, Weakness, VRBPAC, Inflammation, Messenger, Rash, CDC, Formula, Emergency Use Authorization, COVID-19 vaccine, Hospital, Allergy, Dizziness, Risk, Child, Korea Disease Control and Prevention Agency, XBB, European, Viral, Adolescence, BNTX, VAERS, United Kingdom, Pounding, Ageing, Regulation of tobacco by the U.S. Food and Drug Administration, Safety, NYSE, FD, Food, European Commission, Disease, Pericarditis, Pharmaceutical industry, Petroleum jelly, Poultry farming, Myocarditis, Pfizer

Children under the age of 5 may be eligible to receive additional doses of this season’s vaccine if they have not already completed a three-dose series with previous formulations of a COVID-19 vaccine.

Key Points: 
  • Children under the age of 5 may be eligible to receive additional doses of this season’s vaccine if they have not already completed a three-dose series with previous formulations of a COVID-19 vaccine.
  • Pfizer and BioNTech have submitted data for their Omicron XBB.1.5-adapted monovalent COVID-19 vaccine to other regulatory authorities around the world.
  • The COVID-19 vaccines (COMIRNATY®) by Pfizer and BioNTech are based on BioNTech’s proprietary mRNA technology and were developed by both companies.
  • Report vaccine side effects to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) Vaccine Adverse Event Reporting System (VAERS).

Invivyd Announces Positive Initial Data from Ongoing Phase 1 Clinical Trial of VYD222, a Monoclonal Antibody Candidate in Development for the Prevention of Symptomatic COVID-19 in Immunocompromised People

Retrieved on: 
Thursday, June 22, 2023
Vaccine, Omicron, Vaccination, Half-life, Serum, SARS-CoV-2, Hook effect, COVID-19, VRBPAC, Messenger, Șaeș, XBB, Mab, Immunodeficiency

VYD222 is a broadly neutralizing, half-life extended mAb candidate in development for the prevention of symptomatic COVID-19 in vulnerable populations, such as immunocompromised people.

Key Points: 
  • VYD222 is a broadly neutralizing, half-life extended mAb candidate in development for the prevention of symptomatic COVID-19 in vulnerable populations, such as immunocompromised people.
  • Initial Phase 1 data show that a single administration of VYD222 was generally well-tolerated at all three dose levels tested with no serious adverse events (SAEs) reported to date.
  • Higher VYD222 dose levels tested in the Phase 1 clinical trial are designed to provide greater protection from any potential loss of neutralization activity as SARS-CoV-2 evolves over time.
  • Additionally, the company plans to present additional results from the Phase 1 clinical trial at an upcoming medical meeting.

FDA Advisory Committee Votes in Support of Approval for Pfizer’s Vaccine Candidate to Help Prevent RSV in Infants Through Maternal Immunization

Retrieved on: 
Thursday, May 18, 2023
Parenting, Infectious Diseases, Children, FDA, Baby, Maternity, Clinical Trials, Biotechnology, Pharmaceutical, Consumer, Health, Infection, Prescription Drug User Fee Act, Inc., Senior, Life, Safety, The New England Journal of Medicine, PFE, VRBPAC, Committee, Development, RSV, PDUFA, Vaccine, NYSE, Food, Pharmaceutical industry, Pfizer

The Committee voted 14 to 0 on effectiveness and 10 to 4 on safety.

Key Points: 
  • The Committee voted 14 to 0 on effectiveness and 10 to 4 on safety.
  • The vaccine candidate is currently under FDA review for the prevention of medically attended lower respiratory tract disease (MA-LRTD) and severe MA-LRTD caused by RSV in infants from birth up to six months of age by active immunization of pregnant individuals.
  • These results were also recently published in The New England Journal of Medicine.
  • The role of the VRBPAC is to provide recommendations to the FDA; however, these recommendations are not binding.

Pfizer Receives Positive FDA Advisory Committee Votes Supporting Potential Approval for Vaccine Candidate to Help Combat RSV in Older Adults

Retrieved on: 
Tuesday, February 28, 2023
FDA, Infectious Diseases, Health, Pharmaceutical, Clinical Trials, Death, Development, Safety, PDUFA, PFE, Senior, RSV, Committee, NYSE, Disease, Respiratory syncytial virus, Vaccine, Infection, Inc., VRBPAC, Science, Hospital, Prescription Drug User Fee Act, Food, Pharmaceutical industry, Pfizer

The Committee voted 7 to 4 on safety and 7 to 4 on effectiveness.

Key Points: 
  • The Committee voted 7 to 4 on safety and 7 to 4 on effectiveness.
  • The vaccine candidate is currently under FDA review for the prevention of acute respiratory disease and lower respiratory tract disease caused by RSV in adults 60 years of age and older.
  • “In older adults, RSV can result in serious illness, hospitalization, or even death, so there is a significant need to protect this at-risk population,” said Annaliesa Anderson, Ph.D., Senior Vice President and Chief Scientific Officer, Vaccine Research and Development, Pfizer.
  • The role of the VRBPAC is to provide recommendations to the FDA; however, these recommendations are not binding.