ACIP

Bavarian Nordic Announces Commercial Launch of Mpox Vaccine in the U.S.

Retrieved on: 
Tuesday, April 2, 2024
Health, Advisory Committee, Disease, OMX, Partnership, Risk, Trust, Pharmacy, Public, Mpox, Infection, CDC, Vaccination, Vaccine, FDA, Government, ACIP, Pharmaceutical industry

Since 2022, in response to the global mpox outbreak, JYNNEOS has been made available through public health channels for individuals at risk of mpox infection.

Key Points: 
  • Since 2022, in response to the global mpox outbreak, JYNNEOS has been made available through public health channels for individuals at risk of mpox infection.
  • According to estimates from the CDC, two (2) million U.S. individuals are eligible for vaccination against mpox4.
  • Recent data shows 60% of this population remains completely unvaccinated, and 15% have received only one dose of the vaccine5.
  • Through its existing nationwide vaccine distribution structure, Bavarian Nordic is now making the mpox vaccine commercially available across the nation.

Valneva to Present on its Chikungunya Vaccine IXCHIQ®, Participate in Multiple Events at the 24th World Vaccine Congress in Washington D.C.

Retrieved on: 
Thursday, March 21, 2024
Control, EST, Congress, Lyme disease, CEPI, Coalition, Saint-Herblain, Pan American Health Organization, Walter, PAHO, International Vaccine Institute, Chikungunya, Epidemic, Drug, IVI, CDC, Process, VLA, Euronext Paris, Market access, ACIP, The 24th

The Company will have a display in the exhibit area of the congress at booth #433.

Key Points: 
  • The Company will have a display in the exhibit area of the congress at booth #433.
  • There will be two sessions, from 11:40 to 12:20 EST and again from 12:30 to 1:10pm EST.
  • Advisory Committee on Immunization Practices (ACIP)1 and these recommendations were adopted by the Centers for Disease Control and Prevention (CDC)2.
  • Additionally, Valneva CEO Thomas Lingelbach will present the Best Production / Process Development award at the event.

Valneva to Present at Upcoming TD Cowen and Van Lanschot Kempen Healthcare Investor Conferences

Retrieved on: 
Monday, March 4, 2024
Pfizer, ACIP, Indoor Living, Conference, VLA, CHMP, Saint-Herblain, Chikungunya, Euronext Paris

Saint-Herblain (France), March 4, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that its senior management will participate at upcoming investor conferences in the United States and Europe.

Key Points: 
  • Saint-Herblain (France), March 4, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that its senior management will participate at upcoming investor conferences in the United States and Europe.
  • CEO Thomas Lingelbach will present Valneva at the TD Cowen 44th Annual Health Care Conference, taking place March 4 - 6, 2024, in Boston, MA.
  • Mr. Lingelbach and CFO Peter Bühler will also meet with institutional investors during the Van Lanschot Kempen Life Sciences Conference, held April 16 - 17, 2024, in Amsterdam, The Netherlands.
  • VLA15, the Company’s Lyme disease vaccine candidate, is currently in Phase 3 clinical development and partnered with Pfizer for this study and global commercialization.

U.S. CDC Advisory Committee (ACIP) Recommends Use of Valneva’s Single-Dose Chikungunya Vaccine IXCHIQ®

Retrieved on: 
Thursday, February 29, 2024
ACIP, Person, MD, FDA, Food, Risk, VLA, Vaccination, MMWR, Food and Drug Administration, Family, Saint-Herblain, Disease, CDC, Chikungunya, Ageing, Euronext Paris, Vaccine

ACIP recommends IXCHIQ® for persons aged ≥18 years traveling to a country or territory where there is a chikungunya outbreak.

Key Points: 
  • ACIP recommends IXCHIQ® for persons aged ≥18 years traveling to a country or territory where there is a chikungunya outbreak.
  • ACIP also recommended chikungunya vaccination for laboratory workers with potential for exposure to CHIKV.
  • IXCHIQ offers advantages to travelers on vacation and visiting family and to people engaged in business ventures, missions, or laboratory duties.
  • We embrace the ACIP endorsement, marking IXCHIQ® as the only approved and recommended vaccine for the target population.

Rite Aid and Bartell Drugs Announce Additional Dose of Updated COVID-19 Vaccine Available for Customers Ages 65 and Older

Retrieved on: 
Tuesday, March 5, 2024
Retail, Health, Convenience Store, COVID-19, Specialty, General Health, Pharmaceutical, OTC, Rite Aid, Vaccination, ACIP, Aid, Senior, Pharmacist, CDC, Pacific Northwest, Vaccine

Rite Aid (OTC:RADCQ) recently announced that appointments are now available for eligible customers ages 65 and older seeking an additional dose of the updated COVID-19 (2023-2024) vaccines at its locations, including Bartell Drugs locations in the Pacific Northwest.

Key Points: 
  • Rite Aid (OTC:RADCQ) recently announced that appointments are now available for eligible customers ages 65 and older seeking an additional dose of the updated COVID-19 (2023-2024) vaccines at its locations, including Bartell Drugs locations in the Pacific Northwest.
  • “Rite Aid wants to ensure our customers safeguard their health, especially those in vulnerable populations, including our customers ages 65 and older.”
    The updated COVID-19 vaccine provides enhanced protection against currently circulating variants of COVID-19.
  • According to the new recommendation, all customers ages 65 and older who previously received the COVID-19 vaccine (2023-2024) should receive an additional dose four months after receipt of the prior dose.
  • Rite Aid pharmacists are trained to immunize customers ages three and older based on the CDC's vaccine guidelines and state regulations.

Valneva Announces U.S. FDA Approval of World’s First Chikungunya Vaccine, IXCHIQ®

Retrieved on: 
Friday, November 10, 2023
VLA, CEPI, Webcast, LMIC, Epidemic, Disease, Euronext Paris, Health Canada, Viral, Research, Low, Saint-Herblain, Climate change, Licensure, Safety, Food, PRV, Advisory Committee, European Medicines Agency, Ageing, Valneva SE, Risk, Pan American Health Organization, Priority review, Fatigue, EMA, Patient, Climate, FDA, Vaccine, Death, Notifiable disease, ACIP, Coalition, Priority, Trial of the century, Partnership, Arthralgia, R, PAHO, Temperature, Travel, Pharmaceutical industry, Lancet, CHIKV, Instituto Butantan, Chikungunya

Continued approval for this indication is contingent upon verification of clinical benefit in confirmatory studies.

Key Points: 
  • Continued approval for this indication is contingent upon verification of clinical benefit in confirmatory studies.
  • As sponsor of the first chikungunya vaccine approved in the U.S., Valneva has received a Priority Review Voucher (PRV) from the FDA, which it intends to monetize to help finance its research and development (R&D) programs.
  • With this U.S. approval, IXCHIQ® becomes the world’s first licensed chikungunya vaccine available to address this unmet medical need and the third vaccine Valneva1 has brought from early R&D to approval.
  • Initial safety data from this trial were included in the submission to the European Medicines Agency (EMA) in October 202313.

New Data for AREXVY, GSK’s RSV Vaccine, Show Potential to Help Protect Adults Aged 50 to 59 at Increased Risk for RSV Disease

Retrieved on: 
Wednesday, October 25, 2023
Seniors, Biotechnology, Pharmaceutical, Health, FDA, Infectious Diseases, Consumer, Clinical Trials, RSV, COPD, Headache, Ageing, Food, Respiratory syncytial virus vaccine, III, Conditional sentence, US Foods, Safety, Heart, Diabetes, Stockholm Environment Institute US Center, Infection, Pneumonia, Chronic kidney disease, CDC, Chronic liver disease, Risk, Asthma, ACIP, GSK plc, GSK, Hospital, Pain, Chronic obstructive pulmonary disease, Fatigue, Vaccine, Pharmaceutical industry, Adjuvant

The vaccine elicited an immune response in adults aged 50 to 59 at increased risk for RSV disease due to select underlying medical conditions that was non-inferior to that observed in adults aged 60 and above, meeting the trial’s primary co-endpoint.

Key Points: 
  • The vaccine elicited an immune response in adults aged 50 to 59 at increased risk for RSV disease due to select underlying medical conditions that was non-inferior to that observed in adults aged 60 and above, meeting the trial’s primary co-endpoint.
  • The co-primary endpoint was also met for the broader group of adults aged 50 to 59 also enrolled in the trial.
  • Tony Wood, Chief Scientific Officer, GSK, said: “This trial reinforces our confidence in our RSV vaccine’s ability to help protect adults aged 50 to 59 at increased risk for RSV-LRTD.
  • Immune response in participants aged 50 to 59 with pre-defined stable chronic diseases leading to an increased risk of RSV disease was assessed (n=570).

FDA Approves PENBRAYA™, the First and Only Vaccine for the Prevention of the Five Most Common Serogroups Causing Meningococcal Disease in Adolescents

Retrieved on: 
Friday, October 20, 2023
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, Survivor, NYSE, Upstate University Hospital, Food, Meningococcal disease, Vaccine, Mortality, MD, Infection, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Development, Senior, CDC, Inc., Attenuated vaccine, IMD, Head, ACIP, Safety, PFE, Patient, Hospital, Death, Pfizer

Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved PENBRAYA™ (meningococcal groups A, B, C, W and Y vaccine), the first and only pentavalent vaccine that provides coverage against the most common serogroups causing meningococcal disease in adolescents and young adults 10 through 25 years of age.

Key Points: 
  • Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved PENBRAYA™ (meningococcal groups A, B, C, W and Y vaccine), the first and only pentavalent vaccine that provides coverage against the most common serogroups causing meningococcal disease in adolescents and young adults 10 through 25 years of age.
  • “Today marks an important step forward in the prevention of meningococcal disease in the U.S.
  • The Phase 3 trial (NCT04440163) evaluated more than 2,400 patients from the U.S. and Europe.
  • The CDC Advisory Committee on Immunization Practices (ACIP) will meet on October 25, 2023, to discuss recommendations for the appropriate use of PENBRAYA in adolescents and young adults.

4 Common Questions Answered About the New Monoclonal Antibody to Help Prevent Severe RSV in Babies

Retrieved on: 
Wednesday, October 11, 2023
Parent, Monroe Carell Jr. Children's Hospital at Vanderbilt, Antibody, Advisory Committee on Immunization Practices, Risk, Caregiver, Advisory Committee, CDC, ACIP, Respiratory syncytial virus, American Lung Association, Immune system, Korea Disease Control and Prevention Agency, RSV, Vaccine

CHICAGO, Oct. 11, 2023 /PRNewswire/ -- In fall of 2022, the United States saw an early and significant spike in cases of Respiratory Syncytial Virus, or RSV, which is the leading cause of hospitalizations in all infants. Today, the American Lung Association launched a campaign to help inform parents of infants and young children, as well as caregivers, about RSV and the new preventative options that can protect their children.

Key Points: 
  • RSV is so common that nearly 100% of children have been infected with the virus by age two.
  • Here are answers to four common questions about how to help prevent RSV in babies:
    Is nirsevimab a vaccine?
  • No, it is a long-acting monoclonal antibody injection that provides an extra layer of defense to help prevent RSV disease.
  • The protection provided by this preventative antibody is called passive immunity because external antibodies are given to help protect against RSV.

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

Retrieved on: 
Friday, September 22, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Vaccine, ACIP, Pneumococcal pneumonia, Inc., Asthma, Streptococcus, Diabetes, Hospital, Gestational age, PFE, COVID-19, Infection, Risk, Doctor of Philosophy, CDC, Formula, RSV, Ageing, Urinary tract infection, FDA, Immunization, NYSE, Food, Disease, Pfizer

“This fall marks the start of the annual respiratory infection season in the Northern Hemisphere, and we are prepared with vaccines against multiple infectious diseases and -- for the first time in history -- an available RSV vaccine to help prevent disease in two at-risk populations,” said Luis Jodar, PhD, Chief Medical Affairs Officer, Vaccines/Antivirals and Evidence Generation, Pfizer. “Today’s ACIP recommendation for maternal immunization with ABRYSVO reinforces the wide-ranging impact vaccines can have, including helping protect infants immediately at birth from the potentially severe and life-threatening complications that can develop from RSV. Approximately 75 percent of RSV-related hospitalizations in newborns and infants occur in the first six months of life.”

Key Points: 
  • 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 is currently available and recommended using shared clinical decision making for adults 60 years of age and older to help protect against RSV disease.
  • Pneumococcal pneumonia results in more than 180,000 adult hospital admissions and more than 150,000 adult outpatient visits in the U.S. each year.3