Menveo Vaccine Description For 2022
GSK's Menveo helps protect appropriate adolescent patients with a primary and booster dose of MENVEO. It consists of two portions: 10 µg of lyophilized meningococcal serogroup A capsular polysaccharide conjugated to CRM197 and 5 μg each of capsular polysaccharide of serogroup C, W, and Y conjugated to CRM197 in 0.5 mL of phosphate-buffered saline, which is used to reconstitute the lyophilized MenA component. Menveo does not prevent N. meningitidis serogroup B infections.
The immunogenicity of MENVEO was evaluated 28 days after vaccination in a pivotal noninferiority trial that compared MENVEO with Menactra. The primary endpoint was the percentage of subjects with a seroresponse 28 days after a dose of either MENVEO or Menactra.
The U.S. Prescribing Information is available at this weblink. GSK Medical Information: 1-877-GSK-MI4U (1-877-475-6448). The U.S. CDC Advisory Committee on Immunization Practices (ACIP) vaccine committee reviewed on October 20, 2022 - Menveo One-Vial Presentation, led by Sam Crowe, Ph.D., MPH Work Group Lead.
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Menveo is indicated for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135. The U.S. CDC recommends MenACWY vaccination for children who are between 2 months and 10 years old if they:
- Have a rare type of immune disorder called complement component deficiency
- Are taking a type of medicine called a complement inhibitor (for example, Soliris® or Ultomiris®)
- Have a damaged spleen or sickle cell disease, or their spleen has been removed
- Have HIV
- Are traveling to or residing in countries in which serogroup A, C, W, or Y meningococcal disease is common
- Are part of a population identified to be at increased risk because of a serogroup A, C, W, or Y meningococcal disease outbreak
All 11 to 12-year-olds should get a MenACWY vaccine, with a booster shot at 16 years old.
In individuals 2 years through 55 years of age, MENVEO is to be administered as a single dose. Menveo is administered as an intramuscular injection. Menveo is approved for use in persons 2 months through 55 years of age: In children initiating vaccination at 2 months of age, Menveo is to be administered as a 4-dose series at 2, 4, 6, and 12 months of age.
In children initiating vaccination at 7 months through 23 months of age, Menveo is to be administered as a 2-dose series, with the second dose administered in the second year of life and at least 3 months after the first dose.
The Menveo one-vial presentation will initially be available to US federal customers, with broader availability anticipated in mid-2023.
Menveo Adverse Reactions
Common solicited adverse reactions among children initiating vaccination: at 2 months of age and receiving the 4-dose series were tenderness and erythema at the injection site, irritability, sleepiness, persistent crying, change in eating habits, vomiting, and diarrhea; at 7 months through 23 months of age and receiving the 2-dose series were tenderness and erythema at the injection site, irritability, sleepiness, persistent crying, change in eating habits, and diarrhea; at 2 through 10 years of age who received Menveo were injection site pain, erythema, irritability, induration, sleepiness, malaise, and headache. Common solicited adverse reactions among adolescents and adults aged 11 through 55 years who received a single dose of Menveo were pain at the injection site, headache, myalgia, malaise, and nausea. Across all age groups, some events were severe. Similar rates of solicited adverse reactions among adolescents and adults were observed following a single booster dose.
Menveo News 2022
October 17, 2022 - GSK announced that the US FDA had approved a new presentation of Menveo for individuals aged 10 to 55 years to help prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W. The Menveo one-vial presentation now comes in a ready-to-use single vial giving healthcare providers a more convenient option.
August 18, 2022 - Health departments in Florida are offering meningococcal vaccines for free. They have been experiencing an outbreak this year, recording over 50 cases so far.
February 9, 2022 - GSK reported during 2021, Menveo sales were up 3% AER 9% CER to £272 million, primarily driven by 2020 cohort catch-up vaccinations and 2021 higher demand, as well as increased market share in the US.
Menveo Clinical Trials
GSK's Menveo has been involved in many clinical trials.