Pneumovax 23 Pneumococcal Vaccine
Pneumovax®23 Vaccine 2022
Merck's PNEUMOVAX®23 (Pneumococcal Vaccine Polyvalent) is a vaccine that can help protect against infection by 23 types of pneumococcal bacteria, common and often cause serious illnesses. Pneumovax 23 vaccine contains 23 serotypes (1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, and 33F). PNEUMOVAX 23 is approved for use in persons 50 years of age or older and persons aged ≥2 years who are at increased risk for pneumococcal disease.
On October 23, 2020, a study published by PLOS concluded 'That PPV23 vaccination provides moderate long-term protection against hospitalization with PPV23 serotype pneumonia. And, PPV23 vaccination may continue to have an important role in national pneumococcal immunization policies, including the possibility of revaccination of older adults.' In a group of 2,357 patients (717 PPV23 cases, 1,640 controls) with an average time of 10 years since PPV23 vaccination, we estimated the VE of PPV23 against PPV23 serotype pneumonia to be 24% after adjustment for patient factors (95% CI 5%–40%, p = 0.02).
The U.S. Centers for Disease Control and Prevention published on January 28, 2022, newly simplified recommendations for pneumococcal vaccination in the elderly and immunocompromised. The changes were published in the Morbidity and Mortality Weekly Report. Vaccination with PNEUMOVAX 23 may not offer 100% protection from pneumococcal infection.
Merck Sharp & Dohme Corp. is an American multinational pharmaceutical company and one of the world's largest pharmaceutical companies.
Pneumovax 23 Indication
The global prevalence of pneumococcal disease, an infection caused by Streptococcus pneumoniae, is evolving, says the U.S. CDC. Highly aggressive strains, or serotypes, threaten to put more people at risk for non-invasive pneumococcal illnesses such as pneumonia (when it is confined to the lungs), sinusitis, and otitis media (middle ear infection); and invasive pneumococcal illnesses such as bacteremia (infection in the bloodstream), bacteremic pneumonia (pneumonia with bacteremia) and meningitis.
The pneumococcal disease includes pneumococcal infections of the lung, blood, and coverings of the brain and spinal cord. Pneumovax 23 will not prevent disease caused by capsular pneumococcus types other than those contained in the vaccine. PNEUMOVAX 23 will not prevent disease caused by capsular types of pneumococcus other than those contained in the vaccine.
Additionally, the U.S. CDC recommends for people with certain chronic conditions such as diabetes, heart disease, or COPD and are 19 to 64 years old, 1 dose of PCV15 followed by PNEUMOVAX 23 or 1 dose of PCV20. Do not administer PNEUMOVAX 23 to individuals with a history of a hypersensitivity reaction to any vaccine component. Defer vaccination with PNEUMOVAX 23 in persons with moderate or severe acute illness. Use caution and appropriate care in administering PNEUMOVAX 23 to individuals with severely compromised cardiovascular and/or pulmonary function in whom a systemic reaction would pose a significant risk.
Available human data from clinical trials of PNEUMOVAX 23 in pregnancy have not established the presence or absence of a vaccine-associated risk. Since elderly individuals may not tolerate medical interventions as well as younger individuals, a higher frequency and/or greater severity of reactions in some older individuals cannot be ruled out. Persons who are immunocompromised, including persons receiving immunosuppressive therapy, may have a diminished immune response to PNEUMOVAX 23.
Pneumovax 23 Dosage
Pneumovax 23 is administered as an intramuscular or subcutaneous injection only. Pneumovax 23 is for people 50 years of age and older and is approved for persons aged ≥2 years who are at increased risk for pneumococcal disease. And if you are 65 years or older, the U.S. CDC recommends either one dose of PCV15 followed by Pneumovax 23 or one dose of Prevnar 20.
Intervals between PCV and PPSV23. Findings from eight immunogenicity studies that evaluated the immune response after a sequence of 7-valent PCV, PCV13, or PCV15 followed by PPSV23 administered at intervals of 2, 6, or 12 months or 3–4 years were reviewed (16–18,25–29). Three studies comparing intervals ranging from 2 to 6 months between administration of PCV and PPSV23 found no significant difference in immunogenicity measured after PPSV23 receipt, although reactogenicity tended to be higher with shorter intervals (25–29). In a study that compared antibody responses to 1 dose of PCV13 with responses to PCV13 followed by PPSV23 1 year apart, the immune responses following PPSV23 were significantly lower compared with the responses after a dose of PCV13 for eight of 12 common serotypes. In another study that compared antibody response to 1 dose of PCV13 with responses to PCV13 followed by PPSV23 approximately 4 years apart, the immune responses following PPSV23 were significantly higher for seven of 12 common serotypes (26). These findings suggested that longer intervals between administration of PCV and PPSV23 might improve immunogenicity in immunocompetent adults, although a direct comparison between a 1- versus 4-year interval was not made.
Pneumovax 23 Sales in 2021
Merck & Co. reported on February 3, 2022, lower sales of PNEUMOVAX 23, which declined 14% to $292 million, primarily driven by lower demand in the U.S.
Pneumovax 23 News 2021 - 2022
November 11, 2021 - This year's World Pneumonia Day theme is Stop Pneumonia/Every Breath Counts.
June 9, 2021 - As reported by Barron's, the U.S. Food and Drug Administration approved Pfizer's updated pneumococcal vaccine (Prevnar 20) for adults late Tuesday in a development that positions the drug giant for a battle with Merck as both hope to win supremacy in the lucrative market.
April 29, 2021 - Merck confirmed Pneumovax 23 sales decreased by 36% last year.
October 23, 2020 - A case-control test-negative design study: Effectiveness of the 23-valent pneumococcal polysaccharide vaccine against vaccine serotype pneumococcal pneumonia in adults. In establishing an established national childhood PCV13 vaccination program, PPV23 vaccination of clinical at-risk patient groups and adults aged ≥65 years provided moderate long-term protection against hospitalization with PPV23 serotype pneumonia. These findings suggest that PPV23 vaccination may continue to have an important role in adult pneumococcal vaccine policy, including the possibility of revaccination of older adults.
September 25, 2020 - The U.S. FDA approved Merck's request submitted and received November 26, 2019, to supplement your Biologics License Application under section 351(a) of the Public Health Service Act for Pneumococcal Vaccine, Polyvalent, PNEUMOVAX® 23 manufactured at your West Point, Pennsylvania facility to update the package insert to include data on the sequential administration of Prevnar 13® and PNEUMOVAX® 23 in Sections 6.1 Clinical Trials Experience and 14.2 Immunogenicity.
July 20, 2020 - Time for a third-generation pneumococcal conjugate vaccine.
June 22, 2020 - Merck announced results from two initial Phase 3 studies evaluating the safety, tolerability, and immunogenicity of V114, the company's investigational 15-valent pneumococcal conjugate vaccine. These data, in addition to results from V110-029, a study evaluating PNEUMOVAX ® 23 in healthy adults 50 years of age or older, were published via the International Symposium on Pneumococci and Pneumococcal Diseases online digital library.
January 31, 2020 - Updated Pneumococcal Vaccine Recommendations for Older Adults.
November 26, 2019 - The U.S. FDA stated: 'We have approved your request submitted and received June 4, 2019, to supplement your Biologics License Application under section 351(a) of the Public Health Service Act for Pneumococcal Vaccine Polyvalent (PNEUMOVAX®23) manufactured at West Point, Pennsylvania. We hereby approve the draft package insert labeling submitted under Amendment 5001, dated November 8, 2019.'
Pneumovax 23 Vaccine Clinical Trials
Mercks' Pneumovax 23 has been in numerous clinical trials to test the safety, tolerability, and immunogenicity.