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Series Would be Routinely Recommended Both for Adults 65 Years and Older and for Adults Ages 19 to 64 at Increased Risk for Disease, Such as Those with Certain Underlying Medical Conditions
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the U.S. Centers for Disease Control and Prevention's (CDC's) Advisory Committee on Immunization Practices (ACIP) unanimously voted in favor of updates to pneumococcal vaccination recommendations for adults 65 years and older, and for adults ages 19 to 64 with certain underlying medical conditions (e.g., chronic conditions such as diabetes, chronic heart disease, chronic lung disease, or chronic liver disease, as well as HIV, an immunocompromising condition) or other disease risk factors (e.g., smoking, alcoholism). In both groups, the ACIP voted to provisionally recommend vaccination either with a sequential regimen of VAXNEUVANCE followed by PNEUMOVAX 23, or with a single dose of 20-valent pneumococcal conjugate vaccine. These updates would apply to adults who have not previously received a pneumococcal conjugate vaccine or whose previous pneumococcal vaccination history is unknown.
Further details will be available from the CDC. These provisional recommendations will be reviewed by the director of the CDC and the Department of Health and Human Services, and final recommendations will become official when published in the CDC's Morbidity and Mortality Weekly Report (MMWR) .
VAXNEUVANCE is indicated for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F in adults 18 years of age and older. VAXNEUVANCE is contraindicated for individuals with a history of severe allergic reaction (e.g., anaphylaxis) to any component of VAXNEUVANCE or to diphtheria toxoid.
PNEUMOVAX 23 is indicated for active immunization for the prevention of pneumococcal disease caused by the 23 serotypes contained in the vaccine (1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F and 33F), in persons 50 years of age or older and persons aged ≥2 years who are at increased risk for pneumococcal disease; PNEUMOVAX 23 will not prevent disease caused by capsular types of pneumococcus other than those contained in the vaccine. PNEUMOVAX 23 is contraindicated in individuals with a history of a hypersensitivity reaction to any component of PNEUMOVAX 23.
See additional Select Safety Information for each of these vaccines below.
"Today's vote reinforces the potential for VAXNEUVANCE in series with PNEUMOVAX 23 to help address a significant unmet need in the U.S. for adult populations at increased risk of invasive pneumococcal disease (IPD). VAXNEUVANCE in series with PNEUMOVAX 23 elicits a strong immune response to the serotypes shared by both vaccines, and together this regimen can help protect against pneumococcal serotypes responsible for about two-thirds of IPD cases in adults at increased risk," said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. "We look forward to the CDC's final, published recommendations and applaud the ACIP and the CDC for their continued efforts to address the significant burden of IPD by continuously evaluating vaccination recommendations utilizing a comprehensive body of scientific evidence."
Select Safety Information for VAXNEUVANCE (Pneumococcal 15-valent Conjugate Vaccine)
Do not administer VAXNEUVANCE to individuals with a severe allergic reaction (e.g., anaphylaxis) to any component of VAXNEUVANCE or to diphtheria toxoid.
Some individuals with altered immunocompetence, including those receiving immunosuppressive therapy, may have a reduced immune response to VAXNEUVANCE.
The most commonly reported solicited adverse reactions in individuals 18 through 49 years of age were: injection site pain (75.8%), fatigue (34.3%), myalgia (28.8%), headache (26.5%), injection site swelling (21.7%), injection site erythema (15.1%) and arthralgia (12.7%).
The most commonly reported solicited adverse reactions in individuals 50 years of age and older were: injection site pain (66.8%), myalgia (26.9%), fatigue (21.5%), headache (18.9%), injection site swelling (15.4%), injection site erythema (10.9%) and arthralgia (7.7%).
Vaccination with VAXNEUVANCE may not protect all vaccine recipients.
Select Safety Information for PNEUMOVAX 23 (Pneumococcal Vaccine Polyvalent)
Do not administer PNEUMOVAX 23 to individuals with a history of a hypersensitivity reaction to any component of the vaccine.
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 a 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 may not be effective in preventing pneumococcal meningitis in patients who have chronic cerebrospinal fluid (CSF) leakage resulting from congenital lesions, skull fractures or neurosurgical procedures.
The most common adverse reactions, reported in >10% of subjects vaccinated with PNEUMOVAX 23 for the first time in a clinical trial, were: injection-site pain/soreness/tenderness, injection-site swelling/induration, headache, injection-site erythema, asthenia and fatigue, and myalgia.
For subjects aged 65 years or older in a clinical study, systemic adverse reactions which were determined by the investigator to be vaccine-related were higher following revaccination than following initial vaccination.
Vaccination with PNEUMOVAX 23 may not offer 100% protection from pneumococcal infection.
About Merck
For 130 years, Merck, known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases in pursuit of our mission to save and improve lives. We demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to prevent and treat diseases that threaten people and animals – including cancer, infectious diseases such as HIV and Ebola, and emerging animal diseases – as we aspire to be the premier research-intensive biopharmaceutical company in the world. For more information, visit www.merck.com and connect with us on Twitter , Facebook , Instagram , YouTube and LinkedIn .
Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA
This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the "company") includes "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company's management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.
Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the global outbreak of novel coronavirus disease (COVID-19); the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.
The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company's 2020 Annual Report on Form 10-K and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site ( www.sec.gov ).
Please see Prescribing Information for VAXNEUVANCE at https://www.merck.com/product/usa/pi_circulars/v/vaxneuvance/vaxneuvance_pi.pdf .
and Patient Information at https://www.merck.com/product/usa/pi_circulars/v/vaxneuvance/vaxneuvance_ppi.pdf .
Please see Prescribing Information for PNEUMOVAX 23 at https://www.merck.com/product/usa/pi_circulars/p/pneumovax_23/pneumovax_pi.pdf and Patient Information for PNEUMOVAX 23 at https://www.merck.com/product/usa/pi_circulars/p/pneumovax_23/pneumovax_ppi.pdf .
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