FDA Approves Capvaxive Pneumococcal 21-Valent Conjugate Vaccine

Follow Drugslib on

Medically reviewed by Drugs.com.

By Lori Solomon HealthDay Reporter

FRIDAY, June 21, 2024 -- The U.S. Food and Drug Administration has approved the Capvaxive pneumococcal 21-valent conjugate vaccine for the prevention of invasive pneumococcal disease and pneumococcal pneumonia in adults.

Capvaxive is specifically designed to help protect adults against the serotypes that cause the majority of invasive pneumococcal disease cases, including Streptococcus pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B, in individuals ages 18 year and older, and for the prevention of pneumonia caused by S. pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B in individuals 18 years and older.

The priority review was based on the pivotal phase 3 STRIDE-3 trial, which compared Capvaxive to pneumococcal 20-valent conjugate vaccine in adults ages 18 years and older, who had not previously received a pneumococcal vaccine, as well as the phase 3 STRIDE-5 and STRIDE-6 trials, which evaluated Capvaxive in vaccine-naive and vaccine-experienced adults. Capvaxive includes eight unique serotypes not covered by other currently approved pneumococcal vaccines, but that are responsible for approximately 27 percent of invasive pneumococcal disease cases in adults ages 50 years and older and approximately 30 percent of cases in adults ages 65 years and older, according to epidemiological data. The company says the vaccine covers serotypes responsible for approximately 84 percent of invasive pneumococcal disease in adults ages 50 years and older.

"Today's approval is a testament to our population-specific strategy behind Capvaxive, which demonstrated robust immunogenicity in a range of adult populations and is driven by a deep understanding of pneumococcal disease," Dean Y. Li, M.D., Ph.D., from Merck Research Laboratories, said in a statement. "We are proud to provide Capvaxive as a new option specifically designed to help protect against the majority of invasive pneumococcal disease-causing serotypes in adults."

Approval of Capvaxive was granted to Merck.

More Information

Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.

Source: HealthDay

Posted : 2024-06-22 07:15

Read more

Disclaimer

Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Popular Keywords