Expanded Patient Population for Prevnar 13
July 11, 2016 – The U.S. FDA approved Pfizer’s pneumonia vaccine, Prevnar 13® (pneumococcal 13-valent conjugate vaccine [diphtheria CRM197 protein]) expanding the patient population to all individuals over six weeks of age. Previous FDA approval was for adults age 50 and older and for children 6 weeks to 18 years old. Prevnar 13 protects against 13 strains of Streptococcus pneumoniae (also called pneumococcus) bacteria, which are major causes of pneumonia and several other infections. Babies should receive doses of the vaccine at two months, four months and six months of age. A fourth dose should be given when the child is between 12 months and 15 months old. Children over age five, adolescents and adults need only one injection.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and a availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.