On June 8, 2021, pharmaceutical and biotechnology company Pfizer Inc. (“Pfizer”) shared that its Pneumococcal 20-valent Conjugate Vaccine (PREVNAR 20) is now FDA-approved. The vaccine helps protect against 20 different Streptococcus pneumoniae serotypes responsible for many types of invasive pneumococcal disease (IPD). Altogether, the vaccine is appropriate for use in patients aged 18+.
PREVNAR 20
PREVNAR 20 actively immunizes against pneumonia and IPD caused by 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F serotypes. In the past, Pfizer’s Prevnar 13 guarded against 13 of these serotypes. However, PREVNAR 20 offers more comprehensive protection than any conjugate vaccine prior. The newly included serotypes, which account for an estimated 40% of diagnoses and fatalities, are often linked to meningitis, antibiotic resistant IPD, and high mortality.
Initially, PREVNAR 20 was granted Fast Track and Breakthrough Therapy designations in September 2017 and 2018, respectively. Ultimately, these statuses allowed PREVNAR 20 to have expedited review and development, as well as increased regulatory assistance and communication with the FDA. Although the European Medicines Agency (EMA) is still reviewing the Marketing Authorization Application (MAA) for PREVNAR 20, it has been approved within the United States.
The U.S. approval hinged on data from a series of Phase 1, 2, and 3 clinical trials. Altogether, over 6,000 adults participated in the Phase 3 clinical trials alone. Patients included those who were aged 65+, had previously received pneumococcal vaccines, and those who had never received pneumococcal vaccines. Ultimately, the trials suggested that PREVNAR 20 helped produce an effective immune response in patients.
While PREVNAR 20 is relatively safe and well-tolerated, some adverse reactions may occur. These include:
- Muscle and joint pain
- Injection site pain and inflammation
- Note: Swelling at the injection site was most common in patients younger than 60.
- Headache
- Fatigue
Invasive Pneumococcal Disease (IPD)
Altogether, invasive pneumococcal disease (IPD) is an umbrella group of infections caused by the Streptococcus pneumoniae (S. pneumoniae) bacteria. Typically, S. pneumoniae is spread through mucus and saliva secretions or autoinoculation. Additional risk factors include age (under 2 years old or 65+), cigarette smoking, having cochlear implants, or a history of prior conditions like sickle cell disease (SCD).
IPD is usually used for more severe and invasive infections. In this case, invasive means that the infection happens in an area of the body that is usually sterile. For example, IPD includes bacteremia, meningitis, endocarditis, or pericarditis. Symptoms vary based on which form of IPD someone has.
For example, patients with meningitis might experience:
- Nausea and vomiting
- Fever
- Irritability
- Intense headaches
- Lethargy
- Light sensitivity
- Neck stiffness
- Hearing loss
- Paralysis
- Seizures
- Coma
Alternately, patients with invasive pneumococcal pneumonia might experience:
- Difficulty breathing
- Persistent cough
- Nausea and vomiting
- General malaise and full-body weakness
- Headaches
- Rapid heart rate
- Fever
- Chills
- Chest pain
