What are the side effects of Prevnar 20 (Pneumococcal conjugate vaccine)?

From the Guidelines

Prevnar 20 is generally well-tolerated, with the most common side effects being mild and temporary, including injection site pain, muscle pain, fatigue, headache, and joint pain, as reported in a 2023 study published in MMWR Recommendations and Reports 1. The side effects of Prevnar 20, a pneumococcal 20-valent conjugate vaccine, have been assessed in several clinical trials, including a pivotal phase III trial among pneumococcal vaccine–naïve adults 1.

• The most frequently reported adverse reactions were:
  • Injection site pain
  • Muscle pain
  • Fatigue
  • Headache
  • Joint pain These side effects were reported in 55%, 39%, 30%, 22%, and 13% of adults aged ≥60 years, respectively, and in 50%–61%, 50%–67%, 40%–43%, 32%–39%, and 13%–15% of adults aged 18–59 years, respectively 1.
• Serious adverse events (SAEs) were rare, occurring in 1.5% of PCV20 recipients and 1.8% of controls within 6 months after vaccination, with no SAEs or deaths considered related to the study vaccines 1. It is essential to note that these side effects are generally expected immune responses as the body builds protection against pneumococcal bacteria. If severe or persistent side effects occur, individuals should contact their healthcare provider. Overall, the protection provided by Prevnar 20 against potentially serious pneumococcal infections outweighs the temporary discomfort of these side effects.

From the FDA Drug Label

Across studies 1 through 6, performed in individuals of all ages, naïve to and with prior pneumococcal vaccination, the proportion of participants reporting 1 or more SAEs within 6 months after vaccination with Prevnar 20 was 1.5% (67 of 4552 participants). The frequency and severity of the local adverse reactions (redness, swelling, and pain at the injection site) prompted daily in the 10 days after Prevnar 20 vaccination in individuals naïve to pneumococcal vaccination (Study 1) and in individuals with prior pneumococcal vaccination (Study 6) are shown in Table 4 and Table 5, respectively. The most frequently reported local reaction was pain at injection site, followed by redness and swelling. Most local reactions were mild or moderate in severity. The most frequently reported solicited systemic reactions in individuals ≥15 months to <2 years of age were irritability, followed by drowsiness and increased sleep, and decreased appetite. Fever ≥38.0°C was reported by 11.8% of individuals; fever >38.4°C was reported infrequently.

Common side effects of Prevnar 20 include:

• Pain at the injection site
• Redness and swelling at the injection site
• Irritability
• Drowsiness and increased sleep
• Decreased appetite
• Fever

Serious side effects are rare, but may include:

• Serious adverse events (SAEs) such as hypersensitivity reactions, seizures, and urticaria or urticaria-like rash 2
• Febrile seizures 2

Note: The safety profile of Prevnar 20 is based on data from clinical trials, and the actual side effects experienced by individuals may vary. It is essential to consult the FDA drug label and discuss any concerns with a healthcare professional. 2 2

From the Research

Prevnar20 Side Effects

• Local reactions in the first two days following vaccination, including:
  • Erythema (approximately 10%) 3
  • Induration (approximately 10%) 3
  • Tenderness (approximately 20%) 3
• Fever of 38 degrees C or higher (15% to 25% of children in the first two days following vaccination) 3

General Information on Pneumococcal Conjugate Vaccines

• Pneumococcal conjugate vaccines have been shown to be effective in preventing invasive pneumococcal disease and pneumonia in children and adults 3, 4, 5, 6, 7
• The vaccines have also been shown to provide herd protection, reducing the transmission of pneumococcal disease in communities 4
• Different types of pneumococcal conjugate vaccines are available, including PCV13 and Prevnar20, which have been shown to have similar efficacy and safety profiles 3, 7

Specific Information on Prevnar20

• Prevnar20 is a pneumococcal conjugate vaccine that has been shown to be effective in preventing invasive pneumococcal disease and pneumonia in adults 7
• The vaccine has been recommended for use in adults aged 65 years and older, as well as in younger adults with certain underlying medical conditions 5, 7
• The safety profile of Prevnar20 is similar to that of other pneumococcal conjugate vaccines, with common side effects including local reactions and fever 3, 7