Pneumovax II: tolerability of re-vaccination
- Medicines and Healthcare products Regulatory Agency
- 1 October 2007
- Therapeutic area:
- Immunology and vaccination and Paediatrics and neonatology
Healthcare professionals should advise patients who need re-vaccination with Pneumovax II to expect a more intense reaction than after their first vaccination.
Article date: October 2007
Pneumovax II pneumococcal polysaccharide vaccine is recommended for immunisation against disease caused by pneumococcal serotypes contained in the vaccine. Pneumovax II is not effective for prevention of acute otitis media, sinusitis, or other common infections of the upper respiratory tract.
Who should be vaccinated?
Pneumovax II is recommended for all individuals aged 65 years or older and those aged 2 years or older who are at increased risk of serious or fatal pneumococcal disease.
Who should be re-vaccinated and when?
- Healthy adults and children should not be routinely re-vaccinated with Pneumovax II
- Re-vaccination may be considered for individuals older than 10 years of age who are at increased risk of serious pneumococcal infection, and who have not been vaccinated in the past 5 years, or for those known to have had a rapid drop in pneumococcal antibody levels
- For populations who are known to be at high risk of fatal pneumococcal infection (eg, asplenics), re-vaccination at 3 years may be considered
- For children aged 2–10 years, re-vaccination after 3 years should be considered only for those at high risk of pneumococcal infection
Tolerability of re-vaccination
Re-vaccination within 3 years of primary vaccination is not recommended because of an increased risk of adverse reactions. A clinical trial recorded an increased frequency and intensity of local reactions after re-vaccination at 3–5 years after primary vaccination. This effect was most marked in people aged 65 years or older. Injection-site reactions occurred within 3 days of vaccination and typically resolved within 5 days. Systemic adverse experiences such as chills, asthenia, and myalgia were more common after re-vaccination than after primary immunisation in those aged 65 years or older. Most people recovered completely after symptomatic treatment.
Healthcare professionals should avoid antibiotic therapy as symptomatic treatment unless specifically indicated.
Spontaneous data and clinical trial data suggest that more than one in ten vaccinees will experience pyrexia and injection-site redness, pain, induration, and swelling. Pain and swelling of the vaccinated limb, which may result in its reduced mobility, have also been reported. Very rarely, injection-site cellulitis has developed shortly after vaccination.
Article citation: Drug Safety Update October 2007; Vol 1, Issue 3: 6.
Published: 1 October 2007