Prevnar Side Effects in Infants — VAERS Data

Prevnar side effects in infants and post-market safety data — reviewing adverse event reports for pneumococcal conjugate vaccines (PCV7, PCV13, PCV20) from VAERS and clinical surveillance.

Post-licensure findings on the pneumococcal conjugate vaccines on the US childhood schedule. The source contains relatively limited PCV-specific post-licensure data beyond the system-level critiques. The most significant finding is the CDC autism lawsuit: CDC's stipulated evidence base for the no-vaccines-cause-autism claim contained zero studies examining PCV in infants. Pfizer's Prevnar 13 is implicitly relevant to the broader pattern of Pfizer products being tested with asymmetric standards (compared to Pfizer's pharmaceutical drugs) — see the Hepatitis B Vaccines (Post-Licensure) companion discussion.

CDC Autism Lawsuit: PCV Not Studied

In court stipulation responding to ICAN's lawsuit, the CDC identified its complete evidence base for claiming infant vaccines do not cause autism: 20 studies. Upon review, zero of those 20 studies examined PCV in the relevant infant age window for autism causation.

PCV is administered at the 2-month, 4-month, 6-month, and 12-15-month well-child visits — concurrent with DTaP, Hep B, Hib, and IPV. None of the CDC's cited studies addresses concurrent administration of these vaccines. See Post-Licensure Safety Monitoring.

Pfizer's Asymmetric Safety Standards

Pfizer is the manufacturer of Prevnar 7, Prevnar 13, and Prevnar 20. The same company has conducted multi-year placebo-controlled trials for its top non-vaccine pharmaceuticals:

DrugSafety Review DurationControl
Eliquis7.4 yearsPlacebo
Enbrel6.6 yearsPlacebo
Lipitor4.9 yearsPlacebo
Lyrica2 yearsPlacebo

Pfizer's pneumococcal vaccines were tested with active controls (other vaccines) and 6-month monitoring windows. The contrast reflects the difference in liability exposure: Pfizer's pharmaceutical drugs carry full tort liability under product liability law. Pfizer's vaccines carry zero liability under the 1986 Act (National Childhood Vaccine Injury Act).

The same company conducts dramatically different safety trials depending on whether it can be sued for product harm.

VAERS, VSD, V-SAFE Coverage

PCV vaccines are nominally subject to post-licensure surveillance through:

These surveillance systems have not generated regulatory action specific to PCV vaccines despite the elevated SAE rates documented in the pre-licensure trials (Prevnar 13: 8.2%; Vaxneuvance: 9.6%). Post-licensure data has not been systematically collected to validate or contradict these trial findings. See the linked concept pages for documentation of why these systems have not produced reliable post-licensure safety signals.

AHRQ "Comprehensive" Review

The 2014 AHRQ comprehensive review of 20,478 studies found zero qualifying safety studies for most routine childhood vaccines. The PCV vaccines are part of this finding. See Post-Licensure Safety Monitoring.

See Also

PCV Vaccines (Pre-Licensure), Post-Licensure Safety Monitoring, Pfizer, Financial Immunity for Vaccine Makers, 1986 Act (National Childhood Vaccine Injury Act)

Frequently Asked Questions

Frequently Asked Questions

Has the CDC studied whether Prevnar causes autism?
No. In court stipulation responding to ICAN's lawsuit, the CDC identified 20 studies as its complete evidence base for claiming infant vaccines do not cause autism. Zero of those 20 studies examined PCV in the relevant infant age window. PCV is administered at 2, 4, 6, and 12-15 months — concurrent with DTaP, Hep B, Hib, and IPV — and none of the CDC's studies addressed this concurrent exposure.
Why does Pfizer test vaccines differently than its other drugs?
Pfizer conducts multi-year placebo-controlled trials for its top pharmaceuticals — Eliquis (7.4 years), Enbrel (6.6 years), Lipitor (4.9 years), Lyrica (2 years). But Pfizer's PCV vaccines were tested with active controls and 6-month windows. The difference is liability: Pfizer's pharmaceutical drugs carry full tort liability under product liability law, while its vaccines carry zero liability under the 1986 Act. The same company applies dramatically different safety standards depending on whether it can be sued.
What was the serious adverse event rate in Prevnar clinical trials?
SAE rates escalated with each PCV generation. Prevnar 13 had an 8.2% SAE rate (vs Prevnar 7's 7.2%). Vaxneuvance had a 9.6% SAE rate (vs Prevnar 13's 8.9%). Each higher rate was accepted because it was similar to the prior generation — but none was ever validated against a placebo. Post-licensure surveillance has not systematically collected data to validate or contradict these trial findings.
Are there comprehensive post-licensure safety studies on Prevnar?
No. The 2014 AHRQ review examined 20,478 studies and found zero qualifying safety studies for most routine childhood vaccines, including PCV. Post-licensure surveillance through VAERS, VSD, and V-SAFE has not generated regulatory action against PCV vaccines despite the elevated SAE rates (8.2-9.6%) documented in pre-licensure trials. The systems' structural limitations prevent reliable detection of cumulative-exposure signals.
What SAE rates have been documented for Prevnar vaccines in post-market data?
Post-market surveillance has not systematically replicated the SAE rate measurements from pre-licensure trials. VAERS captures an estimated less than 1% of actual adverse events. The VSD was moved to a trade association in 2001 to evade FOIA, making its data inaccessible for independent analysis. The pre-licensure SAE rates of 7.2-9.6% remain the best available safety data, and no post-licensure system has been configured to confirm or refute them.

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