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Cervarix safety information

In clinical studies that enrolled girls and women aged from 10 up to 72 years (of which 79.2% were aged 10–25 years at the time of enrolment), Cervarix was administered to 16,142 subjects whilst 13,811 subjects received control. These subjects were followed for serious adverse events over the entire study period. In a pre-defined subset of subjects (Cervarix n=8,130 vs. control n=5,786), adverse events were followed for 30 days after each injection1

The most common adverse reaction observed after vaccine administration was injection-site pain which occurred after 78% of all doses. The majority of these reactions were of mild-to-moderate severity and were not long lasting.1

Frequencies per dose are defined as follows:1

Very common: ≥10%
Common: ≥1% – <10%
Uncommon: ≥0.1% – <1%

Frequency

Reactions

Very common

Headache; myalgia; injection-site reactions including pain, redness, swelling; fatigue

Common

Gastrointestinal including nausea, vomiting, diarrhoea and abdominal pain. Itching/pruritus, rash, urticaria, arthralgia, fever (≥38°C)

Uncommon

Upper respiratory tract infection, dizziness, other injection-site reactions such as induration, local paraesthesia

Unknown (post-marketing experience)

Lymphadenopathy
Allergic reactions (including anaphylactic and anaphylactoid reactions), angioedema Syncope or vasovagal responses to injection, sometimes accompanied by tonic-clonic movements 

A similar safety profile has been observed in subjects with prior or current HPV infections as compared to subjects negative for oncogenic HPV DNA or seronegative for HPV 16 and HPV 18 antibodies.1

More than 4 years of post-licensure experience may provide confidence to providers and the public about the safety profile of HPV 16/18 vaccine in routine use. The safety profile appears to be consistent with pre-licensure data reporting that HPV 16/18 vaccine has an acceptable benefit–risk profile in adolescent girls and women.2

References:

  1. Cervarix IPI Version number: GDS024/ IPI019 / Date of issue: 02/Mar/15 2015 GSK group of companies
  2. Angelo MG, Zima J, Tavares Da Silva F, et al. Post-licensure safety surveillance for human papillomavirus-16/18-AS04-adjuvanted vaccine: more than 4 years of experience. Pharmacoepidemiol Drug Saf 2014;23:456–465.

Cervarix is a registered trademark of GlaxoSmithKline group of companies.