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  1. Home
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  3. Cervarix - withdrawal of application for variation to marketing authorisation

Cervarix - withdrawal of application for variation to marketing authorisation

Application withdrawn

The application for a change to this medicine's authorisation has been withdrawn.

human papillomavirus vaccine [types 16, 18] (recombinant, adjuvanted, adsorbed)
Post-authorisationHuman

Page contents

  • Overview
  • Key facts
  • Documents
  • Related information on withdrawals
  • News on Cervarix
  • More information on Cervarix

Overview

GlaxoSmithKline Biologicals SA withdrew its application to use Cervarix in individuals from the age of nine years for the prevention of head and neck cancers that are caused by certain types of human papillomavirus (HPV).

The company withdrew the application on 22 October 2021.

Cervarix is a vaccine that is used from the age of nine years to protect against the following conditions caused by certain types of HPV:

  • cancer of the cervix (neck of the womb) or anus;
  • precancerous lesions (abnormal cell growth) in the genital area (cervix, vulva, vagina or anus).

It is a suspension for injection that contains proteins for two types of HPV (16 and 18) and is available in vials or prefilled syringes.

Cervarix has been authorised in the EU since September 2007.

The company applied to extend the use of Cervarix in individuals from the age of nine years to include protection against head and neck cancers that are related to HPV infection. These cancers share important features with HPV-related cancer of the cervix, including onset of disease at a young age and the types of HPV involved.

Papillomaviruses are viruses that cause warts and abnormal tissue growth. There are more than 100 types of papillomavirus, some of which are associated with genital and anal cancers, as well as head and neck cancers, particularly cancers of the mouth and throat. The most common HPV types involved in these cancers are types 16 and 18. All HPV types have a shell or ‘capsid’, which is made up of distinctive proteins called ‘L1 proteins’.

Cervarix contains purified L1 proteins for HPV types 16 and 18. When a person is given the vaccine, the body’s immune system makes antibodies against the L1 proteins. If, later on, the person comes into contact with HPV virus, their immune system will recognise it and be ready to defend the body against it. This will help to protect against the diseases caused by these viruses.

In the prevention of head and neck cancer, Cervarix was expected to work in the same way as it does in its existing indication.

The company presented the results of a main study which looked at the effectiveness of Cervarix in preventing HPV infection in the mouth and throat. The results were based on 4,871 girls aged between 12 and 15 years who received either Cervarix or a comparator vaccine that is not active against HPV (in this case, a vaccine against hepatitis B virus). Effectiveness was measured by testing saliva samples for DNA (genetic material) of the HPV virus.

The application was withdrawn after the European Medicines Agency had evaluated the initial information from the company and had prepared questions for the company. The company had not responded to the questions at the time of the withdrawal.

Based on the review of the available information, at the time of the withdrawal, the Agency had concerns and its provisional opinion was that Cervarix could not have been authorised for the prevention of head and neck cancers. In particular, the Agency had concerns about the design of the main study. The Agency noted that the way prevention of persistent HPV infection in the mouth and throat was measured was not adequate as testing was only done once and not repeated over time. In addition, the results were not statistically meaningful.

Therefore, at the time of the withdrawal, the Agency was not able to draw conclusions on the effectiveness of Cervarix in preventing head and neck cancers related to HPV infection and its opinion was that the benefits of Cervarix in this use did not outweigh its risks.

In its Withdrawal letter: Cervarix notifying the Agency of the withdrawal of application, the company stated that the withdrawal is based on the fact that the available data were not considered sufficient to conclude on a positive risk-benefit balance for the proposed indication.

The company informed the Agency that there are no consequences for people in clinical trials using Cervarix.

If you are in a clinical trial and need more information about your treatment, speak with your clinical trial doctor.
 

Questions and answers on the withdrawal of application to change the marketing authorisation for Cervarix (human papillomavirus vaccine [types 16, 18] (recombinant, adjuvanted, adsorbed))

Reference Number: EMA/627371/2021

English (EN) (106.06 KB - PDF)

First published: 12/11/2021
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Other languages (22)

български (BG) (153.85 KB - PDF)

First published: 12/11/2021
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español (ES) (128.96 KB - PDF)

First published: 12/11/2021
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čeština (CS) (151.46 KB - PDF)

First published: 12/11/2021
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dansk (DA) (130.34 KB - PDF)

First published: 12/11/2021
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Deutsch (DE) (133.71 KB - PDF)

First published: 12/11/2021
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eesti keel (ET) (127.88 KB - PDF)

First published: 12/11/2021
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ελληνικά (EL) (157.05 KB - PDF)

First published: 12/11/2021
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français (FR) (129.58 KB - PDF)

First published: 12/11/2021
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hrvatski (HR) (150.97 KB - PDF)

First published: 12/11/2021
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italiano (IT) (128.18 KB - PDF)

First published: 12/11/2021
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latviešu valoda (LV) (170.47 KB - PDF)

First published: 12/11/2021
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lietuvių kalba (LT) (150.96 KB - PDF)

First published: 12/11/2021
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magyar (HU) (152.83 KB - PDF)

First published: 12/11/2021
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Malti (MT) (164.07 KB - PDF)

First published: 12/11/2021
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Nederlands (NL) (131.19 KB - PDF)

First published: 12/11/2021
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polski (PL) (153.28 KB - PDF)

First published: 12/11/2021
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português (PT) (129.88 KB - PDF)

First published: 12/11/2021
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română (RO) (149.26 KB - PDF)

First published: 12/11/2021
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slovenčina (SK) (151.63 KB - PDF)

First published: 12/11/2021
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slovenščina (SL) (149.46 KB - PDF)

First published: 12/11/2021
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Suomi (FI) (127.88 KB - PDF)

First published: 12/11/2021
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svenska (SV) (127.73 KB - PDF)

First published: 12/11/2021
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Key facts

Name of medicine
Cervarix
EMA product number
EMEA/H/C/000721
Active substance
  • human papillomavirus1 type 16 L1 protein
  • human papillomavirus type 18 L1 protein
International non-proprietary name (INN) or common name
human papillomavirus vaccine [types 16, 18] (recombinant, adjuvanted, adsorbed)
Therapeutic area (MeSH)
  • Papillomavirus Infections
  • Uterine Cervical Dysplasia
  • Immunization
Anatomical therapeutical chemical (ATC) code
J07BM02
Marketing authorisation holder
GlaxoSmithKline Biologicals S.A.
Date of issue of marketing authorisation valid throughout the European Union
20/09/2007
Date of withdrawal
22/10/2021

Documents

Withdrawal letter: Cervarix

English (EN) (175.93 KB - PDF)

First published: 12/11/2021
View

Withdrawal assessment report for Cervarix

AdoptedReference Number: EMA/612496/2021

English (EN) (4.58 MB - PDF)

First published: 10/01/2022
View

Related information on withdrawals

The question-and-answer (Q&A) document provides a summary of the CHMP's evaluation of the application at the time of the withdrawal, and includes a link to the company's formal withdrawal letter.

An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').

News on Cervarix

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 8-11 November 2021
12/11/2021
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 June 2016
24/06/2016
HPV vaccines: EMA confirms evidence does not support that they cause CRPS or POTS
20/11/2015
Review concludes evidence does not support that HPV vaccines cause CRPS or POTS
05/11/2015
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6-9 July 2015
13/07/2015
EMA to further clarify safety profile of human papillomavirus (HPV) vaccines
13/07/2015
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 February 2013
22/02/2013
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 October 2011
21/10/2011

More information on Cervarix

  • Cervarix
This page was last updated on 10/01/2022

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