European Medicines Agency Recommends Continued Vaccination With Gardasil

February 20, 2009 at 11:00 am Leave a comment

The European Medicines Agency (EMEA) has reviewed the available
information on the two cases of status epilepticus with myoclonus
(repeated and prolonged seizures and loss of consciousness) reported in
two girls vaccinated with the cervical cancer vaccine Gardasil in Spain.

Based on the current data, the Agency’s Committee for Medicinal Products
for Human Use (CHMP) has concluded that the cases are unlikely to be
related to vaccination with Gardasil and that the benefits of Gardasil
continue to outweigh its risks. Therefore the Committee is recommending
that vaccination with Gardasil should continue in accordance with
national vaccination programmes in Member States.

Both girls were vaccinated with the same batch of Gardasil, became ill
shortly after vaccination, and are now improving. Following the two
cases, the Spanish public health authorities stopped vaccination with
the batch of Gardasil concerned as a precautionary measure on 9 February
2009. The Italian authorities also stopped vaccination with this batch
shortly thereafter. The distribution of the entire batch was stopped on
10 February 2009.

The CHMP and its Pharmacovigilance Working Party are investigating this
situation further. The marketing authorisation holder has been requested
to provide a full analysis of the batch, as well as further information
on the vaccine’s side effects, any similar cases, and possible ways in
which Gardasil could be linked to the cases seen in Spain. Following
assessment of all of the available data, the CHMP will determine whether
further action is needed.

Gardasil, from Sanofi Pasteur MSD SNC, is a vaccine for the prevention
of cervical cancer and other pre-cancerous diseases caused by human
papillomavirus (HPV). It has been authorised in the European Union (EU)
since September 2006. Around three million girls in Europe have been
vaccinated with this vaccine since it was first authorised.

As part of its continuous monitoring of medicines, the CHMP recommended
an update of the Product Information for Gardasil in January 2009, to
reinforce information on syncope (fainting) as a side effect of
vaccination with Gardasil, indicating that it is sometimes accompanied
by tonic-clonic movements (movements resembling a seizure). This opinion
has been forwarded to the European Commission, for the adoption of an
EU-wide decision.


1. The batch concerned has also been distributed in France, the
Netherlands, Italy and Germany. However, it has not been used to date in
Germany or in the Netherlands.

2. The approved indication in the EU for Gardasil is: “Gardasil is a
vaccine for the prevention of premalignant genital lesions (cervical,
vulvar and vaginal), cervical cancer and external genital warts
(condyloma acuminata) causally related to Human Papillomavirus (HPV)
types 6, 11, 16 and 18. The indication is based on the demonstration of
efficacy of Gardasil in adult females 16 to 26 years of age and on the
demonstration of immunogenicity of Gardasil in 9- to 15-year old
children and adolescents. Protective efficacy has not been evaluated in
males. The use of Gardasil should be in accordance with official

For more information on Gardasil, please see here.

3. The same vaccine is also marketed in the EU as Silgard. For more
information on Silgard, please see here.

4. This press release, together with other information on the work of
the EMEA, can be found on the EMEA website:




Entry filed under: Uncategorized.

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