European Medicines Agency Watch [to 28 March 2015]
http://www.ema.europa.eu/ema/

27/03/2015
Gardasil 9 offers wider protection against cancers caused by human papillomavirus (HPV)
Vaccine covers five more types of HPV than previously approved Gardasil vaccine
The European Medicines Agency (EMA) has recommended Gardasil 9 (human papillomavirus vaccine) for the prevention of diseases caused by nine types of human papillomavirus (HPV). This means that Gardasil 9 covers five more HPV types than Gardasil, one of two HPV vaccines available in the European Union (EU)…

…Gardasil 9 is recommended for use in boys and girls from nine years of age to protect against cervical cancer and pre-malignant cervical lesions, vulvar and vaginal cancers and pre-malignant vulvar and vaginal lesions, pre-malignant anal lesions and anal cancers and external genital warts covered by HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58…
…The safety of Gardasil 9 was evaluated in more than 23,000 people in seven clinical trials. The assessment also took into account experience from the use of Gardasil, which has been authorised in the EU since 2006. The most commonly reported adverse reactions were injection site pain, swelling, redness, and headaches.

Gardasil 9 is administered in three separate injections, with the initial dose followed by additional injections given two and six months later. All three doses should be given within a one year period.

The company received scientific advice from the Committee for Medicinal Products for Human Use (CHMP) which pertained to clinical aspects of the company’s application.

The opinion adopted by the CHMP at its March 2015 meeting is an intermediary step on Gardasil 9’s path to patient access. The CHMP opinion will now be sent to the European Commission for the adoption of a decision on EU-wide marketing authorisation. Once a marketing authorisation has been granted, a decision about price and reimbursement will then take place at the level of each Member State considering the potential role/use of this vaccine in the context of the national health system of that country.

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27/03/2015
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 March 2015
Five new medicines, including one orphan, recommended for approval
…One recommendation on extension of therapeutic indication
The Committee recommended an extension of indication for Tamiflu to include the treatment of influenza in infants below one year of age.

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27/03/2015
Regulatory information – EU recommendations for 2015/2016 seasonal flu vaccine composition
EMA annual recommendations are based on WHO observations
The European Medicines Agency has issued the European Union (EU) recommendations for the influenza virus strains that vaccine manufacturers should include in vaccines for the prevention of seasonal influenza from autumn 2015.

Trivalent vaccines for the 2015/2016 season should contain these three virus strains:
:: an A/California/7/2009 (H1N1)pdm09-like virus
:: an A/Switzerland/9715293/2013 (H3N2)-like virus
:: a B/Phuket/3073/2013-like virus

For quadrivalent vaccines with two influenza B viruses, a B/Brisbane/60/2008-like virus in addition to the strains mentioned above is considered appropriate.
Detailed recommendations including the specific virus strains recommended are available in a report from the Biologics Working Party (BWP) ad-hoc Influenza Working Group…