Pendemrix, a candidate pandemic (H1N1) swine flu adjuvanted vaccine has received a positive opinion from CHMP (the European Committee for Medicinal Products for Human Use) – the vaccine is indicated for protection against pandemic H1N1 2009 influenza (swine flu).

A dose will consist of 3.75ug antigen of pandemic (H1N1) 2009 influenza strain and GSK’s proprietary adjuvant system AS03. The course consists of two single doses administered 3 weeks apart.

Jean Stéphenne, President, GlaxoSmithKline Biologicals said “This positive opinion means that Pandemrix will now be immediately reviewed for approval by the European Commission which is an important step closer to helping reduce the impact of the pandemic. GSK will continue to work closely with regulators, governments and health authorities around the world so that they can determine the most appropriate strategy to address the H1N1 pandemic.”

CHMP’s positive opinion is based on the mock up Pandemrix registration file using the H5N1 antigen which had received European approval in 2008. That file included various clinical and pre-clinical trials which evaluated tolerability, reactogenicity, immunogenicity and cross-protection. Tests indicated that the H5N1 was generally well-tolerated, with the most common side effects being headache, joint pain (arthralgia), muscle pain (myalgia), pain and redness at the site of injection, elevated body temperature and tiredness.

Preliminary data regarding tolerability and efficacy of the vaccine using the H1N1 antigen were also submitted to European regulators for evaluation.

These included latest results from the first clinical study which examined the use of the pandemic (H1N1) adjuvanted vaccine, which demonstrated, that after a single dose, the vaccine can provide a strong immune response beyond the immunogenicity criteria as defined by international licensing authorities for a pandemic influenza vaccine. The early tolerability data following the initial dose of the H1N1 vaccine point to a comparable tolerability profile to what was observed in H5N1 vaccine clinical trials.

GlaxoSmithKline (GSK) is currently carrying out 16 clinical trials in over 9,000 participants, consisting of healthy adults, elderly individuals, children and infants throughout Europe, the USA and Canada to further evaluate its pandemic (H1N1) adjuvanted vaccine.

GSK says that all the information from the current clinical development program will be presented to regulators once they are available. Data will also appear on the company’s Clinical Study Register, GSK informs.

Source: GlaxoSmithKline (GSK)

Written by Christian Nordqvist