EMEA fast tracking H1N1 vaccine data
Manufacturers have begun submitting data to the European Medicines Agency (EMEA) and a review of submissions started this month. The agency has prioritised this process to prepare for the feared spike in cases when the flu season starts.
Mock-up vaccines, those based on data from the H5N1 virus strain, from Baxter, GlaxoSmithKline (GSK) and Novartis have already been approved in Europe. These have already been tested on 8,000 people so substantial, relevant data is already available.
To make the vaccine effective against swine flu manufacturers are replacing the H5N1 virus strain with H1N1.
According to the EMEA this change “should not substantially affect the safety or level of protection offered” but post-marketing monitoring programmes will be implemented by manufactures and the agency.
Clinical trials for the mock-ups are being initiated or currently ongoing and initial data is expected to be available from September onwards. Data on the H1N1 variants will be reviewed by the Committee for Medicinal Products for Human Use (CHMP) as it becomes available.
By conducting this rolling review the EMEA believes that when an application is filed it will have already seen a lot of the data, allowing it to quickly process the regulatory submission.
Although use of the mock-ups gives manufacturers prior data to use, GSK and Sanofi Pasteur are also developing new pandemic influenza vaccines. Preliminary data from these is being assessed on an accelerated basis by the CHMP.
In addition the CHMP is already reviewing data related to the manufacture of vaccines.
Trials around the globe
The US has selected eight cities to conduct trials of H1N1 vaccines and is now seeking volunteers. Initial trials will be performed in healthy adults, with the programme being expanded to include children as young as six months if the vaccines appear safe.
Meanwhile in Australia CSL has begun a trial on 240 healthy adult volunteers. The trial is set to take place over the next seven weeks and generate data for regulatory submissions in Australia, Singapore and the US.
