The latest data from laboratory evaluations of pandemic vaccine made by three manufacturers in Europe are being reviewed today in a meeting of European Medicines Agency (EMEA) experts, according to a virologist speaking at the UK Health Protection Agency’s annual conference yesterday.

 

James Robertson, Principal Scientist at the Division of Virology of the UK’s National Institute for Biological Standards and Control, says Europe’s vaccine manufacturers are very close to getting past one of the regulatory ‘checkpoints’ on the way to getting the vaccines licensed. But final approval is “at least a month away”, he added.

 

“I think we’ll be lucky to see anything [of the first batches used in Europe] before mid-October,” Robertson told EHTF News. “That’s bureaucracy.”

 

Unlike most seasonal flu vaccines, which are licensed in each country, rules put in place before the new A/H1N1 virus emerged specify that the decision to license a pandemic vaccine must be made by the European Commission (EC). This could take some weeks.

 

At the moment “things are moving quite fast,” explains Robertson. Over the last few years, the companies worked on a core ‘mock-up’ vaccine based on the H5N1 virus. To make ‘swine flu’ vaccine all they had to do was switch to the new H1N1 virus, which means vaccine production can now move along much faster.

 

GlaxoSmithKline, Novartis, and Baxter have been submitting to the EMEA small packages of vaccine “quality” data for review on a rolling basis, every two weeks. This is different to normal procedure for approval of a new vaccine, which involves a multi-month assessment of each company’s data package.

 

After an initial evaluation, the EMEA Committee for Medicinal Products for Human Use (CHMP) has final say on whether these data can be approved. If the latest batch looks good, the companies will be given the green light to apply to the EC for authorisation to market the vaccine. Because of the switch from H5N1 to the new H1N1 virus, this is called a ‘variation’ of authorisation for the existing vaccine. The EC will take at least a month to authorise use once the CHMP has approved the lab analysis data.

 

Robertson is unsure how much this process will overlap with the autumn wave of the pandemic in the northern hemisphere, and whether use of the vaccine will overlap with licensure. It is possible that if the approval process is too slow, European countries could go ahead and use available doses of the vaccine before it is formally licensed, he suggests.

 

The data required to issue a license reflect how immunogenic and safe the vaccine appears to be in laboratory tests. Because the swine flu vaccine is made in exactly the same way that the H5N1 vaccine was made, it should work in the same way, Robertson explains. Authorities are “looking for a minimal set of data that says the vaccine will work and will be safe,” he notes.

 

But “follow up measures” will be put in place, adds Robertson, to monitor safety after the immunisation campaign gets underway. In addition to post-marketing surveillance for any adverse events, which is done by health authorities, the vaccine manufacturers will be conducting specific clinical trials to look at vaccine safety across different groups in the population. These clinical trials are due to begin before licensure, he says, and safety assessment will continue well into 2010.