Eu Will Speed Critique Of Pandemic Flu Vaccines Precaution Data
Manufacturers have started submitting information on their vaccines to fight the pandemic virus, known as swine flu or H1N1, the London-based agency said today in a statement on its Web site. The agencys Committee for Medicinal Products for Human Use will fast-track the review process that began this month, according to the statement.
“What we are doing right now is what we call a rolling review,” spokeswoman Monika Benstetter said in a telephone interview today. “We are looking at data generated by the manufacturers as it becomes available. By the time an actual application is filed, it can be looked at in a very short time frame because basically we have already seen most of it.”
The European Union has approved four mock-up pandemic vaccines, which are products that have been designed so that the flu virus can be inserted once the strain is identified. The mock-ups made by GlaxoSmithKline Plc, Novartis AG and Baxter International Inc. are based on the H5N1 avian flu strain, which the World Health Organization has been tracking since 2003 because of its potential to spark a global outbreak in people.
“We are working with the companies to process this virus strain, this strain change,” Benstetter said. “For the mock-up vaccines, we already have a good body of evidence.”
The mock-up plan is similar to the process for making seasonal flu shots, in which strains are changed depending on which viruses are infecting people, Benstetter said.
8,000 Tested
The mock-up inoculations have been tested in more than 8,000 people, the agency said. Manufacturers are starting additional trials in adults and children, and the results will be reviewed in the coming months, the EMEA said. The agency expects initial results on safety and effectiveness from those studies in September.
A number of other pandemic flu vaccines are under development in addition to the mock-up vaccines, the agency said. Preliminary data from Glaxo and Sanofi-Aventis SAs vaccines unit are being assessed on an accelerated basis, the EMEA said.
“The vaccine manufacturers need to come up with the vaccine from scratch and that would take longer for the vaccines to become available through that route” than through the mock- up plan, Benstetter said.
Chicken Eggs
The most common way to make flu vaccine is by growing virus in chickens eggs. The virus is then extracted, purified and killed for jabbing into humans, where it can boost the immune system without causing disease.
Paris-based Sanofi plans to begin testing its experimental shot in coming weeks and expects to have a product ready in November or December, Albert Garcia, a spokesman for the vaccine unit, said on July 21.
Glaxo said on July 22 that it will begin shipping pandemic vaccine in September. The pace of those deliveries will depend on the yield of the virus growing in eggs, the London-based company said.
Novartis Production
Novartis, based in Basel, Switzerland, said it expects to deliver its first vaccines against pandemic flu at the end of the year. The drugmaker, which is using two ways to make the shot, said cell-based production is weeks ahead of the more traditional egg-based approach. The company aims to begin clinical trials this month, Chief Operating Officer Joerg Reinhardt said on a conference call last week.
Baxter will produce a vaccine by early August, after which it will perform clinical tests, said Chris Bona, a spokesman for the Deerfield, Illinois, company.
For each vaccine, the EMEAs committee will make a recommendation to the European Commission on final approval. After that decision, each of the EUs 27 member countries will decide on use and availability of the inoculations.