THE NEW swine flu vaccines will be produced in exactly the same way as the annual seasonal flu vaccines which are given to millions of people around the world each year, according to a leading official with the World Health Organisation.
Dr Mike Ryan, director of WHO’s global alert and response team, said a number of vaccines were currently in production and he expected “safe and efficacious” vaccines to be produced.
“We have been producing as a global community vaccines against the seasonal virus for many, many, many years and these vaccines have been given to hundreds of millions of people and have proven extremely safe across all age groups and risk groups.
“The current vaccines are being produced on the same production platforms, going through exactly the same sort of trials and the same regulatory approvals, so there is no shortcutting in that,” he said.
“The fact remains, though, that because of the pressure every year to produce influenza vaccines, they don’t go through the 10-year cycle of vaccine trials because what we are doing is effectively changing the strain of virus in each vaccine every year and the pandemic vaccines are no different to this,” Dr Ryan added.
“However, seasonal vaccines are given to a couple of hundred million people a year. In this particular case, these [pandemic] vaccines may be given to literally billions of people over a year or two, so we still have to be careful and prudent.”
Dr Ryan, who was speaking on RTÉ's Morning Irelandyesterday, stressed that the national regulatory authorities in each country had to assure themselves though that the vaccines which were being produced were safe and effective.
“We’ve got to ensure that each government has in place monitoring for safety and efficacy because sometimes you do not see all of the side effects in small trials, sometimes it takes the production of hundreds of millions of doses of vaccine and you can pick up more rare side effects but we don’t expect to see that, we expect to see a safe and efficacious vaccine.”
Earlier this month, the WHO said in a statement it was aware of some media reports that expressed concern about the safety of vaccines for pandemic influenza.
“The public needs to be reassured that regulatory procedures in place for the licensing of pandemic vaccines, including procedures for expediting regulatory approval, are rigorous and do not compromise safety or quality controls,” it said.
The Health Service Executive has ordered 7.7 million doses of the pandemic H1N1 vaccine from two companies. It is anticipated everyone will be offered two doses, although healthcare workers and at-risk groups will be offered the vaccine first.
It said yesterday it expected to get “regular supplies” of the vaccine by late September.
It pointed out that delivery schedules would depend on the yield from the production process and then the vaccine would need to be approved by the European Medicines Evaluation Agency and by a special expert group which would advise the Department of Health and the HSE on safety and efficacy.
Meanwhile, the HSE will also be advising those aged over 65, those with chronic conditions and healthcare workers, to get the seasonal flu vaccine when batches arrive here in September.