Swine flu vaccine ‘safe and effective’
Published 07/08/2009 | 10:25
Swine flu jabs set to be given to hundreds of thousands of people in Northern Ireland within weeks will be safe and effective, health chiefs said today.
Health Minister Michael McGimpsey had said the inoculation programme was due to be rolled out in September after the first batch of the drug was set to arrive this month ahead of a predicted pandemic.
In a bid to get the H1N1 vaccine to the public the European Medicines Agency, the EU's top drug regulatory body, has speeded up the approval process — allowing firms to bypass large-scale human medical trials.
It is giving the first doses the green light based on data from a previous ‘mock up’ vaccine of H5N1 bird flu, as both will have the same basic ingredients.
However, World Health Organisation experts have expressed concern at the situation.
WHO flu chief Dr Keiji Fukuda said: “One of the things which cannot be compromised is the safety of vaccines.
“There are certain areas where you can make economies, perhaps, but certain areas where you simply do not try to make any economies.”
In America the government is delaying issuing a vaccine and has started human testing to assess the vaccine's safety.
Human trials of a vaccine to protect against the H1N1 swine flu virus have begun in Australia but it will be at least six weeks before the initial results are known.
But Acting Chief Medical Officer for Northern Ireland Dr Liz Mitchell said she is “confident” that the vaccine delivered to people in Northern Ireland would be both safe and effective.
“Our first priority is to make sure that any vaccine administered would be safe,” she said.
“There has been a strong statement from the EMA to indicate that the insertion of the new strain of vaccine will not substantially affect the safety profile, or level of protection offered. That is based on decades of experience of seasonal flu vaccine.”
According to the Department of Health 30% of the UK population will get swine flu.
Dr Mitchell said each batch of the vaccine has to be cleared before distributed. “Clinical trials have been done before on what is essentially a similar vaccine, it is a relatively minor change that’s why they are able to say they can fast-track it,” she said.
“It is recognised there are occasional adverse effects related to any vaccine, but the balance must be that we are sure we are doing more good than any potential risk that we create.”
Dr Mitchell said the department is now waiting for ministers to approve the high risk priority groups for vaccination.
“We hope it will be available by the end of August in the public domain,” she said. “At the moment we are making plans as far as we can until we have those groups finalised and get a priority order.”
But it is understood frontline medical staff will be vaccinated first, followed by pregnant women, young children and adults with chronic illnesses.
The vaccine, once arrived, will be distributed through GPs.