Due to the ‘public health threat posed by the current pandemic' the European Medicines Agency (EMEA) is speeding up the reviews of data from clinical trials and data relating to the manufacture of vaccines.

The EMEA, the European Unions regulatory body for human and animal medicines, aims to review the authorizations for vaccines before September, when the Northern Hemisphere flu season begins.  

The NHS website has stated that ‘vaccination programmes are likely to begin before the full results are available. However, there should be sufficient results by September or October to spot real safety concerns and to allow governments to begin planning for the use and distribution of the new vaccines.'  

Vaccines created using the ‘mock-up' procedures, whereby pharmaceutical companies create a vaccine that allows the virus strain to be modified once a new strain is discovered, have already been approved by the European Union.  

The vaccines ‘were developed in the knowledge that the virus strain would be changed in the event of a declared pandemic' and have been tested on more than 8,000 subjects.  The EMEA believe that the insertion of the H1N1 strain will not ‘substantially affect the safety or level of protection offered'.  

There are other pandemic influenza vaccines under development which are also being assessed by the regulatory body on an ‘accelerated basis'.

In a press release on its website the EMEA has stated that ‘As with all medicines, rare adverse reactions can only be detected during the wider use of the vaccine.'  

Companies preparing the ‘mock-up' vaccine only need to apply for a ‘variation' of the marketing authorization, and due to the need for expedience in the matter, data is assessed as it becomes available and processed within five days.

The World Health Organisation's Dr. Keiji Fukuda has told the Associated Press that "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."

However, many believe that after forty years of flu vaccines extensive tests are not necessary to ensure the safety of patients.  The vaccine will continue to be monitored when introduced nationally, according to the NHS, with the government having ordered enough for the entire population.

23/07/2009

UNISON welcomes Swine Flu hotline.

UNISON, the UK's largest public sector union, is today (23 July) welcoming the introduction of the swine flu hotline, which will be backed up by a dedicated internet site. The phone line and website will be vital to relieving the pressure on NHS Direct and on GP's surgeries during the pandemic says the union.

Karen Jennings, UNISON Head of Health, said:

“The swine flu hotline and website have been brought in by the Government as a rapid response to the flu pandemic, which has escalated earlier than first expected. The services will be vital to relieving the pressure on NHS Direct and community health teams. They will help make sure that patients with problems other than swine flu can still get the best possible care.

“The hotline will be staffed by trained workers in call centres across the UK. Staff will be checking people's symptoms, and will be supervised by trained medical personnel.

“As the largest trade union for health workers, UNISON would like to thank staff working in the NHS for their hard work throughout the pandemic. The Department of Health have been planning for a pandemic for some years. This forward planning is now paying off, and allowing the rapid response to this outbreak.”

Extra help for NHS Direct 'cannot come fast enough' says UNISON

UNISON, the UK's largest public sector trade union, is today welcoming the extra help promised by the Government to NHS Direct to ease the pressure of the huge weight of calls from people worried about swine flu.

The service is currently taking 93,000 calls a day, an increase of more than 86,000*. With experts predicting that infections are likely to peak in future waves, the extra help will be vital in easing the pressure staff are currently experiencing following the tragic death of a child and a GP. This extra help will also help to alleviate the pressure on community healthcare teams and make sure that the service can keep giving patients with problems other than swine flu the best treatment possible.

Michael Walker, UNISON NHS Direct officer, said:

“NHS Direct is a vital service. The public need to know they can pick up the phone and get advice and support from someone they trust. Our members at NHS Direct are the experts and they are determined to give worried parents and families high quality care.

“Each time a new death is announced, and when the disease peaks, the number of calls rises further. NHS Direct employees and their families are also at risk of swine flu, which makes this extra staff even more essential. They have been working under great pressure, and still need to provide care to patients with problems other than swine flu, so these additional staff really cannot come fast enough.

“UNISON would like to thank all members of the healthcare team for their hard work throughout this outbreak. We would also like to remind members of the public that they can check their symptoms on the NHS Direct website, which would help ease call centre pressure further.”

This week UNISON issued guidance to all its members working in healthcare, advising them on what they should do if they think they have swine flu, and urging them to familiarise themselves with their workplace flu pandemic policy.

*The average number of calls taken by NHS Direct is 7000 per day.

NHS Direct employs 3500 people, at any one time there are 300 nurse and health advisers on duty. The service runs 24 hours a day, 365 days a year.

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