Also, the UK government has already signed a contract for an as yet unapproved vaccine, Celvapan, produced by Baxter. It means the UK has provision for up to 132 million doses – enough for every person in the country.

Finally a third vaccine made by Novartis, Focetria, has also been recommended for licensing by the European Medicines Agency – but this is not planned to be used in the UK.

The decision removes one of the last obstacles to getting the immunization program under way although licensing still needs to be formalized.

Final marketing authorization for the vaccines still needs to be signed off by the European Commission and is expected “as soon as possible”.
The EMEA said they were working with Baxter on some ongoing issues about their vaccine but hoped to be able to resolve those next week.

Approval of the vaccine
The vaccines have undergone an accelerated approval process as “mock-ups” of the vaccine had already been developed in preparation for a pandemic and tested in 6,000 people.
Manufacturers have worked quickly to add the swine flu H1N1 strain to the mock versions.
Early trial data had suggested good immune responses with just one dose of the vaccines.
However, the EMEA is recommending two doses are given three weeks apart for both vaccines, but may revisit that decision as more clinical trials are carried out.

A background of rising cases of swine flu
The number of new cases of swine flu in England has almost doubled from the middle of September 2009.
In Scotland, the new weekly figures showed a slight increase from 6,180 to 7,034.
Across the UK there have been 82 deaths.
Although the figures are rising, they are as yet far short of the 100,000 cases a week seen in July.
Officials are still predicting a second wave of swine flu as winter approaches.
Worldwide some 3,917 people have died from swine flu infections since the H1N1 virus was uncovered in April, World Health Organization figures show.

When will the vaccine be distributed to the population ?
The UK Government plans to start vaccination in October 2009, subject to vaccine being licensed and manufacturers’ delivery schedules.

Why Two vaccines?
The UK has agreed contracts for swine flu vaccine with GSK and Baxter. Having two contracts increases the number of doses available. Also because the Baxter vaccine is not made in eggs it can be used in people with an egg allergy
There are other differences between the vaccines -for example the GSK one contains an adjuvant. It minimizes the risk of problems should one vaccine run into trouble during production or licensing.

Who should be vaccinated against swine flu?
Eventually, everyone, except for people who have the same allergies — primarily, allergy to eggs — that make annual flu shots dangerous for them. But for now, the first vaccine batches are reserved for those most at-risk: health care and emergency workers; pregnant women; people caring for infants younger than 6 months old; people 6 months to 24 years old; and anyone younger than 65 who has a weakened immune system or such medical conditions as asthma, diabetes or morbid obesity. As more vaccines are made, healthy adults ages 25 and up should be vaccinated, too.

How can I be sure it’s safe?
It’s very safe, the H1N1 vaccine is made in the same way as the regular winter flu vaccine that is used by nearly 100 million Americans a year with very few, minor side effects. There’s no biological reason the H1N1 vaccine should react any differently, and no red flags have appeared in studies of several thousand people.

However what you should look for is GBS..
Some Neurologists are concerned that an increase in a brain disorder called Guillain-Barre Syndrome (GBS) could be triggered by the vaccine. GBS attacks the lining of the nerves, causing paralysis and inability to breathe, and can be fatal.

The debacle of the US swine flu Vaccine in 1976
There are concerns that with the new vaccine, there could be a repeat of what became known as the ‘1976 debacle’ in the US, where a swine flu vaccine killed 25 people – more than the virus itself.
A mass vaccination was given the go-ahead by President Gerald Ford because scientists believed that the swine flu strain was similar to the one responsible for the 1918-19 pandemic, which killed half a million Americans and 20million people worldwide.
The swine flu vaccine being offered to children had not been tested on infants
Within days, symptoms of GBS were reported among those who had been immunized and 25 people died from respiratory failure after severe paralysis. One in 80,000 people came down with the condition. In contrast, just one person died of swine flu.
More than 40million Americans had received the vaccine by the time the program was stopped after ten weeks. The US Government paid out millions of dollars in compensation to those affected.
The swine flu virus in the new vaccine is a slightly different strain from the 1976 virus, but the possibility of an increased incidence of GBS remains a concern.

UK regulators have set up a special portal on the website for reporting any problems with swine flu medicines and vaccines when they begin to be used.