Will Europe's fast-track swine flu vaccine be safe?

[Guest guest]

Fast-tracked swine flu vaccine will be safe, officials insist

• EU accelerates approval process for treatment

• WHO chief warns of dangers of untested jabs

* Batty * guardian.co.uk, Sunday 26 July 2009 22.02 BST

The World Health Organisation has raised concerns about the fast-track

production of the swine flu vaccine in Europe, where the treatment is due to be

made available at least two months earlier than in the US. Britain is expected

to be the first country in Europe to provide the vaccine, with the first of 132

million ordered doses due to be administered next month.

The European Medicines Agency (EMA), the drug regulatory body for the EU, is

accelerating the approval process for the vaccine, and countries including

Britain, Greece, France and Sweden plan to start using it as soon as it is

cleared. The most vulnerable groups, such as pregnant women and young children,

will be given priority.

To ensure the vaccine is available as soon as possible, the EMA is allowing

companies to bypass large-scale human trials. Amid concerns about bird flu

several years ago, the EMA designed a protocol to fast-track the approval of a

vaccine. It let companies submit data for a " mock-up " vaccine, using H5N1 avian

flu. The idea was to do most of the testing before a pandemic, so that when it

hit, the drug companies could insert the pandemic virus into the vaccine.

When the first doses are ready, the EMA will approve them largely based on data

from the bird flu vaccine, since both will have the same basic ingredients. The

agency will then require regular reporting of the vaccine's effects as it is

being administered, monitoring that is normally done beforehand.

The US government is taking a more cautious approach, calling for several

thousand volunteers to be injected with the vaccine in tests beginning in August

to assess its safety. Officials say the results should be ready in time for the

vaccination programme to roll out in October.

But some US officials believe the European approach is the best option. " The

consequences of not having a vaccine if this virus gets worse are very high, "

said Leonard Marcus, a public health expert at Harvard University. " If

[regulatory authorities] took all the time that was necessary to make sure there

are no side effects, ironically, in the effort to save a few lives, many lives

could be lost. "

An EMA spokesman said: " Everybody is doing the best they can in a situation

which is far from ideal. With the winter flu season approaching, we need to make

sure the vaccine is available. "

Dr Keiji Fukuda, the WHO's flu chief, warned about the potential dangers of

untested vaccines. " There are certain areas where you can make economies,

perhaps, but certain areas where you simply do not try to make any economies, "

he told Associated Press.

The Department of Health said it was " extremely irresponsible " to suggest the UK

would use an unsafe vaccine. A spokesman said: " In preparing for a pandemic,

appropriate trials to assess safety and the immune responses have been carried

out on vaccines very similar to the swine flu vaccine. The vaccines have been

shown to have a good safety profile. Over 40,000 doses of the vaccines which the

swine flu vaccines are based on have been given without any safety concerns. "

Professor Steve Field, chairman of the Royal College of GPs, added: " I'm sure

the vaccine programme won't be allowed to commence until adequate safety checks

have been carried out. "

Earlier this month the head of the WHO, Dr Margaret Chan, said that while a

vaccine might be produced next month the clinical trial data to ensure it was

safe would not be available for a further two to three months.

Pharmaceutical companies, including GlaxoKline, which is producing the

vaccine for Britain, insist they will be able to start shipping the first

batches of vaccine before then.

Meanwhile the House of Lords science and technology committee is expected to

accuse ministers of failing to keep their promise to set up a flu helpline by

April and question the conflicting advice given to the public, in particular to

vulnerable groups such as expectant mothers.

http://www.guardian.co.uk/world/2009/jul/26/fast-tracked-swine-flu-vaccine