Contentious swine flu jab on shelves in October

Jabs to protect against swine influenza which have not undergone mass testing are expected to be available in Malta, even though the government has decided against using them for vaccination.

The vaccine in question, which should be on the shelves around October, is being manufactured without the usual rigorous human testing that uncovers any side effects and ensures users' safety.

The local authorities have decided not to compromise vaccine safety, preferring to wait for a fully-tested jab expected to be available towards the beginning next year. They are keeping their options open and might still buy a stock of the earlier vaccine, especially for workers more exposed to the risk, in case it proves safe.

However, they could not stop the earlier vaccine from entering the country once it was given the green light by the European Medicines Authority, director general of health Ray Busuttil said.

The UK, Greece, France and Sweden are planning to go for early vaccination while the US is taking a more cautious approach following a medical catastrophe in 1976 when hundreds of people vaccinated for another form of swine flu developed a paralysing disorder - Guillain-Barre syndrome - and more than 30 died.

The World Health Organisation has also voiced concern about skipping mass testing. In an interview with the Associated Press, WHO flu chief Keiji Fukuda warned about the potential dangers of untested jabs, stressing there must be no doubt about the safety of swine flu vaccines before giving them to the public.

His comments last month came days after the local authorities decided not to go for the October vaccines, which were originally intended for the H5N1 avian influenza virus, but were modified for the current H1N1 virus causing a global pandemic.

Last week The Times reported that the issue was discussed at Cabinet level and the authorities decided not to compromise vaccine safety. During a press conference yesterday, Parliamentary Secretary for Community Care Mario Galea said the decision was made following long discussions within the Health Pandemic Committee.

"The experts' advice was the vaccine should be tested and certified as safe before we administer it to the population," he said, adding Cabinet endorsed this advice.

While the manufacturing companies are saying this was an educated risk, governments which opted to go for the vaccines in question were being asked to assume responsibility for any side effects.

"There is a huge disclaimer," Dr Busuttil said.

Although he could not tell the public not to take the jab, which will be sold against a prescription, Dr Busuttil said those taking it should be aware that the vaccine would not have a safety profile.

"It is up to people to decide whether to take it or not, but on a national level, we decided it was not worth the risk," he said.

He said the jab should not be given to children, adding that even the fully-tested one would not be cleared for youngsters immediately.

The government's decision was also taken in the light of the mildness of swine influenza, which has affected thousands worldwide. Malta has had 168 confirmed cases, 115 of whom have totally recovered without complications, while two are being treated in hospital. Since only vulnerable cases were being swabbed, Dr Busuttil said there have probably been more cases.

The authorities reiterated their annual call for people to take the seasonal vaccine, saying although this would also be available around October, it would have undergone the usual rigorous testing.