No word yet on how long the trials for the H1N1 shots will last in the US.
I have spoken to an official at the Maine health department who is reporting that the vaccine delivered here will be one that comes in multidose vials, therefore will be a mercury containing vaccine.
Last week, HHS secretary Kathleen Sebelius said that HHS was "anticipating a voluntary" H1N1 vaccine program this fall, which leaves room for the possibility that HHS could change their minds and make it mandatory.
I would encourage everyone to keep an eye on this story as it develops, as hastily manufactured, tested and delivered vaccines that are not held up to the same scrutiny that is standard during FDA licensure certainly would have a greater potential for adverse reactions when introduced to the general public.
Swine flu vaccine to be cleared after five-day trial
July 12, 2009
The Sunday Times
The path of a popular medicine from the laboratory to the chemist or doctor’s surgery can involve years of clinical trials on a select group of patients.
When the new vaccine for swine flu arrives in Britain, regulators said this weekend, it could be approved for use in just five days.
Regulators at the European Medicines Agency (EMEA) said the fast-tracked procedure has involved clinical trials of a “mock-up” vaccine similar to the one that will be used for the biggest mass vaccination programme in generations. It will be introduced into the general population while regulators continue to carry out simultaneous clinical trials.
The first patients in the queue for the jab - being supplied to the UK by GSK and Baxter Healthcare - may understandably be a little nervous at any possible side effects. A mass vaccination campaign against swine flu in America was halted in the 1970s after some people suffered Guillain-Barré syndrome, a disorder of the nervous system.
However, regulators said fast-tracking would not be at the expense of patient safety. “The vaccines are authorised with a detailed risk management plan,” the EMEA said. “There is quite a body of evidence regarding safety on the trials of the mock-up, and the actual vaccine could be assessed in five days.”
The UK government has ordered enough vaccine to cover the entire population. GPs are being told to prepare for a nationwide vaccination campaign.
Dr Peter Holden, the British Medical Association’s lead negotiator on swine flu, who has been attending Department of Health meetings on the outbreak, said GPs’ surgeries were prepared for one of the biggest vaccination campaigns in almost 50 years.
He said although swine flu was not causing serious illness in patients, health officials were eager to start a mass vaccination campaign, starting first on priority groups. First, the jabs would reduce the chances of a shortage of hospital beds because of people suffering from swine flu. Second, it would reduce the effect on the economy by ensuring workers were protected from the virus.
“The high-risk groups will be done at GPs’ surgeries. People are still making decisions over this, but we want to get cracking before we get a second wave, which is traditionally far more virulent.”
Holden said it was likely the elderly would be given their seasonal flu jab as well as the swine flu vaccination. The new vaccine is likely to require two doses.
Details of the inoculation plans emerged after the death of a patient, reportedly a middle-aged man, at a hospital in the Basildon area of Essex. The victim had no underlying health problems, but officials say there is no evidence the swine flu virus had mutated into a more dangerous strain.
Holden said it would be the biggest campaign in response to an outbreak since mass vaccination against smallpox in 1962. He said surgeries would be aiming to inoculate about 30 people an hour in a “military-style operation”.
The Department of Health said it had still not finalised which groups would be vaccinated first, but children, frontline health workers, people with underlying illnesses and the elderly are likely to take priority.
The European Commission is also identifying population groups which it believes should get priority. It is keen to ensure that countries such as the UK, which had ordered supplies of the vaccine in advance, do not cause inequities in treatment elsewhere in Europe.
It warned health ministers in a note circulated last month that if the vaccines were more readily available in some countries it could cause “vaccine tourism/shopping in other member states”.
About 15 people have died of swine flu in Britain, but most of those infected get only mild symptoms. According to the latest figures from the Health Protection Agency, the UK has had 9,718 confirmed cases of the disease.
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