Canadian officials to “decide” who will get swine flu vaccine

Vaccinate Canadians under 40 and natives first: experts

6.21.09 / Sharon Kirkey / Camwest News Service

Mike Cassese/ReutersHealth Minister Leona Aglukkaq watches researcher George Moussa test flu samples after announcing funding to speed up influenza research and test new vaccines against the H1N1 flu virus, Jun. 5, 2009.

Five-to-40-year-olds and Canada’s aboriginal communities should be the first to get vaccinated against human swine flu, experts say as Canadian officials decide who gets priority for the flu shots.

Under Canada’s official pandemic plan, the entire population would ultimately be immunized against the H1N1 swine flu.

But the vaccine will become available in batches, meaning the entire population can’t be vaccinated at once. It might take four or five months to get all the vaccine we’re going to get, during which time a second wave of swine flu may well be underway.

The Public Health Agency of Canada is working on a priority list, deciding where the first batches should go, and who should get the injections first. All provinces and territories would be expected to follow the national prioritization scheme.

Unlike normal seasonal flu, the H1N1 virus appears to be disproportionately infecting older children and young adults. So far the largest number of confirmed cases have occurred in people between the ages of five and 24.

“It doesn’t mean they’re all getting sick and need to be hospitalized, but they’re getting significant illness,” said Dr. Noni MacDonald, a leader in pediatric infectious diseases and a professor of pediatrics at Dalhousie University in Halifax.

British researchers reported last week that targeting children first would protect not only them, but also unvaccinated adults.

“Even if you are concerned about the elderly, who are often mentioned as another risk group, their main connection to the big pool of infection is often their grandchildren,” said Dr. Thomas House of the University of Warwick.

But adults older than 64 don’t appear to be at increased risk of H1N1-related complications so far in the outbreak. It’s possible they have some antibodies against the virus.

As well, children “are known to be really important for transmitting flu,” said Earl Brown, executive director of the Emerging Pathogens Research Centre at the University of Ottawa.

“They’re important for the cycle of infection. They tend to be naive as far as not having flu antibodies in their system before. And really young kids, their immune systems aren’t fully mature.

“Children tend to be hit, and they can be hit harder,” Brown said. By immunizing children first, “you get to try to block spread, and protect a vulnerable group.”

Gymnasiums would be used for mass school-based vaccination programs but experts say the harder to reach group will be the 18-to-30-year-olds.

“Some of them are in school, a lot of them are not,” MacDonald said. “They’re very much living in the moment and don’t necessarily see themselves as being at risk. We need some fast thinking about how to reach those people.”

She suggested booths could be set up outside bars for information and immunization.

“You’ve got to be creative about this and really think out of the box.”

Canada’s aboriginal communities also appear to be getting more serious infections. Crowded, poorly ventilated housing and poor access to high-quality running water and sanitization are some of the factors being blamed. Aboriginals also have higher rates of asthma, chronic lung disease, obesity and diabetes — the very diseases early data suggests puts people at higher risk of life-threatening complications from swine flu.

The H1N1 vaccine will be a separate vaccine from the regular, annual flu shot. People will require two jabs, and possibly three, depending on how effective the vaccine is in producing immunity. The Public Health Agency of Canada says that no decisions have yet been made about who would get priority first.

One of the challenges will be getting people to agree to the shots. There will be limited information about any vaccine’s safety before immunization campaigns are rolled out across the country.

“We usually do research in healthy adults before we do it in children, because this is a new vaccine, and you want to be sure that it’s safe and effective before you give it to vulnerable populations, or populations who don’t have full capacity to make an informed decision about getting it or not,” said Dr. Joanne Langley, of Health Canada’s National Advisory Committee on Immunization.

“There are pros and cons to putting [children] first.”

Babies under six months of age are not vaccinated against flu.

UK charity Jo’s trust director: 1300 girls getting blindness, paralysis epilepsy from HPV vaccine are benefits that outweigh risks

Concerns over safety of cervical cancer vaccine after 1,300 girls experience adverse side-effects

3.9.09 / Daily Mail

More than 1,300 schoolgirls have experienced adverse reactions to the controversial cervical cancer jab.

Doctors have reported that girls aged just 12 and 13 have suffered paralysis, convulsions and sight problems after being given the vaccine.

Dozens were described as having pain ‘in extremity’ while others suffered from nausea, muscle weakness, fever, dizziness and numbness.

The vaccine is being given to girls under a Government programme to prevent women from developing cervical cancer. Ministers say it will ultimately save 700 lives a year.

Some have dubbed it the ‘promiscuity jab’ because it is given to girls to protect against the sexually-transmitted HPV virus which causes 70 per cent of cervical tumours.

Last night campaigners called for the vaccination campaign to be suspended in the light of the published side-effects.

But Government health experts insisted the Cervarix vaccine was safe and that the total of 1,340 reports was to be expected, given that more than 700,000 girls were vaccinated last year.

They also said many of the reactions resulted from the act of injection rather than the vaccine, and said there was no evidence that the jab caused any of the serious conditions such as paralysis.

Cancer charities urged parents to continue allowing their daughters to have the jabs, saying any risks were so minor and unproven that they could not outweigh the benefit of possibly saving lives.

The vaccination programme of young secondary school girls began in September last year following clinical trials on more than 18,000 women under the age of 26. Critics have claimed that not enough pre-pubescent girls were involved.

The vaccine, which is administered in three doses, is also being given to girls aged 17 and 18. This will ensure that by 2011, all those under the age of 18 will have been vaccinated.

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Reports of adverse reactions to drugs and vaccines are collated by the drug safety watchdog, the Medicines and Healthcare products Regulatory Agency (MHRA), from reports by doctors.

Their latest analysis found there had been 1,340 reports in total, with 2,891 different adverse effects noted. Most were minor complaints such as rashes, swelling on the injection site, pain or allergic reactions.

But there was a range of more worrying problems. Four girls had convulsions, one had a seizure and one had an epileptic fit.

There were several cases of paralysis. One had Bell’s palsy, which paralyses the face; one had hemiparesis, which paralyses or severely weakens half the body; two experienced hypoaesthesia, in which the sufferer loses much of her sense of touch, and one had Guillain-Barré syndrome, which paralyses the legs.

There were almost 20 cases of blurred vision and one girl was reported as developing anorexia.

Last night Jackie Fletcher of the vaccine support group Jabs said: ‘When they introduced this new vaccine, we had major concerns about its safety. The current statistics detailing adverse reactions – including cases of epilepsy and convulsions – bears out that we were right to be concerned.

‘The Government needs to look at the future of this programme given the number of side-effects coming through.’

The MHRA says the number of reported reactions does not necessarily mean they are side effects of the vaccine.

In its report on the most recent figures, released on Thursday, the MHRA said: ‘The vast majority of suspected adverse reactions reported to MHRA in association with Cervarix vaccine have related to either the signs and symptoms of recognised side-effects listed in the product information or were due to the injection process and not the vaccine itself.

‘For the isolated cases of other conditions reported, the available evidence does not suggest that the vaccine caused the condition and these may have been coincidental events. The balance of risks and benefits of Cervarix remains positive.’

Robert Music, director of cervical cancer charity Jo’s Trust, said: ‘I urge every mother to ensure their girls have the vaccine, because we believe the obvious benefits outweigh the risks. Quite simply, the jab could save their daughters’ lives.’

FDA ignored dozens of complaints about pharmaceutical company’s bacteria, debris tainted drugs

FDA ignored debris in syringes

Complaints of filth came in 2005; plant’s microbiologist was a teenage dropout

2.25.09 / Sarah Avery & Sabine Vollner / The News & Observer

RALEIGH — Months before an Angier company shipped deadly bacteria-tainted drugs, the federal Food and Drug Administration received numerous complaints about sediment and debris in the medicine.

The FDA received reports about AM2PAT as early as 2005, but not until December 2007 did the agency issue recall notices to pull the drugs off the market.

AM2PAT, which is now the subject of a criminal investigation, sold tainted syringes of heparin and saline that have been linked to five deaths. At least 100 more people were sickened, often after receiving the medicines during chemotherapy, kidney dialysis and other intravenous procedures.

Two men pleaded guilty in U.S. District Court this week for their roles in the scheme, which involved falsifying documents to make it appear that proper sterility tests had been conducted. The company’s president, Dushyant Patel, faces 10 charges, but he has not been arrested. Authorities believe he fled to his native India.

Conditions at the plant, detailed in court documents and photographs, depict a facility in flagrant violation of proper manufacturing processes. Prosecutor Jason Cowley said the company’s “chief microbiologist” was a teenager who dropped out of high school. A key piece of laboratory equipment designed to catch evidence of contamination was broken, and another gauge was out of commission for a year. The so-called clean room, where air is carefully controlled to reduce the spread of germs, was ventilated with an ordinary room fan.

The U.S. Food and Drug Administration — charged with overseeing more than 10,000 drug-device makers in addition to thousands more pharmaceutical manufacturers, food processing companies and animal-feed plants — received complaints about the company’s saline products the summer before the bacterial infections erupted in December 2007 and January 2008.

Starting in June 2007, doctors and clinics began reporting to the FDA orange specks floating in the syringes. Other complaints noted “wispy debris” or “yellow-orange sediment” that caused the normally clear product to be tan, orange, “muddy” and “dingy brown” in color.

A complaint in 2005 noted food particles inside a heparin syringe.

An FDA spokeswoman. Siobhan DeLancey, said a “non-exhaustive” search of inspection reports indicates the Angier plant was visited six times by FDA inspectors, including May 1999, February 2000, March 2004, June 2005, January 2006 and December 2007. But the company wasn’t licensed to do business in North Caroline until 2001, and it’s original home was in Raleigh. It didn’t get FDA approval to load syringes with heparin until 2003.

Patient advocates said the issues that criminal prosecutors detailed in court documents about the plant were red flags that would have prompted an investigator to shut down the plant.

“If they had done inspections, those people would be alive,” said Dr. Ned Feder, a former scientist with the National Institutes of Health who now researches FDA issues at the advocacy group Project On Government Oversight. The plant operators, he said, “were counting on the fact that they were unlikely to be inspected. They were counting on it.”

Federal law does not require the FDA to inspect a device plant such as AM2PAT before production starts, said Jeffrey Gibbs, an FDA expert with the Washington law firm of Hyman, Phelps & McNamara, who advises health-care companies.

Although they are supposed to be inspected every two years, plants such as AM2PAT have instead gotten site visits about once every five years, according to a report from the Government Accountability Office. Between 2002 and 2007, FDA inspectors visited only about one-quarter of the 5,616 registered plants per year, the GAO report states.