MONTREAL – when Jennifer Madar’s twin girls were born premature at 29 weeks, she dropped her usual wariness about flu shots and got one right away.
So did her husband, her father and anyone else she thought would come into close contact with her girls.
“My babies had spent almost three months in the neonatal intensive care unit,” Madar recalled. “So when they came home, it was very important that they not get sick. We didn’t want to take the chance of one of us getting the flu and passing it on to them.”
Three years later, Madar’s girls – Jessica and Romy – are the picture of health with their rosy cheeks and blond curls, romping around their living room in St. Laurent and often testing the limits of their mother’s patience.
The family is also expanding as the 35-year-old Madar is pregnant again and expects to give birth to a boy in December. At 29 weeks, she’s in her third trimester – and is therefore considered by public-health authorities to be on the priority list to get the influenza A (H1N1) vaccine.
So are her children, but this time Madar isn’t so sure about rolling up her sleeve for a flu shot.
“I’m going to have to get a little bit more informed about it,” she said. “But I have to tell you the truth. For me, it’s a new vaccine and I’m kind of reluctant, because you never know about possible side effects. I’m just worried about the things that they might discover down the line.”
Madar isn’t alone in her misgivings about the H1N1 vaccine. A U.S. public opinion survey released this week found that only 40 per cent of parents said they will get their children vaccinated against the H1N1 virus (while 54 per cent indicated they would give their kids the regular seasonal flu shot.)
Even some health professionals have expressed doubts. in a poll of more than 2,000 Hong Kong health workers, researchers discovered that during the height of the global swine flu panic in may, less than half were willing to get inoculated.
(This week, a pregnant nurse at the Lakeshore General Hospital emailed the Gazette, saying she was having qualms about the H1N1 vaccine. This, despite the fact that two pregnant women in Quebec died over the summer from H1N1 complications.)
To vaccinate or not to vaccinate – that is rapidly becoming the question of 2009.
Acknowledging the public skepticism about the upcoming H1N1 vaccination campaign, Canada’s obstetricians and gynecologists are mounting an information blitz aimed at pregnant women. Posters and fact sheets are being sent to hospitals, clinics and doctor’s offices. Physicians are being told to provide advance prescriptions to pregnant women for the antiviral drug Tamiflu that could be filled at the first sign of H1N1 symptoms.
All of this is predicated on the fact that H1N1 is a relatively new strain and has killed a disproportionately higher number of young people than the seasonal flu. What’s more, the World Health Organization has declared an H1N1 pandemic emergency, and has warned that a second, perhaps deadlier, wave of infections is imminent this fall.
Alain Poirier, Quebec’s public health director, noted that pregnant women in their second and third trimesters are at an elevated risk of developing serious complications should they contract H1N1.
Although the death toll from H1N1 in Quebec is lower than initially feared – it stands at 27 – vaccination is still the best protection, he insisted.
“I’m sure that those people (who died) would have liked to have had the vaccine,” Poirier told reporters two weeks ago.
In Quebec, the government’s H1N1 response is akin to a war-time mobilization. It has purchased 53 million pairs of gloves, 23 million masks and 15 million syringes.
The government has ordered 11.5 million doses of the vaccine from GlaxoSmithKline’s Quebec City plant for the province’s 7.5 million residents. Starting in mid-November, about 100 clinics across the province will vaccinate 200,000 people a day, seven days a week.
In addition to pregnant women, children age six months to five years will be immunized first. they will likely be given a second booster shot, because their immune systems are not yet fully developed. As for those under six months, the vaccine has been shown not to work on them.
Health professionals, people from the ages of five to 18, police and firefighters, and those age 18 to 65 would follow. Paradoxically, the elderly who are usually highly susceptible to the regular flu appear to have some immunity to H1N1.
Yet the question persists – to vaccinate or not?
The doubts about the H1N1 vaccine arise from the perception that it’s being rushed into production and foisted on the public without being tested sufficiently, that it might not be effective, and that it might not even be necessary since the virus has so far proved to be less severe than anticipated.
Adding to the confusion is the fact that Canada has decided to use an adjuvant or immunity-boosting chemical in the vaccine, while the United States has opted for one composed wholly of dead fragments of the H1N1 virus.
And none of these concerns address the question about whether to go ahead with a separate vaccine to guard against the seasonal flu, which kills tens of thousands of people worldwide each year.
Experts readily concede that the H1N1 vaccine is being rolled out with great haste, but argue they have no other choice as they brace for a second wave of the pandemic. usually a new vaccine for a disease like hepatitis can take five years before it’s approved.
But it’s a different story with the seasonal flu vaccine. It’s produced from scratch every year because flu viruses mutate constantly. Typically, such vaccines contain fragments of three flu strains.
In contrast, the H1N1 vaccine is monovalent, containing fragments of only one virus.
“We’re fast-tracking the approval of this vaccine and for obvious reasons, because we are on the threshold of a pandemic, if we’re not already in it,” said Karl Weiss, a microbiologist at Maisonneuve-Rosemont Hospital.
“We have already accepted the vaccine not having the full results. I agree that it has to be fast-tracked. You have to put it in the global context. This is not what we usually do, and there are certain questions for which nobody has the answer.”
Two weeks ago, GlaxoSmithKline unveiled results of a preliminary study of its vaccine, noting that a single dose confers almost 100 per cent immunity from H1N1 three weeks after vaccination. the results were from a clinical trial involving 130 healthy volunteers, aged 18 to 60.
A study of this size is useful to spot any immediate danger signs with a new vaccine, but the world will only learn the full range of possible side effects once hundreds of thousands of people are inoculated.
“Nothing serious will happen out of nowhere,” Weiss said. “But there is the potential that after you’ve given it to 100,000 people, you might see three cases of liver issues, let’s say, which is more than you would expect for something like this. At that point, people would have to take a decision.”
Weiss, however, was certain about one thing: For those who have been confirmed to have been infected by H1N1, getting the vaccine would not be a good idea. That’s because their immune systems could overreact horribly.
Richard Schabas, the medical officer of health for Ontario’s Hastings and Prince Edward Counties and a long-time critic of the WHO, said people shouldn’t worry about the safety of the H1N1 vaccine.
“I’m not particularly concerned about the risk profile of the vaccine,” he added. “We’ve been producing influenza vaccine for many years. It’s a very safe vaccine. And we’ve been putting adjuvants in vaccines for years. Their safety profile is excellent.”
What Schabas finds fault with is the recommendation by public-health authorities to vaccinate every man, woman and child in Canada against H1N1. He also takes issue with the decision to add the adjuvant, saying that has probably delayed the delivery of the vaccine by several weeks, raising the possibility that many people will get the shot only after a second wave hits.
The Canadian Medical Association Journal took a similar position about the adjuvant in an editorial last month. “Having enough vaccine for every Canadian would make more sense if the pandemic virus were highly virulent for large proportions of the population,” the editorial concluded. “But given current evidence, it seems a poorer choice than providing coverage to high-risk groups as early as possible.”
Schabas contends that it’s Canadians who suffer from pre-existing medical conditions like diabetes, morbid obesity as well as heart and lung disease who should get vaccinated.
“For the general population who don’t fall into these categories – healthy people are at a very low risk of H1N1,” he said. “I’m not saying that pregnant women shouldn’t be immunized, but to describe them all as a high-risk group I think misrepresents the data.”
Almost lost in the debate over the H1N1 vaccine is whether to proceed with the seasonal flu vaccine. in fact, the WHO has also recommended a trivalent vaccine for the northern hemisphere this year to protect against three viruses that are not part of the pandemic. One of those viruses, H3N2, has been shown to have sickened many people around the world.
Initially, the government suggested dropping the seasonal vaccine, but late yesterday it announced a compromise: It would put off the seasonal flu vaccinations until January. One of the reasons cited for staggering the two campaigns is that those who have been vaccinated in the past against the seasonal flu appeared to be more susceptible to H1N1. Therefore, it makes more sense to give the H1N1 shot first.
In practical terms, however, this means that adults will have to weigh the pros and cons of getting two different vaccines in one flu season for the first time in their lives. And parents will face the daunting prospect of getting four flu shots for children age six months to two years. That’s because children in this age group require booster shots.
Paul Saba, a family physician who runs a practice in Montreal West and a father of three young children, said he believes that both vaccines are necessary.
“They should have both, and if it means paying doctors and nurses more or opening the clinics for longer hours, then so be it,” he said. “You won’t want the elderly who usually get the regular flu to die. We shouldn’t let them suffer, either.”
To vaccinate or not to vaccinate – there are no clear answers. But for Weiss, that’s the whole nature of medicine, weighing risks against benefits.
“We live in an environment in which people would like to have a 100-per-cent guarantee that everything is safe and good,” he said. “But we can’t do that. there is some uncertainty.
“There is no guarantee that this vaccine will be 100-per-cent efficient. But chances are it’s going to work.”
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