Pregnant women face uncertainty over H1N1 vaccine

by Symptom Advice on February 16, 2011

MONTREAL — Jennifer Madar is in the third trimester of her pregnancy, meaning she’s on the priority list of people who should get the H1N1 vaccine this fall, according to public health authorities.

But the 35-year-old Montreal woman 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. "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, who says she got the traditional flu vaccine three years ago when she had twins, isn’t alone in her misgivings about the H1N1 vaccine. A U.S. public opinion survey released last 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.

To vaccinate or not to vaccinate? It’s rapidly becoming the question of 2009.

This week saw media reports of studies suggesting that getting the seasonal flu shot makes people more susceptible to H1N1 – unpublished data that influenced Ontario’s decision to delay its seasonal flu shots.

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.

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 and has warned that a second, perhaps deadlier, wave of infections is imminent this fall.

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.

Canada has also ordered 1.8 million doses of unadjuvanted swine flu vaccine for pregnant women and children under the age of three.

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.

"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 Montreal’s 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 says he’s certain about one thing: those who have confirmed cases of H1N1 should not get the vaccine. 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 longtime critic of the World Health Organization, 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 said. "We’ve been producing influenza vaccine for many years. It’s a very safe vaccine."

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 mostly 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."

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."

© Copyright (c) Postmedia News

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