Swine Flu: Pregnant Women will be Included in H1N1 Flu Vaccine Trials
By Deborah Kotz
As predicted, pregnant women are, indeed, on the government's list of the first folks to be vaccinated against the H1N1 "swine flu" virus.
The panel of experts convened by the
Some 159 million people fall into these high-priority groups, and whether there will be enough vaccine for all of them when it first becomes available isn't known.
In the event that there are shortages, the panel also came up with a superhigh-priority list of those who should be vaccinated -- some 41 million individuals. Once again, pregnant women are on this list. Just how many of them will rush out to get vaccinated, however, remains a mystery.
Studies suggest that fewer than 15 percent of expectant moms currently get the seasonal flu vaccine, but more may be willing to get the H1N1 vaccine -- and their doctors may push harder for them to have it--given the latest data showing that pregnant women infected with H1N1 are more likely to develop severe complications.
The trouble is, many pregnant women are extremely cautious about getting any shots or medicines because of the potentially harmful effects that these agents could have on a developing fetus. In fact, vaccines that contain live weakened viruses, like measles, aren't administered during pregnancy because of the possibility that they could cause a high fever in the woman -- raising the risk of birth defects -- or an infection in the fetus.
The seasonal flu and H1N1 shots, however, contain dead viruses that don't pose either of these problems.
Still, many experts agree, the H1N1 vaccine should be tested in pregnant women before it's licensed for use during pregnancy. (Studies have already established that seasonal flu vaccine is safe and effective to use at any stage of pregnancy.)
"We're still awaiting word from our institutional review board [which signs off on all clinical trials], so we don't yet know who will be
Although he says there's no reason not to include pregnant women at the earliest stage of pregnancy, the review board could "out of an abundance of caution" limit the trials to women who are beyond the first 12 weeks of pregnancy. Unfortunately, he adds, safety and efficacy data won't be available from those pregnant women trials when the vaccine initially becomes available in late October.
One question the trials may address is at what stage during pregnancy the vaccine should be given.
Swine flu complications tend to be much worse when women get infected near the end of pregnancy as opposed to during the first 12 weeks. And there's always the possibility -- no matter how remote -- that something administered during those early weeks when a fetus's organs are still developing could cause birth defects.
"This is a new vaccine, so we can't say whether it's safer to give during one period of pregnancy or another," says
By and large, there's no reason to think that the H1N1 vaccine will pose any problems for pregnant women since it's being produced in exactly the same fashion as the seasonal flu vaccine.
What's more, Steinhoff adds, pregnant women who get vaccinated will probably also confer antibody protection to their newborns who are too young to be vaccinated themselves. This could prove lifesaving if H1N1 infections become extremely widespread or the virus mutates into a deadlier strain.
Pregnant women are also advised to get Tamiflu if they experience symptoms of swine flu like high fever, sore throat, and a cough.
But some experts are concerned over the lack of research on the use of this drug in pregnant women infected with H1N1.
"We are hugely concerned that we don't know what the right dose is for pregnant women," says
"While it may be that the standard dose of Tamiflu is perfectly appropriate, it's at least possible that it's an insufficient dose for pregnant women at a given stage in pregnancy."
That's because pregnant women's kidneys clear drugs faster from the body, which means that certain drugs may not enter the bloodstream at therapeutic levels. (This has been demonstrated with some antibiotics, but Tamiflu hasn't been tested in pregnant women.)
"I think the message we should be getting out is that pregnant women should be vaccinated," she says, and that those who get infected and treated with Tamiflu should be studied in clinical trials to see if the drug is given at an effective dose. "This is a tough situation. I wish we weren't in it."
The Swine Flu outbreak could peter out, like a 1976 swine flu outbreak did. Or the virus could spread easily from one person to the next, sparking a pandemic in which millions of people are infected. Here's the rundown on what we know so far, as well as the options for avoiding swine flu and for treating it if you get it.
Swine Flu Hits Pregnant Women Harder
New research shows pregnant women who get swine flu are more likely to develop severe complications that result in hospitalization or even death, according to a study published in the journal Lancet.
Dealing with the Swine Flu Threat During Pregnancy
The worldwide death toll from swine flu is now at 700, according to the World Health Organization. And the U.S. government is gearing up for a mass vaccination campaign this fall, one not seen since the polio vaccine first became available in the 1950s. An H1N1 vaccine is still being tested for safety and efficacy. When it becomes available later this fall, should pregnant women be among the first to get it, or the last?
Think You Have Swine Flu? What to Do
By Deborah Kotz
It's OK to go about your life as usual even in the face of this flu "pandemic". But you should be aware of the telltale signs of H1N1: fever, cough, sore throat, stomach cramps, diarrhea, fatigue, and muscle aches.
Wayne Marasco is no doubt the only Harvard medical researcher who abandoned a successful construction firm, Waymar Roofing and Siding, to become an immunologist. The man with the unorthodox history recently made a striking discovery: a human antibody that attacks a newfound vulnerability in flu viruses.
Who's Ready if Swine Flu Pandemic Comes Knocking
Andy Coghlan, Linda Geddes & Rachel Nowak, New Scientist Magazine
Doomsday visions of curfews, sealed borders, travel bans and scuffles over food are a long way from materializing in the current crisis regarding swine flu.
But if the World Health Organization declares a pandemic, countries could bring in draconian measures to isolate and treat infection, prevent further spread and keep societies functioning.
The question, then, is which countries are ready and prepared to handle a Swine Flu Pandemic.
(C) 2009 U.S. News & World Report