H1N1 Vaccine Trial Data Still Needed for High-Risk Groups
The US Food and Drug Administration approved on Tuesday four H1N1 flu vaccines that demonstrated in clinical studies that a single dose produced a strong immune response in healthy adults after 8–10 days. Based on the manufacturers’ production schedules, things seem to be on track for vaccines to be available in four weeks.
But clinical trials of the vaccine are still underway on pregnant women and children, two groups that the Centers for Disease Control and Prevention (CDC) says are especially vulnerable to the H1N1 flu. CDC has identified five priority groups to receive the vaccine once it becomes available: pregnant women, people who live with or care for infants, healthcare and emergency medical services personnel, people between 6 months and 24 years old, and adults with chronic conditions ages 25–64. CDC estimates these populations total approximately 159 million people in the United States.
CDC’s Q&A document titled “2009 H1N1 Influenza Vaccine and Pregnant Women” says certain populations, including pregnant women, may need two doses. That will be confirmed when the data from the clinical trials are in. The National Institutes of Allergies and Infectious Diseases (NIAID) began the initial clinical study in pregnant women on Sept. 9, and it involves up to 120 women, ages 18–39, in their second or third trimester of pregnancy. Participants received an initial injection and will get a second shot 21 days later. Samples of the women’s blood and of the cord blood will measure the immune response and the presence of maternal antibodies crossing the placenta to the infants. NIAID plans to conduct studies at six medical centers nationwide.
FDA’s statement on Tuesday said that ongoing clinical studies of the vaccine in children will point to the appropriate dosage. The agency expects to know for sure “in the near future.”
Safety of the vaccine is a concern for pregnant women and parents. After all the efforts and recommendations of government agencies and vaccine manufacturers around the world, will pregnant women and parents want it? CDC says, “We do not expect that there will be a shortage of 2009 H1N1 vaccine, but availability and demand can be unpredictable.” What if the demand is significantly below what CDC is expecting?
A report on NPR Health Blog says that only about 15% of pregnant women get the seasonal flu shot, despite recommendations by CDC. “The swine flu vaccines are not specifically approved for pregnant women. But neither are ordinary seasonal flu vaccines. The reason, says FDA, is that the agency doesn’t specifically approve most adult drugs for categories of adults, such as pregnant adults,” according to the article, which also suggests that obstetricians do not urge their pregnant patients to get seasonal flu vaccines. Perhaps that is due to this text found on the vaccine labels, explains the article:
“If you look at the fine print on seasonal flu vaccine labels, you’ll see language like this: ‘It is not known whether (this vaccine) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. (This vaccine) should be given to a pregnant woman only if clearly needed.’”
Without strong recommendations from their OBs, pregnant women may not want to line up to get the H1N1 shot when it becomes available.
Uncertainty about the safety of the H1N1 vaccine is evident on community message boards and on websites, such as the pregnancy-focused babycenter.com. In the “Swine Flu Discussion Group,” some moms-to-be are skeptical of the new vaccine, calling it “rushed” or “not tested enough” and generally calling into question the vaccine’s safety, given the speed at which it was produced, and effectiveness against the new form of the flu.
This week, a Los Angeles Times article reported that some parents refuse to vaccinate their children against H1N1, preferring them to catch the virus and develop a natural immunity. Physicians say that young parents could refuse the vaccine for their children for a number of reasons, including fears of a link between vaccines and autism, the fact that many of the parents grew up not knowing about once-common childhood diseases, wariness of a vaccine that is still being tested, and a “distrust of drug manufacturers, media outlets and the federal government,” according to the article.
People remain unsure about the H1N1 vaccine despite FDA’s and CDC’s reassurances that it is made by trustworthy manufacturers using established procedures. In this week’s FDA release, Jesse Goodman, FDA acting chief scientist, says, “The H1N1 vaccines approved today undergo the same rigorous FDA manufacturing oversight, product quality testing, and lot release procedures that apply to seasonal influenza vaccines.” The statement also pointed out that the four vaccine manufacturers “have a long record of producing safe seasonal influenza vaccines.”
Despite public uncertainty, the H1N1 shot is recommended as the best way to prevent catching the virus and avoid complications from it—in addition, of course, to proper hand washing and avoiding sick people. As CDC says in its Q&A document on the vaccine’s safety, “CDC and FDA believe that the benefits of vaccination with the 2009 H1N1 influenza vaccine will far outweigh the risks.”
I am not exposing my unborn child to an untested vaccine. Just read about the effects of the supposedly “safe” morning sickness drug Thalidomide (http://cerhr.niehs.nih.gov/common/thalidomide.html) to get just a small view of what happens when a drug goes wrong. The drug companies just want our money, they couldn’t care less about our kids.
Thalidomide was not approved by the U.S. FDA; in Europe and Canada it was. The immunities that moms will get from the H1N1 vaccine can be passed to the infant, which is a good thing. My doctor recommended both the normal flu shot without preservatives and the H1N1 vaccine when it comes out. Yes, the drug companies may want our money, but good doctors want to keep us safe and healthy and all of the medical advice I’ve gotten says to get the vaccine.
At this time, I will not vaccinate my children. I just don’t think there’s enough data out there yet to say that the vaccination is without risk. Further, since some of the H1N1 vaccines contain the additive thimerosal there is an added concern regarding autism development (although the link between thimerosal and autism is strongly denied by CDC – there is considerable controversy). My biggest concern is the lack of sufficient testing in children, not to mention the neurologic complications that resulted from the 1970s swine flu vaccine. Hopefully further clinical trial information and widespread public vaccine administration will prove the vaccine both effective and safe. I’ll wait for that data. By the way, the pharmaceutical industry has been under pressure to quickly identify a safe vaccine to help mitigate widespread swine flu outbreak and associated fatalities. Yes, it is a business intended to produce a profit, just like your local supermarket, but the primary concern and objective is to improve public health.
I’d be happier about taking the shot if the manufacturers had not gone to so much trouble to get legal immunity!
How can health care workers be REQUIRED to take a shot when there is absolutely NO protection for them if they fall ill FROM that shot?
This is just horrible. How can people put so much faith in the pharmaceutical industry? How often do we see commercials where there is litigation for FDA approved drugs that harm people?
No frankenshot for me thanks!
I personally find this amazing! I work for a Bio-Tech company (not one of the 5 manufacturers of the H1N1 vaccine BTW). We manufacture vaccines for animals . I am well aware of the licensing issues and timeframes for a “new” drug to be able to be marketable. One thing that amazed me in this was Novartis claiming to be close to having a marketable vaccine within a month or two of the first identified case. This process normally takes years!!! Another thing that haunts me is why the regulatory offices are backing this vaccine so forcefully. And why they haven’t questioned some of these companies on how they already had a vaccine in place before we even have a strain of the bug in the wild. It makes one suspicious.