Slik testes vaksinen på gravide

[SusyQ]

Har vært litt debatt her inne om svineinfluensavaksinen er testet på gravide. Her er noen artikler jeg fant om temaet:

 

Intervju med en av de mange gravide som har meldt seg frivillige til å teste den nye svineinfluensa vaksinen:

http://www.usatoday.com/news/health/2009-09-21-swine-h1n1-pregnant_N.htm

 

En laaang artikkel fra Vanderbilt (ett av åtte steder som tester ut vaksinen) om hvordan testingen foregår:

http://www.mc.vanderbilt.edu/root/vumc.php?site=vvrp

 

Og en god Q&A på CNN som også tar for seg testing og gravide:

 

http://edition.cnn.com/2009/HEALTH/09/30/h1n1.vaccine.decision/?imw=Y

• I am 12 weeks pregnant and getting pressure from some family members to get the H1N1 vaccine. I am opposed to it mainly because it is so new. I would like to know what side effects they are projecting?

 

So far, the NIH has vaccinated more than 60 pregnant women as part of a study to see whether the H1N1 vaccine is safe and effective. There have been no reports of serious side effects, according to Linda Lambert of the Division of Microbiology and Infectious Diseases at the National Institute of Allergy and Infectious Diseases. The NIH plans on vaccinating a total of 120 women in its study.

 

Every pregnant woman needs to decide for herself whether she wants the H1N1 vaccine. The swine flu virus has been particularly dangerous for pregnant women; 6 percent of the people who've died from H1N1 since April have been pregnant women, while pregnant women make up only 1 percent of the U.S. population, according to Dr. Anne Schuchat, director of CDC's National Center for Immunization and Respiratory Diseases.

 

Why are pregnant women more vulnerable to H1N1 flu? "It's partly because pregnant women have some degree of compromise of their immune system, and their ability to fight off even fairly common illnesses such as the flu appears to be much lower," said Dr. Neil Silverman, a professor of obstetrics and gynecology at the University of California-Los Angeles School of Medicine.

 

In addition to protecting pregnant women, studies show vaccines give immunity to a newborn for at least a few months as antibodies cross the placenta and reach the fetus. This is especially important since babies cannot get an H1N1 vaccine themselves until they're 6 months old.

 

Og før en eller annen sier at dette bare dreier seg om thimerosalfrie vaksiner:

 

• Will the shots contain thimerosal?

 

Some H1N1 shots will contain the preservative thimerosal, and others won't, according to the CDC. You'll have to ask your doctor (or the clinic administering the shots) which type you're getting. Some people worry about thimerosal for children because it's mercury-based, but the CDC says there's no scientific evidence the preservative is harmful.

 

[SusyQ]

Og for oss som virkelig vil nerde på temaet, her er den komplette oversikten over testing på gravide, hvilke universiteter som utfører det, konkret hvordan det gjøres, hva som måles etc etc.

 

Enjoy ;-)

 

Her er kortversjonen:

 

Official Title: A Phase II Study in Pregnant Women to Assess the Safety and Immunogenicity of an Unadjuvanted Sanofi Pasteur H1N1 Inactivated Influenza Vaccine Administered at Two Dose Levels

 

This purpose of this study is to evaluate an investigational 2009 H1N1 influenza vaccine to determine vaccine safety in pregnant women and how the body reacts to different strengths of the H1N1 influenza vaccine. In this study 2 strengths of the H1N1 influenza vaccine will be tested (given 3 weeks apart). Participants will include approximately 120 healthy pregnant women, ages 18-39 years, in their second or third trimester of pregnancy (14-34 weeks gestation). Study procedures will include 2 doses of vaccine, blood samples, umbilical cord blood samples at delivery, and recording temperature and vaccine side effects in a memory aid for 8 days following each vaccination. Participants will be involved in study related procedures for about 7 months.

 

http://clinicaltrials.gov/ct2/show/NCT00963430

[SusyQ]

Om du lurte på hvorfor bare 120 gravide testes vært sted ligger svar her fra en Q&A på National Instutute of Allergy and Infectious Diseases:

(De som koordinerer testingen)

 

Why is this trial enrolling only 120 women?

 

The trial size is based on vaccine availability and the number of individuals needed to yield sufficient information to determine the safety of the H1N1 vaccine in pregnant women, and to measure their immune response to the vaccine. The information gathered from this study will be compared with information from similar studies comparing one and two doses of candidate 2009 H1N1 influenza vaccines. Those trials have enrolled larger numbers of healthy adults and elderly individuals, but do not include pregnant women.

13.

 

Will the vaccine provide protection to an infant whose mother was vaccinated as well as to the vaccinated woman?

 

 

It is expected that the vaccine will provide protection against infection with 2009 H1N1 influenza virus infection for infants likely as a result of transfer of antibodies across the placenta from the mother to her infant. In a study of maternal immunization published in 2008, there was a 63 percent reduction of influenza illness in infants up to 6 months of age whose mothers had received inactivated seasonal influenza vaccine while pregnant.

 

[see K Zaman et al. Effectiveness of maternal influenza immunization in mothers and infants. New England Journal of Medicine DOI:10.1056/NEJMoa0708630 (2008).]

[AnnieG]

Interessant lesestoff, men ikke relevant for norske forhold dessverre. Vaksinene som testes i USA er ikke tilgjengelig på det norske markedet. Den de kjører i USA er enten med eller uten kvikksølv, og den fra Sanofi Pasteur inneholder verken kvikksølv eller skvalen. (altså uten adjuvant som det står i overskriften .....

 

 

[SusyQ]

Some H1N1 shots will contain the preservative thimerosal, and others won't, according to the CDC. You'll have to ask your doctor (or the clinic administering the shots) which type you're getting. Some people worry about thimerosal for children because it's mercury-based, but the CDC says there's no scientific evidence the preservative is harmful.

[SusyQ]

Why do some people think squalene in vaccines carries a risk?

 

* A few people have tried to link the health problems of Gulf War veterans to the possible presence of squalene in the vaccines these soldiers received.

* One published report suggested that some veterans who received anthrax vaccines developed anti-squalene antibodies and these antibodies caused disabilities.

* It is now known that squalene was not added to the vaccines administered to these veterans, and technical deficiencies in the report suggesting an association have been published.

* Over 22 million doses of squalene-containing flu vaccine have been administered. The absence of significant vaccine-related adverse events following this number of doses suggests that squalene in vaccines has no significant risk.

 

 

[amandan]

Bravo SusyQ! Thank you for finding relevant and factual articles and studies!