The H1N1 Vaccine

With the H1N1 vaccine set to be released this month, I thought that instead of either just ignorantly accepting or declining taking the shot, I would educate myself and make an informed decision.

The government is recommending that all pregnant women receive the inoculation. (As well as caregivers of children younger than 6 months old, individuals in the medical field, children 6 months to 24 years of age, and anyone who could experience complications from contracting the flu.)

From Flu.gov:

Protect Your Unborn Child

If you are pregnant, you should get vaccinated against H1N1 (swine) flu as soon as the vaccine becomes available this fall. Your vaccination can potentially protect your unborn child from infection. The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) has recommended that H1N1 vaccination efforts focus on five groups. One of those groups is pregnant women.

• Severe illnesses among pregnant woman and infants have been reported in the current H1N1 outbreak. Severe illness in the mother can be stressful to the fetus.
  
  
• Changes to a pregnant woman’s immune system can make her more sensitive to the flu and result in serious complications if she is infected with H1N1.
  
  
• A diagnosis of infection in the fetus or infant can be challenging. The effects of the flu on a fetus are also difficult to predict.

When deciding whether to inoculate myself or one of my children, the first thing I try to find out are the ingredients. Note, I said try. It's really not quite so easy as you might imagine to find an unbiased source of information. When it comes to this subject, it seems everybody has an agenda. A list of the ingredients can be found here.

There are 4 different companies manufacturing the vaccine in America. Unlike in Canada where they are administering a live vaccine, the United States will be using inactivated ones. Were I a Canadian, the deal would be sealed right there. Live vaccines scare me half to death. Probably because I know that the live Oral Polio Vaccine can... well... cause polio.

I always appreciate it when I find enough information to make my decision on the side advocating the vaccine. In this case, I found the package inserts at FDA.gov.

CSL Limited

8.1 Pregnancy

Pregnancy Category C: Animal reproduction studies have not been conducted with Influenza A

(H1N1) 2009 Monovalent Vaccine or AFLURIA. It is also not known whether these vaccines

can cause fetal harm when administered to a pregnant woman or can affect reproduction

capacity. Influenza A (H1N1) 2009 Monovalent Vaccine should be given to a pregnant woman

only if clearly needed.

MedImmune

8.1 Pregnancy

Pregnancy Category C

Animal reproduction studies have not been conducted with Influenza A (H1N1) 2009

Monovalent Vaccine Live, Intranasal or FluMist. It is not known whether Influenza A

(H1N1) 2009 Monovalent Vaccine Live, Intranasal or FluMist can cause fetal harm when

administered to a pregnant woman or can affect reproduction capacity. Influenza A

(H1N1) 2009 Monovalent Vaccine Live, Intranasal or FluMist should be given to a

pregnant woman only if clearly needed.

The effect of FluMist on embryo-fetal and pre-weaning development was evaluated in a

developmental toxicity study using pregnant rats receiving the frozen formulation.

Groups of animals were administered FluMist either once (during the period of

organogenesis on gestation day 6) or twice (prior to gestation and during the period of

organogenesis on gestation day 6), 250 microliter/rat/occasion (approximately 110-140

human dose equivalents), by intranasal instillation. No adverse effects on pregnancy,

parturition, lactation, embryo-fetal or pre-weaning development were observed. There

were no FluMist related fetal malformations or other evidence of teratogenesis noted in

this study.

Novartis

8.1 Pregnancy

Pregnancy Category C: Animal reproduction studies have not been conducted

with Influenza A (H1N1) 2009 Monovalent Vaccine or FLUVIRIN. It is also not known

whether Influenza A (H1N1) 2009 Monovalent Vaccine or FLUVIRIN can cause fetal

harm when administered to a pregnant woman or can affect reproduction capacity.

Influenza A (H1N1) 2009 Monovalent Vaccine should be given to a pregnant woman

only if clearly needed.

Sanofi Pasteur

8.1. Pregnancy

Pregnancy Category C: Animal reproduction studies have not been conducted with Influenza A

(H1N1) 2009 Monovalent Vaccine or Fluzone vaccine. It is also not known whether these

vaccines can cause fetal harm when administered to a pregnant woman or can affect reproduction

capacity. Influenza A (H1N1) 2009 Monovalent Vaccine should be given to a pregnant woman

only if clearly needed.

Basically, the inserts all read the same, with the exception being MedImmune which also addresses FluMist, a live vaccine for seasonal flu. Simply insert the one companies name where the other is listed. In section 8.2, you'll see the safety information listed for nursing women. The information is again, virtually identical-

8.3 Nursing Mothers

It is not known whether FLUVIRIN or Influenza A (H1N1) 2009 Monovalent

Vaccine is excreted in human milk. Because many drugs are excreted in human milk,

caution should be exercised when Influenza A (H1N1) 2009 Monovalent Vaccine is

administered to a nursing woman.

(From Novartis)

Ummm... does anyone else see anything contradictory here? Dr Sears does.

What about pregnant and/or nursing mothers?

This is a little scary. The flu shots are ALREADY recommended for pregnant and nursing moms, BUT (and this is a really huge but) the vaccine product inserts make it very clear that the regular flu vaccines have never been tested on pregnant or nursing women to determine if there is any harm to fetuses or young babies (with one exception – the Flumist nasal spray brand did have some testing in this area, BUT not enough, as is stated in the product insert).

Despite this complete lack of research, it is recommended for these moms anyway. Anyone see a problem with that?

If you do get a flu shot, at least make sure it is mercury free (or at least only TRACE mercury).

See his FAQ in it's entirety.