This is the some information about the swine flu vaccine that has been circulated to medical professionals. I think it addresses many concerns in a clear and concise fashion. Remember many health care professionals will have an opinion, but that opinion may not be evidence based. Read the facts, and make the right decision for yourself.
Pregnancy and the swine flu vaccine
Pregnant women are subjected to a barrage of advice and information. It can be difficult
and frustrating to try and wade through complex advice. Swine flu is a respiratory
disease caused by a new strain of flu virus. The seasonal flu vaccines that are already
available don?t protect against swine flu, so a new flu vaccine has been developed.
It?s important that we give clear advice for pregnant women.
Make it your decision. Make it informed.
Q. Why are pregnant women in one of the priority at-risk groups for vaccination?
Evidence shows that pregnant women are at increased risk of severe disease and flu-related
hospital admissions. The risk increases with how advanced the pregnancy is, with women in the
third trimester (last three months of pregnancy) particularly at risk.
7-10% of all hospital admissions for swine flu are pregnant women in their second or third
trimester of pregnancy, according to World Health Organisation (WHO) data. Pregnant
women are also ten times more likely to need care in an intensive care unit compared with the
general population.
Q. Is the vaccine safe for pregnant women?
Yes. Both vaccines have been licensed for use in pregnant women. Licensed vaccines, including
flu vaccines, are held to a very high standard of safety ? they simply would not be licensed if
they were unsafe.
European regulators have considered the safety record of seasonal flu vaccines and the nature
of the adjuvants that were incorporated in the pandemic vaccines. Extensive research has also
been carried out into the use of adjuvants and there is no evidence that they are associated
with any risks in pregnancy. (Adjuvants are additional agents that are added to vaccines to
make the more effective ? see below for more information) The seasonal flu vaccine has been
given to millions of pregnant women at all stages of their pregnancy and has an excellent
safety record, with no reported safety concerns. This is why in the UK, and many other
countries, vaccination against seasonal flu is recommended for pregnant women, whatever the
stage of the pregnancy.
Q Why is thiomersal present in the vaccine and is there any risk from it?
Pandemrix contains five micrograms of thiomersal (a mercury-containing compound) as a
preservative. This is added to prevent the vaccine becoming contaminated by bacteria during
preparation, storage and use. There are now numerous studies from many countries done in
different ways that all come to the same conclusion: that we cannot identify harm from
thiomersal in vaccines. Indeed, the US courts threw out thiomersal as a cause of autism. One of
the most compelling pieces of evidence was that when thiomersal was taken out of US
childhood vaccines, autism rates continued to rise. The minute quantities of thiomersal in
vaccines have been shown not to be harmful.
Q What is an adjuvant?
An adjuvant is a compound that can be added to a vaccine to enhance the immune response to
the vaccine. The use of an adjuvant can also reduce the amount of antigen (an antigen is the
active substance that causes your immune system to produce antibodies) that is needed to
produce a satisfactory immune response, which in turn, makes the vaccine safer.
People understandably want to know what is in the adjuvant; it contains a fish oil (squalene)
and vitamin E - both naturally occurring products that we have in our bodies. There is also a
substance called Polysorbate 80 that is a food additive and is in many medicines.
Q The use of adjuvanted vaccines in pregnant women has raised concerns; why are
pregnant women advised to take Pandremix? Why can?t we choose?
If choice is neutral there is no reason why people cannot choose what they want. However,
when the choice is not neutral we have to advise people to have what we believe to be the
best protection. We know that in healthy adults one dose of Pandemrix protects almost
everybody with very high levels of antibodies. With Celvapan, the proportion of people who
will be protected after one dose is considerably fewer. For this reason, the European
Commission still recommends two doses of Celvapan. At a time when H1N1 viruses are
circulating it has to be better for everybody to be protected after one dose than fewer and
with lower antibodies.
Pregnant women are advised to receive the adjuvanted vaccine Pandemrix as this vaccine
appears to give adequate levels of antibodies after a single dose which provides protection
more rapidly than would be offered by Celvapan. As pregnant women are at increased risk
of severe disease and hospitalisation, it is vital that they are protected as soon as possible
from swine flu infection.
Q Have the vaccines been tested on pregnant women?
Women who are already pregnant are generally not enrolled into clinical trials.
The safety of giving a particular vaccine to pregnant women is assessed from what is already
known about the ingredients in the vaccine and the results of testing that is carried out to see if
the vaccine poses any risk during pregnancy. However, non-pregnant women who are enrolled
into vaccine clinical trials sometimes become pregnant shortly after vaccination or are given
vaccine before they know they are pregnant. These women are followed up and the outcome
of the pregnancy is documented.
Women who were, or became pregnant, during the clinical trials of the swine flu vaccine were
carefully monitored and there was no evidence of any specific risk to the mother or their
unborn child due to the vaccine.
Q Can the swine flu vaccine cause flu?
No. The flu vaccine cannot give you flu as it does not contain a live virus. Some people may
experience mild flu-like symptoms (like fever, headache and muscle aches) for up to 48 hours
after immunisation as their immune system responds to the vaccine, but this is not flu.
Q
Are there any other side effects?
All vaccinations can produce side effects such as redness, soreness and swelling at the site of
the injection. The vast majority of these side effects are not serious.