Swine Flu Vaccine Protects Pregnant Women
1 Dose of H1N1 Vaccine Works for Pregnant Women; Kids Still Need 2 Doses
Nov. 2, 2009 - Pregnant women safely get "robust" protection from one dose
of the H1N1 swine flu vaccine; but children under age 10 really need two doses,
NIH studies show.
The findings are straight-from-the-clinic data from ongoing studies funded
and coordinated by the National Institute of Allergy and Infectious Diseases
(NIAID) at clinical centers across the country.
"This should be reassuring news to those women who already have received the
H1N1 vaccine, and it is vital information for those pregnant women who have not
been vaccinated," NIAID Director Anthony Fauci, MD, said at a news conference.
"Importantly, the pregnant women participating in the trial have tolerated the
vaccine well and no safety concerns have arisen."
As the current wave of the H1N1 swine flu pandemic sweeps the nation, it's
becoming clear that pregnant women -- especially those in their second and
third trimesters -- bear a special risk. They are about six times more likely
than other healthy adults to develop severe complications soon after infection
with H1N1 swine flu.
Alarmingly, a recent CDC survey found that about half of pregnant women and
other adults with
risk conditions do not seek medical attention when they come down with
H1N1 swine flu symptoms.
It's also becoming increasingly clear that H1N1 swine flu is mainly a
disease of young people. Children, teens, and young adults bear the brunt of
infections -- and of hospitalizations and deaths.
The NIAID clinical trials have shown that children, teens, and young adults
over age 10 need just one dose of the H1N1 swine flu vaccine for
Early results from these studies suggested younger children might need two
doses. That's true, new study results show.
Even three weeks after getting their first dose of H1N1 swine flu vaccine,
only 25% of kids ages 6 to 35 months and only 55% of kids ages 3 to 9 years are
protected. Even giving these kids a one-time double dose did not improve immune
The good news: Just eight to 10 days after getting their second dose of the
vaccine -- four weeks after the first dose -- virtually every kid in these age
groups has a protective immune response.
"These data support guidelines that recommend two vaccine doses for younger
children," Fauci said.
H1N1 Swine Flu Vaccine Safety
Bruce Gellin, MD, head of the government's National Vaccine Program Office,
said at the news conference that a group of medical experts will this week
begin regular meetings to analyze safety data on the H1N1 swine flu
The group is part of a larger panel, the National Vaccine Advisory
Committee, that advises Health and Human Services Secretary Kathleen Sebelius
on vaccination issues. It was this group that previously advised the government
to release H1N1 vaccine as soon as it became available.
Gellin also announced the release of a
detailed plan to monitor the safety of the 2009 H1N1 swine flu vaccine. The
plan has 11 elements:
- Analysis of background rates of rare adverse events that occur without
vaccination, to make it easier to determine whether vaccination increases the
rate at which any of these events occurs.
- Use of the CDC's Vaccine Safety Datalink system, which links data from
eight managed-care organizations with data on 9 million Americans -- 3% of the
- Use of the Medicare/Medicaid database.
- The Post-Licensure Rapid Immunization Safety Monitoring (PRISM) system,
which links data from large insurance plans covering about 10% of the U.S.
- Use of the Department of Defense medical databases.
- Use of the Veterans Affairs databases.
- A surveillance program to look specifically for cases of Guillain-Barre
syndrome (GBS), a rare neurological condition.
- A collaboration between Johns Hopkins University and the CDC in which
people who received the H1N1 swine flu vaccine report their experiences via the
- Use of electronic records that will be introduced by the Indian Health
- The Clinical Immunization Safety Assessment (CISA), a collaboration between
six academic centers that will collect and store clinical samples from people
who may be at risk for serious adverse events linked to vaccination or
- The Vaccines and Medications in Pregnancy Surveillance System (VAMPSS), a
collaboration between an association of birth-defect specialists, the American
Academy of Allergy, Asthma, and Immunology, and Boston University, which will
conduct studies of H1N1 swine flu vaccine, H1N1 swine flu antiviral treatment,
and H1N1 swine flu disease.