New shot may curtail crybabies
FDA approves five-in-one immunization for infants. But,
vaccine overload/Autism link not explored.
Houston Chronicle, December 16, 2002
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Parents, expect fewer screams in the pediatrician's office: A
new vaccine that promises to cut out six of the 20 injections
that babies get before age 2 won federal approval Monday.
The vaccine, called Pediarix, combines into one injection
today's shots that protect against five different diseases --
diphtheria, tetanus, whooping cough, hepatitis B and polio.
Until now, it has taken nine separate injections for babies to
get that much protection. Pediarix requires only three shots
staggered through the first six months of life.
Pediarix won Food and Drug Administration approval after
studies involving thousands of babies proved it was as
effective as the nine separate shots. The combination vaccine
will begin selling early next month, and cost about the same
as the separate injections added together, said manufacturer
Pediarix doesn't cover everything: Babies still will need
separate shots to protect against two types of meningitis and
pneumonia. After their first birthday, they start getting
shots against other diseases, such as measles and chickenpox.
In 1980, babies were immunized against just four diseases.
Today, by age 2 most children have had up to 20 shots to
protect against 11 diseases. That means more and more
protection against deadly illnesses -- and it also means more
For parents, eliminating the need for six of the shots is good
Take Yehoshua Halle, who at age 6 months got a whopping six
shots -- the usual four immunization injections in addition to
shots for the flu and another dangerous respiratory infection,
needed because he was born premature.
"Even the nurse was amazed she had to administer six shots at
one time," said his mother, Tamara Halle of Silver Spring,
Md., recalling that October visit. "He did well, he did a
fantastic job, but it's a lot for a little person to have to
Fewer shots per visit doesn't eliminate the fact that babies
still will cry through some injections at ages 2, 4 and 6
months, noted Mimi Laver, a Washington mother who remembered
her now 17-month-old's inoculations as not being too bad.
"It's sad to see him crying. Once he was crying, the extra
shot didn't really matter," she said. Her son, Noah Freedman,
would calm down after a few minutes, leading her to conclude
that while fewer shots are nice, "it doesn't rank high on my
priorities for child health."
Decreased pain isn't the only reason for combination vaccines,
said Dr. Mark M. Blatter of Primary Physicians Research in
Pittsburgh, one of the Glaxo-funded study sites for Pediarix.
Scientists are working to create vaccines against more and
more diseases, and without combining shots there simply won't
be room on babies' tiny thighs for more inoculations, he said.
Vaccine makers have long tried to combine inoculations.
Already there are three-in-one shots for diphtheria, tetanus
and whooping cough, commonly abbreviated as DTaP, and measles,
mumps and rubella, or MMR. Also, there is a combination shot
that combines protection against hepatitis B and
meningitis-causing Haemophilus influenza B.
Adults commonly get a diptheria-tetanus combination shot, and
each year's flu shot contains protection against three strains
But with five-in-one protection, Pediarix becomes the biggest
combination vaccine yet.
The combination could increase the number of children getting
all their recommended vaccinations, experts said.
"It's a big step forward in terms of adding to our
armamentarium of childhood vaccines," said Karen Midthun,
director of the Food and Drug Administration's office of
vaccine research and review.
The vaccine could also alleviate parents' concerns about
giving their children so many shots when they are so young.
In studies, side effects were similar in babies who got
Pediarix and those who got separate shots, the FDA said. There
was one exception: Pediarix patients were slightly more likely
to have a low fever. In one study, 19 percent of Pediarix
patients had a low fever compared with 12 percent of babies
getting the separate shots, Blatter said.
Joel G. Schwab, assistant professor of pediatrics at the
University of Chicago, said doctors would likely not switch
until the American Academy of Pediatrics formally recommends
use of Pediarix, a process that could take several months.
But they're looking forward to fewer shots, he said. "The
nurses will be ecstatic and the kids will be happy, too."
The Washington Post and the Associated Press contributed to