H1N1 vaccine recall: 800,000 doses of kids' swine flu vaccine found to be not potent enough
By Rosemary Black
DAILY NEWS STAFF WRITER
Originally Published:Tuesday, December 15th 2009, 11:14 AM
Updated: Tuesday, December 15th 2009, 2:02 PM
Staver/Bloomberg
Health officials announced a recall Tuesday of 800,000 pre-filled syringes of swine flu vaccine for young children. Take our Poll
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Health officials are recalling some 800,000 pediatric doses of the H1N1 flu vaccine after tests indicated they may not be powerful enough to offer protection against the virus, according to The Associated Press.
It's unclear how many doses already have been distributed, but officials said they don't think children need to be revaccinated, according to the AP.
The federal Centers for Disease Control’s advice for parents worried that their child might have received an ineffective dose of the H1N1 vaccine? Don’t panic.
“If a parent has a child who received this vaccine, they need to do absolutely nothing,” said CDC spokesman Tom Skinner. “But if they were recommended to get a second dose of the vaccine, which in this age group they were, they should be sure to get that second dose.”
The CDC notified doctors about the recall, which involves doses made by Sanofi Pasteur. All of the doses are prefilled syringes intended for children aged 6 months to almost 3 years, according to Skinner.
Tuesday’s announcement is aimed, Skinner said, primarily at clinicians and providers.
“We are reaching out to these clinicians and providers to tell them if they have vaccine around from these lots, don’t use it,” he said. “Most of this vaccine probably has already been used.”
The American Academy of Pediatrics recommends that children ages 9 and under get two doses of the H1N1 vaccine, spaced about a month apart, to obtain the most protection against the virus.
Health officials say the doses that were recalled passed potency tests when they were shipped but that their potency waned later on, according to the AP.
The recall of so many doses “shows the problem with trying to rush these things to market,” said Dr. Kent Holtorf, who specializes in chronic infectious diseases.
“The way the whole swine flu vaccine was put out there was problematic,” he said. “If they’re putting out a product that is ineffective, it makes you wonder what other types of quality control are lacking. Rushing a vaccine is always worrisome.”
But parents should not be concerned, said Dr. Joseph Bocchini, chairman of the AAP’s committee on infectious diseases.
“It’s not a safety thing at all,” he said. “The company found that the potency was slightly below the limit that they set for the vaccine. And since the level of potency was just slightly below, the feeling is that it would have induced a good immune response in children anyway. These kids don’t need an extra, a third dose, because of this recall.”
The recall “is not a dangerous thing, not a health thing,” said pediatrician Dr. Mary Ellen Renna, author of “Medical Truths Revealed,” who recommends that all her patients get the vaccine. “I am telling my patients to be sure they get the second dose, and they will be protected. This is nothing to be concerned about.”
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