Jan 31, 2003 (CIDRAP News) – People who will be receiving their first smallpox shot in coming weeks are getting a small break from the federal Advisory Committee on Immunization practices (ACIP): Instead of 15 pricks of the needle, the ACIP is now recommending only three.
The ACIP previously had recommended 15 needle pricks for both first-time vaccines and those being revaccinated. But in a 40-minute telephone conference Jan 29, the ACIP decided to reduce the recommended number of needle pricks for first-time vaccines to three in order to match the recommendation on the vaccine package insert (printed instructions that come with the vaccine).
"The committee recommended that smallpox vaccine be given in accordance with the package insert, with 3 insertions of the bifurcated needle for primary vaccination and 15 insertions for revaccination," reads a summary of the conference, posted yesterday on the National Immunization Program Web site.
But there's a qualifier: "A trace of blood should appear at the site of vaccination within 15-20 seconds; if no trace of blood is visible, an additional 3 insertions should be made using the same bifurcated needle without reinserting the needle into the vaccine vial," the summary states.
The vaccine package insert has legal standing because it was approved by the Food and Drug Administration (FDA), ACIP members said during the conference call, to which reporters were allowed to listen. "The FDA-approved package insert says the appropriate number of sticks per vaccination is two to three. And we are bound basically to adhere to those requirements," one committee member said.
Another member said that Dr Julie Gerberding, director of the Centers for Disease Control and Prevention (CDC), decided that the CDC has to follow the package insert and recommend two to three jabs for primary vaccines. CDC decided to alert the ACIP of this and give the committee a chance to "revisit its decision" before going on record as contradicting the ACIP recommendation, the member said. The ACIP is a panel of experts that advises the CDC on immunization issues. (Current smallpox vaccination instructions on the CDC Web site advise vaccinators to refer to the package insert to determine how many needle pricks to give.)
A campaign to vaccinate about 450,000 public health and healthcare workers is just getting under way as federal health authorities seek to build a defense against the risk of a terrorist release of smallpox virus. The CDC has shipped 165,900 doses of smallpox vaccine to 38 states and two counties, according to information on the agency's Web site today.
Smallpox vaccine is administered by dipping a bifurcated (two-pronged) needle into a vial of the liquid vaccine and then pricking the skin just enough to draw a little blood.
During their conference, ACIP members said the vaccine package insert states that the needle pricks should be sufficient to elicit a trace of blood in 15 to 20 seconds. The package insert doesn't state explicitly that vaccinators should give more jabs if blood doesn't appear, but that is the implication, members said.
ACIP's previous decision to recommend 15 needle pricks for both primary vaccinees and those being revaccinated was made during a Jan 14 conference call. That decision was based on experience during the global smallpox eradication program and recent clinical trials, according to a CDC summary of the conference.
CDC instructions for administering smallpox vaccine