The Advisory Committee on Immunization Practices (ACIP) has agreed to push back a vote on changing the CDC recommendation for a birth dose of the hepatitis B virus (HBV) vaccine, as panellists were unhappy with the wording of the resolution.
Having already voted unanimously that all pregnant women should be tested for hepatitis B as a precursor to deciding an HBV vaccine strategy, the ACIP had reservations about the proposed recommendation on changing the paediatric vaccine schedule – for different reasons.
The wording proposed was as follows: “If a mother tests HBsAG-negative: The first dose of the hepatitis B vaccine is not given until the child is at least one month old. Infants may receive a dose of hepatitis B vaccine before one month according to individual-based decision-making.”
Vicky Pebsworth said the wording was not strong enough, suggesting that vaccination should be delayed beyond one month in line with other countries, including some in Europe, as side effects like irritability, fussiness, and crying – which she claimed “are not trivial reactions” could point to safety concerns.
Meanwhile, Robert Malone took a similar tack, saying the onus should be on proving an absence of harm with HBV vaccines that was not achieved based on current data, saying: “The burden is to demonstrate safety, not to generate the statistics to state the converse.”
On the other hand, Cody Meissner – who argued a day earlier in favour of the HBV shots’ safety based on long clinical experience – said he voted to table the resolution because it is “very, very difficult to prove the absence of harm, it’s simply not a practical objective.”
He added: “I think the experience that we have accrued of administration of a dose of the vaccine in the first 12 to 24 hours is overwhelming, and the issues that were raised regarding irritability or restlessness are not objective parameters that should be used to assess safety.”
The panel voted by 10 to one to defer the vote.
MMRV revisited
Meanwhile, after a chaotic end to yesterday’s meeting resulted in two conflicting votes on the measles, mumps, rubella, and varicella (MMRV) vaccine, the ACIP revisited the issue with a fresh vote to recommend against its use – across the board – in children aged under four. Instead, they should receive the MMR and V vaccines as two separate shots.
The new vote corrected an issue created yesterday when a second vote was taken to recommend that MMRV should still be available under the Vaccines for Children programme, which would have created a disparity in access. The new vote – which passed by 9 to 3 – brought the VFC into line with the new recommendation.
