Live blogging notes while viewing livestream of today’s ACIP. Apologies for formatting issues, etc. My thoughts/opinions are in this color.
Speaker: Dr. Henry Bernstein
Acknowledged limitations of VAERS (no unvac comparison), states it can rapidly detect rare adverse events.
Dr. Fiona Havers / TDaP – reviewed current policy recommendations along with proposed changes regarding use of TDaP or Td in setting of wound management for Tetanus prophylaxis. One ACIP committee member raised safety concerns
Another individual commented on SGA babies but also dismissed this as being wnl (though there are not adequate comparisons!)
Discussion of economic concerns – TDaP is more expensive, but since the recommendation is not preferential language and is already happening the decision was made by the work group to not “go into the weeds” regarding economic impact.
SGA: slide 16 (Dr Moro’s presentation): looking at women who need more than 1 TDaP for “catch up” immunization during pregnancy. 187 women. Excluded from larger (published) study. Per Moro, rates were comparable to background rates. Citation of study they were referencing was not made available. Given the size of the sample (187 women) how could there be sufficient power to find the adverse effects they were presumably looking for (ie: SGA, preterm birth, etc)? This sort of thing underscores the need for double-blind randomized placebo-controlled trials (yes, in pregnant women too!) – if it is okay to use this product in an off-label use in pregnant women then how could it not be unethical to do a DB RCT in a pregnant population in order to obtain far more robust and adequate data about safety, efficacy, and rate of adverse events? Off-label use and use of pregnancy registries are simply another name for a clinical trial without going through an IRB! That’s ethical?!
Dr Ault commented: He states there is a lot of peripheral data not looked at during today’s session that is reassuring (worldwide use during pregnancy). Personal opinion.
Hunter proposed no longer producing Td if TDaP is frequently substituted for Td. This was opposed by Paul _____ for various reasons.
IDSA rep (could not see name, Baker?) asked about ARTHUS reaction (severe limb swelling). Moro replied data is reassuring.
Rep of NAPNAP chimed in supporting TDaP d/t personal clinical experience with severe pertussis.
NACCHO rep chimed in in support of TDaP for HCWs. SHEA supports this. Hmmm … mandatory yearly flu shots have worked so well, why not expand this to requiring TDaP! This in spite of at least one study showing the more frequently pertussis is vaccinated against the shorter any risk reduction of suppressing symptoms. I think I have also heard of there being issues with being over-vaccinated against Tetanus (I’ll have to look that up and revise later).
AIM rep spoke of resistance among PCPs to carrying both Td and TDaP.
Talbot minimized ARTHUS reaction.