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Is the FDA Reading This Blog?

Well, I'm pretty sure they aren't. Nonetheless I was pleased that they authorized the mix and match strategy for COVID-19 boosters a few days after I described their process as antediluvian for not doing so. This allows much more flexibility to take into account individual patient preferences and circumstances plus streamlining boosters in nursing homes and other settings where not everyone has received the same primary series.

Vaccines for 5-11 Year-Olds?

The FDA posted briefing documents from Pfizer (81 pages) and FDA scientists (39 pages) on October 22. Needless to say I have poured over both of them, and it seems highly likely that the vaccine will be authorized at their October 26 advisory group meeting. Note that if this happens, the actual shots in arms must wait until after the CDC/ACIP meets to provide recommendations, originally scheduled for November 3, but the meeting date has been removed from their website at the time of this writing. In the meantime, pediatric practices would be wise to plan for rollout.

One of our readers, Dr. Michael Schwartz in Pennsylvania, wrote with some very important logistical concerns: how to do this without wasting doses but still accounting for those unscheduled drop-ins wanting vaccine. Thankfully the storage and handling requirements for the Pfizer vaccine have been eased somewhat. For the pediatric doses, which will be supplied in entirely new containers, the initial frozen storage is still at -90 C to -60 C, well below regular freezer temperatures. However, after thawing the vials can be stored at regular refrigerator temperatures (2 C to 8 C) unopened for up to 10 weeks. After an individual vial is entered and diluted it must be used within 12 hours. Each practice will need to figure out if this works within their system, but I suspect most that have utilized mass flu vaccine clinics in the past can use the same strategy here.

Mystery Solved?

In the August 15, 2021, posting in this blog I mentioned the mysterious finding of melioidosis cases in 4 individuals in the US. None had a history of travel to high-risk areas or connection to one another. This past week the mystery might have been solved as researchers discovered contamination of a particular brand of aromatherapy: Better Homes and Gardens-branded Essential Oil Infused Aromatherapy Room Spray with Gemstones "Lavender & Chamomile." Whole genome sequencing testing is pending, but PCR testing of the product did reveal Burkholderia pseudomallei. The product was sold at Walmart but as of October 21 has been removed from their online and brick-and-mortar stores. CDC issued a Health Alert Network message with advice for consumers and clinicians, worth reading.

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