POLICY AND OPERATIONAL ADJUSTMENTS NEEDED TO ACCOMMODATE ADOLESCENT ROLLOUT

The FDA just authorized the Pfizer vaccine for use in kids 12-15 years old.  Pfizer says in their press release (not via peer reviewed data) that their clinical trial (of 2,260 participants) showed that their vaccine was 100% effective in 12-15 year olds and had minimal side effects.

The CDC’s Advisory Committee on Immunization Practices is meeting Wednesday morning to decide whether to recommend the vaccine’s use in 12-to-15-year-olds (here’s the Agenda and webcast link). CDC Director Dr. Rochelle Walensky will decide whether the agency will recommend its use in the new age group. Most likely, the vaccine will be both authorized and recommended for 12-15 year olds by the end of the week.

There are some tricky things about the logistics of administering the Pfizer vaccine that will require the ADHS to make some adjustments in order to make it easy for adolescents 12-17 to get vaccinated in their medical home (the best place for them to be vaccinated).

For one thing, the Pfizer vaccine can only be held in a normal (-20C) freezer for 2 weeks. In order to store it longer than that, doctor’s offices need to have an expensive ultra-cold freezer (-70C).

Doctor’s offices can usually turn-around their vaccine inventory in 2 weeks but a single standard order of Pfizer vaccine contains about 1,170 doses, too much for a small pediatric office to administer over a 2 week period.

One work-around would be for the county/state health departments to “break down” the big Pfizer order into smaller packages so pediatric and family practices won’t need to commit to such a big order (Pfizer has said that by the end of May they will have smaller minimum order boxes, so that’ll help).

Another issue is that we’ll need more pediatric providers to be able to order the SARS CoV2 vaccine. Up until now, doctors offices need to go through a complex ADHS on-boarding process in order to be able to receive the COVID shot.

A good work-around for that is to allow all Vaccines for Children (VFC) providers to be auto-enrolled in the COVID vaccine program. Easy to do. Let’s hope ADHS is flexible enough to make that happen.

Note: Last week the ADHS finally began to allow doctors offices to order vaccine for their practice. The offer was made to providers that were already on-boarded using their process. Only 65 doctors actually ordered vaccine (see this Arizona Republic story).

ADHS needs to do a root-cause analysis to figure out why so few ordered vaccine last week. Is it the cumbersome ordering process? Poor communication? Unreasonable reporting requirements? A combination? Only by figuring out way last week’s effort failed will they be able to make the policy and operational changes to fix this big problem.

In other news, Pfizer submitted their application for full approval (licensure) of their mRNA vaccine last week. The application review will likely take several weeks. Full approval would provide more assurance to some people that are still holding out that the vaccine is safe.

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