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The Arizona Partnership for Immunization put together this super informative PowerPoint summarizing the billing and coding for administering the COVID 19 vaccines. Topics include Medicaid and Medicare reimbursement details, AHCCCS administration fee schedules for both doses ($16.94 for the 1st dose and $28.39 for the booster), how administration fee claims will be handled for uninsured patients, which provider categories need to re-enroll as mass immunizers, ordering and billing links, and more.

A huge shout-out to Jennifer Tinney and the team at TAPI for their terrific leadership over the years and during the pandemic. We’re very lucky to have them assisting with the COVID vaccination planning in Arizona.

The FDA Commissioner granted emergency use authorization (EUA) of the Pfizer/BioNTech COVID19 vaccine on Friday. The decision was made by following last Thursday’s FDA’s Vaccines and Related Biological Products Advisory Committee meeting. Here’s a top line summary of the FDA’s analysis Pfizer/BioNTech’s application.

The CDC’s Advisory Committee on Immunization Practices also held meetings on over the weekend and recommended that the Pfizer vaccine be given to “persons 16 years of age and older in the U.S. population under the FDA’s emergency use authorization“. Importantly, they voted to add the vaccine to the immunization schedules. Within 15 days of being added to the schedule health plans need to cover administration of the vaccine. 

While the clinical trial didn’t include people 16 or 17 years old, that age group was added because many folks in this age range work in fields that put them at risk for exposure. The Committee recommended that pregnant women be able to choose whether to be vaccinated (encouraging them have a conversation with their physician before vaccinating).

While no pregnant women were in the trials, 23 became pregnant after administration of the vaccine. The Committee was in consensus that persons who have had severe allergic reactions to other vaccines should talk with their doctor before being vaccinated.

The ACIP recommendations aren’t on their website yet but I expect them to be posted soon. The CDC Director still needs to approve the recommendations, which I expect to happen later today.

Now that the Pfizer vaccine has EUA status and the ACIP has made their recommendation, the vaccine can now be distributed and used even though it hasn’t been fully approved by the FDA. Because of the ACIP decision, health plans will be required to pay for the administration of the vaccine (15 days after the CDC director approves the ACIP recommendation).

The federal government contracted with the companies to manufacture the vaccine during their Phase III clinical trial- agreeing to pay for the vaccine even if it had not been granted EUA or Approval. Therefore there is already a stockpile of vaccine available for distribution.

Maricopa will be receiving 47,000 doses next week and Pima 11,000. Vaccination at assisted living and skilled nursing facilities is being handled via a state contract with that effort beginning the week between Christmas and New Years. My sources tell me that rural counties will get their first vaccine the week of December 21.

A statewide stakeholder meeting met last week to prioritize the initial doses of vaccine (see the priority populations here).

Note: The New England Journal of Medicine published a study of the Safety and Efficacy of the Vaccine last Thursday. Overall, a two-dose regimen of the vaccine provided 95% protection against Covid-19 and the safety over the 2-month study period was similar to other viral vaccines. The safety profile found short-term, mild-to-moderate pain at the injection site, fatigue, and headache. The incidence of serious adverse events was low and was similar in the vaccine and placebo groups. 

The Arizona Partnership for Immunization put together this super informative PowerPoint summarizing the billing and coding for administering the COVID 19 vaccines. Topics include Medicaid and Medicare reimbursement details, AHCCCS administration fee schedules for both doses ($16.94 for the 1st dose and $28.39 for the booster), how administration fee claims will be handled for uninsured patients, which provider categories need to re-enroll as mass immunizers, ordering and billing links, and more.

A huge shout-out to Jennifer Tinney and the team at TAPI for their terrific leadership over the years and during the pandemic. We’re very lucky to have them assisting with the COVID vaccination planning in Arizona.

Safety and Efficacy of the Pfizer/BNT162b2 mRNA Covid-19 Vaccine

The New England Journal of Medicine published a study of the Safety and Efficacy of the Vaccine today. Overall, a two-dose regimen of the vaccine provided 95% protection against Covid-19 and the safety over the 2-month study period was similar to other viral vaccines.  The safety profile found short-term, mild-to-moderate pain at the injection site, fatigue, and headache. The incidence of serious adverse events was low and was similar in the vaccine and placebo groups.

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Closed Environments Facilitate Transmission of Coronavirus Disease

“The odds that a primary case transmitted COVID-19 in a closed environment was 18.7 times greater compared to an open-air environment (95% confidence interval [CI]: 6.0, 57.9).” 

“It is plausible that closed environments contribute to secondary transmission of COVID-19 and promote superspreading events. Our findings are also consistent with the declining incidence of COVID-19 cases in China, as gathering in closed environments was prohibited in the wake of the rapid spread of the disease.”

This is more evidence that the most effective interventions will focus on crowded indoor environments like bars and nightclubs, consistent with the study in last week’s policy update in Nature.

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CDC Publishes Study on COVID-19 Seroprevalence in the United States as of September 2020

Last week the CDC published a study in JAMA Internal Medicine that shows that most of the U.S. population is likely still susceptible to COVID-19. The study describes CDC’s collaboration with commercial laboratories to conduct and publish results from seroprevalence surveys to estimate the percentage of people in the United States who already have COVID-19 antibodies. Statewide seroprevalence estimates ranged from less than 1% in several sites to approximately 23% in New York state.

Arizona is currently onboarding providers who would like to administer the upcoming SARS CoV2 vaccines. Vaccinators that would like to participate in this historic vaccination effort are asked to complete these Pandemic Provider Onboarding survey forms. 

Providers can go to ADHS’ “AIPO Train” to learn how to order, receive, store, administer, document and account for pandemic vaccines.

So far, only 359 providers have been onboarded to vaccinate, and many of those are pediatric offices. Far more vaccinators will be needed to successfully deploy vaccine over the coming months.

We recorded a webinar about the SARS CoV2 vaccines in collaboration with the U of A that is now posted online on this U of A website. We cover herd immunity, Phase III trials, emergency use authorization vs. full approval, storage and handling requirements, priority populations and more.

Pfizer has completed their Phase III clinical trials and has asked the FDA to approve emergency use of their candidate vaccine. Because this is a public health emergency, the FDA can authorize emergency use of the vaccines prior to issuing full approval of the products. You can read more about how that process works in this blog post: How Are New Vaccines and Drugs Approved?

The FDA’s Vaccines and Related Biological Products Advisory Committee is meeting Thursday to review the Phase III trial data and make their recommendation to FDA Commissioner Hahn about whether to authorize emergency use if the vaccine. Here’s the Agenda for this important meeting. It starts at 7am AZ time. The voting is expected to begin at about 1pm AZ time. The meeting will be broadcast live on You Tube on this URL.

If the FDA Commissioner authorizes emergency use of the vaccine they could potentially become available for distribution within days. The county health departments have been planning for the initial roll out of the vaccine for a while now. You can read about the Maricopa County Department of Public Health’s plans in this piece in the Arizona Republic today.

The Committee meets on Thursday, December 17th on Moderna’s EUA application. Here’s the FDA’s website for that meeting.