Friday, April 23, 2021

Pima County Pursues "Plan B" after state blocks federal offer of vaccine doses

Posted By on Fri, Apr 23, 2021 at 5:32 PM

click to enlarge Pima County Pursues "Plan B" after state blocks federal offer of vaccine doses
Pima County Health Department
"Given that the state and FEMA could not come to an agreement on the contractual language to allow us to pull in a large federal POD, what we have done is we have pivoted to our Plan B,” Pima County Chief Medical Officer Dr. Francisco Garcia said at a press conference Friday, Jan. 22.

The Pima County Health Department has pivoted in the direction of “Plan B” after plans for a federal POD died before implementation.

At the Tuesday Board of Supervisors meeting, County Administrator Chuck Huckelberry announced the Arizona Department of Emergency Management Division had informed them that the State Department of Health and the Federal Emergency Management Agency could not agree on the terms for the federal POD in Pima County.

“Team, after much consideration, and our best efforts, we were unable to find a fair and workable solution related to the FEMA-State agreement," Director of Emergency Management Allen Clark wrote in an email that Huckelberry shared with the board. "Therefore, DEMA, on behalf of the state will not sign the agreement.”

The original FEMA offer, made in March, would have brought enough vaccine to Pima County outside of the state's normal allocation for a six-week clinic that could have vaccinated an estimated 210,000 residents in low-income and minority neighborhoods, as those groups have lagged behind affluent white people in vaccination rates.

The federal POD, which required state approval, was originally denied by Governor Doug Ducey in March. On March 26, Dr. Cara Christ announced they would allow the county to move forward, so long as the site is independent of the state.

The agreement proposed by the state and released by the county on April 13 made clear the state would not be responsible or provide any assistance or resources for the federal POD. They also requested the county use its own registration system different from the state’s system. In the April 13 memo, Huckelberry said some of the terms and conditions appeared “particularly draconian.”

From March until now the vaccination effort has slowed, with the county and the state working on vaccinating individuals who may not have ready access to a vaccine or are vaccine hesitant, as well as dealing with the pause of the Johnson & Johnson vaccine.

Pima County Medical Director Dr. Francisco Garcia said there is much more vaccine available now than there was when state officials were rejecting the deal, so it amounted to a lost opportunity, but the county had other ways to partner with FEMA.

“At the time that we made our ask and if in the timeframe that we would have gotten that resource it would have been terrific," Garcia said. "But given that the state and FEMA could not come to an agreement on the contractual language to allow us to pull in a large federal POD, what we have done is we have pivoted to our Plan B.”

The “Plan B” asks for six mobile sites with funding from FEMA, according to Huckelberry’s April 20 memo. Garcia clarified the plan does not include additional vaccine allocation, but there are a lot more vaccine doses available. "Fortunately, today we have the vaccine in our hands,” Garcia said.

While Garcia believes the county is “dangerously close” to receiving those assets, it has not been finalized.

County Doubles Down on Vaccination Effort and Supports Mask Mandates

As the county continues its mobile vaccination effort to deliver shots to those vulnerable or minority communities, Garcia said the county is planning efforts to address vaccine hesitancy, especially after the pause of J&J.

“We cannot underestimate the impact that the J&J and the federal action to take J&J temporarily off the table has had on vaccine demand,” said Garcia. “Remember that J&J was actually, probably, the most commonly requested, that was actually kind of the only brand that was being requested when we were doing our vaccination pods.”

With the pause, the mobile site began offering Moderna, as the Pfizer vaccine continues to face issues in mobile site implementation.

With both Pfizer and Moderna, Garcia said the challenge was the second dose, and committing the mobile clinic to return to the same location. He said the strategy continues to evolve, but they are making sure that when people vaccinated at a mobile site, “they understand that they need a second shot, and that they understand where to go for that second shot, because in some cases we will not be able to be back in exactly that same neighborhood exactly four weeks down the road in order to vaccinate.”

The county has not administered Pfizer at a mobile clinic because it requires ultra cold chain handling and it comes in multi-use vials with several doses. Garcia said Pfizer would pose the issue of “vaccine wastage.”

“You can imagine that as demand slackens, what happens when you've popped open a vial of Pfizer with 14 doses, but you only have 10 people?” asked Garcia. “We are still feeling that need to be as careful with that resource, but by the same token, not missing the opportunity to pivot. If somebody shows up not missing that opportunity to vaccinate that individual.”

He notes that not only was the Johnson & Johnson vaccine no longer available, but other people getting vaccinated with Pfizer or Moderna were questioning the safety of the vaccines. He said they are working four times as hard for every vaccine delivered.

“We know that a lot of people are not actually truly resistant, but are just hesitant. They're waiting to see how the dust settles,” said Garcia. “We're hoping to make vaccine opportunities so ubiquitous throughout our community, whether it's on Fourth Avenue, whether it's in some of these parts, whether it's at a fixed site. We're trying to make it so damn ubiquitous, that essentially you fall into a vaccination needle without much effort. If we can decrease those barriers for those folks for whom these are obstacles. I believe that we will continue to make progress.”

Following Ducey’s Executive Order rescinding mask mandates for K-12 schools and signing a bill that allows businesses to ignore local jurisdiction mask mandates, the health department updated its Public Health Advisory on Friday.

It made clear for schools that the Board of Supervisors Resolution 2020-96 is still in effect, which requires people over the age of 5 wear masks. They also state businesses should follow “state, county, and industry-specific guidance related to COVID-19 mitigation.”

“We believe that our mask mandate is legal and valid until 90 days after this legislature adjourns and because we have this short window of time to get people vaccinated, we're going to double down and do everything that we can in order to encourage people, cajole, incentivize people to be observant of that mask mandate,” said Garcia. “It really has an impact on the infection in this community.”

The health department surpassed its goal of 300,000 vaccines administered by March 31, with 621,000 vaccines administered as of April 21.

“We’re not done yet folks,” said Garcia, pointing out the plateau of COVID-19 cases daily since March 14, where the state has seen around 600 cases of COVID-19 daily.

ACIP Recommends J&J in the U.S.

The CDC Advisory Committee on Immunization Practices (ACIP) voted 10-4, with one member abstaining, to recommend the use of the Johnson & Johnson vaccine in the U.S.

Members moved to vote on two different interim recommendations. The first only stated the recommendation of the J&J vaccine for persons 18 and older in the U.S. under FDA’s Emergency Use Authorization, while the second added a note that women under the age of 50 should be aware of the “increased risk of Thrombosis with Thrombocytopenia Syndrome (TTS) and may choose another COVID-19 vaccine authorized for use in the U.S.”

The administration paused the vaccine last week after reports of six women developing a rare blood clot disorder after receiving the J&J vaccine.

The disorder combines blood clotting (Thrombosis), often in the brain with a low level of platelets, the blood cells that promote clotting, which is called (Thrombocytopenia Syndrome).

At the meeting, a CDC scientist confirmed 9 new confirmed cases of the rare disorder, all women, bringing the total to 15, with 13 cases in women between 18 and 49 years old.

If the use of Janssen vaccine resumed for those 18 and older, 26 to 45 cases of blood clotting disorder could be expected over the next six months, according to a model presented by CDC Scientist Dr. Sara Oliver. However, we could also expect about 800 to 3,500 fewer ICU admissions and 600 to 1,400 fewer deaths.

The majority voted for the first recommendation, but those in favor agreed with the four that voted no.

“I voted yes. I can live with this recommendation, but I think that under an emergency use authorization, where there is no inside informed consent, that it could be that ACIP recommendations might need to reflect some more nuanced concerns than under the usual procedure,” said Dr. Beth Bell, ACIP voting member and COVID-19 workgroup chair. “I am concerned that the consumers and women in this age group in particular, will not be adequately informed just by the FDA EUA vaccines and so we really are depending on the public health agencies and the partner organizations to make sure that people actually are informed and are empowered, and that they actually get a balanced perspective.”