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October 10, 2020

Unprecedented vaccination effort prepared for Virginia

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Virginia’s plans call for health experts to consider infection control measures at immunization sites, raising the possibility of drive-through clinics or events at large indoor venues that leave room for social distancing.
In the event that Virginia’s allocation during Phase 1 is insufficient to vaccinate all those included in the initial populations of focus, it is important for the Virginia Unified Command to identify and estimate the subset groups within these initial populations of focus to determine who will receive the first available doses of COVID-19 vaccine.
— Virginia vaccination plan
By Kate Masters
Virginia Mercury

Three million dollars for public outreach. Nearly $2.5 million for refrigerators and thermometers. And more than $71 million for mass vaccination clinics, where hundreds of thousands of Virginians could be immunized against COVID-19.

Virginia’s plan, released Friday to the Virginia Mercury, shows the size and scale of a public health campaign designed to protect millions against a historic virus. The plan was submitted to the federal Centers for Disease Control and Prevention for review this week and remains “a living document as more information is understood, more vaccines are introduced, and any other considerations develop,” wrote Joseph Hilbert, the Virginia Department of Health’s deputy commissioner for governmental and regulatory affairs, in a Friday email.

> Document at bottom of story

But the plan also underscores many of the factors that health workers will contend with when it comes to distributing any future vaccine. While VDH is preparing for a potential Nov. 1 release — a date requested by the Trump administration after the president suggested a vaccine could be ready as early as this month — there’s “no absolute guarantee” of when any safe and effective immunization will be approved by the U.S. Food and Drug Administration, said Christy Gray, the director of the department’s division of immunization.

Federal health officials have called a release before Election Day “very unlikely.”

What’s clear is that vaccination will be incremental and unprecedented compared to any previous disease outbreaks within the last decade. Virginia developed pandemic influenza planning more than a decade ago during the H1N1 swine flu outbreak — plans that have informed some of the state’s current coronavirus procedures.

But those mass vaccination efforts were still significantly different than what’s required for the COVID-19 pandemic — a potentially deadly virus that places certain types of people, including the elderly and infirm and those with other health conditions, most at risk.

Virginia’s plans call for health experts to consider infection control measures at immunization sites, raising the possibility of drive-through clinics or events at large indoor venues that leave room for social distancing.

There are also significant outstanding questions about the vaccine itself, including how many doses will initially be available. While the federal government will determine how much of the vaccine is distributed to Virginia, according to the state’s planning document, health officials are planning a phased approach under the assumption that only limited amounts will be available when it’s first released.

The initial planning scenario tasks state officials with developing priority groups for the first distribution. Under the state’s plan, those include residents at long-term care facilities — which in Virginia account for nearly 50 percent of the state’s total COVID-19 deaths, according to VDH data — as well as health care workers and “people who play a key role in keeping essential functions of society running and cannot socially distance in the workplace.”

Those positions have yet to be determined, but could include first responders, teachers and childcare providers, according to the state’s planning document. Priority consideration will also be given to other high-risk groups, including Virginians aged 65 or older, people of color — who have also been disproportionately affected by the virus — and people living in congregate living facilities such as prisons, homeless shelters, or even college campuses.

“In the event that Virginia’s allocation during Phase 1 is insufficient to vaccinate all those included in the initial populations of focus, it is important for the Virginia Unified Command to identify and estimate the subset groups within these initial populations of focus to determine who will receive the first available doses of COVID-19 vaccine,” the plan reads.

More than 20 different divisions and agencies have a role in the 60-page document, including the Virginia Department of Education and the State Council of Higher Education for Virginia, which are expected to coordinate with local health departments on immunizing students and employees at K-12 schools and college campuses.

The plan calls for nearly $121 million in total spending for vaccination efforts, including more than $3.3 million for supplemental supplies such as Band-Aids, syringes and needles. The state anticipates paying nearly $40 million for a pharmacy benefits administrator to manage claims for un- and underinsured patients and distribute payments to pharmacies and other community providers for administering vaccines.

The vaccine itself will be supplied to the state free of charge, but the CDC says that administrative costs will likely be shouldered by state and local governments. Providers must vaccinate patients regardless of their insurance status or ability to pay.

VDH will distribute money to local health departments to assist with mass vaccination, according to the plan. But it’s still not entirely clear how the state will fund the effort. Virginia Finance Secretary Aubrey Layne recently said that roughly $700 million in remaining federal CARES Act money could go toward the state’s immunization campaign.

Ms. Gray said another complication could be the dosages for any future immunization. Many of the vaccines currently under trial will require two doses, “separated by 21 or 28 days,” according to the plan.

“Those vaccines are not interchangeable with each other, so that’s another consideration that wasn’t necessarily the case during any previous disease outbreaks,” she added. In other words, if patients receive an initial dose of a vaccine from a certain pharmaceutical company, their doctor, pharmacist or local health department will need to follow up with them to make sure they receive a second dose of the same vaccine within a certain timeframe.

It’s an effort that requires massive coordination and also the involvement of doctors across Virginia. The state’s planning document encourages patients to be immunized at their “medical home” whenever possible, and describes the early recruitment of doctors as one of the most important early factors in mass vaccination.
Earlier this month, Virginia Health Commissioner Norman Oliver sent a letter to providers asking them to register with the state if they planned on distributing a COVID-19 vaccine.

Dr. Sandy Chung, a Northern Virginia-based pediatrician and president of the Virginia chapter of the American Academy of Pediatrics, said most primary care physicians already have experience in giving out vaccinations to large number of patients, but the state is likely hoping to recruit nontraditional providers such as school systems or large employers.

“I think that’s what they’re trying to assess — which health care providers are able to do this or willing to do this,” Dr. Chung added. “They need to know who’s ready.”

DRAFT Virginia COVID 19 Vac... by Fauquier Now

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badelectronics · October 12, 2020 at 8:56 am
@Linda, he said in hearings that he did not -- not that he is below lying his ass off.
eli3489 · October 11, 2020 at 5:14 pm

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Linda Ward · October 11, 2020 at 1:17 pm
Doesn't the head of the USPS, DeJoy, have stock invested in the UPS?
Linda Ward · October 11, 2020 at 1:16 pm
"Pharma logistics providers have long experience in cold chain management—generally, keeping pharmaceuticals at 2-8°C during storage and shipment. The push in recent years for cellular and genetic therapies, which can involve live cells, has created a growing need for so-called deep-frozen storage: -80°C or even -180°C (requiring liquid nitrogen). Now, it appears that at least some of the coming capacity surge for Covid-19 vaccines will require deep-frozen as well.

According to a recent Bloomberg News story, UPS is building “freezer farms” in Venlo, Netherlands and Louisville, KY (both near UPS air hubs) featuring banks of -80°C freezers (see photo). The farms will contain a total of 600 freezers that can each hold 48,000 vials of vaccine, according to Bloomberg News. Additional freezer capacity will be installed in South America, Germany and the UK.

“Moving parcels with dry ice and critical drug product is not a new thing for UPS. Transportation is our bread and butter,” Wes Wheeler, president of UPS Healthcare and Life Sciences, told Bloomberg. “Storing at -80, blast freezing at -80, making sure that time and transit is reduced to a minimal amount, all that is pretty new to us.”

While there is no mention of what vaccine UPS is preparing for, the -80°C specification would presumably not be suitable for various vaccines based on deactivated viruses, which typically require refrigeration but not freezing. The mRNA vaccines being developed by Moderna, Pfizer and others, however, likely do require freezing to keep the mRNA proteins viable prior to administration. (On the other hand, a freezer that can reach -80°C can also hold a warmer, but still refrigerated, temperature.)

In a related announcement, DHL Global Forwarding, the air and ocean arm of DHL, has just opened a 20,000-sq.ft. facility in Indianapolis, dedicated to life sciences and healthcare logistics. The facility has temperature-controlled storage at 15-25, 2-8 and -20° temperatures, and is within a Free Trade Zone, allowing for international cross-shipping. The facility “expands our global network for the LSH sector [which is] especially important now during these challenging times, when temperature controlled logistics is crucial in helping customers navigate the pandemic,” said David Goldberg, DHL Global Forwarding, US."
Linda Ward · October 11, 2020 at 1:09 pm
What about the refrigeration required for this vaccine to be stored?

"Just like a fresh piece of fish, vaccines are highly perishable products and must be kept at very cold, specific temperatures. The majority of COVID-19 vaccines under development – like the Moderna and Pfizer vaccines – are new RNA-based vaccines. If they get too warm or too cold they spoil. And, just like fish, a spoiled vaccine must be thrown away.

So how do companies and public health agencies get vaccines to the people who need them?

The answer is something called the vaccine cold chain – a supply chain that can keep vaccines in tightly controlled temperatures from the moment they are made to the moment that they are administered to a person.

Ultimately, hundreds of millions of people in the U.S. and billions globally are going to need a coronavirus vaccine – and potentially two doses of it. This mass vaccination effort is going to require a complex vaccine cold chain on a scale like never before. The current vaccine cold chain is not up to the task, and expanding the supply chain is not going to be easy.

Cold Chain Problems Mean Wasted Vaccines
Most vaccines need to be stored within 1 degree Fahrenheit of their ideal temperature. Traditional vaccines are usually stored between 35 degrees Fahrenheit and 46 degrees Fahrenheit, but some of the leading COVID-19 vaccines need to be stored at much colder temperatures. Moderna’s vaccine requires a storage temperature of minus 4 degrees Fahrenheit, whereas Pfizer’s vaccine candidate requires a storage temperature of minus 94 degrees Fahrenheit. These are not easy temperatures to maintain accurately.

A study from 2019 estimated that 25% of vaccines are degraded by the time they arrive at their destination. If a vaccine is exposed to temperatures outside its range, and this gets noticed, then the vaccines are always thrown away. Rarely, a temperature mistake is missed and one of these vaccines is administered. Research shows that these vaccines won’t cause any adverse effects, but could offer decreased protection and might require a patient to be revaccinated.

Temperature mistakes are mostly due to inappropriate shipping procedures in the cold chain, and these losses are estimated at US$34.1 billion annually. But that number does not even take into account the cost – physically as well as financially – of any illnesses that could have been prevented by timely deliveries of high-quality vaccines."
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