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State could see limited doses by mid-December

The region’s hospitals are preparing for the rollout of COVID-19 vaccines that will be in short supply once they receive the approval of the U.S. Food and Drug Administration.

Pending federal approval of Pfizer’s COVID-19 vaccine, Virginia would likely receive limited doses by mid-December, state epidemiologist Dr. Lilian Peake told a House of Delegates committee Nov. 30, while Gov. Ralph Northam said the state would initially receive no more than 70,000 doses. He said this as COVID-19 cases surge around the state and across the country.

However, new information provided on Dec. 3 by the federal government’s Operation Warp Speed indicates Virginia may receive 72,150 initial doses from Pfizer in mid-December, and an estimated total of 480,000 doses of vaccine from two manufacturers by the end of December, according to late-breaking news Friday.

Pfizer officials have said the company plans to roll out 50 million doses of its vaccine worldwide before the end of 2020, which is half of what it had originally projected due to challenges in acquiring raw materials for it.

Moderna says it will have 20 million doses of its vaccine available in the United States before the end of the year.

Peake outlined to a virtual meeting of the House Health, Welfare and Institutions Committee how the state’s phased approach to vaccine distribution would work, as both Pfizer and Moderna have asked the FDA for emergency approval to begin widespread distribution of their COVID-19 vaccines. The FDA will hold a public hearing on Pfizer’s vaccine Dec. 10, and another on Moderna’s Dec. 17. Pfizer said it will be prepared to ship out its vaccine by Dec. 15, pending FDA approval. Moderna, according to news reports, could have its vaccine out, pending the same approval, by Dec. 21.

Peake said that both company’s vaccines have been found to be safe and efficacious following their Phase 3 trials. Pfizer’s two-dose vaccine was found to be 95% effective against COVID-19 beginning 28 days after the first dose. Efficacy was consistent across age, gender, race and ethnicity.

The Moderna two-dose vaccine was 94% effective.

However, Pfizer’s vaccine, which requires it to be shipped and stored at a temperature of -94 degrees Fahrenheit, would likely be the first to be given in Virginia, Peake said.

Pfizer has designed temperature-controlled thermal shippers using dry ice to maintain its vaccine’s ideal temperature for up to 10 days, and by refilling them with dry ice, can continue to be used to store its vaccine for up to 15 days.

The initial vaccines would go toward health care workers, those working or living in long-term care facilities and later in Phase 1, critical infrastructure staff. The first round of 480,000 doses that was announced late Friday would be enough to begin the process for nearly all of the state’s health care workers and long-term care residents.

More than three million people — primarily the medically vulnerable and other priority populations, such as teachers and grocery store employees — would be targeted in Phase 2, and the general public — an additional 4.9 million people — would be targeted in Phase 3.

Guidance from the federal Centers for Disease Control and Prevention calls for health care personnel — paid and unpaid — who have the potential for any kind of exposure to patients or infectious material, as well as non-healthcare essential workers, high-risk adults and those older than 65, whether or not they are in long-term care facilities, to be prioritized for a COVID-19 vaccine.

“We have a number of weapons in our arsenal to fight COVID-19, and we are now, I’m happy to say, on the verge of adding another one — vaccines,” Peake said.

She said the state health department will recommend that everyone get the vaccine, but it will not recommend that they be mandatory.

Cindy Williams, vice president and chief pharmacy officer of Riverside Health System, said it anticipated the possibility of the cold storage needs for Pfizer’s vaccine earlier this year and bought cold storage units in late August for four of its five hospitals, including at Riverside Regional Medical Center in Newport News. They arrived in late September and early October and will help Riverside serve the regions where it has hospitals.

“We’ve had those up and running, and monitoring the temperatures,” Williams said, “and making sure that everyone understands the functioning of those and handling products with special gloves and whatnot, because we are talking ultra-cold temperatures.”

Williams, who also serves on the Virginia Department of Health vaccine advisory committee,  the Virginia Hospital and Healthcare Association’s COVID-19 vaccine group, and on Riverside’s COVID-19 vaccine coordination committee as a co-chair, said an initial survey of Riverside staff in late September and early October showed that roughly 65% to 70% would get the vaccine or would likely get it pending further information.

She noted that the initial survey was before much was known about the efficacy of the vaccines. The questions from Riverside’s staff centered largely on how effective the vaccines would be and whether the FDA had determined them to be safe. Now that two are pending FDA approval, Williams said the hospital sent out another survey Dec. 3 to get updated feedback.

“We really wanted to understand what information the team members needed in order to feel comfortable in making the decision to get vaccinated,” Williams said, “because I think, quite honestly, the team members that we have, that’s a subpopulation of the community at large, because not every one of our team members is a clinical team member.

“And so that not only helped us with the communication strategy that we have for our team members, but also the communication strategy that we’ll have for our patients in the community.”

It will not be mandatory for Riverside employees to receive the vaccine, and its staff who do receive it will not all get it at the same time.

“Through those two state groups, there’s been some further communication on how they see that we would prioritize health care workers into, essentially, very high risk, high risk, moderate risk, low risk, et cetera,” Williams said.

Riverside had already started on prioritizing based on their employees’ job codes and practice location, Williams said, then looking at “are they direct patient care facing, where they routinely are exposed to either patients that are COVID positive or could be COVID positive, because with the number of asymptomatic patients in the community, we really assume, unless proven otherwise that everybody potentially could be COVID positive.”

She said Riverside does not know how much vaccine it will get, but it is based on its size and the number of employees.

Sentara Healthcare states on its website that it expects to receive a limited supply of COVID-19 vaccines once they receive the FDA’s emergency use authorization and would be made available first to high-risk health care employees. Those with the highest risk of COVID-19 exposure — those in COVID inpatient units and emergency personnel — would be given priority. Like at Riverside, no one at Sentara will be required to receive the vaccine.

“We are preparing for COVID-19 vaccine distribution at Sentara,” said Kelly Kennedy, a spokeswoman for Sentara Healthcare, in an email.

Kennedy said Sentara has an ultra-cold storage freezer at Sentara Norfolk General Hospital, and another at one of its hospitals in the Blue Ridge Mountains.

“We have identified employees with the greatest risk of COVID-19 exposure, and they will be offered the vaccine first once it is available to us,” Kennedy said.

In an emailed statement from Bon Secours, it said that it “began planning early for sourcing and distributing COVID-19 vaccines that are approved for use by the U.S. Food and Drug Administration. We have plans in place to support our needs, and we are committed to the appropriate and responsible use of the vaccine in accordance with guidelines from local, state and federal agencies.”

Bon Secours said it is working in collaboration with other health care organizations, along with local, state and federal governments, and it will continue following COVID-19 precautions even after vaccine distribution, such as masking, social distancing and hand washing.

Because both the Pfizer and Moderna vaccines require two doses — Pfizer’s needs to be given 21 days apart and Moderna’s 28 days apart — Peake said locations getting the first dose of the vaccine would also get the second dose.

Williams noted the challenge that the time lapse between the two doses poses, and in particular, how effective the Pfizer and Moderna vaccines will be if people only get one of the two doses.

“I don’t think we’ll know until we get into it what type of abandonment rate are we going to have with that second vaccine,” Williams said.

She said the state health department’s vaccine committee has been looking at how to make sure people receive both doses. For those who get vaccinated at a Riverside location, it will use its electronic health record to help track for people when they need to get their vaccine doses  so it can send text messages or emails to remind people when they need to get another one. Everyone getting vaccinated will also receive a Centers For Disease Control and Prevention immunization card that will record when people have received a dose of the vaccine and when they would need to get the second one.

“I think any vaccine that has a two-series requirement is just generally complicated,” Williams said.

While those in Phase 1 of the vaccine rollout are likely to be “captive” audiences, Williams said, the health system is thinking about how it engages the broader community — people who may be skeptical about vaccines, do not fully trust the process, do not have health insurance or a primary care provider, or do not speak English.

“There’s been a lot of focus on how do we engage the community as a whole, and especially, potentially, those more difficult to reach community members,” Williams said, “and then, what does the message need to look like?”

Riverside is looking at partnerships with community organizations, along with ethnic and faith-based communities to better get the public’s buy-in on getting the vaccine, as well as working with local health departments.
Peake noted that in the first phase, pharmacy chains CVS and Walgreens would receive the vaccines directly, and they would take teams of people to residents and employees at long-term care facilities in the state. She said every long-term care facility in the state could opt into this if they choose.

“They are specifically working with the federal government to be able to provide vaccinations in long-term care facilities,” Peake said.

The VHHA is providing a protocol of health systems that has been approved by the state’s COVID-19 Unified Command. Peake said there are 16 different hospitals where the first Pfizer vaccine doses could be pre-positioned in the early distribution phase, covering about 95% of the state’s health care workers who are the top priority to receive a vaccination. The first seven health systems where the vaccine will go will reach about 70% of the state’s hospitals in all six of its health regions.

Two groups that will not be prioritized for any COVID-19 vaccine early on are children and pregnant women. Peake said that is because studies on the vaccine’s effectiveness in those groups have yet to be studied.

“The vaccines that are coming out now are going to be approved for adults,” Peake said, “and have not yet been studied in children. Those studies still have to be done before the vaccine would be recommended for children.”

Virginia Attorney General Mark Herring on Dec. 4 called on Congress to fund and guarantee that everyone can get a free COVID-19 vaccine.

Though Peake said the vaccines will indeed be free for everyone, as well as to those providing them, the providers will be able to charge an administrative fee to third-party payers, but if someone doesn’t have insurance or is unable to pay, the cost cannot be passed onto the individual, Peake said.

Northam, along with state and regional health officials, caution that while the COVID-19 vaccines are hopeful and provide the proverbial light at the end of the tunnel for the coronavirus pandemic, it doesn’t absolve people from continuing to wear their masks, socially distance and wash hands.

Williams said that, realistically, it will be sometime next summer before there is herd immunity from COVID-19.

“In terms of length of time, it’s really not that far away,” Williams said, “but it may seem like an eternity for those that are just tired of wearing a mask and social distancing and everything else.”