COVID-19 vaccines could be available to Wisconsin healthcare professionals by the end of the year if approved by the FDA. However, experts say that distributing and disseminating the vaccines will be extremely complicated and expensive.
Pfizer LLC announced that its vaccine candidate was “found to be more than 90% effective in preventing COVID-19.” The study evaluated 94 confirmed bases of COVID-19 in trial recipients.
In a similar announcement, company officials from Moderna Inc. said they had met the U.S. NIH-appointed Data Safety Monitoring Board criteria for its efficacy study. The independent board found that their vaccine candidate proved to be 94.5% effective.
Both companies plan to apply for emergency use authorization from the FDA. This triggered State health officials to start working on a distribution plan. This will be a massive undertaking, said Julie Willems Van Dijk, deputy secretary of the Wisconsin Department of Health Services.
“To be candid, this COVID-19 vaccination planning and dissemination are even more complicated than we had ever imagined,” said Willems Van Dijk. “It will be the most extraordinary public health intervention that our state has ever undertaken. It poses significant challenges, such as the need for ultracold storage and multiple vaccines from multiple manufacturers on different schedules.
“However, this is what public health care is up for. And we are building on what we know works.”
The announcement comes at a time when COVID-19 cases and hospitalization rates continue to surge in Wisconsin.
The cost of vaccines
Distributing the vaccines will also be a heavy lift financially.
Robert Redfield, director for the Center for Disease Control, estimated that distributing vaccines nationally would cost $6 billion. Still, the National Association of City and County Health Officers says the price tag is $8.4 billion.
“The Association of Immunization Managers, which represents the 64 state, local, and territorial immunization programs, has said that additional funds are needed for shoring up the healthcare workforce, opening new vaccine administration sites, adapting information systems, purchasing personal protective equipment, and combating disinformation and vaccine hesitancy, among other areas,” according to Kaiser Health News.
Congress has distributed $200 million to the states through the CARES Act. Of that, Wisconsin has received $3.1 million.
“We agree that the State of Wisconsin will need more than $3.1 million to get millions of doses of this vaccine into the arms of everyone in the state who needs it,” Willems Van Dijk said.
Who will get the COVID-19 vaccines first?
Distribution of the vaccine won’t be widely available at first.
Once the vaccine manufacturers receive FDA approval, DHS plans to use a three-phased approach to distribute the vaccine, said Stephanie Schauer, Ph.D., Division of Public Health Immunization Program Manager for DHS.
At first, healthcare workers, support staff, and long-term care staff will receive the vaccination. Essential workers and people at high-risk for getting sick from COVID-19 will qualify to receive the vaccine. Then, the general population will have access to the COVID-19 vaccines.
But even if the state doesn’t reach 80% participation in the vaccination program, the level that would provide herd immunity is unknown, Schauer said.
“I think we’re still learning about what that magic number is,” she said. “I don’t think that we have that yet. We know that we want a fair number of people immunized, and more is better than less.”
Still, even while waiting for people to get the vaccine, residents need to continue the mitigation effort to slow the spread of the disease.
The vaccine also requires two doses, which means immunity isn’t conferred until the person receives that second dose.
“We all need to continue to wear our masks, keep socially distanced, keep our gatherings small, wash our hands and definitely stay home if you’re sick and get tested. So it’ll be important for us to remember that we’ll be doing both sets of activities at the same time,” said Willems Van Dijk.
State Republicans to roll out initiatives
In support of helping to reduce the spread of COVID-19, state Republicans also plan to roll out several key policy initiatives. House Speaker Robin Vos (R-Rochester) said he and his Assembly Republican colleagues plan to put a package of ideas together.
This includes building a robust testing system, doubling the number of contact tracers, ensuring efficient distribution of a COVID vaccine, helping the health care industry, requiring reform for the unemployment insurance program and helping small businesses.
“We have to get on the same team; the virus is the enemy, not each other. Wisconsin needs some bipartisan answers,” said Speaker Vos. “These proposals are from our constituents, stakeholder groups and lawmakers. We look forward to discussing these legislative initiatives with our Senate colleagues and the governor.”
The focus will be on putting together a bipartisan package to better use the CARES Act funding.
“We must dramatically increase our testing with more community and rapid testing,” he said. “We’d also like to make at-home testing possible so we can find the virus faster. We want to ensure that if you think you may have the virus, you can get a test and the results quickly.”
Addressing safety concerns
One major barrier to fulfilling the goal of having 80% of Wisconsin residents vaccinated is whether people feel the vaccines are safe enough.
Pfizer and Moderna developed the vaccines under Operation Warp Speed, a federal program involving the Department of Health and Human Services (HHS). The Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA), and the Department of Defense (DoD) also were included in the program.
But the independent, NIH-appointed Data Safety Monitoring Board (DSMB) is charged with reviewing the data from the COVID-19 vaccines study.
“We know certainly that one concern many people have is: Will this vaccine be safe? I think sometimes when something is developed quickly, people wonder about how much attention was paid to safety,” said Willems Van Dijk. “One of the things that I think is very important for people to understand is that after the DSMB receives the application, their scientists will look at all of the data, themselves.
“They will not count on the analyses from the pharmaceutical companies, they will ask for all of the raw data, and they will do analyses based on safety and side effects that vaccine participants may have experienced, as well as the efficacy of that of the vaccines that have been described so it will be an independent review by scientists who are charged with this, as their public service.”
The role of Operation Warp Speed
Dr. Michael O. Frank, Chief of the Division of Infectious Disease at the Medical College of Wisconsin, said he’s not concerned about the quick turnaround. The federal government, under the auspices of Operation Warp Speed, took the financial risk out of the manufacturing process. But companies were still able to focus on testing.
“The whole point of that (Operation Warp Speed) was they paid companies to make these vaccines not even knowing if they’d work,” Frank said. “So the company wouldn’t be afraid to spend millions of dollars on a vaccine that didn’t work.
“It didn’t make the scientists work faster or harder…So, if it turns out that the FDA approves it. And most of us expect that it will, then the company will have already been manufacturing millions or 10s of millions of doses to be distributed to the public once it gets approved.”