Federal and state health officials are beginning to plan for the possibility of a coronavirus vaccine ready for use this fall.
The Centers for Disease Control asked state health officials to prepare for limited vaccine distribution this fall.
In Olympia, Secretary of Health Dr. John Wiesman warned that early distribution of vaccines, should they become available this year, would be limited in scale, however, and based on numerous factors that haven’t been nailed down yet.
The CDC has instructed states to establish committees and ensure there are statewide infrastructures in place to roll out vaccine distribution, potentially as early as November.
“Limited COVID-19 vaccine doses may be available by early November 2020, but COVID-19 vaccine supply will increase substantially in 2021,” the CDC planning documents obtained and published by the New York Times say.
This week, Dr. Anthony Fauci, the country’s top infectious disease expert, told Kaiser Health News that a vaccine could become available sooner if trials produce “overwhelmingly positive” results, indicating that an independent board of scientists could conclude that the trials can end early. Two of the clinical vaccine trials in the U.S. have yet to even enroll the 30,000 participants needed in each study, however, according to Kaiser Health News.
Wiesman said Wednesday that the Washington Department of Health firmly believes that the Phase 3 clinical trials must be completed, safety and efficacy studies finished, and that an independent panel must confirm the trial findings before a vaccine is distributed. The only exception would be if an independent board of scientists, as Fauci indicated, gave it a stamp of approval early.
“We stand here as a state department of health prepared to stick by what we believe as being important issues and assuring safety and effectiveness of these vaccines,” Wiesman said.
Some health experts have raised concerns that the Trump administration is pushing for a vaccine to be ready ahead of the November election, and Wiesman acknowledged the uncertainty surrounding the rush for a vaccine that works.
“We sort of understand that trust is low for some people, and we want to make sure that the federal government takes all the steps. We need to make sure that any release of this vaccine is not driven by politics,” Wiesman said.
Wiesman again reiterated that the typical vaccine protocols, from completing the trials to independent review and confirmation of their findings, must precede authorizing a vaccine.
“Our concern is that politics might get wrapped into this,” Wiesman said. “We’ve seen this with this administration before, which is why we’re speaking out about it today and being clear about what our expectation is.”
Last week the CDC changed its testing guidance to say that not all close contacts with a confirmed COVID-19 case necessarily have to be tested. The Washington Department of Health quickly countered that guidance, asking Washington health care agencies and providers to continue to test any close contacts of confirmed cases, regardless of whether they are displaying symptoms or not.
Washington state was not alone.
The Association of State and Territorial Health Officials released a statement expressing concerns about the decisions being made at a federal level before or without consulting state and territorial health officials, including the altered testing guidance.
“The failure to provide notice and pre-decisional consultation has a significant impact on our work to protect the health of the American public and in fostering an atmosphere of transparency, trust, and confidence between public health officials and the communities they are working so hard to serve during this historic public health crisis,” a statement from Rachel Levine, president of the association, says.
If a vaccine is approved by an independent board and granted authorization from the Food and Drug Administration, there would likely be tens of millions of doses for the entire country, Wiesman said. This means a limited amount of vaccine would come to Washington state by the end of the year.
The idea would be to distribute vaccines to those at the highest risk for infection or severe disease, such as health care workers and older people. Wiesman noted that guidance for who will get the vaccines first is still under development, Wiesman said.
“It will likely be folks at highest risk for COVID: health care workers, first responders and folks at high risk for severe complications and outcomes including death, or folks who are older,” Wiesman said.
Washington has an electronic system to track childhood immunizations and other immunizations administered in the state, and health department workers are working to ensure the system could handle tracking COVID-19 vaccinations.
The CDC documents indicate that vaccine candidates currently consist of two doses, which would be at least 20 days apart, and health care providers would have to track which vaccine each person receives the first time in order to ensure they get the right candidate for their second dose.
“Because we’re looking at multiple vaccines and most of them require two doses, it will be important that we will be able to track which vaccine people got, and it will be important for them to get the same second dose,” Wiesman said.
Despite all the state coordination and planning that needs to be done in the next few months, the federal government will largely control the vaccine distribution and roll out process.
The CDC will provide vaccines to specific providers, which are enrolled and designated as COVID-19 vaccination providers by the state health department.
“We are working with our health care providers from clinics to hospitals to pharmacies to long-term care facilities to be ready to be able to administer vaccines and looking at whether or not we need to stand up any kind of mass vaccination clinics,” Wiesman said.
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