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As the U.S. Food and Drug Administration weighs whether to issue an emergency use authorization for a coronavirus vaccine, Defense Department officials say the inoculations will remain voluntary once the FDA gives the OK.
Preparations are underway across the Departments of Defense and Veterans Affairs to receive doses of a COVID-19 vaccine once the FDA issues an emergency authorization for use, possibly as early as mid-December.
But as the two departments sort out the details on who should receive the vaccine and where, DoD officials stressed it will not be mandatory for U.S. service members, at least for a while.
According to officials, the vaccine will remain voluntary as long as it is authorized under emergency conditions and doesn’t have official approval from the FDA.
In a town hall forum earlier this month, Air Force Col. Jessica Spitler, 30th Medical Group commander, said everyone who requests the vaccine will be required to give informed consent to receive it — meaning they must speak with their doctor specifically about the immunization and agree to get it.
It will remain voluntary as long as it is not officially approved by the FDA — a process that could take 18 months to two years, she added.
“We don’t know the details of the legal considerations but we are expecting to get that soon,” Spitler said during a Vandenberg Air Force Base town hall meeting Nov. 6.
DoD officials confirmed the decision to Military.com on Friday.
“It is expected that these vaccines will be voluntary until achieving full FDA approval,” said Lou Burton, chief of media operations for the Air Force Surgeon General.
Pfizer and BioNTech filed an emergency use authorization request for its vaccine candidate, paving the way to possibly receive approval on Dec. 10, when the FDA’s Vaccine and Related Biological Products Advisory Committee meets to review the request.
VA and DoD are preparing to receive doses of the vaccine as allocated by the Centers for Disease Control and Prevention.
During the Vandenberg town hall, Col. Anthony Mastalir, 30th Space Wing commander, said the base is slated to receive up to 10,000 doses of the Pfizer vaccine once it receives emergency use authorization.
A VA nurse in the Philadelphia area, who asked that her name not be used because she was not authorized to speak with the press, also said she was told her facility would receive the Pfizer vaccine when it becomes available for staff members and high-risk patients.
VA Press Secretary Christina Noel said Friday that no VA facilities currently have the vaccine, but the department is working “diligently, both internally and externally with its CDC partners, to develop a comprehensive plan” to ensure that it is available across the system, first to high-risk veterans and staff.
According to Noel, decisions on who will receive the vaccine first will rest on their risk of acquiring an infection, developing a severe case or dying from the illness, transmitting it or the risk of harm to society if they don’t receive it, like essential workers who may not be able to function if they get COVID-19.
According to the CDC’s COVID-19 Vaccination Program Interim Playbook for Jurisdiction Operations published Oct. 29, the CDC plans to allocate vaccines as available to DoD for active-duty personnel and their dependents, the Coast Guard, but not their dependents, and all military retirees, but not their dependents.
DoD civilian employees and contractors also will be given priority for DoD’s allocation. Still to be determined, however, is whether CDC will allocate doses to DoD to cover Reserve and National Guard members, and how TRICARE plans to cover military and retiree family members.
“The details for the administration of each vaccine will depend on the language contained in the [emergency use authorization] or [investigational new drug expanded access protocol,” Burton said. “Vaccine quantities are expected to be limited initially and distributed on a rolling delivery basis as more vaccines become available.”
At VA, the number of doses CDC will allocate will be based on the number of VA staff, including volunteers and trainees, as well as veterans who regularly receive care at a VA health facility.
Both DoD and VA are experiencing a surge in the number of coronavirus cases among personnel and patients. In the last five days, more than 5,000 new cases have occurred among military service members, bringing the total cases among U.S. troops since the beginning of the outbreak to 74,992.
The total number of cases among service members, dependents, civilian employees and contractors was 110,982 as of Monday; 124 DoD-affiliated persons, including 11 service members and 76 civilian employees, have died.
As of Monday, 13,334 VA patients, including veterans and staff members, were being treated for COVID-19. VA has seen nearly 100,000 cases since the pandemic was declared March 11. More than 4,580 veteran patients have died, as well as 69 VA staff members.
Mastalir urged personnel assigned to Vandenberg to “keep doing what they are doing,” in terms of limiting contact with others, wearing masks, washing hands and “remaining vigilant.”
He also encouraged them to research the vaccines under development to help determine whether they wanted to receive it. (The frontrunners, by Pfizer and Moderna, both will require two doses).
“It’s going to be voluntary, which is why it’s important to do your own research. I’m going to get it. I’m going to have my kids and my spouse get it,” Mastalir said.Read comments