An order making the COVID-19 vaccine mandatory for U.S. service members will be issued "in the coming days" after the Food and Drug Administration formally approved the Pfizer-BioNTech vaccine Monday.
Defense Department spokesman John Kirby said that troops should expect updated guidance this week, including a timeline for them to be fully vaccinated.
Defense Secretary Lloyd Austin on Aug. 9 announced plans to make the vaccine mandatory for U.S. service members, but delayed the requirement while the FDA completed its review of the shot.
"The health of the force is as always, our military and our civilian employees, families and communities, a top priority," Kirby said during a Pentagon press conference Monday. "These efforts ensure the safety of our service members and promote the readiness of our force, not to mention the health and safety of the communities around the country in which we live."
Formal vaccine approval comes the week after the Defense Department recorded five deaths among U.S. service members between Aug. 11 and 18 -- the deadliest week of the pandemic to date for the military.
The deaths included the first Marine to die from the virus and several young service members between the ages of 27 and 31. To date, the DoD has seen 222,138 cases of COVID-19 in U.S. service members; 34 have died.
FDA officials said Monday that as part of the approval process of the Pfizer-BioNTech vaccine, which now will be known as Comirnaty, "scientific data and information, including hundreds of thousands of pages" of information were analyzed and evaluated, and the vaccine has met the administration's "rigorous, scientific standards." The approval is for patients 16 and older.
"The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S.," said Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research.
The vaccine was first rolled out Dec. 11, 2020, under an FDA emergency use authorization. The Defense Department began vaccinating its first service members days later, starting with military leaders and medical personnel.
Military officials said early during vaccine development that the shots would not be mandatory as long as they were administered under the emergency use designation.
The emergency use authorization required patients to receive counseling on their options to accept or refuse the vaccine -- a provision that military officials interpreted as a legal prohibition on requiring the vaccine.
But with FDA approval, the DoD now is able to require the Pfizer vaccine, as it does with a dozen other immunizations.
According to the DoD, roughly 63% of all U.S. forces, including active-duty, National Guard and Reserve members, had received at least one dose or were fully vaccinated as of Aug. 18.
The mandate will affect roughly 780,000 service members who have not yet been vaccinated.
Shortly after Austin published his plan to make the vaccine mandatory, some service members took to social media to say they would put in their retirement papers or planned to leave the service rather than get the inoculation.
Defense officials have said U.S. troops who refuse the vaccine could face a range of punishments, including administrative separation or court-martial.
However, Navy Surgeon General Rear Adm. Bruce Gillingham said Thursday that refusals to follow a general order would be handled "administratively" but added he doesn't foresee widespread issues once the immunizations are required.
Gillingham acknowledged that there may be medical exemptions for some, including those who are immunocompromised or who have had a previous reaction to the vaccine.
"I think our sailors and Marines will understand that it's, at this point, been deemed a mandatory readiness requirement," he said. "I don't think we're going to face significant resistance, frankly."
A template also has circulated on social media that people claiming they are military personnel or spouses say can be used to file a religious exemption for the vaccines.
Kirby said last week that troops will be able to request an exemption based on their religious beliefs, but the decision to grant the request will be determined by the military service branches, which each have their own policies on religious exemptions.
Those making a request for an exemption will be required to receive counseling from a military physician, as well as their commander, to ensure that they are making "an informed decision."
"There is a religious exemption possibility for any mandatory vaccine, and there's a process that we go through to counsel the individual both from a medical and from a command perspective about using a religious exemption," Kirby said during a press conference.
"We take freedom of religion and worship seriously, in the military. It's one of the things that we sign up to defend," he said. "And so it's something that's done very carefully."
More than 362 million COVID-19 vaccines have been administered in the U.S., including those made by Pfizer, Moderna and Johnson & Johnson.
The most commonly reported side effects of the Pfizer vaccine include pain and swelling at the injection site, fatigue, headache, muscle aches and fever.
A rare side effect, particularly among men under age 40, is heart inflammation, either myocarditis or pericarditis, largely within seven days after the second dose, the FDA noted in its announcement Monday.
While most "have had resolution of symptoms," some patients have required "intensive care support," so the vaccine will be distributed with a warning of the risk, according to the FDA.
At least 30 U.S. service members have developed myocarditis following doses of the Pfizer or Moderna vaccines, which use messenger RNA technology to instruct cells to produce the protein spike that is a hallmark of the SARS-CoV-2 coronavirus, activating the immune response.
Defense Health Agency Director Army Lt. Gen. Ronald Place said earlier this summer that a number of military medical patients also have developed myocarditis as a result of contracting COVID-19, although he did not say how many.
Service members who have died recently from COVID-19 have been identified as:
- Air Force Senior Airman Daniel Moise, 31, with the 919th Special Operations Wing at Duke Field, Florida, who died July 27 and whose death was reported to the DoD on Aug. 11
- Navy Personnel Specialist First Class Debrielle Richardson, 29, of Helicopter Maritime Squadron 60 at Jacksonville, Florida, who died Aug. 13
- Marine Corps Sgt. Edmar Ismael, 27, of 2nd Marine Logistics Group at Camp Lejeune, North Carolina, who died Aug. 14
- Navy Aviation Support Equipment Technician 2nd Class Robert McMahon, 41, of Naval Air Station Joint Reserve Base New Orleans, who died Aug. 14
- Texas Army National Guardsman Chief Warrant Officer 2 Michael Riddick, 49, of the 36th Combat Aviation Brigade, who died Aug. 15
-- Patricia Kime can be reached at Patricia.Kime@Monster.com. Follow her on Twitter @patriciakime.