Two U.S. service members who have recovered from COVID-19 are asking a federal judge to put an immediate stop to the Defense Department's mandatory COVID-19 vaccine order.
Army Staff Sgt. Daniel Robert and Marine Corps Staff Sgt. Hollie Mulvihill filed a suit Aug. 17 in the U.S. District Court for the District of Colorado seeking an exception to the order for military members who have recovered from the illness.
But last week, the pair's attorneys stepped up the effort, requesting a temporary injunction to stop all vaccinations and a judge's order that would require the DoD to exempt everyone with natural immunity from the mandate.
"Service members that have natural immunity, developed from surviving the virus, should be granted a medical exception from compulsory vaccination because the DoD instruction policy reflects the well-established understanding that prior infection provides the immune system's best possible response to the virus," the lawsuit states.
The Centers for Disease Control and Prevention recommends the COVID-19 vaccine for patients who have contracted COVID-19. A study published Aug. 6 by the CDC found that people in Kentucky who had COVID-19 and were unvaccinated were twice as likely to be reinfected than those with COVID-19 who were fully vaccinated.
"These data further indicate that COVID-19 vaccines offer better protection than natural immunity alone and that vaccines, even after prior infection, help prevent reinfections," according to the study.
But Todd Callender, a representative for the plaintiffs and an attorney with Disabled Rights Advocates, argues that his clients and military personnel who have had COVID-19 are relatively young and healthy and therefore should be allowed to make decisions about vaccination on their own.
"These are the healthiest people on the planet in their age group ... so why are we rushing? What is the compelling reason forcing the military to say, 'You must take this vaccine, regardless of what the law says?'" Callender said.
The COVID-19 coronavirus is transmitted from one person to another via airborne droplets emitted while breathing, speaking, coughing or sneezing, and even individuals who don't have symptoms can spread the virus, posing a risk to others and perpetuating transmission -- and the pandemic. CDC officials repeatedly have pushed for vaccination even among the young and healthy to avoid continued transmission, which also leads to increased risk of new variants emerging.
Robert is an infantryman currently stationed at Fort Bragg, North Carolina, while Mulvihill is an air traffic controller assigned to Marine Corps Air Station New River, also in North Carolina, according to court documents.
The two are asking that their suit be certified as a class action to represent an unknown percentage of the nearly 250,000 troops who have contracted COVID-19 and don't think they need vaccination.
In their case, they argue that Army Regulation 40-562 gives troops who are documented survivors of the infection a medical exemption from vaccination because of acquired immunity from having had an illness.
According to the regulation, "General examples of medical exemptions include the following -- underlying health conditions ... evidence of immunity based on serologic tests, documented infection or similar circumstances."
As part of their suit, the plaintiffs also are pointing to the fact that some of the vaccine stock now being used by the DoD was manufactured and issued before the Pfizer-BioNTech vaccine received full FDA approval on Aug. 23. Existing legal precedent suggests that vaccines must receive full approval before troops could be required to receive them.
"The law says they don't have to have [a vaccine]. We just want [them] to follow [their] own law," Callender said during an interview with Military.com.
According to the Food and Drug Administration, the FDA-approved vaccine, licensed under the brand name Comirnaty, is exactly the same as the Pfizer-BioNTech vaccine tested in clinical trials and authorized for emergency use, or EUA. The FDA says they "can be used interchangeably to provide the COVID-19 vaccination series without presenting any safety or effectiveness concerns."
In a memo issued Sept. 3 to medical commanders, Navy Surgeon General Rear Adm. Bruce Gillingham echoed the FDA, saying the vaccines have the same formulation and can be used on service members.
"Navy medical providers can use PfizerBioNTech doses previously distributed under the EUA to administer mandatory vaccinations," Gillingham wrote in a memo contained in court documents.
Aaron Lottes, an expert on the FDA's regulatory processes at Purdue University, said the emergency use authorization remains in place alongside formal approval to ensure that all existing doses of the Pfizer vaccine won't be wasted.
"There's so much vaccine already out there that was manufactured under the EUA and labeled under the EUA, so in order to legally use it, then the EUA still has to be in place or tens of millions of doses would have been unusable," Lottes said.
"Who knows what the legal argument becomes," he added. "From a scientific perspective, there's no difference."
Since the beginning of the pandemic, the DoD has tallied 367,218 cases of COVID-19, including more than 240,000 cases in U.S. service members, 65,997 among civilian employees, 23,054 in contractors and 36,778 among civilians.
Fifty-two service members have died, including 26 since late July with the rise of the Delta variant. Only one -- a sailor -- was known to have been partially vaccinated; the rest were not vaccinated or had received only one dose, according to Pentagon officials.
Of the deceased service members, at least 15 were under age 40 and had no apparent underlying health conditions.
Defense Secretary Lloyd Austin issued a memo Aug. 25 ordering service chiefs to implement a mandatory COVID-19 vaccine order. Austin waited to mandate the vaccine until after the FDA approved the first one, the messenger RNA vaccine made by Pfizer-BioNTech, on Aug. 23.
Callender said the group covered by the lawsuit could expand if it were to include DoD contractors, who also are required to get the vaccine, according to directives from Austin.
Children's Health Defense, a nonprofit founded by Robert F. Kennedy Jr. that supports anti-vaccine regulations and legislation, also filed a lawsuit in late August seeking to toss out the Food and Drug Administration's decision to approve and license the Pfizer vaccine, arguing that the vaccine available in the U.S. was made under the emergency use authorization before the FDA-approved Comirnaty.
Children's Health Defense filed additional paperwork to its suit Sept. 17 saying service members are receiving vaccines they have a right to refuse -- the Pfizer vaccine made under the EUA -- and are being punished for refusing them.
The motion was accompanied by 14 affidavits from service members -- six officers and eight enlisted personnel -- detailing their requests for waivers, subsequent counseling and alleged harassment by their commands pressuring them to get vaccinated.
Of the group of 14, six have applied for religious waivers, four have had COVID-19 and one had a religious waiver granted in 2018 for all vaccines, a medical waiver for a heart condition, and also had COVID-19.
That service member, Army Chief Warrant Officer 2 Robert Perez, wrote in his affidavit that he was repeatedly reminded to get the vaccine. While he remained quarantined at home awaiting the results of a COVID test after falling ill, his unit told him to report to duty before he knew the results.
"Never once in the history of my time in the military have I been treated so horribly," Perez wrote, according to his submission entered into court records.
On Wednesday, YouTube announced it would remove content from its platform by any group or individual that alleges approved vaccines are dangerous, don't work or contain other misinformation.
Not mentioned specifically, but likely included under the new guidelines, would be videos from Children's Health Defense and Kennedy, who vigorously oppose mandatory vaccines.
According to YouTube, candidates for removal "include content that falsely says that approved vaccines cause autism, cancer or infertility, or that substances in vaccines can track those who receive them," the company announced in a blog post.
Robert and Mulvihill's suit also seeks to stop the Defense Department from using any Pfizer-BioNTech product not labeled as Comirnaty; wants the Pentagon to conduct antibody testing on those who have had COVID-19 and grant them a vaccine exemption; and prohibit military leaders from retaliating against plaintiffs or potential class-action participants for seeking an exemption.
It also requests that all military flight crews be grounded until they can be assessed for a rare side effect of the COVID-19 mRNA vaccines, heart inflammation known as myocarditis, which is also a complication of COVID-19.
And, the case argues that the mandate is in violation of an order that states the DoD will use EUA medications only in the absence of approved FDA alternatives.
Callender argued, citing use outside the United States that hasn't been reviewed by U.S. agencies, that FDA-approved medications can be used off-label to treat COVID-19, such as ivermectin and hydroxychloroquine.
Ivermectin is an FDA-approved anti-parasite medication used to treat roundworms, river blindness and some skin conditions in humans. It is not approved to treat COVID-19, and no large-scale trials have been conducted on its effectiveness, leading German researchers to conclude that the current evidence does not support its use, according to their review.
Ivermectin has, however, become popular in some locations, particularly Latin America, where vaccines are not widely available, and in the U.S., among those who don't want to take the vaccine, leading to reports of shortages. Those shortages have even led some to use variants of the drug designed for livestock, leading to poisonings due to the substantially higher concentrations intended for animals weighing hundreds if not thousands of pounds more than people.
And hydroxychloroquine, an anti-malarial drug medication touted -- and used -- by President Donald Trump as a preventative before he contracted COVID-19 in October 2020, fell out of favor after it showed little to no benefit in multiple studies, including one conducted on patients at the Department of Veterans Affairs.
As of last week, 1.2 million service members have been fully vaccinated for COVID-19, while an additional 387,000 have received at least one dose.
Pentagon spokesman John Kirby said 90% of active-duty members are now fully vaccinated. Across the three components, 53% of all troops are fully vaccinated, and an additional 17% have gotten one jab.
Kirby said some service members will receive waivers -- those with health concerns whose doctors recommend against vaccination -- and "some can apply for a religious accommodation."
But disciplinary action will be taken against those who "resist just because they don't want to take the vaccine," he said.
"It is now a lawful order, and what the secretary expects is that commanders will do everything they can to inform and educate these members to get the vaccine," Kirby said. "Because it's not just in their best interest, it's in the best interest of their families, their loved ones and their teammates."
-- Patricia Kime can be reached at Patricia.Kime@Monster.com. Follow her on Twitter @patriciakime.