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Vaccine mandate conflicts with FDA approval requirements

OLYMPIA, Wash., August 19, 2021 — Yesterday, Gov. Jay Inslee announced a new vaccine mandate for all public education employees in Washington in light of the Delta variant’s spread. By October 18th, all education personnel must be fully vaccinated. He also reinstated an indoor mask mandate for the general public, which will go into effect Monday the 23rd. 

Federal law provides that at least until a vaccine is fully approved by the Food and Drug Administration, individuals must have the option to accept or decline an experimental drug. Neither government nor private employers may force anyone to receive any of the COVID injections, according to Liberty Counsel, a national nonprofit that specializes in legal assistance.

The Pfizer, Moderna and Johnson & Johnson COVID vaccines are not FDA approved and are currently under an Emergency Use Authorization (EUA) category.

vaccine mandate
Gov. Inslee announcing new requirements regarding vaccines and public schools in the Capitol building in Olympia, WA, on August 18, 2021. Photo: Bo Brusco.

While the Governor, State Superintendent, and Secretary of Health detailed these new requirements and its necessity, protestors gathered outside the Capitol Building. 

Before rendezvousing outside the Capitol’s doors, protestors held signs by the streets for passersby to see. “LET KIDS BREATHE,” read one sign. Others had “STOP THE MANDATES” and “LET PARENTS CHOOSE” written on them in multi-colored ink. 

Protesting for the Right to Choose

“We are protesting the mandatory mask,” said Christine Laurence. “And mandatory vaccinations,” said Lorena Holst. Laurence, a high school teacher, and Holst, a stay-at-home mom and grandmother.

“It ought to be everyone’s right to choose,” says Holst. 

vaccine mandate
Protestors Christine Laurence (right) and Lorena Holst (left) display their signs for drivers passing by outside the state’s capitol building in Olympia, WA, on August 18, 2021. Photo: Bo Brusco.

This Wednesday marked Laurence’s second time attending a protest. “I was never a political person,” she says, “but I taught all last year with a mask, and I saw how detrimental it was to my kids. I saw how I felt horrible, and I’ve read enough science to know that it’s not keeping them protected, and it actually causes more harm to kids wearing masks all day — especially when they’re wearing them from eight to ten hours a day.”

With these concerns weighing on her mind, Laurence explains, “So when they said that we were going to have to wear masks again this year, I decided I couldn’t stay quiet any longer.”

Speaking more to her experience last year as a public educator, Laurence exclaims, “Oh, it was awful! People don’t understand, wearing masks for like an hour while you’re on a bus or going to the doctor’s office is one thing, but trying to teach for six hours — and a lot of times when you’re reading to the kids — it’s exhausting… It’s exhausting!”

For Laurence and Holst, their actions reflect their concerns for the younger generations. “I’m mainly protesting for my children,” says Holst, “because my child has had a different clean mask every single day last year — I let it be his choice — and he came home with a saturated, dirty mask every single day and there’s a hole in each one of his masks. I don’t know if he’s inhaled it or ingested it or what, but I just — I’ve let it be his choice.”

“And I’ve realized he’s too young to make that choice now,” she said of her eight-year-old son.

Inside the Capitol

Reporters walking into the press room counted roughly three-dozen protestors just outside the building before the conference began. Inside, while Gov. Inslee, Supt. Reykdal, and Sec. Shah spoke, chants rang through walls. Voices erupting from megaphones seeped through the windows. 

Washington Capitol Building in Olympia, WA, on August 18, 2021. Photo: Bo Brusco.

The seemingly non-violent protest reached a climax during the conference as protestors entered the Capitol Building and banged on an outer door of the room. Towards the end of the meeting, the group of three-dozen or so started to wane. Just after the governor made his closing remarks, security noted that only a handful of protestors remained.

Emergency Use Authorization and Vaccine Mandates

Liberty Counsel, a national nonprofit litigation public policy organization, stated in an April 2021 memo that current COVID vaccines cannot be mandated nor required as a condition of employment because of its Emergency Use Authorization (EUA) categorization by the Food and Drug Administration (FDA).

To view the memo on COVID Vaccine Mandates from Liberty Counsel click here.

In a memo from Liberty Counsel, it states, “COVID vaccines are in a special category and cannot be treated like FDA licensed vaccines. None of the COVID vaccines are FDA licensed; nor have they received full FDA approval. Rather, their approval is under the special provision noted above as EUA. This means that there is not enough data (which includes duration of testing) for the FDA to render a final approval. More importantly, no one, including private employers, may coerce individuals (by threatening their employment or otherwise) to take an EUA vaccine. Federal law requires full and informed, voluntary consent.”

The memo further states that under 21 U.S.C. §360bbb-3, individuals — whether employed by religious organizations, or not — have “the option to accept or refuse administration of the product” and that the “FDA has an obligation to ensure that recipients of the vaccine under an EUA are informed… that they have the option to accept or refuse the vaccine.”

Executive Secretary Capt. Amanda Cohn, MD

In an August 2020 meeting by the Centers for Disease Control Advisory Committee on Immunization Practices, Executive Secretary Capt. Amanda Cohn, MD, confirmed the non-mandatory nature of an EUA vaccine: “under an Emergency Use Authorization, an EUA, vaccines are not allowed to be mandatory.”

Employers are prohibited by federal law to single out employees by questioning their COVID status or requiring screening unless there is reasonable belief the employee has the disease. The U.S. Equal Employment Opportunity Commission has also stated that employers cannot inquire about family members of an employee who may have COVID or COVID-like symptoms.

As reported by the Lynnwood Times in June of this year, Pfizer was the first to get emergency use authorization for their COVID vaccine in December 2020, with Moderna receiving authorization a week later and Johnson & Johnson following suit in February.

vaccine mandate

According to the FDA, EUA “may allow the use of unapproved medical products, or unapproved uses of approved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when certain statutory criteria have been met, including that there are no adequate, approved, and available alternatives.” 

Dr. William Moss, the executive director of the International Vaccine Access Center at Johns Hopkins Bloomberg School of Public Health, spoke about some of the differences between EUA and full approval in an interview with ABC News

Moss told ABC that while “both authorization and approval are rigorous processes that look at the safety and efficacy of a vaccine,” time is a key factor. Authorization requires “at least two months of follow-up data from Phase 3 clinical trials” whereas approval needs at least six months of follow-up.

According to the New York Times, researchers are currently testing 99 vaccines in clinical trials on humans, and 33 have reached the final stages of testing.  Thousands of people in the trials have been given a COVID vaccine. Scientists are waiting to see how many become infected, to compare with volunteers who received a placebo. The results can determine the efficacy rate of the vaccine — if the vaccine significantly protects humans against the coronavirus.

Experts have warned of serious risks of administering vaccines without completing Phase 3 clinical trials. However, many countries provided emergency authorizations for COVID vaccines based on preliminary evidence that they are safe and effective.

If the Phase 3 trial results conclude that the current COVID vaccines do protect humans from the virus, the FDA will then decide whether to give full approval. If the trials show worrying symptoms in volunteers, scientists can pause or abandon the trial.

Because there are strong protections under federal law for persons who wish to decline the current EUA-authorized COVID vaccines, the Lynnwood Times has reached out to the Governor’s Office, the Washington State Attorney General, and the Washington State Department of Health for statements.

Vaccine Mandate Protest around Snohomish County

On Wednesday protests outside of hospitals and school offices occurred in several cities across Snohomish County.  One such protest was outside Providence Regional Medical Center Everett.

Other protests are planned in Monroe at 6.p.m. today near HWY 2 and Chain Lake Rd., and another on Saturday at 10 a.m. near Frontier Village in Lake Stevens.

11 thoughts on “Vaccine mandate conflicts with FDA approval requirements

  • Pingback: Is the state-worker vaccine mandate legal and does it violate the Nuremberg Code? - Lynnwood Times

  • This article misrepresents Liberty Counsel as “… a national nonprofit litigation public policy organization.” To be more precise, first paragraph in its About page: “Liberty Counsel is a Christian ministry that proclaims, advocates, supports, advances, and defends the good news that God in the person of Jesus Christ paid the penalty for our sins and offers forgiveness and eternal life to all who accept him as Lord and Savior. Every ministry and project of Liberty Counsel centers around and is based upon this good news, which is also referred to as the gospel.”

    And from Wikipedia: “Liberty Counsel is a 501(c)(3)[2] tax-exempt religious liberty organization that engages in litigation related to evangelical Christian values. . . The Southern Poverty Law Center has listed Liberty Counsel as an anti-LGBT hate group, a designation the group has disputed.[6] The group is a Christian ministry.”

    So very much a conservative organization. Too bad the article’s author did not include a progressive set of viewpoints as well.

    ALSO, since this article was written the Pfizer vaccine was fully authorized by the FDA, so updates are needed.

  • Pingback: JSU to provide free Pfizer COVID-19 vaccines on Friday – WJTV 12 News – CoverStory

  • You got us backwards. 😜 Christine Lawrence is the mom and grandmother and Lorenas the teacher! Otherwise, great article, Bo! 😁 Thanks for covering it!

    • Thank you for the correction! I’ll see to it that we fix that soon!

      • Actually, it’s Lorana Hoopes, but yes, thank you for covering this.

        • Christine and Lorana,
          How can I find out when and where the next protest will be?

  • We (Wa. State Employees) here in Spokane about 50-60 (but has grown since then) met at a park to discuss our options. One thought was to get media to hear our story. We are having a difficult time finding someone who would want to listen and report on it. Would some one from Lynwood Times be willing to interview us? TERRY DUNN 15092303564

    • I do not like that you claimed there were a few of us. I looked through my videos and I counted at least 150 people. But I know there were more outside. I will send Inslee the footage so that he can see for himself that it was closer to 200-250 of us and we are going to keep growing. I also have some bad news for him, but Pfizer is losing their EUA because they only got 37% efficiency. This does not hold up to mandatory levels from FDA. Moderna is next. Sorry Inslee, you can’t force vaccines that are still in clinical trials or failed their clinical trials. It’s 100% illegal.

      • When he was there, there were only about 10.

      • Yes, we did grow. I did a live on my facebook page, Bo if you want to see how many were there. It was a few hundred.


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