Day: September 11, 2021

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Adagio Therapeutics annonce l’élargissement de la population de patients participant à l’essai clinique mondial de phase 2/3 de l’ADG20 pour la prévention de la COVID-19

Le Comité de surveillance des données indépendant approuve l’élargissement aux adolescents ainsi qu’aux femmes enceintes et allaitantes sur la base des données d’innocuité et de tolérance de la partie de pré-inclusion de phase 2

WALTHAM, Massachusetts, 10 sept. 2021 (GLOBE NEWSWIRE) — Adagio Therapeutics, Inc., une société biopharmaceutique au stade clinique axée sur la découverte, le développement et la commercialisation de solutions à base d’anticorps pour les maladies infectieuses présentant un potentiel pandémique, a annoncé aujourd’hui que le Comité indépendant de surveillance des données (IDMC) a formulé une recommandation visant à étendre le recrutement dans l’essai de phase 3 dans le cadre de l’essai EVADE de phase 2/3 de l’ADG20 pour la prévention de la COVID-19, afin d’inclure des adolescents et des femmes enceintes ou allaitantes. ainsi que pour réduire le délai de surveillance post-injection spécifié dans le protocole. Les évaluations de l’IDMC sont basées sur son examen des données d’innocuité et de tolérance sans insu provenant de 200 participants inscrits dans la partie de « pré-inclusion » de phase 2 de l’essai. Adagio n’a toujours pas connaissance des données et prévoit de mettre en œuvre les recommandations de l’IDMC lors de la phase 3 de l’essai. EVADE est mené à l’échelle mondiale, y compris dans les régions où la prévalence des variants du SARS-CoV-2 est élevée, afin d’évaluer la capacité d’une dose intramusculaire unique de l’ADG20 à prévenir la COVID-19 dans les contextes de pré et post-exposition.

« Au vu du besoin urgent de traitements supplémentaires et d’options préventives pour la COVID-19, en particulier dans les populations vulnérables, nous sommes ravis qu’une évaluation indépendante des données d’innocuité provenant de la partie de pré-inclusion d’EVADE ait soutenu l’inclusion d’adolescents et de femmes enceintes ou allaitantes dans la prochaine phase de l’étude », a déclaré Lynn Connolly, M.D., Ph.D., directrice médicale d’Adagio. « Sur la base de l’activité puissante et large de l’ADG20 dans les études non cliniques, ainsi que de sa demi-vie prolongée et de sa facilité d’administration, nous pensons que cet anticorps a le potentiel de devenir une option prophylactique de choix pour la COVID-19, en particulier pour les groupes vulnérables tels que les enfants et les personnes immunodéprimées, pour lesquels les options sont actuellement limitées ou inexistantes. »

L’essai EVADE est un essai clinique mondial, multicentrique, en double aveugle et contrôlé par placebo évaluant l’ADG20 dans deux cohortes indépendantes. La première cohorte (prophylaxie post-exposition) est destinée à évaluer l’innocuité et l’efficacité de l’ADG20 par rapport au placebo dans la prévention de la COVID-19 suite à une exposition à une personne atteinte d’une infection au SARS-CoV-2 confirmée en laboratoire. La deuxième cohorte (prophylaxie pré-exposition) est destinée à évaluer l’efficacité et l’innocuité de l’ADG20 par rapport au placebo chez les individus présentant un risque accru d’infection par le SARS-CoV-2 en raison de leurs situations professionnelles, de leurs conditions de logement ou de leurs loisirs, ainsi que chez les individus présentant un risque accru de mauvaise réponse vaccinale, y compris les personnes dont le système immunitaire est affaibli ou atteintes d’autres co-morbidités. Le critère principal d’efficacité dans les deux cohortes est la prévention de la COVID-19 symptomatique confirmée en laboratoire. Pour tout complément d’information sur l’essai EVADE, veuillez consulter le site https://clinicaltrials.gov/ct2/show/NCT04859517.

Le programme de développement clinique pour l’ADG20 comprend deux essais supplémentaires : l’essai clinique de phase 1 en cours sur l’ADG20 chez des volontaires en bonne santé et l’essai STAMP en cours évaluant l’ADG20 en tant que traitement pour les personnes à haut risque atteintes d’une forme légère ou modérée de la COVID-19 (voir clinicaltrials.gov).

À propos de l’ADG20
L’ADG20, un anticorps monoclonal ciblant la protéine spike du SARS-CoV-2 et des coronavirus connexes, est en cours de développement aux fins de la prévention et du traitement de la COVID-19, la maladie provoquée par le SARS-CoV-2. L’ADG20 a été conçu et élaboré en vue d’offrir de puissantes et vastes capacités de neutralisation du SARS-CoV-2 et des autres sarbecovirus du clade 1 permettant de cibler un épitope bien conservé dans le domaine de fixation du récepteur. L’ADG20 exerce une puissante activité neutralisante contre la souche originale du SARS-CoV-2 et tous ses variants préoccupants connus. L’ADG20 pourrait avoir un impact sur la réplication virale et la maladie subséquente grâce à de multiples mécanismes d’action, notamment le blocage direct de l’entrée virale dans la cellule hôte (neutralisation) et l’élimination des cellules hôtes infectées par le biais d’une activité médiée par Fc des cellules effectrices de l’immunité innée. L’ADG20 est formulé à concentrations élevées, ce qui permet son administration intramusculaire, et a été conçu pour avoir une longue demi-vie, dans le but d’offrir une protection immédiate et durable. Adagio fait progresser l’ADG20 grâce à de multiples essais cliniques à l’échelle mondiale.

À propos d’Adagio Therapeutics
Adagio est une société biopharmaceutique au stade clinique axée sur la découverte, le développement et la commercialisation de solutions à base d’anticorps pour les maladies infectieuses présentant un potentiel pandémique. Le portefeuille d’anticorps de la société a été optimisé grâce aux capacités de pointe d’Adimab en matière d’ingénierie d’anticorps et est conçu pour fournir aux patients et aux cliniciens une combinaison inégalée de puissance, d’ampleur, de protection durable (grâce à l’extension de la demi-vie), de faisabilité de fabrication et de prix abordable. Le portefeuille d’anticorps anti-SARS-CoV-2 d’Adagio comprend plusieurs anticorps fortement neutralisants non concurrents dotés d’épitopes de liaison distincts, dirigés par l’ADG20. Adagio a conclu avec des sous-traitants tiers un contrat portant sur des capacités de fabrication pour la production de l’ADG20 jusqu’à l’achèvement des essais cliniques et, en cas d’approbation par les autorités réglementaires, jusqu’au lancement commercial initial. Pour plus d’informations, rendez-vous sur notre site www.adagiotx.com.

Contacts :
Contact auprès des médias :
Dan Budwick, 1AB
Dan@1abmedia.com

Contact auprès des investisseurs :
Monique Allaire, THRUST Strategic Communications
monique@thrustsc.com

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Adagio Therapeutics Anuncia Expansão da População de Pacientes no Ensaio Clínico Global de Fase 2/3 do ADG20 para Prevenção da COVID-19

Comitê Independente de Monitoramento de Dados Apoia a Expansão para Adolescentes e Gestantes e Mulheres Amamentando com Base em Dados de Segurança e Tolerabilidade da Fase 2 de Lead-In

WALTHAM, Mass., Sept. 10, 2021 (GLOBE NEWSWIRE) — A Adagio Therapeutics, Inc., uma empresa biofarmacêutica de estágio clínico focada na descoberta, desenvolvimento e comercialização de soluções baseadas em anticorpos para doenças infecciosas com potencial pandêmico, anunciou hoje que o comitê independente de monitoramento de dados (IDMC) para o ensaio de EVADE da Fase 2/3 do ADG20 para a prevenção da COVID-19 fez uma recomendação para a expansão da inscrição no ensaio de Fase 3 para incluir adolescentes e mulheres grávidas ou lactantes, bem como para diminuir o tempo de monitoramento pós-injeção especificado pelo protocolo. As avaliações do IDMC têm por base a análise dos dados de segurança e tolerabilidade não cegos de 200 participantes inscritos na parte inicial da Fase 2 do estudo. A Adagio permanece cega em relação aos dados e planeja implementar as recomendações do IDMC para a parte da Fase 3 do estudo. A EVADE está sendo conduzida globalmente, inclusive em regiões onde há uma alta prevalência de variantes preocupantes do SARS-CoV-2, para avaliar a capacidade de uma dose única e intramuscular de ADG20 para prevenir a COVID-19 em ambos os cenários pré e pós-exposição.

“Dada a necessidade urgente de tratamento adicional e de opções preventivas para a COVID-19, particularmente em populações vulneráveis, estamos satisfeitos que uma avaliação independente dos dados de segurança da parte inicial da EVADE apoiou a inclusão de adolescentes e mulheres grávidas ou lactantes na próxima fase do estudo”, disse Lynn Connolly, M.D., Ph.D., diretora médica da Adagio. “Com base na atividade potente e ampla do ADG20 em estudos não clínicos, bem como em sua meia-vida prolongada e facilidade de administração, acreditamos que este anticorpo tenha o potencial de se tornar uma opção profilática preferida para COVID-19, particularmente para grupos vulneráveis, como crianças e imunocomprometidos, para os quais atualmente exista opções limitadas ou não disponíveis.”

O ensaio EVADE é um ensaio global clínico, multicêntrico, duplo-cego, controlado por placebo que avalia o ADG20 em duas coortes independentes. A primeira coorte (profilaxia pós-exposição) é projetada para avaliar a segurança e eficácia do ADG20 em comparação com o placebo para a prevenção da COVID-19 após a exposição a um indivíduo com infecção por SARS-CoV-2 confirmada laboratorialmente. A segunda coorte (profilaxia pré-exposição) é projetada para avaliar a eficácia e a segurança do ADG20 em comparação com o placebo em indivíduos com risco aumentado de infecção por SARS-CoV-2 devido a situações ocupacionais, de alojamento ou recreativas, e em indivíduos com risco aumentado de resposta vacinal ruim, incluindo indivíduos com sistema imunológico comprometido ou outras comorbidades. O desfecho primário da eficácia em ambas as coortes é a prevenção da COVID-19 sintomática confirmada laboratorialmente. Para mais informação sobre o ensaio EVADE, visite https://clinicaltrials.gov/ct2/show/NCT04859517.

O programa de desenvolvimento clínico para o ADG20 inclui dois ensaios adicionais: ensaio clínico de Fase 1 em andamento do ADG20 em voluntários saudáveis e ensaio STAMP em andamento de avaliação do ADG20 como tratamento para indivíduos de alto risco com COVID-19 leve ou moderado (consulte clinicaltrials.gov).

Sobre o ADG20
O ADG20, um anticorpo monoclonal direcionado à proteína Spike do SARS-CoV-2 e coronavírus relacionados, está sendo desenvolvido para a prevenção e tratamento da COVID-19, a doença causada pelo SARS-CoV-2. ADG20 foi projetado e criado para alta potência e ampla neutralização contra SARS-CoV-2 e sarbecovírus de clado 1 adicionais, direcionando-se a um epítopo altamente conservado no domínio de ligação ao receptor. O ADG20 exibe atividade neutralizante potente contra a cepa SARS-CoV-2 original, bem como todas as variantes preocupantes conhecidas. O ADG20 tem o potencial de impactar a replicação viral e a doença subsequente através de múltiplos mecanismos de ação, incluindo o bloqueio direto da entrada viral na célula hospedeira (neutralização) e a eliminação de células hospedeiras infectadas através da atividade efetora imune inata mediada por Fc. O ADG20 é formulado em altas concentrações, permitindo a administração intramuscular, e foi projetado para ter uma meia-vida longa, com o objetivo de fornecer proteção rápida e durável. A Adagio está avançando o ADG20 por meio de vários ensaios clínicos em uma base global.

Sobre a Adagio Therapeutics
A Adagio é uma empresa biofarmacêutica de estágio clínico focada na descoberta, desenvolvimento e comercialização de soluções com base em anticorpos para doenças infecciosas com potencial pandêmico. O portfólio de anticorpos da empresa foi otimizado com os recursos de engenharia de anticorpos líderes da indústria da Adimab, e foi criado para fornecer aos pacientes e médicos uma combinação de potência, amplitude, proteção durável (via extensão de meia-vida), capacidade de fabricação e acessibilidade. O portfólio de anticorpos contra SARS-CoV-2 da Adagio inclui múltiplos anticorpos amplamente neutralizantes não competitivos com epítopos de ligação distintos, liderados por ADG20. A Adagio adquiriu a capacidade de fabricação para a produção do ADG20 com fabricantes terceirizados através da conclusão de ensaios clínicos e, se aprovado pelas autoridades reguladoras, através do lançamento comercial inicial. Para mais informação, visite www.adagiotx.com.

Contatos:
Contato com a Mídia:
Dan Budwick, 1AB
Dan@1abmedia.com

Contato com o Investidor:
Monique Allaire, THRUST Strategic Communications
monique@thrustsc.com

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Olives and Wine: Conagen Makes Accessible Antioxidant Hydroxytyrosol by Fermentation

Bedford, Mass., Sept. 10, 2021 (GLOBE NEWSWIRE) — Leveraging its robust phenolics platform, Conagen announced the expansion of the health ingredient portfolio of its commercial partner Blue California, with the successful scale-up and commercialization of the powerful natural antioxidant ingredient hydroxytyrosol.With its health-promoting properties, hydroxytyrosol is a phenylethanoid found in olives and wine. Most hydroxytyrosol is naturally found in the juice of olives, minorly in oil. Current hydroxytyrosol ingredients on the market are produced mainly through processed olive juice or are synthetic.

Conagen’s high-purity hydroxytyrosol is virtually colorless and odorless, making it ideal for formulating different products. The hydroxytyrosol is produced by using a cost-effective, sustainable natural fermentation process that has led to the filing of several patent applications, making it a preferred option compared to its olive juice concentrate and synthetic counterparts.

“Hydroxytyrosol is derived from one of our four small-molecule platforms.  The flexibility of our phenolics platform has enabled us to rapidly scale and commercialize hydroxytyrosol and other novel ingredients, highlighting our productive innovation engine and reliability as a strategic service partner,” said Vice President of Innovation, Casey Lippmeier, Ph.D. at Conagen.

Hydroxytyrosol has received increasing attention in the dietary supplement world due to its potent antioxidant and anti-inflammatory properties that contribute to the many health benefits of consuming olives. Preclinical and clinical studies demonstrate the positive effects of hydroxytyrosol on heart health and support healthy cholesterol levels.

“The Mediterranean diet is consistently rated as one of the healthiest diets, partially attributed to the use of olives,” Blue California’s Research, Science and Innovation Officer, Linda May-Zhang, Ph.D. “Hydroxytyrosol is one of the most potent antioxidants in olives, and research suggests the great promise of this molecule in healthy aging and potential immune support applications.”

In addition to immune health, emerging research suggests hydroxytyrosol supports heart health, metabolic health, bone health, brain health, and beauty.

Immune health will remain a top priority for consumers as 64% of global consumers are looking to improve their immunity over the next 12 months, reported by FMCG Gurus, Top Ten Trends for 2021, Dec. 2020.

“Conagen is unlocking unprecedented access to sustainable compounds which are only sparingly found in nature,” said Lippmeier. “We expect this and other related compounds will prove useful as cost-effective food or cosmetic ingredients or as additives to other products in which oxidation must be mitigated.”

Using precision fermentation, Conagen produces an extensive portfolio of ingredients, with a recent focus on phenolic antioxidants and natural preservatives such as Rosmarinic acid (Rosavel®), Capsaicin, and the recently announced p-Coumaric Acid (PCA). These ingredients add to a long list of health-promoting flavonoids such as Dihydroquercetin (DHQ), also known as Taxifolin.

Blue California is a provider of solutions and manufacturer/distributor of specialty ingredients, flavors, and fragrances and has a long-standing innovation partnership with Conagen. Conagen focuses on developing sustainable, nature-based ingredients that improve existing options in the market or represent completely novel ingredient solutions.

About Conagen

Conagen is a product-focused synthetic biology R&D company with large-scale manufacturing capabilities. Our scientists and engineers use the latest synthetic biology tools to develop high-quality, sustainable, nature-based products by precision fermentation and enzymatic bioconversion. We focus on the bioproduction of high-value ingredients for food, nutrition, flavors and fragrances, pharmaceutical, and renewable materials industries. www.conagen.com

About Blue California

Blue California is a vertically integrated technology company providing innovative ingredient solutions to global partners. With more than 20 years of innovation success, our ingredients are used in commercial products and applications in nutrition, personal care, healthy aging and wellness, functional food and beverage, and beauty. www.bluecal-ingredients.com

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Ana Arakelian
Conagen
+1.781.271.1588
ana.arakelian@conagen.com
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A Tale of 2 COVID Vaccine Clinics: Lines in Kenya, Few Takers in Atlanta

NAIROBI – Several hundred people line up every morning, starting before dawn, on a grassy area outside Nairobi’s largest hospital hoping to get the COVID-19 vaccine. Sometimes the line moves smoothly, while on other days, the staff tells them there’s nothing available and they should come back tomorrow.

Halfway around the world, at a church in Atlanta in the U.S. state of Georgia, two workers with plenty of vaccine doses waited hours Wednesday for anyone to show up, whiling away the time by listening to music from a laptop. In six hours, one person came through the door.

The dramatic contrast highlights the vast disparity around the world. In richer countries, people can often pick and choose from multiple available vaccines, walk into a site near their homes and get a shot in minutes. Pop-up clinics, such as the one in Atlanta, bring vaccines into rural areas and urban neighborhoods, but it is common for them to get very few takers.

In the developing world, supply is limited and uncertain. Just more than 3% of people across Africa have been fully vaccinated, and health officials and citizens often have little idea what will be available from one day to the next. More vaccines have been flowing in recent weeks, but the World Health Organization’s director in Africa said Thursday that the continent will get 25% fewer doses than anticipated by the end of the year, in part because of the rollout of booster shots in wealthier counties such as the United States.

Bidian Okoth said he spent more than three hours in line at a Nairobi hospital, only to be told to go home because there weren’t enough doses. But a friend who traveled to the U.S. got a shot almost immediately after his arrival there with a vaccine of his choice, “like candy,” he said.

“We’re struggling with what time in the morning we need to wake up to get the first shot. Then you hear people choosing their vaccines. That’s super, super excessive,” he said.

Okoth said his uncle died from COVID-19 in June and had given up twice on getting vaccinated because of the length of the lines, even though he was eligible because of his age. The death jolted Okoth, a health advocate, into seeking a dose for himself.

He stopped at one hospital so often on his way to work that a doctor “got tired of seeing me” and told Okoth he would call him when doses were available. Late last month, after a new donation of vaccines arrived from Britain, he got his shot.

The disparity comes as the U.S. is moving closer to offering booster shots to large segments of the population even as it struggles to persuade Americans to get vaccinated in the first place. President Joe Biden on Thursday ordered sweeping new federal vaccine requirements for as many as 100 million Americans, including private-sector employees, as the country faces the surging COVID-19 delta variant.

About 53% of the U.S. population is fully vaccinated, and the country is averaging about 145,000 new cases of COVID-19 a day, along with about 1,600 deaths, according to Johns Hopkins Coronavirus Resource Center. Africa has had more than 7.9 million confirmed cases, including more than 200,000 deaths, and the highly infectious delta variant recently drove a surge in new cases as well.

John Nkengasong, director of the Africa Centers for Disease Control and Prevention, told reporters Thursday that “we have not seen enough science” to drive decisions on when to administer booster shots.

“Without that, we are gambling,” he said, and urged countries to send doses to countries facing “vaccine famine” instead.

In the U.S., vaccines are easy to find, but some people are hesitant to get them.

At the church in northwest Atlanta, a nonprofit group offered the Johnson & Johnson and Pfizer vaccines for free without an appointment from 10:30 a.m. to 4:30 p.m. But site manager Riley Erickson spent much of the day waiting in an air-conditioned room full of empty chairs, though the group had reached out to neighbors and the church had advertised the location to its large congregation.

Erickson, with the disaster relief organization CORE, said the vaccination rate in the area was low and he wasn’t surprised by the small turnout. The one person who showed up was a college student.

“When you put the effort into going into areas where there’s less interest, that’s kind of the result,” he said. His takeaway, however, was that CORE needed to spend more time in the community.

Margaret Herro, CORE’s Georgia director, said the group has seen an uptick in vaccinations at its pop-up sites in recent weeks amid a COVID-19 surge fueled by the delta variant and the FDA’s full approval of the Pfizer vaccine. It also has gone to meatpacking plants and other work locations, where turnout is better, and it plans to focus more on those places, Herro said.

In Nairobi, Okoth believes there should be a global commitment to equity in the administration of vaccines so everyone has a basic level of immunity as quickly as possible.

“If everyone at least gets a first shot, I don’t think anyone will care if others get even six booster shots,” he said.

Source: Voice Of America

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Republican Backlash Grows Over Biden’s Vaccine Mandate

WASHINGTON – President Joe Biden’s new broad set of federal mandates, aimed at compelling Americans not yet vaccinated against COVID-19 to get the shot, was met with an immediate and forceful backlash from his political opponents.

Republican governors, lawmakers and pundits blasted Biden’s plan, unveiled Thursday, as a major governmental overreach and threatened lawsuits to block enforcement. Biden has called for making vaccines or regular testing mandatory in most workplaces and signed an executive order requiring all executive branch employees and contractors to be vaccinated, with no exception for those preferring testing.

“Joe Biden told Americans when he was elected that he would not impose vaccine mandates. He lied,” said Republican National Committee (RNC) Chairwoman Ronna McDaniel. She said that the RNC will sue the administration on behalf of “small businesses and workers [who] do not have the money or legal resources to fight Biden’s unconstitutional actions and authoritarian decrees.”

It is far from clear that Biden’s mandates are unconstitutional or illegal. Experts say they will likely survive a court challenge. But they certainly represent a change of position for a White House that has, to this point, been careful about seeming to attack or strong-arm unvaccinated individuals.

New tone from Biden

In a departure from his past remarks on the virus, Biden addressed the unvaccinated directly, accusing them of endangering themselves and others.

“We’ve been patient, but our patience is wearing thin,” Biden said in his White House speech. “And your refusal has cost all of us.”

“A distinct minority of Americans, supported by a distinct minority of elected officials, are keeping us from turning the corner,” Biden added. “These pandemic politics are making people sick, causing unvaccinated people to die.”

The U.S. is averaging about 150,000 new coronavirus cases a day, thanks largely to the surge in the delta variant. About 1,500 deaths are being reported daily, or more than at any point since March. The majority of the dead were not vaccinated.

New mandates

Among the new policies Biden announced is a requirement that all federal employees and contractors that do business with the government, with a few exceptions, be vaccinated against the virus. An earlier position, that allowed the non-vaccinated to continue working if they tested frequently and wore masks, has been scrapped. Now, those who fail to comply risk being fired. The new rule will affect more than 4 million employees of the executive branch and the armed forces, plus millions more contractors.

Another new rule is that all employers with more than 100 employees require that their workers either be vaccinated or take weekly COVID-19 tests. The rule, which would be enforced by the Occupational Safety and Health Administration, would affect about 80 million Americans.

In addition, the administration said it would require all workers at any hospitals that accept Medicare or Medicaid payments to be vaccinated, covering another 17 million people. The administration will also require all businesses to give employees paid time off for vaccinations, and is calling on large entertainment venues to require proof of vaccination for entry.

In sum, more than 100 million American workers, or about two-thirds of the workforce, will be subject to the mandates, though a large percentage are already vaccinated. The U.S. Centers for Disease Control calculates that just more than 75% of U.S. adults have received at least one shot.

Republicans blast Biden

“Biden’s vaccine mandate is an assault on private businesses,” said Republican Texas Gov. Greg Abbott on Twitter. “I issued an Executive Order protecting Texans’ right to choose whether they get the COVID vaccine & added it to the special session agenda. Texas is already working to halt this power grab.”

“The Biden administration’s recent announcement seeking to dictate personal freedom and private business decisions is an insult to our American principles of individual liberty and free enterprise,” said Republican Missouri Gov. Mike Parsons. “This heavy-handed action by the federal government is unwelcome in our state and has potentially dangerous consequences for working families.”

“Vaccination protects us from serious illness, but the decision to get vaccinated is a private health care decision that should remain as such,” he said. “My administration will always fight back against federal power grabs and government overreach that threatens to limit our freedoms.”

Reaction to Biden’s announcement was far more positive among Democratic governors.

“Vaccines are the best way for us to get through this pandemic,” tweeted Virginia Gov. Ralph Northam in response to a presidential tweet announcing the mandate. “That’s why we have required vaccinations for over 120,000 state employees—and it’s making our Commonwealth safer.”

Several Republicans promised a legal challenge to the administration’s vaccine mandate.

“I will pursue every legal option available to the state of Georgia to stop this blatantly unlawful overreach by the Biden administration,” said Georgia Gov. Brian Kemp.

‘See you in court’

Republican Gov. Mark Gordon of Wyoming said, “I have asked the Attorney General to stand prepared to take all actions to oppose this administration’s unconstitutional overreach of executive power. It has no place in America. Not now, and not ever.”

South Dakota Gov. Kristie Noem tweeted directly to the president, saying, “See you in court.”

Despite the confident assertions of the mandate’s unconstitutionality by Republican politicians, experts say that lawsuits to block enforcement are likely to fail, with many pointing to a 1905 ruling by the Supreme Court that said states are allowed to mandate vaccines.

Other suits unsuccessful

Two challenges to other vaccine mandates have both failed in federal court in recent months. One was brought by former employees of Houston Methodist Hospital who lost their jobs for failing to comply, and another by students at Indiana University protesting the school’s vaccine requirement. The plaintiffs in the Indiana case appealed to the Supreme Court, but conservative Justice Amy Coney Barrett declined to refer the matter to the full court.

“OSHA has fairly broad authority delegated to it to ensure worker safety,” said Brian Dean Abramson, an adjunct professor of vaccine law at Florida International University and the author of the BloombergLaw/American Health Law Association treatise Vaccine, Vaccination, and Immunization Law.

“The broad strokes of what has been presented — that employers with over 100 employees require employees be vaccinated or have some other measures in place to prevent the spread of infection or face an OSHA fine — I think that is likely to ultimately be upheld,” Abramson said.

Further, he said that given the reluctance of courts to even temporarily enjoin enforcement of mandates in the Houston Methodist and Indiana University, the lawsuits are unlikely even to slow the rollout of an OSHA vaccine mandate.

“My gut instinct is that this will not be put on hold,” Anderson said.

Source: Voice Of America