中首个「数字PCR」试剂获批上市 可检测Delta、Omicron




中首个「数字PCR」试剂获批上市 可检测Delta、Omicron

世界新闻网

01/15/2022

北京清华大学对外发布消息称首个数字PCR试剂盒获批上市。(截屏自中新视频)

中新社报导,北京清华大学15日对外发布消息称,由清华大学医学院郭永教授团队与北京新羿生物科技有限公司等多家单位联合研发的新型冠状病毒(2019-nCoV)核酸检测试剂盒(萤光PCR法)正式获得大陆国家药品监督管理局医疗器械批文。

据介绍,新的试剂盒有效提高检测灵敏度,可以降低阳性漏检情况。此外,这个「嗅觉灵敏」的「新冠探测器」对包括Delta、Omicron等在内目前全球范围内最常见的15种变异株,均不会出现漏检和脱靶。



郭永介绍指出,新的试剂盒采用的是「数字PCR技术」(第三代PCR技术),在先前「萤光定量PCR」(第二代PCR技术)的基础上借助了微流控生物芯片的方式,数字显示新冠病毒数据,极大提升核酸检测的「讯噪比」(指设备中消息与噪声的比例),其灵敏度可达100拷贝/mL。

此外,获批上市的试剂盒还有望在临床研究中发挥两个重要的作用——监测新冠肺炎病人的临床治疗,以及抗新冠药物的临床研究评价。

值得注意的是,新的试剂盒这次获得的批文是大陆国家药监局批准的首张基于数字PCR技术进行新冠病毒核酸检测的III类医疗器械证书,也是全球首个经评审后正式获批的将数字PCR技术运用于新冠领域的研究成果。

Source



中国首款冠病特效药能降低死亡重症率达八成

世界新闻网

12/20/2021

中国首款冠病特效药问世,能将病人的住院率、重型率和死亡率降低80%。

据央视新闻报道,中国国家药品监督管理局12月8日宣布,应急批准腾盛华创医药技术,冠病病毒中和抗体联合治疗药物安巴韦单抗注射液(BRII-196),以及罗米司韦单抗注射液(BRII-198)注册申请,腾盛博药、清华大学和深圳第三人民医院是主要研发单位。这是中国首家获批的自主知识产权冠病病毒中和抗体联合治疗药物。

据中国防疫专家钟南山介绍,今年5月,广州德尔塔毒株传播时,专家曾经签字使用特效药,两、三天内就降低了病人的病毒负荷。此外,特效药对奥密克戎变异株仍然保持综合的抗病毒活性,使用后可提供九到12个月的保护作用。



研究团队领军人物,清华大学医学院教授张林琦教授说,有了这药“或许冠病可以变感冒”。她续称,临床试验是在国际上四大洲,六个国家,111个临床试验基地展开的,在整个过程中它展示了非常好的安全性,有效性,能够降低住院率和死亡率80%以上。

据介绍,美国食品和药物管理局(FDA)此前对这两株抗体组合方案对主要变异病毒株的活性已经进行了鉴定,结果显示BRII-196/BRII-198抗体组合方案对国际上全部主要突变株保持敏感。

Source



中国首款新冠特效药上市 称对Omicron与Delta病毒有效

世界新闻网

12/13/2021

中国首款国产新冠特效药上市。图为杭州市定点收治新冠肺炎患者的西溪医院检验科工作人员正在实验室内进行核酸检测。(新华社)

中国首款国产新冠病毒特效药获批上市,对新病毒Omicron与Delta和Delta+均具有疗效。


China grants emergency approval to first homegrown COVID drug
Dec 10, 2021

China’s National Medical Products Administration approved its first treatment that specifically targets COVID-19. It uses a cocktail of 2 antibodies developed in China. Professor Zhang Linqi of Tsinghua University led the research team. Professor Zhang calls it cocktail therapy developed by selecting two monoclonal antibodies that inhibit the virus from infecting healthy cells. He talks about the drug’s effectiveness.


中通社报导,中国腾盛博药生物科技有限公司12日宣布,新的体外嵌合病毒实验中和数据表明其安巴韦单抗/罗米司韦单抗联合疗法(此前称BRII-196/BRII-198联合疗法)保持对新冠病毒变异株Omicron的中和活性。  

腾盛博药表示,这些数据增加了更多的证据,证明安巴韦单抗/罗米司韦单抗联合疗法对世界卫生组织关注的主要新冠肺炎病毒变异株均保持中和活性,也包括Delta和Delta+。



腾盛华创首席运行官罗永庆早前在12月9日的发布会上表示,FDA目前正对腾盛博药的安巴韦单抗/罗米司韦单抗联合疗法紧急使用授权申请进行审核。这一申请是基于国际三期临床的最终结果。


China grants emergency approval for its first Covid drug
Dec 9, 2021

China’s drug authority has granted emergency approval for the country’s first specialized treatment against Covid-19, found in clinical trials to significantly reduce hospitalizations and deaths among high-risk patients.


最终结果显示,与安慰剂相比,安巴韦单抗/罗米司韦单抗联合疗法使临床进展高风险的新冠门诊患者住院和死亡风险降低80%,具有统计学显著性。且截至28天的临床终点,治疗组为零死亡,而安慰剂组有9例死亡,其临床安全性优于安慰剂组。  

安巴韦单抗和罗米司韦单抗是腾盛博药与深圳市第三人民医院和清华大学合作从新型冠状病毒肺炎康复期患者中获得的非竞争性新型严重急性呼吸系统综合症病毒2(SARS-CoV-2)单克隆中和抗体。12月8日晚间,安巴韦单抗/罗米司韦单抗联合疗法获中国药监局上市批准,成为了首款中国国产新冠特效药。

Source



中国国产新冠药 三期临床零死亡

大公报 | 作者:郭若溪

11/23/2021

深圳市第三人民医院党委书记刘磊

  近日,由清华大学、深圳市第三人民医院和腾盛博药联合研发的新冠药物BRII-196和BRII-198联合用药(中和抗体联合疗法)三期临床试验数据已出炉,给药组在治疗28天后零死亡。

  深圳市第三人民医院党委书记刘磊22日接受记者采访时表示。在4大洲、6个国家、111个临床试验机构进行的837例新冠肺炎患者三期临床试验结果显示,该抗体组合药物能够降低78%的住院和死亡率,且给药组在治疗28天后实现零死亡,对照组8例死亡,且特效药的抗体对于发病5-10天的患者有显著效果。

  刘磊透露,研发团队已向国家药监局滚动提交附条件上市申报材料,有望12月底前获得批准(附条件)上市,预计年底之前在美国和中国同时上市。据统计,目前内地自主研发的新冠药物已有六种,主要围绕阻断病毒进入细胞、抑制病毒覆製、调节人体免疫系统3条技术路线展开。新冠药物如果能顺利上市,将会与已有的新冠疫苗友好互补,形成抗击新冠病毒的巨大合力。

Source



中国自主研发冠病特效药防变异株 部分病人康复

11/17/2021

中国官媒《科技日报》今天报道称,中国自主研发新冠特效药能防变异株,使用后患者体内病毒载量大幅下降,憋喘、味嗅觉减退等症状明显好转,部分病人已康复出院。研发团队带头人——北京大学李兆基讲席教授谢晓亮表示,正在开展国内二期临床试验,希望中国自主研发的新冠特效药早日面世。

报道介绍说,这款特效药的独特之处是,在其他候选药大多使用“一对抗体”预防新冠病毒逃逸时,它实现了“单个抗体”就能防范变异株。它是一种中和抗体药物,它的原型是人体里本来就有的中和抗体。在与新冠病毒过招后,患者本人的免疫机制会择优选出“会打仗”的中和抗体。

这一步算“海选”,特效药就在其中。但特效药必须优中选优,过去优选抗体用时需要以年计,因为中和抗体底数巨大,成千上万,而且痕量捕捉不到。高通量单细胞基因测序技术的发明,让研究者可以逐个细胞快速翻找。

作为单细胞基因组学的开拓者,谢晓亮受访时说,单个抗体取代“抗体对”的特点使它的生产成本将是其他候选药的三分之一以下,目前丹序已与国药集团中国生物达成合作开发意向。



谢晓亮实验室有着领先国际的技术优势。在全球竞速研发中,抗体药研发就像沙石淘金,翻得石头越多越可能捕获最强抗体。

北大团队在短短几个月内实现了对8000余个候选抗体的筛选。数据显示,基于超几倍筛选,北大团队筛选出多个特效候选药,DXP-604就是其中的佼佼者。

这也是为什么该药用于治疗时仅需0.6克,而且还能更少。“我们正在做爬坡实验,很有可能0.3克就够。”谢晓亮说。

报道还说,新冠疫情反复、复杂对新冠特效药提出了应对变异的更高要求。抗体配对是一种常用策略,两个抗体与病毒的结合位点不同,当一个抗体失效时,另一个还可以抑制病毒,例如,再生元和礼来都采用了抗体对,但都有一个抗体被德尔塔株逃逸了。



“我们有一个候选药DXP-593就被德尔塔株逃逸了。”谢晓亮说,它的药效很高,反而给病毒施加了巨大的进化压力,新冠病毒的氨基酸序列发生变化,抗体失效。

对于逃逸付出的惨痛代价,谢晓亮没有讳言:近一亿元(人民币)的研发经费打了水漂。

谢晓亮团队原本打算将DXP-593与DXP-604合用,但一种全新的研究方法却带来了意外惊喜,单用DXP-604就能防住变异株。

“我们最新发展了一种高通量酵母显示技术,把新冠病毒蛋白(S蛋白)受体结合域的单点突变的所有4000多种可能逐一与中和抗体做了测试。”谢晓亮说,新技术能清晰显示在不同抗体药物中,新冠病毒逃逸的可能性。



DXP-604的测试结果令人意想不到,它给了新冠病毒一个“两难”困局:要么不变异,被DXP-604中和,要么变异“出圈”,但会变化多到很难再结合到人体细胞上。让新冠病毒落入“不变等死、变是找死”的境地是DXP-604的“杀手锏”。
 
“它就是我们要找的Super抗体。”回头看一路走来的曲折,谢晓亮总结,抗体特效药并不是全方位的越“强势”越好,太强势会让病毒变异重生,DXP-604在竞争位点上做到恰到好处,最终是“打着太极”让病毒走投无路而死。

“我们拥有了一个全谱的、能够抵抗所有RBD区单点突变的抗体,足以中和所有现存的变异株,并最大程度上不会被未来的变异株所逃逸。”谢晓亮说。

关于DXP-604的临床试验和上市时间表,谢晓亮介绍,正在开展国内二期临床试验,已与国药集团中国生物接洽,推进海外二期和三期临床试验。北京市已批准DXP-604作为“同情用药”在北京地坛医院临床救治,目前临床试验和“同情用药”的药物均由药明生物生产。谢晓亮表示,希望中国自主研发的新冠特效药早日面世。

Source



China speeds up COVID-19 medicine development

Xinhua

11/17/2021

© Provided by Xinhua

BEIJING, Nov. 16 (Xinhua) — With the world still in the grip of the COVID-19 pandemic, Chinese scientists are accelerating the development of COVID-19 medicines.

Tsinghua University, the Third People’s Hospital of Shenzhen and Brii Biosciences have jointly developed a cocktail therapy of monoclonal antibodies BRII-196 and BRII-198, which are derived from antibodies isolated from people who had recovered from COVID-19.

Overseas, the cocktail therapy is undergoing phase-III clinical trials in seven countries, including the United States, Brazil and the Philippines.

“The BRII-196/BRII-198 medicines have been used in the clinical treatment of over 700 patients in China, and the clinical trials data at home and overseas shows the medicines could reduce severe symptoms and mortality by 78 percent,” said Zhang Linqi, professor of the Tsinghua University’s School of Medicine.



The research team applied to the National Medical Products Administration for conditional marketing authorization on Oct. 9.

China has arranged three technical routes for COVID-19 medicine development, mainly focusing on blocking the entry of the virus into cells, inhibiting virus replication and regulating the human immune system.

DXP-604, a new neutralizing antibody medicine, has also been approved at the Beijing Ditan Hospital for compassionate use, an option to treat patients with life-threatening conditions with medical products outside of clinical trials when no other treatments are available.

The drug was jointly developed by Singlomics Biopharmaceuticals and a team led by Xie Xiaoliang, a professor at Peking University.

Source



Mom speaks out after daughter was given wrong COVID-19 vaccine at Virginia pharmacy

By Sierra Fox

11/12/2021

Parents warn of kids vaccine error

A mother is speaking out, frustrated after she says her daughter was given the wrong COVID-19 vaccine at a Loudoun County pharmacy.

LOUDOUN COUNTY, Va. (FOX 5 DC) – A mother is speaking out, frustrated after she says her daughter was given the wrong COVID-19 vaccine at a Loudoun County pharmacy.

Dasha Hermosilla says she took her 7-year-old Gryffin to Ted’s Pharmacy in Aldie.

She says she noticed her daughter was getting the vaccine with a purple cap, which is for children 12 and older, instead of the vaccine with an orange cap, which is for children 5 to 11.

The Virginia Department of Health confirmed on Wednesday that Ted’s Pharmacy incorrectly administered the COVID-19 vaccine formulated for those 12 years and older to children aged 5-11 years old.



“I would have never done this if I knew they were giving the adult reformulated vaccine. Absolutely not,” says Hermosilla. “I should’ve pushed her to show me the vile of orange which she didn’t have and then I should’ve left.”

VDH believes that 112 children aged 5-11 years old were impacted by this situation on Nov. 3-4 at Ted’s Pharmacy in Aldie, which resulted in these children receiving a lower dose than recommended.

FOX 5 contacted Ted’s Pharmacy but did not get through.

The Loudoun County Health Department released an alert about the error giving parents some options.

The board of pharmacy says they are not at liberty to confirm or deny if there is an investigation into a possible violation of law or regulation underway.

Source



维州百名儿童 错打减量的成人疫苗 保护力恐不足

世界新闻网

11/12/2021

图为辉瑞制造的儿童新冠疫苗。美联社

联邦政府授权五至11岁儿童新冠疫苗后,全国各地推动儿童接种,但维州劳登郡(Loudoun County)一药房,近日没有使用辉瑞专门包装的儿童疫苗给五到11岁孩子施打,反而采用减少剂量的成人疫苗,虽未对儿童健康产生严重伤害,但专家担忧减量后的疫苗保护力不足。

目前维州卫生厅(VDH)和维州药房委员会(Virginia Board of Pharmacy)已在调查此事,并将Ted药房从疫苗计划中撤除,联邦政府和维州政府也禁止该药房继续施打新冠疫苗,并将剩余疫苗全部收回。



劳登郡卫生局本周致信受影响的112名儿童家长,表示Aldie区的Ted药房3日至4日给12岁以下儿童施打的辉瑞疫苗剂量错误,原应使用联邦授权专门给五至11岁儿童施打的新冠疫苗,但该药房却把成人疫苗的剂量减至原来的三分之一后给儿童施打,卫生局建议受影响儿童尽快咨询儿科医生。

辉瑞的儿童疫苗与成人疫苗活性成分相同,但配方不太一样,儿童疫苗的建议剂量为成人疫苗的三分之一;辉瑞也用不同包装区分儿童及成人疫苗,儿童疫苗为橙色盖子,成人疫苗为紫色,避免医护人员混淆。

Loudoun County pharmacists diluted adult COVID-19 vaccine dosage to give to kids
Nov 11, 2021

劳登郡卫生官员古德弗尔德(David Goodfriend)表示,Ted药房自行将成人疫苗的剂量减少后给儿童施打,对儿童的疫苗保护力恐怕将打折扣。

根据联邦疾病防治中心(CDC)指南,医生可在第一剂疫苗接种后21天,重新给儿童施打两剂正确剂量的儿童疫苗,或按原计划在第一剂疫苗后21天直接施打第二剂的儿童专用疫苗。

古德弗尔德表示,目前卫生学者及官员尚未发现混打疫苗有任何不良影响,预计应该不会造成伤害,不过,他仍建议家长在儿童接种新冠疫苗后,留意孩子是否出现发烧、发冷、酸痛、头痛等副作用,若有不寻常现象,需尽快咨询专业医护人员。

Source



Covid-19 Vaccine Injuries/Deaths

11/06/2021

Rumble — Roundtable discussion with vaccine injured and medical experts on federal vaccine mandates and the importance of health care freedom.


美国陆军飞行医官特蕾莎中校关于新冠疫苗的证词

By 萧笙客 

11/06/2021

https://www.youtube.com/watch?v=2tpIjfff49g

11月2日,飞行医官特蕾莎·朗中校在约翰逊参议员主持的关于新冠疫苗的圆桌会议上的作证。

美国德州胡德堡陆军基地负责四千名陆军飞行旅官兵身体健康和飞行安全的军医特蕾莎反对对官兵、特别是飞行员强制性注射疫苗,向法院提出的临时禁令书写的补充材料。

Source



Sen. Johnson hosts panel highlighting people claiming to be harmed by COVID-19 vaccines

By WEAU 13 News

11/06/2021

Sen. Ron Johnson held a roundtable with several people who say they or a loved one experienced life-altering side-effects from various COVID vaccinations Tuesday, Nov. 2, 2021.(Gray TV)

WASHINGTON, D.C. (WEAU) – Wisconsin Senator Ron Johnson is giving a stage to people who claim they were harmed by COVID-19 vaccinations.

Tuesday, Johnson held a roundtable with several people who say they or a loved one experienced life-altering side-effects from various COVID vaccinations.

One panelist, who says she experienced adverse side effects from the vaccine, called for a federal safety net for others who are also injured.

Another woman at the meeting claimed that those who catch COVID receive medical help, while those who have adverse side effects to vaccines are ignored.

The panel included researches and doctors who generally agreed vaccines have a role in fighting the pandemic, but also cautioned against mandating them.

Johnson said the panel is not about creating fear or increasing vaccine hesitancy, but says federal health officials aren’t being honest when they say the vaccines are safe and effective, and shouldn’t be mandated.



“I had COVID,” Johnson said. “I’ve had my antibodies tested as my doctor told me. I’ve got a whopping level of antibodies.”

Johnson also spoke about his personal vaccination decision.

“Again, natural immunity should be strong, pretty long-lasting, which is the case of very, you know, many, many illnesses, many viruses,” Johnson said. “And so there’s no reason for me to get a vaccine.”

Centers for Disease Control and Prevention fact page maintains the vaccines are safe and effective. It also acknowledges the existence of some of the adverse effects discussed at Johnson’s roundtable, and says COVID vaccines are under the most intense safety monitoring in U.S. history.

Source


Survey: Majority of Federal Employees Disagree With Biden’s Vaccine Mandate

Comments submitted as part of the survey show a diversity of thought on the requirement. 

By COURTNEY BUBLÉ

he majority of federal employees recently surveyed (53%) strongly or somewhat disagreed with the Biden administration’s COVID-19 vaccine mandate for federal employees, while 44% strongly or somewhat agreed with it. 

The Government Business Council, the research arm of Government Executive, sent a survey between October 27 and November 2 to Government Executive and Defense One readers, which drew 3,186 respondents. The survey had a 95% confidence level and margin of error of +/- 3%; the vast majority of respondents currently work for a federal agency but the results did include some retirees and congressional and private sector workers. President Biden announced the mandate on September 9 and the deadline is November 22. 

“I am not pro or anti-vaccine, I am pro-choice,” wrote one federal employee in the comments section. “It should be a choice not a mandate, last I knew this was a free country.” Anonymous comments submitted as part of the survey show the diversity of thought on the mandate as well as the nuance of arguments on both sides. 


Thirty-percent of respondents said they thought the vaccine mandate will be slightly or moderately effective in protecting the federal workforce from the coronavirus; 42% thought it will be very or extremely effective and 29% thought it will not be effective. 

“The vaccine mandate is most likely legal. It’s also probably effective,” said a respondent. “It, however, does not mean the federal [government] should have the power to force adults and the civilian workforce to get a shot that they don’t want.” 

The mandate requires all federal employees to get vaccinated against COVID-19 by November 22, or claim a religious or medical exemption. Those who decline vaccination and whose agencies deny their exemption requests will face progressive discipline, up to removal from the federal service. 

Another respondent said, “the mandate will not be effective if the many false religious exemptions are approved,” because “most are not sincerely held beliefs, but just people that don’t want to get their vaccine.”



A different person said, “A coworker’s choice not to be vaccinated increases my potential exposure to COVID, potentially increases my workload if I have to cover for them if they are out ill and increases the cost of [Federal Employees Health Benefits]/Medicare.”

The survey looked at the difference of views among those on full telework compared to those going into the office at least one day a week. The chart below shows approval and disapproval levels based on that status, with those going into the office at least once a week more likely to strongly disapprove of the mandate. 

“If you can do your job, i.e. telework, without contacting others there is no reason to be vaccinated,” said one federal employee in the comments section. “It is the individual’s body and they should have the right to decide what is done to it without fearing economic ruin.”

Another said, “​​I worked and put the protocols in to keep everyone safe. I worked on the front lines for the last two years and now you want to fire me?”



One respondent who said they work for the Agriculture Department’s Farm Service Agency said they love their job and customers they serve, “but lately I do not feel the agency has my back or appreciates the work our agency does. After being on the front lines, figuring out telework, changing the way our agency goals are achieved I feel the employees deserve a little more than a ‘do it or get out policy.’ ” 

As for the ability to enforce a vaccine mandate, 50% of respondents strongly or somewhat disagreed that the federal government has the authority to enforce the requirement, while 46% somewhat or strongly agreed. There were no major differences in responses from managers and non-managers to this question; however, there were some differences among those in different work environments, as shown below. 

The Justice Department’s Office of Legal Counsel issued a legal opinion in July that says federal law doesn’t prohibit public and private entities from mandating coronavirus vaccines, even if those vaccines do not yet have full authorization from the Food and Drug Administration. Also, the Equal Employment Opportunity Commission issued a similar decision in May, which it updated in October

As for regions, the area with the highest approval rating (54%) of the mandate was the D.C. metro area, which is where federal agency headquarters are concentrated. Respondents living in the Southwest had the highest disapproval rating. 



“The D.C. power brokers are using us as pawns,” said a respondent. 

While not a question in the survey, many raised concerns in the comments section about loss of employees due to the mandate. 

“Is the federal government prepared to lose 20-30% of its workforce to retirements, resignations or terminations?” said one respondent. 

“I will retire from federal service if I am threatened with discipline/firing,” said another. “ I am proud of my military service (Vietnam veteran) and federal service (FBI and [Internal Revenue Service]) and continually received ‘outstanding’ performance evals as GS-14. The federal mandate is morally wrong.” 

Someone else said, “this is a train wreck, but may provide promotion opportunities for the younger workforce.” 

However, there were also several comments encouraging vaccinations. “I sincerely appreciate efforts to get our team vaccinated,” said one person. “I am grateful for the mandate and wish it had come sooner.”

For comparison, recent survey from Qualtrics, an experience management company, found that the majority of respondents (58%) supported vaccine mandates from either employers or the federal government. 



“Employees in the [technology and information technology] industry are the most supportive of federal vaccine mandates compared to those who work in health care, retail and government,” said Qualtrics. “Roughly a quarter of government, health care, and private employees oppose mandates that would apply to them.” 

Overall, 42% of respondents want their company leaders to enforce the mandate, while 39% do not, the Qualtrics survey found. That survey was done between October 12 and 15. There were 1,309 respondents who were chosen from a randomized panel and deemed eligible if they live in the United States, are an adult and are at least part-time employees. 

Government Executive previously reported about reactions to the mandate from NASAFederal Bureau of Prisons and other federal employees. While some agencies have shared their vaccination levels with reporters, lawmakers or the public, the levels are not known for all. Top House Republicans are seeking those numbers by November 10. 

In one example, as of late October, several intelligence agencies had at least 20% of their workforce unvaccinated, with some as high as 40%, said Rep. Chris Stewart, R-Utah, who is a member of the House Permanent Select Committee on Intelligence, the Associated Press reported on Friday. He cited information that the Biden administration gave to the committee, but hasn’t released publicly, and didn’t name the specific agencies since the full results were classified. 

Source



Biden admin considering vaccine mandate for businesses with fewer than 100 employees

OSHA rule for big businesses forces employees to be vaccinated or wear masks and get weekly COVID-19 tests

By Tyler Olson | FOX Business

11/05/2021

The Occupational Safety and Health Administration (OSHA) says it is “seeking comment” about whether businesses with fewer than 100 employees should be subject to the COVID-19 vaccine and testing mandate it is implementing on big businesses

OSHA’s requirement will force businesses with more than 100 employees to mandate vaccines or else their employees will need to wear masks and be tested for COVID-19 weekly. It will go into effect Jan. 4. 

President Biden holds his face mask and waves as he exits Air Force One at Capital Region International Airport, Tuesday, Oct. 5, 2021, in Lansing, Michigan. Biden’s administration is implementing a COVID-19 vaccine and testing mandate on big busines (AP Photo/Evan Vucci / AP Newsroom)

But according to a summary released by OSHA, it appears to be considering implementing the rule for small businesses as well. 



“OSHA is confident that employers with 100 or more employees have the administrative capacity to implement the standard’s requirements promptly, but is less confident that smaller employers can do so without undue disruption,” the summary says. “OSHA needs additional time to assess the capacity of smaller employers, and is seeking comment to help the agency make that determination.”

The same language is included in the Federal Register page for the vaccine rule.

In this July 27, 2020, file photo, nurse Kathe Olmstead prepares a shot that is part of a possible COVID-19 vaccine, developed by the National Institutes of Health and Moderna Inc., in Binghamton, New York. (AP Photo/Hans Pennink / AP Images)

A Department of Labor spokesperson told FOX Business Friday that it is indeed considering whether to extend the vaccine or mask and testing mandate to businesses with fewer than 100 workers. 



“OSHA chose a 100-employees threshold at this time because the agency is confident that employers with 100 or more employees have the administrative capacity to implement the standard’s requirements promptly,” the spokesperson said. “Because the emergency situation required OSHA to act quickly, the information immediately available to the agency did not allow it to confidently assess the impact on smaller firms.”

The spokesperson added: “OSHA will consider whether to extend the rule to smaller firms in the public rulemaking that begins with the publication of this emergency rule.”

Source



Raytheon CEO warns company could lose ‘several thousand’ employees over vaccine mandate

By Mike Brest

10/27/2021

Raytheon CEO warns company could lose ‘several thousand’ employees over vaccine mandate

Raytheon Technologies’s top boss warned that the U.S. aerospace and defense company will lose thousands of employees who have thus far refused to comply with the COVID-19 vaccine mandate.

“So, we’re going to be faced on Dec. 8 with a choice. We’re going to potentially lose several thousand people who refuse to be vaccinated,” Raytheon CEO Greg Hayes said in a CNBC interview on Tuesday. “Now, this is a tough thing, but we are preparing for it.”



Hayes also said that 83% of the company, which has a total workforce of roughly 125,000 U.S. employees, according to Reuters, is already vaccinated while another 6% are “in the process of being vaccinated.”

Additionally, there is another 3% of employees who are seeking either a religious or medical exemption, while another 3% have said they don’t intend to receive the vaccine, the CEO added, though he did not address the status of the employees who do not fall into those categories.

The company has already begun hiring people to fill the upcoming vacancies, Hayes said.

Raytheon had issued a companywide mandate requiring vaccination by Jan. 1, but that order was usurped when President Joe Biden declared that all federal contractors must receive the vaccine by Dec. 8.



Hayes’s comments came the same day Alabama Republican Sen. Tommy Tuberville sent a letter to the White House claiming that Biden’s “federal contractor vaccine mandate will have negative effects on our national security” and called on the president “to remove — or, at a minimum, delay and clarify — vaccination requirements on private companies and academic research institutions that are actively supporting the Department of Defense.”

Similarly, nearly a dozen Republican lawmakers on the House Armed Services Committee petitioned the White House and Defense Secretary Lloyd Austin to reverse the Pentagon’s vaccine mandate for contractors over fears that it could lead to supply chain issues.

Roughly 100 employees at United Launch Alliance, a Lockheed Martin and Boeing joint venture that contracts to both the Pentagon and NASA, walked off the job Monday over the federal government’s vaccine mandates and pledged to continue protesting in the days leading up to the deadline to be vaccinated.

Source



Former WSU football coach Nick Rolovich to sue university over firing after refusing vaccine

According to a press release sent by his attorney, Rolovich is accusing WSU Athletic Director Pat Chun of “discriminatory and vindictive behavior.”

By KREM Staff

10/20/2021

PULLMAN, Wash. — Former Washington State University football coach Nick Rolovich was fired Tuesday, Oct. 19 after refusing to be vaccinated against COVID-19 and now he plans to sue the university. 

According to his lawyer, Rolovich will be taking legal action against WSU and all parties responsible for his termination. The decision to terminate Rolovich came after his request for a religious exemption from the vaccine was denied by the WSU. According to his lawyer, WSU  “indicated that even if the exemption had been granted, no accommodation would have been made.”

Rolovich is accusing WSU Athletic Director Pat Chun of “discriminatory and vindictive behavior,” according to the statement from his lawyer, Brian Fahling.

“Since at least early April, it became clear that Chun had already determined that Coach Rolovich would be fired,” Fahling says. “Chun’s animus towards Coach Rolovich’s sincerely held religious beliefs, and Chun’s dishonesty at the expense of Coach Rolovich during the past year is damning and will be thoroughly detailed in litigation.”



In the statement, Fahling says, “Chun’s discriminatory and vindictive behavior has caused immeasurable harm to Rolovich and his family. It is a tragic and damning commentary on our culture, and more specifically, on Chun, that Rolovich has been derided, demonized, and ultimately fired from his job, merely for being devout in his Catholic faith.”

Pope Francis, the leader of the Catholic Church, has encouraged people to get the COVID-19 vaccine. 

Here is the statement from Rolovich’s lawyer in full:

“The termination of Washington State football coach Nick Rolovich on Monday was unjust and unlawful. 

It came after Coach Rolovich’s request for a religious exemption from the vaccine was denied by the University. The institution also indicated that even if the exemption had been granted, no accommodation would have been made. As a result, Coach Rolovich will be taking legal action against Washington State University, and all parties responsible for his illegal termination. 



Immediately after terminating Coach Rolovich, WSU Athletic Director, Pat Chun, directed campus police to escort the coach to his car, he wasn’t allowed into his office, and he was not even allowed to speak to his team. Since at least early April, it became clear that Chun had already determined that Coach Rolovich would be fired. Chun’s animus towards Coach Rolovich’s sincerely held religious beliefs, and Chun’s dishonesty at the expense of Coach Rolovich during the past year is damning and will be thoroughly detailed in litigation. 

Chun’s discriminatory and vindictive behavior has caused immeasurable harm to Coach Rolovich and his family. Furthermore, the University’s deceitfulness about being unable to accommodate Coach Rolovich even if his religious exemption request had been granted, is exemplified by Chun’s actions arranging a “secret” donor trip that he had Coach Rolovich attend at the height of the pandemic in July 2020. 

During that excursion, Chun and other attendees contracted the disease, but Coach Rolovich did not. It is a tragic and damning commentary on our culture, and more specifically, on Chun, that Coach Rolovich has been derided, demonized, and ultimately fired from his job, merely for being devout in his Catholic faith.”

KREM has reached out to WSU for a statement but has not yet received a response.

Source



320万年薪傲视全州公务员 华盛顿州立大学教练拒打疫苗遭开除

10/20/2021

华盛顿州立大学(Washington State University, WSU)足球队总教练罗洛维奇(Nick Rolovich)因拒绝遵守华州要求公务员必须接种新冠疫苗的规定,本周稍早已被开除。美联社

华盛顿州立大学(Washington State University,WSU)足球队总教练罗洛维奇(Nick Rolovich)年薪320万元,在领取州政府薪水的公务员收入排行榜称霸。但因罗洛维奇拒绝遵守华州要求公务员必须接种新冠疫苗的规定,本周稍早已被开除。华盛顿邮报报导,罗洛维奇堪称到目前为止,最为引人注目的公职人员拒打疫苗而丢饭碗案例。

华盛顿州立大学18日宣布已经解聘罗洛维奇。华盛顿州立大学美洲狮队(Washington State Cougars)体育主任秦派特(Pat Chun,音译)指出,罗洛维奇拒绝配合疫苗接种规定,已经失去获得校方聘用的资格。

秦派特在声明中说,这起事件让学校足球队感到沮丧。

42岁的罗洛维奇出身于夏威夷大学(University of Hawaii)足球队,2019年曾获西部山区联盟(Mountain West Conference)最佳教练。罗洛维奇年薪320万元,是领取华州州政府薪水的公务员当中排行最高者。



罗洛维奇今年暑假已经表明坚决不打疫苗,太平洋十二校联盟(Pacific-12 Conference)在洛杉矶举办媒体宣传,由于规定全体出席者必须打疫苗,罗洛维奇便因此缺席。

秦派特指出,校方与罗洛维奇协商长达数月,但罗洛维奇态度坚定,「他有权做出选择,他的决定就是不配合规定」。

华盛顿州立大学校长薛尔兹(Kirk Schulz)则在声明中说,虽然少数人士拒打疫苗而引发轩然大波,但学校接近90%雇员及97%学生则都打了疫苗。

薛尔兹说:「人们可以做选择,而且有好几个月的时间可以决定。这并不是突然发生的。」

除了罗洛维奇之外,华盛顿州立大学美洲狮队另外四名助理教练罗戈(Ricky Logo)、理查森(John Richardson)、史特兹曼(Craig Stutzmann)、韦伯(Mark Weber),同样因为拒打疫苗,一并遭到开除。

Source



美国ESPN知名体育记者拒打疫苗被开除

本文源自: 金融界网

10/20/2021

  迪士尼旗下娱乐与体育节目电视网(ESPN)的知名记者艾莉森-威廉姆斯(Allison Williams)周一表示,她因为拒绝接种新冠病毒疫苗而被解雇,下周将是她在这里工作的的最后日子。

  这位明星记者最出名的是她对美国大学橄榄球和篮球比赛的报道,她在社交媒体上的一段视频中说,她要求豁免不接种疫苗的请求被拒绝了。

  威廉姆斯从2011年3月开始为ESPN工作。上个月,她在推特上发表声明称,在咨询了医生后,她拒绝接种疫苗,因为她和她的丈夫正试图生第二个孩子,接种疫苗“不符合我的最佳利益”。

  ESPN的母公司迪士尼是众多要求员工接种疫苗的企业之一。该公司在一份声明中说,不会对威廉姆斯的个案置评。迪士尼表示,公司正在按照其法律义务,处理员工提出的豁免要求。

Source



ESPN’s Allison Williams explains why she’s giving up her job over a vaccine mandate

By ANDREA HSU

10/20/2021

ESPN reporter Allison Williams reports from a college basketball tournament at Barclays Center in Brooklyn, N.Y., on March 8, 2017. Williams said in a recent Instagram video that she is leaving ESPN due to the company’s vaccine mandate.
Lance King/Getty Images

ESPN college basketball and football reporter Allison Williams has joined a small minority of workers who have quit or been fired from their jobs over a vaccine mandate.

“I have been denied my request for accommodation by ESPN and the Walt Disney Company, and effective next week, I will be separated from the company,” she said in a video posted to Instagram on Friday.

ESPN’s parent company, Disney, had announced a vaccine mandate over the summer with a deadline of this Friday, Oct. 22.



In early September, Williams shared on Twitter that she’d decided not to get a COVID-19 vaccine while she and her husband were trying to have a second child.

“Taking the vaccine at this time is not in my interest,” she wrote.

The CDC has urged people who are pregnant or might become pregnant to get vaccinated, saying there is currently no evidence showing COVID-19 vaccines cause fertility problems and no data pointing to an increased risk of miscarriage among people who received an mRNA vaccine during pregnancy.

In the Instagram video, Williams spoke of her medical apprehensions about receiving the vaccine and added, “I am also so morally and ethically not aligned with this.”



“Ultimately, I cannot put a paycheck over principle, and I will not sacrifice something that I believe and hold so strongly to maintain a career,” she said in the video. “I’m going to pray things get better and that I can see you on the television set in some capacity in some stadium, covering some game soon.”

Williams, who had reported for ESPN since 2011, acknowledged she’s not the only one walking away from a career or a profession they love.

Hundreds of hospital workers have quit rather than get vaccinated, but they represent only a tiny fraction of employees overall. For example, Duke Health in North Carolina reported it had fired just 20 people out of a workforce of 23,000.

Meanwhile, United Airlines said it is terminating a couple of hundred of its 67,000 employees who did not comply with the airline’s vaccine mandate. Other employers that have imposed vaccine mandates are also reporting compliance rates topping 90%.

Source




Veteran police officer resigns over vaccine mandate in chronically understaffed department

The department has chronically been understaffed and more officers could resign over the mandate

By Emma Colton | Fox News

9/21/2021

A nearly 30-year police veteran in California resigned over San Jose’s vaccine mandate as the police force continues struggling with chronic understaffing. 

“First of all, it’s my religious belief. I also believe I’ve been given a choice about what to do with my body,” Sgt. David Gutierrez said after he resigned from the San Jose Police Department this weekend, KPIX reported

Gutierrez spent 23 years with the San Jose Police Department working as a homicide detective, internal affairs investigator and patrol supervisor, before retiring in 2019. He then returned to the force as a reserve officer. 



Gutierrez worked his last shift at the department on Saturday, and said he sent a letter to the city manager on Monday denouncing the city’s vaccine mandate, which requires city employees to show proof of vaccination or get a medical exemption. Those who don’t comply face disciplinary action, such as termination.

“Disciplinary action is when you have done something wrong,” Gutierrez said, according to NBC Bay Area. “I have done nothing wrong – by making a choice not to be vaccinated why would you be disciplined?”

Gutierrez added that he is not anti-vaccine and would be open to the city testing him on a weekly basis instead of enforcing the vaccine or getting a medical exemption. 



“I’m not anti-vaccine. I don’t tell people, ‘You shouldn’t get it.’ But when it comes to my body, it’s my choice about what I want to put in my body,” Gutierrez said.

He sent his resignation letter ahead of the city’s Sept. 30 deadline for employees to get the vaccine, and said more officers could also walk off the job amid the department already facing understaffing issues. 

“We are already understaffed and can’t afford to lose more,” Gutierrez said.

“If they let go police officers who’ve been here five years, 10 years, 15 years, you can hire somebody else, but you’re not going to hire that experience though,” he added.



A recent audit examining the last 10 years of the police department found the force has heavily relied on overtime as it struggles with understaffing. 

About 200 officers in the department have so far asked for exemptions, many of which are for religious purposes. But the Democratic mayor, Sam Liccardo, says the vaccine mandate is overall working and doesn’t anticipate an exodus from the force. 

“This is certainly for the protection of the individual members of our city team. But it’s also, critically, for the safety of our entire community because we know, obviously, first responders are out there interacting [with the public] every day,” Liccardo said, according to KPIX.

Source



Northern NY hospital to stop delivering babies after resignations over Covid-19 vaccine

BY Christine Vendel 

9/12/2021

A hospital in New York plans to stop delivering babies later this month because too many maternity workers resigned rather than get the Covid-19 vaccine.

Lewis County Health System Chief Executive Officer Gerald R. Cayer announced at a news conference Friday afternoon that the maternity department would be closed on Sept. 25 until they can find enough vaccinated nurses to safely reopen it.

Cayer told reporters in Lowville, is the North Country of New York state, that seven of the 30 people who have resigned from the hospital worked in the maternity department, according to the news site NNY360.



Seven additional maternity workers have not said whether or not they will get their first vaccine shot by Sept. 27, which is the deadline set by the state for healthcare workers to get at least one shot, according to the news site.

The health system has a higher than average percentage of its staff vaccinated, Cayer told reporters, with 464 employees vaccinated out of 650, or 73 percent.

But there are still 165 employees who have not yet shared their decision with hospital management, WWNY television news reported.

Medical services in five other departments may have to be cut back as well if more staff members resign because they refuse to be vaccinated



“It just is a crazy time,” Mr. Cayer said, according to NNY360, “It’s not just LCHS-centric. Rural hospitals everywhere are really trying to figure out how we’re going to make it work.”

“If you don’t have staff, how do you deliver the service? That’s what I’m going to be talking about,” Cayer said.

The Health System is one of only two county-owned hospitals left in the state and is the largest employer in the county.

Source