Friday, October 15, 2021

 mRNA Covid19Vaccines Are GeneTherapy. In case you had any doubts, these are their own words, in SEC documents describing it, from their 2021 Form 20F:

https://investors.biontech.de/static-files/e862a8ea-5d90-4672-acfb-34de57b58806
"Although we expect to submit BLAs for our mRNA-based product candidates in the United States, and in the European Union, mRNA therapies have been classified as gene therapy medicinal products, and other jurisdictions mayconsider our mRNA-based product candidates to be new drugs, not biologics or gene therapy medicinal products, and require different marketing applications."
"Currently, mRNA is considered a gene therapy product by the FDA. Unlike certain gene therapies that irreversibly alter cell DNA and may cause certain side effects, mRNA-based medicines are designed not to irreversibly change cell DNA. Side effects observed in other gene therapies, however, could negatively impact the perception of immunotherapies despite the differences in mechanism. In addition, the regulatory pathway in the United States and may other jurisdictions for approval is uncertain."
"There have been few approvals of gene therapy products in the United States and other jurisdictions, and there have been well-reported significant adverse events associated with their testing and use. Gene therapy products have the effect of introducing new DNA and potentially irreversibly changing the DNA in a cell. In contrast, mRNA is highly unlikely to localize to the nucleus, integrate into cell DNA, or otherwise make any permanent changes to cell DNA. Consequently, we expect that our product candidates will have a different potential side effect profile from gene therapies because they lack risks associated with altering cell DNA irreversibly. Further, we may avail ourselves of ways of mitigating side effects in developing our product candidates to address safety concerns that are not available to all gene therapies, such as lowering the dose of our product candidates during repeat dosing or stopping treatment to potentially ameliorate undesirable side effects.
"
"Regulatory requirements governing gene and cell therapy products have evolved and may continue to change in the future, and the implications for mRNA-based therapies is unknown. For example, the FDA has established
the Office of Tissues and Advanced Therapies within CBER to consolidate the review of gene therapy and related products, and convenes the Cellular, Tissue and Gene Therapies Advisory Committee to advise CBER on its review. In the European Union, mRNA has been characterized as a Gene Therapy Medicinal Product. In certain countries, mRNA therapies have not yet been classified or any such classification is not known to us. Specifically, in Japan, the Pharmaceuticals and Medical Devices Agency has not taken a position on the regulatory classification. Notwithstanding the differences between our mRNA product candidates and gene therapies, the classification of some of our mRNA product candidates as gene therapies in the United States, the European Union and potentially other counties could adversely impact our ability to develop our product candidates, and could negatively impact our platform and our business. For instance, a clinical hold on gene therapy products across the field due to risks associated with altering cell DNA irreversibly may apply to our mRNA product candidates irrespective of the mechanistic differences between gene therapies and mRNA."
"Adverse events reported with respect to gene therapies or genome editing therapies could adversely impact one or more of our programs. Although our mRNA product candidates are designed not to make any permanent changes to cell DNA, regulatory agencies or others could believe that adverse effects of gene therapy products caused by introducing new DNA and irreversibly changing the DNA in a cell could also be a risk for our mRNA investigational therapies, and as a result may delay one or more of our trials or impose additional testing for long-term side effects. Any new requirements and guidelines promulgated by regulatory review agencies may have a negative effect on our business by lengthening the regulatory review process, requiring us to perform additional or larger studies, or increasing our development costs, any of which could lead to changes in regulatory positions and interpretations, delay or prevent advancement or approval and commercialization of our product candidates or lead to significant post-approval studies, limitations or restrictions. As we advance our product candidates, we will be required to consult with these regulatory agencies and advisory committees and comply with applicable requirements and guidelines. If we fail to do so, we may be required to delay or discontinue development of some or all of our product candidates.
"

 Risk for COVID-19 Infection, Hospitalization, and Death By Age Group:"All rates are relative to the 18- to 29-year-old age category. This group was selected as the reference group because it has accounted for the largest cumulative number of COVID-19 cases compared to other age groups. Sample interpretation: Compared with 18- to 29-year-olds, the rate of death is four times higher in 30- to 39-year-olds, and 570 times higher in those who are 85 years and older. (In the table, a rate of 1x indicates no difference compared to the 18- to 29-year-old age category.)"

https://www.cdc.gov/coronavirus/2019-ncov/covid-data/investigations-discovery/hospitalization-death-by-age.html

 Biden renews OPEC outreach as oil prices climb 10% in September:"The rising price of oil “is of concern for the U.S.,” said White House press secretary Jennifer Psaki. The U.S. has been in touch with OPEC about oil prices, she said at a press briefing. Heading into next week’s meeting between OPEC and its partners, there is increased speculation that the organization will consider raising production more than the previously announced hike of 400,000 barrels a day.

“With oil prices at multi-year highs, we think that OPEC will come under increasingly intense pressure from Washington to increase production,” RBC analyst Helima Croft said in report."

https://www.worldoil.com/news/2021/9/30/biden-renews-opec-outreach-as-oil-prices-climb-10-in-september

Wednesday, October 13, 2021

Seattle mother who died from blood clots got J&J vaccine to be child's 'room mom,'October 5th 2021:"“Jessica was pressured to get the vaccine due to a vaccine mandate at their child’s school requiring ‘room moms’ who wished to serve in the classroom be fully vaccinated,"said Berg Wilson’s obituary.

It was Berg Wilson’s greatest passion to be the best mother to her young daughters who will now grow up with only memories of their Mom."
https://katu.com/news/local/king-county-woman-dies-from-blood-clots-after-getting-johnson-johnson-vaccine

#BloodClots #Thrombosis #CDC #Covid #Seattle #CovidCases #CovidMandates #CovidVaccines #Covid19 #Covid19Mandates #CovidInfection #CovidImmunity #Covid19Passports #Covid19Vaccines #Covid19Mandates #Covid19Variants #Healthcare #HoldTheLine #JoeBiden #NaturalImmunity #NurseUp #Vaccinations #VaccineHesitancy #VaccineMandate #VaccineMandates #VaccinePassports #StopTheMandates

Judge rules against natural immunity claim challenging COVID-19 shot mandate, October 9, 2021:"Jeanna Norris, who works at Michigan State University, challenged the school’s vaccine requirement on the basis that she had COVID-19 and recovered. After having two antibody tests showing her immunity, her doctor instructed her not to get a vaccine at this time.


Still, she faces termination for not complying with Michigan State University’s requirement that all staff and students be vaccinated by Aug. 31 unless they have a religious or medical exemption."

https://www.washingtontimes.com/news/2021/oct/9/judge-rules-against-natural-immunity-claim-challen/


#Covid #CovidMandates #CovidVaccines #Covid19 #Covid19Mandates #CovidInfection #CovidImmunity #Covid19Passports #Covid19Vaccines #Covid19Mandates #DeltaVariant #Covid19Variants #HoldTheLine #HospitalClosures #Hospitalizations #HospitalMandates #JoeBiden #NaturalImmunity #NurseUp #Vaccinations #VaccineFirings #VaccineHesitancy #VaccineMandate #VaccineMandates #VaccinePassports #VaccineRefusals #VaccineTerminations #StopTheMandates

 Texas Gov. Greg Abbott bans any COVID-19 vaccine mandates — including for private employers, OCT. 11, 2021:"Texas Gov. Greg Abbott on Monday issued another executive order cracking down on COVID-19 vaccine mandates — this time banning any entity in Texas, including private businesses, from requiring vaccinations for employees or customers.


Abbott also called on the Legislature to pass a law with the same effect, promising to rescind the executive order once that happened. The Legislature is in this year's third special legislative session, which ends Oct. 19.


"The COVID-19 vaccine is safe, effective, & our best defense against the virus, but should always remain voluntary & never forced," he said in a tweet announcing his latest order."

https://www.texastribune.org/2021/10/11/texas-greg-abbott-covid-19-vaccine-mandate/


#Texas #TexasGovernor #GovAbbott 

#Covid #CovidMandates #CovidVaccines #Covid19 #Covid19Mandates #Covid19Passports #Covid19Vaccines #Covid19Mandates #Healthcare #HoldTheLine #HospitalClosures #Hospitalizations #HospitalMandates #JoeBiden #NurseUp #Vaccinations #VaccineFirings #VaccineHesitancy #VaccineMandate #VaccineMandates #VaccinePassports #VaccineRefusals #VaccineTerminations #StopTheMandates 

Wednesday, October 6, 2021

 Public workers finding religion to avoid COVID-19 shots – Times-Herald:"As the clock goes by, thousands of civil servants, many of whom are police and firefighters, claim religious exemptions from the COVID-19 vaccine requirements adopted by states and local governments to reduce the spread of the virus. I am receiving it.


Vaccine obligations were pushed by civil servants trying to crack down on Shotshanner, who they accuse of promoting the deadly spread of the virus. However, the number of exemptions granted obliges unwilling workers whose religious beliefs are protected under federal and state law, especially if those workers are backed by strong trade unions. It suggests that it can be difficult to force."

https://californianewstimes.com/public-workers-finding-religion-to-avoid-covid-19-shots-times-herald/545854/


#VaccineExemptions #ReligiousExemptions #FindingReligion #California 

#Covid #CovidMandates #CovidVaccines #Covid19 #Covid19Mandates #Covid19Passports #Covid19Vaccines #Covid19Mandates #Covid19Variants #Healthcare #HoldTheLine #Nurses #Nursing #NurseUp #Vaccinations #VaccineFirings #VaccineHesitancy #VaccineMandate #VaccineMandates #VaccinePassports #VaccineRefusals #VaccineTerminations #StopTheMandates

 Kaiser suspends thousands of employees who shunned vaccine, October 6, 2021:"In one of the first signs of an escalating showdown between healthcare providers and vaccine-resistant employees, Kaiser Permanente has suspended more than 2,000 workers who have chosen not to get vaccinated against the coronavirus.


The Oakland-based health care provider is not alone in putting workers who are shunning the vaccine on leave without pay. Across California, hospitals have told workers who have refused a shot to stop showing up to work in recent days. Suspended workers can’t return unless they get jabbed in the coming weeks."

http://usa-today-news.com/2021/10/06/kaiser-suspends-thousands-of-employees-who-shunned-vaccine/


#Kaiser #KaiserPermanente #California #CaliforniaHospitals #CaliforniaNurses 

#Covid #CovidMandates #CovidVaccines #Covid19 #Covid19Mandates #Covid19Passports #Covid19Vaccines #Covid19Mandates #Covid19Variants #Healthcare #HoldTheLine #Nurses #Nursing #NurseUp #Vaccinations #VaccineFirings #VaccineHesitancy #VaccineMandate #VaccineMandates #VaccinePassports #VaccineRefusals #VaccineTerminations #StopTheMandates

Tuesday, October 5, 2021

 

As an enrolled nursing student, it would seriously disturb me if in the middle of my freshman, sophmore, junior or senior year or during clinicals, suddenly I was told "vaccinate or find a new program." Yet that is exactly what is happening :(
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Nursing Students Who Refuse a Mandated COVID-19 Vaccine Could be Disenrolled, October 04, 2021:"Nursing education programs are not obligated to provide alternate clinical experiences requested by unvaccinated nursing students when the designated clinical facility mandates the COVID-19 vaccine, according to a new policy issued by the National Council of State Boards of Nursing (NCSBN).

The NCSBN and eight other leading nursing organizations, including the American Organization for Nursing Leadership (AONL) and the American Nurses Association (ANA), issued a policy brief to provide guidance to boards of nursing and nursing education programs receiving requests from students for alternate clinical experiences when a program’s clinical sites require the COVID-19 vaccine."


#BON #Covid #CovidCases #CovidMandates #CovidVaccines #Covid19 #Covid19Cases #Covid19Mandates #CovidInfection #CovidImmunity #Covid19Passports #Covid19Vaccines #Covid19Mandates #DeltaVariant #Covid19Variants #Healthcare #HealthcareMandates #HealthcareWorkers #HoldTheLine #HospitalClosures #Hospitalizations #HospitalMandates #JoeBiden #NaturalImmunity #NCSBON #Nurses #Nursing #NursingPrograms #NursingSchool #NursingStudents #NurseUp #SchoolsOfNursing #StateBoardofNursing #StudentNurses #Vaccinations #VaccineFirings #VaccineHesitancy #VaccineMandate #VaccineMandates #VaccinePassports #VaccineRefusals #VaccineTerminations #StopTheMandates

 

Did they mandate the Flu/Influenza shot where you worked last year? Was the first year in like two decades that I took it. Medical exemptions were damn near impossible and I didn't try a religious.

They were paranoid over #Covid19 and didn't want to risk even worse staffing shortages from those that came down with the Flu..
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17 states with hospital staff flu shot requirements:"About one-third of states require hospitals to offer employees flu shots or track their vaccination statuses to help boost flu vaccination rates in healthcare settings, according to a new ranking from Kaiser Family Foundation.

The ranking is based on an analysis of state laws and immunization websites outlining vaccine requirements for hospitals as of 2020."