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Full vaccination against COVID-19 and a breakthrough infection builds 'super immunity,' study finds


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A study by Oregon researchers finds that people fully vaccinated against COVID-19 who have a breakthrough infection end up with what the authors call "super immunity."

 

They caution the vaccinated should not seek COVID-19 infection, but the "hybrid immunity" offers some solace for those who catch one despite having been vaccinated. 

"The bottom line of the study is that vaccine provides you with foundational immunity for whatever comes next," said Fikadu Tafesse, a professor of molecular microbiology and immunology in the Oregon Health & Science University School of Medicine in Portland, Oregon.

 

The study matched 26 vaccinated Oregon Health & Science University staff people who had breakthrough infections with a similar group who were vaccinated but hadn't had COVID-19.

The people who were vaccinated and then got COVID-19 showed a substantial increase in antibody levels, said Tafesse.

"The increases were substantial, up to a 1,000% increase and sometimes up to 2,000%, so it's really high immunity," he said. "It's almost 'super immunity.'"

Multiple other studies have shown that infection with COVID-19 followed by one dose of the vaccine is very protective against re-infection.

“This is one of the first that shows a breakthrough infection following vaccination generates stronger immunity than prior infection or vaccination alone,” said Dr. Monica Gandhi, an infectious disease expert at the University of California, San Francisco.

While possibly equally protective, the reverse order is not recommended. Getting COVID-19 before being vaccinated is dangerous because “we cannot predict who will get very ill with COVID,” Gandhi said.

As the highly contagious omicron variant continues to spread in the United States, the findings will be of interest to many, and "is likely what the future will hold for most vaccinated individuals," Gandi said.

Omicron appears to be able to infect even fully vaccinated people, though they so far appear to come down with mild or even asymptomatic cases of COVID-19.

"What we're saying is, we know life happens. If you happen to be exposed to the virus, you'll have this amazing immune response," Tafesse said. "It mirrors the immunity response we get to the booster."

 

The finding shows what a good job the immune system does, said Shane Crotty, a professor at the La Jolla Institute for Immunology in California.

Every time the immune system sees the vaccine or the virus, it is learning more and better able to fight it and potential other variants.

“This is what the immune system evolved to do, to make guesses from something it’s been exposed,” he said.

There is some information being spread online claiming that getting vaccinated after having recovered from COVID-19 is dangerous because it could overstimulate the immune system.

"That's completely made up, it's total rubbish," said Crotty. "It was tested in all the vaccine trials. Getting vaccinated after COVID-19 exposure is totally safe."

Getting a booster is still safer than getting COVID-19, said Dr. Gregory Poland, director of the Mayo Clinic's Vaccine Research Group, particularly for those at risk for severe disease, including those over 70, people with diabetes and those with weakened immune systems.

"Best is getting three doses of an mRNA vaccine and never getting infected. Complications, including long COVID and transmission to others, represent a risk even in that scenario," Poland said.

He offered a hierarchy of safety:

  • Best scenario:  Fully vaccinated and boosted, no infection upon exposure
  • Next best:  Fully vaccinated, boosted and asymptomatic or mild disease upon exposure/infection
  • Next best:  Fully vaccinated, boosted, moderate disease and attendant complication risks upon infection
  • Worse: not fully vaccinated or boosted and risk severe disease/death and its risks upon infection

For those who have had COVID-19 and don't think they need to get vaccinated, Crotty suggested thinking of it another way.

"If you get at least one dose of vaccine, you'll have the best immunity of anyone," he said. "You'll have amazing immunity against omicron and any variant that's been identified."

 

 

 

 

 

“There he goes. One of God's own prototypes.

A high-powered mutant of some kind, never even considered for mass production.

Too weird to live, and too rare to die.”

 

Twitter: @HKTheResistance

 

HipKat, on *** other h***, is genuine, unapoli***tically nasty, and w**** his hea** on his ******. jc856

I’ll just forward them to Bridgett. comssvet11

Seek help. soflabillsfan

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Evusheld long-acting antibody combination retains neutralising activity against Omicron variant in independent FDA study

 

Only antibody authorised in the US for pre-exposure prophylaxis of COVID-19 

 

AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab), a long-acting antibody combination for the prevention of COVID-19, retained  neutralising activity against the Omicron SARS-CoV-2 variant (B.1.1.529), according to new preclinical data.

In this study, Evusheld’s Inhibitory Concentration 50 (IC50), a measure of neutralising potency of an antibody, was 171 ng/ml and 277 ng/ml in two confirmatory tests, which is within the range of neutralising titres found in someone who has been previously infected with COVID-19. Evusheld’s IC50 for the original strain of SARS-CoV-2, previously referred to as the Wuhan strain, was approximately 1.3 ng/ml and 1.5 ng/ml, respectively.

The early data, generated by pseudovirus testing of the full Omicron variant spike against the combination of tixagevimab with cilgavimab, the antibodies that comprise Evusheld, add to the growing body of preclinical evidence demonstrating that Evusheld retains activity against all tested variants of concern to date.1

The study was performed independently by investigators at the US Food and Drug Administration (FDA), Center for Biologics Evaluation and Research. The work was supported by US government research funds.

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, said: “This study shows Evusheld retains neutralisation activity against the Omicron variant. By combining two potent antibodies with different and complementary activities against the virus, Evusheld was designed to evade potential resistance with the emergence of new SARS-CoV-2 variants. Evusheld is the first long-acting antibody to receive emergency use authorisation in the US for pre-exposure prophylaxis of COVID-19, in addition to authorisations in other countries, and we are working with regulators on applications for the use of Evusheld in treating COVID-19.”

The Omicron variant was not in circulation during the Evusheld clinical trials. The Company is continuing to collect further data to better understand the implications of this observation in clinical practice. Additional analyses to evaluate Evusheld against the Omicron variant are being conducted by AstraZeneca and third-party laboratories, with data anticipated very soon.

Evusheld received Emergency Use Authorization (EUA) in the US in December 2021 for pre-exposure prophylaxis (prevention) of COVID-19 in people with moderate to severe immune compromise due to a medical condition or immunosuppressive medications and who may not mount an adequate immune response to COVID-19 vaccination, as well as those individuals for whom COVID-19 vaccination is not recommended. The first doses are expected to become available within days.

About 2% of the global population is considered at increased risk of an inadequate response to a COVID-19 vaccine.3,4 Emerging evidence indicates that protecting vulnerable populations from getting COVID-19 could help prevent viral evolution that is an important factor in the emergence of variants.5

Additionally, the TACKLE Phase III outpatient treatment trial of Evusheld showed it reduced the risk of developing severe COVID-19 or death (from any cause) by 50% compared to placebo in non-hospitalised patients with mild to moderate COVID-19 who had been symptomatic for seven days or less.6

Notes

Evusheld
Evusheld, formerly known as AZD7442 is a combination of two LAABs - tixagevimab (AZD8895) and cilgavimab (AZD1061) - derived from B-cells donated by convalescent patients after SARS-CoV-2 virus. Discovered by Vanderbilt University Medical Center and licensed to AstraZeneca in June 2020, the human monoclonal antibodies bind to distinct sites on the SARS-CoV-2 spike protein7 and were optimised by AstraZeneca with half-life extension and reduced Fc receptor and complement C1q binding. The half-life extension more than triples the durability of its action compared to conventional antibodies and could afford up to 12 months of protection from COVID-19 following a single administration;8-10 data from the Phase III PROVENT trial show protection lasting at least six months.11 The reduced Fc receptor binding aims to minimise the risk of antibody-dependent enhancement of disease - a phenomenon in which virus-specific antibodies promote, rather than inhibit, infection and/or disease.12

In December 2021, the U.S. Food and Drug Administration issued an Emergency Use Authorisation (EUA) for the use of Evusheld (tixagevimab co-packaged with cilgavimab) for the pre-exposure prophylaxis (prevention) of COVID-19. It is the only antibody authorised in the US to prevent COVID-19 symptoms before virus exposure. Evusheld is also authorised for emergency use for prevention of COVID-19 in several other countries.

In August 2021, AstraZeneca announced that Evusheld demonstrated a statistically significant reduction in the risk of developing symptomatic COVID-19 in the PROVENT trial; efficacy was 83% compared to placebo in a six-month analysis announced on 18 November 2021. In October 2021, AstraZeneca announced positive high-level results from the Evusheld TACKLE Phase III outpatient treatment trial.

Evusheld is also being studied as a potential treatment for hospitalised COVID-19 patients as part of the National Institute of Health’s ACTIV-3 trial and in an additional collaborator hospitalisation treatment trial.

Evusheld is being developed with support from the US government, including federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority in partnership with the Department of Defense; Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense, under Contract No. W911QY-21-9-0001.

Under the terms of the licensing agreement with Vanderbilt, AstraZeneca will pay single-digit royalties on future net sales.

 

“There he goes. One of God's own prototypes.

A high-powered mutant of some kind, never even considered for mass production.

Too weird to live, and too rare to die.”

 

Twitter: @HKTheResistance

 

HipKat, on *** other h***, is genuine, unapoli***tically nasty, and w**** his hea** on his ******. jc856

I’ll just forward them to Bridgett. comssvet11

Seek help. soflabillsfan

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Broadly neutralizing antibodies overcome SARS-CoV-2 Omicron antigenic shift

 

SUMMARY

The recently emerged SARS-CoV-2 Omicron variant harbors 37 amino acid substitutions in the spike (S) protein, 15 of which are in the receptor-binding domain (RBD), thereby raising concerns about the effectiveness of available vaccines and antibody therapeutics. Here, we show that the Omicron RBD binds to human ACE2 with enhanced affinity relative to the Wuhan-Hu-1 RBD and acquires binding to mouse ACE2. Severe reductions of plasma neutralizing activity were observed against Omicron compared to the ancestral pseudovirus for vaccinated and convalescent individuals. Most (26 out of 29) receptor-binding motif (RBM)-directed monoclonal antibodies (mAbs) lost in vitro neutralizing activity against Omicron, with only three mAbs, including the ACE2-mimicking S2K146 mAb1, retaining unaltered potency. Furthermore, a fraction of broadly neutralizing sarbecovirus mAbs recognizing antigenic sites outside the RBM, including sotrovimab2, S2X2593 and S2H974, neutralized Omicron. The magnitude of Omicron-mediated immune evasion and the acquisition of binding to mouse ACE2 mark a major SARS-CoV-2 mutational shift. Broadly neutralizing sarbecovirus mAbs recognizing epitopes conserved among SARS-CoV-2 variants and other sarbecoviruses may prove key to controlling the ongoing pandemic and future zoonotic spillovers.

 

 

“There he goes. One of God's own prototypes.

A high-powered mutant of some kind, never even considered for mass production.

Too weird to live, and too rare to die.”

 

Twitter: @HKTheResistance

 

HipKat, on *** other h***, is genuine, unapoli***tically nasty, and w**** his hea** on his ******. jc856

I’ll just forward them to Bridgett. comssvet11

Seek help. soflabillsfan

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NEW PHASE 3 ANALYSES SHOW THAT A SINGLE DOSE OF REGEN-COV® (CASIRIVIMAB AND IMDEVIMAB) PROVIDES LONG-TERM PROTECTION AGAINST COVID-19

 

Single dose of REGEN-COV (1,200 mg subcutaneous) reduced the risk of COVID-19 by 81.6% during the pre-specified follow-up period (months 2-8), maintaining the 81.4% risk reduction previously reported during month 1

During the 8-month assessment period there were 0 hospitalizations for COVID-19 in the REGEN-COV group and 6 in the placebo group

The fully human antibodies in REGEN-COV were developed to provide long-lasting protective effects without any artificial mutations or sequences

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced additional positive results from a Phase 3 trial jointly run with the National Institute of Allergy and Infectious Diseases (NIAID), which assessed use of a single dose of investigational REGEN-COV® (1,200 mg administered via 4 subcutaneous injections) to prevent COVID-19 in uninfected individuals. The new analyses show REGEN-COV reduced the risk of contracting COVID-19 (i.e., laboratory-confirmed symptomatic SARS-CoV-2 infections) by 81.6% during the pre-specified follow-up period (months 2-8), maintaining the 81.4% risk reduction during the first month after administration, which was previously reported in The New England Journal of Medicine.

"Today's new data demonstrate how a single dose of REGEN-COV can help protect people from COVID-19 for many months after administration," said Myron S. Cohen, M.D., who leads the monoclonal antibody efforts for the NIH-sponsored COVID Prevention Network (CoVPN) and is Director of the Institute for Global Health & Infectious Diseases at the University of North Carolina at Chapel Hill. "These results demonstrate that REGEN-COV has the potential to provide long-lasting immunity from SARS-CoV-2 infection, a result particularly important to those who do not respond to COVID-19 vaccines including people who are immunocompromised."

In results previously published, the trial met its primary endpoint, reducing the risk of COVID-19 (i.e., laboratory-confirmed symptomatic SARS-CoV-2 infections) by 81.4% within 1 month of receiving REGEN-COV (p<0.0001). The new results released today describe a pre-specified analysis for the following 7 months, throughout which an additional 45 symptomatic infections occurred. During this time period, REGEN-COV continued to prevent infection, without requiring additional doses. Compared to placebo (n=842), people who received a single dose of REGEN-COV (n=841) experienced:

  • 81.6% reduced risk of developing COVID-19 during the pre-specified follow-up period, between months 2-8 (7 REGEN-COV, 38 placebo; 95% confidence interval [CI]: 59.8%, 91.6%; nominal p<0.0001).
  • 81.5% reduced risk of developing COVID-19 at any time during the 8 months after receiving REGEN-COV (20 REGEN-COV, 108 placebo; 95% CI: 70.6%,88.4%; nominal p<0.0001).
  • During the 8-month assessment period, 0 individuals in the REGEN-COV group were hospitalized due to COVID-19, compared to 6 individuals in the placebo group (1 person in the first month; 5 people during months 2-8). There were no deaths due to COVID-19 in any treatment group during the 8-month assessment period, and there were no new safety signals identified for REGEN-COV.

The trial, which was fully enrolled in early 2021, allowed participants to become vaccinated if they wished once the primary efficacy treatment period (month 1) was complete. Vaccination rates during the months 2-8 assessment period were balanced, with 34.5% (n=290) of the REGEN-COV group and 35.2% (n=296) of the placebo group receiving at least 1 COVID-19 vaccine dose by the end of the 8-month assessment period.

Through an innovative trial design, researchers were able to demonstrate the impact of REGEN-COV in high-risk household transmission settings (month 1, both pre- and post-exposure prophylaxis), as well as after the immediate risk of household infection had subsided (months 2-8, pre-exposure prophylaxis), when most infections were presumably acquired in the broader community. During the initial high-risk period related to household transmission, the rate of COVID-19 (in the absence of protection with REGEN-COV) was 13-fold higher than during the subsequent period of ongoing transmission: during month 1, the rate of COVID-19 in the placebo group was 8.3% per month; and during months 2-8 it decreased to 0.6% per month on average.

"In this trial, a single dose of REGEN-COV provided long-term protection against COVID-19, including times of particularly high risk from household exposure, and in the longer-term during ongoing broader exposure," said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer at Regeneron. "These data add to the increasing body of evidence supporting use of REGEN-COV to prevent COVID-19 in uninfected individuals, which may be especially useful for the many immunocompromised people who do not respond adequately to vaccines and remain 'prisoners of the pandemic.' With infections still occurring despite widespread vaccination, the immunocompromised face an ongoing risk of encountering the virus during their daily lives. We intend to rapidly share these additional data with regulatory authorities to help those in most need of protection from COVID-19."

REGEN-COV is currently authorized in the U.S. to treat people who are at high risk of serious consequences from COVID-19 infection who are either already infected (non-hospitalized) or in certain post-exposure prophylaxis settings. In the U.S., REGEN-COV is not authorized as a substitute for vaccination against COVID-19, or for pre-exposure prophylaxis for prevention of COVID-19, or for use in patients who are hospitalized due to COVID-19 or require oxygen therapy, or for people currently using chronic oxygen therapy because of an underlying comorbidity who require an increase in baseline oxygen flow rate due to COVID-19. REGEN-COV has not been approved by the Food and Drug Administration (FDA), but is currently authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency uses under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

The development and manufacturing of REGEN-COV have been funded in part with federal funds from the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response, under OT number: HHSO100201700020C.

Regeneron is collaborating with Roche to increase global supply of the antibody cocktail, with Roche primarily responsible for development and distribution outside the U.S. Regeneron and Roche share a commitment to making the antibody cocktail available to COVID-19 patients around the globe and will support access in low- and lower-middle-income countries through drug donations to be made in partnership with public health organizations.

About the Trial
The Phase 3 double-blind, placebo-controlled trial enrolled people who lived in the same household as an individual who was diagnosed with SARS-CoV-2 within the prior 4 days. All participants were tested for SARS-CoV-2 at baseline using a RT-qPCR test from nasopharyngeal swabs and for the presence of antibodies using serum antibody testing. Participants were randomized (1:1) to receive either 1 dose of REGEN-COV (1,200 mg) or placebo, administered via 4 subcutaneous injections.

During the trial, participants were tested weekly for SARS-CoV-2 during the initial month (4 weeks), as part of the primary analyses. Following this, from months 2-8 (week 5 to week 32), participants were to be tested if they developed any COVID-19 symptoms.

The new analyses include results from 1,683 people who were not infected with SARS-CoV-2 and did not have antibodies for SARS-CoV-2 (seronegative) at baseline. Across both groups approximately 95% completed the trial. In total, 42% identified as Hispanic/Latino and 9% identified as Black/African American. In addition, 34% were obese and 37% were aged ≥50 years (median age: 43 years; range: 12-92 years).

About the REGEN-COV Antibody Cocktail
REGEN-COV (casirivimab and imdevimab) is a cocktail of two monoclonal antibodies that was designed specifically to block infectivity of SARS-CoV-2, the virus that causes COVID-19, using Regeneron's proprietary VelocImmune® and VelociSuite® technologies. The two potent, virus-neutralizing antibodies that form the cocktail bind non-competitively to the critical receptor binding domain of the virus's spike protein, which diminishes the ability of mutant viruses to escape treatment and protects against spike variants that have arisen in the human population, as detailed in Cell and Science.

REGEN-COV has not been approved by the FDA, but is currently authorized in the U.S. for the treatment and post-exposure prophylaxis in certain high risk individuals. This authorization is for the duration of the declaration that circumstances exist justifying the authorization of the emergency uses under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. Additional information about REGEN-COV in the U.S. is below (authorized uses and important safety information).

In October, the U.S. FDA accepted for priority review the first of two Biologics License Applications (BLAs) for REGEN-COV to treat COVID-19 in non-hospitalized patients and as prophylaxis in certain individuals. The second BLA submission will focus on those hospitalized because of COVID-19, and is expected to be completed later this year.

Emergency or temporary pandemic use authorizations are currently in place in more than 40 countries, including the U.S., several European Union countries, India, Switzerland and Canada, and the antibody cocktail is fully approved in Japan and conditionally approved in the UK. 

About Regeneron's VelocImmune Technology
Regeneron's VelocImmune technology utilizes a proprietary genetically engineered mouse platform endowed with a genetically humanized immune system to produce optimized fully human antibodies. When Regeneron's President and Chief Scientific Officer George D. Yancopoulos was a graduate student with his mentor Frederick W. Alt in 1985, they were the first to envision making such a genetically humanized mouse, and Regeneron has spent decades inventing and developing VelocImmune and related VelociSuite technologies. Dr. Yancopoulos and his team have used VelocImmune technology to create approximately a quarter of all original, FDA-approved fully human monoclonal antibodies currently available. This includes REGEN–COV (casirivimab and imdevimab), Dupixent® (dupilumab), Libtayo® (cemiplimab-rwlc), Praluent® (alirocumab), Kevzara® (sarilumab), Evkeeza® (evinacumab-dgnb) and Inmazeb™ (atoltivimab, maftivimab and odesivimab-ebgn).

AUTHORIZED USES AND IMPORTANT SAFETY INFORMATION

Treatment:
REGEN-COV is authorized for the treatment of mild to moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death

Limitations of Authorized Use (Treatment)

  • REGEN-COV is not authorized for use in patients:
    • who are hospitalized due to COVID-19, OR
    • who require oxygen therapy due to COVID-19, OR
    • who require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity
  • Monoclonal antibodies, such as REGEN-COV, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high-flow oxygen or mechanical ventilation

Post-Exposure Prophylaxis:
REGEN-COV is authorized in adult and pediatric individuals (12 years of age and older weighing at least 40 kg) for post-exposure prophylaxis of COVID-19 in individuals who are at high risk for progression to severe COVID-19, including hospitalization or death, and are:

  • not fully vaccinated or who are not expected to mount an adequate immune response to complete SARS-CoV-2 vaccination (for example, individuals with immunocompromising conditions including those taking immunosuppressive medications) and
    • have been exposed to an individual infected with SARS-CoV-2 consistent with close contact criteria per Centers for Disease Control and Prevention (CDC) or
    • who are at high risk of exposure to an individual infected with SARS-CoV-2 because of occurrence of SARS-CoV-2 infection in other individuals in the same institutional setting (for example, nursing homes, prisons)

Limitations of Authorized Use (Post-Exposure Prophylaxis)

  • Post-exposure prophylaxis with REGEN-COV is not a substitute for vaccination against COVID-19
  • REGEN-COV is not authorized for pre-exposure prophylaxis for prevention of COVID-19

REGEN-COV has not been approved, but has been authorized for emergency use by FDA

These uses are authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner

Healthcare providers should review the Fact Sheet for Healthcare Providers for information on the authorized uses of REGEN-COV and mandatory requirements of the EUA and must comply with the requirements of the EUA. The FDA Letter of Authorization is available for referenceas well as the Dear Healthcare Provider Letter and Patient Fact Sheet

Criteria for Identifying High Risk Individuals

Please refer to the Fact Sheet for Healthcare Providers for criteria for identifying high risk individuals

SARS-CoV-2 Viral Variants

Circulating SARS-CoV-2 viral variants may be associated with resistance to monoclonal antibodies. Healthcare providers should review the Antiviral Resistance information in Section 15 of the Fact Sheet for details regarding specific variants and resistance, and refer to the CDC website (https://www.cdc.gov/coronavirus/2019-ncov/transmission/variant-cases.html) as well as information from state and local health authorities regarding reports of viral variants of importance in their region to guide treatment decisions

Important Safety Information

REGEN-COV (casirivimab and imdevimab) is an unapproved investigational therapy, and there are limited clinical data available. Serious and unexpected adverse events may occur that have not been previously reported with REGEN-COV use

  • Contraindication:
    REGEN-COV is contraindicated in individuals with previous severe hypersensitivity reactions, including anaphylaxis, to REGEN-COV
  • Warnings and Precautions:
    • Hypersensitivity Including Anaphylaxis and Infusion-Related Reactions: Serious hypersensitivity reactions, including anaphylaxis, have been observed with administration of REGEN-COV. If signs or symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration and initiate appropriate medications and/or supportive therapy. Hypersensitivity reactions occurring more than 24 hours after the infusion have also been reported with the use of REGEN-COV under EUA. Infusion-related reactions, occurring during the infusion and up to 24 hours after the infusion, have been observed with administration of REGEN-COV. These reactions may be severe or life threatening
      • Signs and symptoms of infusion-related reactions may include: fever, difficulty breathing, reduced oxygen saturation, chills, nausea, arrhythmia (e.g., atrial fibrillation, tachycardia, bradycardia), chest pain or discomfort, weakness, altered mental status, headache, bronchospasm, hypotension, hypertension, angioedema, throat irritation, rash including urticaria, pruritus, myalgia, vasovagal reactions (e.g., pre-syncope, syncope), dizziness, fatigue and diaphoresis. Consider slowing or stopping the infusion and administer appropriate medications and/or supportive care if an infusion-related reaction occurs
    • Clinical Worsening After REGEN-COV Administration: Clinical worsening of COVID-19 after administration of REGEN-COV has been reported and may include signs or symptoms of fever, hypoxia or increased respiratory difficulty, arrhythmia (e.g., atrial fibrillation, tachycardia, bradycardia), fatigue, and altered mental status. Some of these events required hospitalization. It is not known if these events were related to REGEN-COV use or were due to progression of COVID-19
    • Limitations of Benefit and Potential for Risk in Patients with Severe COVID-19: Monoclonal antibodies, such as REGEN-COV, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high-flow oxygen or mechanical ventilation. Therefore, REGEN-COV is not authorized for use in patients who are hospitalized due to COVID-19, OR who require oxygen therapy due to COVID-19, OR who require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19–related comorbidity
  • Adverse Reactions:
    • COV-2067 (Treatment): Infusion-related reactions (adverse event assessed as causally related by the investigator) of grade 2 or higher severity have been observed in 10/4,206 (0.2%) of those who received REGEN-COV at the authorized dose or a higher dose. Three subjects receiving the 8,000 mg dose of REGEN-COV, and one subject receiving the 1,200 mg casirivimab and 1,200 mg imdevimab, had infusion-related reactions (urticaria, pruritus, flushing, pyrexia, shortness of breath, chest tightness, nausea, vomiting, rash) which resulted in permanent discontinuation of the infusion. All events resolved. Anaphylactic reactions have been reported in the clinical program in subjects receiving REGEN-COV. The events began within 1 hour of completion of the infusion, and in at least one case required treatment including epinephrine. The events resolved
    • COV-2069 (Post-exposure prophylaxis): In subjects who were SARS-CoV-2 negative at baseline (Cohort A), injection site reactions (all grade 1 and 2) occurred in 55 subjects (4%) in the REGEN-COV group and 19 subjects (2%) in the placebo group. The most common signs and symptoms of injection site reactions which occurred in at least 1% of subjects in the REGEN-COV group were erythema and pruritus.  Hypersensitivity reactions occurred in 2 subjects (0.2%) in the REGEN-COV group and all hypersensitivity reactions were grade 1 in severity. In subjects who were SARS-CoV-2 positive at baseline (Cohort B), injection site reactions, all of which were grade 1 or 2, occurred in 6 subjects (4%) in the REGEN-COV group and 1 subject (1%) in the placebo group. The most common signs and symptoms of injection site reactions which occurred in at least 1% of subjects in the REGEN-COV group were ecchymosis and erythema
    • COV-2093 (Subcutaneous Dosing): Injection site reactions occurred in 12% and 4% of subjects following single dose administration in the REGEN-COV and placebo groups, respectively. Remaining safety finding following subcutaneous administration in the REGEN-COV group were similar to the safety findings observed with intravenous administration in COV-2067. With repeat dosing, injection site reactions occurred in 252 subjects (35%) in the REGEN-COV group and 38 subjects (16%) in the placebo group; all injection site reactions were grade 1 or 2 in severity. Hypersensitivity reactions occurred in 8 subjects (1%) in the REGEN-COV group; and all hypersensitivity reactions were grade 1 or 2 in severity. There were no cases of anaphylaxis
  • Patient Monitoring Recommendations: Clinically monitor patients during dose administration and observe patients for at least 1 hour after intravenous infusion or subcutaneous dosing is complete
  • Use in Specific Populations: 
    • Pregnancy: There are insufficient data to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. REGEN-COV should only be used during pregnancy if the potential benefit outweighs the potential risk for the mother and the fetus
    • Lactation: There are no available data on the presence of casirivimab and/or imdevimab in human milk or animal milk, the effects on the breastfed infant, or the effects of the drug on milk production. The development and health benefits of breastfeeding should be considered along with the mother's clinical need for REGEN-COV and any potential adverse effects on the breastfed child from REGEN-COV or from the underlying maternal condition

About Regeneron
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, hematologic conditions, infectious diseases and rare diseases.

Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite technologies, such as VelocImmune, which uses unique genetically humanized mice to produce optimized fully human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.

 

“There he goes. One of God's own prototypes.

A high-powered mutant of some kind, never even considered for mass production.

Too weird to live, and too rare to die.”

 

Twitter: @HKTheResistance

 

HipKat, on *** other h***, is genuine, unapoli***tically nasty, and w**** his hea** on his ******. jc856

I’ll just forward them to Bridgett. comssvet11

Seek help. soflabillsfan

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How many shots are you up to small fry? I heard that once you reach the 10th shot you get a free Starbucks coffee! 

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Sack "The Buffalo Range's TRUSTED News Source!"

“When a well-packaged web of lies has been sold gradually to the masses over generations, the truth will seem utterly preposterous and its speaker a raving lunatic.” ~ Dresden James

Parler @NYexile

 

 

 

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10 hours ago, SackMan518 said:

How many shots are you up to small fry? I heard that once you reach the 10th shot you get a free Starbucks coffee! 

Get back to me when you want to have a serious discussion. 3 of those articles have nothing to do with shots, dipshit, Maybe read something before you show off how fucking dumb you can be.

“There he goes. One of God's own prototypes.

A high-powered mutant of some kind, never even considered for mass production.

Too weird to live, and too rare to die.”

 

Twitter: @HKTheResistance

 

HipKat, on *** other h***, is genuine, unapoli***tically nasty, and w**** his hea** on his ******. jc856

I’ll just forward them to Bridgett. comssvet11

Seek help. soflabillsfan

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I got covid about three weeks ago FTR. Me and the woman. Kids never tested positive or had symptoms.

I never even had a fever, and my symptoms were a cough and some congestion...same with the Mrs. We take pretty good care of ourselves, and we upped our D3 during this time.

Dr Peter McCullough...one of the foremost experts and who broke it all down on the Joe Rogan experience says those who have had covid have perfect immunity and there is no proven case of re-infection of sars-cov2.

Vaccine propaganda is dangerous, and so are the people that buy into it.

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2 hours ago, HipKat said:

Get back to me when you want to have a serious discussion. 3 of those articles have nothing to do with shots, dipshit, Maybe read something before you show off how fucking dumb you can be.

A serious discussion isn't possible with you and I did glance at your links with the first one being an Oregon study that used 26 whole people. In study terms that's a sample size that's lacking. As for as Monoclonal Antibodies are concerned, I'm a big believer since it's a safer delivery system than the vax.

Sack "The Buffalo Range's TRUSTED News Source!"

“When a well-packaged web of lies has been sold gradually to the masses over generations, the truth will seem utterly preposterous and its speaker a raving lunatic.” ~ Dresden James

Parler @NYexile

 

 

 

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5 minutes ago, SackMan518 said:

I'm a big believer since it's a safer delivery system than the vax.

Oh look, we agree on something

“There he goes. One of God's own prototypes.

A high-powered mutant of some kind, never even considered for mass production.

Too weird to live, and too rare to die.”

 

Twitter: @HKTheResistance

 

HipKat, on *** other h***, is genuine, unapoli***tically nasty, and w**** his hea** on his ******. jc856

I’ll just forward them to Bridgett. comssvet11

Seek help. soflabillsfan

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1 hour ago, Philly'sFinest said:

 

Dr Peter McCullough...one of the foremost experts and who broke it all down on the Joe Rogan experience says those who have had covid have perfect immunity and there is no proven case of re-infection of sars-cov2.

There are studies that not everyone who has had Covid has developed antibodies. I saw that Rogan interview, BTW

“There he goes. One of God's own prototypes.

A high-powered mutant of some kind, never even considered for mass production.

Too weird to live, and too rare to die.”

 

Twitter: @HKTheResistance

 

HipKat, on *** other h***, is genuine, unapoli***tically nasty, and w**** his hea** on his ******. jc856

I’ll just forward them to Bridgett. comssvet11

Seek help. soflabillsfan

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5 hours ago, HipKat said:

There are studies that not everyone who has had Covid has developed antibodies. I saw that Rogan interview, BTW

That is 100% true and it also has been observed in the vaccinated as well.

Sack "The Buffalo Range's TRUSTED News Source!"

“When a well-packaged web of lies has been sold gradually to the masses over generations, the truth will seem utterly preposterous and its speaker a raving lunatic.” ~ Dresden James

Parler @NYexile

 

 

 

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