ExpressLane (12-18-2021), Grokmaster (12-18-2021), Sirthinksalot (12-18-2021)
Members banned from this thread: evince, christiefan915, ThatOwlWoman, LV426, reagansghost and Diesel |
Preventative MAbs are here and once again, Florida's got'em at all the Regen sites. Unlike vaccines,
MAbs do not rely on the body to create an immune response, and can therefore help individuals
with weak or compromised immune systems.
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Evusheld long-acting antibody combination retains neutralising activity against Omicron variant in independent FDA study
PUBLISHED 16 December 2021
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.
AstraZeneca
AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on Twitter @AstraZeneca.
Contacts
For details on how to contact the Investor Relations Team, please click here. For Media contacts, click here.
References
1. ACTIV. National Center for Advancing Translational Sciences OpenData Portal. SARS-CoV-2 Variants & Therapeutics, All Variants Reported in vitro Therapeutic Activity. Available at: https://opendata.ncats.nih.gov/variant/activity [Last accessed: December 2021].
2. Neerukonda, S.N. et al. Establishment of a well-characterized SARS-CoV-2 lentiviral pseudovirus neutralization assay using 293T cells with stable expression of ACE2 and TMPRSS2. PLOS ONE March 10, 2021. Available at https://journals.plos.org/plosone/ar...l.pone.0248348 [Last accessed December 2021].
3. Oliver, S. Data and clinical considerations for additional doses in immunocompromised people. ACIP Meeting July 22, 2021. Available at: https://www.cdc.gov/vaccines/acip/me...Oliver-508.pdf. [Last accessed: December 2021].
4. AstraZeneca data on file.
5. Corey L, et al. SARS-CoV-2 Variants in Patients with Immunosuppression. N Engl J Med. 2021; 385:562-566. DOI: 10.1056/NEJMsb2104756.
6. AstraZeneca news release. Evusheld reduced risk of developing severe COVID-19 or death in TACKLE Phase III outpatient treatment trial. Available at: https://www.astrazeneca.com/content/...tpatients.html. [Last accessed: December 2021].
7. Dong J, et al. Genetic and structural basis for recognition of SARS-CoV-2 spike protein by a two-antibody cocktail. bioRxiv. 2021; doi: 10.1101/2021.01.27.428529.
8. Robbie GJ, et al. A novel investigational Fc-modified humanized monoclonal antibody, motavizumab-YTE, has an extended half-life in healthy adults. Antimicrob Agents Chemother. 2013; 57 (12): 6147-53.
9. Griffin MP, et al. Safety, tolerability, and pharmacokinetics of MEDI8897, the respiratory syncytial virus prefusion F-targeting monoclonal antibody with an extended half-life, in healthy adults. Antimicrob Agents Chemother. 2017; 61(3): e01714-16.
10. Domachowske JB, et al. Safety, tolerability and pharmacokinetics of MEDI8897, an extended half-life single-dose respiratory syncytial virus prefusion F-targeting monoclonal antibody administered as a single dose to healthy preterm infants. Pediatr Infect Dis J. 2018; 37(9): 886-892.
11. AstraZeneca news release. New analyses of two AZD7442 COVID-19 trials in high-risk populations confirm robust efficacy and long-term prevention. Available at: https://www.astrazeneca.com/media-ce...revention.html. [Last accessed: December 2021].
12. van Erp EA, et al. Fc-mediated antibody effector functions during respiratory syncytial virus infection and disease. Front Immunol. 2019; 10: 548.
https://www.astrazeneca.com/media-ce...fda-study.html
Last edited by Stretch; 12-18-2021 at 10:39 AM.
Abortion rights dogma can obscure human reason & harden the human heart so much that the same person who feels
empathy for animal suffering can lack compassion for unborn children who experience lethal violence and excruciating
pain in abortion.
Unborn animals are protected in their nesting places, humans are not. To abort something is to end something
which has begun. To abort life is to end it.
ExpressLane (12-18-2021), Grokmaster (12-18-2021), Sirthinksalot (12-18-2021)
RON ROCKS!!!!
TRUMP WILL TAKE FORTY STATES...UNLESS THE SAME IDIOTS WHO BROUGHT US THE 2020 DUNCE-O-CRAT IOWA CLUSTERFUCK CONTINUE THEIR SEDITIOUS ACTIVITIES...THEN HE WILL WIN EVEN MORE ..UNLESS THE RED CHINESE AND DNC COLLUDE, USE A PANDEMIC, AND THEN THE DEMOCRATS VIOLATE ARTICLE II OF THE CONSTITUTION, TO FACILLITATE MILLIONS OF ILLEGAL, UNVETTED, MAIL IN BALLOTS IN THE DARK OF NIGHT..
De Oppresso Liber
ExpressLane (12-18-2021), Stretch (12-18-2021)
Florida Governor Ron DeSantis to make major announcement about Covid-19
__________________________________________________ ___________________________
Antibody Therapy Locator
Monoclonal Antibody Therapy
Monoclonal antibody treatments can prevent severe illness, hospitalization and death in high-risk patients who have contracted or been exposed to COVID-19. The antibodies help the immune system recognize and respond effectively to the virus. According to the treatment guidelines, they should be administered as soon as possible after diagnosis.
Treatment is free and vaccination status does not matter. If you are 12 years and older and are at high risk for severe illness due to COVID-19, you are eligible for this treatment.
There is currently a standing order in Florida signed by the State Surgeon General that allows patients to receive this treatment without a prescription or referral if administered by an eligible health care provider.
In clinical trials, monoclonal antibody treatment showed a 70% reduction in hospitalization and death.
For high-risk patients who have been exposed to someone with COVID19, Regeneron can give you temporary immunity to decrease your odds of catching the infection by over 80%.
For more information, call the Florida Department of Health Monoclonal Antibody Treatment Support Line: 850-344-9637.
AstraZeneca EvuSheld: Preventative Monoclonal Antibody Therapy
On December 8, 2021, the U.S. Food and Drug Administration issued an emergency use authorization for AstraZeneca’s Evusheld
for the pre-exposure prophylaxis (prevention) of COVID-19 in certain populations 12 years of age and older.
AstraZeneca’s Evusheld is authorized for:
Individuals who are moderately to severely immunocompromised and may not mount an adequate immune response to COVID-19 vaccines.
Individuals with a history of severe adverse reactions to COVID-19 vaccines and/or components of the vaccines.
The Florida Department of Health will continue to update the public as this therapy is delivered from the federal government and becomes
available at the providers below. Eligible individuals should contact their health care provider if interested in this pre-exposure therapy.
https://floridahealthcovid19.gov/mon...y/mab-locator/
Last edited by Stretch; 12-18-2021 at 10:41 AM.
Abortion rights dogma can obscure human reason & harden the human heart so much that the same person who feels
empathy for animal suffering can lack compassion for unborn children who experience lethal violence and excruciating
pain in abortion.
Unborn animals are protected in their nesting places, humans are not. To abort something is to end something
which has begun. To abort life is to end it.
Grokmaster (12-18-2021)
Pres.DeSantis has a nice ring to it....
TRUMP WILL TAKE FORTY STATES...UNLESS THE SAME IDIOTS WHO BROUGHT US THE 2020 DUNCE-O-CRAT IOWA CLUSTERFUCK CONTINUE THEIR SEDITIOUS ACTIVITIES...THEN HE WILL WIN EVEN MORE ..UNLESS THE RED CHINESE AND DNC COLLUDE, USE A PANDEMIC, AND THEN THE DEMOCRATS VIOLATE ARTICLE II OF THE CONSTITUTION, TO FACILLITATE MILLIONS OF ILLEGAL, UNVETTED, MAIL IN BALLOTS IN THE DARK OF NIGHT..
De Oppresso Liber
Stretch (12-18-2021)
Governor Ron DeSantis Highlights New Preventative Monoclonal Antibody for Immunocompromised Patients
On December 17, 2021, in News Releases, by Staff
OCALA, Fla. — Today, Governor Ron DeSantis was joined by Surgeon General Dr. Joseph Ladapo to announce a new long-acting COVID-19 monoclonal antibody therapy from AstraZeneca will be available for moderately to severely immunocompromised individuals, such as cancer patients and transplant recipients, at numerous health care provider locations in Florida, upon allocation from the federal government. A one pager about Evusheld can be found here.
“This monoclonal is a new tool for some of our most vulnerable Floridians and we are happy to make this available throughout the state,” said Governor Ron DeSantis. “Florida has been a leader in advocating for early treatment of COVID-19 and the availability of this new monoclonal is a continuation of the state’s efforts. Florida will continue to use a comprehensive approach to respond to COVID-19 and promote healthy living through Healthier You.”
“According to clinical trials, recipients of this new monoclonal antibody therapy saw a 77 percent reduced risk of developing COVID-19,” said State Surgeon General Dr. Joseph Ladapo. “Under Governor DeSantis’ leadership, Florida continues safeguarding vulnerable populations and providing protection options to all. Beyond COVID-19, our Healthier You initiative bolsters efforts to improve Floridians knowledge of how to best support their overall health.”
From staying active to learning new recipes and boosting your nutritional intake, the Florida Department of Health works through Healthier You to educate the public on ways to improve habits and overall health. This is a resource that encourages Floridians of all ages to get active, go outside, improve nutrition, including vitamin D intake, or learn about COVID-19.
The U.S. Food and Drug Administration (FDA) recently issued an emergency use authorization (EUA) for AstraZeneca’s Evusheld for the pre-exposure prophylaxis (prevention) of COVID-19 in certain populations 12 years of age and older.
AstraZeneca’s Evusheld is authorized for:
Individuals who are moderately to severely immunocompromised or are taking immunosuppressive medications and may not mount an adequate immune response to COVID-19 vaccines.
Individuals with a history of severe adverse reactions to COVID-19 vaccines and/or components of the vaccines or its ingredients.
Eligible patients should contact their health care provider if interested. Locations that will administer this monoclonal antibody therapy can be found at www.FloridaHealthCOVID19.gov. The Florida Department of Health will continue to update the public as this therapy is delivered from the federal government and becomes available.
One dose of AstraZeneca’s Evusheld, administered as two separate consecutive intramuscular injections (one injection per monoclonal antibody, given in immediate succession), may be effective for pre-exposure prevention for at least six months. Under the EUA,fact sheets for health care providers, patients and caregivers, and frequently asked questions AstraZeneca’s Evusheld are available on the FDA’s website. These fact sheets include dosing instructions, potential side effects, and drug interactions.
https://dr.flgov.com/2021/12/17/gove...ised-patients/
Abortion rights dogma can obscure human reason & harden the human heart so much that the same person who feels
empathy for animal suffering can lack compassion for unborn children who experience lethal violence and excruciating
pain in abortion.
Unborn animals are protected in their nesting places, humans are not. To abort something is to end something
which has begun. To abort life is to end it.
Abortion rights dogma can obscure human reason & harden the human heart so much that the same person who feels
empathy for animal suffering can lack compassion for unborn children who experience lethal violence and excruciating
pain in abortion.
Unborn animals are protected in their nesting places, humans are not. To abort something is to end something
which has begun. To abort life is to end it.
so far just for immonocompromised -but it's another tool in the box
meanwhile the crazed are locking down for omnicron
Stretch (12-18-2021)
Abortion rights dogma can obscure human reason & harden the human heart so much that the same person who feels
empathy for animal suffering can lack compassion for unborn children who experience lethal violence and excruciating
pain in abortion.
Unborn animals are protected in their nesting places, humans are not. To abort something is to end something
which has begun. To abort life is to end it.
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