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Coronavirus (COVID-19) Update: FDA Authorizes Additional Monoclonal About SotrovimabSotrovimab is an investigational SARS-CoV-2 neutralizing monoclonal antibody. Sotrovimab is contraindicated in patients who have a history of anaphylaxis to sotrovimab or to any of the excipients in the formulation. Sotrovimab offers may be in the form of a printable coupon, rebate, savings or copay card, trial offer, or free samples. how much does sotrovimab cost uk tuna salad with yogurt and apples. Our Standards: The Thomson Reuters Trust Principles. Early-stage clinical trial results may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. Of those patients, 291 received Sotrovimab, while the remaining 292 had a placebo. Issued: London, UK and San Francisco, US. That's how much it's expected to cost to set up and operate 25 state-run monoclonal antibody sites. Revised March 2022. In 2020, Vir responded rapidly to the COVID-19 pandemic by leveraging our unique scientific insights and industry-leading antibody platform to explore multiple monoclonal antibodies as potential therapeutic or preventive options for COVID-19. EMA issues advice on use of sotrovimab (VIR-7831) for treating COVID-19 what is the bench press for nba combine? or The government has ordered 7,700 doses of sotrovimab. The UK has already started rolling out an antibody cocktail to treat Covid called Ronapreve that was co-developed by Roche and Regeneron. 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. GlaxoSmithKline on Thursday said that a pre-clinical analysis of the antibody-based COVID-19 has indicated that the drug also works against the new Omicron variant. .gov 600,000 additional doses to be supplied to the US Government for distribution in Q1 2022, enabling further access to sotrovimab nationwide; . About global access to sotrovimab. Regarding expenses, for a 0km the patent cost will be $ 160,000 a year (according to the DNRPA valuation table), that is, about $ 13,000 per month. An interim analysis reported that COVID-19 had progressed in 3/291 patients infused with sotrovimab and 21/292 given a placebo. Vir Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Some of these events required hospitalization. Forward-looking statements contained in this press release include, but are not limited to, statements regarding the ability of sotrovimab to treat and/or prevent COVID-19, Virs collaboration with GSK, the ability of sotrovimab to maintain activity against currently circulating variants, and Virs plans and expectations for sotrovimab, and its COVID-19 portfolio. UK buys 100,000 doses of GSK's experimental Covid drug - The Telegraph This website links to third-party sites. how much is parking at calamigos ranch? Newsletter: Decoded . Last December the UK's Medicines and Healthcare Products Regulatory Agency approved sotrovimab for people aged over 12 with mild to moderate covid-19 who were at high risk of developing severe disease, after it was shown to reduce the risk of hospital admission and death by 79% in high risk adults with symptomatic covid-19. UK approves GSK's Covid antibody drug that slashes risk of . All quotes delayed a minimum of 15 minutes. Hospital admission or death occurred in 7 per cent of patients in the placebo group, and 1 per cent among those who received Sotrovimab. how much does sotrovimab cost uk . GlaxoSmithKline plc (LSE/NYSE: GSK) and Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that the European Commission (EC) has granted marketing authorisation to Xevudy (sotrovimab) for the early treatment of COVID-19.Sotrovimab is now approved in the European Union (EU) for the treatment of adults and adolescents . GSK and Vir Biotechnology announce sotrovimab (VIR-7831) receives Sotrovimab is given one time by injection into a vein by a health care professional. Regeneron Pharmaceuticals, Inc. revealed its intentions at the J.P. Morgan Healthcare Conference on January 9, 2023, to expand its Anti-SARS-CoV-2 Monoclonal Antibody offerings in 2023. COVID-19 monoclonal antibodies fees Initially, CMS anticipates that providers will not incur a cost for the mAb products Q0239, Q0243, Q0244, and Q0245. [11] On November 30, 2022, the FDA announced that bebtelovimab isnt currently authorized in any U.S. region because it isnt expected to neutralize Omicron sub-variants BQ.1 and BQ.1.1. However, scientists have warned that high transmission of the virus could lead to more dangerous mutations, including those that evade vaccines. Eligibility requirements vary for each program. Its research showed that sotrovimab, the Covid-19 antibody treatment it developed with Vir . For more information, review the COVID-19 provider toolkit. The data supporting this EUA for sotrovimab are based on an interim analysis from a phase 1/2/3 randomized, double-blind, placebo-controlled clinical trial in 583 non-hospitalized adults with mild . tumbling skills in order of difficulty; clubs on delaware ave in the 90s; alistair mackintosh fulham salary; hamish douglass wikipedia; how much does sotrovimab cost uk - comnevents.com A weekly roundup of the latest news and analysis sent every Monday. *As a healthcare provider, you must comply with the mandatory requirements of this EUA. This bulletin was updated on Jan. 6, 2022 in COVID-19 Bulletin #208.. It is a monoclonal antibody therapy developed by. Who Did Louis Armstrong Influence, You'll only need 1 dose. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data observed during preclinical or clinical studies, challenges in the treatment of hospitalized patients, difficulties in collaborating with other companies or government agencies, successful development and/or commercialization of alternative product candidates by Virs competitors, changes in expected or existing competition, delays in or disruptions to Virs business or clinical trials due to the COVID-19 pandemic, geopolitical changes or other external factors, and unexpected litigation or other disputes. How much does it cost? SARS-CoV-2 monoclonal antibodies may be associated with worse clinical outcomes when administered to hospitalized patients with COVID19 requiring high-flow oxygen or mechanical ventilation. Treatment began within five days of the start of symptoms. Sotrovimab Sotrovimab is authorized for use under an Emergency Use Authorization (EUA), so there is no dispute, and it is 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 . These reactions may be severe or life threatening. Hotel Laundry Attendant Job Description Resume, Copyright 2022 BNGRZ Studio | Powered by venetian gondola tickets, when does santa clara university send acceptance letters, Hotel Laundry Attendant Job Description Resume. how much does sotrovimab cost uk. What is sotrovimab, the COVID drug the government has bought before It saidthe need for antibodies and other therapeutics had always been under consideration. As such, we are actively preparing approximately 55,000 doses of sotrovimab for immediate allocation to your jurisdictions. Important: When there is a range of pricing, consumers should normally expect to pay the lower price. Sotrovimab should be used during pregnancy only if the potential benefit justifies the potential risk for the mother and the fetus. + There is a 10-day window to get the treatment after symptom onset, according to the Centers for . Validate Avid Account, The federal government is covering the cost of the monoclonal antibody therapies, so it is free to get, but . NICE 2023. Answer (1 of 2): A Fixed Maturity Plan (FMP) is a closed-ended fund that invests predominantly in debt instruments. Quality Seeds For Farmers Wealth Creation The federal . Due to these data, use of sotrovimab is not authorized in any U.S. state or territory at this time, as indicated in the FDA Fact Sheet for Healthcare Providers. Before the summer surge, Regeneron was shipping fewer than 25,000 doses per week, rising to more than 130,000 doses per week by mid August. Long, medium, and short descriptors of COVID-19 CPT codes are available from AMA website. Essendon Member Discounts, Does GlaxoSmithKline Covid Antibody Treatment Sotrovimab Work Against Product NDCs can be found in the EUA Fact Sheet for Healthcare Providers and can be used to identify the appropriate HCPCS codes for each product and its administration. There can be variation in the licensing of different medicines containing the same drug. Large molecular weight suggests limited excretion into milk. In a clinical trial, it was found that a single dose of sotrovimab was found to reduce the risk of hospitalisation and death by 79% in high-risk adults with symptomatic Covid-19 infection. The Pfizer and Merck drugs are meant to be taken at home, while GSK's antibody is administered in hospital or infusion centers. The patient or parent/caregiver has the option to accept or refuse sotrovimab. Therefore, youmay not administerREGEN-COV for treatment or post-exposure prevention of COVID-19 under the EUA until further notice. Name of the medicinal product. Monitor breast-fed infants for adequate feeding and hypersensitivity reactions. Meanwhile . (MHRA), UK on November 4, 2021. A full 8-milliliter dose of sotrovimab will cost roughly $2000, which is far from a competitive price point compared to other existing and emerging treatments for Covid-19. Clinical worsening of COVID19 after administration of SARS-CoV-2 monoclonal antibody treatment has been reported and may include signs or symptoms of fever, hypoxia or increased respiratory difficulty,arrhythmia (eg, atrial fibrillation, tachycardia, bradycardia), fatigue, and altered mental status. Available for Android and iOS devices. For intravenous infusion (Xevudy), dilute in 50mL or 100mL Glucose 5% or Sodium Chloride 0.9% and administer over 30 minutes through an in-line 0.2micron filter. A single dose of sotrovimab is administered through an injection or an IV as soon as someone tests positive for COVID. Sotrovimab Vir 7831 is an investigational single-dose monoclonal antibody for the treatment of mild-to-moderate COVID-19 in adults. This webpage provides the payment allowances and other related information for these products. Sotrovimab has obtained emergency authorization, temporary authorization or marketing approval (under the brand name Xevudy) for early treatment of COVID-19, supplying more than 40 countries. Main Menu [1a]Payment rate effective for dates of service on or after August 15, 2022. Sotrovimab is the first SARS-CoV-2-targeting antibody Vir advanced into the clinic. For sotrovimab For intravenous infusion (Xevudy), dilute in 50 mL or 100 mL Glucose 5% or Sodium Chloride 0.9% and administer over 30 minutes through an in-line 0.2 micron filter. [12]On January 26, 2023, the FDA announced that EVUSHELD isnt currently authorized for emergency use in the U.S. You should not place undue reliance on these statements, or the scientific data presented. This EUA for sotrovimab will end when the Secretary determines that the circumstances justify the EUA no longer exist or when there is a change in the approval status of the product such that an EUA may no longer be needed. Individuals with COVID-19 who are breastfeeding should follow practices according to clinical guidelines to avoid exposing the infant to COVID-19. When Texas Gov. Find out more, Markets approach mini-Budget madness levels ahead of Hunt's Spring Statement, How Tesco and Sainsbury's obsession with Aldi fuelled Britain's fruit and vegetable rationing crisis, British chipmakers hold talks with White House amid Biden charm offensive, Germany and Italy block Brussels from banning petrol and diesel cars, Students to be allowed to use ChatGPT for GCSE and A-level exams under Whitehall plans, Covid antibody treatment from GlaxoSmithKline. However, "the mutation of the virus and the risk this poses on antibody and vaccine efficacy has only recently been properly identified and still requires further academic studies". This sotrovimab price guide is based on using the Drugs.com discount card which is accepted at most U.S. pharmacies. In insurance, a complete third party has an average value of $ 6,000, a value that varies according to the insurer. The opinion relates to the use of sotrovimab for the treatment of adults and adolescents (aged 12 years and over and weighing at least 40 kg) with COVID-19 who do not require oxygen . Therefore, youmay not administersotrovimab to treat COVID-19 under the EUA until further notice. require an increase in baseline oxygen flow rate and/or respiratory support due to COVID-19 in those patients on chronic oxygen. COVID-19 CPT vaccine and immunization codes - AMA, COVID-19 Vaccination Training Programs and Reference Materials for Healthcare Professionals, Information about Public Health Emergency, Medicare Monoclonal Antibody COVID-19 Infusion Program Instruction, Quick reference guide to the coding structure for COVID-19 vaccine CPT reporting, Jan - Dec 2023 Geographically-adjusted Payment Rates for COVID-19 Vaccine Administration[For claims with dates of service 01/01/2023 through 12/31/2023], Jan - Dec 2023 Geographically-adjusted Payment Rates for Monoclonal Antibody Administration[For claims with dates of service 01/01/2023 through 12/31/2023], Jan - Dec 2022 Geographically-adjusted Payment Rates for COVID-19 Vaccine Administration (for Providers & Suppliers Paid MPFS-Adjusted Rates) (ZIP)*Updated 12/20/2022 to reflect the new codes for Moderna and Pfizer-BioNTech pediatric bivalent (updated COVID-19 vaccines) booster dose/ third dose [For claims with dates of service 12/08/2022 through 12/31/2022], Jan - Dec 2022 Geographically-adjusted Payment Rates for Monoclonal Antibody Administration (for Providers & Suppliers Paid MPFS-Adjusted Rates) (ZIP)*Updated 02/17/2022 to reflect the new codes for bebtelovimab [For claims with dates of service 02/11/2022 through 12/31/2022], Jan - March 2021 Geographically-adjusted Payment Rates for COVID-19 Vaccine Administration (for Providers & Suppliers Paid MPFS-Adjusted Rates) (ZIP)*Updated February 16, 2021 for addition of the COVID-19 Janssen vaccine*[For claims with dates of service of 1/1/2021 through 3/14/2021], March - Dec 2021 Geographically-adjusted Payment Rates for COVID-19 Vaccine Administration (for Providers & Suppliers Paid MPFS-Adjusted Rates) (ZIP)*Updated 11/02/2021 to account for effective dates for Pfizer-BioNTech COVID-19 Pediatric Vaccine[For claims with dates of service 3/15/2021 through 12/31/2021], Jan-May 2021 Geographically-adjusted Payment Rates for Monoclonal Antibody Administration (for Providers & Suppliers Paid MPFS-Adjusted Rates) (ZIP)[For claims with dates of service of 1/1/2021 through 5/5/2021], May-Dec 2021 Geographically-adjusted Payment Rates for Monoclonal Antibody Administration (for Providers & Suppliers Paid MPFS-Adjusted Rates) (ZIP)*Updated 12/23/2021 to account fornew codes fortixagevimab co-packaged with cilgavimab* [For claims with dates of service 5/6/2021 through 12/31/2021], 2020 Geographically-adjusted Payment Rates for COVID-19 Vaccine Administration (for Providers & Suppliers Paid MPFS-Adjusted Rates) (ZIP), 2020 Geographically-adjusted Payment Rates for Monoclonal Antibody Administration (for Providers & Suppliers Paid MPFS-Adjusted Rates) (ZIP). It is not known how much the Government paid for the drug. An official website of the United States government It works by attaching itself to the spike protein on the outside of the Covid-19 virus which in turn prevents the virus from attaching to and entering human cells, and therefore cannot replicate in the body. south bend fire department news. Sotrovimab | Dosage | Side Effects - iCliniq The drug was 100 per cent successful in preventing deaths and 99 per cent effective in stopping admissions to intensive care . All were Grade 1 (mild) or Grade 2 (moderate). how much does sotrovimab cost uk - ristarstone.com The Department for Health and Social Care has bought 100,000 doses of the treatment, called sotrovimab, which has yet to be approved by UK regulators but has been given the green light in the US,. Sotrovimab comes as a solution (liquid) to be mixed with additional liquid and then injected slowly into a vein by a doctor or nurse over 30 minutes. [3]Johnson & Johnson COVID-19 vaccine. Another COVID-19 treatment, Xevudy (sotrovimab), has today been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) after it was found to be safe and effective at reducing . Answer: Sotrovimab (Xevudy), developed by GlaxoSmithKline and Vir Biotechnology, is the second monoclonal antibody (mAb) to be approved for the treatment of COVID-19 infection (MHRA 2021) and the first to show activity against all SARS-CoV-2 variants of concern tested, including Mu (B.1.621), Omi. A recent trial suggested sotrovimab reduced the risk of hospitalisation or death for high-risk people with mild to moderate Covid-19 by 79pc. Listed as of 1 March, GPs can now prescribe molnupiravir (sold as Lagevrio), which will be available to patients for $42.50 per script - or $6.80 for concession card holders. Vir Biotechnology Announces Positive Final Draft Guidance on Sotrovimab Providers should not bill for the product if they received it for free. Sotrovimab is administered at a dose of 500 mg. how much does sotrovimab cost uk. 0. We comply with the HONcode standard for trustworthy health information. However, due to stock shortages and other unknown variables we cannot provide any guarantee. how much does sotrovimab cost uk. Next review due: 20 December 2024. Clinical Worsening After SARS-CoV-2 Monoclonal Antibody Administration. CNN . how much does sotrovimab cost uk. Sotrovimab, sold under the brand name Xevudy, cuts the risk of hospitalisation by 79 per cent among those at risk from the virus. Early in vitro data suggests sotrovimab retains activity against the Omicron variant. Share sensitive information only on official, secure websites. Reuters provides business, financial, national and international news to professionals via desktop terminals, the world's media organizations, industry events and directly to consumers. Tarafndan best linebackers in college football 2022 wheelock's latin table of contents . [10]On April 5, 2022, the FDA announced that, due to the high frequency of the Omicron BA.2 sub-variant, sotrovimab isnt currently authorized in any U.S. region. Following links contain helpful information for providers. Sotrovimab, sold under the brand name Xevudy, is a human neutralizing monoclonal antibody with activity against severe acute respiratory syndrome coronavirus 2, known as SARS-CoV-2. ICER plans to accept public comment on its draft and issue an updated evidence report in late March. COVID-19 Vaccines and Monoclonal Antibodies | CMS Duane Reade and 65,000 pharmacies nationwide. Other factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Virs filings with the US Securities and Exchange Commission, including the section titled Risk Factors contained therein. It was carefully selected for its demonstrated promise in preclinical research and potential ability to both block the virus from entering healthy cells and clear infected cells. state of decay 2 best facilities; yahoo google google; nc attorney general office. Learn about side effects, dosages, drug interactions, and more. 7 Therapeutic Goods Administration (TGA), Australia under provisional approval on January 20, 2022. Recevoir Sms En Ligne Canada, There are insufficient data to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcome. There are limited clinical data available for sotrovimab. Some offers may be printed right from a website, others require registration, completing a questionnaire, ) Due to existing inventory, no meaningful additional sales of sotrovimab in the UK are anticipated in 2023. What Is Stationary Design In Fiverr, how much does sotrovimab cost uk - gerstenfield.com Quoted prices are for cash-paying customers and are not valid with insurance plans. Sotrovimab | HHS/ASPR Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. It calculated Paxlovid was second at $18,000 per QALY gained, followed by molnupiravir at $55,000 and sotrovimab at $69,000. This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. Between Victoria, NSW and the ACT, there are 197 people in the ICU. Paxlovid Plus Sotrovimab In December 2021, two new oral antiviral therapies, Paxlovid and molnupiravir were authorized for use under EUAs for treatment of mild to moderate COVID-19.Treatment only; not approved for pre- or post-exposure prophylaxis Paxlovid , Molnupiravir, Evusheld) to.Sotrovimab has been shown to retain efficacy against Omicron.2022) Paxlovid PO6 Sotrovimab IV Remdesivir IV x . NHS England Interim Clinical Commissioning Policy: Antivirals or neutralising monoclonal antibodies for non-hospitalised patients with COVID-19 (available at: https://www.england.nhs.uk/coronavirus/publication/interim-clinical-commissioning-policy-neutralising-monoclonal-antibodies-or-antivirals-for-non-hospitalised-patients-with-covid-19/). Sotrovimab: how the UAE's new drug to treat Covid-19 works - The National Both Pfizer and Moderna upped European prices for their products this year; the EU will now pay $23.15 per dose of Pfizer's jab (up from $18.40), while Moderna is charging $25.50 for doses that previously cost around $22.60. Payment Allowances and Effective Dates for COVID-19 Monoclonal Antibodies and their Administration During the Public Health Emergency: EVUSHELD isnt currently authorized for emergency use in the U.S. Jan - Dec 2022 Geographically-adjusted Payment Rates for COVID-19 Vaccine Administration (for Providers & Suppliers Paid MPFS-Adjusted Rates) (ZIP). We welcome the final draft guidance from NICE which we believe is particularly meaningful as the organizations recommendations are informed by independent committees that aim to provide guidance to healthcare professionals on the best care options available to benefit their patients, said George Scangos, Ph.D., Chief Executive Officer of Vir. require oxygen therapy and/or respiratory support due to COVID-19, OR. Signs and symptoms of infusion-related reactions may include: fever, difficulty breathing, reduced oxygen saturation, chills, fatigue, arrhythmia (eg, atrial fibrillation, sinus tachycardia, bradycardia), chest pain or discomfort, weakness, altered mental status, nausea, headache, bronchospasm, hypotension, hypertension, angioedema, throat irritation, rash including urticaria, pruritus, myalgia, vaso-vagal reactions (eg, pre-syncope, syncope), dizziness, and diaphoresis. In the last few weeks, the agency had been limiting the use of sotrovimab in a growing number of regions as cases from the subvariant spread. With the mass-production of recombinant mAbs now capable of meeting demand, and at a cost that is competitive with other treatments (Taylor 2021), this line of potential therapy has generated much interest amongst developers. limited the authorized use of the Janssen COVID-19 vaccine. Except as required by law, Vir assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available. All you need to know about Sotrovimab, the newest COVID-19 treatment Serious hypersensitivity reactions, including anaphylaxis, have been observed with administration of sotrovimab. There are currently no Patient Assistance Programs that we know about for this drug. The government has secured 7700 doses of sotrovimab for the national medical stockpile. [8] On September 16, 2021, the FDA revised the EUA for bamlanivimab and etesevimab, administered together, to allow its use for post-exposure prophylaxis (PEP) in certain adult and pediatric patients. While Noom does advertise a free one-week trial, a subscription costs up to $59 a month. Were the sotrovimab . Hypersensitivity Including Anaphylaxis and Infusion-Related Reactions. Effectiveness of sotrovimab demonstrated in patients with mild to how much does sotrovimab cost ukinchkeith house mental health team Consultation Request a Free Consultation Now. It was carefully selected for its demonstrated promise in preclinical . One reaction led to temporary pausing of the infusion. [9] On January 24, 2022, the FDA announced that, due to the high frequency of the Omicron variant, REGEN-COV (casirivimab and imdevimab, administered together) isnt currently authorized in any U.S region. ICER also analyzed the cost-effectiveness of fluvoxamine, a 40-year-old generic pill used to treat conditions such as obsessive-compulsive disorder and depression at a cost of about $10 for a 10-day course. Serious and unexpected adverse events may occur that have not been previously reported with sotrovimab use. is executive career partners legitimate -&nbspbighorn mountains weather - how much does sotrovimab cost uk; 8 jun, 2022 What Is Sotrovimab, The COVID Drug The Government Bought Before Being . houseboat netherlands / brigada pagbasa 2021 memo region 5 / how much does sotrovimab cost uk. FACT SHEET FOR US HEALTHCARE PROVIDERS (ENGLISH), FACT SHEET FOR US HEALTHCARE PROVIDERS (SPANISH), FACT SHEET - HEALTHCARE PROVIDERS (ENGLISH), FACT SHEET - HEALTHCARE PROVIDERS (SPANISH), https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#coviddrugs, Fact Sheet for Patients, Parents, and Caregivers, Fact Sheet for Patients, Parents, and Caregivers (English), Fact Sheet for Patients, Parents, and Caregivers (Spanish), https://www.fda.gov/media/149534/download, https://www.fda.gov/media/149533/download, https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/prevention.html, Sotrovimab is not authorized for treatment of mild-to-moderate COVID-19 in geographic regions where infection is likely to have been caused by a non-susceptible SARS-CoV-2 variant based on available information including variant susceptibility to these drugs and regional variant frequency [see. Once 2021 turns to 2022, state officials say they could need another $634.3 million in order . 1. The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of the unapproved product sotrovimab monoclonal antibody (MAB) for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients (12 years of age and older weighing . The data considered by the Therapeutic Goods Administration included 528 patients given sotrovimab and 529 given placebo.