The new rate reflects updated information about the costs involved in administering these types of monoclonal antibody products for different types of providers and suppliers and the resources necessary to ensure providers administer the products safely and appropriately. According to Public Health England, most side-effects from two Covid vaccines - Pfizer/BioNTech and Oxford/AstraZeneca - are mild and short-lived. Adults and children 12 years of age and olderAt first, 600 milligrams (mg) (two 300 mg injections) injected under the skin at different injection sites. [22] The EUA for sotrovimab is for a single dose of 500 mg IV.[12]. In these situations, use the following HCPCS codes to bill for casirivimab and imdevimab: The September 16, 2021, revised EUA for bamlanivimab and etesevimab allows for its use for PEP in certain adult and pediatric patients. https:// COVID-19 therapeutics can be used to prevent or treat eligible non-hospitalized patients who have tested positive for COVID-19 and have mild to moderate symptoms. As newviral variants emerge, the spike neutralizing effects of monoclonal antibodies become more unclear. However, if the patient is only in that location temporarily (such as if your patient has a permanent home but is in a post-acute stay in a skilled nursing facility), the setting isnt considered a patients home or residence for this purpose, and you shouldnt bill for the higher at home HCPCS code M0221. Wegeographically adjustthe rate based on where you furnish the service. As demonstrated above, monoclonal antibody therapy used in the treatment of outpatient COVID-19 in patients at risk for developing severe disease has the potential to decrease hospitalizations and mortality. Monoclonal Antibodies to Treat Mild-to-Moderate COVID-19 The FDA approved or authorized under EUA the following additional investigational monoclonal antibody therapies: ACTEMRA (tocilizumab) (EUA issued June, 24 2021, latest update December 21, 2022). Evusheld is the only non-vaccine with emergency use authorization (EUA) from the FDA to prevent infection from COVID-19 before you're exposed to the virus. Swollen lips, face or throat. Identify the potential adverse reactions to monoclonal antibody therapy in the management of outpatient COVID-19. Lpez-Medina E, Lpez P, Hurtado IC, Dvalos DM, Ramirez O, Martnez E, Dazgranados JA, Oate JM, Chavarriaga H, Herrera S, Parra B, Libreros G, Jaramillo R, Avendao AC, Toro DF, Torres M, Lesmes MC, Rios CA, Caicedo I. Heres how you know. Note: On April 16, 2021, the FDA revoked the EUA for bamlanivimab when administered alone. You are not required to obtain permission to distribute this article, provided that you credit the author and journal. REGEN-COV (previously known as REGN-COV2), a combination of the monoclonal antibodies casirivimab and imdevimab, has been shown to markedly reduce the risk of hospitalization or death among. Effective for services furnished on or after May 6, 2021, the Medicare payment rate for administering COVID-19 monoclonal antibody products through infusion in a patients home or residence is approximately $750. These include soreness where the jab was. Medicare also pays for treatment to address major complications: For COVID-19 monoclonal antibody products administered before May 6, 2021, the Medicare payment rate is approximately $310. The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the causative agent in COVID-19, has created a global pandemic and overwhelmed hospital systems globally. There are several variants of concern that have been identified, such as the Alpha variant (B1.1.7 lineage, UK origin), Beta variant (B.1351 lineage, South African origin), Gamma variant (P.1/B.1.1.28.1 lineage, Brazilian origin), Delta variant (B1.617.2 lineage, Indian origin). A nurse enters a monoclonal antibody site, Wednesday, Aug. 18, 2021, at C.B. or Nonetheless, monoclonal antibodies appear to be a promising option in the treatment of COVID-19 and have the potential to prevent hospitalizations and mortality. For most Medicare Advantage hospice patients, submit claims to Original Medicare. It works by stopping SARS-CoV-2 from spreading in the body. Early Treatment for Covid-19 with SARS-CoV-2 Neutralizing Antibody Sotrovimab. Getprovider enrollmentinformation. CMS created HCPCS code J0248 for VEKLURY, effective December 23, 2021. Monoclonal antibodies are laboratory-made "substitute antibodies" that can help the immune system recognize and respond more effectively to COVID-19, according to the U.S. Food and Drug. Flu-like symptoms (fever, sweating, chills, cough, sore throat, headache or muscle pain) Upset stomach (nausea, vomiting or diarrhea) Itching, swelling, rash or hives. In vitro studies have shown that sotrovimab maintains spike neutralizing activity against all variants of concern, including Omicron. As a result, CMS issued a new product code for REGEN-COV (Q0244) and updated the descriptors for the existing administration codes (M0243/M0244). But Regeneron Pharmaceuticals, maker of the only authorized, free monoclonal . Risk factors for severe and critically ill COVID-19 patients: A review. Monoclonal antibodies, however, are produced by a single B-lymphocyte clone and are highly specific for their target antigen. Prevention and early treatment for eligible patients can help improve patient outcomes, reduce stress on healthcare facilities, and even save lives. Monoclonal antibodies are proteins developed in a lab in order to fight off infections that our bodies aren't familiar with, like COVID-19. Managing Chemotherapy Side Effects: Achieving Reliable and Equitable Outcomes. Providers and suppliers should use Q0245 and M0245 or M0246 to bill for administering bamlanivimab and etesevimab for PEP. [3]On June 3, 2021, the FDA revised the EUA for REGEN-COV (casirivimab and imdevimab, administered together) to change the allowed dosing regimen from 2400 mg to 1200 mg and allow providers to administer the combination product by subcutaneous injection in limited circumstances. Vaccine recipients with preexisting immunity had systemic side effects at higher frequencies than those without preexisting immunity (fatigue, headache, chills, muscle pain, fever, and joint. Inpatient locations, such as inpatient hospitals, inpatient psychiatric hospitals, long-term care hospitals, and inpatient rehabilitation hospitals, would never qualify as the home or residence for purposes of HCPCS code M0221. Injection site reactions and infusion-related reactions are the most commonly reported adverse events. The effective management of COVID-19 with monoclonal antibodies and ensuring patient safety requires the coordinated efforts of an interprofessional healthcare team, including clinicians (MDs, DOs, NPs, PAs), specialists (e.g., infectious disease specialists, virologists), pharmacists, nurses, and medical assistants. Monoclonal antibodies are intended to trigger the immune system and, in doing so, the body may respond with flu-like symptoms. Sotrovimab targets a highly conserved epitope of the RBD that is present across the entire family of SARS-like coronaviruses. Continue to use the same codes to bill for administering bamlanivimab and etesevimab for PEP and treatment: Effective February 11, 2022, CMS updated the Medicare payment rates for the administration of COVID-19 monoclonal antibody products by intravenous (IV) injection. Doessegger L, Banholzer ML. For many providers and suppliers, we also geographically adjust this rate based on where you furnish the service. Monoclonal antibodies are one such treatment that may . Treatment Locator Monoclonal antibodies targeting the spike protein of the SARS-CoV-2 have yielded positive in vitro results. Get themost current geographically adjusted rates. Vaccines prevent progression for a larger part of the population. ), which permits others to distribute the work, provided that the article is not altered or used commercially. Then, your dose will be reduced to 300 mg every other week. Former President Donald . [16]This receptor is found on the respiratory epithelium, upper esophagus, ileum, myocardium, proximal tubular cells in the kidney, and the urothelium of the bladder. Think of them as reinforcements from someone who had more time to build up defenses against COVID-19 which your immune system can benefit from earlier on. bleeding or infection at the injection site. COVID-19 Genomics UK (COG-UK) Consortium. It's important to note that the pill is meant to be taken after you've experienced COVID-19 symptoms. Effect of Ivermectin on Time to Resolution of Symptoms Among Adults With Mild COVID-19: A Randomized Clinical Trial. Benefits And Risks Of Administering Monoclonal Antibody Therapy For Coronavirus (COVID-19). COVID-19 outbreak: history, mechanism, transmission, structural studies and therapeutics. This rate applies to all providers and suppliers not paid reasonable cost for furnishing these products. Monoclonal antibodies are administered either subcutaneously or as an intravenous infusion. These are not all the possible side effects. Healthcare providers must be able to recognize patients at risk for progression to severe disease who would benefit from monoclonal antibody infusion and recognize which patients must be hospitalized for severe infection. Effective for IV injection services furnished on or after February 11, 2022 (such as the administration of bebtelovimab), the Medicare payment rate for administering these COVID-19 monoclonal antibody products, authorized or approved by the FDA, is approximately $350.50. As with payments for administering other COVID-19 monoclonal antibodies, the separate Medicare payment amount of $450 per infusion of ACTEMRA applies to all hospitals not paid reasonable cost for furnishing these products consistent with the FDA approval or EUA. In the clinical trial, molnupiravir was given to study participants in four capsules twice a day for five daysstarting within five days after patients experienced the first symptoms of COVID-19.. Side effects: Nausea is the most common side effect. Most infusion-related reactions are self-limited and treated by stopping the infusion and symptomatic treatment. For more information about viral variants in your area to help you make treatment decisions: Eligible administration sites must coordinate with their respective state or territorial health department to order these COVID-19 monoclonal antibodies: Get more information on the ordering process and reporting requirements. CMS geographically adjusts the rate based on where you furnish the service. In: StatPearls [Internet]. You might have both United States Government (USG)-purchased and commercial product in your inventory. Get the most currentlist of billing codes, payment allowances, and effective dates for currently authorized monoclonal antibody products. [6] 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. Benefits And Risks Of Administering Monoclonal Antibody Therapy For Coronavirus (COVID-19) [Updated 2022 Apr 28]. Evusheld therapy is made up of 1 injection of tixagevimab and 1 injection of cilgavimab, given separately into your muscle, one right after the other. Get the most current payment allowances and effective dates for these products. Our approach to paying for these products under the Part B preventive vaccine benefitduring the public health emergency (PHE) allows a broad range of providers and suppliers to administer these products, including but not limited to: To help skilled nursing facilities (SNFs) efficiently administer COVID-19 vaccines (including COVID-19 monoclonal antibody products) to residents, CMS has exercised enforcement discretion for certain statutory provisions and any associated statutory references and implementing regulations, including as interpreted in pertinent guidance (collectively, SNF Consolidated Billing Provisions). Effective January 1 of the year after that in which the EUA declaration ends: On May 6, 2021, CMS updated the Medicare payment rates for the administration of COVID-19 monoclonal antibody products. The word "monoclonal" refers to the fact that the antibodies created in the laboratory are clones. An EUA for bamlanivimab and etesevimab for COVID-19. Infusion-related reactions are potential adverse reactions when administering monoclonal antibodies and are common with drugs such as rituximab. Learn more about what to do if you are sick. This activity outlines the indications, actions, contraindications, and adverse events for monoclonal antibody therapy as a valuable treatment for outpatient COVID-19 infections. As more data is released and reviewed, the current recommendations regarding monoclonal antibody therapy may change. swelling. This rate reflects information about the costs involved in furnishing these products in a patients home. Given that, a TGC . Abbott is receiving monoclonal antibody treatment after testing positive for COVID-19. [1]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. TGC has proven to be of value in treatment of multidrug-resistant infections, but therapy can be complicated by multiple dangerous side effects, including direct drug toxicity. Pregnant people. This rate reflects updated information about the costs involved in furnishing these complex products in a patients home. On January 24, 2022, the FDA announced that, Sotrovimab (EUA issued May 26, 2021, latest update February 23, 2022). Hypersensitivity, including infusion-related and . "As you may know, Gov. Monoclonal antibodies, such as casirivimab and imdevimab, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or. Effective for services furnished on or after December 8, 2021, the Medicare payment rate for administering COVID-19 monoclonal antibody products through intramuscular injection for pre-exposure prophylaxis (such as tixagevimab co-packaged with cilgavimab, administered as 2 separate consecutive intramuscular injections), in select patient populations, in a patients home or residence, is approximately $250.50. Healthcare providers should also be aware of the resistance of certain variants of the SARS-CoV-2 virus. Doctors have alternate therapies to battle early. The chances of any of these side effects occurring after vaccination differ according to the specific vaccine. The Food and Drug Administration authorized the first injectable monoclonal antibody cocktail for long-term prevention of Covid-19 among people with weakened immune systems before they have. Continue to bill for administering either type of product. A one-time dose of two long-acting monoclonal antibodies reduced the risk of developing symptomatic COVID by 77% in comparison with placebo ( P < .001) in a randomized, double-blind, placebo . Dizziness or low blood pressure. For more information about the limits of authorized use for these monoclonal antibody therapies, including information about viral variants and antiviral resistance, review the following: The virus that causes COVID-19 (SARS-CoV-2) is constantly changing, and CDC expects new viral variants to continue to emerge. Essentially, monoclonal antibody therapy for viral infection involves generating an antibody molecule type that reacts with the virus. Infusion-related reactions typically present after 30to 60 minutes after initiating the infusion. A monoclonal antibody (mAb) is a type of immune protein produced in a lab that binds to a specific protein on a cell called an antigen . It targets the RBD of the SARS-CoV-2 spike protein. The side effects of receiving any medicine by vein may include brief pain, bleeding, bruising of the skin, soreness, swelling, and possible infection at the injection site. .gov Original Medicare wont pay these claims. In the same patient population, mortality was also greatly increased compared to younger healthy individuals (19.5% vs. Coronavirus Disease 2019 Case Surveillance - United States, January 22-May 30, 2020. Choi JC, Kim WY. Bamlan and etesev infus home, Note: This product isnt currently authorized[6], Long descriptor: Injection, sotrovimab, 500 mg, Long Descriptor: Intravenous infusion, sotrovimab, includes infusion and post administration monitoring, Long Descriptor: Intravenous infusion, sotrovimab, includes infusion and post administration monitoring in the home or residence; this includes a beneficiarys home that has been made provider-based to the hospital during the COVID-19 public health emergency, Short Descriptor: Sotrovimab inf, home admin, Genentechs Antibody ACTEMRA (tocilizumab), Long descriptor: Injection, tocilizumab, for hospitalized adults and pediatric patients (2 years of age and older) with covid-19 who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO) only, 1 mg, Short descriptor: Tocilizumab for COVID-19, Long Descriptor: Intravenous infusion, tocilizumab, for hospitalized adults and pediatric patients (2 years of age and older) with covid-19 who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO) only, includes infusion and post administration monitoring, first dose, Short Descriptor: Adm Tocilizu COVID-19 1st, Long descriptor: Intravenous infusion, tocilizumab, for hospitalized adults and pediatric patients (2 years of age and older) with covid-19 who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO) only, includes infusion and post administration monitoring, second dose, Short descriptor: Adm Tocilizu COVID-19 2nd, AstraZenecas Antibody EVUSHELD (tixagevimab and Cilgavimab)Note: This product isnt currently authorized[8], Long descriptor: Injection, tixagevimab and cilgavimab, for the pre-exposure prophylaxis only, for certain adults and pediatric individuals (12 years of age and older weighing at least 40kg) with no known sars-cov-2 exposure, who either have moderate to severely compromised immune systems or for whom vaccination with any available covid-19 vaccine is not recommended due to a history of severe adverse reaction to a covid-19 vaccine(s) and/or covid-19 vaccine component(s), 300 mg, Long descriptor: Injection, tixagevimab and cilgavimab, for the pre-exposure prophylaxis only, for certain adults and pediatric individuals (12 years of age and older weighing at least 40kg) with no known sars-cov-2 exposure, who either have moderate to severely compromised immune systems or for whom vaccination with any available covid-19 vaccine is not recommended due to a history of severe adverse reaction to a covid-19 vaccine(s) and/or covid-19 vaccine component(s), includes injection and post administration monitoring, Long descriptor: Injection, tixagevimab and cilgavimab, for the pre-exposure prophylaxis only, for certain adults and pediatric individuals (12 years of age and older weighing at least 40kg) with no known sars-cov-2 exposure, who either have moderate to severely compromised immune systems or for whom vaccination with any available covid-19 vaccine is not recommended due to a history of severe adverse reaction to a covid-19 vaccine(s) and/or covid-19 vaccine component(s), includes injection and post administration monitoring in the home or residence; this includes a beneficiarys home that has been made provider-based to the hospital during the covid-19 public health emergency, Short descriptor: Tixagev and cilgav inj hm, Long Descriptor:Injection, tixagevimab and cilgavimab, for the pre-exposure prophylaxis only, for certain adults and pediatric individuals (12 years of age and older weighing at least 40kg) with no known sars-cov-2 exposure, who either have moderate to severely compromised immune systems or for whom vaccination with any available covid-19 vaccine is not recommended due to a history of severe adverse reaction to a covid-19 vaccine(s) and/or covid-19 vaccine component(s), 600 mg, Short Descriptor:Tixagev and cilgav, 600mg, Long descriptor:Injection, tixagevimab and cilgavimab, for the pre-exposure prophylaxis only, for certain adults and pediatric individuals (12 years of age and older weighing at least 40kg) with no known sars-cov-2 exposure, who either have moderate to severely compromised immune systems or for whom vaccination with any available covid-19 vaccine is not recommended due to a history of severe adverse reaction to a covid-19 vaccine(s) and/or covid-19 vaccine component(s), includes injection and post administration monitoring, Long descriptor:Injection, tixagevimab and cilgavimab, for the pre-exposure prophylaxis only, for certain adults and pediatric individuals (12 years of age and older weighing at least 40kg) with no known sars-cov-2 exposure, who either have moderate to severely compromised immune systems or for whom vaccination with any available covid-19 vaccine is not recommended due to a history of severe adverse reaction to a covid-19 vaccine(s) and/or covid-19 vaccine component(s), includes injection and post administration monitoring in the home or residence; this includes a beneficiarys home that has been made provider-based to the hospital during the covid-19 public health emergency, Short descriptor:Tixagev and cilgav inj hm, Eli Lilly and Companys Antibody Bebtelovimab (PDF), Note: This product isnt currently authorized[7], Long descriptor:Injection, bebtelovimab, 175 mg, Long Descriptor:Intravenous injection, bebtelovimab, includes injection and post administration monitoring, Long Descriptor:Intravenous injection, bebtelovimab, includes injection and post administration monitoring in the home or residence; this includes a beneficiarys home that has been made provider-basedto the hospital during the covid-19 public health emergency, Short Descriptor: Bebtelovimab injection home. Nursing staff should be aware of the proper preparation of the medications and the recommended infusion rates. 1.6%).[28]. While the initial data regarding monoclonal antibodies in the treatment of COVID-19 appears promising, at this time, thebulk ofthis data is preliminary and unpublished and has not been peer-reviewed. The U.S. Food and Drug Administration has authorized treatments that have already been taken by millions of people, reducing their COVID-19 symptoms and keeping many of them out of the hospital. Monoclonal antibody therapy is indicated for use in non-hospitalized patients with mild to moderate disease who have risk factors for progression to severe disease. Medicare will establish codes and rates for administering new products as the FDA approves or authorizes each product. These rates dont apply if Medicare pays you for preventive vaccines and their administration at reasonable cost (for example, Federally Qualified Health Centers (FQHCs), Rural Health Clinics (RHCs), and Hospital-based Renal Dialysis Facilities). COVID-19 vaccines protect against the SARS-CoV-2 virus only, so it's still important to keep yourself healthy and well. http://creativecommons.org/licenses/by-nc-nd/4.0/. CMS geographically adjusts the rate based on where you furnish the service. Find More Information about COVID-19 COVID-19 Vaccines Exposed to COVID-19 People With a Weakened Immune System Risk factors for worsening infection include chronic medical problems like diabetes, a weakened immune system, and age greater than 65. At high risk of dying from the virus, Barron remains a virtual prisoner in her . There may not be data from patients, but lab studies strongly suggest the treatments will not help omicron-infected people. While individuals of all ages are at risk of contracting COVID-19 and developing severe disease, several risk factors have been identified that place patients at higher risk for morbidity and mortality. Monoclonal antibodies boost the immune system after you are already sick, speeding up your immune response to prevent COVID-19 from getting worse. [25][26]One percentof the patients who received sotrovimab had infusion-related reactions. The expert clinicians agree that my best hope is Humira (generic name, adalimumab), one in a class of drugs known as monoclonal antibodies that block the immune system proteins that make joints . For outpatients, the treatment is a three-day course of infusions that must be initiated within seven days of symptom onset. Mass immunizers may bill using a roster bill or a traditional claim form, such as a, Enrollment for Administering COVID-19 Vaccine Shots, Medicare Billing for COVID-19 Vaccine Shot Administration, SNF: Enforcement Discretion Relating to Certain Pharmacy Billing, Beneficiary Incentives for COVID-19 Vaccine Shots, CMS Quality Reporting for COVID-19 Vaccine Shots, New COVID-19 Treatments Add-On Payment (NCTAP), FDA approved a supplemental New Drug Application (NDA) for VEKLURY, FDA announced approval of a new indication for ACTEMRA, FDA announced that bebtelovimab isnt currently authorized in any U.S. region, treatment guidelines and recommendations for using monoclonal antibody therapies, Fact Sheet for Health Care Providers EUA of ACTEMRA(tocilizumab) (ZIP), Fact Sheet for Health CareProvidersEUA of Bamlanivimab and Etesevimab, Fact Sheet for Health Care Providers EUA for EVUSHELD (tixagevimab co-packaged with cilgavimab) (ZIP), Fact Sheet for Health CareProvidersEUA of REGEN-COV (casirivimab and imdevimab) (PDF), Fact Sheet for Health Care Providers EUA of Sotrovimab, ordering process and reporting requirements, Genentechs Antibody ACTEMRA (tocilizumab, AstraZenecas Antibody EVUSHELD (tixagevimab and Cilgavimab), most currentlist of billing codes, payment allowances, and effective dates, Section 3713 of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), most current geographically adjusted rates, most current list of billing codes, payment allowances, and effective dates for currently authorized monoclonal antibody products, most currentlist of billing codes, payment allowances, and effective dates for currently authorized monoclonal antibody products, New COVID-19 Treatments Add-on Payment (NCTAP), most current payment allowances and effective dates for these products. Health care providers administering the infusions and injections of COVID-19 monoclonal antibody products will follow the same enrollment process as those administering the COVID-19 vaccines. Once symptoms resolve, the infusion may be restarted at a slower rate. Dont bill for USG-purchased products. Beginning on May 6, 2021, Medicare established separate coding and payment for administering COVID-19 monoclonal antibody products through infusion in a patients home or residence. [19], The monoclonal antibodies developed act by neutralizingthe spike protein of SARS-CoV-2. This rate reflects updated information about the costs involved in furnishing these complex products in a patients home. Health care providers can bill on a single claim for administering COVID-19 monoclonal antibody products, or submit claims on a roster bill. Health authorities worldwide continue to encourage those who receive a COVID-19 vaccine to report any side effects to a healthcare professional. Immunosuppression either via disease or treatment, Cardiovascular disease (including hypertension, coronary artery disease, heart failure, congenital heart defects), Chronic lung disease (COPD, asthma, cystic fibrosis, interstitial lung disease, pulmonary hypertension), Neurodevelopmental disorders or other conditions that increase medical complexity. Share sensitive information only on official, secure websites. Clinical development methodology for infusion-related reactions with monoclonal antibodies. They should review the information found in section 15 on the fact sheets issued for each of the monoclonal antibodies. Side effects can range from mild to serious and may include: Wheezing or trouble breathing. These antibodies were identified by analyzing convalescent plasma obtained from patients infected with COVID-19. There are specific conditions people need to meet in order to receive the medication. Monoclonal antibodies are given intravenously (injected into a vein). Rarely, some patients will have what's called an "infusion reaction," where they have itching and throat tightness it looks similar to an allergic reaction. As mentioned above,the FDA revoked its authorizations for previously authorized monoclonal antibodies as they did not maintain efficacy against the Omicron variant. This study showed a high prevalence of transient COVID-19 vaccine-related side-effects after primary and booster doses. For patients who meet the criteria for repeat dosing, the authorized dosage is an initial dose of 1200 mg, followed by subsequent repeat dosing of 600 mg once every 4 weeks for the duration of ongoing exposure. [1]Since its initial identification,SARS-CoV-2 has spread worldwide and incited a global pandemic. means youve safely connected to the .gov website. An official website of the United States government Few cases of anaphylaxis have been reported.
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