Materiały źródłowe

• #1 Vaccines, therapeutics, and diagnostics for covid-19: redesigning systems to improve pandemic response | The BMJ

  https://www.bmj.com/content/375/bmj-2021-067488

  Vaccines, therapeutics, and diagnostics are key public health tools for controlling the covid-19 pandemic, yet many countries, particularly low and middle income countries (LMICs), have had inadequate access. […] The Access to COVID-19 Tools Accelerator (ACT-A) is a multilateral coordination mechanism set up to accelerate development, production, and equitable access to covid-19 tests, treatments, and vaccines globally. […] Testing did receive political attention but has been a bottleneck in many countries. […] The lack of a clear strategy to guide research and manufacturing also applies to diagnostic tests. The development and use of target product profiles could have established the type of tests wanted, including specifications for sensitivity and specificity, early on. […] WHOs research and development blueprint served to establish a common research agenda quickly. It was most effective in supporting vaccine product development and to a lesser extent for diagnostics.

• #2 COVID-19 Claims Reimbursement to Health Care Providers and Facilities for Testing, Treatment, and Vaccine Administration for the Uninsured | HRSA

  https://www.hrsa.gov/provider-relief/about/covid-uninsured-claim

  The Department of Health and Human Services (HHS) provided claims reimbursement to health care providers for testing uninsured individuals for COVID-19, treating uninsured individuals with a COVID-19 diagnosis, and administering COVID-19 vaccines to uninsured individuals. […] A separate program, the HRSA COVID-19 Coverage Assistance Fund, was available to reimburse providers for COVID-19 vaccine administration to underinsured individuals whose health plan either did not include COVID-19 vaccination as a covered benefit or covered COVID-19 vaccine administration but with cost-sharing. […] No claims submitted after April 5, 2022, at 11:59 p.m. ET for vaccine administration were processed for adjudication/payment.

• #3 COVID-19: Progress in diagnostics, therapy and vaccination

  https://pmc.ncbi.nlm.nih.gov/articles/PMC7359073/

  COVID-19 patients present a wide range of clinical symptoms (e.g., cough, fever, and dyspnea) that are similar to influenza or other respiratory infections and thus cannot be used for accurate diagnosis. […] At present, accurate and rapid diagnosis has evolved as a tool for detecting this novel coronavirus. Molecular-based approaches are the first-line methods to confirm suspected cases. Nucleic acid testing is the main technique for laboratory diagnosis. […] Reverse transcription quantitative PCR (RT-qPCR) is the most common and straightforward method for the detection of SARS-CoV-2 owing to its advantages as a specific, sensitive and simple quantitative assay, which greatly helps in the diagnosis of early infection. […] Although RT-qPCR assays using respiratory samples provided sensitive and specific diagnostic tests at the initial phase of the outbreak, these RT-qPCR test kits have many limitations.

• #4 COVID-19: Progress in diagnostics, therapy and vaccination

  https://pmc.ncbi.nlm.nih.gov/articles/PMC7359073/

  Specific testing for SARS-CoV-2 has great significance for public health and clinical practice, and evidence from studies further demonstrate that RT-qPCR detection combined with serological testing enhances diagnosis sensitivity while maintaining high specificity. […] Another type of rapid diagnostic test (RDT) that detects the presence of viral antigens expressed by SARS-CoV-2 virus in a respiratory tract sample is of low complexity and may provide results typically within 30 minutes.

• #5 Overview of Testing for SARS-CoV-2 | COVID-19 | CDC

  https://www.cdc.gov/covid/hcp/clinical-care/overview-testing-sars-cov-2.html

  Viral tests, including nucleic acid amplification tests (NAATs) and PCR tests, as well as antigen tests, are used as diagnostic tests to detect current infection with SARS-CoV-2, determine the need for prevention measures, and inform a person’s medical care. […] Positive viral test results indicate current infection and the person with COVID-19 should take steps to prevent spreading COVID-19 to others. […] Negative viral test results mean the test did not detect the virus, but this doesn’t rule out that the person could have an infection. […] Antibody (or serology) tests are used to test for the presence of antibodies from previous infection or vaccination and can aid in fulfilling the case definition for multisystem inflammatory syndrome in children (MIS-C) and adults (MIS-A). Antibody testing does not diagnose current infection.

• #6 Coronavirus disease 2019 (COVID-19) – Diagnosis and treatment – Mayo Clinic

  https://www.mayoclinic.org/diseases-conditions/coronavirus/diagnosis-treatment/drc-20479976

  If you have symptoms of coronavirus disease 2019, known as COVID-19, or you’ve been exposed to the COVID-19 virus, contact your healthcare team. Let them know if you’ve had close contact with anyone diagnosed with COVID-19. […] In the United States, at-home COVID-19 tests are available. Free tests can be mailed to U.S. addresses, or you can purchase tests in stores, pharmacies or online. The U.S. Food and Drug Administration, also known as the FDA, approves or authorizes the tests. On the FDA website, you can find a list of the tests that are validated and their expiration dates. You also can check with your healthcare professional before buying a test if you have any concerns. […] COVID-19 tests also are available from healthcare professionals, some pharmacies and clinics, or at community testing sites.

• #7 Overview of Testing for SARS-CoV-2 | COVID-19 | CDC

  https://www.cdc.gov/covid/hcp/clinical-care/overview-testing-sars-cov-2.html

  Positive test results using a viral test (NAAT, antigen or other tests) in individuals with signs or symptoms consistent with COVID-19 indicate that the person has COVID-19. A negative antigen test in individuals with signs or symptoms of COVID-19 should be repeated following FDA recommendations or confirmed by NAAT. […] Vaccination does not affect the results of someone’s SARS-CoV-2 NAAT, antigen, or other diagnostic tests. […] The main effect of vaccination on SARS-CoV-2 testing is related to antibody testing. Because mRNA COVID-19 vaccines use the SARS-CoV-2 spike protein to generate an immune response, a positive serologic (antibody) test for spike protein IgM/IgG could indicate either previous infection or vaccination. […] Antibody testing is not currently recommended to assess a person’s protection against SARS-CoV-2 infection or severe COVID-19 following COVID-19 vaccination or prior infection, or to assess the need for vaccination in an unvaccinated person.

• #8 COVID-19 Vaccine Basics | COVID-19 | CDC

  https://www.cdc.gov/covid/vaccines/how-they-work.html

  COVID-19 vaccines help our bodies develop immunity to the virus that causes COVID-19 without us having to get the illness. […] Different COVID-19 vaccines may work in our bodies differently but all provide protection against the virus that causes COVID-19. […] All COVID-19 vaccines prompt our bodies to recognize and help protect us from the virus that causes COVID-19. […] Currently, there are two types of COVID-19 vaccines for use in the United States: mRNA, and protein subunit vaccines. […] None of these vaccines can give you COVID-19. […] Vaccines cannot cause infection with the virus that causes COVID-19 or other viruses. […] COVID-19 vaccines do not affect or interact with our DNA. […] These vaccines do not enter the nucleus of the cell where our DNA (genetic material) is located, so they cannot change or influence our genes.

• #9 COVID-19 VACCINE INFORMATION – Rheumatology Associates – DIAGNOSIS & TREATMENT

  https://www.dfwra.com/covid-19-vaccine-information/

  We do not support universal testing for COVID-19 antibodies to assess vaccine response at this time. Currently, there is no defined optimal level for COVID-19 antibodies, and no guidance on how to modify the vaccine strategy based on antibody levels. If you are on immune suppressing medications, we recommend you obtain a third dose as described above. […] When getting ready to receive your vaccine, please be aware that The American College of Rheumatology has published guidance regarding the use of immune suppressing medications around the time of the vaccine. […] Based on the available information, patients taking the following medications may continue them without change during their primary vaccine series or third dose/booster: Prednisone 20 mg/day (or glucocorticoid equivalent), Actemra, Kevzara, Cosentyx, Taltz, Tremfya, Stelara, Kineret, Ilaris.

• #10 Overview of Testing for SARS-CoV-2 | COVID-19 | CDC

  https://www.cdc.gov/covid/hcp/clinical-care/overview-testing-sars-cov-2.html

  Positive test results using a viral test (NAAT, antigen or other tests) in individuals with signs or symptoms consistent with COVID-19 indicate that the person has COVID-19. A negative antigen test in individuals with signs or symptoms of COVID-19 should be repeated following FDA recommendations or confirmed by NAAT. […] Vaccination does not affect the results of someone’s SARS-CoV-2 NAAT, antigen, or other diagnostic tests. […] The main effect of vaccination on SARS-CoV-2 testing is related to antibody testing. Because mRNA COVID-19 vaccines use the SARS-CoV-2 spike protein to generate an immune response, a positive serologic (antibody) test for spike protein IgM/IgG could indicate either previous infection or vaccination. […] Antibody testing is not currently recommended to assess a person’s protection against SARS-CoV-2 infection or severe COVID-19 following COVID-19 vaccination or prior infection, or to assess the need for vaccination in an unvaccinated person.

• #11 COVID-19 | Quest Diagnostics

  https://www.questdiagnostics.com/business-solutions/health-plans/covid-19

  The antibody test is not meant for detecting an active infection. The swab test (sometimes also known as a molecular, RNA or PCR test) should be used to test for active infection. […] Health Plans should be aware that currently available vaccines in the US target the spike protein and, based upon timing of vaccination, could provide a positive result with this test. […] The CDC has not issued guidelines about the use of serology testing related to vaccination. Antibody response related to COVID-19 vaccines have not been studied in vaccine recipients.

• #12 Overview of Testing for SARS-CoV-2 | COVID-19 | CDC

  https://www.cdc.gov/covid/hcp/clinical-care/overview-testing-sars-cov-2.html

  Positive test results using a viral test (NAAT, antigen or other tests) in individuals with signs or symptoms consistent with COVID-19 indicate that the person has COVID-19. A negative antigen test in individuals with signs or symptoms of COVID-19 should be repeated following FDA recommendations or confirmed by NAAT. […] Vaccination does not affect the results of someone’s SARS-CoV-2 NAAT, antigen, or other diagnostic tests. […] The main effect of vaccination on SARS-CoV-2 testing is related to antibody testing. Because mRNA COVID-19 vaccines use the SARS-CoV-2 spike protein to generate an immune response, a positive serologic (antibody) test for spike protein IgM/IgG could indicate either previous infection or vaccination. […] Antibody testing is not currently recommended to assess a person’s protection against SARS-CoV-2 infection or severe COVID-19 following COVID-19 vaccination or prior infection, or to assess the need for vaccination in an unvaccinated person.

• #13 IDSA Guidelines on the Diagnosis of COVID-19: Serologic Testing

  https://www.idsociety.org/practice-guideline/covid-19-guideline-serology/

  In individuals with previous SARS-CoV-2 infection or vaccination, we suggest against routine serologic testing given no demonstrated benefit to improving patient outcomes (conditional recommendation, very low certainty of evidence). […] The high seroprevalence of antibodies against SARS-CoV-2 worldwide limits the utility of detecting anti-SARS CoV-2 antibody. The certainty of available evidence supporting the use of serology for diagnosis was graded as very low to low. […] The current IDSA guideline includes two new recommendations. The first is a weak recommendation to use serologic assays that target nucleocapsid protein rather than spike protein when evidence of prior COVID-19 is desired. […] The second new recommendation suggests against routine serologic testing in patients with previous SARS-CoV-2 infection or vaccination, given that no demonstrated benefits for improving patient outcomes were identified.

• #14 New diagnosis codes for COVID-19 immunization status | AAFP

  https://www.aafp.org/pubs/fpm/blogs/gettingpaid/entry/covid_immunization_codes.html

  The Centers for Disease Control and Prevention (CDC) and the Centers for Medicare Medicaid Services have announced three new diagnosis codes, including two for COVID-19 immunization status. The following codes will be available as of April 1: […] According to ICD-10-CM guidelines, clinicians may assign code Z28.310, Unvaccinated for COVID-19, when the patient has not received a dose of any COVID-19 vaccine. Clinicians may assign code Z28.311, Partially vaccinated for COVID-19, when the patient has received at least one dose of a multi-dose COVID-19 vaccine regimen, but has not received the doses necessary to meet the CDC definition of fully vaccinated at the time of the encounter. […] New code Z28.39 is for reporting when a patient is not current on other, non-COVID vaccines. […] Per the ICD-10-CM table, These codes should not be used for individuals who are not eligible for the COVID-19 vaccines, as determined by the health care provider.

• #15 COVID-19 CPT vaccine and immunization codes | American Medical Association

  https://www.ama-assn.org/practice-management/cpt/covid-19-cpt-vaccine-and-immunization-codes

  New Current Procedural Terminology (CPT) codes have been created that consolidate over 50 previous codes and greatly streamline the reporting of immunizations for the novel coronavirus (SARS-CoV-2, also known as COVID-19). […] The CPT Editorial Panel approved five new COVID-19 vaccine product codes and one administration code in August 2023. These new COVID-19 codes replaced all previously approved specific COVID-19 product and administration codes, except for vaccine product code 91304 for the Novavax vaccine. […] All existing CPT codes that describe COVID-19 vaccine products and associated administration codes that end in A for products that are no longer covered under an existing Emergency Use Authorization (EUA) or Biologics License Application (BLA) from the US Food and Drug Administration (FDA) will be deleted effective Nov. 1, 2023. […] Access a file with the new CPT codes for testing and vaccine products and vaccine administrations.

• #16 COVID-19 Vaccine Basics | COVID-19 | CDC

  https://www.cdc.gov/covid/vaccines/how-they-work.html

  The clinical trials for COVID-19 vaccines have involved tens of thousands of volunteers of different ages, races, and ethnicities. […] Results from these trials have shown that COVID-19 vaccines are safe and effective, especially against severe illness, hospitalization, and death. […] Reports of serious adverse events after vaccination are rare.

• #17 COVID 19 vaccine and heart patients Myocarditis and pericarditis | VCU Health

  https://www.vcuhealth.org/pauley-heart-center/the-beat/latest-updates/covid-19-vaccine-and-heart-patients-myocarditis-and-pericarditis/

  Q: How are myocarditis or pericarditis secondary to COVID-19 diagnosed and treated? […] Shah: The diagnosis of myocarditis and pericarditis are based on a clinical examination paired with laboratory testing and imaging of the heart structures by echocardiography and/or cardiac magnetic resonance imaging. The treatment depends on the amount of inflammation and injury and generally consists of anti-inflammatory therapies and restriction from exercise. In rare instances, mechanical support to unload the heart and allow for healing is required. […] […] Q: Is there a risk of myocarditis or pericarditis with the SARS-CoV2 mRNA vaccines used to prevent COVID-19? […] Danielides: Rare cases of myocarditis reported to the Vaccine Adverse Event Reporting System (VAERS) have occurred after mRNA COVID-19 vaccination (Pfizer-BioNTech or Moderna), especially in male adolescents and young adults, more often after the second dose, usually within several days after vaccination. The Center for Disease Control (CDC) and its partners are actively monitoring reports of myocarditis and pericarditis after COVID-19 vaccination. Active monitoring includes reviewing data and medical records and evaluating the relationship to COVID-19 vaccination. In a very large case-control study of vaccination with Pfizer-BioNTech mRNA vaccination in Israel, the vaccination was association with a very small increased risk of myocarditis. Although the risk related to vaccination may up to 3 times higher than the general population, the risks of developing myocarditis or pericarditis due to COVID-19 itself are up to 35 times higher. […]

• #18 Improved diagnosis of COVID-19 vaccine-associated myocarditis with cardiac scarring identified by cardiac magnetic resonance imaging | medRxiv

  https://www.medrxiv.org/content/10.1101/2024.03.20.24304640v1

  Myocarditis is a rare but potentially serious complication of COVID-19 vaccination. Cardiac magnetic resonance (CMR) late gadolinium enhancement (LGE) imaging can identify cardiac scar, which may improve diagnostic accuracy and prognostication. […] To define the incidence of long-term LGE post COVID-19 vaccine-associated myocarditis (C-VAM) and to establish the additive role of CMR in the diagnostic work-up. […] The presence of LGE on follow-up CMR was then integrated into the diagnostic algorithm and the reclassification rate (definite vs. probable) was calculated. […] With integration of CMR LGE data, 16 patients (28%) were reclassified from probable to definite myocarditis. […] Persistent LGE on CMR occurs in one third of patients with C-VAM. Without CMR at diagnosis, almost one third of patients are misclassified as probable rather than definite myocarditis.

• #19 COVID 19 vaccine and heart patients Myocarditis and pericarditis | VCU Health

  https://www.vcuhealth.org/pauley-heart-center/the-beat/latest-updates/covid-19-vaccine-and-heart-patients-myocarditis-and-pericarditis/

  Q: How are myocarditis or pericarditis secondary to COVID-19 diagnosed and treated? […] Shah: The diagnosis of myocarditis and pericarditis are based on a clinical examination paired with laboratory testing and imaging of the heart structures by echocardiography and/or cardiac magnetic resonance imaging. The treatment depends on the amount of inflammation and injury and generally consists of anti-inflammatory therapies and restriction from exercise. In rare instances, mechanical support to unload the heart and allow for healing is required. […] […] Q: Is there a risk of myocarditis or pericarditis with the SARS-CoV2 mRNA vaccines used to prevent COVID-19? […] Danielides: Rare cases of myocarditis reported to the Vaccine Adverse Event Reporting System (VAERS) have occurred after mRNA COVID-19 vaccination (Pfizer-BioNTech or Moderna), especially in male adolescents and young adults, more often after the second dose, usually within several days after vaccination. The Center for Disease Control (CDC) and its partners are actively monitoring reports of myocarditis and pericarditis after COVID-19 vaccination. Active monitoring includes reviewing data and medical records and evaluating the relationship to COVID-19 vaccination. In a very large case-control study of vaccination with Pfizer-BioNTech mRNA vaccination in Israel, the vaccination was association with a very small increased risk of myocarditis. Although the risk related to vaccination may up to 3 times higher than the general population, the risks of developing myocarditis or pericarditis due to COVID-19 itself are up to 35 times higher. […]

• #20 Improved diagnosis of COVID-19 vaccine-associated myocarditis with cardiac scarring identified by cardiac magnetic resonance imaging | medRxiv

  https://www.medrxiv.org/content/10.1101/2024.03.20.24304640v1

  Myocarditis is a rare but potentially serious complication of COVID-19 vaccination. Cardiac magnetic resonance (CMR) late gadolinium enhancement (LGE) imaging can identify cardiac scar, which may improve diagnostic accuracy and prognostication. […] To define the incidence of long-term LGE post COVID-19 vaccine-associated myocarditis (C-VAM) and to establish the additive role of CMR in the diagnostic work-up. […] The presence of LGE on follow-up CMR was then integrated into the diagnostic algorithm and the reclassification rate (definite vs. probable) was calculated. […] With integration of CMR LGE data, 16 patients (28%) were reclassified from probable to definite myocarditis. […] Persistent LGE on CMR occurs in one third of patients with C-VAM. Without CMR at diagnosis, almost one third of patients are misclassified as probable rather than definite myocarditis.

• #21 ASH Guidelines: Diagnosis and Management of COVID-19 Vaccine-Induced Thrombosis with Thrombocytopenia – PcMED Project

  https://pcmedproject.com/c19-vax/ash-c19-thrombosis/

  ASH Guidelines: Diagnosis and Management of COVID-19 Vaccine-Induced Thrombosis with Thrombocytopenia. Although very rare, thrombosis with thrombocytopenia syndrome (TTS) has been associated with AD26.COV2.S (J&J) vaccine in the US and similar events have been documented outside the US with use of the CHaDOx1 nCov-19 (AstraZeneca) vaccine. This syndrome has been referred to by alternate names in the literature, including vaccine-induced prothrombotic immune thrombocytopenia (VIPIT) or ‘vaccine-induced immune thrombotic thrombocytopenia (VITT)’. TTS is being used by the FDA and CDC. The American Society of Hematology has provided guidance on diagnosis and when to refer. […] TTS Diagnostic Criteria: All 4 criteria must be met: J&J or AstraZeneca vaccine within 4 to 30 days, Venous or arterial thrombosis (often cerebral or abdominal), Thrombocytopenia (current TTS definition <150,000/μL), Positive PF4 ‘HIT’ (heparin-induced thrombocytopenia) ELISA.

• #22 ASH Guidelines: Diagnosis and Management of COVID-19 Vaccine-Induced Thrombosis with Thrombocytopenia – PcMED Project

  https://pcmedproject.com/c19-vax/ash-c19-thrombosis/

  ASH Guidelines: Diagnosis and Management of COVID-19 Vaccine-Induced Thrombosis with Thrombocytopenia. Although very rare, thrombosis with thrombocytopenia syndrome (TTS) has been associated with AD26.COV2.S (J&J) vaccine in the US and similar events have been documented outside the US with use of the CHaDOx1 nCov-19 (AstraZeneca) vaccine. This syndrome has been referred to by alternate names in the literature, including vaccine-induced prothrombotic immune thrombocytopenia (VIPIT) or ‘vaccine-induced immune thrombotic thrombocytopenia (VITT)’. TTS is being used by the FDA and CDC. The American Society of Hematology has provided guidance on diagnosis and when to refer. […] TTS Diagnostic Criteria: All 4 criteria must be met: J&J or AstraZeneca vaccine within 4 to 30 days, Venous or arterial thrombosis (often cerebral or abdominal), Thrombocytopenia (current TTS definition <150,000/μL), Positive PF4 ‘HIT’ (heparin-induced thrombocytopenia) ELISA.

• #23 ASH Guidelines: Diagnosis and Management of COVID-19 Vaccine-Induced Thrombosis with Thrombocytopenia – PcMED Project

  https://pcmedproject.com/c19-vax/ash-c19-thrombosis/

  Note: Do not use non-ELISA rapid immunoassays for HIT | Non-ELISA tests are not sufficiently sensitive nor specific for TTS. […] KEY POINTS: TTS is suspected: Obtain immediate CBC with platelet count and imaging for thrombosis based on symptoms. If thrombosis and/or thrombocytopenia is present, referral to hematologist with expertise in hemostasis is recommended.

• #24 ASH Guidelines: Diagnosis and Management of COVID-19 Vaccine-Induced Thrombosis with Thrombocytopenia – PcMED Project

  https://pcmedproject.com/c19-vax/ash-c19-thrombosis/

  Note: Do not use non-ELISA rapid immunoassays for HIT | Non-ELISA tests are not sufficiently sensitive nor specific for TTS. […] KEY POINTS: TTS is suspected: Obtain immediate CBC with platelet count and imaging for thrombosis based on symptoms. If thrombosis and/or thrombocytopenia is present, referral to hematologist with expertise in hemostasis is recommended.

• #25 New Study: Is There a Link Between COVID-19 Vaccination and POTS?

  https://www.cedars-sinai.org/newsroom/new-study-is-there-a-link-between-covid-19-vaccination-and-pots/

  Findings from a recent study by Cedars-Sinai investigators suggest it may be helpful to keep an eye on patients with underlying health issues after COVID-19 vaccination to monitor for post-vaccine POTS, a condition that causes an abnormal increase in heart rate after standing or sitting up. […] A new research study from the Smidt Heart Institute at Cedars-Sinai aimed to understand the possible connection between COVID-19 vaccination and a difficult-to-diagnose heart condition called postural orthostatic tachycardia syndrome, or POTS. […] These findings suggest it may be helpful to keep an eye on patients with underlying health issues after COVID-19 vaccination to monitor for post-vaccine POTS, said Chen, who also holds the Burns and Allen Chair in Cardiology Research at Cedars-Sinai. […] Although there is an association between POTS and COVID-19 vaccination, a previous study of patient data across the Cedars-Sinai Health System found that patients diagnosed with COVID-19 were five times more likely to develop the cardiac condition after infection than after vaccination. […] COVID-19 infection itself seems to be either causing or unmasking a startling amount of POTS or POTS-like conditions globally, said Debbie L. Teodorescu, MD, a cardiology fellow at the Smidt Heart Institute and first author of the study.

• #26 New Study: Is There a Link Between COVID-19 Vaccination and POTS?

  https://www.cedars-sinai.org/newsroom/new-study-is-there-a-link-between-covid-19-vaccination-and-pots/

  Findings from a recent study by Cedars-Sinai investigators suggest it may be helpful to keep an eye on patients with underlying health issues after COVID-19 vaccination to monitor for post-vaccine POTS, a condition that causes an abnormal increase in heart rate after standing or sitting up. […] A new research study from the Smidt Heart Institute at Cedars-Sinai aimed to understand the possible connection between COVID-19 vaccination and a difficult-to-diagnose heart condition called postural orthostatic tachycardia syndrome, or POTS. […] These findings suggest it may be helpful to keep an eye on patients with underlying health issues after COVID-19 vaccination to monitor for post-vaccine POTS, said Chen, who also holds the Burns and Allen Chair in Cardiology Research at Cedars-Sinai. […] Although there is an association between POTS and COVID-19 vaccination, a previous study of patient data across the Cedars-Sinai Health System found that patients diagnosed with COVID-19 were five times more likely to develop the cardiac condition after infection than after vaccination. […] COVID-19 infection itself seems to be either causing or unmasking a startling amount of POTS or POTS-like conditions globally, said Debbie L. Teodorescu, MD, a cardiology fellow at the Smidt Heart Institute and first author of the study.

• #27 COVID-19 Vaccine and Death: Causality Algorithm According to the WHO Eligibility Diagnosis

  https://www.mdpi.com/2075-4418/11/6/955

  The current challenge worldwide is the administration of anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines. […] This study aims to establish a practical workflow to define the relationship between adverse events following immunization (AEFI) and COVID-19 vaccination, following the basic framework of the World Health Organization (WHO). Post-mortem investigation plays a pivotal role to support this causality relationship when death occurs. […] We suggest the adoption of the proposed methodology in order to confirm or rule out a causal relationship between vaccination and the occurrence of AEFI. […] This study aims to establish a practical workflow to define the causal relationship between adverse events following immunization (AEFI) and COVID-19 vaccination, following the basic framework of the World Health Organization (WHO).

• #28 COVID-19 Vaccine and Death: Causality Algorithm According to the WHO Eligibility Diagnosis

  https://www.mdpi.com/2075-4418/11/6/955

  Autopsy should be considered mandatory in all deaths temporarily related to vaccine administration. […] The proposed procedures are based on the same structure of the WHO AEFI guidelines, including eligibility (case ascertainment), checklist, algorithm and final classification. […] The novelty of the proposed structure of the causality assessment for AEFI following COVID-19 vaccine administration is represented by the autopsy tool. […] The discussed cases concerned two subjects, one male and one female, in apparent previous healthy status. […] Based on the proposed workflow, the last step is the presence of literature in support of causal effects between vaccine administration and severe AEFI. […] Based on the discussed evidence, we may define a causality relationship between COVID-19 vaccine administration and AEFI, and the pathogenesis of this disease is related to the development of antibodies versus platelet factor 4.

• #29 COVID-19: Vaccines – UpToDate

  https://www.uptodate.com/contents/covid-19-vaccines

  COVID-19: Vaccines […] Vaccines to prevent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection are considered the most promising approach for curbing the coronavirus disease 2019 (COVID-19) pandemic. Several COVID-19 vaccines are available globally. The World Health Organization (WHO) maintains an updated list of vaccine candidates under evaluation and available for administration. […] GENERAL PRINCIPLES […] Pace of COVID-19 vaccine development – Although COVID-19 vaccine development has been accelerated, each vaccine that has received emergency use listing by the World Health Organization (WHO; which includes those that have been authorized or approved in the United States) has gone through the standard preclinical and clinical stages of development. Safety criteria have remained stringent; data safety and monitoring committees (DSMCs) composed of independent vaccine experts and study sponsors assess adverse events that are reported in each phase of clinical study and must give approval before a candidate vaccine can advance to the next phase of evaluation.

• #30 COVID-19: Vaccines – UpToDate

  https://www.uptodate.com/contents/covid-19-vaccines

  Calculation of vaccine efficacy – Vaccine efficacy in percent is defined as the reduction in disease incidence among those who received vaccine versus those who received the control product and is calculated with the following formula: […] ([attack rate in the unvaccinated – attack rate in the vaccinated]/attack rate in the unvaccinated) x 100, often abbreviated as ([ARU – ARV]/ARU) x 100.

• #31 COVID-19: Vaccines – UpToDate

  https://www.uptodate.com/contents/covid-19-vaccines

  Calculation of vaccine efficacy – Vaccine efficacy in percent is defined as the reduction in disease incidence among those who received vaccine versus those who received the control product and is calculated with the following formula: […] ([attack rate in the unvaccinated – attack rate in the vaccinated]/attack rate in the unvaccinated) x 100, often abbreviated as ([ARU – ARV]/ARU) x 100.

• #32 Overview of Testing for SARS-CoV-2 | COVID-19 | CDC

  https://www.cdc.gov/covid/hcp/clinical-care/overview-testing-sars-cov-2.html

  Positive test results using a viral test (NAAT, antigen or other tests) in individuals with signs or symptoms consistent with COVID-19 indicate that the person has COVID-19. A negative antigen test in individuals with signs or symptoms of COVID-19 should be repeated following FDA recommendations or confirmed by NAAT. […] Vaccination does not affect the results of someone’s SARS-CoV-2 NAAT, antigen, or other diagnostic tests. […] The main effect of vaccination on SARS-CoV-2 testing is related to antibody testing. Because mRNA COVID-19 vaccines use the SARS-CoV-2 spike protein to generate an immune response, a positive serologic (antibody) test for spike protein IgM/IgG could indicate either previous infection or vaccination. […] Antibody testing is not currently recommended to assess a person’s protection against SARS-CoV-2 infection or severe COVID-19 following COVID-19 vaccination or prior infection, or to assess the need for vaccination in an unvaccinated person.

• #33 A high-throughput neutralizing antibody assay for COVID-19 diagnosis and vaccine evaluation | bioRxiv

  https://www.biorxiv.org/content/10.1101/2020.05.21.109546v1

  Virus neutralization remains the gold standard for determining antibody efficacy. Therefore, a high-throughput assay to measure SARS-CoV-2 neutralizing antibodies is urgently needed for COVID-19 serodiagnosis, convalescent plasma therapy, and vaccine development. Here we report on a fluorescence-based SARS-CoV-2 neutralization assay that detects SARS-CoV-2 neutralizing antibodies in COVID-19 patient specimens and yields comparable results to plaque reduction neutralizing assay, the gold standard of serological testing. Our approach offers a rapid platform that can be scaled to screen people for antibody protection from COVID-19, a key parameter necessary to safely reopen local communities.

• #34 A high-throughput neutralizing antibody assay for COVID-19 diagnosis and vaccine evaluation | bioRxiv

  https://www.biorxiv.org/content/10.1101/2020.05.21.109546v1

  Virus neutralization remains the gold standard for determining antibody efficacy. Therefore, a high-throughput assay to measure SARS-CoV-2 neutralizing antibodies is urgently needed for COVID-19 serodiagnosis, convalescent plasma therapy, and vaccine development. Here we report on a fluorescence-based SARS-CoV-2 neutralization assay that detects SARS-CoV-2 neutralizing antibodies in COVID-19 patient specimens and yields comparable results to plaque reduction neutralizing assay, the gold standard of serological testing. Our approach offers a rapid platform that can be scaled to screen people for antibody protection from COVID-19, a key parameter necessary to safely reopen local communities.

• #35 Continuous innovation for COVID-19 vaccines, diagnostics, and therapeutics

  https://covidtimeline.ifpma.org/milestone/continuous-innovation-for-covid-19-vaccines-diagnostics-and-therapeutics

  As new SARS-CoV-2 variants emerge, and regulatory agencies consider the inclusion of COVID-19 vaccines into annual immunization strategies, the innovative pharmaceutical industry continues its RD efforts for vaccines that can target multiple strains of the virus and/or multiple viruses. […] The WHO’s Strategic Advisory Group of Experts on Immunization (SAGE) updates COVID-19 vaccination guidance, recommending COVID-19 vaccine booster doses only to high-risk groups. […] Moderna announced that the next-generation, refrigerator-stable COVID-19 vaccine candidate, mRNA-1283, has entered Phase III clinical trial. […] Initial results from Novavax’ COVID-19-Influenza Vaccine Trial show the feasibility of its combination vaccine.

• #36 Artificial Intelligence in Surveillance, Diagnosis, Drug Discovery and Vaccine Development against COVID-19

  https://www.mdpi.com/2076-0817/10/8/1048

  As of August 6th, 2021, the World Health Organization has notified 200.8 million laboratory-confirmed infections and 4.26 million deaths from COVID-19, making it the worst pandemic since the 1918 flu. […] Despite mass vaccination all over the world, COVID-19 still poses a threat to human lives and livelihood. […] In this review, we will focus on the role of Artificial intelligence (AI) and machine learning (ML) tools in managing the COVID-19 pandemic. […] In this review, we will discuss how AI has been utilized during this pandemic to address key issues such as surveillance, detection, rapid diagnosis, drug discovery, and vaccine development. […] Precise diagnosis of COVID-19 infected patients is fundamental in the process of providing proper treatment and avoiding the overburdening of the healthcare system.

• #37 Artificial Intelligence in Surveillance, Diagnosis, Drug Discovery and Vaccine Development against COVID-19

  https://www.mdpi.com/2076-0817/10/8/1048

  Large-scale testing during a pandemic has been a challenge due to huge costs and a shortage of resources. […] Therefore, additional assistance from different AI-based modalities can be highly beneficial for accurate screening and diagnosis of COVID-19 and many other diseases. […] The various imaging techniques such as chest X-rays (CXR) and Computerized Tomography (CT) images are shown to be suitable in identifying COVID-19 (+) patients. […] Researchers have shown that computer vision-based models can be accurate in analyzing these images. […] The application of CNN-based deep learning methods in radiological image analysis for COVID-19 patients is discussed in great detail in a recent review. […] Overall, these examples suggest that ML and other AI-based approaches can be useful in the objective assessment of imaging data obtained from COVID-19 patients.

• #38 Artificial Intelligence in Surveillance, Diagnosis, Drug Discovery and Vaccine Development against COVID-19

  https://www.mdpi.com/2076-0817/10/8/1048

  Combining blood tests with advanced AI-based methods can significantly improve the sensitivity and accuracy of diagnosis. […] ML models were able to predict positive and negative samples with high sensitivity (~95%) and accuracy (~86%). […] AI has provided novel solutions in the fight against COVID-19. […] The application of AI strategies in COVID-19 also faces certain challenges. […] The challenges in manufacturing, storage, logistics, and issues related to the safety and efficacy of different vaccine candidates can be overcome by AI algorithms. […] AI tools can help the local governments to assess public perception of COVID-19 vaccines and help in spreading vaccine awareness to the public. […] AI modalities are also used in effective vaccine design and assessing the safety of these vaccines.

• #39 Artificial Intelligence in Surveillance, Diagnosis, Drug Discovery and Vaccine Development against COVID-19

  https://www.mdpi.com/2076-0817/10/8/1048

  Combining blood tests with advanced AI-based methods can significantly improve the sensitivity and accuracy of diagnosis. […] ML models were able to predict positive and negative samples with high sensitivity (~95%) and accuracy (~86%). […] AI has provided novel solutions in the fight against COVID-19. […] The application of AI strategies in COVID-19 also faces certain challenges. […] The challenges in manufacturing, storage, logistics, and issues related to the safety and efficacy of different vaccine candidates can be overcome by AI algorithms. […] AI tools can help the local governments to assess public perception of COVID-19 vaccines and help in spreading vaccine awareness to the public. […] AI modalities are also used in effective vaccine design and assessing the safety of these vaccines.

• #40 Vaccines, therapeutics, and diagnostics for covid-19: redesigning systems to improve pandemic response | The BMJ

  https://www.bmj.com/content/375/bmj-2021-067488

  Vaccines, therapeutics, and diagnostics are key public health tools for controlling the covid-19 pandemic, yet many countries, particularly low and middle income countries (LMICs), have had inadequate access. […] The Access to COVID-19 Tools Accelerator (ACT-A) is a multilateral coordination mechanism set up to accelerate development, production, and equitable access to covid-19 tests, treatments, and vaccines globally. […] Testing did receive political attention but has been a bottleneck in many countries. […] The lack of a clear strategy to guide research and manufacturing also applies to diagnostic tests. The development and use of target product profiles could have established the type of tests wanted, including specifications for sensitivity and specificity, early on. […] WHOs research and development blueprint served to establish a common research agenda quickly. It was most effective in supporting vaccine product development and to a lesser extent for diagnostics.

• #41

  https://link.springer.com/article/10.1007/s43440-022-00425-5

  The US Food and Drug Administration has just fully approved the Pfizer/BioNTech vaccine for human use, while 38 vaccine candidates are undergoing emergency use licensing. […] Vaccination is the safest method for combating the COVID-19 pandemic. […] According to a recent press release by US FDA, they have authorized limited use of Johnson and Johnson (JJ) COVID-19 vaccine for the individuals that are 18 years or greater in age but do not have access to the approved vaccines as well as to those who opt for JJ vaccine. […] The reports define the safety concern relating to rare events of blood clots reported previously also for the adenovirus-based vaccines. […] The emergence of new variants of concern resulting from mutations in the viral genome has become a great problem in the treatment of infection and prevention by vaccination. This is because many of the widely used repurpose drugs and some vaccines are rendered ineffective when used against the new variants. […] The major goal to mitigate and manage COVID-19 is by effective prophylactic measures and prevention, and initiation of recording patients immune responses from time to time with the help of healthcare personnel.

• #42 COVID-19 Vaccine Development & Implementation Workshop 2021 – June Edition | AME

  https://academicmedicaleducation.com/covid-19-vaccine-development-implementation-2021/june-edition

  Session 3: Vaccines and Diagnostics – Update on SARS-CoV-2 Virological Diagnostics Anne-Genevive Marcelin Anne-Genevive Marcelin, MD Piti-Salptrire Hospital, Sorbonne Universit, Paris, France Video Slideset […] How to Assess Protection Against Infection and Transmission After Vaccination? Monica Gandhi 2021 Monica Gandhi, MD, MPH University of California San Francisco, United States Video Slideset […] Adapting Diagnostics to SARS-CoV-2 Viral Variants Annemarie Wensing Annemarie Wensing, MD, PhD University Medical Center Utrecht, the Netherlands Video Slideset […] COVID NAb testTM. A Quantitative Neutralising Antibody Lateral Flow point of care assay Dale Godfrey Dale Godfrey, PhD, FAHMS The Peter Doherty Institute, University of Melbourne, Australia Video Slideset […] Increase understanding of SARS-CoV-2 diagnostics, including emerging variants […] Understand vaccine-induced protection against infection and transmission, both in real-world settings and modeling studies.

• #43 With COVID Vaccines, Why Have Testing? Here’s Why. | Abbott Newsroom

  https://www.abbott.com/corpnewsroom/diagnostics-testing/with-COVID-vaccines-why-have-testing-here-is-why.html

  While vaccines have been given Food and Drug Administration emergency use authorizations and have been shown to be safe and effective, only time will show long-term protections against the virus and its variants. […] While it appears vaccines offer protections for the vaccinated as well as stopping them from spreading the virus to others, more study is needed to confirm. […] Continued COVID viral surveillance programs just as we have for HIV, hepatitis and more are necessary to understand variant circulation as well as the longevity of vaccine protections. […] For these reasons and billions more around the world testing isn’t going anywhere, either. So long as COVID-19 is in the world, testing will be too. […] The BinaxNOW COVID-19 tests have not been FDA cleared or approved. They have been authorized by the FDA under an emergency use authorization. They have been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens, and are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

• #44 Impact of diagnosis and treatment on response to COVID-19 vaccine in patients with BCR-ABL1-negative myeloproliferative neoplasms. A single-center experience | Blood Cancer Journal

  https://www.nature.com/articles/s41408-021-00579-0

  The SARS-CoV-2 coronavirus infection causing the coronavirus disease 2019 (COVID-19) is a highly contagious and life-threatening disease critically associated with a high rate of respiratory failure, thrombo-hemorrhagic complications, and death, mainly due to an abnormal inflammatory response. […] According to this survey, the incidence of COVID-19 infection in BCR-ABL1-negative MPNs appears to be rather low and a possible protective function of ruxolitinib could not be ruled out. […] About the issue of response to COVID-19 vaccine in patients with hematological malignancies, several studies have already demonstrated a substantially reduced seroconversion rate, particularly in heavily treated groups and in those with aggressive disease, marked cytopenias, or B-cell neoplasms. […] Instead, not surprisingly owing to its immunomodulatory properties, in MPN patients treated with ruxolitinib an impaired early response to SARS-CoV-2 vaccine was found as compared to healthy adults of a similar age group.

• #45 Impact of diagnosis and treatment on response to COVID-19 vaccine in patients with BCR-ABL1-negative myeloproliferative neoplasms. A single-center experience | Blood Cancer Journal

  https://www.nature.com/articles/s41408-021-00579-0

  The SARS-CoV-2 coronavirus infection causing the coronavirus disease 2019 (COVID-19) is a highly contagious and life-threatening disease critically associated with a high rate of respiratory failure, thrombo-hemorrhagic complications, and death, mainly due to an abnormal inflammatory response. […] According to this survey, the incidence of COVID-19 infection in BCR-ABL1-negative MPNs appears to be rather low and a possible protective function of ruxolitinib could not be ruled out. […] About the issue of response to COVID-19 vaccine in patients with hematological malignancies, several studies have already demonstrated a substantially reduced seroconversion rate, particularly in heavily treated groups and in those with aggressive disease, marked cytopenias, or B-cell neoplasms. […] Instead, not surprisingly owing to its immunomodulatory properties, in MPN patients treated with ruxolitinib an impaired early response to SARS-CoV-2 vaccine was found as compared to healthy adults of a similar age group.

• #46 Impact of diagnosis and treatment on response to COVID-19 vaccine in patients with BCR-ABL1-negative myeloproliferative neoplasms. A single-center experience | Blood Cancer Journal

  https://www.nature.com/articles/s41408-021-00579-0

  In conclusion, the rate of seroconversion to mRNA SARS-CoV-2 vaccines in MPN patients (77.4%) is lower as compared to adult healthy people (e.g., 99% among workers of our Hospital), with MF patients showing the worst response (60%). In addition, among responders, median anti-Spike titers were adversely affected by treatment with ruxolitinib. Even though the exact mechanism for this impaired response is not yet known, it might be the result of both disease- and treatment-mediated immune dysfunction. Although clear-cut relationships between specific anti-Spike titers and protection against the virus has not been unequivocally established, MPN patients, in particular those with MF either receiving ruxolitinib or not, should be urged to maintain high levels of protective measures against COVID-19 also after being vaccinated.

• #47 Cancer Patients & the COVID-19 Vaccine | Southern Illinois Healthcare

  https://www.sih.net/services/cancer-care-treatment-and-diagnosis/cancer-patients-and-the-covid19-vaccine

  Based on the opinions of physicians and other experts at SIH Cancer Institute, Washington University School of Medicine in St. Louis, Siteman Cancer Center, BJC HealthCare, we recommend that cancer patients who have completed their treatment get the vaccine. […] Cancer patients who have not completed their treatment should discuss risks and benefits with their oncologist. […] The two COVID-19 vaccines do not contain a live virus and do not interact with your DNA. […] We do not recommend that cancer patients receive any vaccine that has a live virus. […] We recommend if you are completing your chemotherapy in the next two to three months that you delay getting the COVID-19 vaccination until treatment is completed. […] For those undergoing chemotherapy for a longer period, it might be beneficial to receive the COVID-19 vaccine in between rounds of chemotherapy.

• #48 Vaccines, therapeutics, and diagnostics for covid-19: redesigning systems to improve pandemic response | The BMJ

  https://www.bmj.com/content/375/bmj-2021-067488

  Vaccines, therapeutics, and diagnostics are key public health tools for controlling the covid-19 pandemic, yet many countries, particularly low and middle income countries (LMICs), have had inadequate access. […] The Access to COVID-19 Tools Accelerator (ACT-A) is a multilateral coordination mechanism set up to accelerate development, production, and equitable access to covid-19 tests, treatments, and vaccines globally. […] Testing did receive political attention but has been a bottleneck in many countries. […] The lack of a clear strategy to guide research and manufacturing also applies to diagnostic tests. The development and use of target product profiles could have established the type of tests wanted, including specifications for sensitivity and specificity, early on. […] WHOs research and development blueprint served to establish a common research agenda quickly. It was most effective in supporting vaccine product development and to a lesser extent for diagnostics.

• #49 Vaccines, therapeutics, and diagnostics for covid-19: redesigning systems to improve pandemic response | The BMJ

  https://www.bmj.com/content/375/BMJ-2021-067488

  Vaccines, therapeutics, and diagnostics are key public health tools for controlling the covid-19 pandemic, yet many countries, particularly low and middle income countries (LMICs), have had inadequate access. […] The Access to COVID-19 Tools Accelerator (ACT-A) is a multilateral coordination mechanism set up to accelerate development, production, and equitable access to covid-19 tests, treatments, and vaccines globally. […] Testing did receive political attention but has been a bottleneck in many countries. […] The lack of a clear strategy to guide research and manufacturing also applies to diagnostic tests. The development and use of target product profiles could have established the type of tests wanted, including specifications for sensitivity and specificity, early on. […] WHOs research and development blueprint served to establish a common research agenda quickly. It was most effective in supporting vaccine product development and to a lesser extent for diagnostics.

• #50 Vaccines, therapeutics, and diagnostics for covid-19: redesigning systems to improve pandemic response | The BMJ

  https://www.bmj.com/content/375/BMJ-2021-067488

  Vaccines, therapeutics, and diagnostics are key public health tools for controlling the covid-19 pandemic, yet many countries, particularly low and middle income countries (LMICs), have had inadequate access. […] The Access to COVID-19 Tools Accelerator (ACT-A) is a multilateral coordination mechanism set up to accelerate development, production, and equitable access to covid-19 tests, treatments, and vaccines globally. […] Testing did receive political attention but has been a bottleneck in many countries. […] The lack of a clear strategy to guide research and manufacturing also applies to diagnostic tests. The development and use of target product profiles could have established the type of tests wanted, including specifications for sensitivity and specificity, early on. […] WHOs research and development blueprint served to establish a common research agenda quickly. It was most effective in supporting vaccine product development and to a lesser extent for diagnostics.

• #51 Equitable global access to vaccines, treatments and diagnostics is key to tackling COVID-19 pandemic – Unitaid

  https://unitaid.org/news-blog/equitable-global-access-to-vaccines-treatments-and-diagnostics-is-key-to-tackling-covid-19-pandemic/

  Equitable global access to vaccines, treatments and diagnostics is key to tackling COVID-19 pandemic. […] It is both a public health need and a moral duty to ensure that this response is grounded in solidarity to ensure that the vaccines, treatments and diagnostics being developed are accessible to all, everywhere and at the same time. […] Unitaid fully supports the declaration by the French Prime Minister douard Philippe that access for all to any COVID-19 vaccine, as well as treatments and diagnostics, is not negotiable.

• #52 Coronavirus Research Part 2: Identifying potential COVID-19 diagnostics and vaccines

  https://www.licorbio.com/blog/covid-19-research-2

  The second post in our three-part series on the massive world-wide research response to the COVID-19 pandemic will cover research into potential diagnostics and vaccines for SARS-CoV-2. […] Since the COVID-19 pandemic began, the immediate global response of the scientific community has led to an unprecedented pace of discovery in the field of diagnostics and preventives. Tools for quickly identifying positive cases has meant sick individuals can receive treatment more quickly and public health professionals can trace and quarantine cases more easily. Additionally, the speed with which the COVID-19 vaccines have been developed is historically unmatched and offers the best long-term solution for ending the pandemic. […] Because of the urgent necessity for diagnosing and preventing COVID-19, the basic discoveries about how SARS-CoV-2 interacts with the human immune system were made while other researchers were simultaneously developing diagnostics and vaccines.

• #53 Designing for Differentiation: Why We Need Highly Specific Diagnostics for a COVID-19 Vaccine – The Native Antigen Company

  https://thenativeantigencompany.com/designing-for-differentiation-why-we-need-highly-specific-diagnostics-for-a-covid-19-vaccine/

  Assessment of vaccine-induced immune responses in clinical trials will require highly specific diagnostic assays to ensure safety. […] To assess the safety of vaccine candidates, researchers will need to thoroughly assess patient antibody responses in a qualitative and quantitative manner. […] However, considering that vaccine-induced anti-Spike IgG levels may be indistinguishable from those conferred by natural infection, alternative antigens will be needed to design vaccine-specific assays. […] While it has yet to be proven if ADE is implicated in the pathogenesis of SARS-CoV-2, its potential to cause adverse events will have serious implications for the design of a COVID-19 vaccine. […] To achieve immunoassay specificity, there are multiple routes of investigation. […] Undoubtedly, the most crucial consideration when designing serological diagnostics is the identification, selection, and presentation of virus-specific epitopes.

• #54 Designing for Differentiation: Why We Need Highly Specific Diagnostics for a COVID-19 Vaccine – The Native Antigen Company

  https://thenativeantigencompany.com/designing-for-differentiation-why-we-need-highly-specific-diagnostics-for-a-covid-19-vaccine/

  Assessment of vaccine-induced immune responses in clinical trials will require highly specific diagnostic assays to ensure safety. […] To assess the safety of vaccine candidates, researchers will need to thoroughly assess patient antibody responses in a qualitative and quantitative manner. […] However, considering that vaccine-induced anti-Spike IgG levels may be indistinguishable from those conferred by natural infection, alternative antigens will be needed to design vaccine-specific assays. […] While it has yet to be proven if ADE is implicated in the pathogenesis of SARS-CoV-2, its potential to cause adverse events will have serious implications for the design of a COVID-19 vaccine. […] To achieve immunoassay specificity, there are multiple routes of investigation. […] Undoubtedly, the most crucial consideration when designing serological diagnostics is the identification, selection, and presentation of virus-specific epitopes.

• #55 Designing for Differentiation: Why We Need Highly Specific Diagnostics for a COVID-19 Vaccine – The Native Antigen Company

  https://thenativeantigencompany.com/designing-for-differentiation-why-we-need-highly-specific-diagnostics-for-a-covid-19-vaccine/

  Assessment of vaccine-induced immune responses in clinical trials will require highly specific diagnostic assays to ensure safety. […] To assess the safety of vaccine candidates, researchers will need to thoroughly assess patient antibody responses in a qualitative and quantitative manner. […] However, considering that vaccine-induced anti-Spike IgG levels may be indistinguishable from those conferred by natural infection, alternative antigens will be needed to design vaccine-specific assays. […] While it has yet to be proven if ADE is implicated in the pathogenesis of SARS-CoV-2, its potential to cause adverse events will have serious implications for the design of a COVID-19 vaccine. […] To achieve immunoassay specificity, there are multiple routes of investigation. […] Undoubtedly, the most crucial consideration when designing serological diagnostics is the identification, selection, and presentation of virus-specific epitopes.

• #56

  https://www.who.int/publications/i/item/WHO-2019-nCoV-HCF_assessment-Products-2021.1

  This tool was developed to assess present and surge capacities for the treatment of COVID-19 in health facilities. […] The tool encompasses key components that are essential to managing COVID-19 in a hospital setting, including: […] diagnostic testing, imaging and patient monitoring devices and supplies […] COVID-19 vaccine readiness […] Do facilities have the necessary diagnostic equipment and supplies for COVID19 testing? […] Do facilities have a functioning cold chain capacity and other arrangements in place to support COVID19 vaccination?

• #57 COVID-19 | Quest Diagnostics

  https://www.questdiagnostics.com/business-solutions/health-plans/covid-19

  Quest Diagnostics is receiving COVID-19 specimens and performing testing nationwide. […] COVID-19 antibody testing to indicate prior infection is now readily available at Quests patient service centers (PSCs). […] Note that diagnostic testing for active COVID-19 infection cannot be performed at Quest PSCs. Members must visit their physician or other healthcare provider. […] The Quest Analytics data feed system now offers dedicated daily COVID-19 test result data reports for health plan customers. […] To increase testing capacity and make the ordering process more convenient for healthcare providers, Quest has implemented a one code ordering system for all types of molecular tests used to diagnose COVID-19 active infection. […] SARS-CoV-2 antibody testing is a major part of managing the spread of COVID-19, and Quest Diagnostics offers a full complement of antibody serology testing to provide additional insights into a patients recent or prior infection.

• #58 Coding for COVID-19 Vaccine Shots | CMS

  https://www.cms.gov/medicare/payment/covid-19/coding-covid-19-vaccine-shots

  Review information about Medicare coding for administering COVID-19 vaccines during and after the PHE. […] After the FDA issues an emergency use authorization (EUA) or approves licensure of each COVID-19 vaccine product, CMS will identify the following for Medicare payment: […] CMS and the American Medical Association (AMA) collaborated on a new approach to report use of COVID-19 vaccines. […] Together, these codes describe the administration of the COVID-19 vaccines and the monoclonal antibody products, as they become available. […] CMS and the AMA developed this code structure to make claims processing for administration of COVID-19 vaccines and monoclonal antibody infusions that get FDA EUA or FDA approval more efficient. […] Use HCPCS Level II code M0201 to bill for the additional payment for administering the COVID-19 vaccine to Medicare patients in their homes under certain circumstances. […] Report this code in addition to the CPT code that describes the COVID-19 vaccine administration (90480). […] Report the COVID-19 vaccine administration CPT code (90480) for each Medicare patient you vaccinated in the home that day.

• #59 R&D Blueprint and COVID-19

  https://www.who.int/teams/blueprint/covid-19

  WHO Target Product Profiles for COVID-19 Vaccines. Revised version April 2022 […] COVID-19 Target product profiles for priority diagnostics to support response to the COVID-19 pandemic v.1.0 […] WHO Working Group Target Product Profiles for COVID-19 Vaccines […] COVID-19 vaccines: Knowledge gaps and research priorities – WHO ad hoc consultation […] Methodological approaches to assess variants effect on vaccine efficacy, effectiveness and impact.

• #60 R&D Blueprint and COVID-19

  https://www.who.int/teams/blueprint/covid-19

  WHO Target Product Profiles for COVID-19 Vaccines. Revised version April 2022 […] COVID-19 Target product profiles for priority diagnostics to support response to the COVID-19 pandemic v.1.0 […] WHO Working Group Target Product Profiles for COVID-19 Vaccines […] COVID-19 vaccines: Knowledge gaps and research priorities – WHO ad hoc consultation […] Methodological approaches to assess variants effect on vaccine efficacy, effectiveness and impact.

• #61 R&D Blueprint and COVID-19

  https://www.who.int/teams/blueprint/covid-19

  WHO Target Product Profiles for COVID-19 Vaccines. Revised version April 2022 […] COVID-19 Target product profiles for priority diagnostics to support response to the COVID-19 pandemic v.1.0 […] WHO Working Group Target Product Profiles for COVID-19 Vaccines […] COVID-19 vaccines: Knowledge gaps and research priorities – WHO ad hoc consultation […] Methodological approaches to assess variants effect on vaccine efficacy, effectiveness and impact.

• #62 Vaccines, therapeutics, and diagnostics for covid-19: redesigning systems to improve pandemic response | The BMJ

  https://www.bmj.com/content/375/bmj-2021-067488

  Future systems for vaccines, therapeutics, and diagnostics should be prenegotiated among countries, manufacturers, and international institutions. […] Agreements around technology transfer and intellectual property licensing, regional trial networks, inclusive governance, and substantial predictable financing are essential.

• #63 Don’t Exhale Yet: COVID-19 Isn’t Done Testing Us | Abbott Newsroom

  https://www.abbott.com/corpnewsroom/diagnostics-testing/no-exhale-yet-COVID-19-isnt-done-testing-us.html

  While the vaccine rollout continues, the necessity of preventative measures remains, including testing. […] „Testing is a critical first-line of defense,” Andrea Wainer, Executive Vice President, Rapid and Molecular Diagnostics at Abbott, told Bloomberg reporter Michelle Fay Cortez during this year’s CES, the Consumer Electronics Show. „It needs to be used in context with other hygiene practices of wearing your mask and washing your hands and by no means does this replace that. It comes together along with vaccinations. So, the more you can test, the more you can catch the virus. It’s just simple math. Because at any one point in time, anyone can become infected.” […] A Harris Poll conducted at the end of 2020, showed „82% of Americans say the COVID-19 vaccine rollout will be more effective if it works in partnership with testing.”

• #64 Don’t Exhale Yet: COVID-19 Isn’t Done Testing Us | Abbott Newsroom

  https://www.abbott.com/corpnewsroom/diagnostics-testing/no-exhale-yet-COVID-19-isnt-done-testing-us.html

  „What we see is that the vaccination rollout, this needs to be done in conjunction with that. The vaccination rollout, it’s going to take time to get everyone vaccinated, there’s going to be individuals that are not comfortable with being vaccinated, and the demand continues to rise as people are trying to get back to work and school,” Wainer told CES. „So it needs to be done together and right now it’s about detecting the virus, and as soon as we can have high levels of vaccination, some of the testing is going to turn to also antibody testing, determining how effective these vaccines are, how responsive individuals are to these vaccines.” […] „Our goal is to make sure that we have the capacity to be able to address what’s needed,” Wainer said.

• #65 With COVID Vaccines, Why Have Testing? Here’s Why. | Abbott Newsroom

  https://www.abbott.com/corpnewsroom/diagnostics-testing/with-COVID-vaccines-why-have-testing-here-is-why.html

  With widespread COVID-19 vaccinations, you might not see testing as the necessity it was just last year. […] However, healthcare professionals and infectious disease experts including those at Abbott are reminding people how not testing could reverse the progress we’ve made. […] Let us paint the picture about the reasons COVID-19 testing is going to be vitally important for a long time to come. […] Having accessible, rapid testing is critical to catching new outbreaks, particularly for communities hardest hit already and where vaccine accessibility may be limited. […] For those who are unvaccinated, the World Health Organization reports that temperature screening alone is not effective at stopping the spread because people may not be feverish early in infection. That makes rapid testing all the more important.

• #66 With COVID Vaccines, Why Have Testing? Here’s Why. | Abbott Newsroom

  https://www.abbott.com/corpnewsroom/diagnostics-testing/with-COVID-vaccines-why-have-testing-here-is-why.html

  While vaccines have been given Food and Drug Administration emergency use authorizations and have been shown to be safe and effective, only time will show long-term protections against the virus and its variants. […] While it appears vaccines offer protections for the vaccinated as well as stopping them from spreading the virus to others, more study is needed to confirm. […] Continued COVID viral surveillance programs just as we have for HIV, hepatitis and more are necessary to understand variant circulation as well as the longevity of vaccine protections. […] For these reasons and billions more around the world testing isn’t going anywhere, either. So long as COVID-19 is in the world, testing will be too. […] The BinaxNOW COVID-19 tests have not been FDA cleared or approved. They have been authorized by the FDA under an emergency use authorization. They have been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens, and are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

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