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1.
Vaccine ; 40(4):689-690, 2022.
Article in English | ProQuest Central | ID: covidwho-1627314

ABSTRACT

Throughout my own career as a physician-scientist and vaccinologists, past President of the Armed Forces Epidemiological Board, President of the Defense Health Board, and a prior member of every US national committee that deals with vaccines, as well as a participant in multiple tabletop exercises designed to improve our pandemic preparedness I have never ceased to be amazed at the conscious and collective “group-think” that pervades what passes for pandemic preparedness and planning. The chapter titles alone are concise and revealing summaries of critical aspects of our willful delusions about the pandemic, and our anemic responses (America the Vulnerable, Confusion and Subterfuge, Pandemics as National Security Threats, The Outbreak We Didn’t Want to See, Looking for Spread in the Wrong Places, the Zika Misadventure, the CDC Fails, Not Enough Tests and Not Enough Labs, Shortage after Shortage, Preparing for the Wrong Pathogen, Stay-at-Home Orders, A Plan Gone Awry, The Information Desert, Hardened Sites, Evidence Is Hard to Collect in a Crisis, Getting Drugs to Patients, the mRNA Breakthrough, A New Doctrine for National Security). Future pandemic planning should only be conducted with adult supervision, include experts other than the same people who have repeatedly failed the nation, involve checks and outside review, and include experts from outside the usual field – such as psychologists, futurists, supply chain and logistical experts, and others – and be chaired by persons such as Gottlieb who have a clear and comprehensive grasp on the multifaceted nature of the complexities involved in preparedness and response.

2.
Clin Infect Dis ; 2021 Mar 17.
Article in English | MEDLINE | ID: covidwho-1597035
3.
Lancet Infect Dis ; 21(11): e342-e347, 2021 11.
Article in English | MEDLINE | ID: covidwho-1561809

ABSTRACT

Large-scale deployment of COVID-19 vaccines will seriously affect the ongoing phases 2 and 3 randomised placebo-controlled trials assessing SARS-CoV-2 vaccine candidates. The effect will be particularly acute in high-income countries where the entire adult or older population could be vaccinated by late 2021. Regrettably, only a small proportion of the population in many low-income and middle-income countries will have access to available vaccines. Sponsors of COVID-19 vaccine candidates currently in phase 2 or initiating phase 3 trials in 2021 should consider continuing the research in countries with limited affordability and availability of COVID-19 vaccines. Several ethical principles must be implemented to ensure the equitable, non-exploitative, and respectful conduct of trials in resource-poor settings. Once sufficient knowledge on the immunogenicity response to COVID-19 vaccines is acquired, non-inferiority immunogenicity trials-comparing the immune response of a vaccine candidate to that of an authorised vaccine-would probably be the most common trial design. Until then, placebo-controlled, double-blind, crossover trials will continue to play a role in the development of new vaccine candidates. WHO or the Council for International Organizations of Medical Sciences should define an ethical framework for the requirements and benefits for trial participants and host communities in resource-poor settings that should require commitment from all vaccine candidate sponsors from high-income countries.


Subject(s)
COVID-19 Vaccines/immunology , COVID-19/prevention & control , Clinical Trials as Topic , COVID-19/epidemiology , COVID-19/immunology , COVID-19/virology , COVID-19 Vaccines/administration & dosage , Double-Blind Method , Humans , Immunogenicity, Vaccine , Pandemics/prevention & control , SARS-CoV-2/immunology
4.
Vaccine ; 2021 Nov 27.
Article in English | MEDLINE | ID: covidwho-1537111

ABSTRACT

We retrieved data on 8940 anaphylaxis cases post-COVID-19 vaccination from the US Vaccine Adverse Event Reporting System and the European EudraVigilance from week 52/2020 through week 31/2021 and compared them with those of other vaccines. Overall, 837,830,000 COVID-19 vaccine doses were delivered in the US and Europe during the study period, for which the vaccine name was known. The mean anaphylaxis rate was estimated at 10.67 cases per 106 doses of COVID-19 vaccines (range: 7.99-19.39 cases per 106 doses depending on the vaccine). COVID-19 vaccines ranked fifth in reported anaphylaxis rates, behind rabies, tick-borne encephalitis, measles-mumps-rubella-varicella, and human papillomavirus vaccines (70.77, 20, 19.8, and 13.65 cases per 106 vaccine doses, respectively). COVID-19 vaccines are within the range of anaphylaxis rates reported across several common vaccines in these two passive reporting systems. These data should be communicated to reassure the general population about the safety profile of COVID-19 vaccines.

5.
J Allergy Clin Immunol Pract ; 9(10): 3599-3603, 2021 10.
Article in English | MEDLINE | ID: covidwho-1363230

ABSTRACT

Influenza is an annual seasonal epidemic, and occasionally pandemic, respiratory disease that causes considerable morbidity and mortality worldwide. Despite the widespread availability of safe and effective vaccines since the 1950s, this virus continues to pose a significant public health threat. Variable and often weak vaccine effectiveness, antigenic drift and shift, and vaccine hesitancy are some of the obstacles that must be overcome to control this disease. In this article, we briefly review current influenza vaccines, address safety concerns and the need for newer influenza vaccines of higher efficacy, and discuss efforts to create broadly protective, universal influenza vaccines.


Subject(s)
Influenza Vaccines , Influenza, Human , Humans , Influenza, Human/epidemiology , Influenza, Human/prevention & control , Pandemics
6.
Vaccine ; 39(41): 6111-6116, 2021 10 01.
Article in English | MEDLINE | ID: covidwho-1386705

ABSTRACT

Little is known about COVID-19 mRNA vaccine humoral immune responses in patients with central nervous system autoimmune demyelinating diseases, multiple sclerosis (MS) and neuromyelitis optica (NMO), who are on B-cell depleting therapies (BCDT) and other disease modifying therapies (DMTs). We conducted a single center prospective study to identify the clinical and immunological features associated with vaccine-induced antibody response in 53 participants before and after COVID-19 mRNA vaccination. This is the first report on the anti-spike RBD and anti-nucleocapsid antibody response, along with pre- and post-vaccine absolute lymphocyte counts (ALC) and flow cytometry analysis of CD19 and CD20 lymphocytes in patients with MS and NMO. We tested the hypothesis that patients on BCDT may have impaired COVID-19 vaccine humoral responses. Among patients on BCDT, 36.4% demonstrated a positive antibody response to spike RBD, in comparison to 100% in all other groups such as healthy controls, untreated MS, and patients on non-B cell depleting DMTs (p < 0.0001). Immunological data revealed lower baseline (pre-vaccination) levels of IgM in patients on BCDT (p = 0.003). Low CD19 and CD20 counts and a shorter interval from the last B cell depleting therapy infusion to the first vaccine dose were associated with a negative spike RBD antibody response (non-seroconverter) in patients on BCDT. Age, body mass index (BMI) and total treatment duration did not differ between seroconverters and non-seroconverters.


Subject(s)
COVID-19 , Multiple Sclerosis , COVID-19 Vaccines , Humans , Multiple Sclerosis/therapy , Prospective Studies , RNA, Messenger , SARS-CoV-2
7.
Clin Pharmacol Ther ; 110(3): 546-548, 2021 09.
Article in English | MEDLINE | ID: covidwho-1372710
9.
Mayo Clin Proc ; 96(8): 2095-2101, 2021 08.
Article in English | MEDLINE | ID: covidwho-1253365

ABSTRACT

OBJECTIVE: To assess the readability of the informed consent forms from the phase 3 COVID-19 vaccine trials conducted in the United States. PATIENTS AND METHODS: English consent forms were used for patients in phase 3 COVID-19 vaccine clinical trials. Consent forms were obtained in October 2020. Using Microsoft Word tools, we analyzed the readability (ie, the ease of reading) of written consent forms and informational documents from phase 3 COVID-19 vaccine clinical trials in the United States from the following manufacturers: AstraZeneca, Moderna, Pfizer, Johnson & Johnson, and Novavax. RESULTS: Owing to low readability and several format factors, this study determined that none of the consent forms or informational documents from the recent phase 3 COVID-19 vaccine clinical trials conducted in the United States met readability standards at the recommended 7th grade readability level for the average vaccine research volunteer in any readability category. The average English-speaking vaccine trial volunteer would have great difficulty comprehending the information provided in the consent forms and informational documents. To ensure that study subjects receive and fully comprehend information regarding a clinical study and can provide reliable consent, greater attention should be given to the development and use of simplified consent forms, multimedia formatting, personal discussion, and comprehension assessments.


Subject(s)
COVID-19 Vaccines , Comprehension , Consumer Health Information , Health Literacy , Informed Consent , Clinical Trials, Phase III as Topic , Humans , United States
12.
Lancet ; 397(10277): 854-855, 2021 03 06.
Article in English | MEDLINE | ID: covidwho-1117242
16.
Vaccine ; 38(41): 6347, 2020 09 22.
Article in English | MEDLINE | ID: covidwho-734468
17.
Immunol Rev ; 296(1): 205-219, 2020 07.
Article in English | MEDLINE | ID: covidwho-998975

ABSTRACT

This article provides a review of studies evaluating the role of host (and viral) genetics (including variation in HLA genes) in the immune response to coronaviruses, as well as the clinical outcome of coronavirus-mediated disease. The initial sections focus on seasonal coronaviruses, SARS-CoV, and MERS-CoV. We then examine the state of the knowledge regarding genetic polymorphisms and SARS-CoV-2 and COVID-19. The article concludes by discussing research areas with current knowledge gaps and proposes several avenues for future scientific exploration in order to develop new insights into the immunology of SARS-CoV-2.


Subject(s)
Betacoronavirus/immunology , Coronavirus Infections/immunology , Disease Resistance/genetics , Genetic Predisposition to Disease , Host-Pathogen Interactions/genetics , Pneumonia, Viral/immunology , Animals , Betacoronavirus/pathogenicity , COVID-19 , Coronavirus Infections/epidemiology , Coronavirus Infections/genetics , Coronavirus Infections/virology , Host-Pathogen Interactions/immunology , Humans , Middle East Respiratory Syndrome Coronavirus/immunology , Middle East Respiratory Syndrome Coronavirus/pathogenicity , Pandemics , Pneumonia, Viral/epidemiology , Pneumonia, Viral/genetics , Pneumonia, Viral/virology , SARS Virus/immunology , SARS Virus/pathogenicity , SARS-CoV-2 , Severe Acute Respiratory Syndrome/genetics , Severe Acute Respiratory Syndrome/virology
18.
Vaccine ; 38(51): 8185-8193, 2020 12 03.
Article in English | MEDLINE | ID: covidwho-997580

ABSTRACT

BACKGROUND: While administration of the measles-mumps-rubella (MMR-II®) vaccine has been effective at preventing rubella infection in the United States, the durability of humoral immunity to the rubella component of MMR vaccine has not been widely studied among older adolescents and adults. METHODS: In this longitudinal study, we sought to assess the durability of rubella virus (RV)-specific humoral immunity in a healthy population (n = 98) of adolescents and young adults at two timepoints: ~7 and ~17 years after two doses of MMR-II® vaccination. Levels of circulating antibodies specific to RV were measured by ELISA and an immune-colorimetric neutralization assay. RV-specific memory B cell responses were also measured by ELISpot. RESULTS: Rubella-specific IgG antibody titers, neutralizing antibody titers, and memory B cell responses declined with increasing time since vaccination; however, these decreases were relatively moderate. Memory B cell responses exhibited a greater decline in men compared to women. CONCLUSIONS: Collectively, rubella-specific humoral immunity declines following vaccination, although subjects' antibody titers remain well above the currently recognized threshold for protective immunity. Clinical correlates of protection based on neutralizing antibody titer and memory B cell ELISpot response should be defined.


Subject(s)
Immunity, Humoral , Measles-Mumps-Rubella Vaccine/immunology , Rubella/immunology , Adolescent , Adult , Antibodies, Neutralizing/immunology , B-Lymphocytes/immunology , Female , Humans , Immunoglobulin G/blood , Male , Measles-Mumps-Rubella Vaccine/pharmacology , Rubella/prevention & control , Time Factors , Vaccination , Young Adult
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