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Outcome Reporting Bias in COVID-19 Mrna Vaccine Clinical Trials
medicina Perspective Outcome Reporting Bias in COVID-19 mRNA Vaccine Clinical Trials Ronald B. Brown School of Public Health and Health Systems, University of Waterloo, Waterloo, ON N2L3G1, Canada; [email protected] Abstract: Relative risk reduction and absolute risk reduction measures in the evaluation of clinical trial data are poorly understood by health professionals and the public. The absence of reported absolute risk reduction in COVID-19 vaccine clinical trials can lead to outcome reporting bias that affects the interpretation of vaccine efficacy. The present article uses clinical epidemiologic tools to critically appraise reports of efficacy in Pfzier/BioNTech and Moderna COVID-19 mRNA vaccine clinical trials. Based on data reported by the manufacturer for Pfzier/BioNTech vaccine BNT162b2, this critical appraisal shows: relative risk reduction, 95.1%; 95% CI, 90.0% to 97.6%; p = 0.016; absolute risk reduction, 0.7%; 95% CI, 0.59% to 0.83%; p < 0.000. For the Moderna vaccine mRNA-1273, the appraisal shows: relative risk reduction, 94.1%; 95% CI, 89.1% to 96.8%; p = 0.004; absolute risk reduction, 1.1%; 95% CI, 0.97% to 1.32%; p < 0.000. Unreported absolute risk reduction measures of 0.7% and 1.1% for the Pfzier/BioNTech and Moderna vaccines, respectively, are very much lower than the reported relative risk reduction measures. Reporting absolute risk reduction measures is essential to prevent outcome reporting bias in evaluation of COVID-19 vaccine efficacy. Keywords: mRNA vaccine; COVID-19 vaccine; vaccine efficacy; relative risk reduction; absolute risk reduction; number needed to vaccinate; outcome reporting bias; clinical epidemiology; critical appraisal; evidence-based medicine Citation: Brown, R.B. -
Ethics of Vaccine Research
COMMENTARY Ethics of vaccine research Christine Grady Vaccination has attracted controversy at every stage of its development and use. Ethical debates should consider its basic goal, which is to benefit the community at large rather than the individual. accines truly represent one of the mira- include value, validity, fair subject selection, the context in which it will be used and Vcles of modern science. Responsible for favorable risk/benefit ratio, independent acceptable to those who will use it. This reducing morbidity and mortality from sev- review, informed consent and respect for assessment considers details about the pub- eral formidable diseases, vaccines have made enrolled participants. Applying these princi- lic health need (such as the prevalence, bur- substantial contributions to global public ples to vaccine research allows consideration den and natural history of the disease, as health. Generally very safe and effective, vac- of some of the particular challenges inherent well as existing strategies to prevent or con- cines are also an efficient and cost-effective in testing vaccines (Box 1). trol it), the scientific data and possibilities way of preventing disease. Yet, despite their Ethically salient features of clinical vac- (preclinical and clinical data, expected brilliant successes, vaccines have always been cine research include the fact that it involves mechanism of action and immune corre- controversial. Concerns about the safety and healthy subjects, often (or ultimately) chil- lates) and the likely use of the vaccine (who untoward effects of vaccines, about disturb- dren and usually (at least when testing effi- will use and benefit from it, safety, cost, dis- ing the natural order, about compelling indi- cacy) in very large numbers. -
Thimerosal in Vaccines—An Interim Report to Clinicians
AMERICAN ACADEMY OF PEDIATRICS Committee on Infectious Diseases and Committee on Environmental Health Thimerosal in Vaccines—An Interim Report to Clinicians ABBREVIATIONS. AAP, American Academy of Pediatrics; and for preventing bacterial contamination, particu- USPHS, US Public Health Service; FDA, Food and Drug Admin- larly in opened multidose containers. Some but not istration; IPV, inactivated polio vaccine; OPV, oral polio vaccine; all of the vaccines recommended routinely for chil- DTP, diphtheria-tetanus-pertussis (vaccine); Hib, Haemophilus in- dren in the United States contain thimerosal.1 fluenzae type b (vaccine); EPA, Environmental Protection Agency; ATSDR, Agency for Toxic Substances and Disease Registry; Thimerosal contains 49.6% mercury by weight and is HBsAg, hepatitis B surface antigen; HBIG, hepatitis B immune metabolized to ethyl mercury and thiosalicylate. globulin. Data are limited regarding potential differences in toxicity between ethyl mercury and methyl mercury. n July 7, 1999, the American Academy of Both forms of organic mercury are associated with Pediatrics (AAP) issued with the US Public neurotoxicity in high doses, and definitive data re- Health Service (USPHS) a joint statement garding the doses at which developmental effects O occur in infants are not available. When vaccines alerting clinicians and the public of concern about thimerosal, a mercury-containing preservative used containing thimerosal have been administered in the in some vaccines. That statement was disseminated recommended doses, hypersensitivity has been widely, including on the AAP members e-mail list, noted, but no other harmful effects have been report- 2 Massive overdoses from inappropriate use of and was posted on the AAP web site since July 7, ed. -
COVID-19 Vaccine Trials
COVID-19 VACCINE TRIALS SUMMARY OF PFIZER AND MODERNA COVID-19 VACCINE RESULTS Some of the most common concerns voiced involve the A review of unblinded reactogenicity data from the speed with which these vaccines were developed and final analysis which consisted of a randomized subset whether they are safe or not. How were the companies of at least 8,000 participants 18 years and older in able to get these vaccines developed and ready for the phase 2/3 study demonstrates that the vaccine distribution so fast? Were they tested in persons who was well tolerated, with most solicited adverse events are most vulnerable? Are the vaccines safe? resolving shortly after vaccination. Even though COVID-19 vaccines were developed at While the vaccine was well tolerated overall, and side an extraordinary speed, companies were required effects lasted for only a day or two, persons taking to take all of the regulatory and operational steps the vaccine should be aware that the side effects normally required for all vaccine trials, so none of are more than is seen in general for the flu vaccine these steps were skipped. What did occur that does and be prepared for them. Most side effects were not normally occur was some upfront financial mild to moderate and included injection-site pain, assistance from the federal government (Moderna redness and swelling at the injection site, fatigue/ accepted, Pfizer declined) and federal regulatory tiredness, headache, chills, muscle pain, and joint agencies working closely with the companies, pain. “Severe” side effects, defined as those that providing near real-time data with companies prevent persons from continuing daily activities were receiving review and advice more quickly. -
Needle Tips Fall/Winter 1998-1999
Volume 8 - Number 2 NEEDLE TIPS Fall/Winter 1998-1999 & the Hepatitis B Coalition News Published by the Immunization Action Coalition for individuals and organizations concerned about vaccine-preventable diseases. Holy contraindications, Robin! That person was coughing! WHAT'S ON THE INSIDE: Why did you vaccinate him? Ask the Experts CDC’s immunization expert Dr. William Atkinson answers your questions ......................... 1 CDC’s hepatitis experts, Harold Margolis, MD, and Linda Moyer, RN, answer hepatitis A and B questions .................................................................................................. 17 What’s New? Vaccinate, don’t vacillate! by Walter A. Orenstein, MD, Centers for Disease Control ........... 3 Vaccine highlights: new vaccines and new recommendations .............................................. 4 ? ? ? It’s federal law! by Neal Halsey, MD, Institute for Vaccine Safety ....................................... 6 What’s your state doing? hepatitis B laws, pneumococcal, influenza rates, etc. .................... 9 Unprotected people...five varicella-related deaths ................................................................ 13 Photocopy these materials! Holy missed opportunities, Batman! Polio Vaccine Information Statement (VIS) ......................................................................... 7 A mild illness is NOT a reason to NEW! Vaccinations for adults with hepatitis C virus infection ............................................. 10 withhold vaccinations. You’d know this, Revised! -
Plant-Based COVID-19 Vaccines: Current Status, Design, and Development Strategies of Candidate Vaccines
Review Plant-Based COVID-19 Vaccines: Current Status, Design, and Development Strategies of Candidate Vaccines Puna Maya Maharjan 1 and Sunghwa Choe 2,3,* 1 G+FLAS Life Sciences, 123 Uiryodanji-gil, Osong-eup, Heungdeok-gu, Cheongju-si 28161, Korea; punamaya.maharjan@gflas.com 2 G+FLAS Life Sciences, 38 Nakseongdae-ro, Gwanak-gu, Seoul 08790, Korea 3 School of Biological Sciences, College of Natural Sciences, Seoul National University, Gwanak-gu, Seoul 08826, Korea * Correspondence: [email protected] Abstract: The prevalence of the coronavirus disease 2019 (COVID-19) pandemic in its second year has led to massive global human and economic losses. The high transmission rate and the emergence of diverse SARS-CoV-2 variants demand rapid and effective approaches to preventing the spread, diagnosing on time, and treating affected people. Several COVID-19 vaccines are being developed using different production systems, including plants, which promises the production of cheap, safe, stable, and effective vaccines. The potential of a plant-based system for rapid production at a commercial scale and for a quick response to an infectious disease outbreak has been demonstrated by the marketing of carrot-cell-produced taliglucerase alfa (Elelyso) for Gaucher disease and tobacco- produced monoclonal antibodies (ZMapp) for the 2014 Ebola outbreak. Currently, two plant-based COVID-19 vaccine candidates, coronavirus virus-like particle (CoVLP) and Kentucky Bioprocessing (KBP)-201, are in clinical trials, and many more are in the preclinical stage. Interim phase 2 clinical Citation: Maharjan, P.M.; Choe, S. trial results have revealed the high safety and efficacy of the CoVLP vaccine, with 10 times more Plant-Based COVID-19 Vaccines: neutralizing antibody responses compared to those present in a convalescent patient’s plasma. -
Vaccine Refusal, Mandatory Immunization, and the Risks of Vaccine-Preventable Diseases
The new england journal of medicine special article Vaccine Refusal, Mandatory Immunization, and the Risks of Vaccine-Preventable Diseases Saad B. Omer, M.B., B.S., Ph.D., M.P.H., Daniel A. Salmon, Ph.D., M.P.H., Walter A. Orenstein, M.D., M. Patricia deHart, Sc.D., and Neal Halsey, M.D. Abstract Vaccines are among the most effective prevention tools available to clinicians. How- From the Hubert Department of Global ever, the success of an immunization program depends on high rates of acceptance Health, Rollins School of Public Health (S.B.O.), and the Emory Vaccine Center and coverage. There is evidence of an increase in vaccine refusal in the United States (S.B.O., W.A.O.), Emory University, At- and of geographic clustering of refusals that results in outbreaks. Children with lanta; the Department of International exemptions from school immunization requirements (a measure of vaccine refusal) Health (S.B.O., D.A.S., N.H.) and the In- stitute for Vaccine Safety (N.H.), Johns are at increased risk for measles and pertussis and can infect others who are too Hopkins Bloomberg School of Public young to be vaccinated, cannot be vaccinated for medical reasons, or were vacci- Health, Baltimore; the National Vaccine nated but did not have a sufficient immunologic response. Clinicians can play a Program Office, Department of Health and Human Services, Washington, DC crucial role in parental decision making. Health care providers are cited as the most (D.A.S.); and Maternal and Child Health frequent source of immunization information by parents, including parents of un- Assessment, Washington State Depart- vaccinated children. -
Print Who's Afraid of Gardasil?
Who's Afraid of Gardasil? by KAREN HOUPPERT March 8, 2007 This article appeared in the March 26, 2007 edition of The Nation. The HPV vaccine story has gotten all tangled up. As recently as June 8, 2006, public health advocates, progressives and many parents were celebrating a huge victory: The Food and Drug Administration had approved Merck's new vaccine Gardasil, a shot series that would help protect girls from cervical cancer and genital warts. To their continuing delight, the Centers for Disease Control's immunization committee recommended less than a month later that the shots immediately be given to all females between the ages of 9 and 26. The committee acted on persuasive data indicating that the vaccine, which prevents the sexually transmitted human papillomavirus (HPV), works best before girls are sexually active. Human papillomavirus is the most common sexually transmitted infection in the world, and most women have had it-- 80 percent of US women, by the CDC's estimates. Often it goes away on its own, without its carrier's awareness. But each year hundreds of thousands of women and girls in the United States develop persistent infections from it, more than 10,000 get cervical cancer and 3,700 die from the cancer. Gardasil, given in a series of three shots, protects against four strains of HPV. Two of those strains cause 70 percent of the nation's cervical cancer cases, and two of them cause 90 percent of genital warts. This new vaccine, widely given, has the potential to make cervical cancer almost obsolete here. -
Considerations for the Design of Vaccine Efficacy Trials During Public Health Emergencies
bioRxiv preprint doi: https://doi.org/10.1101/261875; this version posted February 13, 2018. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted bioRxiv a license to display the preprint in perpetuity. It is made available under aCC-BY-ND 4.0 International license. Considerations for the design of vaccine efficacy trials during public health emergencies Natalie E. Dean1*, Pierre-Stéphane Gsell2, Ron Brookmeyer3, Victor De Gruttola4, Christl A. Donnelly5, M. Elizabeth Halloran6,7, Momodou Jasseh8, Martha Nason9, Ximena Riveros2, Conall Watson10, Ana Maria Henao-Restrepo2, Ira M. Longini, Jr.1* 1Department of Biostatistics, University of Florida, Gainesville, FL, USA. 2World Health Organization, Geneva, Switzerland. 3Department of Biostatistics, University of California, Los Angeles, CA, USA. 4Department of Biostatistics, Harvard University, Boston, MA, USA. 5MRC Centre for Outbreak Analysis and Modelling, Department of Infectious Disease Epidemiology, School of Public Health, Imperial College London, London, UK. 6Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA. 7Department of Biostatistics, University of Washington, Seattle, WA, USA. 8Medical Research Council, Banjul, The Gambia. 9Biostatistics Research Branch, National Institute of Allergy and Infectious Diseases, Rockville, MD, USA. 10Department of Infectious Disease Epidemiology, London School of Hygiene & Tropical Medicine, London, UK. *To whom correspondence should be addressed: [email protected] or [email protected], Dauer Hall, PO Box 117450, Gainesville, FL 32611, USA. +1 (352) 294-1945 One Sentence Summary: As part of the WHO research and development Blueprint for action to prevent epidemics, we describe key considerations for the design and analysis of trials and studies to evaluate experimental vaccines during public health emergencies. -
Congressional Record—House H5074
H5074 CONGRESSIONAL RECORD — HOUSE June 23, 2005 As Thomas Jefferson once said, MERCURY AND AUTISM them while at the same time changing Whenever people are well informed, The SPEAKER pro tempore. Under a the Vaccine Injury Compensation Fund they can be trusted with their own gov- previous order of the House, the gen- in a way that will protect these fami- ernment. tleman from Indiana (Mr. BURTON) is lies and help those who have been dam- Maintaining our commitment to pub- recognized for 5 minutes. aged, but so far we have gotten abso- lic broadcasting will help keep the very Mr. BURTON of Indiana. Mr. Speak- lutely nowhere with them; and it is people who elect us well informed, and er, I have been down here a lot talking something I think we need to continue in doing so, help to promote the integ- about autism over the years and my to work on. rity and proper functioning of this very committee had many hearings on the Just recently, there was an article body itself. issue of autism. My grandson became that was published in a magazine I nor- I applaud the Members of this body autistic after receiving 9 shots in one mally do not read. It is called Rolling who rose to the defense of public broad- day, 7 of which contained mercury, in a Stone, but this article was brought to casting earlier today by voting to re- product called thimerosal. And he is my attention, and I think everybody in store funding to a cherished American doing better but it has been a very dif- this body ought to read that article. -
Enrolling Minors in COVID-19 Vaccine Trials
Prepublication Release Enrolling Minors in COVID-19 Vaccine Trials Kevin Mintz, PhD, E. Jardas BS, Seema Shah, JD, Christine Grady, RN PhD, Marion Danis, MD, and David Wendler, PhD DOI: 10.1542/peds.2020-040717 Journal: Pediatrics Article Type: Special Article Citation: Mintz K, Jardas E, Shah S, Grady C, Danis M, Wendler D. Enrolling minors in COVID-19 vaccine trials. Pediatrics. 2020; doi: 10.1542/peds.2020-040717 This is a prepublication version of an article that has undergone peer review and been accepted for publication but is not the final version of record. This paper may be cited using the DOI and date of access. This paper may contain information that has errors in facts, figures, and statements, and will be corrected in the final published version. The journal is providing an early version of this article to expedite access to this information. The American Academy of Pediatrics, the editors, and authors are not responsible for inaccurate information and data described in this version. Downloaded from www.aappublications.org/news by guest on October 4, 2021 ©2020 American Academy of Pediatrics Prepublication Release Enrolling Minors in COVID-19 Vaccine Trials Kevin Mintz, PhDa, E. Jardas, BSa, Seema Shah, JDb,c,, Christine Grady, RN, PhDa, Marion Danis, MDa, and David Wendler, PhDa Affiliations: aDepartment of Bioethics, National Institutes of Health, Bethesda, Maryland; bAnn & Robert H. Lurie Children’s Hospital of Chicago, Chicago, Illinois; cNorthwestern University, Feinburg School of Medicine, Chicago, Illinois Address correspondence to: David Wendler, Department of Bioethics, National Institutes of Health, 10 Center Drive, Building 10, Room 1C118, Bethesda, MD 20892-1156, [email protected]. -
Pcic Remarks
:3f47 Good Morning Commissioners of the IRRC, My name is Alison Mullins and I am here on behalf of members of The Pennsylvania Coalition for Informed Consent. Our volunteer organization is neither for nor opposed to vaccinations, believing that adults, not the government, should make health care choices for themselves and their children. I am opposed to the proposed regulation #3 147 and ask that it not be accepted. The five day provisional period was protested by 2/3 of those who commented, whether or not they were for the new mandates. Valid concerns were completely dismissed by the Department which caused many to question the validity of the entire process. The Department used the theory of Herd Immunity tojustifi the five day provisional period. However, many vaccines are designed to lessen disease symptoms instead of preventing disease transmission which would actually impact herd immunity. • Vaccines for Tetanus, inactivated Polio, and diphtheria toxoid are intended for personal protection only. • Hepatitis B is a blood borne virus and unlikely to spread in a school community. • The Hib vaccine only covers type B and the vaccine has shifted strain dominance toward types A-F, making the general population more vulnerable to the disease than prior to the start of the Hib vaccination campaign. • Asymptomatic carriers of pertussis may inadvertently spread the disease as their symptoms are diminished. When responding to a primate study which showed the acellular pertussis vaccine is not capable of preventing colonization and transmission of B. pertussis, The Department dismissively said that it “disagrees with the commentator” and said they will follow the ACIP recommendation.