Las vacunas contra la COVID-19, ¿cuál es mejor?

Desde el comienzo de la pandemia por SARS-CoV-2 las vacunas se plantearon como una de las principales estrategias para hacerle frente, debido a esto se inició una carrera en el desarrollo de una vacuna contra la COVID-19. Dicho proceso implica el conocer al agente patógeno de interés, así como el proceso mediante el cual causa enfermedad. Durante el proceso de desarrollo se ponen a prueba las diferentes vacunas en múltiples escenarios pero solo un porcentaje pequeño logra finalizar las diversas etapas. Existen diversos tipos de vacunas, cada una tiene una forma diferente de transportar hacia dentro de la célula al antígeno, o a las partes de este, para inducir una respuesta inmune, y precisamente un dato sorprendente respecto a las vacunas contra COVID-19 es que se están desarrollando bajo una cantidad nunca antes vista de plataformas y tipos de vacunas. Actualmente se desarrollan más de 200 vacunas, pero solo 21 de ellas se encuentran en ensayos clínicos de fase III, cinco de las cuales han sido aprobadas por la COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios), tan solo tres por la FDA (Food and Drug Administration) y tres por la EMA (European Medicines Agency). En el presente trabajo se evidencian los resultados de una revisión de la literatura publicada hasta el momento en la base de datos en línea PubMed y el motor de búsqueda Google Academico, todo con el objetivo que fue responder la pregunta ¿Cuál de las vacunas ya aprobadas contra la COVID-19 es la mejor opción?

Transparency in European Medicines Agency and US Food and Drug Administration Decision Making: Is It Possible to Identify the Rationale for Divergences in Approved Indication From Public Assessment Reports?

Clinical Therapeutics ◽

10.1016/j.clinthera.2021.03.010 ◽

2021 ◽

Author(s):

Magda Bujar ◽

Sara Ferragu ◽

Neil McAuslane ◽

Lawrence Liberti ◽

Thomas C. Kühler

Keyword(s):

Decision Making ◽

Drug Administration ◽

Assessment Reports

The Food and Drug Administration reports provided more data but were more difficult to use than the European Medicines Agency reports

Journal of Clinical Epidemiology ◽

10.1016/j.jclinepi.2014.06.019 ◽

2015 ◽

Vol 68 (1) ◽

pp. 102-107 ◽

Cited By ~ 5

Author(s):

Jeppe Bennekou Schroll ◽

Maher Abdel-Sattar ◽

Lisa Bero

Keyword(s):

Drug Administration ◽

The Food and Drug Administration (FDA) and the European Medicines Agency (EMA) perspective on cardiovascular Polypill: A multidimensional concept

Cardiology Journal ◽

10.5603/cj.2016.0074 ◽

2016 ◽

Vol 23 (5) ◽

pp. 515-517 ◽

Cited By ~ 1

Author(s):

Mariusz Mogielnicki ◽

Damian Swieczkowski ◽

Witold Bachorski ◽

Grzegorz Zuk ◽

Natasza Gilis-Malinowska ◽

...

Keyword(s):

Drug Administration ◽

Multidimensional Concept

PRS61 A COMPARISON OF EUROPEAN MEDICINES AGENCY (EMA) AND FOOD AND DRUG ADMINISTRATION (FDA) PATIENT-REPORTED OUTCOME (PRO) GUIDANCES FOR CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)

Value in Health ◽

10.1016/j.jval.2019.09.2550 ◽

2019 ◽

Vol 22 ◽

pp. S883

Author(s):

K. Gittings ◽

I. Kang ◽

H. Lee ◽

A. Gaiser ◽

D. Louie ◽

...

Keyword(s):

Chronic Obstructive Pulmonary Disease ◽

Pulmonary Disease ◽

Drug Administration ◽

Patient Reported Outcome ◽

Chronic Obstructive ◽

Obstructive Pulmonary Disease ◽

Patient Reported

Are the European Medicines Agency, US Food and Drug Administration, and Other International Regulators Talking to Each Other?

Clinical Pharmacology & Therapeutics ◽

10.1002/cpt.1617 ◽

2019 ◽

Vol 107 (3) ◽

pp. 507-513 ◽

Cited By ~ 4

Author(s):

Tania Teixeira ◽

Sandra L. Kweder ◽

Agnes Saint‐Raymond

Keyword(s):

Drug Administration ◽

Patient-reported outcomes: Assessment and current perspectives of the guidelines of the Food and Drug Administration and the reflection paper of the European Medicines Agency

European Journal of Cancer ◽

10.1016/j.ejca.2008.09.032 ◽

2009 ◽

Vol 45 (3) ◽

pp. 347-353 ◽

Cited By ~ 103

Author(s):

Andrew Bottomley ◽

Dave Jones ◽

Lily Claassens

Keyword(s):

Drug Administration ◽

Patient Reported Outcomes ◽

Outcomes Assessment ◽

Patient Reported

Comparisons of Food and Drug Administration and European Medicines Agency Risk Management Implementation for Recent Pharmaceutical Approvals: Report of the International Society for Pharmacoeconomics and Outcomes Research Risk Benefit Management Working Group

Value in Health ◽

10.1016/j.jval.2012.06.019 ◽

2012 ◽

Vol 15 (8) ◽

pp. 1108-1118 ◽

Cited By ~ 25

Author(s):

Yvonne Lis ◽

Melissa H. Roberts ◽

Shital Kamble ◽

Jeff J. Guo ◽

Dennis W. Raisch

Keyword(s):

Risk Management ◽

Drug Administration ◽

International Society ◽

Outcomes Research ◽

Working Group ◽

Agency Risk

Assessment of Food and Drug Administration– and European Medicines Agency–Approved Systemic Oncology Therapies and Clinically Meaningful Improvements in Quality of Life

JAMA Network Open ◽

10.1001/jamanetworkopen.2020.33004 ◽

2021 ◽

Vol 4 (2) ◽

pp. e2033004

Author(s):

Vanessa Arciero ◽

Seanthel Delos Santos ◽

Liza Koshy ◽

Amanda Rahmadian ◽

Ronak Saluja ◽

...

Keyword(s):

Quality Of Life ◽

Drug Administration ◽

Exciting Developments in the Medical Management of Cushing’s Disease

US Endocrinology ◽

10.17925/use.2015.11.02.95 ◽

2015 ◽

Vol 11 (02) ◽

pp. 95

Author(s):

Susan L Samson ◽

◽

Keyword(s):

Adverse Effects ◽

Medical Therapy ◽

Drug Administration ◽

Cushing’S Disease ◽

Medical Management ◽

Cushing's Disease ◽

Patient Specific ◽

Failed Surgery

Until recently, there have been few options for the treatment of patients with Cushing’s disease who have failed surgery or have recurred. With the approval of US Food and Drug Administration (FDA) and European Medicines Agency (EMA) of mifepristone and pasireotide, endocrinologists now have additional therapies they can consider for their Cushing’s disease patients. Each of these medications has its own positive characteristics and adverse effects so that patient-specific characteristics must be taken into account when deciding on a suitable medical therapy.

Nephrogenic systemic fibrosis

Oxford Textbook of Rheumatology ◽

10.1093/med/9780199642489.003.0123 ◽

2013 ◽

pp. 1001-1006

Author(s):

Cate H. Orteu

Keyword(s):

United States ◽

Renal Failure ◽

Contrast Agents ◽

Drug Administration ◽

Nephrogenic Systemic Fibrosis ◽

The United States ◽

United States Food ◽

States Food

Nephrogenic systemic fibrosis (NSF) is a severe and disabling fibrosing condition of the skin and systemic organs. It occurs in patients with renal failure who have been exposed to gadolinum-based contrast agents (GBCAs). The development of NSF should be preventable if adequate precautions are taken in relation to GBCA exposure in susceptible patients. New cases should be reported to the European Medicines Agency and/or the United States Food and Drug Administration.