Speed, Evidence, and Safety Characteristics of Vaccine Approvals by the US Food and Drug Administration

Puthumana, Jeremy; Egilman, Alexander C; Zhang, Audrey D; Schwartz, Jason L.; Ross, Joseph S.

doi:10.1001/jamainternmed.2020.7472

Cited by 18 publications

(25 citation statements)

References 2 publications

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“…Concerning safety data, all phase 3 trials enrolled thousands of participants, allowing for a good assessment of short-term adverse reactions, which are known to occur within 6 weeks after injection (34). No trial reported major adverse events.…”

Section: Types Of Vaccine and Current Resultsmentioning

confidence: 99%

Challenges and Issues of Anti-SARS-CoV-2 Vaccines

Blumental

Debré

2021

Front. Med.

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At the beginning of 2021, anti-SARS-CoV-2 vaccination campaigns had been launched in almost 60 countries with more than 500 million doses having been distributed. In addition to the few vaccines already in use, many other candidates are in preclinical phases or experimental stages in humans. Despite the fact that the availability of anti-SARS-CoV-2 vaccine constitutes a major advance and appear to be the only way to control the pandemic, some investigation remains to be carried out, and this is notably concerning the impact on transmissibility, the duration of the conferred protection in the mid- and long term, the effectiveness against present and future viral mutants, or the ideal schedule that should be applied. In this paper, we review the circumstances that facilitated such a rapid development of anti-SARS-CoV-2 vaccines and summarize the different vaccine platforms under investigation as well as their present results and perspectives in different settings. We also discuss the indications of vaccination under special conditions, such as a history of previous COVID-19 infection or belonging to extreme age categories like children and elderly. Overall, this review highlights the multiple challenges to face if aiming to find a global solution to the pandemic through high vaccination coverage all over the world.

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Section: Types Of Vaccine and Current Resultsmentioning

confidence: 99%

Challenges and Issues of Anti-SARS-CoV-2 Vaccines

Blumental

Debré

2021

Front. Med.

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“…Using FDA approval letters, we identified all novel vaccines granted accelerated approval from the pathway’s inception in 1992 through 2017, allowing 3 years minimum for completion of postapproval trials. Following previously described approaches, 3 , 4 we identified pivotal efficacy trials (i.e., those serving as the basis of FDA approval) and extracted trial characteristics from FDA’s clinical reviews, as well as the total number of studies supporting approval and the prelicensure safety population. Next, we identified postapproval trials FDA required for accelerated approval, including ClinicalTrials.gov registrations and corresponding publications on PubMed, and extracted trial characteristics and determined study status.…”

Section: Methodsmentioning

confidence: 99%

Characteristics of Preapproval and Postapproval Studies of Vaccines Granted Accelerated Approval by the US Food and Drug Administration

Egilman

Wallach²,

Puthumana

et al. 2021

J GEN INTERN MED

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“…Cualquier problema que surja con esta vacuna produciría una mayor inquietud y hay que recordar que no existe un sustituto mejor para certificar la seguridad de una vacuna que los ensayos clínicos bien planteados, doble ciego, prospectivos y aleatorizados [16]. Dada la gravedad de la pandemia, la autorización apresurada de alguna vacuna es contemplada con preocupación por las autoridades sanitarias de todo el mundo [17][18][19][20].…”

Section: Las Mutacionesunclassified

Vaccine against COVID-19

Picazo

2021

Rev Esp Quimioter

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The COVID-19 pandemic has produced a huge health, economic and psychological collapse in our society. Health workers have had to face one of the greatest challenges in history, trying to show the population how to deal with this disease. We have learned that vaccines are the great instrument for the fight against infectious diseases and a large number of them began to appear, not as a product of chance but as a product of the enormous progress experienced in recent years with vaccines against new infectious diseases, against other diseases such as Alzheimer’s and especially against cancer. All this knowledge has been applied to this disease. Practitioners lamented the little information available to them when asked questions from patients. This document wanted to be a response to these concerns, with a scientific desire, with evidence that put aside unverified data and hoaxes. Faced with an avalanche of information, most of it without the appropriate “peer review” as indicated in the introduction, any publication becomes obsolete at the time of publication, and we opted for an “online” publication, with the incorporation of versions. This online publication has been published in the documents of Spanish Society of Chemotherapy.

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Speed, Evidence, and Safety Characteristics of Vaccine Approvals by the US Food and Drug Administration

Cited by 18 publications

References 2 publications

Challenges and Issues of Anti-SARS-CoV-2 Vaccines

Challenges and Issues of Anti-SARS-CoV-2 Vaccines

Characteristics of Preapproval and Postapproval Studies of Vaccines Granted Accelerated Approval by the US Food and Drug Administration

Vaccine against COVID-19

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