An Overview Of Vaccine Development, Approval, And Regulation, With Implications For COVID-19

Abstract

The Food and Drug Administration generally approves vaccines when their benefits outweigh their risks for their intended use. In this paper, we review current and potential approaches to this critical role of the FDA. The FDA has established pathways to accelerate vaccine availability prior to approval, such as emergency use authorization, and to channel resources to high-priority products and allow more flexibility in the evidence required for approval, including accelerated approval based on surrogate markers of effectiveness. Among the 35 new vaccines approved in the US from 2006-2020, about two-thirds of their pivotal trials used the surrogate outcome of immune system response, and just one-third evaluated actual disease incidence. Post-approval safety surveillance of new vaccines-particularly vaccines receiving expedited approval-is crucial. Currently this is accomplished through such mechanisms as the Centers for Disease Control and Prevention/FDA Vaccine Adverse Event Reporting System, the CDC Vaccine Safety Datalink, and the CDC Clinical Immunization Safety Assessment Project. Adverse events detected in this way may lead to changes in a vaccine's recommended use or its withdrawal from the market. Regulatory oversight of new vaccines will have to balance speed with rigor and decisiveness to effectively address the coronavirus disease 2019 (COVID-19) pandemic.

Covid-19 vaccines: In the rush for regulatory approval, do we need more data?

“…Among the six "first in disease" vaccines approved by the FDA since 2006, pre-licensure pivotal trials were a median of 23 months in duration, according to a recent analysis. 9 Six months also seems substantially shorter than previously conceptualised expectations. A World Health Organization expert group on covid-19 vaccines (which included FDA regulators) in August 2020 called for follow-up "until at least month 12, or until an effective vaccine is deployed locally."…”

“…An approval based on six months of data would represent one of the fastest for a novel vaccine in FDA history. Among the six “first in disease” vaccines approved by the FDA since 2006, pre-licensure pivotal trials were a median of 23 months in duration, according to a recent analysis 9…”

Global covid-19 vaccine rollout and safety surveillance—how to keep pace

“…Safety of vaccines after licensing should ideally be monitored by a combination of passive and active surveillance 1617. Passive vaccine safety surveillance systems rely on spontaneous reporting of adverse events by vaccine manufacturers, healthcare providers, care givers, or patients.…”

The willingness of the Saudi Arabian population to participate in the COVID-19 vaccine trial: A case–control study

“… 8 The FDA has launched fast-track paths for vaccine availability before approval. 9 This vaccine validation approach would facilitate high-priority outcomes and the production of required evidence for approval based on alternate efficacy markers. 9 No studies have assessed the public's attitudes or willingness to participate in clinical trials for the COVID-19 vaccine on the Saudi population.…”

“… 9 This vaccine validation approach would facilitate high-priority outcomes and the production of required evidence for approval based on alternate efficacy markers. 9 No studies have assessed the public's attitudes or willingness to participate in clinical trials for the COVID-19 vaccine on the Saudi population. This study examines and compares the willingness among recovered COVID-19 cases and healthy individuals to participate in a COVID-19 vaccine trial, and the factors responsible for their decision.…”