COVID-19 Vaccine Post-Authorization Reviews Begin
The British Medical Journal (BMJ) published an article that stated, 'when Covid-19 vaccines were first authorized, regulators required post-authorization studies to tackle important uncertainties about efficacy and safety.'
'But these studies may have little practical value unless there is greater engagement and scrutiny from the broader scientific community,' argued Christof Prugger and colleagues on December 23, 2021.
There is 'a long history of concerns about the wisdom of shifting clinically significant efficacy and safety assessments from before to after authorization.'
The U.S. FDA listed important remaining unknowns in its review in December 2020, such as whether Covid-19 vaccines reduce the risk of hospital admission, intensive care unit admission, severe covid-19, and mortality, as well as whether the vaccines are effective in populations at high risk of severe Covid-19.'
However, 'evidence on relevant outcomes often remains inconclusive for several years, and post-authorization safety events are seen more frequently for drugs with expedited approval.'
Journals also have a role in providing a place for third-party critiques and analyses of post-authorization studies.
Both the scientific community and the public increasingly perceive the urgent need for independent evaluation of regulatory requirements.
'Without external scrutiny, we risk repeating the mistakes of the past—with many promises made but little follow-through.'
'And researchers should get involved in the independent evaluation of this material. Regulatory research (third party appraisal of industry-funded studies mandated by regulatory authorities), independent of manufacturers and political interests, might relieve pressure on regulators.'
'And improve public trust by helping to ensure the safety, efficacy, and value of all medicines, including covid-19 vaccines—particularly those authorized through expedited regulatory pathways' concluded the excerpts from this BMJ article.