Many people were sceptical when the first COVID-19 vaccines were approved, in part because of the short time frame of introduction and availability compared to other vaccines. How was it possible, that vaccines were available just one year after the start of the pandemic?
A number of important reasons for the accelerated availability of vaccines stem from the specific pandemic situation of COVID-19. On the one hand, research regarding vaccines of related viruses was already at an advanced level. Furthermore, immense resources were devoted to research activities worldwide and collaborations formed. The rapidly increasing incidence could accelerate patient recruitment. As a result, faster study completions were possible. Additionally, vaccine production took place in parallel with the approval process.
Regulatory reasons: Resources and accelerated procedures by EMA
Regulatory procedures are also responsible for the rapid availability of the first COVID-19 vaccines. With the emergence of COVID-19, the EMA formed an expert group to advise applicants both scientifically and on regulatory procedures. Acceleration of approval can occur through a rolling review, which occurs prior to submission of the marketing authorisation application and complete data set. This means that during phase III studies, the EMA already reviews individual parts of the dossier to be submitted. This gives the applicant the opportunity to answer any questions that may already arise. In addition to the rolling review, there is an accelerated approval procedure for conditional approvals. This procedure can reduce the period between submission and final approval from 277 to 153 days. A conditional approval is valid for one year, after which it can be extended for another year and, if necessary, become fully approved. This is subject to a positive risk-benefit balance and the condition that the pharmaceutical company provides further comprehensive data later on. The conditional approval underlies EU legislation in the case of public health emergencies.