Regulatory concepts to guide and promote the accelerated but safe clinical development and licensure of COVID‐19 vaccines in Europe

Abstract

the coronavirus disease 2019 (COVID-19) caused by the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) developed into a worldwide pandemic within several months. Until April 2021, globally more than 131 Mio cases of COVID-19 were diagnosed with a death toll of more than 2.8 Mio. In the WHO European region alone, more than 46 Mio cases were diagnosed and more than 990,000 deaths were recorded. 1 SARS-CoV-2 is a beta coronavirus that is closely related to the severe acute respiratory syndrome coronavirus(SARS-CoV) and the Middle East respiratory syndrome-related coronavirus (MERS-CoV) that caused epidemic outbreaks in 2002 and 2012, respectively. 2,3However, these previous outbreaks did not evoke such a dramatic worldwide health emergency situation than SARS-CoV-2. A wide

COVID‐19 vaccines—The way forward

“…In this issue, experts from the Paul-Ehrlich Institute, the regulatory institution for vaccine development in Germany, describe the regulatory procedures, concepts and requirements that are applied to guide and promote the accelerated development and licensure of safe and efficacious COVID-19 vaccines in Europe. 2 Vaccine regulation worldwide began in the USA, when on 1st July 1902, the U.S. Congress passed 'An act to regulate the sale of viruses, serums, toxins, and analogous products', later referred to as the 'Biologics Control Act' that established the government's right to control the manufacturing of vaccines. This is now regarded as the first modern federal legislation to control the quality of drugs and emerged in part as a response to 1901 contamination events in St. Louis and Camden involving smallpox vaccine and diphtheria antitoxin.…”

“…So far, the EU granted a conditional marketing authorization (CMA) to four COVID-19 vaccines and four other vaccine candidates are under rolling review at the EMA. 2 A CMA can be issued for vaccines in emergency situations as a valuable option to expedite vaccine licensure with postponement of some data requirements but based on the reliable demonstration of a positive benefit-risk balance. 2 Moreover, procedural timelines for data evaluation were drastically reduced and the regulatory assessment at the EMA and FDA was further expedited by applying a 'rolling review' approach allowing for a very flexible and time-optimized processing and assessment of individual data packages immediately upon their availability.…”

“…This patchwork of approval processes has revived a long‐standing question, how to better facilitate harmonization in vaccine regulation and whether a harmonized approval process would make the vaccine development procedures more effective, quicker, broadly accessible and administered by the whole world and even less expensive. In this issue, experts from the Paul‐Ehrlich Institute, the regulatory institution for vaccine development in Germany, describe the regulatory procedures, concepts and requirements that are applied to guide and promote the accelerated development and licensure of safe and efficacious COVID‐19 vaccines in Europe 2 …”

“…So far, the EU granted a conditional marketing authorization (CMA) to four COVID‐19 vaccines and four other vaccine candidates are under rolling review at the EMA 2 . A CMA can be issued for vaccines in emergency situations as a valuable option to expedite vaccine licensure with postponement of some data requirements but based on the reliable demonstration of a positive benefit‐risk balance 2 …”

Analysis of BNT162b2‐ and CVnCoV‐elicited sera and of convalescent sera toward SARS‐CoV‐2 viruses

“…In Switzerland (19 December 2020) and the EU (21 December 2020), BNT162b2 received conditional market authorization for active immunization against COVID-19 for individuals 16 years of age and older [5][6][7] . The mRNA vaccine produced by Moderna obtained the conditional marked authorization in the EU in January 2021 8,9 . A further vaccine candidate based on mRNA is developed by Curevac (CVnCoV) 10 .…”