Clinical development and approval of COVID-19 vaccines

ABSTRACT

Introduction

The coronavirus 19 (COVID-19) pandemic triggered a simultaneous global demand for preventative vaccines, which quickly became a high priority among governments as well as academia and the pharmaceutical industry. Within less than a year after COVID-19 was declared a pandemic, vaccines had received emergency approvals and vaccination campaigns were initiated.

Areas covered

We discuss the several factors that led to the unprecedented, accelerated development and approval of COVID-19 vaccines, which includes optimization of processes by regulatory authorities, redesign of sequential development processes, learnings from previous pandemics, and prior development of novel vaccine platforms.

Expert Opinion

Despite unanticipated and complex challenges presented by real-time vaccine development in the context of the evolving COVID-19 pandemic and subsequent ever-changing landscape of public health measures and recommendations, important milestones were reached within extraordinarily short periods and, following roll-out to billions worldwide, the approved vaccines have proven to be well tolerated and effective. Whilst this is an exceptional feat and an example of what can be achieved with collaboration and innovation, there are lessons that can still be learned, including the need for further harmonization between regulatory authorities, modes to react to the pandemic’s ever-evolving challenges, and ensuring equitable vaccine access among low-income countries.

KEYWORDS:

• COVID-19
• pandemic
• public health
• regulatory processes
• vaccine development

Article highlights

• Vaccine development usually takes anywhere between 10 and 15 years and, whilst learnings were made through previous pandemics and accelerated emergency approval mechanisms were in place to allow rapid access to vaccines, the urgency of the COVID-19 pandemic meant vaccine development needed fundamental optimization.

• Regulatory authorities quickly reacted to the pandemic by optimizing their processes, such as accelerated review timelines, issuing COVID-19 vaccine-specific guidance and facilitating real-time dialogue with manufacturers.

• Multilateral global collaboration and work sharing between regulatory authorities, government and the private sector facilitated expedited vaccine development.

• Pre-existing data were available owing to previous coronavirus outbreaks, and the mRNA- and adenovector platforms that were used for the first approved COVID-19 vaccines were already being used in clinical trials or other marketed vaccines (Zabdeno/Mvabea vaccine for Ebola).

• Funding was another aspect that expedited development; private-public initiatives, such as Operation Warp Speed and the Coalition for Epidemic Preparedness Innovations provided scaffolds for manufacturers to drive development of their candidates forward.

• Vaccine developers started manufacturing their vaccines well before commencing late-stage trials, allowing them to be poised and prepared for mass supply.

• These factors led to some vaccines gaining emergency approval in major highly regulated markets less than 10 months after the start of Phase I trials and positive clinical trial results are now reflected in global real-world data.

• Challenges lie with vaccine variants and waning immunity; vaccine developers and vaccine policymakers must adopt effective strategies to swiftly and in a coordinated manner react as the pandemic evolves.

• Regulators, manufacturers, and policymakers can learn from COVID-19 for the future; they must continue to work harmoniously together and adopt new strategies to respond even more rapidly and effectively in the case of other outbreak situations.

Acknowledgments

The authors would like to thank Ugur Sahin (BioNTech SE) for his support in developing the outline of this manuscript. Medical writing support was provided by Cindy Cheung, PhD, from Scion (development of the initial outline and literature search) and Camilla West, PhD, from BioNTech SE (assisting authors with the development of the initial draft and incorporation of comments and revisions) according to Good Publication Practice guidelines.

Author contributions

All authors substantially contributed to the writing, intellectual revisions, and preparation of this review. All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article and have given their approval for this version to be published.

Declaration of interests

D Barouch is co-inventor on provisional vaccine patents (63/121,482; 63/133,969; 63/135,182). P Neels provides consultancy services for COVID-19 dossiers for the following: BioNTech SE, ACMBio, Icosavac, Curevac, Univercells, Moderna, Egypt authorities: EDA, Saudi Arabia FDA. Ö Türeci is employed by BioNTech SE, has issued patents with BioNTech SE and TRON Translational Oncology Mainz, has a leadership role with The Association for Cancer Immunotherapy (CIMT), is co-founder of and holds shares with BioNTech SE. R Rizzi, E Lagkadinou, and S Pather are employed by BioNTech SE. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

BioNTech SE provided funding to the Medical Communications agency Scion for the development of the initial outline and literature search.