Accelerated development and licensure of Coronavirus vaccines

by Michael Pfleiderer

Currently, the world is experiencing the third coronavirus epidemic caused by the 2019 novel coronavirus (2019-nCoV) succeeding outbreaks observed in 2003 caused by the SARS Coronavirus (SARS CoV) and in 2012 caused by the MERS Coronavirus (MERS CoV) . All these outbreak scenarios were paralleled by huge expectations and enthusiastic announcements emphasizing that development and licensure of Coronavirus vaccines could be accomplished in months rather than years.

Similar statements are currently echoed by numerous stakeholders most of them being aware of the fact that vaccine development in compliance with regulatory expectations is a very cumbersome and time-consuming process obviously taking years rather than months until completion.

In addition, economical aspects such as difficulties in building up sustainable markets allowing sustainable commercialization of Coronavirus vaccines might deter developers and investors.

Altogether, high costs and long development timelines combined with high risks of failure are the most likely reasons why suitable Coronavirus vaccines are still not available and will most likely not become available within the next years.

Nevertheless, sequence and intensity of the three Coronavirus outbreaks occurring within the last two decades clearly indicate that Coronaviruses have gained priority on the list of emerging and re-emerging viral diseases characterized by an increased probability that more severe outbreaks will probably materialize in the future.

Although the two past as well as the ongoing Coronavirus outbreaks presented mild to moderately severe for the majority of infected individuals (with more severe and lethal outcomes for the elderly and persons at risk) these transient findings cannot be taken as a guarantee for future outbreaks as further adaptation of Coronaviruses to the human host may occur possibly resulting in even larger outbreaks characterized by a higher burden of morbidity and mortality.

These issues are amongst the main drivers for another attempt led by WHO to convene scientists, regulators and funders to investigate pathways facilitating development and early availability of Coronavirus vaccines.

However, as outlined above, development and licensure of one or more suitable Coronavirus vaccines is complex requiring concerted action to create a common understanding on product target profiles and regulatory pathways.

As it is unlikely that a single vaccine construct will be effective against all past and future Coronavirus strains flexible approaches allowing swift adaptation of a known process to newly emerging Coronavirus strains should be top on the list of items defining the preferred product profile of Coronavirus vaccines.

During the past years regulatory systems have become quite open and supportive regarding the development of vaccines needed during outbreak and emergency situations. However, certain standards need to obeyed requiring a fundamental understanding of what regulators want and on how to achieve an agreement with regulatory agencies on the minimal requirements allowing fast and effective vaccine development.

BE has regularly made proposals (1) on how the current regulatory landscape could best be capitalized to significantly accelerate development programs for urgently needed vaccines. In addition, BE is regularly presenting new concepts on how the rules and procedures governing vaccines could be complemented facilitating even faster and more flexible development programs.

 We have proven track records on how to successfully take vaccines from lab to licensure. Our profound expertise in vaccine regulation is complemented by ample expertise in basic and developmental research topics relevant to etiological agents including Coronaviruses2.

If you are interested in receiving scientific and regulatory support for the development program for a Coronavirus vaccine ensuring compliance with expectations from WHO, regulatory agencies and other stakeholders don’t hesitate to contact us.

(1) Accelerating vaccine development

• Platform technologies applied for the production of vaccines against emerging viral pathogens – a scientifically justifiable and legally feasible regulatory approach?

• Pregnant women and vaccines against emerging epidemic threats

• EMA’s Article 58 procedure and WHO’s prequalification procedure – Pathways to licensure worth to consider for vaccines and other medicinal products

• Platform technologies for vaccines – why is there still no regulatory guidance available?

• Do We Need an EU Vaccine Regulation?

• Are biomarkers ushering a new era in vaccine discovery?

(2) Providung scientific expertise specific for Coronaviruses

• Flory, E., Pfleiderer, M., Stuhler, A., et al. (1993). Induction of protective immunity against coronavirus-induced encephalomyelitis: evidence for an important role of CD8+ T cells in vivo. Eur J Immunol, 23(8), 1757-1761.

• Stauber, R., Pfleiderer, M., & Siddell, S. (1993). Proteolytic cleavage of the murine coronavirus surface glycoprotein is not required for its fusion activity. Adv Exp Med Biol, 342, 165-170.

• Pfleiderer, M., Routledge, E., Herrler, G., et al. (1991). High level transient expression of the murine coronavirus haemagglutinin-esterase. J Gen Virol, 72 ( Pt 6), 1309-1315.

• Routledge, E., Stauber, R., Pfleiderer, M., et al. (1991). Analysis of murine coronavirus surface glycoprotein functions by using monoclonal antibodies. J Virol, 65(1), 254-262.

• Pfleiderer, M., Routledge, E., & Siddell, S. G. (1990). Functional analysis of the coronavirus MHV-JHM surface glycoproteins in vaccinia virus recombinants. Adv Exp Med Biol, 276, 21-31.

• Pfleiderer, M., Skinner, M. A., & Siddell, S. G. (1986). Coronavirus MHV-JHM: nucleotide sequence of the mRNA that encodes the membrane protein. Nucleic Acids Res, 14(15), 6338.