Behind the Scenes in Vaccine Development

Vaccines were back on the public agenda recently, for very different reasons. In late March 2016, actor Robert De Niro, a founder of the Tribeca Film Festival, pulled a documentary film about vaccines and autism from the event. The film was directed and co-written by the author of a 1998 Lancet article-which was widely discredited and retracted in 2010-that linked the measles, mumps, and rubella vaccine to the development of autism in children. In a statement reported in media outlets, De Niro-who has a child with autism-noted that his original intent in screening the film was to have a conversation about autism. When members of the medical and scientific community protested the film’s inclusion in the festival, arguing that it was giving exposure to discredited scientific ideas, organizers decided to remove it from the lineup.

This incident illustrates the debate about the recommended use of vaccines by medical and public health officials and distrust by segments of the general public about vaccine safety. A different set of concerns arise over the lack of effective vaccines to address public health threats.

On Feb. 1, 2016, the World Health Organization (WHO) declared a public health emergency of international concern in response to a cluster of microcephaly cases and neurological disorders in Brazil that were strongly suspected, but not scientifically proven, to be caused by the Zika virus.

WHO called for a coordinated international response to improve surveillance, detect infections, better understand neurological complications, increase control of mosquito populations, and expedite the development of diagnostic tests and vaccines. In the weeks following the WHO declaration, more evidence pointed to the virus as the cause of the neurological disorders, and cases of transmission via sexual contact were reported in five countries, including the United States (1).

With no approved vaccine available, governments and drug companies looked to accelerate research programs. On Feb. 2, 2016, Sanofi Pasteur announced the launch of a vaccine R&D program noting the established R&D and industrial infrastructure for its recently licensed dengue vaccine, Dengvaxia, can be used to speed identification of a candidate for clinical development (2).

In February 2016, Inovio Pharmaceuticals reported the company expected start Phase I human testing by the end of the year for a vaccine it is creating with GeneOne Life Sciences and academic collaborators (3).

The drive for new vaccines in the current Zika emergency is similar to the 2014-2015 Ebola epidemic in West Africa, which prompted governments and drug companies around the world to accelerate the vaccine development. Several vaccines are in clinical trial stage. In this issue, experts from Sanofi Pasteur and Janssen Vaccines share strategies used to fast-track development for Ebola vaccine candidates. Collaboration, working with regulators early in the process, and combining new approaches with newer processing technologies were key elements of program development (4).

A strong understanding of vaccine manufacturing technology, the use of quality by design, and advanced analytical tools were key to the accelerated process development, demonstrating that a science-based approach is best. 

References
1. WHO, Zika situation report, accessed March 29, 2016.
2. Sanofi Pasteur, “Sanofi Pasteur to leverage its strong vaccine legacy in hunt for Zika vaccine,” Press Release (Lyon, France, Feb. 2, 2016). 
3. Inovio Pharmaceuticals, “Inovio Pharmaceutical’s DNA Vaccine for Zika Virus Induces Robust Immune Responses in Preclinical Study,” Press Release (Plymouth Meeting, PA, Feb. 17, 2016).
4. C. Challener, BioPharm International, 29 (4), 38-40, 45 (April 2016).

Article DetailsBioPharm International
Vol. 29, No. 4
Pages: 6

Citation
When referring to this article, please cite it as R. Peters, " Behind the Scenes in Vaccine Developments," BioPharm International 29 (4) 2016.