Pasteur; Gardasil against Human papillomavirus (HPV) infection from Merck;

Fluzone/Vaxigrip against influenza infection from Sanofi-Pasteur; and Pediatrix for

prevention of diphtheria/tetanus/pertussis/whooping cough/hepatitis B/polio from

GSK. The sales of the last four vaccines range from US$1.7 to 2.3 billions. Other

well-positioned vaccines in the top ten list such as Varivax against varicella, Zostavax

against Zoster virus infection, Rotateq against rotavirus infections and Pneumovax 23

for pneumonia infection are all produced by Merck, whereas Twinrix for prevention

of Hepatitis A&B is produced by GSK. It is expected that the global vaccine market in

2021 and beyond will be restructured with the approval and sales of new COVID-19

vaccines.

Often referred to as the vaccine market north and south gap, figures collected by

the WHO compare the burden of disease (how much diseases are present in popu-

lation), which is present at 93% in the developing countries and 7% in industrialized

country to the vaccine sales as being 82% in industrialized countries and only 18% in

developing countries. These figures need to be interpreted taking into consideration

the many different vaccine procurement processes put in place by the different

countries. For example, high-income countries’ (HICs) self-procurement of vaccines

account for most of the market value, at over US$12 billion annually representing less

than 5% of the global market volume [13].

As a consequence of the 2009 H1N1 influenza pandemic declaration, which

raised concerns especially about aging populations, a sense of urgency dominated.

The influenza vaccine market was estimated at $2.9 billion in 2011 and increased to

$3.8 billion by 2018. Only in the U.S. market, the value increased from $1.6 billion

in 2011 to $2.2 billion in 2018. The global market is projected to rise to US

$ 58.4 billion by 2024 [14] with more than 120 new products in the development

pipeline, among which 60 are of importance for the developing countries.

Clearly, vaccines are becoming an engine for the pharmaceutical industry and

new business models are emerging. For example, many companies that did not

have vaccines in their portfolio have started making alliances or acquiring

smaller companies that could produce vaccines. It is also expected that the global

vaccine market will be dramatically reshaped following the COVID-19 pan-

demic that revealed several challenges additionally to existing ones such as

increased competition and narrowed traditional vaccine markets, new vaccine

opportunities, and markets and threats driving rapid development of novel

technologies within a new regulatory framework. Consequently, the vaccine field

has a predicted spectacular growth rate of 10.7% a year for the forecast period

2019–2027 [15].

1.4

SAFETY AND REGULATION OF VACCINES

Safety of vaccines is paramount as they are prophylactic interventions that are

delivered to healthy people including infants. Confidence of the population on the

safety of vaccines and their efficacy is a priority for the public health regulatory

bodies and vaccine manufacturers. It is well understood by the vaccine community

that one single failure will impact public faith in the entire product class. Post-

marketing surveillance assesses the effectiveness and safety of vaccines and begins

Viral vaccines

5