As the COVID-19 pandemic showed, vaccines are humanity’s best weapon in the fight against infectious diseases. Nowhere is this more evident than Latin America, where specific climatic, geographic, and social conditions combine to create a propensity for the spread of diseases like dengue and chagas.

 

With most countries in the region having some form of universal healthcare provision, vaccination is considered a fundamental right in LatAm and receives strong attention from the continent’s national governments as well as from organisations like the United Nations Pan American Health Organisation (PAHO). Consequently, on many markers, LatAm is a relatively strong performer on vaccine awareness and uptake, with several industry sponsors now rolling out early launch programs for new products. 45 countries and territories in LatAm have introduced the HPV vaccine, 37 the pneumococcal vaccine, and 22 the rotavirus vaccine, for example.

However, PAHO reports a worrying decline in vaccination rates, with 1.4 million of the 15 million children living in the Americas having not completed their basic vaccination schedule and regional coverage for the third dose of the vaccine containing antigens against diphtheria, tetanus, and pertussis (DTP3) falling from 89 percent in 2018 to 85 percent in 2020

 

A Strong Performer

Overall, though, industry stakeholders strike a positive tone when discussing the progress that LatAm has made on immunisation. GSK’s Emerging Markets SVP Luis Arosemena points out that “within vaccines, Latin America is an example of prevention, of how to see value in them. It is helpful that the region has an institution like PAHO to help countries build immunisation calendars and strategies. That is something that you do not see in Asia, for example, where there are no supranational organisations supporting countries to execute prevention campaigns.”

In addition to delivery, LatAm’s largest country is also performing well around awareness. Arosemena’s colleague, GSK Brazil country manager Andre Vivan da Silva asserts that “Brazil has one of the highest levels of awareness [of vaccination] globally. A survey conducted among 12 countries right after COVID found Brazil had the highest level of awareness about vaccination among adults; in children, it was even higher.”

 

It is helpful that the region has an institution like PAHO to help countries build immunisation calendars and strategies. That is something that you do not see in Asia, for example, where there are no supranational organisations supporting countries to execute prevention campaigns

Luis Arosemena, GSK

 

The COVID-19 pandemic response was a good example of LatAm’s willingness to embrace and roll out potentially lifesaving new vaccines, according to Takeda’s Maria Gabriella Pittis, whose remit covers the entirety of LatAm bar Brazil. “LatAm performs quite well in terms of vaccine rollout and adherence, as borne out by the fact that in some countries over 80 percent of the total population is vaccinated with a full dose against COVID-19,” she notes.

However, the vaccination situation is far from perfect and last year UNICEF and PAHO warned that one in four children in Latin America and the Caribbean is missing out on vaccines for DTP3. “The decline in vaccination rates in the region is alarming and puts millions of children and adolescents at risk of dangerous yet preventable diseases,” says Jean Gough, UNICEF’s regional director for Latin America and Caribbean. “The solution to this issue lies within the strengthening of immunisation programmes and overall health systems.”

da Silva agrees, adding “coverage is getting lower and lower for children. The average in Brazil used to be 90 percent coverage for children, but this now stands at 60-65 percent. During COVID parents were scared to bring their children for vaccinations and kept postponing them but we are now putting a lot of energy into trying to regain the level of coverage we had before.”

 

Early Access

The region’s unique natural environment, its people’s susceptibility to certain diseases, and its supporting regulatory framework are all contributing to global pharma companies launching new vaccines in LatAm. “GSK has a rotavirus vaccine that was first launched in Latin America,” states Arosemena. “We also launched a new vaccine indicated for the prevention of herpes zoster (shingles) in the United States and Europe and have already introduced it in Brazil. Because of the institutional setup, I am quite optimistic about our vaccine portfolio here.”

Japanese giant Takeda, for its part, has high hopes around the potential impact its dengue fever shot, recently approved by the European Medicines Agency (EMA), can have in LatAm. “It is a tetravalent vaccine that covers all four serotypes and can be used both in people that have and have not previously been exposed to dengue,” explains Pittis. “This is a momentous achievement for Takeda and will have a big impact on LatAm, which – along with Asia – is home to many of the endemic regions for dengue. The World Health Organisation (WHO) ranks dengue among the top ten threats to public health, so we hope that this new vaccine will prove to be an important tool in this vital fight.”

Maria Gabriela Pittis

 

[Takeda’s dengue vaccine] will have a big impact on LatAm, which – along with Asia – is home to many of the endemic regions for dengue. The WHO ranks dengue among the top ten threats to public health, so we hope that this new vaccine will prove to be an important tool in this vital fight

Maria Gabriella Pittis, Takeda

 

Pittis is also keen to highlight the unique regulatory journey of its dengue jab and her hopes on how EMA approval will quickly lead to LatAm rollout. “The EMA approval was a very important step forward, not only because it comes from one of the world’s most important regulatory agencies, but because the approval process was run with a special protocol, ‘EU-Medicines for all’ or ‘EU-M4all’ (previously known as Article 58),” she notes.

“Under EU-M4all, members of other countries’ regulatory agencies are invited to be part of the evaluation process and access data at the same time as the EMA. Representatives of the Argentinian National Administration of Drugs, Food and Medical Devices (ANMAT), the Brazilian Health Regulatory Agency (ANVISA), the Colombian National Food and Drug Surveillance Institute (INVIMA), and the Mexican Federal Commission for the Protection against Sanitary Risk (COFEPRIS) have therefore had access to information on Takeda’s dengue vaccine at the same time as EMA.

“Takeda has also submitted dossiers within these four countries, which – following the EMA approval and given the amount of time that these four national regulators have had with the dossiers – should expedite the approval process. The approval of the vaccine in Indonesia – where it was launched in February 2023 – should also be a catalyst for a quicker market entry process in LatAm. We have already had a positive recommendation from the new molecule committee in Mexico and are confident of obtaining in-country approvals in the next calendar year.”

In March 2023, Takeda’s dengue vaccine was approved by Brazilian regulator ANVISA, which CEO Christophe Weber called “a significant moment for global public health, Takeda and most importantly, the people of Brazil, who experience the burden of the second-highest incidence of dengue globally. In 2022, Brazil saw more than 1.4 million cases of dengue and more than 1,000 deaths according to the Ministry of Health.”

 

Partnership Prioritisation

For Sarah Aiosa of MSD, which would be the world’s largest vaccines company if COVID-19 shots were excluded, “vaccines are an investment in current and future generations and a key priority which we partner globally, regionally, and locally to advance.” Aiosa, SVP and president for LatAm, outlines that “52 national immunisation programs in LatAm include at least one MSD vaccine and our vaccine portfolio covers children, adolescents, and adults in many diseases. We are very proud of the contribution we have made in helping eliminate some diseases and vaccines will remain a focus.”

 

Vaccines are an investment in current and future generations and a key priority which we partner globally, regionally, and locally to advance

Sarah Aiosa, MSD

 

Elaborating on the importance of partnerships and collaboration around vaccines to solve complex healthcare problems, Aisoa outlines, “one example of how we work in collaboration with other stakeholders to achieve our goals was our participation in the signing of the proclamation for the elimination of HPV-associated cancers in Puerto Rico, in alignment with the WHO’s call to eliminate diseases such as cervical cancer based on three key pillars: vaccination, screening and treatment.”

She goes on, “On March 4th, when the International HPV Awareness Day of Human Papillomavirus (HPV) is celebrated and during one of my first assignments as president of the region, I had the privilege of joining the Puerto Rico team and the government to sign the proclamation. It was humbling and very personal for me to take part of such a powerful initiative.”

“While the pandemic did create a coverage challenge for non-COVID related vaccines, we have a renewed focus on bringing coverage rates for routine immunisations back up to pre-pandemic levels. Educational and awareness campaigns, in collaboration with government stakeholders, will form an important part of this push.”