July 2022
When the first shots of the COVID-19 vaccine were administered in December 2020, many were stunned by the speed at which scientists created a product to tackle the new virus assailing the planet.
In fact, research and development for messenger RNA (mRNA) vaccines are the result of collaborative efforts that began in the 1980s and involved numerous scientists, with substantial accomplishments occurring once the pandemic began.
Today, two centers in Latin America are working to produce mRNA vaccines, aiming at reducing the high dependence of the Americas on health technology imports: the Bio-Manguinhos Institute of Technology on Immunobiologicals at the Oswaldo Cruz Foundation (Fiocruz) in Brazil, and Sinergium Biotech, a private biopharmaceutical company in Argentina.
Both centers joined an initiative led by the World Health Organization (WHO), the Medicines Patent Pool (MPP) and the Pan American Health Organization (PAHO) to collaborate in the development of these groundbreaking health tools.
The region of Latin America and the Caribbean imports 10 times more pharmaceutical products than it exports, leaving it vulnerable to fluctuations in global supply, particularly during emergencies.
The efforts to distribute the COVID-19 vaccines underscored this. Limited global supply delayed the capacity in some parts of the region to respond to the pandemic, with a high cost. To the date, over 2.7 million people have died and some of these fatalities could have been prevented.
And when the doses arrived in Latin America and the Caribbean, some countries struggled to swiftly get these in the arms of their populations, especially the most vulnerable.
In September 2021, when only about 23% of the people in the Americas were fully vaccinated, PAHO launched the Regional Platform to Advance the Manufacturing of COVID-19 Vaccines and other Health Technologies in the Americas to boost regional production by facilitating technology transfer. The initiative included the collaboration with the Bio-Manguinhos Institute and Sinergium Biotech, building from their existing manufacturing capacity.
"We are proud to have been selected together with Brazil to produce [mRNA vaccines] in the region," said Germán Sánchez Alberti, Development and Innovation Manager, Sinergium Biotech. "This will leave us much more prepared to supply the region and decrease waiting times in the event of a new pandemic."
mRNA vaccines build on cutting-edge technology that reduces complexities and biosafety risks for producers. Without using live virus, as many traditional shots do, these vaccines teach our cells how to make a protein that triggers an immune response inside our bodies so it can defend itself against the virus.
This versatility leads scientists to believe the mRNA technology can be used to develop new and effective vaccines against future threats to public health.
Through PAHO’s platform, experts from the Bio-Manguinhos Institute and Sinergium Biotech are now working with the mRNA technology transfer hub established by WHO in South Africa to learn how to apply the mRNA processes, and update their laboratories and training standard to include this methodology.
In March 2022, scientists from both institutions became the first to receive training on the development of these new vaccines from the company Afrigen, in Cape Town. In May, they met again for a follow-up session in Brazil.
In 2021, the Bio-Manguinhos Institute produced 153 million doses of another COVID-19 vaccine (the recombinant vaccine) through a partnership with the biopharmaceutical company AstraZeneca
Building on solid experience
From the Technological Vaccine Complex in Rio de Janeiro, one of the largest production centers in Latin America, the Bio-Manguinhos Institute guarantees self-sufficiency in essential vaccines for the routine immunization schedule of the Brazilian Ministry of Health. It also exports vaccine doses to over 70 countries against diseases such as yellow fever and meningitis, through PAHO’s Revolving Fund and UN distribution mechanisms.
In 2021, the Institute provided more than 233 million doses of vaccines, including 153 million doses of the COVID-19 recombinant vaccine through a partnership with the biopharmaceutical company AstraZeneca.
“The development of a Fiocruz mRNA vaccine is a fundamental step for the advancement in the development of immunobiologicals. With this project and the support of WHO, we are reaffirming our commitment to science and technology at the service of the population”, said the president of Fiocruz, Nisia Trindade Lima.
“We intend to enter the first phase of scale-up and production next year to conduct the necessary clinical studies,” Luiz Lima, Deputy Director of Production at Bio-Manguinhos-Fiocruz added.
From the outskirts of Buenos Aires, Sinergium Biotech studies how to construct a model of the vaccine in a pilot scale, while learning from Afrigen’s experience and sharing lessons learned with the Bio-Manguinhos Institute.
The company was founded during another health emergency, the influenza A(H1N1) pandemic, and for the past two years supplied influenza vaccines to PAHO’s Revolving Fund.
“Having this installed capacity here allows us to pursue challenging projects to bring other health technologies and products to the region,” Fernando Lobos, Business Development Director, Sinergium Biotech said.
For Lobos, the PAHO platform provides a unique opportunity for cooperation for the sake of science and public health. “The truth is that it is rare to see a team so united in pursuit of an objective that we know will bring benefits in a long term”, he said.
“This is not a project. This is a program. It’s the start of a long road that will bring us many options and many vaccines for the region. This technology, undoubtedly, will have a strong impact on the health situation in the Americas and improve everyone’s access to vaccines”.
Two years into the pandemic, vaccine inequity continues to be a challenge for the COVID-19 response in the Americas.
In lower-middle income countries, only 46.1% of the general population has been fully vaccinated as of 13 July 2022 – compared to 70.8% in upper-middle income countries and 69.1% in high-income countries. Regionally, 221 million people have not yet received a single shot.
The regional platform will support collaboration across countries and institutions under the principle that vaccine manufacture should benefit the entire region, with distribution coordinated by PAHO’s Revolving Fund.
This July, PAHO announced a plan with additional efforts to increase the manufacturing capacity of drugs, biopharmaceuticals and health technologies and equipment in Latin America and the Caribbean. It includes developing a stronger regional regulatory system and the definition of a shared roadmap in cooperation with international partners, such as the European Union.
“There are likely to be outbreaks of other diseases that will require us to rapidly develop and deploy new vaccines, diagnostics, and drugs to fight them,” PAHO Director, Carissa F. Etienne, said. “We must be better prepared for the future”.