The raw materials and inputs for vaccines are produced in different countries and subject to undersupply risk, said speakers in a webinar on Facing the Challenges of Vaccine Distribution organized by FAPESP (photo: Wikimedia Commons)
Published on 03/16/2021
By Elton Alisson | Agência FAPESP – With at least two COVID-19 vaccines winning regulatory approval in the UK, US and Canada, and vaccination starting in those countries, the next challenge is large-scale production of vaccines and equitable global distribution to contain transmission of the disease.
In developing countries such as Brazil, it will be necessary to set up and manage supply chains for vaccine production, fill-and-finish, transportation, and storage. The inputs required, ranging from biological components to vials, syringes, and needles, are manufactured in different parts of the world and subject to shortages due to the sharp rise in world demand and the fall in air traffic, among other factors.
This was one of the main emphases of the webinar Facing the Challenges of Vaccine Distribution, held on December 14 as the seventh in the FAPESP COVID-19 Research Webinar series.
“No country has been able to have all the resources needed for COVID-19 vaccine production because the inputs required depend on a global supply chain in which one raw material may be produced in Europe and another in Canada, for example,” said healthcare supply chain expert Prashant Yadav, a lecturer at Harvard Medical School and Senior Fellow at the Center for Global Development (CGD).
According to Yadav, the vaccine supply chain involves antigen manufacturing and production of such inputs as lipids, adjuvants, excipients, vials etc. in different countries, all of which have to be flown to vaccine plants for filling, finishing, and distribution.
This global supply chain has been affected by the significant reduction in passenger flights due to the pandemic. “Because it’s global, the vaccine supply chain is exposed to risks such as air cargo capacity,” he said. “So we need specialized cargo operators and logistics companies. In some cases, even global agencies have started playing a large role in this.”
The speakers noted other factors that make the challenges of mass immunization even more complex, such as the short period of time in which to vaccinate large numbers of people, the fact that the COVID-19 vaccines available so far require two doses, and the need for cold chain or ultra-cold chain transportation and storage infrastructure.
The Pfizer-BioNTech vaccine, authorized for emergency use in several countries, requires special shipping containers and storage facilities capable of keeping vials at temperatures as low as minus 70 °C. Even storage at between 2 °C and 8 °C could be a problem in some parts of Brazil, such as the North and Northeast, said Tiago Rocca, Manager of Strategic Partnerships and New Business at Butantan Institute, attached to the São Paulo State Department of Health.
33,000 vaccination rooms
Butantan Institute is partnering with China’s Sinovac Biotech to produce a vaccine called Coronavac that does not need to be deep-frozen during shipping and storage.
FAPESP and the Todos pela Saúde movement (“Everyone for Health”, led by Itaú Unibanco, Brazil’s largest privately-owned bank) have joined forces with Butantan Institute to invest BRL 82.5 million in Phase 3 clinical trials and the construction of a vaccine manufacturing, filling and finishing plant.
FAPESP has allocated BRL 32.5 million to fund clinical trials, immunogenicity studies, and research on vaccine safety for children and groups at high risk of contracting the disease. Itaú Unibanco and the other participants in its initiative are investing BRL 50 million in the vaccine plant.
“The cold chain for our COVID-19 vaccine requires a stable supply of electricity to ensure that the product is stored at a temperature between 2 °C and 8 °C. This is a challenge in some parts of Brazil,” Rocca said. “In the case of vaccines requiring ultra-cold shipping and storage, the challenge is even more daunting.”
Brazil’s 5,000-plus municipalities have more than 33,000 vaccination rooms, he added, and all the vaccines approved by ANVISA, the national health surveillance agency, must be stored there in the right conditions. “We’ll have to guarantee a stable power supply to these tens of thousands of vaccination rooms across the country,” he said.
Shipping hundreds of millions of vials in refrigerated trucks is another challenge. “We don’t have many shipping companies with the expertise and equipment to transport vaccines in accordance with the applicable pharmaceutical requirements,” Rocca said.
To keep the vials at the right temperature during shipping, they will have to be packed in passive containers with dry ice or liquid nitrogen. Alternatively, the vaccines can be shipped in active containers, similar to portable fridges with a battery to keep them running in the absence of an electric power supply. Butantan Institute began to use active containers in its vaccine logistics system some years ago and has experienced problems with battery recharging in some airports.
“Some airports have upgraded their infrastructure considerably in recent years, but others haven’t, and handling large numbers of active containers may be a challenge there,” Rocca said.
For Margareth Dalcolmo, a researcher at Oswaldo Cruz Foundation (FIOCRUZ), these challenges are surmountable. “We can have generators, for example, to guarantee the supply of electricity when using vaccines that depend on a cold chain,” she said. “This is perfectly manageable once we have the vaccines available. But no vaccines have been approved in Brazil to date.”
FIOCRUZ is a public-sector institution linked to the federal government. It has signed an agreement with the pharmaceutical company AstraZeneca to produce the COVID-19 vaccine developed by the University of Oxford in the UK. Like Butantan’s, this deal also involves technology transfer.
“We’re all set to receive the API [active pharmaceutical ingredient] from AstraZeneca and start producing the vaccine in early January,” Dalcolmo said.
FAPESP’s Scientific Director, Luiz Eugênio Mello, also participated in the meeting, which was moderated by Victor Wünsch Filho, a professor at the University of São Paulo’s School of Public Health (FSP-USP).
Source: https://agencia.fapesp.br/34899
