Seeking to address inequitable access to Covid-19 vaccines, two manufacturers touted plans to either expand production or boost donations in Africa. But the announcements were met with varying degrees of skepticism over concerns the efforts will not provide sufficient relief quickly enough to a continent where the shots remain in very short supply.
In one move, BioNTech (BNTX) announced plans to create a state-of-the-art facility that will begin construction in mid-2022 and become what it called a “first node” in establishing an end-to-end manufacturing network to produce vaccines using its mRNA technology. Currently, the company only makes a Covid-19 vaccine, but is developing vaccines to combat tuberculosis and malaria.
Initially, BioNTech, which partnered with Pfizer (PFE) on a Covid-19 shot, will staff, own and operate a plant in Rwanda, but will transfer manufacturing capabilities and know-how to local partners. For now, about 50 million doses are expected to be produced yearly, but output may later reach several hundred million doses for different infectious diseases as production lines and sites are added. Pfizer is not part of this deal.
Separately, Moderna (MRNA) announced a memo of understanding to provide up to 110 million doses of its Covid-19 vaccine to the African Union over a staggered period of time. The company is prepared to deliver the first 15 million doses in the fourth quarter of 2021, 35 million doses in the first quarter of 2022, and up to 60 million doses in second quarter 2022. All doses are offered at its lowest tiered price.
The Moderna offer comes several months after talks with the African Union fell apart because the shots would not have been available until 2022. At the time, Moderna reportedly offered to sell its Covid-19 vaccine for about $10 each. The company did not specify the price at which it would provide its vaccine under the new arrangement. We asked Moderna for comment and will pass along any reply.
The announcements come amid growing anxiety over the spread of the Covid-19 pandemic and the inability of low-income countries to quickly inoculate their citizens. Since the emergence of the coronavirus in early 2020, many wealthy nations raced to lock in supply contracts with vaccine makers, leaving the poorest governments to rely on a World Health Organization program for supplies.
Consequently, the vaccine makers are scrambling to respond, but their efforts continue to generate a mix of praise and criticism, even though the WHO recently noted supplies have gradually increased in some countries in recent months. Still, less than 5% of all Africans have been vaccinated, or roughly 60 million people as of the end of September, according to the World Health Organization.
“These companies are being backed into a corner. And the pressure is forcing them to consider how they can start scaling up manufacturing,” said Fatima Hassan, a health and human rights lawyer at the Health Justice Initiative, an advocacy group based in South Africa. “The problem is that these announcements don’t deal with the immediate needs.
“It’s a good thing to scale up manufacturing in Africa. It’s taken a long time to get to this point. But the production goal, once operational, is very low. That’s a drop in the ocean. What happens in the meantime?” she continued. “We’re not looking at large volumes. It’s the same thing with Moderna. This latest donation is peanuts.”
The WHO responded to the crisis last year by creating COVAX with the GAVI alliance and the Coalition for Epidemic Preparedness Innovations. But the effort has fallen behind in distributing vaccines and continues to seek donations and funding. So far, wealthy nations account for 43% of the 16.6 billion doses locked up in purchase agreements, according to the Duke Global Health Innovation Center.
As a result, Covid-19 vaccine makers are increasingly criticized for not doing more to ensure wider access to their shots. The Biden administration, for instance, has pressured Moderna to increase supplies to poor countries, because the company was reportedly shipping more shots to wealthy countries paying higher prices and a timetable for previously announced plans to donate 500 million doses to COVAX was unclear. The company now says shipments will start this quarter.
To deflect the criticism, Moderna also recently announced plans to build a factory in Africa, but the move was panned by advocacy groups because the company did not offer details about an actual location for the facility because a site selection process had not begun. As a result, it remains unclear when production might begin, underscoring concerns about alleviating the pandemic more quickly.
Moreover, Moderna did not address calls by the WHO to transfer technology to a new hub in Africa for increasing production of mRNA vaccines. Without the technology, low-income countries will not gain the expertise to more quickly produce enough doses. The BioNTech announcement did not mention the hub, but the company previously indicated it would “co-locate” the sites within the hub.
“It’s encouraging that at least one company is willing to start the transfer of vaccine technology to an African country. But this should not be the exception, it should be the rule,” said Ellen ‘t Hoen, a senior researcher in the global health unit at the University of Groningen in the Netherlands and a former executive director of the Medicines Patent Pool, which works with drug makers to license medicines in low-income countries.
“It would be important to see the details of the agreements not just a press release. Transparency in such deals is key. I would like to see BioNtech engage with the WHO Covid-19 technology access pool (another WHO effort that has, so far, unsuccessfully sought to convince drug makers to provide intellectual property rights) and other tech and IP transfer initiatives.”
For his part, BioNTech chief executive officer Ugur Sahin was bullish about the deal with Rwanda and Senegal. “Our goal is to develop vaccines in the African Union and to establish sustainable vaccine production capabilities to jointly improve medical care in Africa. We have made great progress in the past few weeks, which will help us on our way to turn these plans into reality,” he said in a statement.
He also noted plans to expand a production deal Pfizer and BioNTech signed with The Biovac Institute, a vaccine maker backed in part by the South African government, to assemble the final stages of their Covid-19 vaccine, a process known in the pharmaceutical industry as “fill-and-finish.” From there, more than 100 million finished doses will be supplied exclusively to all 55 African Union countries annually.
That arrangement, however, was also panned by patient advocates, because fill-and-finish operations will not make it possible for Biovac or other companies located in low and middle-income countries to gain the know how and expertise to more quickly produce enough Covid-19 shots to combat the fast-moving coronavirus variants. Details about the planned expansion were not disclosed.
Nonetheless, concrete plans to eventually boost production on the African continent is a positive sign, explained Paul Fehlner, senior vice president and chief legal officer at a biotech called Axcella, who was formerly global head of pharmaceutical intellectual property at Novartis (NVS). In his view, the commitment is by BioNTech is ambitious, but the timetable makes the ultimate goal challenging.
“When they do it, it could lead to other investment to create the critical mass of human capital and manufacturing technology for a sustainable biopharmaceutical sector,” he wrote us. “The mere relocation of manufacturing lines and personnel to Africa may improve logistics for greater access, but have little impact on local biopharmaceutical manufacturing capability.”