Big pharma tried to thwart Africa’s bid to manufacture Covid-19 vaccines locally

By PAULINE KAIRU

BioNTech tried to thwart plans mooted by the World Health Organization for Africa to manufacture Covid-19 vaccines, according to an investigation by medical journal BMJ.

Pointing to the kENUP Foundation, a consultancy firm hired by BioNTech, the BMJ said in its study published on February 9 that the company had protested against the WHO hub, claiming that it would infringe patents and that it was unlikely to succeed.

kENUP is meant to promote global partnerships in research-based innovation for Europe with public and societal benefits.

The BMJ said it obtained documents containing the objections and other details of KENUP’s promotion of BioNTech’s plan to ship mRNA factories housed in sea containers from Europe to Africa.

According to the BioNTech plan, shipping containers would be staffed with BioNTech workers, and a proposed new regulatory pathway to approve vaccines made in these factories, in a plot widely described as “paternalistic and unworkable” by some experts, as it appears to circumvent regulators local.

Industrial consortia

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The WHO Technology Transfer Center, launched in June 2021 and based in South Africa, uses publicly available information to reverse engineer mRNA vaccines, like those from Pfizer and Moderna, to teach companies and mainland scientists how to use mRNA technology. The result would be for companies to develop a comparable vaccine, which, if it passes clinical trials and is approved by regulators, will be manufactured industrially.

South African companies, Afrigen Biologics & Vaccines and the Biovac Institute, have joined a consortium to develop and manufacture the mRNA vaccine, with guidance from organizations including the WHO, Medicines Patent Pool, South Africa Medical Research Council and the Africa Centers for Disease Control (Africa CDC), as part of the larger Partners for African Vaccine Manufacturing project coordinated by Africa CDC, launched in April 2021.

In January, Afrigen Biologics announced that it had successfully used Moderna Inc’s publicly available Covid-19 mRNA vaccine sequence to create its own version of the vaccine, which it hopes to submit to clinical trials before the end of this year. year. It will be the first mRNA vaccine developed and produced at laboratory scale on the African continent.

Afrigen Biologics chief executive Petro Terblanche said they would then experiment with other formulations that are cheaper to produce and don’t need to be frozen in storage. He added that Afrigen is in talks with two biotech companies to help expand manufacturing.

The BMJ reports that the kENUP Foundation wrote to South African government officials after a visit to the country from August 11-14 last year to call for the hub’s activities to cease.

Reverse engineering

“The WHO Vaccine Technology Transfer Center’s project to copy Moderna’s Covid-19 vaccine manufacturing process must be stopped immediately. This is to prevent damage to Afrigen, BioVac and Moderna. Provided release of patent coverage is only granted by Moderna during the pandemic, the prospects for sustainability of this WHO Vaccine Technology Transfer Center project are not favourable,” the BMJ quotes in the hurry.

The Medicines Patent Pool, which supports the WHO hub, responded in November to allegations that it infringes patents, saying: “The Medicines Patent Pool, which is responsible for the intellectual property and licensing elements of the hub , would like to clarify that this is not the case.”

South African law allows scientists and manufacturers to carry out research and development independently of patent protection, meaning reverse engineering of Moderna’s vaccine by the hub is legal, he added. .

Moderna also publicly pledged not to enforce its Covid-related patents during the pandemic and said it was willing to license its intellectual property after that time.

The hub is in talks with Moderna to obtain such a license.

Medicines Patents Pool executive director Charles Gore told the BMJ the rumors were “ridiculous”, saying such claims were “completely untrue”.

Public health advocate and attorney Ellen Hoen told BMJ BioNTech that she should be held accountable for kENUP’s actions.

“If you’re running a nonprofit foundation and you’re trying to stop people from developing life-saving vaccines, then I don’t know what your agenda is, but that smells really bad,” she said.

“If kENUP is on BioNTech’s payroll, then BioNTech should be held accountable for this type of behavior.”

It was hoped that Pfizer-BioNTech or Moderna would share technology and know-how with the African hub, which could then teach local companies how to manufacture the vaccines.

So far the two companies have refused, although the hub is in talks with Moderna about some form of collaboration – likely a voluntary license, an authorization given to companies to allow them to produce Moderna’s vaccine in return for a royalty fee.

Technology transfer

In a statement, a spokesperson for Moderna said trying to speed up technology transfers could “jeopardize” the delivery of its current production lines, with “negative consequences for efficiency, safety and quality”.

But BMJ says Pfizer and BioNTech disagreed with that characterization, arguing that sharing the technology would not lead to an increase in vaccine supply in the near term and could take needed raw ingredients out of established manufacturers. .

In October 2021, five months after the hub was officially announced, Moderna and BioNTech announced their own initiatives. Moderna has announced that it will spend up to $500 million to build its vaccine factory in Africa, aiming to manufacture 500 million doses of mRNA vaccines each year.

He said he plans to start filling doses there in 2023 and also hopes to manufacture other mRNA products at the facility.

In the same month, BioNTech announced that it had signed memorandums of understanding with the governments of Rwanda and Senegal to build mRNA production facilities, with construction starting in mid-2022.

container factories

kENUP’s mission report to South Africa, sent to the South African government last August, describes the BioNTech initiative. It offers to export fully equipped mRNA production lines in a series of shipping containers.

Made in Europe and staffed initially by BioNTech workers, these shipping container factories would create the mRNA, the active ingredient of the vaccine, which would have to be put into vials by another company, a process known as “filling and finishing”.

A second document from the kENUP Foundation, marked as “confidential” and sent to South African and European government officials in November, outlines a framework for regulating such factories.

He suggested that in order to quickly start producing mRNA vaccines in Africa, a new regulatory pathway should be agreed in which shipping container factories are licensed by the European Medicines Agency, saying this would allow them to be accelerated for WHO pre-qualification. , the global mechanism for ensuring the safety, efficacy and quality of a medicine.

The document outlines longer-term local regulatory capacity building.

But experts have called this concept flawed. Containers can be “useful innovations” for flexible vaccine manufacturing and distribution, said Prashant Yadav, a researcher at the Center for Global Development.

“However, they must be approved by local regulatory bodies, and there should be a local quality person in the country or site where such modular fabrication is to be used,” he added.

Marie-Paule Kieny, who chairs the hub’s steering committee as chair of the Medicines Patent Pool and worked on vaccines at the WHO, said it was “pure nonsense” to believe a license of the European Medicines Agency intended to authorize vaccines used in Europe would apply to those manufactured on another continent under such different circumstances.

“Only someone who doesn’t know how it works can say something like that,” she said.

Local regulators are needed to test vaccines before they hit the market, something European regulators won’t do for African countries, Kieny said. She called the approach proposed by kENUP “paternalistic” and advocated more local programs.

Margareth Sigonda-Ndomondo, who leads regulations for Partners for African Vaccine Manufacturing, said her department had several interactions with kENUP about its white paper and was “not well informed”.

She rejects the idea that the African regulatory system lacks capacity and that another avenue of approval is needed.

“So we’ve actually expressed our concern that we have existing systems on the continent,” she said.

“We explained to them that they just had to work within existing initiatives, structures and systems.”

The African Medicines Agency was ratified in 2021 and will harmonize regulations across the continent. South Africa has a laboratory capable of carrying out the necessary tests, which has been inspected by the WHO, hopefully enabling its regulator to approve vaccines by the end of the year. , she said. Once done, it could act as a center of excellence, supporting other regulators.

Sigonda-Ndomondo added that kENUP and BioNTech cannot expect to bring in mRNA factories and expect African regulatory agencies to “give the green light without having to go through the review process. scientist”.

However, she welcomed plans to build mRNA factories on the continent and said she would continue to engage with kENUP to find a solution that would give Africans access to these vaccines.

Others look forward to more specific details on the proposal from kENUP and BioNTech. “The real proof of the pudding will be: ‘This vaccine, made in Rwanda and approved by this new regulatory process, will it be accepted in Europe?'” said Patrick Tippoo, executive director of the African Manufacturing Initiative. vaccines and science and innovation manager at Biovac. “And if the answer to that question is yes, then I would say maybe it could be accepted in Africa as well.”

The push for vaccines made in Africa was launched due to vast global inequalities in the distribution of Covid-19 vaccines. So far, 10.3 billion doses have been administered worldwide, but only 392 million have been distributed in African countries.

Afrigen and Biovac can manufacture up to 500 million doses per year.

Martin Friede, coordinator of the Initiative for Vaccine Research at WHO, which supports the centre’s work, anticipates bottlenecks due to shortages of reagents, glass vials and trained personnel. “The vaccine manufacturing process would have taken a year with the help of the companies, but without them it would take three,” Friede said.

About Margie Peters

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