Pressure to transfer mRNA vaccine technology

Officials in the US and many countries are trying to push manufacturers, especially Moderna, to share mRNA vaccine technology to solve the problem of vaccine inequality.

The successful race to develop a vaccine last year, combined with a lack of supply, has created an advantage in the market for companies like Moderna and Pfizer. But currently, in low-income countries, less than 10% of the population is vaccinated. Vaccine shortages lead to millions of deaths. US and foreign health officials therefore constantly urge pharmaceutical companies to make more efforts to address the worldwide need for vaccination.

The administration of President Joe Biden is calling on both Pfizer and Moderna to enter into a joint venture model, transferring technology to contract manufacturers. The goal is to increase vaccine availability to low- and middle-income countries.

After many negotiations, Pfizer sold an additional 500 million doses of the vaccine to the US at a non-profit price, but has not yet made technology transfer. Discussions with Moderna reached a dead end, according to an official. This person expressed deep disappointment with the company.

A major alliance of drug and vaccine manufacturers in the developing world has asked Biden to take stronger action to persuade companies to share vaccine formulas and manufacturing processes.

The World Health Organization also has difficulty bringing Moderna to the negotiating table, said Dr Martin Friede, WHO official, and Charles Gore, head of the Medicines Patent Pool at the United Nations. The two are working with a WHO-backed technology transfer center in South Africa, set up to support the development of an mRNA vaccine.

“We’d love to discuss intellectual property with Moderna. If successful, this would make things a lot simpler. But for now, all efforts have gone unanswered.” Dr. Friede said.

Supporters argue that Moderna is obligated to share vaccine technology, because during development, it received support from the National Institutes of Health (NIH) and $2.5 billion from the federal government. , part of Operation Lightning.

In an email response on the evening of September 21, Colleen Hussey, a spokeswoman for Moderna, said the company had agreed to give up intellectual property rights and was ready to share it with other parties “in the post-pandemic period”. However, experts say that the airline should have done this now, not after Covid-19 ended.

Besides, while sharing vaccine recipes is important, it’s not enough for countries to set up production sites quickly and efficiently, said Alain Alsalhani, a vaccine expert at Doctors Without Borders, identify.

“You need to have on hand the whole process (from preparation to finished product) because this is a new technology. One of the problems we have is that the scientific literature on manufacturing mRNA vaccines on an industrial scale is too thin. That’s why it’s important to fully transfer technology, not just come up with a single vaccine formula,” he said.

People in Manila wait in line for the Moderna vaccine. Photo: Reuters

Meanwhile, Pfizer-BioNTech announced that it has signed a letter of intent with the South African biological company Biovac to produce a vaccine for Africans. However, Biovac only plays the role of bottling, not manufacturing according to technological processes. The actual vaccine will be made in Europe.

Many people think that Biovac is not yet qualified to produce a vaccine, but a recent visit by WHO showed that both the company and its affiliated teaching institution, Afrigen, fit the criteria set forth. According to the report of the visit, the team in Afrigen was “capable and experienced” and “have put in place a serious plan with the mRNA vaccine”.

In the case of pharmaceutical companies Involuntary, the US government could use the powers of the Defense Production Act to promote “sharing of intellectual property”. Accordingly, Mr. Biden will declare the pandemic a national security threat. This allows him to “require the company to sign a technology transfer agreement in return for reasonable compensation” from the federal or manufacturing partner, said Lawrence O. Gostin, a public health law expert at the University Georgetown, explained.

“Moderna has received substantial federal funding during Operation Speed. Both it and Pfizer have benefited from NIH funding in fundamental research into mRNA technology that has spanned more than a decade,” according to the report. Mr. Gostin. He argues that companies have a social and ethical responsibility to share that technology for the global good.

But many US officials believe that forcing companies to do this it’s not simple. It will always lead to a lengthy and ultimately counterproductive legal battle.

According to the executives of Pfizer and Moderna, the process of producing mRNA in vaccines is very complex. To date, too few people have had the experience of doing this. Setting up a new production facility in another country is not feasible, fast and inefficient. The companies think they have enough capacity to meet the worldwide demand for vaccines by the middle of next year. The fastest way to address vaccine inequality is to distribute donated doses.

However, after tracking the pandemic for 18 months, some pharmaceutical experts point out that manufacturing in developed countries is extremely important to ensure vaccination equity. For example, the majority of vaccines donated to Africa come from the Serum Institute of India. But five months ago, the government blocked exports to prioritize supplies for people experiencing a devastating wave of infections. The country said it would resume exports next month.

“We hear all the time, ‘The vaccine is coming, the vaccine is coming,’ but three million people have died since Pfizer was approved by the FDA,” Zain Rizvi, an expert with Public Citizen, said.

Protecting the mRNA technology helps Moderna and Pfizer make a direct profit, maintaining a competitive edge, not just in vaccine sales. In addition to more than $53 billion in revenue this year from the pandemic, mRNA has many other lucrative potentials, such as in cancer, HIV and malaria drugs.

“They don’t want a competitor in the future,” said Mr. Rizvi.

The WHO said that even without Moderna’s coordination, the technology transfer center in South Africa would still try to copy as much as possible its vaccine formula. This will be the gold standard for comparing candidates from other bioproducts companies. The center can retrain manufacturers wishing to produce large-scale vaccines.

“If we have Moderna or BioNTech as a partner, we will have an approved vaccine in 18 months. Without them, we have to go through the full development process, which takes 36 months if everything goes smoothly, or longer,” says Dr. Friede.

Thuc Linh (Follow NY Times)


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