WHO Vaccine Push Rattles Arguments Against Covid Patent Waiver

More Covid-19 vaccines are poised to reach poor countries thanks to a World Health Organization effort that some policy experts say dismantles a key argument against waiving protections on pandemic-related innovations.

Critics argue that the vaccines by Pfizer Inc. and Moderna Inc. are too complicated to produce without big pharma oversight, and that allowing at-need countries to try to replicate them could do more harm than good. Such arguments are part of an ongoing push against a proposed global waiver on vaccine intellectual property rights that’s been under discussion since 2020.

But the WHO has been opening facilities overseas to produce vaccines using genetic material called messenger RNA, like those by Moderna and Pfizer, for poor and middle-income countries.

“High-income country drugmakers like to recite the mantra that only they are capable of making these mRNA vaccines. But we’re on the verge of seeing this narrative debunked,” said Priti Krishtel, co-founder of the Initiative for Medicines, Access, and Knowledge.

The WHO’s vaccine technology transfer hub, announced last June, aims to expand manufacturing capacity and know-how for mRNA Covid-19 vaccines. It announced in February the first six countries in Africa that will receive the technology for the vaccines. It also said it plans to open a new training facility in South Korea.

Companies abroad like India’s Gennova have already “initiated the process” in making vaccines, and over two dozen manufacturers from lower- and middle-income countries have “expressed interest and capability,” Krishtel said. She also pointed to research from AccessIBSA and Médecins Sans Frontières finding that at least eight African sites and six in Latin America could produce mRNA vaccines.

South Africa, the European Union, India and the United States have reached a tentative compromise for a Covid vaccine IP waiver. That compromise, however, would need official approvals before going into effect.

‘Giving People the Know-How’

South Africa and India first floated the concept of a Covid vaccine waiver in 2020, an idea that has since spurred revisions before the World Trade Organization and has drawn the support of numerous countries and U.S. Democratic lawmakers.

The Biden administration in May 2021 threw its support behind the idea of waiving vaccine IP protections, though the announcement was quickly met with resistance. Republican senators warned against an IP waiver, describing the idea as a ploy that would allow nations to steal U.S. innovations. Other major nations, like Germany and France weren’t entirely on board either.

WTO members have yet to sign off on a formal IP waiver framework. But the WHO’s push to develop vaccines “removes a key argument from skeptics, which is, even if we completely waived IP restrictions, there would still be a lack of know-how,” said Daniel Takash, a policy fellow at the Niskanen Center.

The WHO said it was providing technology to Bangladesh, Indonesia, Pakistan, Serbia, and Vietnam to help them jump-start manufacturing. Senegal, Nigeria, Kenya, Egypt, South Africa, and Tunisia are also getting technology to produce jabs.

“They are giving people the know-how, so that practical knowledge restriction is removed, so that makes the legal intellectual property restrictions more relevant,” Takash said of the WHO. “It’s addressable. And they are moving to address it.”

Issues For Immunity

Since becoming available, vaccines have remained more accessible to wealthier nations with the means to pay for doses.

Countries like France, Japan, and Italy have fully vaccinated around 80% of their respective populations, according to Bloomberg’s vaccine tracker. Many wealthier countries have likewise secured more than enough jabs to go around for their citizens—Bloomberg pegged the U.S. as having offered about 166 doses per 100 people, while Canada had over 210 doses per 100 people, and China 224 doses per 100 people.

African nations have fared worse. Chad, South Sudan, and Cameroon count less than five doses per 100 people, Bloomberg reported, while the Democratic Republic of the Congo came in at less than one dose per 100 individuals.

Critics from both sides of the political spectrum say a waiver would have little impact on vaccine access.

David Kappos and Andrei Iancu, directors of the U.S. Patent and Trademark Office under former presidents Barack Obama and Donald Trump, respectively, signed on to a November 2021 white paper claiming “every qualified manufacturing facility on the planet is churning out as many Covid-19 shots as is safely possible.”

Various countries have “requested that the manufacturers of vaccines suspend their shipments because they can’t deliver them to patients fast enough,” problematic given required storage temperatures and expiration dates, Iancu said in an interview. He added that regulatory hurdles and vaccine shipment issues that “have nothing to do with intellectual property” pose the real problems for broader immunization.

“The supply of vaccines is not the issue anymore,” he said.

The Long Game

The WHO told Bloomberg Law that the organization is “in discussions with other countries wishing to receive mRNA technology” from its South Africa hub, and that it will “announce new countries once they are selected.”

While WHO maintains its actions “are not to counter patent protections,” organization officials have said things would’ve been easier had Pfizer and Moderna shared their knowledge on making vaccines.

“We could’ve been several steps ahead of the game had companies like Pfizer and Moderna taken ethical action and shared their technology,” said Ameet Sarpatwari, assistant professor of medicine at Harvard Medical School. “As a result of this delay, we’re increasing the possibility of emerging variants, some of which could be quite deadly.”

Even with the WHO effort underway, it could take years for WHO mRNA vaccines to make it to those who need them most. It will take as long as two years for WHO partners to develop and get approvals to produce their own vaccine, Bloomberg reported.

Given that the mindset that poorer countries “are helpless has been disproven,” Sarpatwari said the WHO’s effort marks “an important step in the evolving debate of pharma policy.”

“What matters in the long term is, are we going to see investment across the world into infrastructure in the global south to allow those countries to really address their health problems using novel technologies,” he said. If so, the WHO bid “will definitely pay dividends.”

Conflict Coming

Advocates note that the WHO is already heading for a conflict over its mRNA production efforts with Moderna as its the potential adversary.

Medecins Sans Frontieres and others have asked the company to drop three patent applications filed in South Africa, contending they could hinder an effort to make vaccines in a Cape Town hub.

Charles Gore, director of the Medicines Patent Pool, said earlier this month the patents allow Moderna to block anyone from selling an mRNA vaccine in South Africa.