Covid-19 Care TV

The sudden emergence of the Omicron variant of the coronavirus is adding pressure on vaccine makers to ensure their shots are available worldwide, but it remains unclear whether the companies will provide the intellectual know-how and technology that could help boost global production.

After the coronavirus appeared last year, wealthy nations quickly snapped up supplies by signing lucrative contracts and, in some cases, providing development funding to manufacturers. By doing so, however, a wide gulf opened up between rich and poor countries, leading to warnings that “vaccine inequity” would come back to haunt the world if large swaths of humanity remained unvaccinated.

The Omicron variant is a “We told you so” moment.

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As vaccine makers scramble to determine whether their existing shots will be useful against the variant or whether they may need to be retooled, public health advocates are redoubling calls for the World Trade Organization to adopt a proposal made more than a year ago to temporarily waive intellectual property rights so other companies can also produce vaccines.

“The emergence of the Omicron variant tells us what leaders have been saying but have failed to act upon: that no one is safe until we all are,” 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.

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“Vaccine nationalism, hoarding of vaccines and the knowledge needed to produce them will perpetuate the situation. Companies are now working on adjusting vaccines so they become Omicron-specific. The destination of the first batches of these vaccines should be Africa. The IP waiver should be adopted but accompanied by commitments to also make tech transfer happen.”

Africa is of particular concern because just 6% of the 1.2 billion people on the continent have been inoculated, and the Omicron variant was first detected in South Africa. So far, roughly 44% of Covid-19 vaccine doses have gone to wealthy nations, and nearly the entire African continent remains uncovered by contracts that would provide doses, according to the Duke Global Health Innovation Center.

A World Health Organization program called COVAX, which was launched last year to solicit vaccine donations, has also lagged. Although more than 90 million doses have been distributed to Africa through the program and the African Vaccine Acquisition Trust, most donations have been ad hoc, provided with little notice and have short shelf lives, according to the WHO, the African Union and other organizations.

This helps explain why the WTO proposal is a flashpoint in the global fight against the pandemic.

The initial proposal would cover patents, industrial designs, copyrights, and protection of trade secrets. In theory, such a waiver could make it easier for countries that permit compulsory licensing to allow a domestic manufacturer to export vaccines. A WTO agreement reached in 2001 permits countries to issue compulsory licenses, but many countries argue the language is insufficient for the pandemic.

The proposal has been opposed, though, by the pharmaceutical industry and several wealthy nations, mostly in Europe, where the companies are headquartered or have substantial facilities. The clash has reflected long-standing debate over patent rights, which many large drug makers have argued are not a barrier to greater access. Patient advocates counter the companies are too concerned with profits.

In a surprise move, the Biden administration in May decided to support the proposal, but has so far failed to bridge the differences between other wealthy nations and the dozens of low and middle-income countries that have been arguing for adoption. The WTO needs consensus from all of its 164 members for the proposal to be adopted.

As a result, the proposal has stalled amid disagreement on the fundamental question of whether a waiver is appropriate and the most effective way to tackle inequitable distribution of Covid-19 vaccines and treatments. A WTO Ministerial Conference was scheduled for this week where a report was to have been submitted, but has been postponed – and not yet rescheduled – due to the Omicron variant.

A flurry of activity occurred last week just before the new variant emerged, though.

The European Commission suggested a ‘targeted waiver’ on compulsory licenses. But the move was derided because waivers are not needed for countries to issue such licenses. The idea is “basically meaningless” and a public relations “stunt,” said Brook Baker, a Northeastern University professor who specializes in access to medicines and intellectual property and is a senior policy analyst for Health GAP.

At the same time, more than two dozen patient advocacy and human rights groups wrote to the Canadian, U.K., German, and Norwegian governments threatening legal action if the countries did not support the WTO waiver proposal. The groups argued that obstructing the adoption of the waiver would breach legal duties to perform international human rights obligations.

“U.N. human rights treaty monitoring bodies have also made it clear that a failure to support the waiver would violate obligations under ratified international human rights treaties and other international human rights law. These include obligations of international co-operation to ensure rights to health and life,” the letter to Canadian International Trade Minister Mary Ng stated.

We asked several vaccine makers whether they would consider embracing the proposal, given that the Omicron variant has accelerated concerns. Not all of the companies responded, although a BioNTech (BNTX) spokesperson wrote us that “any statement would be speculation. Let us wait for the data from the lab tests and then we can provide on an update on the next steps.”

In a statement, a spokesperson for Pfizer (PFE), which partnered with BioNTech, noted that the two companies have donated 91.5 million doses to 37 African countries. Pfizer argued that availability is not the problem and pointed to vaccine hesitancy, slow uptake, and weak health system infrastructures as the “key challenge.”

The waiver proposal is “based on the incorrect notion that vaccine access is limited due to current levels of manufacturing. That is not the case. The industry already is well on its way to produce enough vaccines for the entire world by the middle of next year. The waiver does not offer real solutions to improve vaccine access,” the company argued, adding that the proposal does not address trade barriers, support frontline health workers in administering vaccines, or implement dose sharing programs.

Such responses, though, do not address production challenges. Toward that end, the WHO recently announced plans for a manufacturing hub in Africa for creating multiple locations to produce vaccines. So far, though, none of the vaccine makers have lent their support. Instead, Pfizer and BioNTech teamed with a South African company, but only for final-stage production, not actual vaccine production.

In a recent interview with us, BioNTech chief executive officer Ugur Sahin maintained that the WHO manufacturing hub and the hope that African companies can supply the African continent is a worthy goal. But he argued more details needed to be sorted out and that an “ecosystem” must be in place to manufacturing with uniform safety and quality standards.

Seeking to provide a stopgap, the Biden administration earlier this month announced plans to invest billions of dollars to expand U.S. manufacturing capacity with an eye toward producing at least 1 billion doses annually no later than the second half of 2022. The funds will support production of vaccines using mRNA technology, which include those manufactured by Pfizer and Moderna (MRNA).

The Biden administration, however, is locked in a dispute over patents to the Moderna vaccine, prompting patient advocates to exert its rights in order to widen access to poor countries. In fact, a South African company, Afrigen Biologics and Vaccines, is using publicly available information and help from outside advisers to make a copy of the Moderna vaccine. But if the company made its recipe available, the time could be cut to one year from three years.

“This variant shows us that, early in the pandemic we ought to have had two clear priorities. One is to significantly augment manufacturing capacity to reach a global scale and the other is to clear barriers to technology transfer tech and IP  so that companies worldwide can make vaccines,” said Peter Maybarduk, who heads the access to medicines project at Public Citizen, the advocacy group.

“In the U.S., we had Operation Warp Speed, which got the U.S. up to scale but left the rest of the world out which was a significant oversight. The U.S. should have a very active role for transferring technology for mRNA vaccines to other governments, because timelines could be significantly shorter if recipes are made available worldwide. It’s obviously too late for Omicron but it’s important for future variants.”