Manufacturing limits spark fears of COVID-19 vaccine nationalism

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There is broad agreement on the importance of creating policies to determine which countries will receive COVID-19 vaccines, but little concurrence on what those policies should be or how they will be created.

On Wednesday, pharmaceutical company executives, former senior U.S. government officials and the leader of an academic COVID-19 vaccine development collaboration presented differing views on what will and should happen.

The issue is urgent because regardless of the speed of development and manufacturing scale-up, initial supplies of COVID-19 vaccines will fall far short of demand, raising concerns about the potential for vaccine nationalism.

Supplies could initially be restricted to individuals living in countries where vaccines are manufactured, wealthy countries could out bid poorer nations for surplus vaccines, and governments could use vaccines as instruments of diplomacy or coercion.

Speaking Wednesday at webinar sponsored by the Duke-Margolis Center for Public Health Policy and the Alexandria Summit, Luciana Borio called for governments to agree on equitable distribution schemes. “I don’t think you can morally justify vaccine producing countries retaining all of the supply.” Borio is a former National Security Council staffer and former acting CSO at FDA.

A viewpoint published last week in JAMA argues that there will “only be losers” in a competitive race to develop effective vaccines and therapeutics. The commentary, by Thomas Bollyky, director of the global health program at the Council on Foreign Relations, Lawrence Gostin, a professor at Georgetown University, and former FDA Commissioner Margaret Hamburg stated that “only a well-coordinated global plan that harnesses the best science and delivers it to everyone in need can effectively counteract the COVID-19 scourge and future pandemics.”

The WHO, leaders of national governments -- except the U.S. and China -- international organizations, philanthropies and international biopharmaceutical trade associations have committed to global equitable access (see “World Leaders -- Except U.S. and China -- Commit to Collaborate on Defeating COVID-19”).

Who pays the piper

While they express hopes for equitable global distribution, vaccine manufacturers that have received substantial backing from the U.S. government assume that vaccine manufactured in the U.S. will be turned over to the U.S. government, which will determine how vaccine doses are distributed.

It would be “naïve” to think that national leaders will share vaccines before their own population’s needs have been met, Scott Gottlieb, a board member of Pfizer Inc. (NYSE:PFE) and former FDA Commissioner, said on the Duke webinar. “Any leadership that doesn’t do that is likely to be accused of being irresponsible by its own population.”

Bloomberg News reported on Wednesday that Sanofi (Euronext:SAN; NASDAQ:SNY) CEO Paul Hudson said Americans will likely get first access to the company’s vaccine, if it is approved, because the U.S. government stepped up to the plate first to provide funding for company’s COVID-19 vaccine development program.

Sanofi followed up later in the day with a statement emphasizing its commitment to global access. “We have always been committed in these unprecedented circumstances to make our vaccine accessible to everyone.”

The company added that it has capacity “in the U.S., Europe and all other main regions. The U.S. production will be mainly for the U.S. and the rest of the manufacturing capacity will cover Europe and the rest of the world.”

That stance is consistent with comments David Loew, Sanofi’s global head of vaccines, told BioCentury in March. He contrasted U.S. funding for pandemic vaccine development and manufacturing with Europe and the rest of the world.

“The U.S. government is particularly well organized” with respect to COVID-19 vaccine development funding, Loew said. “The mechanisms in place with BARDA are transparent, they are pragmatic and there is open communication.”

In contrast, he said, “in Europe, things are in a set-up phase.”

Sanofi can make up to 600 million doses of its candidate COVID-19 vaccine in the U.S. while it is under development, Loew told BioCentury, noting that would be enough to provide two doses to the entire U.S. population.

The company could produce larger quantities through a Japanese contract manufacturer and have them available for rapid deployment if and when its vaccine is ready for distribution if a third party provided funds for at-risk manufacturing, Loew said. The company did not respond to queries from BioCentury on Wednesday about the availability of such funding.

Sanofi’s assumption that the U.S. government will allocate COVID-19 vaccines manufactured in the U.S. is consistent with the expectations of other companies that have received BARDA funding.

For example, Stéphane Bancel, CEO of Moderna Inc. (NASDAQ:MRNA), told BioCentury this month that the company expects to supply the U.S. market from vaccine manufactured domestically at its own plant and at facilities operated in the U.S. by CMO Lonza Group Ltd. (SIX:LONN). It also expects to supply Europe from a facility Lonza operates in Switzerland, and to export to the rest of the world from these plants and possibly from Lonza’s Singapore facility.

“Everybody is hoping to secure local supply,” Bancel said. “We’ve heard that loud and clear from governments.”

Speaking on the Duke-Margolis webinar Wednesday, Paul Stoffels, vice chairman of the executive committee and CSO of Johnson & Johnson (NYSE:JNJ), said that the best way to ensure adequate supplies is to manufacture massive quantities of vaccines, quickly. “The answer to nationalism is capacity.”

Johnson & Johnson is scaling up to manufacture its COVID-19 vaccine candidate in the U.S., at least two European countries, Japan, and possibly somewhere in the southern hemisphere, Stoffels said.

Engineering global access

Some COVID-19 vaccine developers are engineering global access into their products from their inception.

Adrian Hill, director of the Jenner Institute at Oxford University, said his group, which is collaborating with Vaccitech Ltd. on the ChAdOx1 nCoV-19 vaccine, has a “non-U.S. centric strategy.” It has licensed manufacturing rights to the Serum Institute of India, the world’s largest vaccine manufacturer by volume, and to WuXi Biologics Inc. (HKEX:2269) (see “India Emerging as Major COVID-19 Vaccine Manufacturer”).

Oxford also has a manufacturing partnership with AstraZeneca plc (LSE:AZN; NYSE:AZN).

While it is committed to global distribution, Hill noted that the Jenner Institute has received substantial funding from the U.K. government which has made clear that it expects to receive priority access to the vaccine.

Biotech companies, including Novavax Inc. (NASDAQ:NVAX), which have received funding from the Coalition for Epidemic Preparedness Innovations (CEPI), have also made commitments to equitable global distribution.

The assumption that countries will ensure that their own residents’ needs are met before exporting COVID-19 vaccines is not incompatible with broader global access, Richard Hatchett, CEO of CEPI, said at the Duke-Margolis webinar. “One of the things l’d like to dispel is the idea that national efforts are in competition with global collective efforts. I think they can be joined together in a way that serves the world.”

Hatchett explained that countries are likely to invest in capacity that exceeds their needs and that capacity “will not be turned off when national need has been met.”

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