Transatlantic tensions over access to COVID-19 vaccines mount after Sanofi CEO says US is first in queue

French pharmaceutical company Sanofi is at the centre of a transatlantic row over access to its COVID-19 vaccines, after CEO Paul Hudson said the US would get “first access, because it was first to fund the research.”

French politicians slammed the remarks by Sanofi’s (British) CEO Paul Hudson, who told Bloomberg on Wednesday that, “The US government has the right to the largest pre-order because it’s invested in taking the risk,” in reference to funding the company is getting from the US Biomedical Advanced Research and Development Authority for clinical development and to build up manufacturing capacity.

“Equal access to a vaccine for all is non-negotiable,” French Prime Minister Édouard Philippe said on Twitter. In a further riposte, Philippe said he had “just reminded” Serge Weinberg, the chair of “this large, deeply French company” of the need clarify its position. “He gave me all the necessary assurances regarding the distribution in France of a possible Sanofi vaccine,” Phillipe said.

Sanofi is developing two COVID-19 vaccines, both of which it expects to begin first human studies in the fourth quarter of 2020, with the earliest date of approval, the second half of 2021.

The first, being developed in collaboration with Glaxosmithkline, will deliver antigens from the spike protein the virus uses to enter human host cells, to promote an immune response. Depending on how large a dose is needed to elicit a response, Sanofi has said there is existing capacity to manufacture 100-600 million doses and that it will expand production to one billion doses in the second half of 2021, if the product is shown to be safe and effective.

The second Sanofi vaccine uses a lipid nanoparticle as the delivery vehicle for mRNA encoding viral antigens, for which the company has said it is in a position to install capacity for 90 – 360 million doses by the first half of 2021.

“At this stage, we do not have any pre-orders from any country including the US,” said Sanofi spokeswoman Marion Breyer. “The vaccine profile will determine how many doses we can produce and governments along with WHO guidance will determine which populations need to be vaccinated as a priority (we may only need to vaccinate at-risk [people aged] 65+ for example). Given these unknowns, we can estimate scenarios for total volumes we can seek to produce, but we don’t have enough information to know how those doses could be distributed.”

MEPs debate

Ensuring a supply of any COVID-19 vaccine that gets approval was preoccupying MEPs meeting in Strasbourg on Thursday.

Across the board, MEPs expressed support for compulsory licensing of any approved vaccine, allowing it to be manufactured without formal agreement of the rights holder.

The health spokesman of the centre-right European People’s Party (EPP), Peter Liese, called for the EU to prepare a “plan B” in case the US is first to license a vaccine, and then refuses to provide equal access to it for the rest of the world.

“We need to be prepared to be coordinated in Europe to provide forced licenses, or to use other instruments,” Liese said.

Underlining the high level of cross-party support, Tiemo Wolken of the centre-left socialist group said, “When the EEP talks about forcing licenses, we really do have a big problem.”

Wolken said that following Hudson’s comments, the EU should be more careful about committing future money to corporate research. “This should not be a gift to a company,” he said.

Marc Botenga, a member of the European United Left grouping of left and far-left members, agreed the EU should consider overriding intellectual property laws to ensure equal access to vaccine.

Speaking in the debate, Margaritis Schinas, commission vice-president, tried to reassure MEPs European and low- and middle-income countries will get equal access to a vaccine, if and when one is approved.

“We can organise an EU joint procurement mechanism, which will secure purchase commitments. Or the commission can procure directly on behalf of member states,” Schinas said.

The commission’s forthcoming pharmaceutical strategy legislation, to be presented later this year, will include more detail on vaccine production and delivery, he added.

First right of access

Officials in Europe fear US president Donald Trump could be especially aggressive in seeking first right of access for the US.

The sense of urgency around this issue first surfaced in March, when commission president Ursula von der Leyen moved rapidly to secure €80 million in loan guarantees for Germany’s CureVac, after it was reported that Trump was attempting to secure exclusive access to the vaccine it is developing. US officials strongly denied the reports of an offer to CureVac, as did the company.

As, when, and if, any of the 90 or so vaccines in development get approval, there will be a huge demand for access. Some countries fear the benefits of a vaccine will not be shared equally, and they will fall far back in the queue.

An open letter Thursday, signed by the heads of state of three African countries, the prime minister of Pakistan and former leaders of four dozen countries, including the ex-heads of Portugal, Finland and Romania, asks for “a global guarantee” that when a safe and effective vaccine is developed, it is “produced rapidly at scale and made available for all people, in all countries, free of charge.”

“Now is not the time to allow the interests of the wealthiest corporations and governments to be placed before the universal need to save lives, or to leave this massive and moral task to market forces. We cannot afford for monopolies, crude competition and near-sighted nationalism to stand in the way,” the letter says.

Missing from the list of signatories are any prominent politicians from the US and China. The ever-present tension between the two nations was ratcheted up further this week when the US, which is now the epicentre of the outbreak, accused Chinese hackers of trying to steal COVID-19 vaccine research.