LONDON – Geopolitical tensions over the issue of access to COVID-19 vaccines intensified this week, after the CEO of French pharmaceutical company Sanofi SA said the U.S. government would get first access to its product because it was first to fund the research.
That triggered a riposte from French Prime Minister Edouard Philippe, who said there should be universal access, and an international call for health ministers to rally behind a “people’s vaccine,” while members of the European Parliament asked the European Commission to start laying the ground for compulsory licensing, to ensure availability of any approved products.
Responding following an interview with Bloomberg News, in which Sanofi’s (British) CEO Paul Hudson said the U.S. has the right to the biggest pre-order “because it’s invested in taking the risk,” Philippe said a vaccine against COVID-19 should be a global public good. “Equal access for everyone to the vaccine is not negotiable,” he said on Twitter.
Concerns about the scramble for access – as, when and if a COVID-19 vaccine is available – came from across the political spectrum in a debate on the issue in the European Parliament on Thursday afternoon.
The largest group in the parliament, the center-right European People’s party (EPP), called on the EU to prepare a “Plan B” for the scenario that a COVID-19 vaccine “is developed outside Europe, by a country that does not want to share it.”
“I’m sure all pharmaceutical companies, they want to deliver also to the European market, that’s clear,” said Peter Liese, Member of the European Parliament (MEP), who is EPP’s health spokesman. “But there may be governments that are not so keen on helping us, like the U.S. government under Donald Trump,” he said.
Liese said it is “legally possible” to issue a compulsory license, opening the way to manufacture a vaccine without formal consent of the patent holder.
EPP wants the EU to act together to prepare for that. “It would not make any sense for France and Germany to allow such a compulsory license, while Italy and Spain do not. The European Commission should be in charge of the process and coordination at an EU level,” said Liese. MEPs from left wing groups agreed with the proposition.
Margaritis Schinas, vice president of the European Commission (EC), spoke in the debate, attempting to lower the temperature by telling MEPs the EU could apply the heft of a joint procurement to secure advance purchase undertakings.
In March, the EC mounted a joint procurement exercise to get hold of personal protective equipment and ventilators for a central stockpile, after member states encountered difficulties accessing those products.
Surface tension masks behind-the-scenes cooperation
In a press briefing on Thursday morning, EMA officials stressed there is a high level of interaction with the FDA and other agencies to support development and authorization of safe and effective vaccines.
“We are working with [EU] national regulators and international regulators to standardize our approach,” said Noel Wathion, EMA deputy executive director. “We have to make sure all patients in Europe and worldwide have access as quickly as possible. In terms of lack of rules on vaccines access, these are still being developed,” he said.
Sanofi is developing two COVID-19 vaccines. In the first, a recombinant version of the COVID-19 spike protein will be combined with Glaxosmithkline plc’s AS03 adjuvant. There is existing capacity to manufacture 100 million to 600 million doses of that construct, with the goal of expanding production to 1 billion doses in the second half of 2021, if the product is approved.
The vaccine has backing from the U.S. Biomedical Advanced Research and Development Authority.
The second Sanofi vaccine is a lipid nanoparticle-delivered mRNA construct, for which Sanofi said it is in a position to install capacity for 90 million to 360 million doses by the first half of 2021.
Both are expected to start first-in-human studies in the fourth quarter of 2020, with the earliest date of approval the second half of 2021.
Further increasing international vaccine tensions, on May 13, the U.S. Federal Bureau of Investigation (FBI) warned companies of an espionage threat to COVID-19-related research, saying it is investigating the targeting and compromise of U.S. organizations conducting COVID-19-related research by China-affiliated hackers.
“These actors have been observed attempting to identify and illicitly obtain valuable intellectual property and public health data related to vaccines, treatments, and testing from networks and personnel affiliated with COVID-19-related research,” the FBI said.
Disquiet over access to COVID-19 reaches far beyond Europe, and in an open letter published on May 14, three African heads of state and more than 140 leading public figures from around the world, including Nobel prize winners and former national leaders, called for a “global guarantee” to ensure that when a safe, 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 government to be placed before the universal need to save lives,” the letter says. “We cannot allow monopolies, crude competition and near-sighted nationalism to stand in the way.”
That may sound an impossible demand, but the vaccines alliance Gavi has previously negotiated and managed financing mechanisms to accelerate the roll-out and availability of pneumococcal conjugate vaccines and Ebola vaccines, by committing funds to guarantee the price or purchase of vaccines once they were licensed.