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Another potential COVID-19 savior has entered the game: Valneva, a French specialist vaccine developer, has started manufacturing its candidate ahead of hoped for approval.
Valneva started small-scale clinical trials last month, with 150 volunteers, ages 18 through 55, and it expects initial results in April. A large-scale Phase III trial is still only on the horizon. But the company already has a deal with the U.K. government to supply 60 million doses in the second half of the year; the deal foresees the delivery of up to 190 million doses overall. Valneva says it is also in “advanced discussions” with the EU to supply another 60 million doses.
The firm may be French, but it has been working closely with the Brits on this. The U.K. Vaccine Taskforce and National Institute for Health Research helped recruit volunteers for the Phase I/II study that is underway, and the manufacturing is taking place in Livingston, Scotland.
“We believe that our vaccine, assuming successful development, can make a major contribution in the U.K. and beyond,” said Valneva CEO Thomas Lingelbach in a Thursday statement.
“Thanks to the U.K. Vaccine Taskforce, we have ordered up to 60 million jabs of Valneva’s promising vaccine if it proves to be safe, effective, and suitable in its clinical trials this year,” said Business Secretary Kwasi Kwarteng in a separate statement. “By starting manufacturing, we will have a running start at rolling these out as quickly as possible to protect the British public if it receives regulatory approval.”
Speed game
The U.K.’s speed in securing yet-to-be-approved vaccines has paid off so far, giving the country a significant head start in inoculations as compared to the EU. It is also central to the explosive argument over AstraZeneca’s vaccine, which was green-lit in the U.K. last month and is expected to be approved by the European Medicines Agency on Friday.
Apparently owing to a production glitch at a Belgian manufacturing plant, AstraZeneca informed the EU late last week that its deliveries this quarter would be 60% less than planned. The EU says this breaks the terms of their confidential contract, but AstraZeneca CEO Pascal Soriot has maintained that the contract only commits his company to best efforts, given that it had a pre-existing commitment to supply large amounts of its vaccine to the U.K., which signed with AstraZeneca three months before the European Commission did.
The commission, which disputes Soriot’s version of events and is calling on AstraZeneca to make the contract public, is now talking about instituting some form of export controls on vaccines made in the EU. Depending on the details, which should emerge on Friday, this could affect supplies reaching the U.K.
Valneva’s is the only COVID-19 vaccine candidate in European trials that is “inactivated.” While the already approved Pfizer/BioNTech and Moderna vaccines use a fancy new messenger-RNA (or mRNA) technique to prime the immune system, and AstraZeneca uses a harmless virus to carry the coronavirus’s spike gene into the body, inactivated vaccines use a dead version of the coronavirus itself to provoke an immune-system response.
A similar approach is being taken by China’s Sinovac in its CoronaVac COVID-19 vaccine, which reportedly has an efficacy rate of just 50%, compared with the 90%-plus efficacy rates of the mRNA vaccines. AstraZeneca’s efficacy rate is supposedly around 70%, though there has been furious debate in recent days over how useful it is in older people—an issue that may be resolved on Friday when the European Medicines Agency delivers its recommendations.
