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Dive Summary:
- The European Union signed its third deal with a coronavirus vaccine maker, securing 200 million doses of Johnson & Johnson’s experimental injection, provided it is cleared for use by regulators.
- EU member states also have the option to purchase up to 200 million additional doses. The advance purchase agreement follows similar agreements with AstraZeneca and partners Sanofi and GlaxoSmithKline.
- The European Commission also announced a contract with Gilead, which allows EU member countries, the UK, and several other countries to purchase up to 500,000 remdesivir treatments. Sold under the Veklury brand name, the drug is the first ever shown to reduce the recovery time of hospitalized COVID-19 patients.
Dive Insight:
After initially moving slower than the United States to block supplies of a potential coronavirus vaccine, the EU has signed a series of deals with drug makers in recent weeks. In addition to the AstraZeneca and Sanofi-GSK agreements, the commission has finalized the first stage of contract talks with CureVac, Moderna and partners Pfizer and BioNTech.
European regulators have also begun “ongoing” reviews of AstraZeneca and Pfizer-BioNTech candidates, although their results will depend on test results yet to come.
Johnson & Johnson is not as far along as some of its rivals in testing a vaccine, but it may have the advantage of requiring only one injection, rather than two. Early data from a phase 1/2 study in the US and Belgium showed that an injection elicited an immune response in almost all volunteers, although it is not yet known if that will be protective.
The company began a phase 3 study last month for the single injection regimen and plans to enroll more than 60,000 volunteers, more than any other coronavirus vaccine trial. Johnson & Johnson also intends to conduct a second phase 3 trial to evaluate a two-dose regimen later this year.
Paul Stoffels, Johnson & Johnson’s chief scientific officer, said the company is moving to provide the vaccine as quickly as possible. But Johnson & Johnson also emphasized in its statement that it is working within “customary rigorous ethical standards for safety and sound scientific principles” as the pharmaceutical industry faces pressure from President Trump to produce a vaccine before Election Day.
Gilead’s EU deal for COVID-19 treatment will have tangible results much more quickly. Gilead said it will begin fulfilling orders the week of October 12 under the new agreement, which temporarily bypasses the usual country-by-country refund process.
Gilead’s latest deal with the European Commission follows a previous contract covering 33,380 treatment courses for the EU and the U.K. The biotech company has increased production of the drug and can now meet increased global demand for the treatment of coronavirus.
