PCI 7 November 2023, 15:44
Temax_Krautz
Owen Mumford 12 January 2022, 17:40

Current Edition

EU stocks up on coronavirus vaccine, drug supplies with J&J and Gilead deals

  • The European Union inked its third deal with a coronavirus vaccine maker, securing 200 million doses of Johnson & Johnson’s experimental shot, provided it’s cleared for use by regulators.
  • EU member states also have an option to buy as many as 200 million additional doses. The advanced purchase agreement follows similar deals with AstraZeneca and partners Sanofi and GlaxoSmithKline.
  • The European Commission also announced a contract with Gilead, allowing EU member nations, the U.K. and a number of other countries to procure many as 500,000 treatment courses of remdesivir. Sold under the brand name, Veklury, the drug is the first shown to reduce recovery time for patients hospitalized with COVID-19.

After initially moving slower than the U.S. to lock up supplies of a potential coronavirus vaccine, the EU has signed a series of deals with drugmakers in recent weeks. In addition to the AstraZeneca and Sanofi-GSK agreements, the commission has finished the first stage of talks for contracts with CureVac, Moderna, and partners Pfizer and BioNTech.

European regulators have also begun “rolling” reviews of AstraZeneca and Pfizer-BioNTech’s candidates, though their outcomes will depend on trial results still to come.  

Johnson & Johnson isn’t as far along as some of its rivals in testing a vaccine but may have an advantage in requiring only a single shot, instead of two. Early data from a Phase 1/2 study in the U.S. and Belgium showed that one injection led to an immune response in almost all of the volunteers, although it’s not yet known whether that will prove protective.

The company began a Phase 3 study last month for the single-shot regimen and plans to enroll more 60,000 volunteers, more than any other coronavirus vaccine trial. Johnson & Johnson also intends to run a second Phase 3 trial evaluating 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’s working within “usual rigorous ethical standards of safety and sound scientific principles” as the pharmaceutical industry faces pressure from President Trump to produce a vaccine before Election Day.

The EU deal for Gilead’s COVID-19 treatment will have tangible results much more quickly. Gilead said it will begin fulfilling orders the week of Oct. 12 under the new agreement, which temporarily bypasses the usual country-by-country reimbursement process.

Gilead’s latest deal with the European Commission follows an earlier contract that covered 33,380 treatment courses for the EU and U.K. The biotech company has ramped up production of the medicine and is now able to meet more of the global demand for the coronavirus treatment.