EU Inks Remdesivir Supply Deal with Gilead

30.07.2020 - The European Commission has signed a €63 million contract with Gilead Sciences to deliver batches of Veklury, Gilead’s name for the antiviral remdesivir, to the EU’s 27 member states as well as the UK, starting in early August.

In a statement, the Commission said the supplies would ensure that 30,000 patients with “severe” Covid-19 symptoms could be treated with the drug. The EU executive body said it is preparing a pan-European procurement deal for additional shipments to cover potentially higher needs from October this year.

“The Commission is leaving no stone unturned in its efforts to secure access to safe and efficient treatments,” health commissioner Stella Kyriakides said. It was initially unclear why the deal included the UK, as The British government earlier declined to participate in European vaccine procurement negotiations.

The Reuters news agency reported earlier this week that negotiations between the Commission and several vaccine manufacturers had stalled, due to price issues, among other things. The Commission has not commented.

US experts concerned about rushed vaccine approval

In the US, where the number of deaths from Covid-19 this week crossed the 150,000 threshold, health professionals are increasingly worried that President Donald Trump’s rush to have a vaccine available before the Nov. 3 election could endanger safety.

Both US biotech Moderna, whose coronavirus vaccine development is being partly funded by the US emergency preparedness agency BARDA, and Germany’s BioNTech, which is cooperating with US pharma giant Pfizer, kicked off Phase 3 trials with their respective candidates this week.

BioNTech’s vaccine is being tested independently of the National Institutes of Health, which is partially funding the Moderna trial as well as tests for an Oxford University/AstraZeneca vaccine trial. The British drugmaker has said some doses of its vaccine might be ready as early as September 2020, while October has been named as the earliest possible date for the other two.

The Oversight and Reform subcommittee on economic and consumer policy of the US House of Representatives is preparing a bill that would require the US Food and Drug Administration (FDA) to have any Covid vaccines reviewed and recommended by an expert panel before FDA commissioner Stephen Hahn makes a decision on approval.

In the past, the procedure has been for the FDA to appoint a review committee composed of vaccine experts who examine all evidence before recommending approval.  Although records don’t show a sitting FDA commissioner overriding a committee’s decisions, some fear the current office holder, Stephen Hahn, could be an exception.

Hahn’s decision earlier this year to issue an Emergency Authorization Use (EUA) declaration for the old malaria treatment hydroxychloroquine, a drug Trump touted as a cure for Covid-1, without consulting an independent committee irked many in the US scientific and medical community. The FDA later revoked the authorization.