Covid-19 roundup: WHO recommends against 'high cost' remdesivir, disappointing Gilead; EU deals with Pfizer/BioNTech, CureVac top $10B — report
Veklury, or remdesivir, may be the first Covid-19 treatment to earn full approval at the FDA, after it won a full-throated endorsement from President Trump. But the WHO is taking the opposite view.
The UN agency said a panel tasked with developing its guidelines has recommended against the use of remdesivir, an antiviral Gilead originally developed for Ebola, for Covid-19, citing limited data supporting its benefits on one hand and “relatively high cost and resource implications associated” with the intravenous drug on the other.
As a result of that decision, the WHO has also suspended remdesivir from an official list of medicines designed to be a benchmark for developing countries — in order to signal to those countries that it doesn’t recommend that they procure the drug (not that they are likely to, as developed countries have bought up the majority of available doses).
Gilead hit back by pointing to studies that suggested the drug cut down recovery times, which had cemented approvals in the UK, Germany, Japan and other countries.
The WHO has been throwing cold water on remdesivir since a large trial comparing remdesivir and three other treatments concluded that none had substantial effect on certain key metrics for hospitalized Covid-19 patients. The other therapies in the study were hydroxychloroquine, lopinavir and interferon.
But the experts were careful to stress that they weren’t saying remdesivir isn’t effective — they just want more clinical data before they would endorse it.
“The evidence suggested no important effect on mortality, need for mechanical ventilation, time to clinical improvement, and other patient-important outcomes,” the WHO wrote in a statement.
Gilead had hit back at the SOLIDARITY data, saying they appear inconsistent with “more robust evidence” from studies such as ones led by the NIH and hinting that the WHO’s trial may not offer conclusive findings due to its design.
In response to the new recommendations, Gilead still stood firmly by remdesivir.
“We are disappointed the WHO guidelines appear to ignore this evidence at a time when cases are dramatically increasing around the world and doctors are relying on Veklury as the first and only approved antiviral treatment for patients with Covid-19 in approximately 50 countries,” Gilead in a statement.
With a price tag of $3,120 for US insurers, analysts have estimated a multibillion-dollar windfall for Gilead.
EMA on tract to stay in sync with FDA regarding vaccine OK
As the FDA prepares to welcome Pfizer and BioNTech’s EUA filing, the EMA doesn’t expect to be far behind.
Ursula von der Leyen, president of the European Commission, told reporters that the EMA has suggested it could clear a vaccine for conditional approval as soon as the second half of December. The regulators are in daily contact with the counterparts across the Atlantic in order to “synchronize” assessment, she added.
Moderna has said that it will apply for an EUA soon, after its vaccine was shown to be 94.5% effective in Phase III. The FDA is reportedly scheduling an advisory committee for early December, which it has promised to complete before sanctioning any candidate.
EU deals with Pfizer/BioNTech, CureVac top $10B — report
The European Union is ready to shell out more than $10 billion for two Covid-19 vaccines developed by Pfizer/BioNTech and CureVac, Reuters reported.
While the pre-orders have previously been announced, the prices were kept under wraps.
For Pfizer and BioNTech — which are angling for the first emergency OK in the US and EU after concluding their mRNA jab is 95% effective — the EU deal represented the largest initial order. The first 200 million doses cost $3.7 billion (€3.1 billion), translating to $18.5 per vial; if it grabs the optional 100 million, the total deal value would be $5.52 billion.
The US has agreed to buy 100 million doses at $19.5 a pop.
CureVac, meanwhile, is so early in the development stage that it doesn’t expect to score regulatory clearance until Q3 of next year. The EU is its first customer, agreeing to pay 11.84 (€10) per dose, or $2.6 billion total, for an initial supply of 225 million doses.
According to Reuters, the German biotech had initially asked for €12. But the EU might also purchase 180 million more doses at an undisclosed price.
So far the list of vaccines that the EU has secured access to have overlapped largely with what Operation Warp Speed has tapped, featuring J&J, AstraZeneca, Sanofi/GSK and BioNTech/Pfizer. It’s also completed exploratory talks with Moderna. Novavax, a Maryland-based biotech, has the only OWS candidate that the EU has not expressed interest in obtaining.
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