Covid-19 roundup: Pfizer, Moderna say Biden's goal of having 600M doses by July is within sight; EMA to consider expanding remdesivir authorization
Pfizer and Moderna are on track to deliver a combined 220 million doses of their mRNA vaccines in the US by the end of March, the companies told a congressional committee, setting them up to offer enough shots to vaccinate 300 million Americans by the end of July — a goal President Joe Biden has outlined in recent days.
Previously, supply wasn’t supposed to reach that level until September.
Both drugmakers say the new goal reflects significant expansions in their manufacturing capacity. And J&J said it could come in with millions of its one-shot vaccine if the FDA authorizes that third option following an adcomm scheduled later this week.
In a prepared testimony, Pfizer CBO John Young noted that it’s already shipped around 40 million doses of its BioNTech-partnered vaccine so far. Thanks to improvements and expansions, by mid-March it could be supplying 13 million doses per week; for comparison, the weekly numbers were around 4 to 5 million in early February.
At Moderna, President Stephen Hoge tells a similar story:
We have doubled our monthly deliveries since late 2020, and we are aiming to double them again by April to more than 40 million doses per month. Based on this progress scaling up manufacturing, we recently agreed to move up our delivery timeline: we now are aiming to deliver a second hundred million doses by the end of May and a third hundred million doses by the end of July.
Breaking down the multiple steps it takes to make an mRNA vaccine, he adds that Moderna is in the process of onboarding a second fill-finish partner with a US facility that, like Catalent, would be putting mRNA-1273 into vials. — Amber Tong
EMA to consider expanding remdesivir authorization
Gilead’s remdesivir is authorized in Europe for Covid-19 patients requiring oxygen, but the EMA is looking into expanding that access.
European regulators have started considering whether or not remdesivir, sold under the brand name Veklury, should be used in cases where patients don’t need supplemental oxygen. The EMA’s CHMP body will issue an opinion on the matter sometime before the summer after Gilead submitted new data, regulators said Monday.
Remdesivir was first authorized on the continent back in July, and any potential endorsements by the EMA will have to be formally OK’ed by the European Commission.
The drug ended up the winner of the Covid-19 treatment race, despite some deep skepticism over its effectiveness. Gilead received full approval for Veklury in the US last October, with a label for treatment in adults and children older than 12 in Covid-19 cases that require hospitalization.
But that green light came less than a week after a WHO study said the drug had little, if any, effect on improving mortality rates, reducing the amount of patients needing ventilators or shortening hospital stays. That led to the UN organization recommending against its use in November, citing the limited data and high costs associated with the drug.
Remdesivir has already brought in a fortune for Gilead, having netted nearly $2 billion in sales in last year’s fourth quarter alone. The drugmaker has priced a five-dose regimen of Veklury at $3,120. — Max Gelman
BioNTech stock is keeping Biden adviser Eric Lander out of certain Covid-19 vaccine discussions
A Senate confirmation isn’t the only hurdle standing between Eric Lander and his new job as President Joe Biden’s top scientific adviser.
There’s also the stock he owns in BioNTech — worth between $500,000 and $1 million — and a portfolio of other biopharma companies that he plans to divest if confirmed, Axios reported.
While Lander, the founding director of the Broad Institute, is already advising the Office of Science and Technology Policy, he’s recused from “particular matters related to any stocks he holds pending divestiture, including any such matters related to COVID vaccines,” a White House spokesperson told the outlet.
He disclosed his stock ownership in paperwork made public on Monday. Among the other drugmakers he has a stake in are Codiak BioSciences, an exosome player he co-founded. The biotech has also indicated plans to develop a Covid-19 vaccine. — Amber Tong
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