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Eli Lil­ly says bam­lanivimab low­ered the risk of con­tract­ing symp­to­matic Covid-19 in a first-of-its-kind tri­al in­volv­ing nurs­ing home res­i­dents and staff, paving the way for a new op­tion to ...


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Paul Stoffels, J&J CSO (Andrew Harnik/AP Images)

J&J on track to roll out sin­gle-shot Covid-19 vac­cine in March, Paul Stof­fels con­firms, al­though man­u­fac­tur­ing de­lays raise ques­tions

We should know how effective J&J’s Covid-19 vaccine — the single shot that’s closest to potential authorization — is by the end of this month or early February.

CSO Paul Stoffels added that they are on track to roll out the vaccine in March, just as the pharma giant published Phase I/IIa results in the New England Journal of Medicine. But a New York Times report also raises doubts about how many it can actually deliver in spring, citing unanticipated manufacturing delays.

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Covid-19 roundup: Re­gen­eron scores $2.6B US sup­ply deal for an­ti­body cock­tail; Brazil­ian re­searchers walk back ef­fi­ca­cy rate for Sino­vac's can­di­date

The US is continuing to buy up every dose of antibody cocktail that Regeneron can produce, signing off on a $2.625 billion deal to follow $450 million of investments made in July.

Whether Regeneron can deliver the best-case scenario — 1.25 million doses by the end of June — depends in large part on the FDA’s stance on the 1,200mg dose. The pair of antibodies, casirivimab and imdevimab, is currently authorized only at the 2,400mg dose level (1,200mg each). Right now, the big biotech is in the process of delivering doses to treat 300,000 people following the emergency use authorization in November.

Moncef Slaoui (AP Images)

Mon­cef Slaoui to step down from Op­er­a­tion Warp Speed in a month — re­port

Moncef Slaoui’s tumultuous reign as chief of Operation Warp Speed is coming to an end.

The former GlaxoSmithKline vaccine exec has submitted his resignation at the request of the incoming Biden administration, CNBC reported. Under his current contract and agreed plan, he will stay on for a month to aid with transition — although his role is expected to be diminished after the inauguration on Jan. 20.

President Trump (Evan Vucci/AP Images)

Covid-19 roundup: Trump ad­min­is­tra­tion plan­ning to speed up shots; EMA to re­view As­traZeneca/Ox­ford vac­cine

Following reports from Joe Biden’s transition team that the President-elect is planning to release nearly every available dose of Covid-19 vaccines when he takes office, the Trump administration is planning to speed up vaccinations before next week’s inauguration.

New federal guidelines planned for Tuesday will recommend letting everyone older than 65 get a vaccine, as well as all adults at high risk for infection, according to reports from Axios and the Associated Press. The move would get shots into arms rather than holding some doses back for second shots of two-dose regimens.

Covid-19 roundup: Pfiz­er, BioN­Tech set new pro­duc­tion quo­ta for vac­cine at 2B dos­es in 2021; New da­ta show IL-6 in­hibitor could be ef­fec­tive treat­ment af­ter all

Pfizer and BioNTech are well on their way to a global rollout of their mRNA-based Covid-19 vaccine, BTN162b2. Even with logistical challenges hampering that plan, Germany’s BioNTech is planning a vast expansion of its production capacity in the coming year.

BioNTech plans to churn out more than 2 billion doses of BNT162b2 in 2021, far outpacing the 1 billion doses tied up in supply commitment around the globe, the company said in a virtual presentation at the virtual JP Morgan Healthcare Conference.

Covid-19 roundup: Pfiz­er, BioN­Tech study sug­gest vac­cine works against vari­ants; Re­searchers say Sino­vac's vac­cine is 78% ef­fec­tive

Amid heightened concerns about new, largely unknown variants of SARS-CoV-2 that appear to spread more rapidly, Pfizer and BioNTech say they have preliminary evidence that their Covid-19 vaccine is still effective against coronaviruses with one key mutation.

Pfizer partnered with the University of Texas Medical Branch on an in vitro study, in which the academic scientists generated a virus with the N501Y mutation, which they say is shared by the SARS-CoV-2 variants reported in the UK and South Africa. This particular mutation is located in the receptor binding site of the spike protein — the protein that the BNT162b2 vaccine encodes in an mRNA molecule.

Covid-19 roundup: Cure­Vac finds big vac­cine part­ner in Bay­er; Slaoui will stay on as Biden con­sul­tant

Aside from donating chloroquine in the early days of the pandemic, Bayer has largely stayed out of the spotlight as other Big Pharmas deal and invest their way into leading roles in developing Covid-19 vaccines and therapeutics.

But that’s changing today as Bayer puts its weight behind CureVac, a fellow German player, and its mRNA vaccine candidate.

The companies are entering a “collaboration and services agreement,” which will see Bayer take up responsibilities in development, supply and key territory operations — leveraging its expertise in areas like clinical operations, regulatory affairs, pharmacovigilance, supply chain and on-the-ground infrastructure in certain countries.

Covid-19 roundup: EMA rec­om­mends Mod­er­na vac­cine for au­tho­riza­tion; Wood­cock re­turns to FDA as Hahn ad­vi­sor — re­ports

After delaying its decision earlier this week, the EMA announced it has formally recommended authorizing Moderna’s Covid-19 vaccine.

Regulators came to the decision Wednesday morning, marking the second vaccine given authorization in Europe following Pfizer and BioNTech. EMA had previously scheduled a deadline for Jan. 12 to reach a decision.

The ball will now head to the European Commission’s court, which has the final say on any opinions given by the EMA and CHMP. Should the body give it the thumbs up — a virtual certainty — the EU would become the fourth to OK the vaccine, following authorizations in the US, Canada and Israel.

Mod­er­na inks deal for over­seas Covid-19 vac­cine fin­ish­ing work as Eu­ro­pean ap­proval hangs in bal­ance

Despite a lack of formal approval from the European Medicines Agency, Moderna is moving to nail down production capacity for the doses of its mRNA-based Covid-19 vaccine that will be jabbed into arms outside of the U.S.

Just before the new year, Moderna inked a deal with Recipharm, the Swedish CDMO, for formulating and fill-finish work on an undisclosed portion of Moderna’s vaccine supply outside of the US at Recipharm’s drug product manufacturing facility located in France.

FDA commissioner Stephen Hahn (AP Images)

Covid-19 roundup: FDA all but re­jects changes to au­tho­rized vac­cine plans; Is­rael ap­proves Mod­er­na's vac­cine as coun­tries race to get shots in arms

Just one day after OWS chief Moncef Slaoui said he had pushed the FDA to consider halving Moderna’s Covid-19 vaccine doses to counteract distribution lags, the agency poured cold water on the notion Monday night, as well as on other potential alternatives.

The idea of changing authorized vaccine doses or schedules for any Covid-19 vaccine is “premature” and not supported by available data, FDA chief Stephen Hahn and CBER director Peter Marks said in a joint statement. Hahn said regulators have been following the recent debates and news reports about trying to get more people vaccinated more quickly, but noted altering any authorized procedure amounts to a “significant risk” for public health.