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Covid-19 roundup: As­traZeneca ships first CO­V­AX dos­es as Cana­da rec­om­mends against 65+ use; In­ovio, still stuck in PhI­II, to re­spond to FDA in May

AstraZeneca’s Covid-19 vaccine has had a bumpy ride, but the prominent drugmaker is ready to start supplying their shots to COVAX.

The first doses of the AstraZeneca/Oxford vaccine were shipped to Ghana and Cote D’Ivoire, AstraZeneca announced Tuesday, with more set to begin arriving this week in the Philippines, Indonesia, Fiji, Mongolia and Moldova. For many of these countries, these doses represent their first Covid-10 vaccines, AstraZeneca said.

UP­DAT­ED: Feds clear the road for J&J to start de­liv­er­ing mil­lions of dos­es of their Covid-19 vac­cine — but frets linger about run­ner-up sta­tus

All the pieces needed to trigger a third wave of Covid-19 vaccine supply to start washing over the US fell neatly into place over the weekend.

After providing for a brief mime of regulatory judiciousness, the FDA stamped their emergency approval on J&J’s Covid-19 vaccine Saturday, adding to the Biden administration’s plan aimed at ending the pandemic in the near term — at least in the US. The CDC came through on Sunday with its stamp of approval and J&J is reportedly expected to start delivering vaccine sometime in the next few days.

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J&J ad­comm live blog: Com­mit­tee votes 22-0 to rec­om­mend an FDA OK for the J&J vac­cine, set­ting up 3rd US Covid-19 jab

The US could have a third authorized Covid-19 vaccine within hours.

The FDA’s advisory committee voted unanimously — 22-0 — to recommend the agency issue an emergency use authorization for J&J’s vaccine. If they follow the precedent of the Pfizer and Moderna vaccine, the FDA will likely authorize the vaccine by Saturday, immediately adding a few million doses to the US supply and adding a 100 million by June. An authorization would give the world its first single-dose vaccine, a major weapon in the effort to vaccinate the world and bring the virus to heel, particularly in rural and developing areas.

Covid-19 roundup: US se­cures 100,000 dos­es of Eli Lil­ly's an­ti­body cock­tail; Mer­ck­'s $356M sup­ply deal on hold as FDA asks for more da­ta

A couple weeks after racking up its third EUA for a Covid-19 treatment — this one for its antibody cocktail — Eli Lilly has struck a deal with the US government for at least 100,000 doses.

The US will pay $210 million for doses of bamlanivimab and etesevimab, which will be delivered through March 31, Lilly said in a statement. The deal builds on 1.45 million doses of bamlanivimab alone that the US has already purchased, more than 1 million of which have been delivered. Another 450,000 doses of the single antibody are also expected to arrive by March 31.

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Re­gen­eron halts place­bo en­roll­ment in Covid-19 cock­tail tri­al af­ter IDMC finds 'clear' ef­fi­ca­cy — but there are no da­ta yet

Despite having already received an emergency use authorization for its Covid-19 antibody in non-hospitalized patients last November, Regeneron continued to conduct trials to evaluate the cocktail’s effectiveness. Now, the big biotech has received some good news from their IDMC.

On the IDMC’s recommendation, Regeneron will be shutting down enrollment in the placebo group of a Phase III outpatient trial for their REGN-COV program — a mix of casirivimab with imdevimab — after investigators found “clear clinical efficacy” in both doses compared to the control, the company announced Thursday. CSO George Yancopoulos also said in a statement that the cocktail can neutralize emerging strains of the novel coronavirus.

Covid-19 roundup: Pfiz­er/BioN­Tech shot just as ef­fec­tive in re­al world, study says, as pair preps vari­ant boost­er shots

The first real-world evidence for Pfizer/BioNTech’s Covid-19 vaccine is in, and there’s a lot for the companies to like.

Two months into the vaccine’s rollout in Israel, researchers from the country’s Clalit Research Institute have published the first study to be peer-reviewed over whether or not the shot is effective outside a controlled clinical trial setting. They have found the two-dose vaccine regimen cut symptomatic Covid-19 cases by 94% across all age groups and severe cases by almost as much.

Glax­o­SmithK­line re­thinks strat­e­gy for Covid-19 an­ti­body — not the Vir ones — af­ter tri­al flop. Is there hope in high-risk pa­tients?

In the search for a better Covid-19 therapeutic, GlaxoSmithKline and Vir have partnered up on two antibodies they hope have a chance. GSK is also testing its own in-house antibody, and early results may have shut the door on its widespread use.

A combination of GSK’s monoclonal antibody otilimab plus standard of care couldn’t best standard of care alone in preventing death and respiratory failure in hospitalized Covid-19 patients after 28 days, according to data from the Phase IIa OSCAR study unveiled Thursday.

Covid-19 roundup: CanSi­no sub­mits vac­cine to Chi­nese reg­u­la­tors; As­traZeneca says an­ti­bod­ies show ear­ly ef­fi­ca­cy against new vari­ants — re­port

CanSino says their single-dose Covid-19 vaccine is 65.28% effective at preventing symptomatic Covid-19 cases, and they’ve officially filed for authorization with China’s National Medical Products Administration.

The vaccine was 90.07% effective at preventing severe disease 28 days after the single dose, according to a statement reported by local media. Efficacy rates were slightly higher 14 days after the single dose, at 68.83% for symptomatic disease and  95.47% for severe disease.

CEO Jonathan Javitt (NeuroRx)

Neu­roRx chief lines up Hail Mary for once-re­ject­ed Covid-19 drug

NeuroRx’s Covid-19 treatment was already shot down by the FDA once, and it failed the primary endpoint in a Phase IIb/III readout — but that won’t stop CEO Jonathan Javitt from lining up a Hail Mary pass to regulators.

Javitt gave Endpoints News a preview of Phase IIb/III data based on an initial 28-day endpoint on Monday afternoon. At 28 days, critically ill Covid-19 patients given NeuroRx and Relief Therapeutics’ aviptadil were 35% more likely to recover and be discharged from the hospital compared to those on a placebo, Javitt said. However, the p-value was 0.08 — falling well below the 0.05 p-value needed to demonstrate statistical significance, meaning there’s a greater chance that the results were random and not tied to the treatment.

President Biden (AP Images)

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.