Coronavirus channel feed

Da­ta do not sup­port wide­spread Covid vac­cine boost­ers right now, out­go­ing FDA lead­ers write in the Lancet

Even with the Delta variant, vaccine efficacy against severe Covid-19 is so high that booster doses for the general population are not appropriate at this stage in the pandemic, the FDA’s two top vaccine leaders, who recently announced their upcoming retirements on the same day, wrote in the Lancet on Monday.

The viewpoint, which was also co-authored by WHO and other academic experts from around the world, comes as the FDA is considering authorizing the use of boosters, with an adcomm of outside experts due to weigh in on Friday (briefing docs coming Wednesday).

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Covid-19 roundup: UK pulls out of bil­lion-dol­lar vac­cine sup­ply deal as na­tion em­braces mix-and-match boost­er ap­proach

A vaccine agreement between the UK and French biotech Valneva worth $1.65 billion has been abandoned after the country says terms of the deal were not met.

Valneva’s vaccine candidate uses an inactivated virus to invoke an immune response. While that may provide greater coverage against the virus, it can also cause a longer manufacturing timetable. The company announced that Phase III results for VLA2001 were expected in early Q4 2021, and will be a part of the candidate’s submission to the MHRA for approval.

Ugur Sahin, AP Images

Covid-19 roundup: BioN­Tech pre­pares for vac­cine launch in 5- to 11-year-olds; Sino­vac weighs vac­cine pro­duc­tion site in South Africa — re­port

As children return to school and youth Covid-19 hospitalizations hit a new high, BioNTech is reportedly prepping a launch for its mRNA vaccine developed with Pfizer in those between 5 and 11 years old.

BioNTech CMO Özlem Türeci told the weekly German magazine Der Spiegel that the company will file the results of its trial in 5- to 11-year-olds with regulators across the world “over the next few weeks,” and that final production steps are being adjusted to bottle a lower-dose pediatric version of the vaccine.

As Delta takes con­trol, US re­sumes use of Lil­ly's Covid-19 mAb com­bo na­tion­wide

A little more than two months after the US halted all shipments of Eli Lilly’s monoclonal antibody combo for the treatment of Covid-19 on a national basis, the FDA has decided that the use of the drug can resume across the country.

“Based on the most currently available data, bamlanivimab and etesevimab are now authorized in all U.S. states, territories, and jurisdictions,” the FDA said yesterday, noting in a fact sheet that the combo retained activity against the Delta variant. The combo had previously been pulled because it struggled to work against the Beta and Gamma variants, which are now no longer prevalent in the US.

Cameron Durrant, Humanigen CEO (Columbia University Technology Ventures via YouTube)

Hu­mani­gen crash­es as FDA shoots down its Covid-19 drug EUA

Humanigen, once led by the imprisoned Martin Shkreli, is finding itself in a similarly confined space.

On Thursday, the company said the FDA declined its request for an EUA for its lead drug lenzilumab to treat newly hospitalized Covid-19 patients, sending shares of the company’s stock $HGEN down by more than 50% pre-market.

Why exactly the FDA rejected the EUA remains largely unknown as the company offered few specifics.

Covid-19 roundup: Gates Foun­da­tion, Ex­sci­en­tia team up on pan­dem­ic an­tivi­ral dis­cov­ery pact; No­vavax opens tri­al for coro­n­avirus/flu com­bo vac­cine

UK-based AI discovery outfit Exscientia has signed its name to a $70 million collaboration with the Bill and Melinda Gates Foundation to drum up five antiviral candidates for use against coronaviruses and potential pandemic viruses, the partners said Wednesday.

The partnership will pay Exscientia $35 million in equity through the Gates Foundation’s Strategic Investment Fund with the potential for more grant funding. Exscientia, meanwhile, will front $35 million in matching funds to support the discovery work up to Phase I. The term of the pact is four years, and Exscientia will be tasked with finding “small molecule therapeutics with less susceptibility to variants and greater patient access than current approaches,” the company said in a release.

Covid-19 roundup: Brazil holds Sino­vac dos­es af­ter man­u­fac­tur­ing mix up; Take­da to pro­duce No­vavax vac­cine

The use of more than 12.1 million doses of the Chinese Sinovac vaccine will be halted in Brazil, after regulators learned that the manufacturing site was not approved for emergency use by Anvisa, the national health agency.

Anvisa announced the 90-day suspension in a statement Saturday. Another 17 batches, or 9 million doses, are also en route to Brazil, and will be held due to being bottled at a site that was not inspected.

Eric Lander [Yuri Gripas/Abaca/Sipa USA(Sipa via AP Images)]

White House seeks $65B to pre­pare for fu­ture pan­demics in 'Apol­lo'-like ef­fort

Eric Lander, the famed geneticist who now serves as the Biden administration’s top science advisor, unveiled a sweeping plan Friday to transform the US’ preparedness for future pandemics, drawing a parallel to the ambitious Apollo program that put the first humans on the moon.

The plan calls for $65 billion in spending over the next 7 to 10 years, including an immediate $15 billion ask in the current $3.5 trillion budget reconciliation efforts currently moving through Congress. Lander said the proposal would include funding for vaccine and drug development, as well as improving testing and pandemic detection systems.

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Stéphane Bancel, Moderna CEO (Nancy Lane/The Boston Herald via AP Images, Pool)

Mod­er­na's boost­er plan comes in­to fo­cus with pre-print stud­ies in im­muno­com­pro­mised pop­u­la­tions, Delta break­throughs

Moderna submitted initial data to the FDA for its Covid-19 vaccine booster plan earlier this week, and that plan is sharpening into view following several published pre-prints over the last few weeks.

Studies outlining the Moderna vaccine’s effectiveness in different immunocompromised populations, as well as examining the shots’ ability to prevent breakthrough infections, have come to light recently. And most, if not all, of the pre-prints show Moderna’s shot netting higher rates at preventing Covid-19 than the jab from Pfizer and BioNTech.

Emma Walmsley, GlaxoSmithKline CEO (Credit: Fang Zhe/Xinhua/Alamy Live News)

Covid-19 roundup: Glax­o­SmithK­line man­dates vac­cines as lat­est phar­ma to join the push; South Africa's As­pen wants to li­cense J&J jab

GlaxoSmithKline will join the growing list of biotechs that mandate vaccinations for its US employees, and a company spokesperson said it is looking into UK policy as well.

Complementary workers and visitors to its sites will also need to be fully vaccinated, the company said. The policy will be put into place in the next few weeks, and exceptions will be made for those with disabilities, medical conditions or religious exemptions.