Covid-19 roundup: New preprint suggests Omicron sub-variant can evade Vir antibody; BioNTech-backed nonprofit undermined WHO equity efforts — report
After Omicron began spreading across the world, it quickly became clear that Vir-GSK’s antibody sotrovimab would be the only FDA-approved Covid-19 monoclonal antibody treatment to remain effective against the new immune-evasive variant. And it is now the only such treatment used in the US, causing mass shortages.
But a new preprint, released late Wednesday night by prominent Columbia University HIV researcher and antibody expert David Ho, suggests doctors may not be able to use sotrovimab for long. The antibody isn’t effective at neutralizing BA.2, the Omicron subvariant that is gaining ground in Europe, the US and much of the globe, the researchers found.
They wrote it was 27 times less effective at neutralizing BA.2 than against the original strain of the virus.
The preprint prompted Vir to put out a press release at 1:24 am Thursday morning — 10:24 PT — saying that their own lab analyses suggest sotrovimab “retains neutralizing activity” against BA.2.
Vir said its own preprint would be posted in the “coming week.” It’s difficult to know how to interpret the dueling data until then, and it may continue to be difficult to discern. Different labs can come up with different neutralization results for antibodies, depending on how the antibody is expressed and tested.
Notably, the Ho lab also found in December that sotrovimab lost efficacy against a different subvariant of Omicron, while a University of Washington lab that works directly with Vir found the opposite.
Antibodies with reduced neutralization can still prevent severe Covid-19, depending on how sizable the reduction is. And the other methods now increasingly employed to keep patients out of the hospital — the IV antiviral remdesivir and the oral pills from Merck and Pfizer — don’t target the coronavirus spike protein and are likely to remain effective against the new variant.
Even if the new Ho results prove out, they also do provide one note of optimism: Bebtelovimab, Eli Lilly’s next generation Covid antibody, retains potent activity against all Omicron sub-variants.— Jason Mast
BioNTech-backed nonprofit allegedly undermined WHO tech transfer hub, per report
WHO’s efforts to boost mRNA vaccine manufacturing capabilities in African countries were undermined by a nonprofit group last summer with ties to BioNTech, a new report claims.
The kENUP Foundation allegedly tried to dissuade African governments from participating in the programs by saying the project was doomed, The BMJ reported Wednesday. Per documents obtained by the publication dated last August, the nonprofit argued the WHO Vaccine Technology Transfer Hub should be “terminated immediately” in order to not infringe on mRNA vaccine patents.
Instead, kENUP promoted a BioNTech-backed plan to ship ready-made mRNA factories in sea containers, to be staffed by BioNTech employees, the report says. The group also allegedly tried to devise a new regulatory pathway to make it easier to approve vaccines made in such factories, which at times went against local government regulations.
The report comes amidst the backdrop of some African biotechs, namely Afrigen Biologics, attempting to reproduce the mRNA vaccines using publicly available information. Last month, Afrigen successfully reconstructed Moderna’s shot — both the mRNA aspect and the full formulation — with plans to launch clinical trials on the continent later this year.
In addition, the emergence of the Omicron variant last fall reignited a debate around global vaccine equity, with pharma industry critics slamming companies and rich nations for focusing efforts on booster shots while many in Africa have yet to receive their first vaccine dose. More than 10 billion doses have been administered globally, but only about 350 million in Africa.
The WHO and COVAX-backed technology transfer hub is aiming to reduce that gap, with Afrigen and the Biovac Institute — another South African company — shooting to make around 500 million doses per year thanks in part to the hub.
And BioNTech and Moderna have launched separate efforts to build their own factories in African countries: Moderna announced in October it would spend $500 million to build a vaccine plant on the continent, while BioNTech the same month signed memorandums of understanding with Rwanda and Senegal to build production facilities starting this year. — Max Gelman
Novartis, Molecular Partners submit EUA for DARPin antiviral candidate
Novartis on Thursday requested an EUA for ensovibep, a DARPin antiviral therapeutic candidate to treat Covid-19, its partner Molecular Partners said in a statement.
This submission is based on data from the Phase 2 portion of the EMPATHY study, a randomized, placebo-controlled study which enrolled 407 symptomatic patients infected with SARS-Cov-2. The companies said one month ago that the primary endpoint in the trial was met with a statistically significant reduction in viral load over eight days, compared to placebo, for all three dosing arms.
The placebo arm with 99 patients had a total of five hospitalizations, two of whom died due to worsening of Covid and one patient had an ER visit only. In the 301 patients treated with ensovibep, there were four events, including two hospitalizations and two ER visits. But no deaths occurred in any of the patients treated with ensovibep. — Zachary Brennan