Covid-19 roundup: Abivax pulls the plug on its anti-inflammatory treatment; J&J says it could fall short on Q2 vaccine supply for EU — report
Another Covid-19 treatment is biting the dust after an independent Data Safety and Monitoring Board flagged it for lack of efficacy.
Paris-based Abivax shared last week that it’s slamming the brakes on its Phase IIb/III clinical trial for ABX464 in high-risk Covid patients. The study, dubbed miR-AGE, had already recruited 500 patients of the planned 1,034.
Researchers were testing the anti-inflammatory to see if it could prevent severe disease. But a planned interim analysis of data from 306 patients showed no difference between the drug and a placebo. ABX464 was well-tolerated and safe, Abivax noted.
The results came as a shock to some researchers, including Jorge Kalil, a professor at the University Hospital Center in São Paulo and national coordinator of the miR-AGE study in Brazil.
“As an immunologist, I am puzzled by the outcome of the interim analysis, as ABX464 addresses both the viral and inflammatory aspects of the disease,” Kalil said in a statement. “However, we recognize that Covid-19 is a novel, hyper-acute and complex disease that involves various viral and inflammatory pathways, plus the coagulation system, which are still not fully understood.”
While Abivax CEO Hartmut Ehrlich called the findings “disappointing,” he emphasized that ABX464 has shown positive data in ulcerative colitis, where it was already being tested before entering the Covid study.
ABX464 isn’t the only potential Covid-19 treatment candidate to come up short. Just last week, the UK’s RECOVERY trial halted enrollment in its colchicine study after a data monitoring committee saw “no convincing evidence that further recruitment would provide conclusive proof of worthwhile mortality benefit either overall or in any pre-specified subgroup.”
J&J says it could fall short on Q2 vaccine supply for EU — report
The EU could soon be facing more vaccine distribution woes, as Johnson and Johnson worries it won’t be able to meet its Q2 quota.
J&J told the EU that it was “under stress” to meet its goal of 55 million doses by the end of June, an unnamed EU official told Reuters. The company cited issues with the supply of ingredients and equipment, according to the official.
The single-dose vaccine has already been authorized by the FDA, and is expected to get the OK for use in the EU on March 11. J&J is on the hook for 200 million doses to the bloc this year, and deliveries are expected to start as early as April, Reuters reported.
Failing to meet the Q2 goal could spell out a headache for the EU, which has already been dealing with distribution lags. Italy threatened to take legal action back in January, alleging that deliveries of the Pfizer/BioNTech vaccine were unexpectedly cut. Germany’s Hamburg also reported receiving a smaller shipment. And last week, Italy and the EU blocked a 250,000-dose shipment of AstraZeneca’s vaccine to Australia to protect its own supply.
Tensions rise between EMA and Russian vaccine developer
After the head of the EMA’s management board advised EU countries to hold off on authorizing Russia’s Sputnik V vaccine, the shot’s developers want an apology.
“We demand a public apology from EMA’s Christa Wirthumer-Hoche for her negative comments on EU states directly approving Sputnik V,” a post from the official Sputnik V Twitter account reads. “Her comments raise serious questions about possible political interference in the ongoing EMA review.”
Wirthumer-Hoche said during a talk show on Sunday that the EU should wait to authorize the vaccine while the EMA reviews its safety and efficacy, according to a Reuters report.
We demand a public apology from EMA’s Christa Wirthumer-Hoche for her negative comments on EU states directly approving Sputnik V. Her comments raise serious questions about possible political interference in the ongoing EMA review. Sputnik V is approved by 46 nations.
— Sputnik V (@sputnikvaccine) March 8, 2021
While the vaccine has been met with much skepticism, a Lancet study published last month suggests Sputnik V has an efficacy rate of 91.6%. The results came from a 20,000-person Phase III trial, and efficacy rate was based on the number of Covid-19 cases tracked 21 days after the first dose was administered. Sputnik V’s protection applied to all age groups, including those older than 60, the Lancet results said. No serious adverse events related to the vaccine were noted, though 45 patients in the vaccine group experienced serious side effects unrelated to the vaccine, according to the Gamaleya National Research Center of Epidemiology and Microbiology.
Russia registered the vaccine back in August — and President Vladimir Putin says his daughter took it — well before Phase III studies were completed. The move spurred much backlash, including from the Association of Clinic Trials Organizations, which wrote a letter urging Russian health minister Mikhail Murashko not to give out an unproven vaccine.
“EMA did not allow such statements about any other vaccine. Such comments are inappropriate and undermine credibility of EMA and its review process,” the Sputnik V account tweeted. “Vaccines and EMA should be above and beyond politics.”
Pfizer/BioNTech vaccine neutralizes variant spreading in Brazil — study
In a test to see how Pfizer and BioNTech’s vaccine fares against new variants emerging around the world, the jab was able to neutralize the P.1 variant, which was first detected in Brazil, according to a letter to the editor of the New England Journal of Medicine.
The jab also neutralized variants first detected in the UK (B.1.1.7-spike) and South Africa (B.1.351-spike), and two subsets of mutations derived from B.1.351 lineage. But compared to an early isolate of the virus, neutralization of the South Africa variant was weaker by about two-thirds.
From the letter:
Our data are also consistent with poorer neutralization of the virus with the full set of B.1.351- spike mutations than virus with either subset of mutations and suggested that virus with mutant residues in the receptor-binding site (K417N, E484K, and N501Y) is more poorly neutralized than virus with Δ242-244, which is located in the N-terminal domain of the spike protein.
Geometric mean neutralizing titers against the UK and Brazil variants were “roughly equivalent” to those produced against the early isolate, while titers against the South African variant were “robust but lower,” the authors from the University of Texas Medical Branch wrote.
Prior studies have suggested that Pfizer and BioNTech’s vaccine can protect against variants spreading in the UK and South Africa, though may be less potent against the South Africa variant. The companies are testing booster options, including a third dose of the current vaccine and a new formulation that specifically targets the variant.
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