Covid-19 roundup: Scientists pull pre-print with inflated incidence of myocarditis post mRNA vaccine; AstraZeneca seeks EUA for long-acting antibody
Canadian scientists recently withdrew an alarming pre-print manuscript that mistakenly said the incidence of the heart condition myocarditis was a lot more frequent than actually identified following vaccination with either Moderna’s or Pfizer’s mRNA shot.
“In order to avoid misleading either colleagues or the general public and press, we the authors unanimously wish to withdraw this paper on the grounds of incorrect incidence data. We thank the many peer reviewers who went out of their way to contact us and point out our error. We apologize to anyone who may have been upset or disturbed by our report,” they wrote in an update.
The manuscript, first published on the preprint site medRxiv last month identified 32 patients with myocarditis and incorrectly said that 32,379 doses were administered, leading to an estimated incidence of 1 in 1,000. In reality, the number of administered doses during the period was more than 800,000, the researchers said, meaning the correct incidence rate was really about 1 in 25,000.
As of mid-August, the CDC said that it identified 2,574 reports of myopericarditis or pericarditis in a federal database of adverse events, following more than 350 million doses administered. The CDC also noted that most patients (77%) recovered from symptoms at time of report or follow-up.
Walid Gellad, a physician and professor of medicine at the University of Pittsburgh, told Endpoints News that his understanding of the risk of vaccine-associated myocarditis according to CDC estimates and others is that it is between 1 in 6,000 and 1 in 10,000 for young men, after the 2nd dose in particular.
“CDC most recently had it at 1 in 14,000 after 2nd dose in men <30. If you look at Ontario data which reports regularly but also includes pericarditis, it is 1 in 6,000 for 18-24 and 1 in 8,000 for under 17. It varies widely and CDC needs to update what they are seeing. In women, it is much much lower and of much less concern. This is really about males,” he added.
AstraZeneca submits EUA for prophylactic treatment
AstraZeneca on Tuesday sought an EUA from the FDA for its long-acting antibody (LAAB) combination drug, which, like the Regeneron mAb, can be used prophylactically for symptomatic Covid-19.
The application relies on data from a Phase III trial showing the LAAB combo reduced the risk of developing symptomatic Covid-19 by 77% (95% confidence interval (CI): 46, 90) compared to placebo, based on 25 cases of symptomatic Covid-19 at the primary analysis. More than 75% of the trial population included people with co-morbidities and who may see an increased risk of severe disease or a reduced immune response to vaccination.
AstraZeneca licensed the drug from Vanderbilt University, which discovered it. The company has received almost $700 million from the US government to fund the late stage clinical trial and large scale manufacturing of the treatment. Under the terms of the licensing agreement with Vanderbilt, AstraZeneca will pay single-digit royalties on future net sales.
The company previously estimated 100,000 doses of AZD 7442 could be available from this project for the nation’s high-risk population.
Pfizer/BioNTech vaccine 90% effective against hospitalizations for at least 6 months, Lancet study shows
New data published Monday evening in the Lancet show that the Pfizer/BioNTech vaccine effectiveness against hospitalization for all variants, including Delta, remains at 90% for at least six months.
The Pfizer-funded study provides additional data to support the FDA’s recent decision to authorize boosters for Americans at higher risk of infections. Researchers analyzed more than 3 million electronic health records from the Kaiser Permanente Southern California health system between Dec. 2020, and Aug. 2021, finding vaccine effectiveness against Delta variant infections at one month after two doses of the Pfizer vaccine was 93%, but that fell to 53% after four months.
In a variant-specific analysis, the Pfizer and Kaiser researchers found that reductions in the vaccine’s effectiveness against infections over time were more likely due to waning than the Delta variant escaping vaccine protection.
Effectiveness against Delta-related hospitalizations remained high (93%) for the duration of the study period.
J&J submits booster data to FDA for EUA
J&J on Tuesday morning officially said it’s submitted data to the FDA for its booster shot.
The submission relies on recent results from the Phase III ENSEMBLE 2 study that found a booster of the vaccine given 56 days after the primary dose provided 94% protection against symptomatic Covid-19 in the U.S. (CI, 58%-100%) and 100% protection (CI, 33%-100%) against severe/critical Covid-19, at least 14 days post-booster.
J&J said it plans to submit the data to other regulators too, as well as the WHO and National Immunization Technical Advisory Groups worldwide to inform decision-making on local vaccine administration strategies, as needed.