Just released: Pretty remarkable 1-year durability data for Novavax 2-dose primary series. Though there is some expected waning, there was >65% efficacy at 1y (mRNA options typically wane to this level by ~4-5 months). Also fewer waning differences by age. sciencedirect.com/science/articl…
To illustrate age stratified data, I took NVX data from the Japan paper and compared w/ a BNT paper from Norway. For BNT, nAbs & IgG largely back to baseline levels in older individuals by 5m, but remain at protective level at 1y w/ NVX, and more similar to young ages throughout.
Long-term durability is challenging to assess due to hybrid immunity, mutations, etc. More long-term durability studies are needed. But this adds to evidence from other observational data and animal models re: NVX durability
Interesting new study comparing individuals with ME/CFS, Long COVID, and healthy controls using MRI spectroscopy, cognitive tests, and metabolites.
ME/CFS patients had higher lactate in pgACC & dACC, hinting at mitochondrial dysfunction & anaerobic metabolism. Long COVID patients showed lower total choline in dACC, possibly tied to clotting & brain fog. nature.com/articles/s4138…
Cognition: In ME/CFS, higher lactate correlated with worse verbal fluency. In Long COVID, lower choline linked to poorer executive function. No significant differences in muscle metabolites.
The Novavax COVID-19 platform results in lower relative levels of IgG4 compared with mRNA.
IgG4 is additionally linked with lower neutralizing antibody & Fc effector functions.
Lower levels of immune imprinting also seen with NVX, highlighting further benefits of the platform.
Link to study:
"Overall, IgG4 levels were notably higher (>150x) in participants primed by mRNA vaccines (8567.1 ng/mL) compared with those primed by the rS protein–based vaccine (48.7 ng/mL)."journalofinfection.com/article/S0163-…
And link to my prior thoughts on the pre-print:
In short, the Novavax vaccine drives a robust immune response, with higher IgG3 antibodies compared w/ mRNA vaccines. IgG3 is key for potent neutralization & Fc-effector functions like phagocytosis
Additional findings from the PREVENT novavax randomized trial on the 4th sequential dose:
- Robust and durable immune responses (8+ months)
- Original strain vaccine had cross protection vs. strains circulating 3 years later (BA.5, BQ.1.1)
- Low reactogenicity (side effects)
Durability is notable. The antibody levels 8 months after the first booster were similar or higher than levels after the primary series, in both adults and adolescents.
Folks have asked me about how I feel about this. Honestly, just sad.
Sad that health has become a political football.
Sad for all the infants who will suffer from preventable illness.
Sad that more children will not have the option of preventing long COVID.
It's common sense and good science that infants do not have the natural immunity that protects the vast majority of the rest of the population.
Studies agree infants and the elderly are at highest risk of severe disease. cdc.gov/mmwr/volumes/7…
Simply, recent variants appear milder largely because nearly everyone has vaccine and/or infection acquired immunity. Newborns do not have this and thus the risk remains similarly high as people's first infection. Maternal immunization provides antibodies
Marty Markary and Vinay Prasad (FDA Chief and CBER Director) released their perspective on COVID-19 vaccination in a NEJM piece today, with an accompanying webcast.
First, I think they raise some reasonable points. I support their goal of increasing trust in vaccines. They do point out young children as having higher risk with COVID infections. They see significant antigenic shifts requiring broad booster uptake.
I have a few concerns as well. A recurring theme on the webcast was being able to provide individual guidance. I agree that booster decisions are ideally individual. However, if the proper evidence base is there, restricting authorization simply limits choice.
Large study in children and adolescents shows that SARS-CoV-2 infection is linked with long term cardiovascular complications
Study is part of the RECOVER consortium with over 1 million kids.
Link to the paper: nature.com/articles/s4146…
Children and adolescents with SARS-COV-2 infection had higher risk of heart failure, chest pain, myocarditis, cardiac arrest, among others. Nearly double the risk of any outcome with infection.