Lost in the recent ACIP meeting: A lack of distinction between non-mRNA Novavax & mRNA. They voted on restrictions largely based on mRNA-specific concerns (many false assertions) when these issues flat-out don't apply to Novavax. A brief overview
The ACIP voted to add language about six additional risks with COVID vaccines. Let's see how those apply to Novavax
1. Poor effectiveness & duration?
Effectiveness of COVID vaccines remains strong (around 50%). Importantly, these are population level estimates comparing against a background of infection-acquired immunity (see CDC slide).
Further, duration is likely different across platforms. Although it's nearly impossible to evaluate duration with behavioral differences, variant shifts, etc., the Novavax platform has shown excellent durability up to 1 year in multiple studies
2. Increased risk after vaccination?
They repeatedly cited the Cleveland Clinic study. See fact check for more on this and why the assertion is probably not true. Either way, this update clearly notes mRNA, not protein. factcheck.org/2023/06/sciche…
3. Myocarditis risk with vaccination?
The key point is that the risk of myocarditis is greater with infection compared with vaccination. heart.org/en/news/2022/0…
Although they only cite mRNA, here is a NVX risk benefit analysis w/ myocarditis: sciencedirect.com/science/articl…
4. Post-vaccine syndrome?
Again their slides only note mRNA here. Although important to research this rare outcome, it's certainly not common enough to guide policy. It'd be like removing seat belts from all cars because in a few accidents a year, they contribute to the outcome
5. Lipid nano-particle persistence?
Well, Novavax doesn't have LNPs. Also, preclinical and clinical studies show lipid nanoparticles are biodegradable, rapidly cleared, and have an acceptable safety profile. nature.com/articles/s4157…
6. Birth defects?
There was some debate about internal numbers from a Pfizer RCT in pregnant women. Aside from the fact that, again, mRNA was the focus - it seemed clear that many of the malformations were present before vaccination.
Importantly, COVID-19 infection in pregnancy raises risks of severe illness, ICU admission, preterm birth, and stillbirth. Vaccination reduces those risks.
Further, maternal antibodies provide newborns w/ protection in the first months of life. acog.org/news/news-rele…
Summary: Six tenuous or wrong claims about COVID vaccines drove new restrictions. Four are irrelevant to protein-based Novavax, two only mildly so, yet the less-reactogenic NVX gets lumped in anyway. Hopefully future discussions are more nuanced.
As anticipated, COVID levels are rising nationally with a late summer wave.
Wastewater detection rising quickly.
Early increases in hospitalization rates (those lag infections and viral detection).
I would expect rates to continue accelerating as kids go back to school.
Rates are variable by region. For example Texas is matching the highest levels in the last two years. Some areas remain at low levels. Check your state cdc.gov/nwss/rv/COVID1…
Emergency department rates (early clinical indicator) remain relatively low, but there are substantial increases nationally
The cardiovascular impacts of SARS-CoV-2 infection have been well described since the beginning of the pandemic.
Risk of outcomes like heart attack are higher for months or years after infection. nih.gov/news-events/ne… nature.com/articles/s4159…
Vaccination halves the risk of cardiovascular outcomes when infected. Vaccines are even more protective if you include prevention of infection (roughly halves the risk of infection vs reference population of mostly infection acquired immunity) jamanetwork.com/journals/jama/…
Excellent durability up to one year following Novavax booster doses shown in a new study from Japan.
Correlates of protection estimate 66% throughout the first year following first booster, and 88% throughout second year after 2nd booster.
Link to study:
Slight limitation that antibody patterns suggest some people likely had asymptomatic infections that were not captured. However, I'll note that the asymptomatic infection scenario (avoiding moderate/severe disease) is also a good outcome.sciencedirect.com/science/articl…
Lastly, correlates of protection have a degree of uncertainty. However, the data for NVX are quite good on this front nature.com/articles/s4146…
Long COVID doesn't just pose threat to personal wellbeing, it impacts families, communities, and the national economy.
Recent estimates show it’s sidelined millions of workers, cost trillions in lost productivity, and is quietly reshaping the U.S. labor market and economy.
A recent nationwide study found:
- 35 million U.S. adults (1 in 7) have had long COVID symptoms
- 30 million are working-age
- 24 million face mental health or financial strain
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