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.
Quick personal note. A close friend recently died from a heart attack a week after COVID.
COVID increases risk of cardiac events.
It may have faded from the news cycle, but COVID continues to take people from their families. Please take it seriously.
I’ve gotten questions about whether JN.1- or LP.8.1-based COVID vaccines are better.
Short answer: both should be similarly effective against currently circulating strains. The important thing is to get vaccinated.
Longer answer: see thread
We are fortunate in that nearly all currently circulating strains stem from JN.1 (i.e. JN.1 lineage). JN.1 first emerged in late 2023 and became dominant during the winter 2023-2024 surge. Since then, we have gone through waves of KP.2, KP.3, XEC, and in spring 2025, LP.8.1.
Given the dominance of LP.8.1 during the spring, many suspected the WHO committee on COVID-19 vaccine composition (TAG-CO-VAC) and the US FDA Advisory Committee (VRBPAC) would select LP.8.1. However, selection of a dominant strain (assuming forward drift) is potentially flawed.
New study evaluating vascular and inflammatory diseases after COVID-19 infection and vaccination in nearly 14 million children.
Large persistent increase in major cardiovascular risks following infection. A small transient myocarditis risk following vaccination
Paper:
"COVID-19 infection in children & young people was associated w/ elevated risks... including venous thromboembolism, thrombocytopenia, myocarditis, & pericarditis particularly in the first month... w/ some risks remaining elevated up to 12 months"thelancet.com/journals/lanch…
"By contrast, COVID-19 vaccination was associated with a short-term increased risk of myocarditis or pericarditis, mainly within the first 4 weeks. However, no increased risk was observed beyond that period, and there was no evidence of long-term myocarditis signal"
Excellent study on correlates of protection for nuvaxovid / novavax. Higher IgG and nAb levels are excellent predictors for risk of any and severe infection. Helpful data on durability as well. 🧵
This study group received the original wuhan vaccine and assessed IgG and nAb levels vs Delta. This phase 2 follows the initial CoP analysis, which had no severe cases. That is great, but precluded analysis for severe COVID: nature.com/articles/s4146…
A key finding was that there were no severe cases above the 33rd percentile of IgG levels at day 35 - i.e. based on initial immune responses, no one with an average immune response had severe illness.
Excellent systematic review of COVID, flu, and RSV vaccines. Hundreds of studies, and millions of individuals represented, all demonstrating that these important vaccines help reduce the risk of severe illness and hospitalization.
Link to study:
Remember that the COVID vaccine effectiveness of ~50% is comparing up to date vaccination vs a background of infection acquired and prior vaccine immunity.nejm.org/doi/full/10.10…
Protection against long COVID in children and adults was also high (~60%) and lines up nicely with prior large studies thelancet.com/journals/lanre…
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