Novavax announced their vaccine protects adolescents from Delta infection by 80% (95% CI, 47-92%) after dose 2 vs placebo. Side effects were stated as similar or milder than adults.
To compare to RNA vaccines, we can look at Pfizer results. In one study Pfizer protection was 91% at week 3 after dose 2. It appears in the high 80s at week 2 and 4. medpagetoday.com/infectiousdise…
Another study had Pfizer protection at 93% between weeks 1 and 3. So Novavax appears close, maybe the same (difference is well within the CI). Antibody levels are higher with Novavax in adults so you might have expected better VE. nejm.org/doi/full/10.10…
Novavax says reactogenicity (side effect profile) in adolescents is similar or milder than adults. The same was said for Pfizer (cdc.gov/vaccines/covid…). Then we can compare adult side effect distributions below
We can focus on the most common side effects of fatigue and fever. For both Novavax and Pfizer, these are more common after dose 2. Placebo-subtracted fatigue rate is 25% for Novavax, 37% for Pfizer. Placebo-subtracted fever is 4% Novavax, 15% Pfizer. (Again, old adult data)
Teen rates of vaccination are only 57% in the US, lower than older ages. So there's a lot of room for improvement. news.northeastern.edu/2022/02/08/chi…
While we still don't know about rare side effects like myocarditis (due to low n), it may be useful to have Novavax as an option for nervous parents who can be reassured that it is a protein + adjuvant formulation similar to annual flu vaccines and other childhood vaccinations.
Forgot to mention, the Novavax press release didn't specify the length of the follow-up period after vaccination. Given small number of participants it's likely longer than 4 weeks, so the Pfizer numbers may not be directly comparable.
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In "The lessons of Lander", @ScienceMagazine chief editor @hholdenthorp points out WH hasn't fulfilled its pledge to revitalize our scientific agencies.
What we need: clear deadlines for NIH, FDA, and OSTP appointments, and accountability at HHS and CDC
Here's one calm sentence that is nevertheless alarming in pointing out the danger we are in. There's been a complete absence of government leadership in this epidemic; no wonder the only people in charge seem to be company CEOs.
The entire article is worth reading; it ends with a call to quickly fill our scientific leadership positions.
This shouldn't be hard, given the number of scientific/medical leaders in the US. Just search beyond 1º of separation from the WH, and make competence the only criterion
Essentially type 2 statistical errors are errors. And relying on those errors to hold back useful interventions led to deadly lack-of-recommendations by public health agencies
@DLeonhardt Good to see inaction on boosters for J&J cited as one of the examples. Seems the CDC would like to ignore #JnJers so it's good to be reminded that they have been treated badly.
Also good to mention again the FDA officials opposed to boosters (who still insist they are correct!)
Only thing I'd add: anti-intervention messages get traction citing "lack of solid data" precisely because newspapers, including (especially?) the @nytimes, publishes articles featuring them. Often these are news articles citing "experts" with a track record of being wrong.
This study aims to address what is necessary for high levels of Omicron immunity. As we should define adjectives quantitatively if possible (thinking of a particular big pharma), we can define "high levels" as those associated with >75% disease protection in clinical observations
So let's take a look at the findings. They're very comprehensive, so there are a lot of comparisons to parse. Unfortunately graphs are arranged by # of vax doses, not # of immunity events (ugh). I hope you like brainteasers.
Today in Science, two prominent viral drug experts express concerns about molnupiravir, Merck's mutagenic COVID pill: 1. Mutating patient DNA not ruled out 2. Mutating viral genomes for sure, risk unknown
Raymond Schinazi is a well known antiviral drug developer, called the "King of the Pills". His wikipedia page lists the many marketed HIV and HCV drugs he has developed based on nucleoside analogues like molnupiravir. science.org/doi/10.1126/sc…
In fact Schinazi is the one person who has the most knowledge of molnupiravir (MOV). He's been studying its active metabolite NHC as an antiviral since 2003 (PMID 12499198). He didn't push it to clinic because of mutagenesis concerns. That comes out clearly above, but also below
The article reveals many things not publicly known earlier.
First, Merck had (like my own lab and others) found boceprevir to have some activity against SARSCoV2. Not too surprising, as boceprevir is a HCV protease inhibitor, and SARSCoV2 protease is homologous to HCV protease.
I had emailed Merck to let them know in case they didn't already. But I expected the to know, and this confirms it. They determined that is was unlikely to work well for COVID19 on its own, but Merck was in a good position to modify it to work better, but they didn't.
A recent study by Novavax suggests it may be able to provide broader protection across variants than other vaccines so far. That has interesting implications for vaccine design, if true.
This seems to have escaped analysis entirely, so we'll take a look.
The study came out on 12/25. It contains the data behind Novavax's 12/22 announcement that 3 shots of their vaccine provided Omicron protection. That got into the news, but nobody came back on Christmas to write about the actual findings (I wonder why). ir.novavax.com/2021-12-22-Nov…
Sorry, Novavax, but you might benefit from hiring a science communication consultant for advice on publication strategy and writing. Besides the poor decision to release your article on 12/25, assuring no one will analyze it, the abstract is a disaster. Because there isn't one.