The interim results of the Moderna vaccine trial released this morning are thrilling. Like the Pfizer/BioNTech vaccine, the Moderna vaccine (called mRNA-1273) is an mRNA vaccine and this trial enrolled 30,000 participants, 42% of whom were high-risk (7000 over 65 years and 5000
<65 years old with comorbid conditions) and 11,000 of whom were from communities of color. The press release of the interim results of the phase 3 trial of the Moderna vaccine shows a 94.5% efficacy rate at 95 infections (e.g. 5 infections in the vaccine group; 90 in the placebo
group). Vaccine trials often have a secondary endpoint of mitigating severe disease and all 11 of the severe cases of COVID-19 occurred in the placebo group. The vaccine trial will go up to 151 infections and 2 months for safety data before Moderna will file for an emergency use
authorization. The Pfizer/BioNTech vaccine showed similarly high efficacy results at 90% but that mRNA vaccine requires ultra-cold storage (-70o C), which can present hurdles in widespread distribution.
The Moderna press release includes data that its mRNA-1273 vaccine can stay stable at more standard temperatures for long periods of time (2° to 8°C, the temperature of a standard home or medical refrigerator, for 30 day or -20° C for up to six months), easing distribution
So, these non-pharmaceutical interventions (distancing, masks, hand hygiene, ventilation, no crowds), testing, tracing, isolation & quarantine will need to take us through equitable vaccine distribution (and understanding if boosters necessary) but lots of hopeful news.
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Our group including the very smart @MattSpinelliMD was asked to comment on the DANMASK study found here: acpjournals.org/doi/10.7326/M2…. Others have already smartly commented that implementation science is the way to study mask wearing but here goes:
First the study team (many cardiologists in Denmark) should be commended for performing a randomized controlled trial of a non-pharmaceutical intervention (mask-wearing) in the early days of a pandemic; there are study design flaws that will impair our ability to draw conclusions
The study was a non-blinded study of providing 50 surgical face masks tor community participants spending >3; hours outside of the home in April-May (intervention group) versus the standard of care of Denmark not recommending widespread use of face masks in the community at time
Got a call from science reporter about what we hope & expect from Biden administration on COVID19 response, should be organized and consistent on NPIs and testing. But HIV expertise from advisors is essential to inform public health messaging, I think.
Why? Because HIV doctors have learned over many years and in close contact with their patients to NOT use stigmatizing messaging ("you got COVID? what were you doing??!) and to use kind, harm-reduction-based ways to message on prevention and adherence
I have so many patients right now (I treat patients with HIV) who are totally traumatized by the punitive and harsh aspect of public health messaging right now and make suggestions on how to make messaging more effective via gentleness, kindness, acknowledging loneliness and pain
HI all, we submitted a paper on this today but we want to go from cheapest interventions to most expensive in our response. Cheapest are NPIs (masks, hand hygiene, distancing, ventilation), then more expensive (testing, I&Q, contact tracing), then most expensive (treatments).
Cheapest are "easiest" to enact and yet take behavior change (e.g. masking) so is that so easy? Not really, it is why we came up with prevention strategies for HIV ("biomedical prevention strategies" like PrEP) that didn't rely solely on behavior (condoms)- then it turns out
PrEP ALSO relies on behavior (mainly daily pill taking- this is what I study, adherence in HIV). So, I am not saying behavior change (masks) is easy, I am saying that we as a populace have to trust tbose who recommend them and I so I think we have to turn to building trust
The word "lockdown" is really disturbing. San Francisco has essentially been locked down x 8 months. Testing is helpful but acknowledge limitations of each test. Non-pharmaceutical interventions (distance, masks, hand hygiene, ventilation) work.
and everyone has to decide for themselves their level of fear (I call it "strata of fear", stratosphere) which will determine what they do in terms of being with each other (e.g. is it more ethical to stay away from demented elderly relative or more ethical to see them with NPI?)
No one has seen a movie or performance in 8 months; very few things open (at least in SF) so lockdown hard. What you do to behave "ethically" towards family/friends should be a personal decision, right? The elderly, widows, orphans may be more scared of no contact than contact.
I & my co-authors suggested a hypothesis, acknowledged limitations, and we & others are trying to study it further (inoculum & severity of disease). Science has never been a fixed thing – people got KILLED for thinking of scientific ideas that didn’t fit the predominant paradigm.
A hypothesis is based on an idea; a theory gathers more (but indirect) evidence for the hypothesis; a fact has been proven by usually experimental means (and even that can be disputed based on bias)
There are two things that masks may do- decrease transmission and decrease severity of disease by decreasing viral load. Even decreasing transmission has been questioned because physical sciences can show that a virus can leak around a mask.
How do we show viral inoculum related to severity of disease? We can't do this with dangerous viruses like SARS-CoV-2 (only animal models like this one): pnas.org/content/117/28…
Don't think this relationship is true of all viruses, but seems to be true of some viruses where human experimentation was possible because they are not as dangerous (e.g. giving human volunteers doses of virus and showing that a higher dose gives more symptoms).