NOVAVAX trial from this morning: First want to remind you that we have 9 vaccine candidates out there, 6 of which involve the spike protein in some way (Novavax actually gives the spike protein + an adjuvant) and 3 of which are whole inactivated virions. Table below
Here is our clinical trial data for the 6 spike protein vaccines (will summarize Novavax in moment as the phase 3 trial called PREVENT-19 came out today) and the next tweet shows the phase 3 data for the 3 whole inactivated vaccines (Covaxin, Sinopharm, Sinovac)
And here is phase 3 clinical trial data for the 3 whole inactivated vaccines. Okay, then, going back to Novavax, it is the spike protein put together with an effective adjuvant and we had a phase 2b study in S. Africa & UK study before, but PREVENT-19 was largest, results 6/14
Novavax looks very good and - unlike with previous clinical trials - could sequence breakthrough cases with vax and failures with placebo to detect for variants. Overall, 90.4% effective; ALL cases of moderate/severe disease occurred in placebo so 100% effective for this outcome
Results look amazing - of 14 cases in vaccine group, all mild. Importantly, enrolled a very diverse population, large, across sites in US and Mexico, and also with high rates of co-morbidities and older- still did well in this population, see below.
And this is variant data, works against them as expected because they ALL do (and anyone telling you variants evade vaccines are incorrect). This is a 2-dose vaccine, not mRNA or DNA but spike protein itself with adjuvant, can be stored at 24 hours room temp/6 months in fridge
sorry, here is link for Novavax's press release- I am very interested in this vaccine as mRNA vaccines not being given out worldwide at rate & generosity as hoped so this stable protein-based vax may be very helpful ir.novavax.com/news-releases/…
• • •
Missing some Tweet in this thread? You can try to
force a refresh
HOW LONG DOES IMMUNITY LAST? To COVID vaccines or infection? We do not really know but there have been some really nice papers lately that give us more information. Please remember immunity divided into antibodies (which can come down & not work as well against variants)
IgA is one in the nose & mouth ("mucosa") that is raised by shots (vaccines) to certain extent but rise higher after natural infection; IgG is the one that is "humoral" or in the bloodstream. Many threads on here about cellular-mediated immunity: B & T cells cover all variants
This recent preprint is really important and summarized by @florian_krammer below in depth. Main take-aways: Breakthrough infections induce IgA (we knew) but protection from vaccine long-lasting even against former variants to severe disease/mortality
RSV VACCINE FOR OLDER ADULTS: Respiratory syncytial virus (RSV) respiratory virus (most common after flu pre-COVID). 2 subtypes, A&B (1 dominates/season). Droplet; Recurrent infections. Most severe in neonates & adults >65; FDA approves 1st RSV vax today msn.com/en-us/news/us/…
RSV vaccine 3 trials of new RSV vaccine, all published in the @NEJM recently so just to keep them straight- here is the vaccine which just got approved May 3 by the FDA for older adults. Remember our T/B cells so protection against severe disease higher! nejm.org/doi/full/10.10…
A single dose of the RSVPreF3 OA vaccine had an acceptable safety profile and prevented RSV-related severe respiratory illness by 94% in adults>=60 years (71% against RSV infection, likely to fall with time as antibodies fall but severe disease protection will remain)
NASAL VACCINES: To explain nasal vaccines, we have to explain the immune system first.
IgA is an antibody that helps attack the pathogen and exists in mucosal surfaces (like nose/mouth)
IgG is an antibody that is in the bloodstream bbc.com/news/world-asi…
Cellular immunity is fantastic, redundant (so even if one cell line down in immunocompromised, have other), generated by either vaccine or infection; Comprised of
T cells- so in breadth from vax - works even across spike protein with its mutations
And the 2nd type of cell produced by vaccines or infection -B cell- amazing thing about B cells is that - if see omicron or one of its subvariants in future- they make antibodies adapted to that variant or subvariant (aided by T cells); adaptive immunity
PUBLIC HEALTH POLICY: Seem to be at reckoning phase of COVID response- what worked, what didn't. Which interventions will be used in future pandemic responses? Interventions asked of public need good medical evidence for them (e.g. RCTs preferably, systematic reviews) to impose
In our field, Cochrane reviews represent best way to sum up the medical evidence to date by performing meta-analyses or systemic reviews of currently-available data; here is Cochrane on masks & other interventions for respiratory viruses including COVID cochranelibrary.com/cdsr/doi/10.10…
Many asked past 3 years how CDC developed policies on masks (& age to mask), distancing (feet), ventilation, schools-> all non-pharmaceutical interventions. Originally theory-based. Now 3 years in, have data (RCTs highest level) to form policies from both US and other countries
VACCINE DISCRIMINATION: We need to stop vaccine requirements for US entry like almost every other country. Am finishing COVID chapter for our ID "bible" & vaccines prevented transmission early on with alpha, but not enough now with current variants to justify such discrimination
Moreover, shame, stigma, blame (remember COVIDiots?), coercion, discrimination not good public health tools. When used for HIV, public health & ID physicians decried them but tactics used a lot in COVID. This book tries to explore & correct that for future barnesandnoble.com/w/endemic-moni…
Concept of #harmreduction in pandemic responses means watching carefully if vulnerable people (like students, older people, low-income populations, migrants, sex workers, prisoners, those with disabilities, refugees, minorities) harmed more by response nature.com/articles/s4146…
FEAR: Some media & public health officials concerned Americans aren't fearful of COVID now. But the vaccines & therapeutics DO WORK. If we can't celebrate biomedical advances & imbibe their effectiveness (we have better tools for COVID than flu), what is point of developing?
In HIV medicine, when therapies came out, we didn't say to people- stay fearful; make this the controlling principle of your life. The book #Endemic I wrote (coming out July 11, 2023) hails these biomedical advances & the age we are in to fight pandemics to reassure the world
This is a rather brilliant summary of the issue from @benryanwriter