While I appreciate biotech articles being on hacker news, this one is nothing I would expect on the frontage. Three of the authors have interest in the company that makes HD-map. This in combination with being linked as a preprint without peer review makes me look twice. The wording „complete protection“ does the rest.
Does anyone have information if this was ever peer reviewed?
Given it was posted May 31st, 2021 it's at best weeks away from completed peer review, and realistically with the timelines of COVID-19 papers these days, months.
BioNTech/Pfizer published a press release regarding 94% efficacy in November 2020 (1 month before publishing any study) and it too landed on the front page:
Completely different - They are a large company with a proven track record and a lot to lose if they incorrectly claim efficacy. They were reporting on the results of a registered clinical trial with 30,000 subjects.
This shows results for ~ 48 transgenic mice. I would say that, at the time, the vaccine reported in the press release from Pfizer had a 99% chance of being approved by FDA, while this vaccine has maybe a 10% chance of being approved by the FDA at best.
You’re right, they completely differ from each other (regarding their relevance) and should therefore face an adjusted amount of scrutiny.
If you’re one of the top pharmaceutical companies in the world, some press releases and study protocols are simply not enough [1] and should be (imo) discarded.
If you’re a new player (Vaxxas) claiming “complete protection” by testing your product on mice, it’s simply not enough and should be (imo) discarded.
The University of Queensland website has a nice summary [0] if you're in a hurry:
> The University of Texas Hexapro vaccine candidate – delivered via the UQ-developed and Vaxxas-commercialised high-density microarray patch (HD-MAP) – provided protection against COVID-19 disease with a single, pain-free ‘click’ from a pocket-sized applicator.
It sounds like that pill variant is an anti-viral treatment, not a vaccine, though. Still an excellent development, but it would complement vaccination rather than competing with it.
At this point many of them believe that anyone with vaccine induced immunity is a spike protein factory which they believe causes infertility, the only solution being to socially distance from vaccined people forever and wear masks
(This is hilarious and so obviously a counterintel campaign, the FBI and others have a history[1] and mandate of infiltrating groups and steering them into compliance with more absurd information
Your [0] sounds great as a treatment if it works, and complementary to vaccines for prevention. The paper is about a vaccine slapped on your skin ("This delivers the vaccine directly to the dermal and upper dermal layers of the skin").
Along those lines, some other interesting companies in early stages are:
* ImmunityBio - oral/sublingual/subcutaneous injection/combo - https://immunitybio.com/covid-19/, https://www.globenewswire.com/news-release/2021/01/12/215692... (some of their papers also compare against intramuscular versions of their drug, but they appear to want to avoid big needles and have some means of injecting just below the skin, but not as shallow as this HD-MAP approach it seems)
If the Milken Institute is up-to-date, Inovio should be furthest along (prepping phase 3), followed by ImmunityBio (phase 1/2). Anyone succeeding would be a wonderful addition for the world!
Sounds like a cool technology - basically 5000 very tiny needles instead of one standard one (though conventional vaccine needles have gotten very small). I wonder how much it costs to manufacture.
That is a paper about the patch. It's an array of 3,000 micro-needles. The needles are coated with dry vaccine. The needles destroy many cells during application, which increases the body's immune response and uptake of the vaccine.
The dry vaccines do not spoil as easily as the liquid ones. I recall seeing injections of dry medicine powder many years ago in rural West Africa. The nurse first used a sterile syringe to draw sterile water from a vial, injected it into a new medicine vial, withdrew the syringe, shook the vial and let it sit for a minute, and then drew the liquid medicine suspension and injected it into the patient.
Are any injectable covid vaccines distributed as dry powder?
Yes, the patch is coated with the actual spike protein, with some modifications:
> The HD-MAP is a 1 x 1 cm solid polymer microprojection array containing 5,000 projections of 250 μm in length. Vaccine is coated onto the microprojections via a nitrogen-jet-based drying process before application to the skin at a velocity of 18-20 m/s via a spring-loaded applicator.
> Here, we explore HD-MAP delivery of a subunit vaccine candidate –a recombinant SARS-CoV-2 spike glycoprotein, termed HexaPro which has been stabilized in its prefusion conformation by removal of the furin cleavage site and the inclusion of six stabilizing proline mutations
Hm, does that mean the side effects would be expected to be about the same as the vaccines we have already? I'm worried that regular boosters will be an extremely hard sell if so many people get sick for days after each one.
I think they made the Pfizer and Moderna vaccines extra strong (and double dose) because we were in the middle of a once-in-a-century pandemic. Would've been still somewhat effective at lower dosage. Folks have tested Pfizer at lower dose, and it seems to work still. But being high dose and double dose probably has also helped protect well against variants.
> I think they made the Pfizer and Moderna vaccines extra strong (and double dose) because we were in the middle of a once-in-a-century pandemic.
Was looking into Pfizer’s effectiveness against the Indian variant since that seemed to be the most worrisome one out there and this was the vaccine I got.
What it boils down to:
1 shot + 3 weeks: 33% effective.
2 shots + 2 weeks: 88% effective.
Happy to have gotten both shots of Pfizer as overkill looks like exactly the right amount of kill. If I can get boosters down the line in the form of a patch, all the better really.
The Moderna shots seem to be far more overkill than even the Pfizer ones. 100 micrograms of mRNA vs 30 in the Pfizer. Both are probably more than necessary but they had one shot to nail it and they went all in on the first try. Likely related, myself and everybody I know had far worse side effects from the Moderna shots than the people I know who received the Pfizer ones.
The 3-4 week spacing was based on the first clinical results that came back. Now that we have data on longer spacings, it looks like waiting at least 3 months results in a stronger immune response. https://www.bmj.com/content/372/bmj.n18https://journals.plos.org/plosbiology/article?id=10.1371/jou... We had to rush the second shots to get immunity quickly, but for a later booster, the required dose might be a lot lower.
Not sure about this one specifically, but these microneedle array vaccines seem to use a slightly different mechanism to elicit an immune response (they stimulate Langerhans cells, which are dendritic cells in the skin). Hard to say if that would make side effects worse or better or have no effect -- this trial was in mice so it's not like the researchers could ask -- but it's probably different enough a system that people's experiences with the injectable vaccines probably aren't especially predictive either way.
could slap a skin patch onto everyone that walks through the door.. viola, spike proteins for everyone! It wouldn't bother those that already have anti-bodies for it, and the rest would naturally start making anti-bodies.
Off topic, but I really can’t wait for the approval/EUA for children under 12 to happen because the only people who are still unvaccinated in my family are my kids which to a large degree means we have to keep being very careful. Seems like that age group won’t be able to get vaccinated until October at the earliest and frankly that sucks.
New infections means new opportunities to mutate, does it not? So maybe it silently infects kids now, but, through infecting kids, it changes enough to evade current vaccines, or, starts producing more symptoms in kids.
I don't know how likely either of these scenarios is. But it seems like leaving kids unvax'd allows a possible reservoir of virus that could resurface and affect people.
it's not like we'll ever get anywhere near all US adults to take the vaccine anyways, the subject has become far too politicized.
At this point there's a substantial chunk of the US population hellbent on demonstrating the lockdowns and vaccines and everything that's been done throughout 2020 was completely unnecessary, by simply continuing to do nothing. They will never take a vaccine, they'll risk getting sick and let the natural immunity unfold. They're more concerned with overturning the 2020 election results.
> Schools can be considered continuous super-spreader events.
Where is the data to support this? Duke University released a peer reviewed study[1] in January that showed the opposite (when schools take appropriate measures).
> Duke and UNC researchers evaluated the secondary transmission of COVID-19 in 11 North Carolina school districts that held in-person instruction in the first nine weeks of the 2020-2021 school year and identified minimal COVID-19 transmission in the schools -- much lower than the rate of community spread.
The CDC have also published this[2] helpful overview about the susceptibility of children to the virus/disease (low) and the risk of transmission (also low).
I'd also urge you (or anyone) to read this very helpful article in the BMJ[3] about the risks of covid-19, but for those worried about their children it may help alleviate some concerns:
> The second row of table 2 shows that three deaths from covid-19 have been recorded among over 7 million schoolchildren aged 5 to 14 (around 1 in 2.4 million), an extremely low risk that represents only 2% of the average normal risk faced by this group. This amounts to around two days’ extra risk of dying during the 112 days of the epidemic. In the same period this age group experienced 138 deaths from other causes.
The CDC report gives a clue as to where the focus should be:
> Underlying medical conditions are also more commonly reported among children who are hospitalized or admitted to an ICU
In short, schools aren't providing super-spreader events.
Is the virus 100% safe? Weigh them against each other and account for who the kids could spread it to, how much vaccine uptake there is, immune compromised they could spread it to who can't be protected well from the vaccine, etc.
If the risk of harm to kids from the virus is say 1%, and 0.1% for the vaccine, then it would still be better to go unvaccinated since the risk of catching the virus is most likely less than 10% once adults are vaccinated.
But this is also true of any communicable disease. Rare serious complications taken with anything and not just to “sick” people.
We don’t go back to normal when the earth is a sterile disease free environment, we go back when the outsized risk of this particular disease reduces to the noise floor of everything else.
Realistically until your country or least your local area reaches herd immunity rates you should still be careful to try and help the people who cannot get the vaccine.
As a total needlephobe, I'm very glad about this kind of research. I hope such delivery methods become standard in the future. I'm not particularly looking forward to a repeated freakout before my second dose of Pfizer's nonetheless awesome vaccine.
Complete protection? Does this mean that the reports of deaths following fully vaccinated people are incorrect or does this skin patch provide some extra protection sufficient to warrant the word 'complete'?
What we need is some sort of misting system where a vaccine could be made airborne and automatically respirated into the lungs of people passing by. Therefore people would automatically become vaccinated just by frequenting areas of social gathering.
Does anyone have information if this was ever peer reviewed?