Vaccino/ Vaccini.
Mentre la stampa (non specializzata) si scatena nel sparare date ed enfatizzare successi parziali... ecco una sorta di "stato dell'arte".
buona lettura ( ho evidenziato alcuni passaggi "interessanti" ma vi suggerisco la lettura per intero)
https://www.fiercebiotech.com/biotech/hope-hype-and-pandemic-vaccines-we-re-not-there-yetVaccines are not big money spinners: They are typically under the radar R&D and commercial products, there in the background quietly and generally quite cheaply savings billions of lives while we all get excited about a few partial responses from a next-gen cancer drug that will cost as much as the average house.
No more, however: The series of COVID-19 vaccine data sets coming this month are probably the most sought after, read and interrogated trial results ever released. The global economy, our health present and future, and our very way of life depends almost exclusively on having a safe, effective vaccine that can artificially (and much more safely) create the herd immunity we need to go “back to normal,” if there can be such a thing.
AstraZeneca and the University of Oxford, Pfizer and BioNTech, Moderna, CanSino and CureVac are all now in human testing trying to find a shot that will end the misery of lockdowns, viral anxiety and massive job losses, with all but CureVac (which only recently started human testing) reporting broadly encouraging, though still very early, results this month.
They all exhibited an immune response; most are generally safe, with headaches, fevers, injection site reactions and muscle aches the typical side effects (and not unusual in vaccines), most pared down with paracetamol.
The debate now turns to which is the most efficacious and which is producing antibody and T-cell responses, the latter now becoming, in the media at least, an equally important factor.
There are no definitive answers. Analysts overnight were a little down on the AZ/Oxford data posted Monday, saying a rival vaccine from Pfizer and BioNTech, one of four they are working on and using a different MOA, was a bit better.
But no one can give a final answer or use cross comparisons with other trials, always a risky no-no, on which is the “best” vaccine.
There are different patient numbers, different patient groups, different patient ages. The trials are still early, so dosing and safety are key considerations; speed is a necessity, but while we want these vaccines now, we also want them safe. Even if only 1% of those taking a vaccine had serious side effects, if we vaccinated 1 billion people, that would be 10 million people affected.
We also need more inclusiveness. Many of the trials are not weighted toward Black and Asian populations, for instance, which recent reports from the likes of the U.K. government have found could be an elevated risk factor; so too is the fact that in Western countries, nonwhite communities are far more likely to work on the front lines and therefore be at higher risk of infection from the start.
We’re also seeing generally younger adults being tested, around 18-55 years old with a median of 35 in the AZ study, for instance, which is both too old and too young. Those aged 70 and older are at much higher risk of hospitalization and death from COVID-19, so a vaccine needs to work for them.
While adolescents and younger children have generally been spared the worst of the effects of this virus, they can and are still getting it and are able to spread it; having working vaccines for this group is also very important and will help those of use with children feel safer sending them back to nurseries/schools/colleges.
Although ongoing and future tests will zero in on this, the current data are, again, early and not giving us the answers we desperately want. This is because they are as yet not set up to do that.
This is where the hype needs to be locked away: The Lancet editor was tease-tweeting about the vaccine data the day before it released AZ’s trial results, as AZ’s stock had climbed steadily over the week before. There were no slam-dunk data, so those gains tailed off. It also made the editor of one of the most prestigious medical journals look foolish while also hyping the already overhyped data.
Merck CEO Ken Frazier has been the most level-headed, saying any attempt to get a vaccine this year is very unlikely, as it’s a long process, and a long process for a reason. This is not political red tape that can be cut; trials of tens of thousands of people take time. Data collection, rigorous interrogation, the correct protocols and long-term safety data are all necessities, and more so than ever if you are looking at inoculating huge swathes of the global population at once.
Governments are already trying to get first in line for vaccines, making risky early bets (the U.K. is picking up 100 million doses of AZ’s vaccine despite only seeing some early data this week), and of course the richer the country, the higher up the queue you will be.
Even if you’re lucky enough to be in one of these countries, don’t expect to be getting a shot the day after any approval. It will likely take months, with those who need it the most given priority: Front-line workers, those over 70 and those with preexisting conditions making them more susceptible to die or be seriously sidelined by the disease.
And here, a major, never-before manufacturing effort, not just of the shots themselves but the physical vials and people needed to given them, which will almost certainly have to be expanded, is required; all the while fighting the anti-vaccine campaign and the fears that it has brought to many people who may forgo these shots through a fear of potential side effects. Misinformation paired with the speedy way these vaccines are going through development will be key battlegrounds for governments to overcome. It’s hard enough to get people to wear masks.
Then there's the question over how long a shot will last: AZ thinks around a year for its attempt, which is not a long time. Having repeated vaccinations, with the threat of SARS-CoV-02 also mutating in the future, making new inoculations necessary, are extra burdens we may also have to bear. In all likelihood, we'll be living with this virus for some time.
Research and development is tough: Most drugs and vaccines fail because of the complex nature of our biology, and the blunt tools we use to try and change it in a way that suits us don’t always align. That is the reality we face, pandemic or not. It took around five years for the first Ebola vaccine to be developed and approved since the 2014 outbreak, and that was at a never before seen pace.
We don’t have a working defense against this virus yet, and even the more optimistic tones suggesting we could have one by the fall are being rowed back. Even if we did, it would be in short supply, with questions on safety and efficacy likely still to be answered. These data are a peek at how things might work, but little more. As hard as it is, we need to wait for better answers.
proprio perchè non se ne sa abbastanza o i dati rilasciati non sarebbero cosi "entusiasmanti", o peggio effetti collaterali.
c'è poco da fare purtroppo ....
che non dia tutti questi eventi avversi.
