It is not rare to meet a doctor who has delved into the study of various medical branches during an over thirty-year-long career, specializing in several fields. It is surely rarer to meet one who is a clinical pharmacologist, a nutrition expert and a professional counselor at once, since these three sciences do not appear to have anything in common.
Meeting doctor Diana Scatozza has allowed us to understand the common denominator of her business: her patients’ physical and mental well-being as a whole.
“When patients walk into my office, my goal is their well-being,” explains doctor Scatozza. “My job focuses on rebalancing, not just on treating, and my goal is my patients’ global health. At the same time, I work as a counselor on clinical research and scientific communication methods.”
Our first question is urged by this devastating pandemic that is gripping us, and covers first and foremost your work as a counselor on clinical methods: why is it taking so long for the Covid-19 vaccine to be made available? What approval procedures does AIFA (the Italian Medicines Agency) adopt?
You see, the testing of vaccines normally takes years. It consists of a preclinical phase at the end of which healthcare regulators approve human testing, if the submitted data supports it. Human testing goes through three phases before the authorities establish that the products are safe to market, and thus make them available.
The first phase of human testing, the so-called “healthy volunteer” phase, assesses the vaccine’s short-term tolerability and pharmacokinetics, meaning how it behaves inside the human body. In the second phase, different doses of the drug, which is the vaccine in this case, are tested on a limited number of subjects in order to assess its tolerability; in the case of vaccines, their ability to get the immune system to produce antibodies is also considered. Once the objective of identifying the dose that maximizes the production of antibodies with the best tolerability is reached, the next phase starts, which tests the results hereby gained on a large scale; only later, during the final phase, the drug or vaccine is presented to the national or supranational regulator. A procedure that may take as long as 10 years!
In this specific case, how has it been possible to shorten times?
First of all, in this very special case, more vaccines have been developed simultaneously thanks to parallel investments by many companies. Moreover, the data have been assessed using a rolling review process, instead of evaluating them in sequence. This means that, while all acquired data are normally collected in a dossier that is sent to the regulators only at the end of trials, in this case data have been sent to the regulators as soon as available, without waiting for all the three testing phases to end.
Moderna, Pfizer-Biontech, Novavax, AstraZeneca and Sputnik, just to name a few: what makes these vaccines different from one another?
Moderna and Pfizer have used a new technique based on the m-RNA, also known as the messenger RNA, i.e. the part of the genetic code that contains the basis giving the imprint to produce the spike protein that the virus relies on to bind to human cells and enter them in order to reproduce.
Could you tell us how it works?
The part of the vaccine’s genetic code (m-RNA) that acts as a “mold” for the production of the spike protein is isolated.
Once isolated, the m-RNA is copied in the laboratory. Last, it is prepped for injection. In order to help it enter human cells, the vaccine’s m-RNA is enclosed in tiny lipid vesicles called liposomes. These vesicles enter human cells, and cells produce the spike protein that triggers an immune response and the production of specific antibodies.
If we are injected with a part of the virus, however, how can we possibly not get infected?
What really happens is that it is not the whole virus to be isolated, but just the part of its genetic code that contains the information carried by the spike protein.
We have only discussed the Moderna and Pfizer-Biontech vaccines. How do the others work?
The other vaccines are based on a long-known technique. A deactivated virus is used, meaning a virus that has lost its ability to cause the disease. In this case, it is the adenovirus, the virus responsible for common cold. The adenovirus is deprived of its infectious ability, the coronavirus spike protein is inserted into it, and the adenovirus is injected into humans. The human immune system will respond by producing antibodies against the spike protein.
How does the immune response to the vaccine take place?
The immune response depends on the characteristics of the spike protein in relation to the immune system of the subject who receives the vaccine.
Once immunity is acquired, it lasts for 6 to 8 months at least. We still lack accurate data about this because, as previously mentioned, all tests are relatively recent, and we still do not have the follow-up data, which are data referring to the months and years following the injection.
Companies keep monitoring subjects who have taken part in the trials in order to gain further information on the duration of their immunity and to evaluate any delayed responses to the vaccine.
At present, the only situations requiring special attention involve immunosuppressed patients or patients suffering from strong allergies.
If the companies currently producing the vaccine cannot meet the demand quickly, as it seems to be the case, why are not other pharmaceutical companies offering to produce it?
Patents are obviously an issue, but should this be bypassed, we should still consider that this procedure to produce parts of the virus, the m-RNA or the spike protein, which we have tried to explain in simple words, is actually extremely delicate and complex, as it needs to be carefully monitored and maintained in constant conditions. Not all the existing pharmaceutical companies produce biotechnologies, and transfers between companies is currently extremely complicated.
In a situation like this, with the vaccines being so scarce, will it be possible to inject doses of equivalent vaccines? A first shot of the Pfizer vaccine, for example, followed by the Moderna one, or viceversa?
No, this option has not been tested yet at the moment. Although it is true that these vaccines rely on the same technology, their production processes are different, and we do not know how they might interact.
What about the monoclonal antibody therapy? Could this be a viable alternative to the vaccine?
No. As the name says, monoclonal therapy is a treatment that can slow down our immune system’s abnormal reaction to the Covid-19, called the cytokine storm. Basically, in the presence of the virus, our immune system overproduces inflammatory substances (cytokines) that are not able to eradicate the infection right away, but cause a serious inflammation instead, which damages the structure of the lungs and other vital organs, to the point of degrading them. Monoclonal therapy is based on the injection of lab-developed antibodies from specific cells (lymphocytes) that produce the same specific antibody for the substances responsible for the storm; our immune system, however, is not stimulated to self-produce the antibodies. This way, when the therapy stops, its beneficial effects stop, too. Not to mention that it is extremely costly!
While we wait to get vaccinated, then, the only prevention measures that we can take, besides the social distancing we all know about, are hand sanitizers and face masks. Speaking of the latter, let’s get things straight: FFP2, FFP3 or surgical masks?
That depends on the level of protection that you are looking for. Surgical masks do not adhere to your face, and this is why wearing them only ensures limited protection; however, as they cover your mouth and nose, they help preventing the spread of potentially infectious respiratory secretions, and thus protect others. FFP masks protect both the wearers and the others, and are classified into three protection classes depending on their filtration efficiency. FFP1 masks have a low filtration efficiency rate, FFP2 have a 94% protection efficiency rate at least, and FFP3 a 99% one at least (and are reserved to healthcare professionals). The best masks are thus the FFP2 ones.
People are often seen wearing as many as two masks at once, one for protection and a second one, possibly in a patterned fabric, for a more pleasant aesthetics.
It has become a widespread habit, but there is not any real need to wear two masks.
We should consider that masks made from fabric or other materials provide extremely limited protection. So if we wish to wear more aesthetically pleasant masks, double masks can be an option, but only for aesthetic reasons; it needs to be clear that they do not provide double protection.
What about Taffix, the anti-Covid spray from Israel? Is it a viable solution?
This spray relies on a simple technique: it contains a substance that creates a protective film on the mucous membrane of our nose. It works on the same principle used by sprays that protect from pollen allergies, for example. In this case, however, one of the spray’s components is citric acid, which reduces the mucosal pH and makes things harder for the virus.
Acidity alters proteins, including the spike protein we have been talking about. Once again, this is a physical barrier, not a miracle cure, but paired with other protection devices, it can work!
Can diet help?
Of course! We can stimulate our immune system through our vitamin D daily intake.
It can be naturally found in food like egg yolks, herrings, salmon, sword fish, mackerel and anchovies, plus bluefish, milk, dairy products and oil in general.
It is no coincidence that in the Scandinavian countries, where people eat large quantities of herrings, salmon and mackerel, and consequently have high vitamin D levels in their blood, the incidence of Covid-19 cases has been remarkably lower than in the other European countries.
This data has first been observed by a team of researchers from Turin, and has later been variously remarked and developed in the United States.
Unfortunately, vitamin D can be found in fat foods, which is why said foods are not often eaten in Italy.
It is not by chance that in my experience as a nutritionist, vitamin D has been scarcely present in 98% of my patients.
However, we should consider that only 20% of our recommended vitamin D intake comes from food, with the remaining 80% coming from the sun.
As we wait for a chance to bask in the summer sun, a valid vitamin D supplement is highly recommended.
Covid-19 has been assumed to have a more serious incidence in the most polluted areas. What connection is there?
All the particles we inhale slow down the motility of the cilia that cover the mucous membranes of the upper respiratory tract, making them more vulnerable to the virus. It is what happens to smokers, for example, and naturally to people living in areas with high particulate pollution levels.
Anxiety, stress, eating disorders: how are they related to the recent Covid-19 pandemic?
Based on my experience as a nutritionist and counselor, I can say that during the lockdown, restrictive eating disorders (i.e. anorexia) and bulimic eating disorders have surfaced, especially in teenagers. Being home with their parents has exacerbated or revealed relational situations that had previously been kept at bay by the limited time spent together. We have noticed different effects on adults. As a reaction to the prolonged social abstinence during the first, unexpected lockdown, social gatherings multiplied between last June and September. During the second lockdown, people have been suffering more, and have thus turned to food as a gratification. We should think that for many, working from home has determined longer working hours, and a consequently reduced private life. The offering of take-away food has broadened, and after stockpiling flour and yeast for homemade bread, we have more and more often opted for home deliveries. The consumption of alcohol has increased, too. At the end of a work day, with no other entertainment opportunities available, happy hours – although homemade – have become more and more frequent, with easily imaginable consequences on fat accumulation. However, paradoxically, a return to normality is almost feared. People feel the need for more freedom of movement, the need to start living their lives again, yes, but not at the hectic pace they had before. Slowing down has paved the way to new ways of living well. Not exactly a praise of slowness… but something really close to that!