5 things to know about the Covid vaccine

The V Day has arrived, fortunately: here is a summary with the most important information to keep in mind in view of the start of vaccinations

(Image: Unsplash) by Sandro Iannaccone and Simone Valesini

V Day, here we are. After those of the United Kingdom and the United States, the European Medicine Agency (Ema) has also given its positive opinion for conditional marketing (i.e. dictated by the state of emergency in progress) Coronavirus vaccine developed by Pfizer-BioNTech. Positive opinion that, in all probability, will be confirmed in the coming weeks also for two other vaccine candidates, that of Moderna, expected for January 6, and that of Astra-Zeneca. The Italian vaccination campaign begins on Sunday 27 December: the first to receive the vaccine will be five workers of the Spallanzani National Institute of Infectious Diseases in Rome - a nurse, a social and health worker, a researcher and two doctors - which will be followed by another 955 administrations to people who in turn will be vaccinators. And then you should start in earnest. While we waited, we tried to summarize the five most important information to keep in mind before getting vaccinated.

1. Who will get vaccinated?

At the start, vaccines will be available in extremely limited quantities, and the priorities for their administration will also be guided by the epidemic phase in which we find ourselves. At the moment Italy is classified in the phase of sustained community transmission, and with the virus circulating everywhere, the priority is to directly affect the mortality and collateral damage caused by the virus. In order to move to a containment strategy, which aims to decrease the circulation of the virus, not only much higher quantities of vaccine will be needed, but also some more data that confirm the ability of the drugs in question to prevent the transmission of the pathogen, and not only the development of the symptoms of the disease. The first three groups of people who will receive the vaccines in the coming months will therefore be health and social health personnel, residents and staff of the RSA, and over 80 years old.

According to the estimates of the Ministry of Health, contained in the Strategic Plan of Italy for the anti-Sars-Cv-2 / Covid-19 vaccination, we are already talking about almost six and a half million people (probably the initial doses that will arrive from Pfizer will not be enough to exhaust this audience), a drop in the sea that however, it represents the first obstacle to overcome in trying to reduce the mortality of the virus and keep the hospitals and the health service operational.

Except for changes in progress (always possible if the vaccine, for example, does not prove particularly effective in the elderly) once the first phase of vaccination has been completed, the audience will be broadened to include people over 60 years of age, people with frailty who greatly increase the risk of death due to Covid, any socio-demographic groups that are most at risk, and staff engaged in strategic activities such as teaching. If and when the vaccine doses available increase and vaccination sites begin to be homogeneously organized throughout the territory, this phase 2 should end with a vaccination coverage of 50% of the Italian population.

The arrival of further doses and the implementation of the vaccination network will therefore open the doors to the vaccination of essential service workers, people with moderate comorbidity, prison staff and prisoners, workers in sectors with a high risk of contagion. Once this phase 3 has been completed, it will therefore be time to start vaccinating the rest of the country (always stocks and logistics permitting), aiming (hopefully) to approximate 100% vaccination coverage as close as possible.

3. How and where?

Where will the vaccinations take place? The logistical organization will also follow the evolution of vaccine supplies and the population called to get vaccinated. In the initial phase, the plan provides for centralized management, with vaccination points in hospitals or in the peri-hospital setting, and mobile units to reach people unable to move. Obviously, medical and nursing staff will be needed to support this epochal effort: forecasts speak of 20 thousand professionals to be recruited ad hoc, of which 13 thousand identified through a call issued by Commissioner Arcuri, who calls on Italian doctors, nurses and health assistants (also open to retired doctors) to collaborate in the vaccination campaign with fixed-term contracts.

The call is designed to guarantee the administration of 60 million doses within the next 7 months, and will allow the creation of administration points with a doctor and four nurses, able on paper to administer about 6 vaccinations per hour, and a team of a doctor and a nurse for home injections, which should guarantee about 3 vaccinations per hour. This was in the first weeks of the campaign. With the arrival of a sufficient quantity of vaccine doses (and perhaps less complex vaccines to manage than Pfizer and Moderna), it is planned to also activate walk-in vaccination points and to involve traditional vaccination channels (doctors family, local vaccination centers, etc ...), to kick off a large-scale campaign that would allow about 90% of the Italian population to be vaccinated quickly.

3. How many doses will we have available?

As can be seen in the document produced by the Ministry of Health, the Italian vaccination plan is closely linked to the arrival of the promised doses, and purchased, by various pharmaceutical companies. The problem is that there are still no certainties on the delivery times for the vaccines already approved, and for the others it is not even clear if and when they will actually be sold. The first 9,750 doses of the Pfizer vaccine arrived in recent days for the opening of the dances with the European Vaccine Day on December 27.

Later, from the statements of Commissioner Arcuri in the State Regions conference, we await another load from 1.8 million doses for the first of January and a second from 2.5 million in the following weeks, with which the first dose and booster should be covered for a part of the stage 1 audience. After which the arrival is expected of 9 million doses per month for the first quarter of 2021, and therefore of 20 million doses per month between April and June.

If that were the case, we should have vaccinated 27 million people by the summer. Unfortunately, the if, in this case, is written in large letters. Indeed, our country's vaccination shopping list contains more good intentions than certainties: in the first quarter of 2021 we expect 8.749 million doses of the Pfizer vaccine and 1.3 million of the Moderna vaccine, the two already approved (or in the pipeline in the case of the Modern one), and which therefore have a good chance of being actually delivered; but also 2 million of the Curevac vaccine, whose phase 3 trial started in early December and will hardly give results for a few months, and 16 million doses of the Astra-Zeneca vaccine, which after the problems and errors that emerged in the results of the phase 3 trial it is very difficult to predict when it will actually receive the green light of the EMA.

In total, the doses of vaccines from Pfizer and Moderna optioned by Italy are just 37 million, enough to immunize about 18 million Italians. For the rest of the population, the plan relies on 40 million doses of that of Astra-Zeneca, 30 million of Curevac, 53 million doses of the Johnson & Johnson vaccine, still being tested and of which the first data are expected in January. , and 40 million of the Sanofi / Gsk one, which for now has proved disappointing, and for which a new trial (with a different formulation) will start in February next year.

At the moment, in short, we there are very few certainties on the supply of vaccines with which to carry out the strategic vaccination plan imagined by the Ministry of Health. The only certainty, in effect, is the cost: thanks to a gaffe by the Belgian budget secretary Eva de Bleeker, who erroneously published a confidential table on her Twitter account, we know the prices (negotiated in secret) that the European Union will pay for the vaccines just mentioned. And taking into account the total for Italy exceeds one and a half billion euros, against a total expenditure in the EU of almost 14 billion.

4. What's inside?

Luckily, neither microchips that control us nor heavy metals. The ingredient list of Pfizer's vaccine has been public for some time: the most important is a fragment of the so-called messenger rna, which causes the host's body (i.e. the recipient of the vaccine) to produce a protein - a small piece - of the virus . After producing it, the body recognizes it as foreign and prepares an immune response to counter it: in this way it will be ready to face the whole virus if and when it encounters it. To be more stable, the messenger rna is transported in the organism packaged inside lipid nanoparticles. The preparation also contains a mixture of sugar, salt and fat to make it possible to dispense it by intramuscular injection. Almost the same speech for Moderna's vaccine (here its public data sheet), which contains, in addition to the messenger RNA, the usual lipid nanoparticles, sugar and salts.

As for the AstraZeneca vaccine, what is he knows at the moment is that it is a weakened and unable to replicate version of the cold virus (an adenovirus, to be precise) taken from chimpanzees and engineered to contain instructions for the production of the Sars-Cov-2 spike protein.

5. How do we know it will work?

Clearly we are not absolutely sure. But all the information we have gathered so far bodes very well. Let's think of Pfizer's vaccine, for example. As already mentioned, it is a messenger rna vaccine, the first ever approved for human use. To suggest that it could be an excellent weapon against Covid-19 are the results of phase 3 clinical studies, the last stage of the research, disclosed by the pharmaceutical company in mid-November.

The experimentation involved about 43 thousand participants and, according to what Pfizer said, it was declared closed when 170 cases of Covid-19 were observed, of which 162 in the control group (i.e. among people who received only a placebo) and 8 in the vaccinated group. These, in short, the results, evaluated one month after the first dose and one week after the second: the vaccine is 95% effective in all the groups considered, without differences in age, sex and ethnicity. Even among people over 65, the effectiveness would be over 94%, which bodes well, given that with advancing age the immune response and the production of antibodies are less efficient (this is the so-called process immunosenescence).

The vaccine has also been confirmed to be safe and well tolerated: the only severe and recurrent adverse reactions in more than 2% of cases concern fatigue (in 3.8% of the participants) and headache (in 2% of participants). The results were then also definitively published in a peer-reviewed journal (the prestigious New England Journal of Medicine) and confirmed a very high efficacy range, ranging from 90.3% to 97.6%. The information was finally passed to the scrutiny of the regulatory bodies of the United States, the United Kingdom and the European Union, which, as mentioned at the beginning, gave their positive opinion for the administration of the vaccine.

After the start of the Inoculations have been reported, in rare cases, adverse reactions of the allergic type, and at the moment the scientific community is trying to understand what is the factor that triggers them: one possibility, as we have told you, is that the immune system is overexcited polyethylene glycol (Peg) nanoparticles that surround the messenger RNA contained in the vaccine. But it is a hypothesis yet to be verified.

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Topics

Coronavirus treatments Covid-19 Vaccines Vaccine coronavirus vaccine Oxford Pfizer BioNTech vaccine globalData.fldTopic = "Coronavirus, Covid-19 therapies, Vaccines, Coronavirus vaccine, Oxford vaccine, Pfizer BioNTech vaccine"

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