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Covid vaccine, a serological test before the third dose

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The current situation in Italy is certainly not comparable to that experienced in the same period last year, nor to that of the remaining European countries. This improved condition is the effect of the efficacy of the vaccine and the greater adhesion observed in Italy compared to the rest of Europe. However, the onset of a fourth wave is evident, with an observable worsening of all indicators (cf. percentage change in new cases, deaths, hospitalizations in intensive care and in the medical area, etc.), probably due to the stay in closed places as well as to the reduction (the so-called waning) of the protective efficacy of the vaccine.

Vaccination (as of 07/12, 45,809,339 people have completed the vaccination course, 1,625,497 are awaiting a second dose and 9,135,126 have received the dose booster) has avoided, at least so far, from exacerbating the restrictions again and a probable massacre caused by the spread of the Delta variant, saving about twelve thousand lives up to last June and has made it possible to resume about half of the social contacts existing before the Covid emergency. Of all this he was able “for free” (without, that is, having made any contribution) also the unfortunately large (about 6.5 million citizens eligible for vaccination), albeit a minority, audience of no-vax, which, on the contrary, undermined and continues to undermine the effectiveness of the vaccination campaign and the possibility of returning to a normal life.

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Il Super Green Pass

The current objectives are essentially two: to reduce the number of unvaccinated subjects as much as possible and to guarantee the 45 million vaccinated persons a reinforcement of protection (the third dose in fact). With regard to the first objective, measures have recently been adopted, such as the so-called Super Green Pass, which have certainly given a new impetus to the administration of first doses. However, while the third dose campaign is proceeding at a rapid pace (almost 80% of those who have completed the vaccination course for 6 months have already received the booster, 23% in the last week alone, at a pace almost of 3.5% of subjects “recalled” per day), the first doses trudge at a measly 0.5% daily (compared to the current audience of unvaccinated people), covering 3.2% of the audience in the last week.

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The obligation of the vaccine?

Probably these numbers should push for more decisive measures (from the obligation extended at least to the over 18s to the attribution of fines or costs to those who, after refusing the vaccine, should fall ill), considering also that it is these subjects that compromise the control of the pandemic rather than those involved in the third dose campaign. With regard to this last aspect, the official position is to define the need for this recall exclusively on a temporal basis: after 5 months from the second dose it is recommended to do the booster. However, several interesting elements emerge aimed at optimizing the dose vaccination campaign booster:

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I study

The results obtained in some rigorous and well-structured studies, in fact, could facilitate and support decision-makers to define a strategy that is as effective as possible and at the same time more sustainable in terms of financial resources. In this context, the results of a study conducted using the Health Technology Assessment method called Covidiagnostix, a project born in April 2020 and funded by the Ministry of Health with a Finalized Research call, which concerned the evaluation of serological tests according to the HTA method (as indicated, in April 2020, by the guidelines on diagnostic tests for Covid-19 by the European Commission). It was recently presented at the XIV SIHTA National Congress and at the Risk Management Forum in Arezzo.

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Covid Watch

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Vaccinate everyone

The ultimate conclusion of Covidiagnostix, deriving from the integration of all observable and measurable parameters (i.e. on the basis of the HTA), can be traced back to the identification of the ‘Test & Vaccine‘ strategy (i.e. to precede the third dose with a quantitative serological test) as the most performing one with respect to the ‘Vaccine strategy ‘, which plans to vaccinate the entire population identified as the target in the study without distinction (cf. over 60, frail and health and social health personnel).

Serological tests before the recall

Despite the absence of an antibody threshold shared by the scientific community, the only possibility of defining a differentiated calendar based on the test results (a subject with 150 BAU / ml certainly needs the booster more and with greater urgency than one with 2000 BAU / ml), turns out to be the ‘winning’ strategy capable of guaranteeing a higher reduction (%) of deaths (since subjects with lower protection would be vaccinated first, guaranteeing again, quickly, a more robust overall coverage of the community) and a reduction in adverse events from third dose (although already very rare) as a consequence of the absolute smaller number of subjects destined for the third dose, allows to reach the desired number of vaccinated in shorter times and using lower doses of supply doses overall, resulting in a consequent saving of resources both in terms of number of doses and better financial management of the budget.

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An economic saving

Depending on the scenarios (whose main variables are the Rt of the period, the daily administration capacity and the availability of doses, the degree of adhesion of the population), in fact, the optimization of financial flows could reach a few hundred million euros, which could subsequently translate into consolidated economic savings if the control and the waning of the pandemic make postponed administrations no longer necessary as they are not a priority.

* Professor Giuseppe Banfi, Scientific Director of IRCCS Galeazzi Orthopedic Institute, Milan – Principal Investigator Covidiagnostix research project
Professor Pietro Derrico is an engineer and lecturer at the University of Trieste, Past President of the Italian Society of Health Technology Assessment
The engineer Matteo Ritrovato, PhD, is secretary of the Scientific Technical Committee of the Italian Society of Health Technology Assessment

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