Green light to the third dose for the anti-Covid vaccination by the Italian drug agency (Aifa). In fact, a positive opinion would be ready. Priority will be given, in a first phase, to immunosuppressed subjects, transplanted, elderly people, guests of the Rsa and health professionals at greater risk (for example if they are active in Covid departments).
For boosters the choice would fall on vaccines a mRna, namely Pfizer and Moderna vaccines. The third booster dose of the anti-Covid vaccine should be administered, according to what is learned, “at least after 28 days” from the second dose for immunosuppressed and transplanted subjects, “at least after six months” for the other categories indicated.
There are 5,522 Covid-19 cases ascertained in the last 24 hours in Italy with 291,468 molecular and antigenic swabs carried out (301,980 were carried out yesterday). The positive / swab ratio remained stable at 1.9% (yesterday 2%). There are 59 deaths registered today, which brings the total count to 129,766 deaths since the beginning of the pandemic. The number of patients admitted to intensive care is also stable (today there are 6 fewer, 558 total), and that of hospitalized patients with symptoms, 5 fewer than yesterday (there are 4,230 in total).
We will start with “the most fragile, those who after two doses do not have a sufficient response” underlined the Minister of Health Roberto Speranza announcing that “in the next few hours there will be a circular from the head of the Prevention Department of the Ministry of Health, Gianni Rezza, who will indicate exactly what these categories are ”.
The Technical Scientific Commission (Cts) of Aifa “expressed its opinion on the administration of additional doses of vaccine against Covid-19” and considered “it appropriate, pending Ema’s authorization, to make Comirnaty vaccines available (Pfizer ) and Spikevax (Modern). This was underlined by a note from the Italian Medicines Agency. The CTS, “responding to the questions posed by the Ministry of Health” noted “that the priority of the vaccination campaign remains the achievement of a high vaccination coverage with the completion of the cycles currently authorized to reduce the circulation of the virus and the development of variants and effectively prevent the onset of serious pathology and deaths “.
The CTS has established that the ‘additional dose’ of Covid vaccine will be administered “at least 28 days after the last administration, to complete the vaccination cycle in adults and adolescents over 12 years of age (Comirnaty vaccine) or over 18 years ( Spikevax vaccine) in conditions of clinically relevant immunosuppression. Solid organ transplant recipients and subjects presenting, on the basis of clinical evaluation, an assimilable level of immunocompromise fall into the aforementioned category “.
While as a ‘booster’ dose “in order to maintain an effective immune response to the vaccine after the completion of the vaccination cycle” it will be administered “at least 6 months after the last administration, in the elderly (over 80 years old) and in patients hospitalized in RSA – continues the note – This option can also be made available to health professionals, depending on the level of exposure to the infection, the individual risk of developing severe forms of Covid-19 and in accordance with the general strategy of the vaccination campaign “.
“As an additional dose, one of the two m-Rna vaccines authorized in Italy (Comirnaty * and Spikevax *) should be administered. If a first vaccination with adenoviral vaccine has been performed or if the same m-Rna vaccine used for the first two doses is not available, an additional ‘heterologous’ dose may be used with the different type of vaccine. to m-Rna. Based on current knowledge, the recommended dosage for the booster dose is the same as the authorized dosage for the primary cycle ”, it is also known. “The additional dose – it is highlighted – should be administered at least six months after the last dose”.
The European Medicines Agency (EMA) has also given the “green light”, leaving the final choice to individual governments. EU states can start with the third dose of the covid vaccine even before EMA, the European drug agency, expresses itself. “The Member States of the European Union, through their national technical advisory groups on immunization (Nitag), can however proceed in planning campaigns for the administration of additional doses or ‘booster’ doses” of the anti-Covid vaccine, “as a proactive measure of public health, even before a regulatory decision is made. This type of choices are fully understood by the agency in the emergency context in which we are ”, explained Marco Cavaleri, head of Vaccines and Therapeutic Products for Covid-19 of the European Medicines Agency EMA, during a press briefing.
“The number of antibodies halves approximately in three months” explains Andrea Mengarelli, head of the hematology unit of the Regina Elena Oncology Institute in Rome, La Repubblica. “In our patients, the immune system is less efficient. The levels were not high from the start. Today we have fallen to values that may be insufficient ”. In the case of frail people, therefore, the third dose seems very important.