“The third dose will be in Italy, we will start as early as September with fragile patients such as oncologists or transplanted patients. Ema and Ecdc have already expressed themselves on this point. So already in the month of September these first third doses will start in Italy, then we will analyze to continue with the over 80 and RSA residents and health personnel, who are the first categories that have received the vaccine and from which one will start “. This was stated by the Minister of Health, Roberto Speranza, at the press conference at the conclusion of the work of the G20 Health in Rome.
«Young people are getting vaccinated more than other generations and this is a very nice message – added Speranza – Italy’s numbers are positive and important but we need to grow even more. There is an ongoing discussion, which will also take place in the next ones, which will lead us to decisions that will allow us to extend the vaccination campaign, I am thinking of the extension of the green pass and other hypotheses to strengthen the vaccination campaign “.
Third dose, Ema: “States can already prepare plans”
The European drug agency EMA has started evaluating the booster dose of Comirnaty (the anti Covid vaccine developed by Pfizer-Biontech) to be administered 6 months after the second dose in persons aged 16 and over. The booster doses, the so-called dosi booster (reinforcement), they are given to vaccinated people (i.e. people who have completed their primary vaccination) to restore protection when it decreases (i.e. when the level of antibodies falls). But states that want to start with the third dose can already do so. For this reason, “while the EMA evaluates the data, the Member States can already take them into consideration preparatory plans for the administration of boosters and additional doses“. The third dose is already in the plans of the Italian government. Prime Minister Mario Draghi said he was in favor and Minister of Health Roberto Speranza said that the administration of the third dose will start at the end of September: «We will start from fragile subjects and this indication has also come from the EMA and the CTS Scientific Technical Committee has already expressed its opinion in this sense ».
Pfizer, Ema evaluates third vaccine dose
EMA’s specific committee (the CHMP) will carry out an accelerated evaluation of the data submitted by Pfizer, the company that markets Comirnaty, including the results of an ongoing clinical trial in which approximately 300 adults with healthy immune systems received a booster dose. about 6 months after the second dose.
The CHMP will recommend whether updates to the product information are appropriate. The result of this evaluation is expected within the next few weeks, unless additional information is needed.
In addition, the EMA is also evaluating the available data on the use of an additional third dose of an mRNA vaccine (Comirnaty or SpikeVax) in severely immunocompromised people (i.e. with a weakened immune system). People with severely weakened immune systems who do not achieve an adequate level of protection from their standard primary vaccination may indeed need an “additional” dose. The EMA will also communicate the result of these assessments in due course.
While these assessments are ongoing, EMA and the European Center for Disease Prevention and Control (ECDC) have already spoken out about the need for additional doses and boosters of Covid-19 vaccines. Although the EMA and ECDC do not believe that the need for booster doses of the Covid-19 vaccine is urgent in the general population, this request is being considered to ensure that evidence is available to support further doses as needed.
The same agency writes in a statement on its website that: «Advice on how vaccinations should be administered remains the prerogative of the National Immunization Technical Advisory Groups (NITAGs) that lead vaccination campaigns in each EU Member State. While the EMA evaluates the relevant data, Member States can already consider preparatory plans for the administration of boosters and additional doses».
In Italy, Prime Minister Mario Draghi, when asked about the advisability of administering a third dose, when approved by the EMA, replied that it would be favorable.