While in China on March 29th we witness the biggest lockdown ever The US Food and Drug Administration has approved a new booster dose of PfizerBioNTech or Moderna vaccines: Basically he extended the fourth dose to everyone over 50.
Why take the fourth dose
Making one available is the stated goal of the new US strategy second booster dose to other populations at higher risk of serious illness, hospitalizations, and death. In fact, mounting evidence suggests that a second booster dose of a Covid mRNA vaccine improves protection against severe Covid and is not associated with new safety concerns.
WhileAlert for the arrival of new, more contagious and dangerous variantscurrent evidence suggests some decrease in protection over time against severe COVID19 in elderly and immunocompromised individuals.
Based on an analysis of the resulting data, a A second booster dose of either Pfizer or Moderna vaccines could help increase the level of protection for these highrisk individualssaid Peter Marks, director of the FDA’s Center for Biological Evaluation and Research.
In addition, the data shows that an initial booster dose is crucial to protect all adults from the potentially serious consequences of Covid (here the discovery that Covid can shrink the brain, here the new omicron symptoms identified). For this reason, those who have not received the initial booster dose are strongly advised to do so.
How safe is the fourth dose
The FDA has determined that the known and potential benefits of a fourth dose of the vaccine outweigh the known and potential risks in this type of people. Evidence considered for approval of a second booster dose after the primary series and the first booster dose included safety and immune response information provided to the agency and additional efficacy information submitted by Pfizer and Moderna.
A summary of safety monitoring data for the fourth dose Pfizerthe FDA from the Israeli Ministry of Health after administration at approx 700,000 people at least 4 months after the third dose in adults 18 years and older (About 600,000 of them were 60 years or older), They revealed no new security issues.
The safety of the vaccine Modernwhen administered as a second booster dose, was demonstrated by an independently conducted study in which the preparation was administered as a second booster dose 120 participants aged 18 and over who had received a twodose primary series and a first booster dose of Pfizer’s vaccine at least 4 months previously. No new safety concerns were reported during the followup period of up to three weeks after the fourth dose.
Immunogenicity data collected from an ongoing clinical study involving healthcare professionals at a center in Israel were also reported in a publication made available to the FDA.
In this study, subjects 18 years and older who received the primary series and a first booster received a second booster dose of either Pfizer (154 subjects) or Moderna (120 subjects) at least 4 months after the first booster.
Among these people Increases in antibody levels were reported 2 weeks after the second booster dose Neutralization against SARSCoV2 virus, including Delta and Omicron variants, compared to 5 months after the first booster dose.
Who should take the fourth dose in the US and when?
but who have to do the fourth dose in the USA? Here’s the details:
- Subjects aged 50 and over at least 4 months lateror have received a first booster shot (i.e. the third dose, so to speak) of an approved or approved Covid vaccine
- a second booster dose of Pfizer vaccine may be given a Individuals 12 years and older with certain types of immunodeficiency at least 4 months later have received a first booster dose of an approved or approved Covid vaccine. These are people who have had solid organ transplants or who are living with conditions thought to have an equivalent level of immunodeficiency
- a second booster dose of Moderna vaccine may be given to subjects 18 years or older with the same specific types of immunodeficiency at least 4 months later the first booster dose of an approved or approved Covid vaccine.
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Extension of the fourth dose also in Italy?
And in Italy? Who makes the fourth dose? As we know, from Friday April 1st, the roadmap for the end of restrictions starts in our country (here all the data to be collected), but the discussion is open. The Covid emergency is not over, the strategy to deal with it has only changed.
In our country there is already a clear indication from the Ministry of Health who should take the fourth dose. But back on topic, after the spike in infections over the past few days, this Minister Roberto Speranza He clarified that “when we talk about the fourth dose, we are not talking about the fourth dose for everyone, only for the most vulnerable groups, who are the ones who risk paying a higher price if they encounter the virus “.
The fourth dose is not currently intended for everyone. “There is no country in the world that provides the fourth dose for everyone,” but “there is an ongoing discussion” about the categories to which it should be administered, he explained, indicating that it was himself it “promotes” this discussion primarily at European level so that there are no diverging decisions between different European countries about a fourth dose for the vulnerable population.
So far, only immunosuppressed people in Italy have to undergo the fourth dosebut the government is considering the possibility of extending it to older people as well. “Therefore, if it is decided in Italy to extend the fourth dose of the antiCovid vaccine, it will affect groups of the elderly population, which must be defined on the basis of the indications expected from Europe,” he told Radio Anch’io “Clear on Rai Radio 1.
We shall see what it means for older people to be over 80, over 70 or over 75. There are different hypotheses that different countries are thinking about. Speranza asked the European Commission to make a clear statement “because it makes no sense that they say 70 years in Berlin and 80 years in Paris. As a European community, we must make a common decision.