Usa call for suspension of the Johnson & Johnson vaccine

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April 13, 2021 The United States calls for a suspension on the Johnson & Johnson vaccine after a few cases of clotting.

The New York Times reports it stressing that the Food and Drug Administration and the Centers for Disease Control will stop using the vaccine at federal sites and will urge states to do the same pending investigations into safety problems.

The suspension is linked to six cases in the United States who developed a rare disease involving blood clots in the two weeks following vaccination.

In all cases, these are women between 18 and 48 years old.

One woman has died and another is hospitalized in serious condition in Nebraska. 

Nearly seven million people in the United States have received Johnson & Johnson doses so far, and about nine million more doses have been shipped to the United States, according to data from the Centers for Disease Control and Prevention.

"Today the FDA and @CDCgov released a statement regarding the Johnson & Johnson vaccine for COVID19. We recommend a pause in the use of this vaccine for abundant caution," the Food and Drugs Administration announced on Twitter.

A press conference on the affair was announced for 10 am US time (4 pm in Italy).

Today FDA and @CDCgov issued a statement regarding the Johnson & Johnson # COVID19 vaccine.

We are recommending a pause in the use of this vaccine out of an abundance of caution.

- US FDA (@US_FDA) April 13, 2021

I wouldn't stress that Johnson & Johnson is a single-dose vaccine.

At the moment it has been studied as a vaccine that is given a single dose and we know that it gives protection 14 days after administration, we do not know how long it lasts, it could very well be that a booster is needed later, there are studies that are evaluating it.

In the meantime, however, we can begin to vaccinate. "So on Buongiorno, on Sky TG24, Armando Genazzani, Member of the Committee for Medicinal Products for Human Use of EMA." In Ema and Aifa we believe that the intervals studied in the clinical studies, of 21 and 28 days, are the optimal ones because we have data on those - he explained -.

In clinical trials it is not always possible to have a booster on the exact day and there are patients who have been treated for a little longer or less.

There are also patients who were treated at 42 days.

From a scientific point of view I don't think that reaching 42 days between two dosages should become the norm, but I believe it is possible.

At the moment, moreover, from a biological plausibility point of view, the dose extension could even lead to an increase in the antibody response.

It must not become the norm but, in a difficult moment in which we do not know when the doses will arrive, we can start, then if they arrive we will give them in the right time. " 

Finally, as regards the possibility of using different vaccines for the first and second dose, underlines Genazzani , "at the moment we have no data on this, there are some countries, such as Germany, that are studying the possibility of using adenovirus as the first dose and an mRna vaccine as a second dose.

There is a biological plausibility that booster with a different vaccine may work but I would recommend waiting for the data before doing so. "