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Johnson & Johnson vaccine, possible recall for everyone soon

A few days ago came the approval of the booster with the Moderna (third dose) or Johnson & Johnson (second) vaccine by the US FDA. The European Ema is expected shortly. Meanwhile, the experts are beginning to prepare the field: whether for those who have completed the cycle with an mRna vaccine or with AstraZeneca the third dose still remains an open question (net of those who, from the frail to the sanitary ones, are already proceeding and at a good pace), the million and a half of Italians vaccinated with the single-dose Janssen will in all likelihood undergo a recall as soon as possible. Starting two months after the injection. Considering that that product has been excluded from the vaccination campaign for a long time, substantially all vaccinated with Johnson & Johnson, as soon as Ema, Aifa and the ministry proceed in this direction, they will be in a position to be vaccinated. Contrary to the others, therefore, even those under 60.

Franco Locatelli, president of the Superior Health Council, explained on Sunday a What’s the weather like on Rai3 that J&J «is a viral vector vaccine, like Astra Zeneca, which has obtained approval from regulatory agencies for a single single-dose administration. Now there is news of a review process by the FDA, later there will certainly also be by Ema. If there are indications on the possibility of administer a second dose with a messenger RNA vaccine, it would have the advantage of inducing an even better immunological response. These people will be called, there is a very precise vaccination registry. Administering over two months does not compromise efficacy. As soon as the indications of the regulatory agencies arrive everything will be done quickly».

It had been yesterday Walter Ricciardi, advisor to the Minister of Health Roberto Speranza, to return to the point: «The Fda – said a Republic – has just approved the booster dose for both those who have been vaccinated with Moderna and for those who have had Johnson and Johnson, but while for the immunized Moderna the booster (as for Pfizer) is expected at least six months after the second administration, for recent Johnson studies have found that, being a single-dose, already after two months the effectiveness of the protection decreases significantly, especially with the Delta variant. It is therefore necessary that those who have opted for this vaccine, being less protected, carry out the booster dose “. While the FDA has authorized the third emergency dose for people over 65, or for people aged 18 to 64 at high risk of contracting Covid-19, the authorization for Johnson & Johnson applies to everyone aged 18 and over. Here the official pronouncement of the FDA.

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In all likelihood, therefore, although Ricciardi says he is convinced that in the end the third dose will be administered to everyone, at the moment the scenario that is taking shape is the following: third dose for those over 60 or the immunocompromised of any age for those who have received Moderna, Pfizer or AstraZeneca, as is already being done in Italy, and second dose – always heterologous, therefore with one between Pfizer and Moderna – for all vaccinated with Johnson & Johnson, which will be authorized shortly after the green light from the European and national authorities. Finally, from next year it will be assessed, also on the basis of autumn and winter numbers, whether the third dose is also necessary for the rest of the population that has received mRna or AstraZeneca vaccines..

“The evidence tells us that the third dose is certainly recommended for people who have connotations of frailty or for personal reasons or concomitant pathologies – explained Locatelli – I would call this additional dose for immunosuppressed subjects (here we had explained precisely what Locatelli means, at). We have evidence that with the third dose half of those who did not respond, because they were taking immunosuppressive therapy to prevent rejection in the event of an organ transplant, then reacted better ». At the moment “there is a booking system widely available for the over 60s, then there is the possibility over time that we will be able to consider it also for the youngest».

A vial of Hanssen vaccine (Photo by JOSEPH PREZIOSO / AFP via Getty Images)

JOSEPH PRECIOUS

Masks indoors, hand washing e distancing remain fundamental, especially with the autumn season ready to go live: «The Italian situation is far more favorable than that of other countries, even compared to Germany, in terms of viral circulation. All this did not happen by chance – added the president of the CSS – it is the result of one of the highest percentages of vaccinated subjects in the vaccinable population. Also because we have had a gradual reopening. When, as technicians, the importance of gradualness was emphasized, it was not to negatively impact the lives of Italians, but to avoid risks. Finally, it is important to maintain non-pharmacological measures: mask, hand washing and spacing. All things that have been abandoned in the UK ».

Soon the anti Covid-19 vaccine will also touch the people children: always the Fda has recently confirmed the effectiveness of Pfizer: 90.7% in the prevention of symptomatic Covid-19 in a clinical study of 2,268 children aged 5 to 11 years. For children, one third of the dose intended for over 12s and adults is enough 10 micrograms per injection (with two injections given three weeks apart) compared to 30 for adults. There are no risks of serious side effects and the US authority explains that it has “balanced the dangers of hospitalization and death or other serious consequences of Covid with the risk of myocarditis, concluding that the clinically significant situations related to Covid have clearly exceeded the number of cases of excess myocarditis associated with the vaccine “. If the authorization comes during an Advisory Committee meeting scheduled for this week, in the United States it will start in November with injections among the under 12s.

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