The US Food and Drug Administration, a drug regulatory body, gave the green light in recent days to the administration of a second dose of Johnson & Johnson vaccine two months after the first, aged 18 and over.
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The decision is based on immune response data in 39 participants in a clinical study (24 people aged 18 to 55 and 15 people aged 65 and over). Study participants received a booster dose approximately 2 months after the first dose, and the results demonstrated an immune response. Overall, approximately 9,000 clinical trial participants received two doses of Janssen administered at least two months apart and of these, approximately 2,700 had at least two months of safety follow-up after the booster dose. Janssen’s safety analyzes from these studies have not identified any new safety concerns, the FDA said in a statement.
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The booster in the United States can be done either with a second dose of Janssen vaccine or in heterologous mode with one of the two available mRna vaccines (Pfizer / Comirnaty or Moderna / SpikeVax). A similar ruling from the European regulatory agency Ema is expected shortly. In Italy 1,844,952 people were vaccinated with Janssen: this is what is stated in the report of the extraordinary commissioner for the health emergency.
“The J&J vaccine is one of the adenoviral vector vaccines, like that of Astrazeneca, single-dose. A review process is underway by the FDA and subsequently there will certainly also be Ema, if indications arrive, as is widely possible, to administer a second dose: a messenger RNA vaccine would also have the advantage of an even better immunological response “like Pfitzer or Moderna. This was stated by the president of the CSS and coordinator of the CTS Franco Locatelli during the broadcast ‘Che Tempo Che Fa’ on Rai3.
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Of the same opinion Walter Ricciardi, advisor to the Ministry of Health, in an interview with Messaggero: “I am convinced that we will administer the third dose to all groups of the population. After six months from the second for those who have been immunized with mRna vaccines, after two months for who was protected with a single injection of Johnson & Johnson, at least this is the indication of the Fda, the American agency “.
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“Probably the third dose will be necessary for everyone” and with precedence to those who have made the Johnson & Johnson vaccine “who will need a booster at short notice”. But “within the year we will proceed to administer the third dose for the elderly and healthcare personnel. Then from January to the rest of the population, staggered according to when the first and second dose was administered”. The Undersecretary of Health said so Pierpaolo Sileri, its Capital Radio.
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