The administration of the single-dose vaccine restarts after 11 days off Johnson & Johnson in the United States. The decision was made by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA), after the opinion of an independent commission.
Updated indications
There is something new: by accepting the recommendation of the panel of experts, the FDA has updated the product instructions, warning women under 50 of the risk of thrombosis, albeit remote. The injections in the US had been suspended after 15 cases of thromboembolism, of which 13 in women between 18 and 49 years: the link with the vaccine was defined plausible and the age group at risk for women would be between 30 and 39 years. We concluded that the recognized benefits of the vaccine outweigh the known and potential risks in individuals aged 18 and over. Janet Woodcock, interim commissioner of the FDA -. We are convinced that this vaccine continues to meet our safety standards. The pharmaceutical company was fully available to change the label. We will also indicate the possible symptoms – reassured the head of the medical area, Joanne Waldstreicher -, so that they can be immediately identified, diagnosed and treated. Those who have had episodes of thrombosis have reported, within three weeks of vaccination, severe headache, abdominal pain, leg pain and shortness of breath. So far nearly 8 million doses of J&J have been administered in the US (with 3 deaths and 7 hospitalizations): another 9.5 million are ready to be distributed and injected as early as this weekend.
The doses for Italy
In Italy, the first injections of the single-dose vaccine were made on Thursday, after the green light from Ema (European Medicines Agency) and Aifa (Italian Medicines Agency): the Ministry of Health with a circular recommended the use preferably in the over 60, as for AstraZeneca, but the EMA has not indicated age limits. With the entry of Johnson & Johnson, the vaccination campaign accelerates, aiming at the goal of 500 thousand daily administrations by the end of April. 15 million doses are expected from J&J by May. The president of Johnson & Johnson assured me that a further supply of 380,000 doses will arrive by the end of April, said the emergency commissioner Francesco Paolo Figliuolo. The great advantage of this vaccine, based on a viral vector like AstraZeneca, is that it is single-dose. Therefore, the recall is not necessary. A feature that makes it particularly “palatable”: in Tuscany the 11 thousand doses made available to over 70s on the booking portal are sold out in 21 minutes.
The efficacy data
Not only. According to phase 3 data, published in the New England Journal of Medicine, J&J vaccine works against Brazilian (P2) and South African (B.1.351) variants. The study enrolled 19,630 participants who received the vaccine and 19,691 who received a placebo. It has been seen that protection begins after the seventh day from inoculation and continues to increase even after 8 weeks. In South Africa, vaccine efficacy was 64% against moderate to severe forms of the disease and 81.7% against severe forms (on the 28th day after vaccination). In Brazil 68.1% efficacy against moderate to severe forms of the disease and 87.6% against severe forms 4 weeks after injection. Overall, the vaccine is 85% effective in preventing severe disease, 100% effective in preventing hospitalizations and deaths.. Cross protection in the various age groups, including adults over 60 and those with comorbidities (previous illnesses).
April 24, 2021 (change April 24, 2021 | 16:29)
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