Rome, May 4, 2021 – The administration of the Janssen vaccine, from the Johnson & Johnson group, has begun throughout Italy for days: it is the fourth vaccine available in Italy to prevent Covid-19, the first single-dose, in the sense that it has a gear moreover, as, in addition to evoking an almost immediate response, generates long-term antibody memory, unlike the others, which require a second booster dose to achieve the purpose. To date 336,800 doses of the J&J vaccine have been delivered in Italy (provisional figure) and 7 million and 300 thousand doses are expected in the second quarter of this year, therefore by the end of June (source press office of the commissioner structure, General Figliuolo). This vaccine is suitable for everyone, over 18 years, as specified on the Aifa website (https://www.aifa.gov.it/domande-e-risposte-su-vaccini-vettore-virale).
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“The results of the Ensemble study on Covid-19, published in the New England Journal of Medicine show that a single administration is enough, and the Johnson & Johnson single-dose vaccine offers a high level of activity on all variants in the studied regions ”. This is the message of Mathai Mammen, head of research and development at Janssen, the pharmaceutical company engaged in research, also in Europe. “These data – wrote the illustrious doctor, a Harvard graduate – support the important role that the vaccine can play in helping to tackle the pandemic”.
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Meanwhile, the push and pull on the distribution continues. The technical commission of the government Canadian recommended the Johnson & Johnson vaccine for people over 30. Experts from the National Advisory Committee on Immunization explained that the J&J vaccine is highly effective in preventing severe infections and hospitalizations caused by the Sars-Cov2 virus, while acknowledging that there have been 17 cases of thrombosis out of over eight million doses administered in the United States. an infinitesimal number on probably predisposed subjects. More prudent is the (isolated) position taken by Denmark, which following the very rare cases of clots found, as already happened for AstraZeneca, decided to exclude the serum from prophylaxis. WHO considers this product to be one of the best so much so that it recommends it for mass vaccinations.
“The inhomogeneity between the Italian regions on the administration of vaccines is being reduced,” he said Pierpaolo Sileri, Undersecretary of Health. “The controversy over Astrazeneca and Johnson and Johnson they have led to a kind of distrust in some areas of the country ”. But Commissioner Figliuolo was clear: ahead with the vaccines authorized at European level, it is time to hasten the pace to protect our society from the risk of infection. From the opinions we return to the facts that lead us to prefer the J&J vaccine, now distributed in Europe. So it means that, at present and without further AIFA specifications, the serum can be administered even under the age of 60, from 18 years on.
Johnson & Johnson’s single-dose Covid-19 vaccine prevents hospitalization and death, it did so in all participants in the Ensemble study, 28 days after vaccination. It has proven to be effective against severe / critical forms already seven days after vaccination, with efficacy that continues to increase eight weeks after administration. Experiments on adolescents are underway, and the authorization to extend coverage to very young people is seen as a crucial step towards achieving herd immunity in a short time.
The vaccine has also been shown to be effective against symptomatic infection in a linear fashion, including in South Africa and Brazil where there was a high prevalence of rapidly emerging SARS-CoV-2 variants. These data demonstrated that despite the high prevalence of emerging variants, including the South African B.1.351 strain and the P2 strain variant identified in Brazil, the efficacy of the vaccine was cross-cutting against symptomatic infection, and the vaccine has been shown to prevent hospitalization and deaths regardless of geographic origin, ethnicity of the tested subjects, regardless of age and other factors.
Data from the Ensemble study showed that Johnson & Johnson’s single-dose Covid-19 vaccine was 85% effective against severe / critical forms of the disease. In addition, the study achieved 67% efficacy at 14 days and 66% efficacy at 28 days after vaccination. Protection was transversal between ethnicities and age groups, including adults over 60. According to what was found, out of 3,000 participants followed for 11 weeks and another 1,000 participants followed for 15 weeks. Reactogenicity (reaction to vaccination) was greater with the Johnson & Johnson COVID-19 vaccine than with placebo, but reactions were generally mild to moderate and transient.
Studies pass and the overall risk-benefit profile remains positive. Therefore, Johnson & Johnson will update the Summary of Product Characteristics and the Package Leaflet of the Covid-19 vaccine to include updated information on the diagnosis and management of any thrombosis, adverse event very rare. Following the recommendations of the PRAC, the Company will resume the shipment of the Janssen vaccine against COVID-19 to the European Union (EU), Norway and Iceland.
Johnson & Johnson’s single-dose vaccine against Covid-19 is already being administered in Italy. Compatible with standard storage channels and distribution of vaccines, is distinguished by ease of delivery to remote areas. The vaccine is estimated to remain stable for two years at -20 ° C, and for up to three months at ordinary refrigeration temperatures of 2 to 8 ° C. The company will ship the vaccine using the same cold chain technologies it currently uses to transport other medicines. The COVID-19 vaccine should not be refrozen when dispensed at temperatures of 2 to 8 ° C.
Can we trust them?
Johnson & Johnson’s COVID-19 vaccine leverages the AdVac vaccine platform, a proprietary technology that was used to produce Janssen’s European Commission-approved Ebola vaccine regimen and to build its experimental Zika vaccines. , RSV and HIV.
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