World COVID-19: The effectiveness of the Janssen vaccine questioned

11:10  14 september  2021
11:10  14 september  2021 Source:   lexpress.fr

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A: Janssen COVID - 19 Vaccine is authorized to prevent coronavirus disease 2019 ( COVID - 19 ) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older. Specifically, as of April 21, 2021, 15 cases of thrombosis with thrombocytopenia following Janssen COVID - 19 Vaccine have now been confirmed, involving cerebral venous sinuses and other sites in the body (including, but not limited to the large blood vessels of the abdomen and the veins of the legs) and these have been associated with three deaths.

The Janssen COVID - 19 vaccine or Johnson & Johnson COVID - 19 vaccine is a COVID - 19 vaccine that was developed by Janssen Vaccines in Leiden, Netherlands, and its Belgian parent company Janssen Pharmaceuticals, subsidiary of American company Johnson & Johnson.

with an abnormally high rate of vaccinated patients in Janssen but admitted to the hospital, the serum of the Johnson & Johnson laboratory will be the subject of additional investigations.

Les premières injections du vaccin Janssen ont eu lieu en France le 24 avril 2021 © AFP.com/jorge Guerrero The first injections of the Janssen vaccine took place in France on April 24, 2021

Will Janssen vaccine live the same fate as Astrazeneca? The effectiveness of the Johnson & Johnson laboratory vaccine calls for health authorities. In an report unveiled on Monday, the National Health and Medicine Agency (ANSM) notes a "important number" of cases of failure of the Janssen vaccine in France, which works with a single dose, questioning the Effectiveness of the vaccine, including the Delta Variant.

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J&J's Janssen COVID - 19 vaccine is a viral vector vaccine that requires only 1 shot. Learn about safety data, efficacy, and clinical trial demographics. This translates to a rate of about 8 fainting events for every 100,000 doses of the J&J/ Janssen COVID - 19 Vaccine given. These events occurred during the recommended 15-minute wait after vaccination . It’s not clear at this time whether these events were associated with the vaccine or with anxiety, possibly related to preexisting concerns some people who chose to get the one-dose J&J/ Janssen COVID - 19 Vaccine may have about needles or

Reports after the use of J&J/ Janssen COVID - 19 Vaccine suggested an increased risk of a rare adverse event called thrombosis with thrombocytopenia syndrome (TTS). Most reports of this serious condition, which involves blood clots with low platelets, have been in adult women younger than 50 years old. However, women younger than 50 years old especially should be aware of the rare but increased risk of this adverse event, and they should know about other available COVID - 19 vaccine options for which this risk has not been seen. CDC and FDA continue to monitor the safety of all

"A significant number of Janssen vaccine failure cases has been reported, including serious forms (death, resuscitation) as well as a surrepresentation of patients vaccinated by Janssen in resuscitation in two CHUs", in Marseille and Tours, Note ANSM in its periodic vaccine monitoring report.

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since April, about one million injections of this vaccine (the only one to be administered with a single dose) have been carried out in France. Of all these vaccinated people with Janssen, 32 CVIV-19 infection cases have been reported at (a rate of 3.78 per 100,000).

An excessive proportion of hospitalized

on these 32 cases, 29 were serious and 4 deaths were recorded (persons aged 73 to 87). These severely affected patients presented "mostly comorbidities at a serious risk", according to the ANSM. For the 17 cases of infection where the variant is known, it was each time from the delta variant.

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Janssen ’s COVID - 19 Vaccine Status >. Menu close. Janssen global change location >. The authorization or approval status of Janssen ’s COVID - 19 vaccine varies by country. Unless approved or licensed by the relevant health authority, the product is investigational and its safety and efficacy have not been established.

The Janssen COVID ‑ 19 Vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized by FDA through an Emergency Use Authorization (EUA) for active immunization to prevent Coronavirus Disease 2019 ( COVID ‑ 19 ) in individuals 18 years of age and older. The emergency use of this product is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of the medical product under Section 564(b)(1) of the FD&C Act

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In addition, two hospitals reported an abnormally high number of vaccinated patients with Janssen among hospitalized people in resuscitation despite vaccination. In Marseille, on seven fully vaccinated patients but still admitted to Réa (that is, four of them had been with Janssen. In Tours, this proportion was three out of six. For the ANSM, "this significant proportion of serious cases could be explained by the message of the DGS of [August 3, 2021], to report serious cases of vaccination failure".

No signal on

deaths, on the other hand, on adverse effects, including cases of thrombosis, facial paralysis, stroke, or convulsions, the health authority is rather reassuring.

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If almost half of the side effects identified "have occurred on the same day of vaccination", these cases "are isolated and not evocative of the role of the vaccine (identified risk factors, incomplete etiological balances)." In addition, "to date, there is no particular signal regarding deaths reported in France with the Covid-19 Janssen vaccine," concludes the ANSM.

Towards a new dose after the Janssen

All these elements justify "additional investigations" to check if the failures are more important with Janssen than with the other vaccines available in France.

Faced with the Variant Delta Variant, the High Health Authority has also recommended at the end of August for people vaccinated with Janssen, a second dose of RNA messenger vaccine (Pfizer or Moderna). In fact, there is indeed on long-term effectiveness that is not yet proven due to lack of data.

Several real-life studies showed that the first dose of Pfizer or AstraZeneca vaccine did only protect against the Delta variant. No data on this point is available for Janssen, but the has had judged probable that it is also the case.

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