JANSSEN VACCINE. In its latest report, the ANSM lists several vaccination failures, including 4 deaths despite the injection of the Janssen vaccine.
[Mis à jour le 13 septembre 2021 à 17h43] In its new report published on Monday, September 13, the National Medicines Safety Agency reports several cases of vaccine failures after the injection of the Janssen vaccine. In detail, a total of 605 cases were analyzed by the CRPV reporters (Lyon and Grenoble). While the majority of the side effects are not serious such as discomfort, 32 cases of Covid-19 infection have been observed following vaccination with Janssen, including 4 deaths from the coronavirus. According to the report, those affected have a median age of 68, with multiple co-morbidities. The ANSM indicates that the “investigations are continuing”.
For the Janssen vaccine from Johnson & Johnson which concerns people over 55 years of age, a single dose is sufficient to be vaccinated and the vaccination schedule is considered complete four weeks later. So, by getting vaccinated on Tuesday July 13, you will get your health pass on August 10.
The side effects of Janssen’s vaccine appear to be similar to those of other vaccines. There is a risk of a serious allergic reaction, like the one seen once in South Africa. In addition, during clinical trials, pain at the injection site, headaches, fatigue and muscle pain were noted. According to information reported by Janssen’s Chief Medical Officer on the Phase 3 clinical trial, one of the the most common side effects after vaccination was fever (9% of individuals) this generally lasts between 24 and 48 hours. This side effect was generally moderate since only 2 people in 1000 (0.2% of vaccinated subjects) had a fever above 39 ° C “.
The ANSM has only 243 cases of side effects reported after an injection of the Janssen vaccine and “the majority of the side effects are non-serious, expected and with a favorable outcome” according to the latest report of July 23. The National Medicines Safety Agency (ANSM) draws attention to two points, including the contraindication to vaccination with Janssen for people with a history of capillary leak syndrome. She also reminds us about cases of thrombosis and thrombocytopenia that have occurred after vaccination, inviting those concerned to be attentive to the appearance of the second symptom when one of the two has been diagnosed: “People who have been diagnosed with thrombocytopenia. diagnosed within 3 weeks of vaccination with Janssen vaccine should be actively screened for signs of thrombosis. Similarly, people who develop thrombosis within 3 weeks of vaccination should be screened for of a search for thrombocytopenia. “
The agency recalls the risk of occurrence of Guillain-Barré syndrome, four cases have been reported in France since the start of the use of the vaccine, that is to say on April 24, but three of them presented a “favorable evolution “. The EMA recognizes since July 22 this syndrome as a rare side effect of the vaccine and counts 108 cases of the neurological syndrome in the world as of June 30 with one death. However, the European authority specifies “that the benefits of the Covid-19 Janssen vaccine continue to outweigh the risks of the vaccine”. As a reminder, Guillain-Barré syndrome is an attack on the peripheral nerves characterized by weakness or even progressive paralysis, most often starting in the legs and sometimes going up to reach the breathing muscles then the nerves of the head. and neck.
Regarding efficacy, Johnson & Johnson has indicated that its vaccine was effective at 66% in general: the results of phase 3 of their clinical trial reveal an effectiveness between 57% and 72% depending on the territories to prevent moderate forms and severe virus, 28 days after vaccination. Johnson & Johnson above all guarantees 85% reliable protection against severe forms, and “complete protection against hospitalizations and deaths linked to Covid-19”. The figures announced on January 30 in a press release are based on an extended study in eight countries and mobilizing more than 40,000 participants, including 468 symptomatic cases. Tested in different geographical areas, protection against Covid-19 infection is evaluated at the lowest in South Africa, where a more contagious variant of the virus is rife. The vaccine still offers an effectiveness of 57%, higher than the expectations of the World Health Organization, set at 52%.
“The Janssen remains quite effective against the South African variant, which is reassuring because there is good reason to believe, even if they are not the same variants – not quite the same mutations , even if there are common elements – that the level of protection should be rather good “, explained Alain Fischer. Despite everything, “with regard to adenovirus vaccines, Janssen specifically, there is no information yet,” explained the government vaccine man at the end of May.
The Janssen vaccine uses the principle of the viral vector, the specialty of the J&J group and already used against viruses such as Ebola. A fragment of the Covid-19 RNA is associated with an adenovirus to be injected into the patient. Human cells react to the fragment of Covid-19 to create antibodies, and a satisfactory and lasting immune response. Alex Gorsky, Chairman of the Board and CEO of Johnson & Johnson, confirmed in the statement: “Our goal has always been to create a simple and effective solution for as many people as possible and to have maximum impact to help end the pandemic “.
The first protective effects appear from the fourteenth day after injection and are gradually reinforced. But a question remains, that of the duration of the protection offered by the vaccine. J&J explained that he was unable to provide precise information but confirmed that he did not observe a drop in the number of antibodies before the first three months.
Telma Lery, medical director of infectious diseases at Janssen explained to the Journal des femmes: “To be able to assess long-term efficacy, all vaccine trials plan to follow volunteers for two years. . This will make it possible to observe whether this protection is stable over time or if it wears off, in which case it may be necessary to consider a booster. “For the three vaccines already on the market, the second dose aims precisely to consolidate the immune and neutralizing response.
Scientists are divided on this point: if Marie-Paule Kieny, president of the Covid-19 vaccine committee and research director at Inserm assures that “this is not a problem that seems prohibitive for Janssen’s vaccine, as much as with other vaccines, we do not know this duration either “, others believe that there is a risk of lack of protection.
Six cases of blood clots have been reported in the United States after an injection of the Janssen vaccine, as of April 13. This is two more than the figure given in the press release from the EMA and another from the United States Medicines Agency, both published on April 9. The six cases of thrombosis occurred in women between the ages of 18 and 48, and within six to thirteen days after vaccination, one of them died. “We recommend a pause in the use of this vaccine as a precaution” say Anne Schuchat, deputy director of the Center for Disease Control and Prevention (CDC) and Peter Marks, director of the Center for Product Evaluation and Research biologics from the Food and Drug Administration (FDA), in a joint statement repeated by The New York Times. Scientists admit all the same: “At the present time, these adverse events seem extremely rare.” The CDC and the FDA will cooperate to study the possible link between thrombosis and the vaccine. The FDA will decide based on the results whether vaccination with the Janssen product can be continued. In the meantime, the US government has decided to put the vaccination with Janssen’s product on hold.
The EMA clarified that the pharmacovigilance risk assessment committee is investigating these cases and that “regulatory action” will be taken if necessary. She plans to voice her opinion on the vaccine next week. The European Agency also recalled that the causal link between vaccination and the appearance of blood clots has not been established. The American laboratory spoke the same day to indicate that cases of thromboembolic incidents had been reported “with all Covid-19 vaccines”. Across the Atlantic, Washington has decided to suspend vaccine use.
The temporary suspension of the Janssen vaccine resembles the AstraZeneca affair that rocked Europe. The US health authority recommends a “pause” in vaccination using the product J&J, after the reporting of six cases of thrombosis. The symptoms are reminiscent of those suspected of being caused by the injection of the Anglo-Swedish vaccine, 79 cases of blood clots have been identified in Europe. In both cases, women under 50 seem to be more affected by the phenomenon.
The Janssen and AstraZeneca vaccines work using the same technique, that of the viral vector, with the only difference that Astrazeneca uses a chimpanzee adenovirus to create an immune response and Janssen a human adenovirus. Investigations by European and American health agencies seek to find out whether the method used may be the cause of blood clots associated with low platelet counts. Professor Odile Launay, director of the Cochin-Pasteur vaccinology center, makes a hypothesis in this direction:“This is probably an effect linked to the viral vector, which generates antibodies against platelets in an exceptional way “.
In the case of AstraZeneca, the European Medicines Agency has systematically reiterated that the risk-benefit balance is favorable to the use of the vaccine, even if a link between the vaccine and thrombosis is considered “possible”. This episode shattered citizens’ confidence in the Anglo-Swedish vaccine, which is struggling to find a taker. Doctors must use education to convince patients of the effectiveness and low risk of the vaccine. They fear that history will repeat itself with Janssen’s product.
The product developed by the American laboratory can be stored between 2 and 8 degrees for three months, which facilitates its transport and use. Vaccination centers but also doctors and pharmacists will therefore be able to build up a stock and administer doses.
Clinical trials have shown similar efficacy of this vaccine for all categories of the population, regardless of their age, origin or possible comorbid factors according to the various clinical trials conducted by the group. The High Authority for Health estimated, when the vaccine was approved that it could be administered to all people over 18, including those over 65 and those at risk of co-morbidities. However, the government has supervised the use of the vaccine for people over 55, in accordance with the vaccination schedule. The situation could change after the reporting of suspected thrombosis cases in the United States, one to two weeks after the injection of the vaccine.
Johnson & Johnson is an American pharmaceutical company founded in 1886. It produces pharmaceutical and medical equipment, hygiene products, cosmetics. Due to the pandemic, the group put itself at the service of the search for a vaccine and announced at the beginning of 2021 that its Belgian subsidiary, Janssen, has developed an effective vaccine against the coronavirus.