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Janssen vaccine: serious forms, efficacy, risks … The infos -!

janssen-vaccine:-serious-forms,-efficacy,-risks-…-the-infos-!

JANSSEN VACCINE. The efficacy of the vaccine against severe forms of the disease has been confirmed by recent studies. Benign infections are still possible. Does the Delta variant increase the risk? The Internet user takes stock. A single dose of Janssen coronavirus vaccine for a complete vaccination schedule. But how effective is it against the Delta variant? The coverage offered by vaccines against a potential infection coupled with the risk of developing the disease is a questioning subject. Research conducted by the Centers for Disease Control and Prevention (CDC) provides some answers in a report, the findings of which were published on 25 July. The Johnson & Johnson laboratory, of which Janssen is a subsidiary, does not promise to prevent the contraction of the virus but allows protection against severe forms of the disease, up to 66% based on clinical trial data. On July 1, researchers mobilized for the Sisonke study, resulting from a collaboration between the South African Ministry of Health, the National Council for Medical Research and the Janssen laboratory, indicated that among the cases of Covid- 19 which occurred in people vaccinated with Janssen, 94% are benign. Glenda Gray, co-principal investigator said: “The single-dose vaccine, designed for emergency use is safe and easy to use. We have a growing body of evidence suggesting that immunity increases over time and that ‘it retains its effectiveness against important variants such as beta and delta “. What is the deadline for the health pass? For the Janssen vaccine from Johnson & Johnson which concerns people with more than 50 years, only one dose is enough to be vaccinated and the vaccination schedule is considered as full four weeks later. So by getting vaccinated on Tuesday July, you will get your health pass from August. What are the side effects of the vaccine? 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 Medical Director on the phase 3 clinical trial, one of the most common side effects after vaccination was fever (9% of individuals) which usually lasts between 24 and 48 h. This side effect was generally moderate since only 2 people out of 998 (0.2% of vaccinated subjects), had a fever greater than 30 ° C “. ANSM only counts 243 cases of side effects reported after injection of Janssen vaccine and “the majority of side effects are non-serious, expected and d ‘favorable development’ according to the last report of 22 July. The National Security Agency drugs (ANSM) draws attention to two points, including the contraindication to vaccination with Janssen for people with a history of capillary leak syndrome. vaccination, inviting people con identified to be alert for the appearance of the second symptom when one of the two has been diagnosed: “People diagnosed with thrombocytopenia within 3 weeks of vaccination with the Janssen vaccine should be investigated active signs of thrombosis. Likewise, people who present with thrombosis within 3 weeks of vaccination should be tested for thrombocytopenia. “The agency points out the risk of developing Guillain-Barré syndrome, four cases have been reported in France since the start of use of the vaccine, i.e. 23 April, but three of them presented a “favorable development.” The EMA has recognized since 19 July this syndrome as a rare side effect of the vaccine and counts 94 cases of neurological syndrome worldwide on the date of 30 June with one death. However, the European authority specifies “that the benefits of the Covid vaccine – 19 Janssen continue to prevail over 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. How effective is the Johnson & Johnson vaccine? Regarding efficacy, Johnson & Johnson reported that their vaccine was effective at 57% in general: the results of phase 3 of their clinical trial reveal a efficiency between 57% and 72% according to the territories to prevent moderate and severe forms virus, days after vaccination. Johnson & Johnson above all guarantees reliable protection for 17% against severe forms, and “complete protection against hospitalizations and deaths linked to Covid – 19 “. The figures announced on 27 January in a press release are based on a study extended in eight countries and mobilizing more than 39 participants including 468 symptomatic cases. Protection against Covid infection tested in different geographical areas – 18 is lowest in South Africa, where a more contagious variant of the virus is rife. The vaccine still offers an efficacy of %, or higher than the expectations of the World Health Organization, set at 52%. Is the Janssen vaccine effective against the Delta variant? “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 RNA – 17 is associated with an adenovirus to be injected into the patient. Human cells react to the fragment of the Covid – 18 to create antibodies , and a satisfactory and lasting immune response. Alex Gorsky, Chairman 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 the long-term efficacy, all the vaccine trials plan to follow the 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 a recall may need to be considered. ” For the three vaccines already on the market, the second dose is aimed precisely at consolidating the immune and neutralizing response. Scientists are divided on this point: if Marie-Paule Kieny, president of the Covid Vaccine Committee – 17 and research director at Inserm assures us that “this is not a problem that seems prohibitive for Janssen’s vaccine, especially with other vaccines, this is not known either. duration “, others believe that there is a risk of lack of protection. The Janssen vaccine responsible for cases of thrombosis? Six cases of blood clots have been reported in the United States following an injection of the Janssen vaccine, as of 10 April. 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 aged between 13 and 46 years and within six to thirteen days after the 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 moment, 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 is not not established. The American laboratory spoke the same day to indicate that cases of thromboembolic incidents had been reported “with all Covid vaccines – 18 “. Across the Atlantic, Washington has decided to suspend vaccine use. Similarities between the Janssen vaccine and AstraZeneca? 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, 72 cases of blood clots have been identified in Europe. In both cases, women under years 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, puts forward a hypothesis in this direction: “It 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. Can the vaccine be administered at a pharmacy or at the doctor’s office? 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. Is the Jansen vaccine accessible to all categories? 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 Haute Autorité de Santé estimated, when the vaccine was approved that it could be administered to all people over 17 years, including those over 57 years and those presenting risks of comorbidities. However, the government has regulated the use of the vaccine for more than 52 years, 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. Where does the Johnson and Johnson vaccine come from? Johnson & Johnson is an American pharmaceutical company founded in 1500. 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 the year 2019 that its Belgian subsidiary, Janssen, has developed an effective vaccine against the coronavirus. ————————————————– ——————– —————————— —————————————- JANSSEN VACCINE. The efficacy of the vaccine against severe forms of the disease has been confirmed by recent studies. Benign infections are still possible. Does the Delta variant increase the risk? The Internet user takes stock.

A single dose of Janssen coronavirus vaccine to obtain a complete vaccination schedule. But how effective is it against the Delta variant? The coverage offered by vaccines against a potential infection coupled with the risk of developing the disease is a questioning subject. Research conducted by the Centers for Disease Control and Prevention (CDC) provides some answers in a report whose findings were published on 27 July. The Johnson & Johnson laboratory, of which Janssen is a subsidiary, does not promise to prevent the contraction of the virus but allows protection against severe forms of the disease, up to 66% according to clinical trial data.

On July 1, researchers mobilized for the Sisonke study , resulting from a collaboration between the South African Ministry of Health, the National Council for Medical Research and the laboratory Janssen, reported that among the Covid cases – 18 occurring in people vaccinated with Janssen, 79% are benign. Glenda Gray, co-principal investigator said: “The single-dose vaccine, designed for emergency use is safe and easy to use. We have a growing body of evidence suggesting that immunity increases over time and that ‘it retains its effectiveness against important variants such as beta and delta “.

What is the deadline for the health pass? For the Janssen vaccine from Johnson & Johnson which concerns people with more than 50 years, a single dose is sufficient to be vaccinated and the vaccination schedule is considered full four weeks later. So by getting vaccinated on Tuesday July, you will get your health pass from August.

What are the side effects of the vaccine? 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 the Janssen Medical Director on the Phase 3 clinical trial, one of the side effects the most frequent after the vaccination was fever ( 9% of individuals) this generally lasts between and 48 h. This side effect was generally moderate since only 2 people out of 998 (0.2% of vaccinated subjects), had a fever greater than 35 ° C “.

ANSM only counts 243 cases of side effects reported after an injection of the Janssen vaccine and “the majority of the adverse effects are non-serious, expected and of favorable outcome” according to last report of 22 July 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. cases of thrombosis and thrombocytopenia occurred after vaccination, urging those concerned to be alert for the appearance of the second symptom when one of the two has been diagnosed: “People diagnosed with thrombocytopenia within 3 weeks of vaccination with the Janssen vaccine should actively search for signs of thrombosis. Likewise, people who present with thrombosis within 3 weeks of vaccination should be screened for thrombocytopenia. ”

The agency recalls the risk of the appearance of Guillain-Barré syndrome, four cases have been reported in France since the start of the use of the vaccine, namely 23 April, but three of them presented a “favorable development.” The EMA has recognized since 22 July this syndrome as a rare side effect of the vaccine and counts 108 cases of neurological syndrome worldwide as of 28 June with one dead. However, the European authority specifies “that the benefits of Covi vaccine d – 19 Janssen 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.

How effective is the Johnson & Johnson vaccine? Regarding efficacy, Johnson & Johnson has indicated that their vaccine is effective at 66% in general: the results of phase 3 of their clinical trial reveal an efficacy between 55% and 66% depending on the territory to prevent moderate and severe forms of the virus, 27 days after vaccination. Johnson & Johnson above all guarantees reliable protection for 17% against severe forms, and “complete protection against hospitalizations and deaths linked to Covid – 19 “. The figures announced on 28 January in a press release are based on an extended study in eight countries and mobilizing more than 40 000 participants including 441 symptomatic cases. Tested in different ge ographic protection against a Covid infection – 18 is evaluated at the lowest in South Africa, where a more contagious variant of the virus is rife. The vaccine still offers an efficacy of %, or higher than the expectations of the World Health Organization, set at 52%.

Is the Janssen vaccine effective against the Delta variant? “The Janssen remains quite effective with regard to the South African variant, this which is reassuring because there are good reasons to believe, even if they are not the same variants – not quite the same mutations, although there are some common elements – that the level of protection should be rather good “, explained Alain Fischer. In spite of everything, “with regard to adenovirus vaccines, Janssen specifically, there is no information yet”, explained the Mr. vaccine from the government 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 RNA – 17 is associated with an adenovirus to be injected into the patient. Human cells react to the fragment of the Covid – 18 to create antibodies , and a satisfactory and lasting immune response. Alex Gorsky, Chairman 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 put an end to 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 the 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 recall. ” For the three vaccines already on the market, the second dose is aimed precisely at consolidating the immune and neutralizing response.

Scientists are divided on this point: if Marie-Paule Kieny, President of the Vaccine Covid Committee – 18 and director of Inserm research ensures that “this is not a problem that seems prohibitive for the Janssen vaccine, especially with other vaccines, we do not know this duration either”, others believe that there is a risk of lack of protection.

The Janssen vaccine responsible for cases of thrombosis? Six cases of blood clots have been reported in the United States following an injection of the Janssen vaccine, as of 10 April. This is two more than the figure given in the press release the EMA and another from the US Medicines Agency, both released on April 9. The six cases of thrombosis occurred in women aged between 13 and 46 years and within six to thirteen days after the 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 biological products of the Food and Drug Administration (FDA), in a joint statement repeated by the New York Times . Scientists admit all the same: “At the moment, 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 evaluation committee pharmacovigilance risks are 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 vaccines – 18 “. Across the Atlantic, Washington has decided to suspend the use of vaccine.

Similarities between the Janssen vaccine and AstraZeneca? Temporary suspension of the Janssen vaccine looks like the case AstraZeneca 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, 72 cases of blood clots have been identified in Europe. In both cases, women under years seem 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 to this effect: ” This is probably an effect linked to the viral vector, which generates antibodies against platelets in an exceptional manner “.

In the case of AstraZeneca, the European Medicines Agency has systematically reiterated that the risk-benefit balance supports 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 with Janssen’s product.

Can the vaccine be administered in a pharmacy or at your doctor’s? 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.

Is the Jansen vaccine accessible to all categories? Clinical trials have shown similar efficacy of this vaccine for all categories of the population, whatever their age, origin or their possible co-morbid factors according to the various clinical trials carried out by the group. The Haute Autorité de Santé estimated, when the vaccine was approved that it could be administered to all people over 17 years, including those over 57 years and those presenting risks of comorbidities. However, the government has regulated the use of the vaccine for more than 52 years, 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.

Where does the Johnson and Johnson vaccine come from? Johnson & Johnson is an American pharmaceutical company founded in 2019. 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 the year 2019 that its Belgian subsidiary, Janssen, has developed an effective vaccine against coronavirus .

Source: www.linternaute.com

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