EMA for Johnson & Johnson Vaccine: Possible association with thrombosis

The European Medicines Agency (EMA) says it has found a link between the Johnson & Johnson vaccine against COVID-19 and rare cases of thrombosis in adults who have received the vaccine in the United States. The EMA said the pharmacovigilance committee had concluded that a warning for unusual thrombosis with low platelet counts should be added to the vaccine instructions. The agency found that all cases involved adults under the age of 60, mostly women, within three weeks of vaccination, and added that all available data, including eight case reports from the United States, were part of its assessment. The regulator also said that most blood clots appeared in the brain and abdomen, as with the AstraZeneca vaccine, and reiterated that the overall benefits of the vaccine outweigh the risks. As EMA experts have pointed out, these rare blood disorders should be considered “very rare side effects of the vaccine”.

“Good news on the progress of vaccination campaigns in the EU,” said Commission President Ursula von der Leyen. “I welcome the announcement by the European Medicines Agency on the safety of the Johnson & Johnson vaccine. This is good news for vaccination campaigns across the EU,” he said.

Johnson & Johnson: Hopes a solution will be found soon after the suspension of her vaccine

Johnson and Johnson remains “absolutely certain” about its vaccine against Covid-19 and hopes to find a solution “very soon” with regulators regarding its use, which has currently been suspended in Europe and the United States due to the appearance of rare severe blood clots, its financial director said today.

“We remain very confident” and “we hope that the balance between benefits and risks will work in our favor,” Joseph Walk said in an interview with CNBC.

“We are working with regulators to make sure they have all the information they need to make their decisions,” he said. “We expect to have a decision on how we can proceed very soon, perhaps by the end of this week, from Europe and the FDA,” said J & J’s chief financial officer. these statements on the occasion of the publication of the quarterly results of the group.

In a statement detailing the company’s financial performance, J&J did not specify the vaccine, which it sells at cost, but said it had sold the vaccines for $ 100 million in the United States. The group also has production problems at a plant in Baltimore, Maryland, run by Emergent BioSolutions, with a batch of vaccine doses that do not meet quality standards. The FDA requested the suspension of production at this plant pending the completion of the inspection. If the regulatory process “goes well, we will be able to meet all our contractual commitments (in terms of vaccine delivery), in the United States and around the world,” assured Joseph Walk.

USA: The CDC is examining whether there are other side effects

Earlier, the CDC announced that it was investigating whether there were other side effects besides thrombosis. “U.S. health authorities are examining available data on cases of potentially serious side effects among people who have received the Johnson & Johnson coronavirus vaccine in addition to those that have already led to the suspension of its use,” said Rossell Wallinski, director of the Centers for Disease Control and Prevention (CDC).

Last week, U.S. regulators called for a halt to J&J product delivery due to severe blood clots in six women under the age of 50 who were among the 7 million people who received the vaccine, given one dose. “It encourages us that there have not been a large number of cases, but we are looking at it, studying (the reports) we have,” Ms Wallinski told a news conference yesterday.

The Federal Drug Administration (FDA) is monitoring the US government’s database of additional side effects, he added. Rosell Wallinski did not elaborate on the nature of the side effects, other than blood clots. A CDC Advisory Committee will meet on Friday to review the data on possible serious side effects of the J&J product and to give an opinion on whether its use should be continued as part of the immunization campaign. Experts expect it to start again, but once there are clear guidelines for diagnosing and treating thrombosis, a potential side effect.

Theodoridou: 85% effectiveness of Johnson & Johnson vaccine – When will the vaccinations start

During Monday’s regular briefing, Maria Theodoridou, chairwoman of the National Vaccination Committee, referred to the suspension of the Johnson & Johnson vaccine. “The reason given in the announcement of the US regulatory authorities, FDA and CDC is the recording of six cases of venous thrombosis in women aged 18-48 years for a total of 6.8 million vaccines. The suspension, as stated in the announcement, “It is done for a detailed investigation of the cases but also to properly inform and sensitize both the health workers and the public so that the recognition is timely and the treatment is immediate” pointed out Mrs. Theodoridou.

“The J&J vaccine comes from decades of research and has been developed using the viral vector method using human adenovirus type 26. It is different in type and receptor from that of AstraZeneca. This vaccine has many advantages. First, “Viral carrier vaccines are generally resistant to highly sensitive messenger mRNA vaccines. They can be stored at normal cooling temperatures and are more convenient to transport. But the main advantage is that it is single-dose.” Mrs. Theodoridou also emphasized, describing the advantages of the long-awaited vaccine of Johnson & Johnson. He continued: “The protection of the vaccine with a single dose begins after 14 days while its effectiveness against the serious effects of covid disease manifests itself after 28 days and is estimated to be of the order of 85%. After 49 days it protects almost fully from both hospital admissions and death “.

“It is worth noting that the efficacy in both the US and South Africa, where there is a mutant that reduces the effectiveness of vaccines, is similar and this is very important,” he added. “Investigating a possible predisposing factor for these rare forms of thrombosis is important because it will shed light on the scientific enigma created by these rare pathogenic manifestations, and the elucidation of this enigma will strengthen confidence in monitoring the safety of vaccines, despite the great upheaval it has caused. This inhibition, which is not uncommon for vaccine monitoring or clinical trials, and in Europe and America, this disturbance, we must focus on the positive side, which is that there is an organized, strict surveillance system that allows for timely detection of very rare complications, side effects, of which that one can take the appropriate measures. “Let us wait a few hours or days for the opinion of the competent bodies of the USA and Europe, the EMA, in the hope that we will have another weapon in our hands to deal with the pandemic”.

For his part, Marios Themistokleous, Secretary General of Primary Care, stressed that “regarding the vaccine, we are waiting for the decisions of both Coreper and the National Vaccination Committee to start the vaccinations, which will most likely start in May”.

The J&J vaccine was the fourth to be licensed in Europe last month, after those of Pfizer / BioNTech, Moderna and AstraZeneca / Oxford. “While its research is ongoing, Coreper remains of the opinion that the benefits of the Covid-19 vaccine outweigh the risk of side effects,” the agency said in a statement last week, which it reiterated today.


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