Filenews 20 April 2021
The European Medicines Agency (EMA) has found that there is a possible link between Johnson & Johnson's vaccine against COVID-19 and rare thrombosis issues in adults who had received the vaccine in the United States, the European Union's medicines regulator said.
The onset of thrombosis combined with low platelet values should be recognised as a "very rare side effect" of Johnson & Johnson's Covid-19 vaccine, the European Medicines Agency announced on Tuesday.
The announcement was issued shortly before the official press conference on the subject began at 18.00 BST from the EMA offices in Amsterdam.
However, the Agency stresses that the benefits of the vaccine outweigh the potential risk and therefore its use can continue as planned.
A total of eight cases have been reported in the US among the approximately 7 million recipients of the vaccine, meaning the risk is about one in a million.
J&J had earlier announced that it was freezing the availability of its vaccine in the EU until the findings of the relevant US authorities, which "as a precautionary measure" discontinued vaccinations in the US, were announced.
The EMA's Pharmacovigilance Committee's finding dealt another blow to the EU's vaccination programme, following the corresponding warning about the same technology-based AstraZeneca vaccine.
'All cases involve people under 60 years of age and occurred within three weeks after vaccination, the majority in women. Based on the available data, specific risk factors have not been confirmed," says EMA.
Risk factors, such as age or gender, have not been identified in the case of AstraZeneca vaccine either, despite dozens of cases of thrombosis recorded in the EU.
The extremely rare possible side effect looks the same in both vaccines. The combination of thrombosis and low platelets is considered a peculiar condition, since platelets are the factors that create the clots.
As the EMA points out, clots tend to appear in "unusual places" such as the arteries and veins of the brain and bowels.
The mechanism of the phenomenon remains unclear, however the disorder is likely due to an incorrect overreaction of the immune system. The same side effect occurs in rare cases after use of the anticoagulant drug heparin used in millions of patients.
Johnson & Johnson's vaccine is produced by its Swiss subsidiary Janssen.
Like the Astra vaccine, it is based on a genetically modified adenovirus, which causes human cells to produce the coronavirus spike protein, which is then recognized by the immune system to produce antigens.
The J&J vaccine is considered critical for the treatment of the pandemic, especially in the developing world, since it requires only one dose and is kept in a simple refrigerator.
Johnson & Johnson confident about their vaccine
The pharmaceutical company Johnson & Johnson (J&J) remains "absolutely confident" about its vaccine against Covid-19 and hopes to find a "very soon" solution with regulators regarding its use, which is currently suspended in Europe and the United States due to the occurrence of rare severe blood clots, its chief financial officer said today.
"We remain very confident" and "hope that the balance between benefits and risks will work in our favour," Joseph Walk said in an interview with US network CNBC.
"We are working with regulators to make sure they have all the information they need to make their decisions," he stressed.
"We expect to have very soon, perhaps by the end of this week, from Europe and the FDA (the US Food and Drug Administration) a decision on how we can proceed," said J&J's chief financial officer, who made these statements on the occasion of the publication of the group's quarterly results.
In the announcement detailing the company's financial performance, J&J does not specifically mention the vaccine, which it sells at a cost price, but suggests that it has sold vaccines instead of $100 million in the United States.
The group is also experiencing production problems at a plant in Baltimore, Maryland, managed by Emergent BioSolutions, with a batch of doses of vaccines 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 fulfil all our contractual commitments (in terms of vaccine delivery.) in the United States and around the world," Joseph Walk assured.
Source: in.gr/ RES- ICM/ eyenews
