J&J starts European COVID-19 vaccine roll-out
According to the EMA, the very rare cases of cerebral venous thrombosis, which were observerd after vaccination with J&J’s COVID-19 jab, didn't affect its benefit to risk ratio in a significant way. However, according to the EMA, the vaccine is to be labelled with a warning in future. According to calculations of German immunologists, a 20-year-old woman has a higher risk of getting a severe COVID-19 course than of cerebral venous thrombosis.
Adverse drug effects (ADEs) are commonly observed in mass vaccination campaigns. As AstraZeneca’s vaccine AZD1222 showed the same ADE as J&J’s jab, MEP Dr. Peter Liese speculated that this might be a group effect of adenoviral vectors. Realword data from Israel also suggest an association between Herpes zoster activation and Biontech/Pfizer's mRNA vaccine BNT162b2, which is expected to make sales of €24bn this year.
The EMA's Pharmacovigilance Risk Assessment Committee reevaluated cases from the US where vaccination with J&J’s vaccine was transiently paused after the ADEs occured. The CDC, however, said that affected patients can be treated wiith venous IgGs or mAbs as the underlying events of the ADE resemble heparin-induced thrombocytopenia for which a market-authorised therapy is available. In Europe, the vaccine has hardly been used so far, said EMA head Emer Cooke.
In the USA, more than seven million vaccinations with the Janssen vaccine had already taken place when the use of the preparation was temporarily suspended. In the EU, roll-out of the vaccine will now be restarted. it has the huge advantage that only one dose is needed for immunisation and that it is also effective against most variants. Researchers at USCF stated that the vaccine indudes such a strong humoral and cell-dependent immunity against SARS-CoV-2 that one vaccine shot is sufficient for protection. Experts thus hope that vaccination with J&J’s jab will accelerate vaccination campaigns significantly.The EU Commission has ordered vaccine doses for 200 million people.