EMA Assessing Variant-Adapted Spikevax, Probes Heart Inflammation With Nuvaxovid
A rolling review of an adapted version of Moderna’s COVID-19 vaccine Spikevax aimed at variants of SARS-CoV-2 has begun at the European Medicines Agency. The EMA has also given an update on its latest vaccine safety reviews, including reports of heavy menstrual bleeding with Spikevax and Comirnaty.
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Coronavirus Notebook: Moderna’s New Boosters More Effective Against Omicron BA.4/BA.5, Inotrem Reports Good Results For Nangibotide In Severe COVID-19
The European Medicines Agency has recommended updating the vaccine product information to include heavy menstrual bleeding with both Spikevax and Comirnaty, and urticaria with Spikevax. The World Health Organization says that the Omicron BA.5 strain and all its descendent lineages continue to be dominant at global level.
EU Boosts COVID-19 Vaccine Supplies With Moderna & HIPRA Deals
New supply arrangements with the two firms are expected to offer greater protection to people in Europe as the autumn/winter season approaches. The EU’s health crisis preparedness body HERA has also identified its “top three health threats.”
Pace Of Omicron Variants Hindering Work On Adapted COVID-19 Vaccines
The European Medicines Agency says regulators are currently discussing the extent to which clinical data will have to be submitted to support the approval of an adapted vaccine against Omicron variants.