Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

EMA Assessing Variant-Adapted Spikevax, Probes Heart Inflammation With Nuvaxovid

Executive Summary

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.

You may also be interested in...



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.

Related Content

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS146361

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel