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

CDC Data More Positive on Myocarditis Benefit-Risk Than FDA’s Assessment of Pfizer’s Vaccine

Executive Summary

Updated modeling on heart events in young adults presented to CDC’s vaccine advisors points towards much lower rates of the adverse event from mRNA vaccines than some of FDA’s modeling.

You may also be interested in...



Moderna’s COVID Vaccine Had Longer FDA Review Than Pfizer’s; Similar Post-Market Requirements

Moderna fell behind Pfizer after receiving EUA for Spikevax, as it took three months longer to file its BLA and had an extra two months of FDA review for full approval. Novavax files request for FDA emergency use authorization of its vaccine.

US Real-World Evidence On COVID-19 Vaccine Safety Is Inadequate, Former HHS Official Says

US government does not have an adequate system to monitor vaccine safety in real time, Nicole Lurie, former assistant secretary for emergency preparedness says. Low-income countries sometimes do not receive same COVID product that FDA reviewed, a former agency official notes.

US FDA Panel Rejects Pfizer's Broad COVID Booster Plan But Backs Narrower Authorization For Third Vaccine Shot

Advisory committee meeting reflected internal tensions among FDA staff on need for boosters and adequacy of the data; mRNA vaccine Comirnaty should be authorized for a third dose in populations at high risk for severe disease or exposure, panel says after overwhelmingly rejecting Pfizer's bid for booster approval in the 16-and-older population. 

Related Content

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS144876

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