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

The Pfizer Effect: Moderna Tries To Escape Big Pharma’s Shadow At US FDA Vaccines Panel

Executive Summary

Sponsor and agency sought to proactively address questions about the potential for anaphylactic reactions with the COVID-19 vaccine given the early real-world experience with Pfizer’s inoculation, which is also uses mRNA technology.

You may also be interested in...



COVID-19 Vaccine Race: With Moderna EUA, US FDA Finally Gets Some Bragging Rights

US FDA’s global first for Moderna’s vaccine gets a small mention as agency looks to pharmacovigilance, follow-up studies for both coronavirus inoculations that have now been authorized. Moderna's 18 December EUA comes after an even faster review than for Pfizer/BioNTech's vaccine.

Severe and Asymptomatic Data Could Give Moderna’s COVID-19 Vaccine Slight Edge Over Pfizer’s

Moderna’s COVID-19 vaccine looks better than Pfizer/BioNTech’s at preventing severe disease and like it may offer some benefit in preventing asymptomatic infections, but these advantages may be short-lived and hard to capitalize on due to supply limitations.

COVID-19: US FDA Weighing UK Anaphylactic Reaction Reports For Pfizer Vaccine Labeling

Agency could revisit contraindications and warnings regarding allergic reactions and anaphylaxis management depending upon what it hears from the MHRA; FDA and Pfizer say there was no signal for severe allergic reactions in the Phase III trial, but advisory committee member Paul Offit suggests a dedicated study is needed.

Related Content

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS143488

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