news
FDA application to be submitted for Comirnaty® booster dose
Pfizer and BioNTech will submit a supplemental biologics licence application to the FDA for booster dose of COVID-19 Vaccine Comirnaty.
List view / Grid view
COMIRNATY®
news
Comirnaty and Moderna COVID-19 vaccine supply to increase in the EU
The CHMP has adopted recommendations to increase manufacturing capacity and supply of COVID-19 Vaccines Comirnaty and Moderna in Europe.
![Gloved hand holding a vial labelled 'COVID-19 Vaccine' with Pfizer and BioNTech logos [Credit: malazzama / Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Pfizer-BioNTech-COVID-19-vaccine-300x278.jpg)
![Gloved hand holding a vial labelled 'COVID-19 Vaccine' with Pfizer and BioNTech logos [Credit: malazzama / Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Pfizer-BioNTech-COVID-19-vaccine-e1629795881701.jpg)
news
Pfizer-BioNTech becomes the first FDA-approved COVID-19 vaccine
Pfizer and BioNTech's vaccine is the first to be approved by the FDA for the prevention of COVID-19 in people aged 16 years and older.
news
Pfizer and BioNTech submit Phase I data to FDA for COVID-19 booster
Pfizer and BioNTech have announced the submission of initial data to the US FDA to support booster dose of COVID-19 vaccine.
news
FDA allows additional COVID-19 vaccine dose for immunocompromised
The FDA has authorised an additional dose of COVID-19 Vaccines Pfizer-BioNTech and Moderna in certain immunocompromised patients.
article
ebook: Waiving intellectual property rights for COVID-19-related interventions and technologies: a comprehensive guide
This ebook explores the intellectual property rights waiver for COVID-19 treatments, vaccines, diagnostics and technologies, its potential ramifications for the drug development industry and potential solutions for overcoming COVID-19 vaccination inequalities.
![Pfizer logo on a sign in New York city, US [Credit: Molly Woodward / Shutterstock.com]](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Pfizer-4-300x278.jpg)
![Pfizer logo on a sign in New York city, US [Credit: Molly Woodward / Shutterstock.com]](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Pfizer-4-e1627904909506.jpg)
news
Pfizer reports 92 percent increase in revenues for Q2
The company’s second quarter (Q2) results reveal a $9.1 billion increase in revenues from Q2 2020 and significant operational growth.
news
Vaxzevria has similar safety profile to mRNA COVID-19 vaccines, finds study
New studies show rates of blood clots were similar following vaccination with Vaxzevria and Comirnaty®, plus rates of rare blood clots are lower after the second Vaxzevria dose.
news
Regulators call for clinical research to include pregnant and breastfeeding women
The FDA and other global regulators are co-operating to address inadequacies in clinical research that leave pregnant and breastfeeding women lacking data on which to base their medical decisions.
article
Has the threat of waiving COVID-19 vaccine intellectual property rights had its desired effect?
In this final article on the TRIPS waiver for COVID-19 vaccines, medicines, diagnostics and technologies, EPR’s Hannah Balfour considers whether it is the correct strategy to overcome COVID-19 treatment inequalities and explores other options.
podcasts
EPR Podcast Episode 3 – Inhaled and intranasal drug formulations and delivery – Dr Bill Williams, University of Texas
Join Dr Bill Williams as he discusses formulation for inhaled and intranasal drug delivery and goes into detail about thin film freezing, a novel powder formulation technique he developed.
news
Pharmacovigilance Risk Assessment Committee (PRAC) meeting highlights, July 2021
The Pharmacovigilance Risk Assessment Committee (PRAC) provided safety warnings on COVID-19 vaccines, and found no evidence linking Zynteglo to blood cancer.
article
How could waiving COVID-19-related intellectual property rights affect biopharma?
In this article, EPR’s Hannah Balfour discusses the potential impact of waiving intellectual property rights for COVID-19-related medicine and technology on pharma, biopharma and biotech companies.
article
What are the challenges in developing and delivering lipid nanoparticle mRNA-based vaccines?
In response to the COVID-19 pandemic caused by the SARS-CoV-2 virus, the emergence of RNA vaccine technology has enabled rapid development of critical vaccines. Traditional vaccine production methods makerapid development challenging, requiring cell line production of viral proteins and laborious purification development, which requires extensive effort and long timelines. RNA…
news
COVID-19 vaccines highly effective against hospitalisation by Delta variant
21 June 2021 | By
An analysis shows Comirnaty® and the COVID-19 Vaccine AstraZeneca are both over 90 percent effective in preventing hospitalisation from the Delta variant.
