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CHMP issue positive opinion on Comirnaty® for five to 11 year olds
The human medicines committee issue a positive opinion on the COVID-19 vaccine Comirnaty® in children aged five to under 12 years.
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BioNTech
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Comirnaty® booster dose displays high efficacy in Phase III study
The vaccine showed a relative vaccine efficacy of 95.6 percent and is the first efficacy results from a COVID-19 vaccine booster trial.
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First patient dosed with BioNTech’s mRNA-based immunotherapy
BioNTech expands clinical oncology portfolio with first patient dosed in Phase II trial of mRNA-based vaccine for colorectal cancer.
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FDA authorises Comirnaty® booster dose for certain populations
The US FDA amended the emergency use authorisation to allow for a Comirnaty booster dose in individuals at high-risk for COVID-19.
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Comirnaty® effective in children aged five to 11 years
Positive results from pivotal trial show that the COVID-19 vaccine Comirnaty is safe and effective in children aged five to 11 years old.
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BioNTech evaluates mRNA vaccine manufacturing capabilities in Africa
BioNTech will evaluate mRNA vaccine manufacturing facilities in Rwanda and Senegal to support vaccine supply in African states.
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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.
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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.
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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.
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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.
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BioNTech strengthens neoantigen TCR programme with Kite acquisition
BioNTech acquires Kite’s solid tumour neoantigen T cell receptor research platform and Gaithersburg manufacturing facility for undisclosed amount.
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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.
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BioNTech to develop and supply mRNA malaria vaccine
Collaborating with global partners BioNTech will work to develop a safe and effective malaria vaccine and set up its sustainable supply for the African continent.
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.
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2021 a pivotal year for personalised neoantigens, says GlobalData
With multiple catalysts coming up in late 2021, GlobalData reports a boom in the field of personalised neoantigen immuno-oncology therapeutics.
