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Pharmacovigilance Risk Assessment Committee (PRAC) meeting highlights, September 2021
The EMA’s drug safety committee (PRAC) assessed risks of thrombocytopenia and venous thromboembolism with the Janssen COVID-19 Vaccine.
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Cancer therapy influences COVID-19 vaccine response
New study finds patients receiving chemotherapy have lower COVID-19 antibody levels post-vaccination than patients receiving targeted cancer therapy.
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Ronapreve™ reduces COVID-19 viral load within seven days
Phase II/III trial shows Ronapreve significantly reduced viral load in seronegative patients hospitalised with COVID-19, complimenting previous findings.
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Sanofi’s first mRNA vaccine shows neutralising antibody seroconversion
Sanofi’s first mRNA COVID-19 vaccine displayed neutralising antibody seroconversion in 91 to 100 percent of participants in a Phase I/II study.
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EMA evaluate booster dose of COVID-19 vaccine Spikevax
The European Medicines Agency (EMA) is evaluating an application for the use of a booster dose of Spikevax in people aged 12 years and older.
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3D-printed vaccine patch boasts greater immunity than usual vaccine shot
A newly designed 3D-printed microneedle patch demonstrated immune responses 50 times greater than typical subcutaneous injection in animals.
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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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Temperature stable microneedle patch successfully delivers DNA COVID-19 vaccine
A microneedle patch, which can be stored for >30 days at room temperature, safely delivered a DNA-based COVID-19 vaccine in mice.
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Veklury® (remdesivir) reduces COVID-19 hospitalisation risk by 87 percent
Veklury (remdesivir) significantly reduced the risk of COVID-19 related hospitalisation and death in high-risk patients in Phase III study.
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J&J vaccine booster dose displays 94 percent protection
Johnson & Johnson announced Phase III data demonstrating effective COVID-19 protection and an increase in protection with a booster dose.
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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.
![Moderna COVID-19 vaccine vials [Credit: Giovanni Cancemi/Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/shutterstock_1893225814-300x278.jpg)
![Moderna COVID-19 vaccine vials [Credit: Giovanni Cancemi/Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/shutterstock_1893225814-e1631790550214.jpg)
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COVID-19 Vaccine Moderna effective against variants of concern
New data shows that Moderna’s COVID-19 vaccine protects against variants of concern and reduces breakthrough infection risk.
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Immuno-bridging studies are sufficient for authorising new COVID-19 vaccines, say regulators
The Access Consortium, comprising regulators from the UK, Australia, Canada, Singapore and Switzerland, announce that immuno-bridging studies can be used to support COVID-19 vaccine authorisation.
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US government purchases additional 1.4 million doses of REGEN-COV™
Regeneron announced a new US government agreement to purchase additional doses of REGEN-COV (casirivimab and imdevimab) antibody cocktail.
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Viral vector purification market expected to reach over $1 billion by 2028
New research suggests the viral vector purification market will attain a compound annual growth rate of 14.2 percent between 2021 and 2028.
