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Pharmacovigilance Risk Assessment Committee meeting highlights, June 2021
The European Medicines Agency (EMA)’s drug safety committee (PRAC) concluded three safety signal reviews, two for COVID-19 interventions, at its June meeting.
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COMIRNATY®
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Comirnaty® COVID-19 vaccine protects against multiple viral variants
Laboratory study shows the blood sera of people vaccinated against COVID-19 with Comirnaty® can neutralise at least six viral variants including three variants of concern.
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Waiving COVID-19 vaccine intellectual property rights
South Africa and India’s request that the World Trade Organization waive intellectually property rights for COVID-19 vaccines, treatments, diagnostics and technology has garnered extensive media coverage, particularly since the US decision to support the proposal. In a three-part series, European Pharmaceutical Review’s Assistant Editor, Hannah Balfour, will discuss the IP…
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US begins testing mixed COVID-19 vaccine regimens
A Phase I/II trial will enrol 150 individuals already vaccinated against COVID-19 with one vaccine and assess the safety and immunogenicity of a booster dose of a different COVID-19 vaccine.
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EMA recommends first COVID-19 vaccine for children aged 12 to 15
The EMA is recommending that the Comirnaty® COVID-19 vaccine’s indication be extended to include children aged 12 to 15 years.
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EU secures up to 1.8 billion additional doses of Comirnaty® COVID-19 vaccine
Pfizer and BioNTech have agreed to supply Europe with 900 million additional doses of Comirnaty® with the option to request 900 million more in future.
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mRNA COVID-19 vaccination is immunogenic in the immunocompromised
Research suggests patients who receive COVID-19 vaccines prior to a transplant and subsequent immunosuppression may be protected from the disease.
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FDA allows Pfizer’s COVID-19 vaccine to be used in adolescents
The Comirnaty® vaccine’s emergency use authorisation has been extended to allow its administration to those 12 years of age and above in the US.
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Highlights of the May 2021 Pharmacovigilance Risk Assessment Committee (PRAC) meeting
In its May meeting, the EMA’s drug safety committee (PRAC) concluded two safety signal reviews for COVID-19 vaccines and began several more.
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Paediatric and adolescent COVID-19 vaccines update
The EMA is evaluating whether to lower the age at which Comirnaty can be administered and Novavax has begun testing its COVID-19 vaccine in paediatric patients.
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COVID-19 vaccine rollout: a logistics success story
The dedication of the science community and healthcare workers in the fight against COVID-19 has been unwavering and justly praised. Yet logistics workers and the industries that support it have also achieved tremendous feats to support the resulting aid. Here, Zoe McLernon, Multimodal Policy Manager at Logistics UK, highlights the…
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Novel time-temperature indicator could help preserve mRNA vaccines
Researchers have developed a novel sensor, known as a time-temperature indicator, that could be used to monitor the storage conditions of mRNA vaccines.
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WHO issues alert for falsified COVID-19 vaccine
The World Health Organization (WHO) has warned that a falsified COVID-19 vaccine, identified as Pfizer’s BNT162b2, could still be in circulation in the Americas.
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EMA approves increased manufacturing capacity for COVID-19 vaccines
The approval of at least one new manufacturing site based in Europe for each of the approved COVID-19 vaccines should increase supply for the EU.
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Why real-time environmental monitoring is the most important aspect of the modern pharmaceutical cold chain
Glenn Abood, founder and CEO of rfxcel, explains how real-time environmental monitoring can combat supply chain shortcomings, providing companies with level of data integrity, traceability, transparency and security that is virtually beyond reproach.
