news
Six COVID-19 boosters are safe and effective, shows Phase II study
Study finds six different COVID-19 vaccine boosters increase immunity and pose no safety concerns, although immune responses varied.
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COMIRNATY®
news
Pharmacovigilance Risk Assessment Committee (PRAC) meeting highlights, Dec 2021
EMA's drug safety committee (PRAC) confirmed the risks of myocarditis and pericarditis with COVID-19 messenger RNA (mRNA) vaccines.
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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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FDA authorises Comirnaty® for emergency use in five to 11 year olds
The US Food and Drug Administration has authorised the emergency use of COVID-19 vaccine Comirnaty in children aged five to 11 years.
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Pharmacovigilance Risk Assessment Committee (PRAC) meeting highlights, Oct 2021
EMA's drug safety committee (PRAC) assessed risks with COVID-19 vaccines and identified no risk of death with Imbruvica and ACE inhibitors.
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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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Heterologous COVID-19 booster doses show 68 percent effectiveness
A Swedish study found that heterologous Vaxzevria and mRNA prime-boost vaccination is effective against COVID-19.
podcasts
EPR Podcast Episode 4 – UV/Vis in mRNA vaccine QC with Dr Hans-Joachim Muhr, Mettler Toledo
Join Mettler Toledo's Dr Hans-Joachim Muhr as he explains the key quality considerations for mRNA vaccines and why UV/Vis spectrophotometry should be applied in their QA/QC.
news
COVID-19 vaccines will require outsourced manufacturing, says report
The pharma industry will need to outsource manufacturing for COVID-19 vaccine doses for booster doses and children, reports GlobalData.
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EMA approve Comirnaty®and Spikevax booster doses
The EMA concludes that booster doses of the COVID-19 vaccines Comirnaty and Spikevax can be given to people with severely weakened immune systems.
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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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MHRA approve Pfizer and AstraZeneca COVID-19 vaccine booster doses
The UK regulator confirmed that the Pfizer and AstraZeneca COVID-19 vaccines can be used as safe and effective booster doses.
news
EMA evaluates data on Comirnaty® COVID-19 vaccine booster dose
EMA begins evaluating the application for a booster dose of Comirnaty® in adults to be given six months after the second dose.
news
Pharmacovigilance Risk Assessment Committee (PRAC) meeting highlights, September 2021
The EMA’s drug safety committee (PRAC) reviewed COVID-19 vaccine risks and issued a new safety signal for Imbruvica with rituximab.
