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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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Immunisation
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CHMP recommends COVID-19 vaccine Spikevax booster dose
The European Medicines Agency (EMA)'s human medicines committee (CHMP) concludes that a booster dose of Spikevax can be administered in adults aged 18 or over.
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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.
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Influenza vaccine with COVID-19 booster shot shows positive results
Sanofi’s Fluzone® with Moderna’s COVID-19 mRNA investigational booster dose showed an immunogenicity response similar to individual doses.
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WHO recommends groundbreaking malaria vaccine for children
The World Health Organization (WHO) recommends GSK's RTS,S/AS01 (RTS,S) malaria vaccine for use in children in sub-Saharan Africa.
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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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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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Janssen’s RSV vaccine provides 80 percent protection in Phase II study
The investigational respiratory syncytial virus (RSV) vaccine candidate demonstrated 80 percent efficacy in adults aged 65 and older.
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Promising Phase II results for Lyme disease vaccine candidate
Valneva and Pfizer’s Lyme disease vaccine VLA15 displayed a seroconversion rate of 100 percent for all OspA serotypes in Phase II study.
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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.
