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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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Immunisation
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WHO lists Sinopharm’s COVID-19 vaccine for emergency use
The inactivated Vero Cell COVID-19 vaccine is now eligible for global rollout alongside the four other vaccines with World Health Organization Emergency Use Listing.
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Moderna’s COVID-19 variant booster vaccine shows promise in trial
Preliminary Phase II data shows a dose of mRNA-1273.351, Moderna’s strain-matched booster, is safe and may offer protection against the B.1.351 and P.1 variants of concern.
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Novel vaccination regimen shown to be effective in preventing malaria
A three-dose regimen of Plasmodium falciparum sporozoites under chemoprophylaxis (PfSPZ-CVac) was shown to be safe, well tolerated and highly effective in a Phase II trial.
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Novavax’s COVID-19 vaccine 49 percent effective against B.1.351 variant
New data shows NVX-CoV2373 offered complete protection against severe COVID-19 and 60 percent efficacy against infection with the B.1.351 variant in healthy adults.
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Vaccine-induced prothrombotic immune thrombocytopenia: pathogenetic and epidemiological issues of concern
Giovanni Di Guardo, DVM, Dipl. ECVP, retired Veterinary Pathologist, discusses the association between adenoviral vector COVID-19 vaccines and rare blood clots, outlining four areas warranting further research.
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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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Cell-based seasonal influenza vaccine safe and effective in children
Phase III data shows Seqirus’ cell-based quadrivalent seasonal influenza vaccine was as effective and safe as an equivalent FDA-approved egg-based vaccine in paediatric patients.
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Novel vaccine 77 percent effective in preventing malaria, finds study
The R21 vaccine candidate, when administered with 50mg of adjuvant, was found to be 77 percent effective in preventing malaria in children over 12 months.
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EMA and ECDC to collaborate on post-marketing monitoring of COVID-19 vaccines
Under a new initiative, the EMA will monitor on the safety of marketed COVID-19 vaccines while the ECDC monitors their effectiveness in Europe.
![Two vials labelled 'Janssen COVID-19 Vaccine' [Credit: oasisamuel/Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Janssen-COVID-19-Vaccine-300x278.jpg)
![Two vials labelled 'Janssen COVID-19 Vaccine' [Credit: oasisamuel/Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Janssen-COVID-19-Vaccine-e1619436264802.jpg)
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Janssen COVID-19 Vaccine approved for continued use in US
The US FDA and CDC have confirmed that the single-shot COVID-19 vaccine’s benefits continue to outweigh the risks of clotting and have given approval for its use to resume.
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Inactivated COVID-19 vaccine candidate enters comparative immunogenicity trial
The Phase III trial aims to demonstrate that Valneva’s VLA2001 is more immunogenic than AstraZeneca's conditionally approved COVID-19 vaccine, Vaxzevria.
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INO-4800 COVID-19 vaccine provides cross-reactive immune responses against variants
Antibodies induced by the investigational DNA vaccine candidate, INO-4800, were found to be able to neutralise three SARS-CoV-2 emerging variants of concern.
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Novel leishmaniasis vaccine safely induces immune responses in patients
The ChAd63-KH vaccine, used to treat leishmaniasis rather than prevent in this trial, significantly improved symptoms in patients with persistent post-kala-azar dermal leishmaniasis.
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Novavax’ COVID-19 vaccine to be included in UK’s mixed regimen study
Novavax has agreed to participate in the University of Oxford’s Com-COV2 study evaluating the safety and efficacy of regimens consisting of doses of COVID-19 vaccines from different manufacturers.
