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AstraZeneca Pauses Vaccine Trial for Safety Review

NY Times

The company halted late-stage trials of its coronavirus vaccine because of a serious suspected adverse reaction in a participant.

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Health Canada approves Novavax’s Covid-19 vaccine for adolescents

Pharmaceutical Technology

Health Canada has granted approval for a supplement to a New Drug Submission (sNDS) of Novavax ’s Covid-19 vaccine (Recombinant protein, Adjuvanted), Nuvaxovid (NVX-CoV2373), for use in adolescents aged 12 to 17 years. The trial is designed to analyse the safety and effectiveness of the vaccine.

Vaccines 105
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EC approves Novavax’s Covid-19 vaccine CMA expansion for adolescents

Pharmaceutical Technology

The European Commission (EC) has granted approval for the expanded conditional marketing authorization (CMA) of Novavax’s Covid-19 vaccine, Nuvaxovid (NVX-CoV2373), in the European Union (EU) for adolescents of the age 12 to 17 years. A protein-based vaccine, NVX-CoV2373 is made from the genetic sequence of the SARS-CoV-2 virus’ first strain.

Vaccines 105
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FDA reviewers back Pfizer/BioNTech COVID-19 vaccine ahead of panel

pharmaphorum

Reviewers from the FDA have given their blessing to the Pfizer/BioNTech COVID-19 vaccine ahead of a key meeting tomorrow – but the regulator noted that there are still uncertainties about whether the shot can stop the disease from spreading. The post FDA reviewers back Pfizer/BioNTech COVID-19 vaccine ahead of panel appeared first on.

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Allergic reactions prompt Moderna COVID vaccine pause in California

pharmaphorum

Public health authorities in California are seeking a halt on dosing of one lot of Moderna’s COVID-19 vaccine after reports of allergic reactions at one immunisation clinic. The clinic in question switched to another lot of Moderna vaccine after closing for a few hours.

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Rare MIS-C Does Not Appear to Impact COVID-19 Vaccine Safety in Children

Pharmacy Times

Children who experienced COVID-19-induced multisystem inflammatory syndrome did not experience severe adverse reactions following COVID-19 vaccination.

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STAT+: Pharmalittle: FDA holds rare second meeting over an ALS drug; U.S. to expand distribution for monkeypox vaccine

STAT

 Moving forward, the company will expand patient monitoring in the trial to watch for low magnesium levels, which had resulted in a serious adverse reaction in one study participant that led the FDA to suspend testing earlier this year. Food and Drug Administration on changes to the study’s plan , BioPharma Dive writes. Moving