The Pharma Data

NOVEMBER 22, 2020

As the Pfizer and BioNTech COVID-19 vaccine goes to regulators and the Moderna vaccine approaches the end of its Phase III trials, AstraZeneca and the University of Oxford announced high-level results from an interim analysis of their COVID-19 vaccine, AZD1222. There were no serious adverse safety events.

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The Pharma Data

SEPTEMBER 23, 2020

The halting of AstraZeneca’s COVID-19 vaccine trial around the world was cause for much initial concern over the eventual safety and efficacy of the therapy. Eventually, it’s the public who will either take this vaccine or not, so it is to their advantage to be transparent as possible.”. Matt Fellows. Source link.

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The Pharma Data

SEPTEMBER 9, 2020

The vaccine supply for the EU would be produced by BioNTech’s manufacturing sites in Germany and Pfizer’s manufacturing site in Belgium. The proposed supply agreement with the European Commission would represent the largest initial order of vaccine doses for Pfizer and BioNTech to date. billion doses by the end of 2021.

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Agency IQ

DECEMBER 1, 2023

The FDA also implemented new flexibilities for certain regulated products and processes, typically via enforcement discretion. It also stated that companies should consider whether an investigational product might interact with an administered vaccine for Covid-19.

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Agency IQ

NOVEMBER 3, 2023

Unfortunately, there is no regulatory body that governs the terminology used in this space, although there are definitions that are generally accepted by the scientific community. Postbiotic: “Preparation of inanimate micro-organisms and/or their components that confers a health benefit on the host,” according to the ISAPP definition.

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The Pharma Data

OCTOBER 22, 2020

The twenty-sixth meeting of the Emergency Committee under the International Health Regulations (2005) (IHR) on the international spread of poliovirus was convened and opened by the WHO Deputy Director-General on 14 October 2020 with committee members attending via video conference, supported by the WHO Secretariat.

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Agency IQ

NOVEMBER 3, 2023

A 2017 European Parliament resolution called on the European Commission and the European Council “to formulate a better definition of the concept – and analyse the causes – of shortages of medicines.” Regulation (EU) 2022/123 became applicable on March 1, 2022, with the exception of most provisions related to medical devices.

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