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Vaccine Development and Approval in a Time of Pandemic

Eye on FDA

Today the Food and Drug Administration will hold a meeting of the Vaccines and Related Biologics Advisory Committee (VRBAC) to consider the application for an Emergency Use Authorization (EUA) submitted by Pfizer/BioNTech for their investigative vaccine for COVID-19. After nearly 40 years, a vaccine still eludes us.

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Covid vaccine: Trial of new coronavirus vaccine starts in UK

The Pharma Data

A trial of a new vaccine that appears to train the immune system to fight coronavirus has begun in the UK. The trial on 10,000 people will now see if the vaccine can prevent people getting ill. Some of the vaccines being developed for Covid-19 use either completely new or barely proven technologies. .

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Deliberate Dysentery

Codon

Today, refined versions of these human challenge studies have become standard practice in testing vaccines for vector-borne diseases (e.g., Human challenge trials were an indispensable part of the development of the malaria vaccine, R21/Matrix-M, endorsed by the World Health Organization last October.

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COVID-19 Vaccine Developers Adjust Phase 3 Trial Protocols to Allow Authorized Vaccines | 2020-12-17

The Pharma Data

COVID-19 vaccine developers are faced with an ethical quandary — whether to let phase 3 trial participants become “unblinded” and to receive authorized vaccines as they become available, which could hinder the collection of meaningful trial data. Pfizer, which has received emergency approvals in the U.S.

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Nearly 700,000 US hospitalizations and 110,000 deaths prevented from the Pfizer-BioNTech COVID-19 vaccine

The Pharma Data

The profound health and economic impact of the Pfizer-BioNTech vaccine during its first year of rollout in the US is described in detail in a new study in the peer-reviewed Journal of Medical Economics. It is estimated that in 2021 the vaccine, the most widely used against COVID-19 in the US, prevented 8.7

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Sanofi and Translate Bio initiate Phase 1 clinical trial of mRNA influenza vaccine

The Pharma Data

Sanofi and Translate Bio initiate Phase 1 clinical trial of mRNA influenza vaccine. The trial will evaluate the safety and immunogenicity of a monovalent flu vaccine candidate coding for the hemagglutinin protein of the A/H3N2 strain of the influenza virus. JUNE 22 , 2021.

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Promising Interim Results from Clinical Trial of NIH-Moderna COVID-19 Vaccine

The Pharma Data

November 16, 2020 — An independent data and safety monitoring board (DSMB) overseeing the Phase 3 trial of the investigational COVID-19 vaccine known as mRNA-1273 reviewed trial data and shared its interim analysis with the trial oversight group on Nov.