The European Directorate for the Quality of Medicines and Healthcare (EDQM) has published a text on analytical strategy options for the control of COVID-19 recombinant viral vectored vaccines.
Novavax’s Phase 3 COVID-19 vaccine trial in the UK has been expanded to 15,000 participants; while a 30,000 strong Phase 3 clinical trial is due to start in the US and Mexico next month.
Johnson & Johnson says it is preparing to resume recruitment in its Phase 3 Janssen COVID-19 vaccine trial in the US: after the trial was paused because of an unexplained illness earlier this month.
Current COVID-19 vaccine Phase 3 trials are not designed to show whether they will save lives or reduce transmission: with trials instead based on events with mild symptoms, according to a feature published in The BMJ.
The UK is set to begin COVID-19 human challenge trials in January: aiming to increase understanding of coronavirus and speed up development of vaccine candidates.
Pfizer’s CEO says the company will apply for Emergency Use Authorisation (EUA) for its COVID-19 vaccine candidate ‘soon after’ a safety milestone is reached in the third week of November.
Potential vaccines for COVID-19 should not be affected by changes in SARS-CoV-2 seen to date, nor are they likely to need to be redeveloped seasonally, according to Australian scientists.
Johnson & Johnson has paused dosing in all its COVID-19 vaccine candidate clinical trials – including its Phase 3 trial – due to an unexplained illness in a study participant.
The progress in the race for a COVID-19 vaccine to date has been nothing short of phenomenal. But what can the industry learn from these achievements to inform vaccine development in the future?
On Tuesday the FDA released its guidance on Emergency Use Authorization for COVID-19 vaccines: a move welcomed by the industry as a ‘tried and true tradition of releasing guidance in a public and transparent way’.
Vaxxas has received a $22m US Government award to conduct a Phase 1 clinical study for its novel skin-patch vaccination platform. While the trial will use a pandemic influenza vaccine, Vaxxas is also investigating opportunities to use the technology against...
The Serum Institute of India will receive six 4,000L CSR bioreactors from ABEC to help it scale up manufacture of Novavax’s COVID-19 vaccine candidate.
Johnson & Johnson has launched its pivotal global Phase 3 trial for its COVID-19 vaccine candidate: anticipating the first batches of its vaccine will be available for emergency use authorization in early 2021.
Sanofi and GSK will provide the EU with up to 300 million doses of their COVID-19 vaccine candidate, with the agreement suppporting scale-up of manufacturing capabilities in several European countries.
BioNTech will acquire Novartis’ GMP certified manufacturing facility in Marburg, Germany: with the site set to become one of the largest mRNA manufacturing plants in Europe.
AstraZeneca has resumed UK clinical trials for its Oxford coronavirus vaccine, having paused all trials last week for a safety review. Other late-stage global trials, however, remain on hold while AstraZeneca waits for regulators in each market.
Transporting a COVID-19 vaccine to 7.8 billion people around the world would fill 8,000 jumbo jets – illustrating the enormity of the distribution challenge. The International Air Transport Association (IATA) warns of potential capacity constraints,...
The Australian Government has made a $1.7bn AUD ($1.24bn USD) supply and production agreement for COVID-19 vaccines: with the first doses set to come from AstraZeneca’s vaccine in January 2021.
