When did pfizer announce vaccine trial#

“We recruited more than 44,000 patients and made our submission for emergency authorization in 248 days – for anyone familiar with clinical trial timelines, even considering vaccine trials generally have to move fast, this is unprecedented. “The Pfizer/BioNTech clinical trial was one of the largest and fastest randomised trial ever conducted,” Nuala Murphy, president of ICON Clinical Research Services, told us. This ranged from providing site training, document management and operational support for patient Informed Consent Form review, coordinated eConsent in most countries, and assisting with clinical supply management services. In 2020 it stepped up to take on the COVID-19 vaccine trial. In July, the selected candidate – BNT162b2 – moved into a global Phase 2/3 trial.ĭublin-headquartered ICON had already been providing Pfizer with clinical trial services for some 30 years and formed a strategic relationship with the company in 2011 on the planning, execution, management and conduct on clinical trials. At this point, Pfizer/BioNTech were still assessing four different candidates: with a novel design of the trial allowing for the evaluation of the various mRNA candidates simultaneously in order to identify the safest and most efficacious in a greater of number of volunteers, in a manner to facilitate the sharing of data with regulatory authorities in real time.

Here, the Phase 1/2 studies in Germany and the US - designed to determine the safety, immunogenicity and optimal dose level of a vaccine – were already deviating from the norm. Taking the vaccine into the clinicĬlinical trials for the Pfizer/BioNTech vaccine began in May 2020: having brought a potential vaccine using new mRNA tech into the clinic in less than four months. And it notes that the pandemic has accelerated an existing trend towards decentralised and hybrid trials. It was able to draw on its experience in running trials on the ground during the Ebola pandemic – meaning it was able to adapt to difficult circumstances – but had to scale up this know-how into a global trial working with 150 sites across the US, Europe, South Africa and Latin America.ĭigital innovations – such as remote monitoring – proved their worth in the pandemic and the learnings from COVID-19 trials will be able to help improve future clinical trial processes, says the company. Global contract research organization ICON ran the trial.

When did pfizer announce vaccine