Pfizer Inc and BioNTech announced on Tuesday the start in Japan of combined Phase I and Phase II clinical trials of their mRNA vaccine candidate against the coronavirus. The study will recruit 160 people aged from 20 to 85, the firms said in a statement. Earlier, they had agreed to supply Japan with 120 million doses of their experimental coronavirus vaccine in the first half of 2021.
Pfizer, which is developing the vaccine with German partner BioNTech, has said it may confirm if the vaccine is effective as soon as this month, but also needs safety data from a global trial of 44,000 people that will not be available until next month. Japan has pledged to secure enough vaccine supply for its entire population by the middle of 2021. In addition to Pfizer, it has struck deals on supplies with AstraZeneca Plc and other overseas makers of vaccine candidates.
U.K. Begins World’s First COVID-19 Challenge Study
Researchers in the U.K. are set to deliberately infect young, healthy volunteers with SARS-CoV-2. The challenge study, which has £33.6 million ($43.6 million) in government support, could shed light on how people react to the virus and accelerate development of vaccines.
Challenge studies have been used to study vaccines and medicines against influenza and a range of other viral pathogens. The studies entail the infection and close monitoring of volunteers in highly controlled environments. Advocates of the approach have pushed for its use in the study of vaccines against COVID-19 since early in the pandemic in the belief it can accelerate development.
Now, the U.K. has taken a big step toward running the first COVID-19 challenge study. Working with funding from the U.K. government, specialist contract research organization hVIVO, Imperial College London and The Royal Free Hospital are set to start a challenge study in January.