Herewith three items of Covid-19 news you may have missed this week: the FDA wants more AstraZeneca data, Operation Warp Speed’s military staffing, and a deep dive into the vaccine testing process. Plus a brace of fripperies. FDA wants more … Continue reading →
This week two Operation Warp Speed-supported vaccine makers began Phase III trials: Johnson & Johnson began enrolling 60,000 participants in the US and worldwide on Monday, and yesterday Novavax opened a 10,000-person trial in the UK. Johnson & Johnson / … Continue reading →
The Washington Post reports that the FDA will soon release tough new standards for granting emergency authorization for any Covid-19 vaccine — standards that all but guarantee that none could get the green light before mid-November. It looks to me … Continue reading →
After pressure from scientists and public health experts, vaccine makers are releasing the detailed protocols for their Phase III vaccine trials. Moderna went first yesterday morning and Pfizer followed in the afternoon. The others will come around. These documents let … Continue reading →
The biggest drawback to one of the vaccine candidates receiving an FDA Emergency Use Authorization: it would halt the Phase III trial and destroy any chance of getting more data about that vaccine’s safety, efficacy, and longevity. On the This … Continue reading →
You have probably heard that one of the three vaccine makers in Phase III trials in the US, AstraZeneca, has paused its effort while an outside committee studies a “serious adverse incident.” This is jargon for “something bad happened.” AZ … Continue reading →
Yesterday AstraZeneca opened a US branch of the worldwide Phase III study of its Covid-19 vaccine, developed by Oxford University. The study, funded by NIAID and BARDA, will enroll 30,000 subjects in 80 sites across the US. AstraZeneca / Oxford … Continue reading →
J&J confirmed reports that its large-scale clinical trial will begin in September, involving 60,000 subjects worldwide — twice the size of the Phase IIIs begun in July by Pfizer and Moderna. The study is not yet recruiting. Johnson & Johnson … Continue reading →
Yesterday two of the four farthest-along candidates for a Covid-19 vaccine announced Phase III trials for safety and efficacy. Pfizer / BioNTech and Moderna will each enroll 30,000 test subjects, ages 18–85, in the US. Pfizer / BioNTech candidate BNT162b2: … Continue reading →
