AstraZeneca and Oxford University announced interim results for their vaccine candidate, AZD1222, reporting (via press release) on an interim analysis of 131 cases of Covid-19 among experimental subjects in the UK and Brazil, using two dosing regimes. The more effective … Continue reading →
Moderna announced interim results for their vaccine candidate (and provided a bit more detail than Pfizer had): 94.5% efficacy. Of 95 cases observed in the Phase III trial, five had gotten the vaccine, and 90 the placebo. Moderna’s results come … Continue reading →
Pfizer and BioNTech announced that their vaccine candidate demonstrated greater than 90% efficacy in an early look at data from their Phase III trial. This is massively promising news from the first announced result from a late-stage US trial. The … Continue reading →
We have been writing about potential vaccines in late-stage trials — prophylactics intended to prevent Covid-19 disease and, ideally, infection with SARS-Cov-2. Another class of drugs is the therapeutics, such as the Regeneron “cocktail” the President received. The vaccines from … Continue reading →
Herewith three items of Covid-19 news you may have missed this week: Pfizer’s timeline for EUA application, normally apolitical science publications criticize the Trump administration, and the $16T cost of the pandemic in the US. Plus the accustomed frippery. Pfizer … Continue reading →
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 →
