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Category Archives: Phase III

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AstraZeneca: Efficacy Is 90%

Suddenly at Home Posted on 2020-11-23 by Keith Dawson2020-11-23

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 →

Posted in Phase III, Vaccines | Leave a reply

Moderna: Efficacy Is 94.5%

Suddenly at Home Posted on 2020-11-16 by Keith Dawson2020-11-16

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 →

Posted in Phase III, Vaccines | 1 Reply

Pfizer: Efficacy Is Above 90% 95%

Suddenly at Home Posted on 2020-11-09 by Keith Dawson2020-11-18

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 →

Posted in Phase III, Vaccines | 4 Replies

Prophylactics, Therapeutics, and AstraZeneca

Suddenly at Home Posted on 2020-10-21 by Keith Dawson2020-10-21

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 →

Posted in Monoclonal Antibodies, Phase III, Vaccines | 3 Replies

Friday Update for 2020-10-16

Suddenly at Home Posted on 2020-10-16 by Keith Dawson2020-11-09

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 →

Posted in Phase III, Politics | Leave a reply

Friday Update for 2020-10-02

Suddenly at Home Posted on 2020-10-02 by Keith Dawson2020-10-02

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 →

Posted in Phase III | 2 Replies

Johnson & Johnson, Novavax Phase IIIs

Suddenly at Home Posted on 2020-09-25 by Keith Dawson2020-12-29

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 →

Posted in Medical Studies, Phase III, Vaccines | Leave a reply

No Authorized Vaccine by Election Day [Update — ??]

Suddenly at Home Posted on 2020-09-23 by Keith Dawson2020-09-24

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 →

Posted in Phase III, Politics, Vaccines | Leave a reply

Phase III Detailed Protocols

Suddenly at Home Posted on 2020-09-18 by Keith Dawson2020-09-21

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 →

Posted in Medical Studies, Phase III, Vaccines | Leave a reply

The Real Cost of an Early EUA

Suddenly at Home Posted on 2020-09-10 by Keith Dawson2020-12-11

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 →

Posted in Emergency Use Authorization, Medical Studies, Phase III, Vaccines | Leave a reply

AstraZeneca / Oxford Phase III Paused [Update: restarted]

Suddenly at Home Posted on 2020-09-09 by Keith Dawson2020-09-12

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 →

Posted in Medical Studies, Phase III | 1 Reply

AstraZeneca / Oxford Phase III

Suddenly at Home Posted on 2020-09-02 by Keith Dawson2020-09-23

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 →

Posted in Medical Studies, Phase III, Vaccines | Leave a reply

Johnson & Johnson / Janssen Phase III

Suddenly at Home Posted on 2020-08-21 by Keith Dawson2020-09-08

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 →

Posted in Clinical Trials, Medical Studies, Phase III | Leave a reply

Pfizer and Moderna Phase IIIs

Suddenly at Home Posted on 2020-07-28 by Keith Dawson2020-09-08

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 →

Posted in Medical Studies, Phase III, Vaccines | 1 Reply

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