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Category Archives: Phase III

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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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Recent Posts

  • Tuesday Update for 2021-01-12: Inhalable 2021-01-12
  • Friday Update for 2021-01-08: Plasma 2021-01-08
  • Tuesday Update for 2021-01-05: Dosing 2021-01-05
  • Vaccine Availability Projections Over Time 2021-01-04
  • Friday Update for 2021-01-01: Threshold 2021-01-01
  • The UK Goes Its Own Way 2020-12-31
  • Tuesday Update for 2020-12-29: Novavax 2020-12-29
  • Friday Update for 2020-12-25: Comirnaty 2020-12-25
  • Tuesday Update for 2020-12-22: Sleep 2020-12-22
  • Not Throwing Away My Shot 2020-12-21
  • Two New Viral Variants 2020-12-20
  • The Twelve Months of Covid 2020-12-19

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Recent Comments

  • Keith Dawson on Friday Update for 2021-01-01: Threshold
  • Karen Muller on Friday Update for 2021-01-01: Threshold
  • Kathryn Ellis Moore on Tuesday Update for 2020-12-29: Novavax
  • Keith Dawson on Friday Update for 2020-12-25: Comirnaty
  • Linda Graziano on Friday Update for 2020-12-25: Comirnaty
  • Keith Dawson on Friday Update for 2020-12-25: Comirnaty
  • Linda Graziano on Friday Update for 2020-12-25: Comirnaty
  • Keith Dawson on Friday Update for 2020-12-25: Comirnaty
  • Keith Dawson on Friday Update for 2020-12-25: Comirnaty
  • Linda Graziano on Friday Update for 2020-12-25: Comirnaty
  • Keith Dawson on Not Throwing Away My Shot
  • Doug Pardee on Not Throwing Away My Shot

Recent Updates

  • The UK Goes Its Own Way on 2021-01-02
  • The UK Goes Its Own Way on 2021-01-01
  • Tuesday Update for 2020-12-22: Sleep on 2020-12-23
  • Two New Viral Variants on 2020-12-22
  • Two New Viral Variants on 2020-12-21
  • Two New Viral Variants on 2020-12-20
  • AstraZeneca: Efficacy Is 90% on 2020-11-23
  • Friday Update for 2020-11-20 on 2020-11-20
  • Pfizer: Efficacy Is Above 90% 95% on 2020-11-18
  • Moderna: Efficacy Is 94.5% on 2020-11-16
  • Mink Reservoir on 2020-11-10
  • Tuesday Update for 2020-10-27 on 2020-10-29
  • Pandemic Time Travel on 2020-10-09
  • No Authorized Vaccine by Election Day on 2020-09-24
  • Phase III Detailed Protocols (2) on 2020-09-21
  • AstraZeneca / Oxford Phase III Paused on 2020-09-12
  • The Vaccine Makers Pledge on 2020-09-08

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