SARS-CoV-2 Vaccine Update

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In this episode, we review what we know, as of November 29, 2020, about the major SARS-CoV-2 vaccine candidates – their mechanisms of action and preliminary data. Be aware that most of the data is preliminary and exact numbers may change (and long-term data is not yet available)

Moderna vaccine data

Phase I dose-escalation trial (Jackson et al NEJM 2020) and small 40 patient study of immunogenicity in older adults (Anderson et al NEJM 2020). (phase III study protocol )

Phase III trial results (Baden et al, NEJM)

  • >30,000 participants within the US
    • 37% from racial/ethnic minority groups (>6000 Hispanic participants, >3000 African American participants)
    • 22% healthcare workers
    • >14,000 female
    • >7000 >65 years old

Pfizer/BioNTech vaccine data

Data from the FDA Emergency Use Authorization Briefing and Polack et al in NEJM

About 19,000 participants were followed for ≥2 months

  • Looked at common side effects in 8,000 of the participants. Fatigue 3.7% after 2nd dose, headache 2%

Distribution fact sheet

AstraZeneca vaccine data

Phase I/II safety/immunogenicity study (Folegatti et al Lancet 2020)

Press Release data (11/23/20) from an interim (phase III trial protocol)

Lancet manuscript Phase 2/3 trial results

Johnson & Johnson vaccine data

Phase I/IIa safety/immunogenicity study (Sadoff et al MedRxiv.org [pre-print])

Novavax vaccine data

Phase I/II safety/immunogenicity trial

Phase III information (US trial not yet underway)

Steroids in COVID-19

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We are bringing you near-daily updates on COVID-19. There is a firehose of information and most of us are too busy to read and digest it all. Note: If you are listening to these more than a few days in the future, please beware that information may have changed and check subsequent episodes. This episode was recorded September 3, 2020.

We have previously covered the RECOVERY trial’s reporting of the use of dexamethasone in hospitalized patients with COVID-19. In the wake of those results, several ongoing trials of steroids in COVID-19 were halted, due to concerns about loss of equipoise. Three of these trials were published in JAMA on September 2, 2020 in conjunction with a meta-analysis from the WHO REACT working group.

COVID-19: Convalescent Plasma Update

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We are bringing you near-daily updates on COVID-19. There is a firehose of information and most of us are too busy to read and digest it all. Note: If you are listening to these more than a few days in the future, please beware that information may have changed and check subsequent episodes. This episode was recorded August 24, 2020.

Convalescent plasma has been a potential therapy for COVID-19. We covered the basics in this post, an RCT (Li et al) in this post. Here we discuss the US experience to date, which, despite detailing >35,000 patients who received plasma, did not randomize patients.

COVIDcast: Remdesivir vs Standard of Care

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We are bringing you near-daily updates on COVID-19. There is a firehose of information and most of us are too busy to read and digest it all. Note: If you are listening to these more than a few days in the future, please beware that information may have changed and check subsequent episodes. This episode was recorded August 23, 2020.

Remdesivir, an inhibitor of viral RNA-dependent RNA polymerase, has been investigated for COVID-19. We have previously covered the initial uncontrolled report, the ACTT-1 trial, and a trial of 5-days vs 10 days of remdesivir which showed no difference. Here we have another trial by Spinnner et al in JAMA 2020.

COVID-19: Hydroxychloroquine [RECOVERY trial]

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We are bringing you near-daily updates on COVID-19. There is a firehose of information and most of us are too busy to read and digest it all. Note: If you are listening to these more than a few days in the future, please beware that information may have changed and check subsequent episodes. This episode was recorded June 22, 2020

We’ve been looking at a treatment for severe COVID-19 and this massive trial from the United Kingdom, the RECOVERY trial published a pre-print of the results from the hydroxychloroquine arm (previously they published their promising results on dexamethasone). Note: these results are preliminary and have not been peer-reviewed

Hornby et al. [pre-print] supplement

COVID-19: Dexamethasone [RECOVERY trial]

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We are bringing you near-daily updates on COVID-19. There is a firehose of information and most of us are too busy to read and digest it all. Note: If you are listening to these more than a few days in the future, please beware that information may have changed and check subsequent episodes. This episode was recorded June 22, 2020

We’ve been looking at a treatment for severe COVID-19 and this massive trial from the United Kingdom, the RECOVERY trial [protocol], published a pre-print of the results of the dexamethasone portion of the trial. Note: these results are preliminary and have not been peer reviewed

Hornby et al [pre-print]