COVID-19 Boosters

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On September 24, 2021, the United States’ CDC made recommendations on who should or may receive a COVID-19 vaccine booster. These recommendations overstepped the vote made by the CDC’s Advisory Committee on Immunization Practices (ACIP), who voted against the recommendation that those 18-64 who have occupational exposure may receive a booster vaccine. In this podcast, we discuss the current evidence as of September 24, 2021 on boosters as well as the evidence-based risk-benefit analysis from the CDC ACIP meeting. Jeremy’s insights can be found at Inside Medicine.

First, the data presented from Pfizer is minimal and involves a total of 312 individuals who received boosters. We have no insight into effectiveness based on this.

In Israel, boosters were available to those ≥60 who completed the series ≥5 months prior beginning at the end of July. Bar-On et al report on this natural experiment.

The data presented at the CDC ACIP meeting can be found in the presentation slides available here.

Convalescent Plasma in Older Outpatients with Mild, Early COVID-19

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In this podcast, we cover a new article on convalescent plasma – this time, one that is promising! We cover Libster et al in NEJM, an RCT that administered placebo or plasma to older outpatients with mild COVID-19.

We have covered convalescent plasma multiple times before, including this introduction in May 2020, an RCT in June 2020, and another update in August 2020.

SARS-CoV-2 Vaccine in Pregnancy / Lactation

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Despite multiple Phase II/III vaccine trials of >30,000 participants, pregnant patients or those who are lactating have been largely excluded. In this podcast, we cover what we know (and what we don’t know thus far). The Pfizer BNT162b2 trial data submitted for FDA Emergency Use Authorization does include information on a minuscule number of patients who were immunized and became pregnant, as does the Moderna briefing. Although the risk of the vaccine in pregnancy is thought to be very low, the decision to receive the vaccine during pregnancy should balance the risks of the pregnant individual (to their health/family etc) and their comfort. At the University of Massachusetts Medical School – Baystate, we created a decision aid to help.

The biggest potential risk appears to stem from the reactogenicity of the vaccine – specifically the development of fever. However, the evidence on the harms from maternal fever during pregnancy is variable. Regardless, individuals who are pregnant and receive the vaccine, should probably take acetaminophen if they develop fever.

The Society for Maternal and Fetal Medicine has released statements on vaccines in SARS-CoV-2.

The Academy of Breastfeeding Medicine has also released guidance regarding the vaccine

In the United Kingdom, Public Health England has released guidance for their population on vaccination in pregnancy and breastfeeding which are rooted in the lack of data

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.