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Tag: vaccines
January 29, 2021
Johnson & Johnson Announces Single-Shot Janssen COVID-19 Vaccine Candidate Met Primary Endpoints in Interim Analysis of its Phase 3 ENSEMBLE Trial
[Press release, not peer-reviewed] The Johnson and Johnson single-dose COVID-19 candidate vaccine had 66% efficacy against moderate to severe COVID-19, based on a press release describing the phase 3 clinical trial results from the ENSEMBLE trial. Among all participants including those infected with an emerging viral variant the vaccine prevented moderate to severe COVID-19 28…
January 28, 2021
Novavax COVID-19 Vaccine Demonstrates 89.3% Efficacy in UK Phase 3 Trial
[Press release, not peer-reviewed] Preliminary results for phase 2/3 trials for the recombinant protein-based COVID-19 vaccine NVX-CoV2373 made by Novavax showed up to 89.3% efficacy in the UK cohort (n= >15,000), where 56 participants in the placebo group developed COVID-19 vs 6 in the vaccine group. Of note, the B.1.1.7 variant was observed in 32…
Neutralization of Spike 6970 Deletion E484K and N501Y SARS-CoV-2 by BNT162b2 Vaccine-Elicited Sera
[Pre-print, not peer-reviewed] Sera from recipients who completed the 2-dose regimen of the Pfizer vaccine BNT162b2 (n=20) had similar neutralizing geometric mean titers (GMTs) against SARS-CoV-2 viruses engineered to contain key spike protein mutations from variants emerging from the UK (B.1.1.7) and South Africa (B.1.351) compared to GMTs against the wild-type virus. Compared to the…
January 27, 2021
Trends Regional Variation and Clinical Characteristics of COVID-19 Vaccine Recipients a Retrospective Cohort Study in 23.4 Million Patients Using OpenSAFELY
[Pre-print, not per-reviewed] A retrospective cohort study of electronic health record data from the National Health System in England from 23.4 million patients using the OpenSAFELY-TPP platform found that between December 8 and January 13, 2021, a total of 961,580 people received a COVID-19 vaccine. Of 1,160,062 patients aged 80 or over and not living…
Increased Resistance of SARS-CoV-2 Variants B.1.351 and B.1.1.7 to Antibody Neutralization
[Pre-print, not per-reviewed] The SARS-CoV-2 variant B.1.1.7 (UK) was resistant to neutralization by several monoclonal antibodies (mAbs) targeting either the N-terminal domain (NTD) of the virus’s spike protein or its receptor-binding domain (RBD). This variant was also modestly more resistant to neutralization with convalescent plasma (about 3 fold) and sera from people who had received…
January 25, 2021
MRNA-1273 Vaccine Induces Neutralizing Antibodies against Spike Mutants from Global SARS-CoV-2 Variants
[Pre-print, not peer-reviewed] Sera from human subjects or non-human primates (NHPs) that received the mRNA-1273 (Moderna) vaccine showed no significant reduction in neutralization activity against the SARS-CoV-2 B.1.1.7 variant emerging from the UK, but reduced activity against the B.1.351 variant emerging from South Africa. The study used two pseudovirus neutralization assays expressing spike proteins of…
The Potential Public Health and Economic Value of a Hypothetical COVID-19 Vaccine in the United States: Use of Cost-Effectiveness Modeling to Inform Vaccination Prioritization
A Markov cohort model estimating COVID-19 related direct medical costs and deaths in the US found that with a SARS-CoV-2 vaccine with 60% efficacy, the incremental cost per quality-adjusted life-year (QALY) gained for the US adult population would be $8,200 (compared to no vaccination). For those at high risk of hospitalization and death, vaccination was…
January 22, 2021
Allergic Reactions Including Anaphylaxis After Receipt of the First Dose of Pfizer-BioNTech COVID-19 Vaccine
CDC identified 21 case reports of anaphylaxis during the administration of a reported 1,893,360 first doses of Pfizer-BioNTech COVID-19 vaccine between December 14 and 23, 2020. Of these 21 cases, four people (19%) were hospitalized and 17 (81%) were treated in emergency departments. No deaths from anaphylaxis were reported. Seventeen (81%) of 21 patients with…
Allergic Reactions Including Anaphylaxis After Receipt of the First Dose of Moderna COVID-19 Vaccine — United States, December 21, 2020–January 10, 2021
Between December 21, 2020 and January 10, 2021, monitoring by the Vaccine Adverse Event Reporting System detected ten cases of anaphylaxis after administration of a reported 4,041,396 first doses of the Moderna COVID-19 vaccine in the US. In nine cases, onset occurred within 15 minutes of vaccination. Nine of the ten cases of anaphylaxis occurred…
January 20, 2021
Neutralization of SARS-CoV-2 Lineage B.1.1.7 Pseudovirus by BNT162b2 Vaccine-Elicited Human Sera
[Pre-print, not peer-reviewed] A study comparing two SARS-CoV-2 non-replicating laboratory-produced pseudoviruses bearing either the spike proteins of the Wuhan reference strain or the B.1.1.7 variant strain concluded that it was unlikely that the new variant would escape immune effectors induced by the Pfizer/BioNTech vaccine (BNT162b2). No biologically significant difference in neutralization activity against the two…
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