Novavax, 14th June, NVX-CoV2373
https://ir.novavax.com/news-releases/news-release-details/novavax-covid-19-vaccine-demonstrates-90-overall-efficacy-and
https://novavax.reportablenews.com/pr/novavax-covid-19-vaccine-19-demonstrates-90-overall-efficacy-and-100-protection-against-moderate-and-severe-disease-in-prevent-19-phase-3-trial
Recombinant nanoparticle protein-based COVID-19 vaccine
Soapbark tree
Influenza and HPV
Fridge, 2 doses, 3 week gap
Placebo-controlled, double blind, randomized 2:1
100% protection against moderate and severe disease
All hospitalizations and deaths in placebo group
90.4% efficacy overall
91% efficacy in high-risk populations
(over 65 or comorbidities)
N = 29,960, 119 sites, U.S. and Mexico
File for regulatory authorizations in the third quarter
100 million doses per month, then 150 million per month by end of 2021
UK, with GlaxoSmithKline, 60 million doses, Barnard Castle
Results: Consistent, high efficacy among circulating variants
77 infections
Placebo group, 63
Ten moderate cases and four severe
Vaccine group, 14 in the vaccine group
All cases observed in the vaccine group were mild
January 25 through April 30, 2021
Alpha (B.1.1.7) variant, became the predominant strain in the U.S
100% efficacy against variants not considered VoC/Vo
Favorable safety profile
Generally well-tolerated
Serious and severe adverse events few, balanced between vaccine and placebo groups
Injection site pain and tenderness, generally mild to moderate, lasting less than 3 days
Fatigue, headache and muscle pain, lasting less than 2 days
The placebo-controlled portion of PREVENT-19 continues in
Adolescents, 12 to 18 years of age
Completed enrolment, n = 2,248
Operation Warp Speed, awarded Novavax $1.6 billion contract for 100 million future doses
Favorable outcome on viral load and culture viability using Ivermectin in early treatment of non-hospitalized patients with mild COVID-19 – A double-blind, randomized placebo-controlled trial
Sheba Medical Center, and Tel Aviv University
Ivermectin is an FDA-approved broad spectrum anti-parasitic agent
Initially approved in humans in 1987
Nobel prize of Medicine in 2015
With its high safety profile, ivermectin is a potential treatment against COVID-19 in its different stages.
https://www.medrxiv.org/content/10.1101/2021.05.31.21258081v1
To assess whether ivermectin can shorten the viral shedding in patients at an early-stage of COVID-19 infection
Double blinded randomized control trial
Patients receiving ivermectin 0·2 mg/kg for 3 days vs placebo
Non-hospitalized COVID-19 patients
RT-PCR, recruitment and then every two days
Primary endpoint was reduction of viral-load on the 6th day
As reflected by Ct level more than 30 (non-infectious level)
Primary outcome was supported by determination of viral culture viability
Results
N = 89
Ivermectin group, 47
Placebo group, 42
Females, 21·6%
Asymptomatic at recruitment, 16.8%
Symptomatic, 83%
On day 6
Ivermectin group
34 out of 47 (72%) reached the endpoint, (non-infectious level)
Placebo group
21 out of 42 (50%) reached the endpoint, (non-infectious level)
Odds of a negative test at day 6 was 2.62 time higher in the ivermectin group
Also
Ivermectin group, cultures at days 2 to 6 were positive in 3/23 (13·0%)
Placebo group, cultures at days 2 to 6 were positive in 14/29 (48·2%)
(p=0·008)
3 hospitalisations, 3 in the placebo group
Diarrhoea, 2 and 1
No other adverse effects were reported
Conclusions
There were significantly lower viral loads and viable cultures in the ivermectin group, which could lead to shortening isolation time in these patients.
https://ir.novavax.com/news-releases/news-release-details/novavax-covid-19-vaccine-demonstrates-90-overall-efficacy-and
https://novavax.reportablenews.com/pr/novavax-covid-19-vaccine-19-demonstrates-90-overall-efficacy-and-100-protection-against-moderate-and-severe-disease-in-prevent-19-phase-3-trial
Recombinant nanoparticle protein-based COVID-19 vaccine
Soapbark tree
Influenza and HPV
Fridge, 2 doses, 3 week gap
Placebo-controlled, double blind, randomized 2:1
100% protection against moderate and severe disease
All hospitalizations and deaths in placebo group
90.4% efficacy overall
91% efficacy in high-risk populations
(over 65 or comorbidities)
N = 29,960, 119 sites, U.S. and Mexico
File for regulatory authorizations in the third quarter
100 million doses per month, then 150 million per month by end of 2021
UK, with GlaxoSmithKline, 60 million doses, Barnard Castle
Results: Consistent, high efficacy among circulating variants
77 infections
Placebo group, 63
Ten moderate cases and four severe
Vaccine group, 14 in the vaccine group
All cases observed in the vaccine group were mild
January 25 through April 30, 2021
Alpha (B.1.1.7) variant, became the predominant strain in the U.S
100% efficacy against variants not considered VoC/Vo
Favorable safety profile
Generally well-tolerated
Serious and severe adverse events few, balanced between vaccine and placebo groups
Injection site pain and tenderness, generally mild to moderate, lasting less than 3 days
Fatigue, headache and muscle pain, lasting less than 2 days
The placebo-controlled portion of PREVENT-19 continues in
Adolescents, 12 to 18 years of age
Completed enrolment, n = 2,248
Operation Warp Speed, awarded Novavax $1.6 billion contract for 100 million future doses
Favorable outcome on viral load and culture viability using Ivermectin in early treatment of non-hospitalized patients with mild COVID-19 – A double-blind, randomized placebo-controlled trial
Sheba Medical Center, and Tel Aviv University
Ivermectin is an FDA-approved broad spectrum anti-parasitic agent
Initially approved in humans in 1987
Nobel prize of Medicine in 2015
With its high safety profile, ivermectin is a potential treatment against COVID-19 in its different stages.
https://www.medrxiv.org/content/10.1101/2021.05.31.21258081v1
To assess whether ivermectin can shorten the viral shedding in patients at an early-stage of COVID-19 infection
Double blinded randomized control trial
Patients receiving ivermectin 0·2 mg/kg for 3 days vs placebo
Non-hospitalized COVID-19 patients
RT-PCR, recruitment and then every two days
Primary endpoint was reduction of viral-load on the 6th day
As reflected by Ct level more than 30 (non-infectious level)
Primary outcome was supported by determination of viral culture viability
Results
N = 89
Ivermectin group, 47
Placebo group, 42
Females, 21·6%
Asymptomatic at recruitment, 16.8%
Symptomatic, 83%
On day 6
Ivermectin group
34 out of 47 (72%) reached the endpoint, (non-infectious level)
Placebo group
21 out of 42 (50%) reached the endpoint, (non-infectious level)
Odds of a negative test at day 6 was 2.62 time higher in the ivermectin group
Also
Ivermectin group, cultures at days 2 to 6 were positive in 3/23 (13·0%)
Placebo group, cultures at days 2 to 6 were positive in 14/29 (48·2%)
(p=0·008)
3 hospitalisations, 3 in the placebo group
Diarrhoea, 2 and 1
No other adverse effects were reported
Conclusions
There were significantly lower viral loads and viable cultures in the ivermectin group, which could lead to shortening isolation time in these patients.
