Vaccination and ivermectin

Novavax, 14th June, NVX-CoV2373

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.

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.