Novavax
https://www.novavax.com/covid-19-coronavirus-vaccine-candidate-updates
https://www.gov.uk/government/news/novavax-publishes-positive-efficacy-data-for-its-covid-19-vaccine
US company, US and UK science
Operation Warp Speed
Engineered viral protein, with a plant-based ingredient
Normal fridge
UK, N = 15,000
Over the age of 65, n = 4,000
NVX-CoV2373
Novavax COVID-19 Vaccine Demonstrates 89.3% Efficacy in UK Phase 3 Trial
First to Demonstrate Clinical Efficacy Against UK and South Africa Variants
51% of phase 3 participants had new UK variant
Efficacy against old strain = 95.6%
Efficacy against new variant = 85.6%
Based on 62 cases
56 cases in the placebo group
6 cases in the vaccine group
Of the 62 cases, 61 were mild or moderate, and 1 was severe (in placebo group).
Safety
Interim analysis
Severe, serious, and medically attended adverse events occurred at low levels
Balanced between vaccine and placebo groups
Clive Dix, Chair, UK Vaccine Taskforce
These are spectacular results
The efficacy shown against the emerging variants is also extremely encouraging
UK timelines
UK, 60 million doses, second half of 2021
Made in Teesside, north east England
FUJIFILM Diosynth Biotechnologies’s facilities in Billingham
Company is planning to submit its data to the regulators
Over to Medicines and Healthcare products Regulatory Agency (MHRA)
Joint Committee on Vaccination and Immunisation (JCVI)
South Africa Novavax Results
N = 4,400
Phase 2b clinical trial
Approximately 92.6% of cases attributed to South Africa variant
Triple mutant variant, 3 critical mutations in the receptor binding domain (RBD)
Multiple mutations outside the RBD
HIV Negative participants
94% of the study population was HIV-negative
60% efficacy for disease prevention
One severe case in the placebo group
All other cases mild or moderate
HIV-positive participants (19% of adults)
49.4% efficacy
Also about South Africa
Prior infection with COVID-19 may not completely protect against subsequent infection by the South Africa escape variant
Vaccination with NVX-CoV2373 provided significant protection
Novavax, working on a vaccine specifically targeted to the variant
Novavax, US and Mexico phase 3 trial
Significant progress on PREVENT-19 Clinical Trial in US and Mexico
PREVENT-19 has randomized over 16,000 participants
Complete targeted enrolment of 30,000 patients in the first half of February
Janssen, J and J
https://www.jnj.com/johnson-johnson-announces-single-shot-janssen-covid-19-vaccine-candidate-met-primary-endpoints-in-interim-analysis-of-its-phase-3-ensemble-trial
Adenovirus vector
Fridge temperatures
Phase 3, ENSEMBLE, 29th January
N = 43,783
468 symptomatic cases
Efficacy in preventing disease
66% effective overall in preventing disease
United States, 72% efficacy
Latin America, 66%
South Africa, 57%
28 days post-vaccination
Onset of protection was observed as early as day 14
Efficacy in preventing severe disease at 28 days
Globally, 85 %
Demonstrated complete protection against COVID-related hospitalization and death, 28 days post-vaccination.
In all adults 18 years and older
Efficacy against severe disease increased over time, with no cases in vaccinated participants reported after day 49
Protection
Generally consistent across race, age groups, including adults over 60 years of age (N= 13,610)
Including South Africa where nearly all cases B.1.351 lineage
Safety Data
Independent group of experts
Did not report any significant safety concerns
Vaccine candidate was generally well-tolerated.
Fever rates were 9%
Overall serious adverse events (SAEs) reported were higher in participants who received placebo as compared to the active vaccine candidate
No anaphylaxis was observed
Rollout
About £7 per dose (not for profit)
UK, ordered 30 million doses
8 plants in 7 countries
Over to, Medicines and Healthcare products Regulatory Agency (MHRA)
Joint Committee on Vaccination and Immunisation (JCVI)
Source