Novavax

https://www.novavax.com/covid-19-coro...

https://www.gov.uk/government/news/no...

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-a...

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)