Good vaccine news in US

AZD1222 US Phase III trial met primary efficacy endpoint in preventing COVID-19 at interim analysis

Interim safety and efficacy analysis

N = 32,449

2:1 randomisation of vaccine to placebo

Accruing 141 symptomatic cases of COVID-19

Statistically significant vaccine efficacy of 79% at preventing symptomatic COVID-19

100% efficacy at preventing severe disease and hospitalisation

Vaccine efficacy was consistent across ethnicity and age

Aged 65 years and over, vaccine efficacy was 80%

The vaccine was well tolerated

Favourable reactogenicity and overall safety

Independent data safety monitoring board (DSMB) identified no safety concerns

DSMB conducted a specific review of thrombotic events, as well as cerebral venous sinus thrombosis

(CVST) with the assistance of an independent neurologist

DSMB found no increased risk of thrombosis or events characterised by thrombosis, n = 21,583, receiving at least one dose of the vaccine

The specific search for CVST found no events in this trial

79% white/Caucasian

8% black/African American

4% native American

4% Asian

22% of participants were Hispanic.

Two doses administered, four week interval

Extended interval of up to 12 weeks demonstrated greater efficacy

Supported by immunogenicity data

This evidence suggests administration of the second dose with an interval

Longer interval could further increase efficacy

and accelerates the number of people who can receive their first dose

Stored, transported and handled at normal refrigerated conditions

2-8 degrees Celsius or 36-46 degrees Fahrenheit, for at least six months

Counter argument

Concerned by information released by AstraZeneca on initial data from its COVID-19 vaccine clinical trial.

AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data.

Food and Drug Administration and Centers for Disease Control and Prevention to decide.

After thorough review of the data by independent advisory committees