Encouraging data from AZ/Oxford coronavirus shot

The coronavirus vaccine being developed by Oxford University and AstraZeneca produces a strong immune response in higher risk older patients, a study has found.

The phase 2/3 trial results published in The Lancet about the UK-developed shot follow more detailed findings from Pfizer/BioNTech showing that their vaccine protected 94% of adults over 65 years old.

Although both vaccines are not yet approved by regulators, the results are encouraging as older people seem to be most at risk from the virus.

The results from the UK-developed vaccine, codenamed AZD1222, come from a trial in 560 healthy adult volunteers.

Results from the phase 2 component of the trial were published ahead of phase 3 data expected in the coming days or weeks, which will provide a much clearer picture about the vaccine’s safety and efficacy.

Those taking part were assessed to see if they were fit and healthy enough to take part before being assigned to receive either an intramuscular injection of the coronavirus vaccine or a control vaccine.

Booster regimes were given 28 days apart and dosing regimen varied according to age group.

Findings showed that the vaccine, which is based around a weakened chimpanzee cold virus, produced a similar immune response across all age groups and was better tolerated in older adults than in younger adults.

Regulators in the UK and Europe have begun rolling reviews of several coronavirus vaccines, including the Oxford vaccine, but these results will not be enough for them to fully assess its safety and efficacy.

The data needed for that will come from the larger phase 3 trial, which will be reviewed quickly by the regulators in real-time under the rolling review to hasten a decision.

Separate results published by Pfizer yesterday show the vaccine it is developing with Germany’s BioNTech protect around 94% of adults over 65 years old.

The trial involved 41,000 people worldwide, half of whom received the vaccine, with the remainder given a placebo.

These latest figures from the older age group are an improvement on the 90% overall efficacy figures announced in top-line results earlier this month.

Pfizer is reportedly close to filing results with the FDA for an Emergency Use Authorization after gathering the required amount of safety data.

 

Don't miss your daily pharmaphorum news.
SUBSCRIBE free here.