Six deaths in Pfizer vaccine trial
Two people who received Pfizer's COVID-19 vaccine died during clinical trials, documents presented to the US Food and Drug Administration have revealed, but their deaths were regarded as normal events for their age group.
And the vaccine was found to provide strong protection against the virus 10 days after the first doses, the first detailed report on the vaccine provided to US regulators reveals.
Ten days after the first dose of the vaccine 52 per cent of people were protected from COVID-19, after two doses the vaccine was 95 per cent effective the papers reveal.
The coronavirus vaccine made by Pfizer-BioNTech is being rolled out in Britain this week and US regulators will decide within days whether it can be used there.
Australia has 10 million doses on order but our regulator is unlikely to approve it until January next year.
Pfizer and BioNTech released a 53-page briefing on its vaccine trial this morning and it revealed six people on the trial died.
Two of these people had received the experimental vaccine while the other four had received the placebo.
One older participant who received the vaccine experienced thickening of the arteries cutting off blood supply to their organs and died three days after receiving the first dose of the vaccine.
Another in the older age group who received the vaccine suffered a cardiac arrest 60 days after receiving the vaccine and died 3 days later.
"All deaths represent events that occur in the general population of the age group where they occurred, at a similar rate," the report said.
The briefing materials show the vaccine works well in both men and women and had similar efficacy rates in white, black and Latino people.
Obese people are at greater risk from COVID-19 and the clinical trial showed it worked well in them as well as the elderly.
A large number of people felt unwell after receiving the vaccine with half developing fatigue and headaches, one in three felt chills and muscle pain.
Originally published as Six deaths in Pfizer vaccine trial