(The New Daily) Six people died in Pfizer’s late-stage trial of the COVID-19 vaccine, the US Food and Drug Administration has revealed just hours after Britain became the first country in the world to roll out the vaccine.
Related Pfizer CEO ‘not certain’ its Covid vaccine prevents transmission
by Staff Writer, December 9th, 2020
But the deaths are said to raise no new safety issues or questions about the vaccine’s effectiveness because all represented events that occurred in the general population at a similar rate, the FDA concluded.
Its 53-page briefing report, released on Wednesday morning (Australian time) is the first detailed analysis of the vaccine trial by Pfizer and BioNTech, which found in November that its vaccine was 95 per cent effective in preventing coronavirus infections.
The documents revealed that two people who received the experimental vaccine had died during the trial. Four others who died were on a placebo.
“All deaths represent events that occur in the general population of the age groups where they occurred, at a similar rate,” the report said.
It confirmed the vaccine was, as reported by Pfizer, 95 per cent effective at least seven days after the second injection.
Data shows the vaccine was just 52 percent effective after the first dose.
The report concluded the vaccine’s efficacy data met the FDA’s expectations for emergency use authorisation.
There was, however, insufficient data for the FDA to conclude how safe the vaccine is in children under 16, pregnant women and people with compromised immune systems.
Later this week, a panel of independent scientists will assess the FDA’s report before recommending whether people aged 16 and older should receive the vaccine.
The FDA said results “showed similar efficacy point estimates across age groups, genders, racial and ethnic groups, and participants with medical comorbidities associated with high risk of severe COVID-19″.
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Source:
https://thenewdaily.com.au/news/coronavirus/2020/12/09/pfizer-oxford-astrazeneca-vaccines/
Pretty worthless headline when it you get to know 4 of the people died was in the placebo group :)
Where did you get that?
“There was, however, insufficient data for the FDA to conclude how safe the vaccine is in children under 16, pregnant women and people with compromised immune systems.
Later this week, a panel of independent scientists will assess the FDA’s report before recommending whether people aged 16 and older should receive the vaccine.”
Should that not read “16 and younger”?