Here are key findings of the Food and Drug Administration's analysis of the Covid-19 vaccine developed by Pfizer and German partner BioNTech, as well as findings from the manufacturers. Both reports were released Tuesday.
The Vaccine is Effective
The vaccine is 95% effective at protecting against symptomatic Covid-19.
After the first dose, the vaccine showed to be more than 52% effective, protection that rose to 95% a week after the second dose was administered.
Effectiveness varies little by age, ethnicity, race
White people: 95% effective
Black people: 100% effective
All others, including American Indian, Asians and Pacific Islanders: 89% effective
People over 55: 94% effective
People with underlying conditions: 95% effective
Side effects are common but mostly minor
Eighty-four percent of trial subjects reported reactions at the injection site. After getting the vaccine, 63% of trial subjects reported fatigue, 55% headaches, 32% chills, 24% joint pain and 14% fever.
Bell's palsy, which is temporary muscle paralysis in the face, was found in four patients who received the vaccine, and none on the placebo. Three of the cases hadn't been resolved by Pfizer's regulatory submission in November. Sixty-four subjects who received the vaccine reported swelling of lymph nodes, compared with six on the placebo.
Next steps
Pfizer plans to monitor patients for two years to learn more about duration, since it isn't clear how long protection might last.
The FDA report goes to an outside advisory panel Thursday, which will recommend on whether the vaccine can be distributed on an emergency basis.
FDA authorization of the vaccine could come within days after Thursday's meeting.
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