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Newly released info about the UK approval of @pfizer @BioNTech_Group #COVID19 #vaccine h/t @hildabast
- Approved is for those 16 yrs & older
- 2 doses at least 21 days apart
- Immune response peaks >= 7 days after
- Should not be given during severe acute febrile illness 1/
- Approved is for those 16 yrs & older
- 2 doses at least 21 days apart
- Immune response peaks >= 7 days after
- Should not be given during severe acute febrile illness 1/
Safety data from 2 trials enrolling 44,060 people in US, Europe, Turkey, South Africa, & South America. 9K ppl received the vaccine and have been followed for 2 months. Mild adverse reactions common: pain (>80%), fatigue (>60%), headache (>50%), myalgia (>30%), chills (> 30%). 2/
Suspected adverse reactions will continue to be reported among UK vaccinees via the Coronavirus Yellow Card reporting site to ensure ongoing evaluation of safety. 3/ https://coronavirus-yellowcard.mhra.gov.uk/
Efficacy data from same 2 trials, 36,621 participants eligible for primary analysis, stratified by age into groups: 12-15 years, 16-55 years, and 56 years & older. Excluded those previously infected w/SARS-CoV-2 or ill w/COVID19 & those immunocompromised. 4/
@pfizer @BioNTech_Group
#COVID19 #Vaccine Efficacy estimate for those 16 yrs and older, at least 7 days after dose 2, plus no prior SARS-COV-2 infection:
95.0% (95% credible interval: 90.3 to 97.6).
5/
#COVID19 #Vaccine Efficacy estimate for those 16 yrs and older, at least 7 days after dose 2, plus no prior SARS-COV-2 infection:
95.0% (95% credible interval: 90.3 to 97.6).
5/
@pfizer @BioNTech_Group #COVID19
#Vaccine Efficacy estimate for those 65 yrs and older, 7 days after dose 2, plus no prior SARS-COV-2 infection:
94.7% (two-sided 95% confidence interval: 66.7 to 99.9).
6/
#Vaccine Efficacy estimate for those 65 yrs and older, 7 days after dose 2, plus no prior SARS-COV-2 infection:
94.7% (two-sided 95% confidence interval: 66.7 to 99.9).
6/
@pfizer @BioNTech_Group #COVID19
#Vaccine Efficacy estimate for those 75 yrs and older, 7 days after dose 2, plus no prior SARS-COV-2 infection:
100% (two-sided 95% confidence interval: -13.1 to 100.0)
[sample too small for robust precision]
7/
#Vaccine Efficacy estimate for those 75 yrs and older, 7 days after dose 2, plus no prior SARS-COV-2 infection:
100% (two-sided 95% confidence interval: -13.1 to 100.0)
[sample too small for robust precision]
7/
@pfizer @BioNTech_Group #COVID19
#Vaccine Efficacy estimate for those 16 yrs and older, at least 7 days after dose 2, with or without prior SARS-COV-2 infection:
94.6% (95% credible interval: 89.9 to 97.3).
8/
#Vaccine Efficacy estimate for those 16 yrs and older, at least 7 days after dose 2, with or without prior SARS-COV-2 infection:
94.6% (95% credible interval: 89.9 to 97.3).
8/
Primary outcome for all efficacy estimates given above:
Confirmed case of COVID19: at least 1 symptom(fever, new/increased cough, new/increased shortness of breath; chills, new/increased muscle pain, new loss of taste/smell, sore throat, diarrhea, vomiting) +RT-PCR confirmed 9/
Confirmed case of COVID19: at least 1 symptom(fever, new/increased cough, new/increased shortness of breath; chills, new/increased muscle pain, new loss of taste/smell, sore throat, diarrhea, vomiting) +RT-PCR confirmed 9/
Special considerations:
- Store at -80°C to -60°C
- 6 mo shelf life
- Thaw before administration
- Once thawed, store up to 5 days at 2°C to 8°C
- Use or discard within that window
10/
- Store at -80°C to -60°C
- 6 mo shelf life
- Thaw before administration
- Once thawed, store up to 5 days at 2°C to 8°C
- Use or discard within that window
10/
