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Pfizer-BioNTech COVID-19 VACCINE UPDATE
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Pfizer-BioNTech and Moderna, have applied for @US_FDA Emergency Use Authorization for their mRNA based vaccines.
Here is what we know about the Pfizer vaccine and what it means. @MayoClinic @MayoClinicINFD
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Pfizer-BioNTech and Moderna, have applied for @US_FDA Emergency Use Authorization for their mRNA based vaccines.
Here is what we know about the Pfizer vaccine and what it means. @MayoClinic @MayoClinicINFD
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The Pfizer vaccine has received Emergency Use Authorization in the UK and Canada and the vaccination campaign in the UK has commenced. An FDA expert panel has recommended approval of the Pfizer vaccine.
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44,000 patients were enrolled in the Pfizer-BioNTech trial. Half received two doses of the COVID-19 vaccine separated by 21 days, the other half received a placebo. Data from the first 36,621 patients was analyzed in mid-November
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The study included persons with asthma, diabetes, hypertension and approximately 20% of the study population was > 65 years of age. 76% of participants were from the US.
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Results have been published in @NEJM
8 cases of COVID -19 in the vaccinated group, and 162 cases in the unvaccinated group, which indicates a vaccine efficacy of 95% overall. https://www.nejm.org/doi/full/10.1056/NEJMoa2034577
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8 cases of COVID -19 in the vaccinated group, and 162 cases in the unvaccinated group, which indicates a vaccine efficacy of 95% overall. https://www.nejm.org/doi/full/10.1056/NEJMoa2034577
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Efficacy:
95.6% in the 16-55 year age group
93.7% in those older than 55 years
93% in those were older than 65 years.
>90% efficacy in older people with additional risk factors for severe disease (obesity, high blood pressure, diabetes, chronic heart and lung disease).
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95.6% in the 16-55 year age group
93.7% in those older than 55 years
93% in those were older than 65 years.
>90% efficacy in older people with additional risk factors for severe disease (obesity, high blood pressure, diabetes, chronic heart and lung disease).
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No major safety concerns. Side-effects included pain at the injection site, headache, fever and fatigue. These occurred more commonly after the second dose of the vaccine and in those younger than 55 years of age. Side-effects resolved in 24 hours
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The vaccination seemed to have a protective effect as early as 14 days after the first dose of the vaccine. The benefit from vaccination evident starting 14 days after the first dose bodes well for control of the pandemic.
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Note that Immunosuppressed individuals, those younger than 16, pregnant and breastfeeding women were excluded from the trial. Thus pregnant and breast feeding women, and those less than 16 years of age will likely be excluded from the EUA.
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While the efficacy in persons with weakened immune systems is unknown, there should be no risk to them from the vaccine.
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Health care workers and nursing home residents will be the first to be vaccinated, followed by additional groups.
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The United States has pre-ordered 100 million doses of the Pfizer-BioNTech vaccine and approximately 50 million doses are expected to be available by the end of December. @pfizer @BioNTech_Group
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13/ note: while vaccine begins protecting as early as 12-14 days after first dose, this should not be interpreted as only one dose is needed. Two doses are necessary until we have an RCT that tells us otherwise
Vaccinated individuals should continue to wear a mask in public as we don’t know whether vaccination protects against asymptomatic infection and transmission
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