The first COVID-19 Vaccine: Trial Results, Regulatory Review, Distribution
Results of Phase 2/3 Clinical Trial:
On December 10, 2020, a team of investigators described the Safety and Efficacy of Pfizer’s BNT162b2 mRNA Covid-19 Vaccine. In the Phase 2/3 clinical trial, 21,720 patients received two doses, 21 days apart, while 21,728 participants received a placebo. Eight participants in the vaccine-treated group and 162 in the placebo-treated group developed COVID-19 infection at least 7 days after the vaccination. Ten of these participants experienced severe COVID-19 infection, 1 in the vaccinated group, and 9 in the placebo-treated group. The study group concluded that vaccination with a 2-dose regimen of BNT162b2 led to 95% protection against COVID-19 in individuals 16 years or older.
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Emergency Use Authorization:
On December 11, 2010, The US Food and Drug Administration authorized the Emergency Use of Pfizer’s vaccine for the prevention of COVID-19 infection in individuals 16 years and older.
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The FDA Advisory Committee which reviewed the Phase 2/3 clinical trial data noted the following:
Participants included 83.1% White, 9.1% African American, 4.3% Asian participants, and <3% from other racial groups; 28.0% of participants were Hispanic/Latino; 21.6% of participants were >65 years of age. The median age was 52 years. Comorbidities were obesity (35.1%), diabetes (without chronic complications, 7.8%), and chronic pulmonary disease (7.8%). Geographically, 76.7% of participants were from the US, 15.3% from Argentina, 6.1% from Brazil, and 2.0% from South Africa.
Among all-enrolled 43,448 participants, 0.6% of vaccinated and 0.5% of placebo-treated participants experienced at least 1 serious adverse event during the conduct of the entire study.
Common side effects included -
- Fatigue 5.5%,
- Fever 6.1%,
- Headache 5.2%
- Muscle aches 4.8%, and
- Diarrhea 1%.
FDA concluded that “There are currently insufficient data to make conclusions about the safety of the vaccine in subpopulations such as
- children less than 16 years of age,
- pregnant and lactating individuals, and
- immunocompromised individuals."
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Per General Perna, CEO of Operation Warp Speed, 145 larger healthcare facilities with readily available cold storage facilities, will receive doses of the Pfizer vaccine by Monday, December 14th. An additional 500 facilities will receive the vaccine by Tuesday or Wednesday.
First in line to receive vaccinations are 17 million Healthcare workers and 3.7 million Nursing home residents.
Second in line are 14 million essential workers, 9.6 million teachers, and 2.3 million first responders
Third in line are 89 million with pre-existing conditions and 6.7 million individuals age 65 and older.
The initial shipments are not enough to vaccinate all first-line recipients. With the approval of the Moderna vaccine, the first line vaccination targets are expected to be met.
To read more about Operation Warp Speed and Vaccine distribution schedules, visit these link below
COVID-19 is a respiratory illness caused by the SARS-CoV-2 coronavirus. It has caused a global pandemic. In the United States, 16 million individuals have been infected and nearly 300,000 of them have lost their lives.
Wearing masks, hand hygiene, social distancing, and following state guidelines for gatherings and isolation can limit the effects of this pandemic on the most vulnerable individuals. These individuals are those over 65 years of age, healthcare and essential workers, and those with underlying conditions.
Understanding immunity to COVID-19
Vaccination can lead to antibodies that prevent the virus from infecting cells in the body. The cellular immune system also fights the virus with T-cells which are trained to kill the virus.
To learn more about testing for antibody and cellular immunity to COVID-19, visit: