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Pfizer and BioNTech’s Tattoo Skull shirt . coronavirus vaccine, called BNT162b2, is an mRNA vaccine given as two shots administered 21 days apart. One dose is to prime the body, and then a few weeks later, the second dose is to boost the response. The messenger RNA or mRNA used in the vaccine codes for a structure called the spike glycoprotein of the virus. That’s the part of the virus that it uses to attach to cells. The vaccine prompts the human body to produce copies of that protein, eliciting an immune response that leads to some protection against coronavirus infection. Such mRNA vaccines are the newest approach to vaccine technology. Safety and efficacy data on Pfizer and BioNTech’s Covid-19 vaccine candidate published in the New England Journal of Medicine on Thursday morning.
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The data come from more than 43,000 trial participants: 21,720 who were randomly given the vaccine and 21,728 who were randomly given a placebo Tattoo Skull shirt . The data show that there were only eight Covid-19 cases among people who received the vaccine, compared with 162 cases among those given the placebo. The paper notes that a two-dose regimen of the vaccine has an efficacy of 95% in people ages 16 and older. “BNT162b2 was 95% effective in preventing Covid-19,” the paper’s abstract notes. “Safety over a median of 2 months was similar to that of other viral vaccines.” However, FDA briefing documents also note that the vaccine appears to provide “some protection” against Covid-19 following just one dose. The documents describe the efficacy of Pfizer’s vaccine in the time between the first and second dose as 52.4%, but the document notes that “the efficacy observed after Dose 1 and before Dose 2, from a post-hoc analysis, cannot support a conclusion on the efficacy of a single dose of the vaccine, because the time of observation is limited by the fact that most of the participants received a second dose after three weeks.” In other words, “the trial did not have a single-dose arm to make an adequate comparison.” The document goes on to detail the safety profile of the vaccine as “favorable” and notes that the most common adverse reactions to the vaccine have been reactions at the injection site, fatigue, headache, muscle pain, chills, joint pain and fever.
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