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This study, based on data from more than 44,000 volunteers, also includes 800 participants from South Africa, where a variant of the coronavirus with some ability to avoid antibodies, called B.1.351, causes the majority of new COVID-19 infections. However, the vaccine still appears to be effective in protecting against this variant of the coronavirus, according to a report from Pfizer.
These data are confirmed by laboratory blood tests in vaccinated people, which have also shown that the vaccine elicits a strong neutralizing antibody response against B.1.351, according to a report published in The New England Journal of Medicine in early March.
“The high efficacy of the vaccine, which lasts up to six months after the second dose and is more common in South Africa, gives us even more confidence in the effectiveness of our vaccine,” said Albert Bourla, President and CEO of Pfizer.
The vaccine has now been tested in more than 44,000 participants (16 years and older), and more than 12,000 vaccinated study participants have been followed for at least six months after the second dose. The companies plan to publish this data in a scientific journal “in the near future.”
According to the company, the vaccine shows 91.3 percent. efficacy against symptomatic COVID-19 and 95.3%. efficacy against “severe forms of COVID-19 as defined by the US Food and Drug Administration (FDA),” the company said.
The FDA definition of “severe COVID-19” includes a variety of symptoms, such as increased heart rate and respiratory failure, indicating respiratory distress, in 93 percent of cases. or decreased oxygenation of the blood, liver dysfunction or need for additional oxygen, or placement in intensive care units, writes CNN.
The US Centers for Disease Control and Prevention (CDC) has a slightly different definition of “severe COVID-19” at 94 percent. or decreased oxygen saturation in the blood and signs of pneumonia as determined by x-ray. By the CDC’s definition, “the vaccine was 100 percent. effective against serious diseases, ”said Pfizer.
In total, the company recorded 927 confirmed symptomatic cases of COVID-19 in its late-stage trials. 850 of these cases occurred in people who took placebo instead of the vaccine. Of the 77 cases in vaccinated people, none were severe by CDC standards, and only one was severe by FDA standards, Pfzier reported.
Nine cases of COVID-19 were reported among 800 South African volunteers, all of which occurred in the placebo group, “indicating 100 percent. vaccine efficacy, ”the report says. Since this study has a relatively small subset of participants compared to the overall study, this evaluation of vaccine efficacy is less accurate than the overall 91.3%. evaluation of effectiveness.
“In exploratory analysis, nine strains were sequenced and six of them were confirmed as B.1.351,” adding to the evidence that the vaccine protects against the South African coronavirus variant, the company noted.
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