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Wednesday, dec 11
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Ugur Sahin
News
Covid-
19: Pfizer Asks FDA For Emergency Use Authorization Of Vaccine For Children Under 5
New York-based Pfizer and its European partner BioNTech has requested that the Food and Drug Administration (FDA) expand the use of its COVID-19 vaccine to include children between the ages of 6 months and 5 years old, officials announced. On Tuesday, Feb. 1, citing a host of clinical trials, the pharmaceutical company announced it is seeking emergency use authorization (EUA) to admit the vaccine to a wider range of children. Currently, the vaccine is only approved for children 5 years old and older. Pfizer said that it plans to complete its EUA submission “in the coming days,” and has alre…
News
Covid-
19: FDA Expands Pfizer Booster Eligibility Among Adolescents As Omicron Cases Skyrocket
As the Omicron COVID-19 variant rages across the country, federal health officials have expanded the eligibility for booster shots in younger Americans. The Food and Drug Administration (FDA) announced on Monday, Jan. 3 that it is expanding the eligibility for Pfizer and BioNTech booster shots to American between the ages of 12 and 15 years old as children return to school amid a surge of new COVID-19 infections. FDA vaccine chief Dr. Peter Marks said in a statement the agency made its decision because a booster “may help provide better protection against both the delt…
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Covid-
19: First Findings Released On Vaccine Effectiveness Against Omicron Variant
The first findings on the effectiveness of vaccines against the COVID-19 Omicron variant have been released. Pfizer and its European partner BioNTech said that a booster shot offers significant protection against Omicron and "neutralizes" the strain. Two vaccine doses "show significantly reduced neutralization titers" but could protect against severe disease from COVID, the companies said. The findings come from an initial laboratory study. According to the companies’ preliminary data, "a third dose provides a similar level of neutralizing antibodies to Omicron as is observ…
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Covid-
19: Pfizer Seeks Federal Approval To Market Vaccine Directly To Consumers
Pfizer and European partner company BioNTech are seeking full approval from the federal government to market their two-dose COVID-19 vaccine directly to people age 16 and over, as well as businesses and schools. The vaccine has been available in the United States since mid-December under an Emergency Use Authorization waiver by the Food and Drug Administration. Since then, the companies have delivered more than 170 million doses of the vaccine across the United States. “We are proud of the tremendous progress we’ve made since December in delivering vaccines to millions of Americans, in col…
News
Covid-
19: Pfizer Will Seek Vaccine Rollout For Younger Teens After Encouraging Trial Results
Clinical trials of the Pfizer/BioNTech’s COVID-19 vaccine showed that it has a 100 percent efficacy in adolescents and is well-tolerated in minors between the ages of 12 and 15, paving the way for distribution, the companies announced. Officials said that initial trials were fruitful, and they plan to submit the data to the U.S. Food and Drug Administration for expanded emergency use authorization of the two-dose vaccine in adolescents. According to Pfizer, the third phase of the clinical trial included 2,260 participants between the ages of 12 and 15, which found that strong antibody respo…