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COVID-19: Moderna Seeks Approval For Second Booster Shot For All Adults COVID-19: Moderna Seeks Approval For Second Booster Shot For All Adults
Covid-19: Moderna Seeks Approval For Second Booster Shot For All Adults Though the COVID-19 case numbers across the country have either plateaued or are showing improvement, Moderna is now seeking federal approval to administer a second booster shot for adults. Moderna is seeking an amendment of the US Food and Drug Administration’s emergency use authorization for its COVID-19 vaccine to allow for a fourth vaccine to adults 18 and older who have gotten an initial booster. The move by Moderna comes days after Pfizer and BioNTech submitted a similar request for authorization of an additional booster shot, though that vaccine would only be eligible for adults 65 a…

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by Zak Failla
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COVID-19: Pfizer Asks FDA For Emergency Use Authorization Of Vaccine For Children Under 5 COVID-19: Pfizer Asks FDA For Emergency Use Authorization Of Vaccine For Children Under 5
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…

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by Zak Failla
Business
COVID-19: Pfizer Launches Clinical Trial For Vaccine Targeting Omicron Variant COVID-19: Pfizer Launches Clinical Trial For Vaccine Targeting Omicron Variant
Covid-19: Pfizer Launches Clinical Trial For Vaccine Targeting Omicron Variant New York-based Pfizer and its European partner BioNTech have launched a clinical study to evaluate a COVID-19 vaccine that specifically targets the Omicron variant. The study will evaluate the safety and efficacy of an Omicron-based vaccine among healthy adults ages 18 through 55, Pfizer announced on Tuesday, Jan. 25. According to a recent update from the Centers for Disease Control and Prevention (CDC), the Omicron variant is estimated to have accounted for 99.5 percent of circulating variants of COVID-19 in the United States between Sunday, Jan. 9, and Saturday, Jan. 15. Pfizer said up t…

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by Nicole Valinote
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COVID-19: FDA Expands Pfizer Booster Eligibility Among Adolescents As Omicron Cases Skyrocket COVID-19: FDA Expands Pfizer Booster Eligibility Among Adolescents As Omicron Cases Skyrocket
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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by Zak Failla
News
COVID-19: First Findings Released On Vaccine Effectiveness Against Omicron Variant COVID-19: First Findings Released On Vaccine Effectiveness Against Omicron Variant
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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by Joe Lombardi
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COVID-19: Pfizer Expected To Seek Approval For Boosters For All Adults COVID-19: Pfizer Expected To Seek Approval For Boosters For All Adults
Covid-19: Pfizer Expected To Seek Approval For Boosters For All Adults Pfizer and European partner BioNTech are expected to seek federal authorization to administer its COVID-19 booster shot to all Americans over the age of 18. As soon as this week, the biopharmaceutical company is reportedly planning to seek US Food and Drug Administration (FDA) approval for booster shots for anyone 18 and older. Currently, only Americans 65 and older, those who are immunocompromised and anyone whose job puts them at a larger risk for exposure are eligible for Pfizer booster shots. The FDA is considered likely to grant the request, potentially before Thanksgiving and the hol…

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by Zak Failla
News
COVID-19: Mixed Messaging About Booster Shots From CDC, Pfizer Causing Confusion COVID-19: Mixed Messaging About Booster Shots From CDC, Pfizer Causing Confusion
Covid-19: Mixed Messaging About Booster Shots From CDC, Pfizer Causing Confusion Pfizer has announced plans to submit data on a COVID-19 booster vaccine it is developing to regulatory agencies in the coming weeks.  However, the Centers for Disease Control and Prevention and the Food and Drug Administration are pushing back, saying booster vaccines are not needed at this time. Confused? You're not alone. On Thursday, July 8, Pfizer and European partner BioNTech said in a news release that the companies are working on a third vaccine dose to combat COVID-19 and its variants, including the Delta variant. The companies said they expect clinical studies will begin in A…

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by Nicole Valinote
News
COVID-19: Pfizer Seeks Federal Approval To Market Vaccine Directly To Consumers COVID-19: Pfizer Seeks Federal Approval To Market Vaccine Directly To Consumers
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…

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by Joe Lombardi
News
COVID-19: Moderna Announces How Long Vaccine Can Be Stored, How Many Doses It Will Make In 2022 COVID-19: Moderna Announces How Long Vaccine Can Be Stored, How Many Doses It Will Make In 2022
Covid-19: Moderna Announces How Long Vaccine Can Be Stored, How Many Doses It Will Make In 2022 New data has found that the Moderna COVID-19 vaccine vials will maintain its efficacy and stability for several months if it is properly stored at temperatures found in refrigerators. Currently, the vaccine is approved to be stored in a refrigerator between 36 and 46 degrees Fahrenheit for up to 30 days and up to seven months at minus 4 Fahrenheit. However, new data from Moderna found that it could support a three-month refrigerated shelf life that could “facilitate easier distribution to doctor’s offices and other smaller settings” if authorized by the Food and Drug Administration (FDA). …

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by Zak Failla
Business
COVID-19: Did You Get Now-Paused J&J Vaccine? These Are Rare Symptoms To Watch For, CDC Says COVID-19: Did You Get Now-Paused J&J Vaccine? These Are Rare Symptoms To Watch For, CDC Says
Covid-19: Did You Get Now-Paused J&J Vaccine? These Are Rare Symptoms To Watch For, CDC Says The one-dose Johnson & Johnson COVID-19 vaccine has proven efficient in getting the needles in as many Americans’ arms as possible, but some are reporting debilitating side effects after receiving their shot. Recently, some have come forward with severe symptoms after being administered the COVID-19 vaccine, prompting some health officials to issue warnings and the FDA to press pause on distributing new allocations to pharmacies and healthcare providers across the country. Earlier story - CDC, FDA Call For Pause On Johnson & Johnson Vaccine Symptoms include a severe, persisting hea…

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by Zak Failla
News
COVID-19: Pfizer Seeks FDA Approval To Give Vaccines To Kids In New Age Group COVID-19: Pfizer Seeks FDA Approval To Give Vaccines To Kids In New Age Group
Covid-19: Pfizer Seeks FDA Approval To Give Vaccines To Kids In New Age Group Pfizer is seeking federal approval to expand the use of its COVID-19 vaccine in adolescents between the ages of 12 and 15. The company announced that it is asking the Food and Drug Administration to amend its emergency use authorization, which was granted for people ages 16 and up late last year. Now, Pfizer is looking to expand its usage to adolescents as they work to get students back to full in-person learning for the fall semester. Clinical trials of the Pfizer/BioNTech’s COVID-19 vaccine have shown that it has a 100 percent efficacy in adolescents and is well-tolerated in minors betw…

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by Zak Failla
News
COVID-19: US Tops 15M Cases, But Here's How Many Times Higher Actual Number Likely Is, CDC Says COVID-19: US Tops 15M Cases, But Here's How Many Times Higher Actual Number Likely Is, CDC Says
Covid-19: US Tops 15M Cases, But Here's How Many Times Higher Actual Number Likely Is, CDC Says The United States continues to set records as new COVID-19 are mounting over the fall, though the numbers reported may not truly represent the actual number of infections, according to the Centers for Disease Control and Prevention. As the country tops 15.5 million COVID-19 cases, the most in the world, the CDC is estimating that the actual number could be between two and seven times between that, based on surveys and models. Between Feb. 27 and Sept. 30, there were nearly 7 million laboratory-confirmed COVID-19 infections, but when adjusted for potential false-negative test results, incomp…

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by Zak Failla
News
COVID-19: Pfizer Boasts Vaccine Candidate That's More Than 90% Effective COVID-19: Pfizer Boasts Vaccine Candidate That's More Than 90% Effective
Covid-19: Pfizer Boasts Vaccine Candidate That's More Than 90% Effective More reliable than the flu shot? Pfizer on Monday trumpeted a COVID-19 vaccine candidate as more than 90% effective – nearly three times better than the effectiveness of last season’s influenza vaccine. Pfizer said it hopes to have 50 million doses of the free vaccine ready by the end of this year and as many as 1.3 billion doses available next year to fight the deadly global pandemic. Two doses per person of BNT162b2 would be necessary, said the Manhattan-based drug maker, which teamed up with BioNTech of Germany to develop the booster. Pfizer plans to ask the federal Food and Drug Admini…

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by Jerry DeMarco