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Saturday, apr 27
Tag:
Emergency Use Authorization
News
Covid-
19: FDA Announces New At-Home Test Recall
Federal health officials are cautioning Americans not to use a specific COVID-19 at-home testing kit that has not been approved or authorized by medical authorities. The US Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC), are advising against the use of the LuSys Laboratories COVID-19 Antigen Test because they have not been cleared for use. In total, nearly 165,000 at-home kits are subject to the recall, according to the FDA. Officials said that the LuSys Laboratories COVID-19 Antigen Test uses a nasal swab, or a saliva (spit) sample intended to de…
News
Covid-
19: Moderna Vaccine Gets Full Approval From FDA
Federal officials have granted full approval to Moderna’s COVID-19 vaccine following its authorization last year for emergency use. On Monday, Jan. 31, the Food and Drug Administration (FDA) announced that Moderna’s vaccine has been granted its full approval, joining the Pfizer shot which was authorized months ago. The move comes after tens of millions of doses of the Moderna vaccine have already been administered across the country. It also represents Moderna’s first FDA-approved product in the US. Officials said the FDA reviewed months of additional follow-up data submitted by Moderna to…
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…
News
Covid-
19: FDA Authorizes Second Antiviral Pill
For the second time in as many days, the Food and Drug Administration (FDA) has authorized the use of an antiviral pill to treat mild and moderate COVID-19 cases. On Thursday, Dec. 23, the FDA approved the use of Merck’s molnupiravir pill for emergency use authorization, a day after officials authorized the use of Pfizer’s COVID-19 treatment pill. Earlier story - COVID-19: FDA OKs First Authorized Home Treatment For Virus Merck’s pill has been cleared for use by adults 18 and older who have tested positive for COVID-19 and are at the greatest risk of being hospitalized or dying from t…
News
Covid-
19: FDA Expands Booster Vaccine Eligibility To Include Ages 16 & 17
The United States Food and Drug Administration (FDA) has expanded eligibility for Pfizer's COVID-19 booster vaccines to include 16- and 17-year-olds. The FDA said in an announcement on Thursday, Dec. 9, that it has amended the emergency use authorization of the booster vaccine to include those aged 16 and older at least six months after they've completed their primary vaccination. “Vaccination and getting a booster when eligible, along with other preventive measures like masking and avoiding large crowds and poorly ventilated spaces, remain our most effective methods for fighting COVID-19,”…
News
Covid-
19: Pfizer Asks FDA To Approve Vaccine For Children Ages 5 To 11
Pfizer has officially asked the US Food and Drug Administration (FDA) for emergency use authorization for its COVID-19 vaccine to be administered to children between the ages of 5 and 11. With parents and politicians alike agreeing that keeping children learning in the classroom after a lost year in 2020, Pfizer is pushing to allow its vaccine to be administered among younger Americans. Pfizer tweeted this week that the company had submitted their formal request for Emergency Use Authorization of the vaccine to the FDA. "With new cases in children in the U.S. continuing to be at a high lev…
News
Covid-
19: NY Setting Up 120 Pop-Up Sites In Move To Get Young People Vaccinated
New York State is setting up 120 pop-up COVID-19 vaccination sites in an effort to increase vaccination rates among younger residents. The State Department of Health will work with localities, health care centers and community-based organizations over the next 12 weeks to establish these sites, state officials announced on Tuesday, Sept. 21. Children ages 12 to 17 are eligible to receive the Pfizer COVID-19 vaccine. The vaccine received Emergency Use Authorization from the United States Food and Drug Administration (FDA) for those ages 12 to 15, and it is fully approved for people 16 years …
News
Covid-
19: Here's When Vaccine Rollout May Start For Kids Ages 5 To 11
The Pfizer COVID-19 vaccine could be available to children ages 5 and older late in the fall or early this winter, according to a company board member. Former Food and Drug Administration (FDA) Commissioner Dr. Scott Gottlieb told CNBC that he believes the company's COVID vaccine will be approved for emergency use for children ages 5 to 11 sometime this fall or winter. Gottlieb told the news outlet that the application will likely be submitted to the FDA in October. He said the FDA will likely take four-to-six weeks to review the application, so the emergency use authorization c…
News
Covid-
19: FDA Aims To Give Final Approval To Pfizer Vaccine Next Month
The Food and Drug Administration (FDA) is expected to determine whether or not to give full approval of Pfizer’s COVID-19 vaccine as soon as next month. As the Delta variant rapidly rages through the country, causing spikes in new COVID-19 cases, the FDA is reportedly accelerating its timeline to fully approve the Pfizer vaccine, which was the first shot available. Currently, the Pfizer - as well as the Johnson & Johnson and Moderna - vaccines have been given emergency use authorization. Under the current timeline, the FDA hopes to have full approval by Labor Day (Monday, Sept. 6). It…
News
Covid-
19: Pfizer Begins Vaccine Study On Younger Children
Pfizer is moving forward with new clinical tests on thousands of children under the age of 12 as they look to expand the authorization of its COVID-19 vaccine. The company announced on Tuesday, June 8 that it will enroll up to 4,500 children between the ages of 6 months and 12 years old in the United States, Finland, Poland, and Spain with the intention of getting emergency use authorization before school begins in the fall. Currently, the Pfizer vaccine has only been authorized for use in children 12 and older. According to Pfizer, it has selected a dose of 10 micrograms in children betw…
News
Covid-
19: CDC Advisory Panel Endorses Use Of Pfizer Vaccine In Children 12 And Up
A panel of experts advising the Centers for Disease Control and Prevention (CDC) voted to move forward with the approval process for the use of the Pfizer COVID-19 vaccine among children between the ages of 12 and 15. By a 14-0 vote on Wednesday afternoon, May 12, the CDC panel recommended the use of the Pfizer vaccine in children 12 and up, with the decision now moving forward to CDC Director Dr. Rochelle Walensky for final approval. Once approved by Walensky, which is expected to happen quickly, it will be at states’ discretion about whether or not to move forward vaccinating children. …
News
Covid-
19: NY Could Begin Administering Vaccine To Children 12 To 15 This Week
Children in New York between the ages of 12 and 15 may soon become the latest group eligible to receive the COVID-19 vaccine if their parents give their approval. Gov. Andrew Cuomo said that the Pfizer double-dose vaccine could be authorized for use among children in New York as soon as Thursday, May 13 if the state health commissioner and his Clinical Advisory Task Force recommend it. Cuomo said that if the Centers for Disease Control and Prevention (CDC) gives the green light following a scheduled meeting on Wednesday, May 12, as expected, it will go to the state’s advisory board, simila…
News
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…
Business
Covid-
19: Pfizer Nearing Release Of Vaccine For New Age Group Of Children, FDA Says
The US Food and Drug Administration could authorize Pfizer's COVID-19 vaccine for children ages 12 to 15 as early as next week, The New York Times reported on Monday, May 3, citing federal officials. The timing could not be better for school districts that are resuming in-person instruction and hoping for a full return to normalcy next fall. Vaccinating children is also a crucial element in achieving herd immunity and decreasing numbers of hospitalizations and deaths, The Times says. While NJ, NY and CT positive rates have been dropping, other states including Pennsylvani…
News
Covid-
19: Moderna Seeks Full FDA Approval For Vaccine
With six months having passed since Moderna began clinical trials for its COVID-19 vaccine, the pharmaceutical company is seeking full approval from the Food and Drug Administration. Moderna, which currently has emergency use authorization from the FDA to distribute its vaccine, reported in its latest trial data that it has proven 90 percent effective in preventing the symptoms of COVID-19, and 95 percent effective in the most severe cases of the virus. Currently, no COVID-19 vaccine is fully approved by the FDA, but three - Moderna, Pfizer, and the currently questionable Johnson & John…
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…
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