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Management: Food and Drug Administration (FDA)
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Total 1725 results found since Jan 2013.
F.D.A. Panel Recommends Pfizer and Moderna Vaccines for Youngest Children
States have already ordered millions of doses; if the agency authorizes them in the coming days, babies, toddlers and preschoolers could start receiving shots next week.
Source: NYT Health - June 16, 2022 Category: Consumer Health News Authors: Sharon LaFraniere and Noah Weiland Tags: Vaccination and Immunization Coronavirus (2019-nCoV) Clinical Trials Food and Drug Administration Centers for Disease Control and Prevention Walensky, Rochelle Moderna Inc Pfizer Inc BioNTech SE Children and Childhood Source Type: news
Allergy evaluation of messenger RNA vaccine reactions is crucial, with a specific role for polyethylene glycol testing
The US Food and Drug Administration granted emergency authorization to both Pfizer-BioNTech's BNT162B2 messenger RNA (mRNA) and Moderna's mRNA-1273 coronavirus disease 2019 (COVID-19) vaccines in December 2020. Uncommon (2.5-4.7 events per million) anaphylactic reactions were observed that had not been reported in phase III studies which excluded individuals with a history of an allergy to a vaccine or components of the mRNA vaccines. From that moment on, allergists have played a crucial role in the vaccine rollout and have clarified a very specific role for polyethylene glycol (PEG) testing.
Source: Annals of Allergy, Asthma and Immunology - June 16, 2022 Category: Allergy & Immunology Authors: Pragya Shrestha, Cosby Allen Stone Tags: Perspective Source Type: research
F.D.A. Panel Recommends Pfizer and Moderna Vaccines for Youngest Children
States have already ordered millions of doses; if the agency authorizes them in the coming days, babies, toddlers and preschoolers could start receiving shots next week.
Source: NYT Health - June 16, 2022 Category: Consumer Health News Authors: Sharon LaFraniere and Noah Weiland Tags: Vaccination and Immunization Coronavirus (2019-nCoV) Clinical Trials Food and Drug Administration Centers for Disease Control and Prevention Walensky, Rochelle Moderna Inc Pfizer Inc BioNTech SE Source Type: news
F.D.A. Panel Recommends Agency Clear Pfizer and Moderna Vaccines for Young Children
Neither Pfizer ’s nor Moderna’s pediatric doses have been tested against the subvariants that may soon be dominant in the U.S.
Source: NYT Health - June 16, 2022 Category: Consumer Health News Authors: Sharon LaFraniere and Noah Weiland Tags: Coronavirus (2019-nCoV) Coronavirus Omicron Variant Vaccination and Immunization Children and Childhood Food and Drug Administration Pfizer Inc BioNTech SE Moderna Inc United States Source Type: news
FDA advisers back authorization of coronavirus vaccines for tots
Food and Drug Administration officials could act on the recommendation within days, potentially setting the stage for shots to be available next week.
Source: Washington Post: To Your Health - June 15, 2022 Category: Consumer Health News Authors: Laurie McGinley Source Type: news
F.D.A. Panel Recommends Agency Clear Pfizer and Moderna Vaccines for Young Children
Neither Pfizer ’s nor Moderna’s pediatric doses have been tested against the subvariants that may soon be dominant in the U.S.
Source: NYT Health - June 15, 2022 Category: Consumer Health News Authors: Sharon LaFraniere and Noah Weiland Tags: Coronavirus (2019-nCoV) Coronavirus Omicron Variant Vaccination and Immunization Children and Childhood Food and Drug Administration Pfizer Inc BioNTech SE Moderna Inc United States Source Type: news
Pfizer Vaccine Effective in Children Under 5, the F.D.A. Says
Outside experts will make their recommendations this week on how the agency should rule on applications from Pfizer and Moderna to vaccinate the nation ’s youngest children.
Source: NYT Health - June 13, 2022 Category: Consumer Health News Authors: Sharon LaFraniere Tags: Coronavirus (2019-nCoV) Vaccination and Immunization Drugs (Pharmaceuticals) BioNTech SE Pfizer Inc Food and Drug Administration Moderna Inc Source Type: news
A Fourth COVID-19 Vaccine, From Novovax, Passed a Key Stage in the Authorization Process
American adults who haven’t yet gotten vaccinated against COVID-19 may soon get another choice, as advisers to the Food and Drug Administration on Tuesday backed a more traditional type of shot.
Next, the FDA must decide whether to authorize the protein vaccine made by latecomer Novavax as the nation’s fourth coronavirus shot for adults. It’s made with more conventional technology than today’s dominant Pfizer and Moderna shots and the lesser-used Johnson & Johnson option.
Novavax shots are already available in Australia, Canada, parts of Europe and multiple other countries, either for initial va...
Source: TIME: Health - June 8, 2022 Category: Consumer Health News Authors: LAURAN NEERGAARD / AP Tags: Uncategorized COVID-19 healthscienceclimate wire Source Type: news
FDA Advisers Back a New COVID-19 Vaccine, Made By Novavax
American adults who haven’t yet gotten vaccinated against COVID-19 may soon get another choice, as advisers to the Food and Drug Administration on Tuesday backed a more traditional type of shot.
Next, the FDA must decide whether to authorize the vaccine made by latecomer Novavax, a protein vaccine that’s made with a more conventional technology than today’s U.S. options.
Novavax shots are already used in Australia, Canada, parts of Europe and dozens of other countries. But U.S. clearance is a key hurdle for the Maryland-based company.
FDA’s vaccine chief Dr. Peter Marks said another choice in the U....
Source: TIME: Health - June 7, 2022 Category: Consumer Health News Authors: Lauran Neergaard / AP Tags: Uncategorized COVID-19 wire Source Type: news
F.D.A. Advisers Meet on Covid Shots by Novavax
Clinical trials found the vaccine to work well, but the company has long struggled with manufacturing.
Source: NYT Health - June 7, 2022 Category: Consumer Health News Authors: Carl Zimmer and Rebecca Robbins Tags: Novavax Inc Coronavirus (2019-nCoV) Vaccination and Immunization Food and Drug Administration Clinical Trials Public-Private Sector Cooperation Factories and Manufacturing your-feed-science Source Type: news
GC-MS profiling of Bauhinia variegata major phytoconstituents with computational identification of potential lead inhibitors of SARS-CoV-2 M < sup > pro < /sup >
Comput Biol Med. 2022 Jun 1;147:105679. doi: 10.1016/j.compbiomed.2022.105679. Online ahead of print.ABSTRACTSevere acute respiratory syndrome coronavirus 2 was originally identified in Wuhan city of China in December 2019 and it spread rapidly throughout the globe, causing a threat to human life. Since targeted therapies are deficient, scientists all over the world have an opportunity to develop novel drug therapies to combat COVID-19. After the declaration of a global medical emergency, it was established that the Food and Drug Administration (FDA) could permit the use of emergency testing, treatments, and vaccines to de...
Source: Molecular Medicine - June 6, 2022 Category: Molecular Biology Authors: Pallavi More-Adate Kiran Bharat Lokhande K Venkateswara Swamy Shuchi Nagar Akshay Baheti Source Type: research
Children Under 5 Could Get Covid Shots in Late June, White House Says
President Biden ’s coronavirus response coordinator shared the timeline in anticipation of federal regulators authorizing coronavirus vaccines for children younger than 5.
Source: NYT Health - June 2, 2022 Category: Consumer Health News Authors: Sheryl Gay Stolberg Tags: Coronavirus (2019-nCoV) Children and Childhood Vaccination and Immunization Centers for Disease Control and Prevention Food and Drug Administration Jha, Ashish (1970- ) Source Type: news
Ionizable Lipid Nanoparticles Enhanced the Synergistic Adjuvant Effect of CpG ODNs and QS21 in a Varicella Zoster Virus Glycoprotein E Subunit Vaccine
In this report, we found that ionizable lipid nanoparticles (LNPs) approved by the Food and Drug Administration (FDA) as vectors for coronavirus disease 2019 (COVID-19) mRNA vaccines could enhance the synergistic adjuvant effect of CpG oligodeoxynucleotides (CpG ODNs) and QS21 on VZV-gE, affecting both humoral immunity and CMI. Vaccines made with these LNPs showed promise as varicella vaccines without a potential risk of herpes zoster, which identifies them as a novel type of herpes zoster vaccine similar to ShingrixTM. All of the components in this LNP-CpG-QS21 adjuvant system were proven to be safe after mass vaccination...
Source: Herpes - May 28, 2022 Category: Infectious Diseases Authors: Ning Luan Han Cao Yunfei Wang Kangyang Lin Cunbao Liu Source Type: research
