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    EMA boosts mRNA vaccine capacity, refines AstraZeneca risk-benefit

      The European Medicines Agency (EMA) is working to secure additional doses of the COVID-19 vaccine developed by Pfizer and BioNTech with an aim to deliver 1.8 billion doses to Europe by the end of 2023.   After touring the Pfizer plant in Puurs, Belgium, European Commissioner Ursula von der Leyen issued a joint statement with Belgium’s prime minister and BioNTech’s chief medical officer. “I am now confident that we will have sufficient doses to vaccinate 70% of th...
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    FDA, CDC recommend J&J vaccine pause while rare clots investigated

    In a joint statement followed by a Tuesday morning press conference, the US Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) have recommended that administration of the one-dose Johnson & Johnson COVID-19 vaccine be paused.   The recommendation follows reports of six US cases of women between the ages of 18 and 48 years who received the vaccine and then experienced cerebral venous sinus thrombosis (CVST) – a blood clot in a larg...
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    COVID innovation lessons could be applied elsewhere

    The global urgency of the COVID-19 pandemic spurred the development of new models of vaccine and drug development. Could these innovations help with researching non-pandemic vaccines or drugs, and potentially serve as a template in other areas of medicine?   Two papers recently published in Health Affairs suggest that, yes, these innovations could be applied elsewhere if deemed successful—but it’s also important to note the shortcomings of these new models as well. ...
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    CDC’s vaccines panel recommends COVID vaccine; first doses administered

    The first doses of COVID-19 vaccine were given to healthcare workers around the US less than 72 hours after the US Food and Drug Administration’s (FDA’s) emergency use authorization of the vaccine jointly developed by Pfizer and the German firm BioNTech, and less than 48 hours after the US Centers for Disease Control and Prevention’s (CDC’s) vaccines committee recommended use of the vaccine.   In a 13 December press release that followed the 12 December meeting of CDC’...
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    Updated: Redfield endorses ACIP's first-wave COVID-19 vaccine priorities

    Meeting the week before an FDA advisory committee convenes to consider the first application for emergency use authorization of a COVID-19 vaccine, an advisory committee of the Centers for Disease Control and Prevention (CDC) voted 13-1 to allocate the first vaccine rounds to health care workers and residents of long-term care facilities.   “We hope that this vote gets us all one step closer to the day when we can all feel safe again and when this pandemic is over fina...
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    FDA, CMS, CDC Launch Task Force for Emergency Diagnostics

    Three US Department of Health and Human Services agencies announced Tuesday the launch of the Tri-Agency Task Force for Emergency Diagnostics (TTFED) to better respond to public health emergencies. With the distinct roles set for each of the agencies, TTFED is intended to leverage the expertise of the US Food and Drug Administration (FDA), the Centers for Medicare and Medicaid Services (CMS) and the Centers for Disease Control and Prevention (CDC) around the development...
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    CDC National Stockpile of Medical Products Could be at Risk in Public Health Emergency

    The US Department of Health and Human Services’ Office of Inspector General (OIG) warns that "systemic issues" with the Centers for Disease Control and Prevention’s (CDC) stockpile of vaccines, antibiotics, antidotes, antitoxins, medications and other supplies could place at risk approximately $7 billion of inventory and negatively affect readiness during a national emergency. Background Created in 1999, the stockpile is meant to supplement and resupply state and...
  • New Study Says 63% of US Adults Trust FDA

    A study published Tuesday in PLOS reveals that the US Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) might have more work to do to ensure Americans trust them. In a study of more than 5,000 adults and 1,100 adolescents, the researchers from the University of North Carolina found that among adults, awareness of CDC and FDA was high (83.6% and 94.3%, respectively) but adults’ trust in the agencies was lower, with 64.6% reported...
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    FDA, CDC Find Contaminated Water at Florida Plant Linked to Multistate Outbreak

    An investigation into a multistate outbreak has identified the bacteria, Burkholderia cepacia , in more than 10 lots of oral liquid docusate sodium linked directly to a contract manufacturing organization’s (CMO) Florida-based site.   PharmaTech in August voluntarily recalled all of its liquid drug formulations made at the Davie, Florida facility after being linked to the outbreak. The recall impacted products distributed and labeled by six firms – Rug...
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    Genetically Engineered Mosquitoes to Aid Zika Response? FDA Plans to Release More Info

    The US Food and Drug Administration's (FDA) acting chief scientist told members of the House Energy and Commerce Committee on Wednesday that FDA is investigating all avenues to combat Zika, including a proposal to release genetically engineered mosquitoes in Florida. Scientists expect that the virus, which has swept across Latin America and the Caribbean, will eventually reach US shores, especially in states like Texas and Florida that have experienced outbreaks of dengu...
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    FDA Clears First Zika Diagnostic for Emergency Use

    The US Food and Drug Administration (FDA) on Friday approved the first diagnostic to detect the Zika virus under its emergency use authorization (EUA) pathway, which allows the agency to authorize unapproved products during a public health emergency. The authorization is significant as there are currently no other approved diagnostics available to detect Zika, a mosquito-borne virus that has rapidly spread across much of Latin America and the Caribbean and is thought to ...
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    CDC, NIH 'Working Closely' With FDA on Zika Response

    At a Congressional hearing in Washington, DC on Wednesday, officials from the Centers for Disease Control and Prevention (CDC) and National Institutes of Health (NIH) say they are working closely with the US Food and Drug Administration (FDA) in their response to the Zika virus. During the hearing, CDC Director Tom Frieden and Anthony Fauci, director of the National Institutes of Allergy and Infectious Disease (NIAID) briefed members of the House Foreign Affairs Committe...