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As part of long-standing, ongoing efforts to be better prepared to save lives following radiological and nuclear emergencies, the U.S. Department of Health and Human Services is purchasing a supply of the drug Nplate from Amgen USA Inc; Nplate is approved to treat blood cell injuries that accompany acute radiation syndrome in adult and pediatric patients (ARS). Amgen, based in Thousands Oaks, California, developed Nplate for ARS with support from the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Administration for Strategic Preparedness and Response (ASPR), as well as the National Institute of Allergy and Infectious Diseases,...

BREAKING: In a major blow to vaccine efforts, senior FDA leaders stepping down Two of the FDA’s most senior vaccine leaders are exiting from their positions, raising fresh questions about the Biden administration and the way that it’s sidelined the FDA. Marion Gruber, director of the FDA’s Office of Vaccines Research & Review and 32-year veteran of the agency, will leave at the end of October, and OVRR deputy director Phil Krause, who’s been at FDA for more than a decade, will leave in November. The news, first reported by BioCentury, is a massive blow to confidence in the agency’s...

FDA approves drug to treat smallpoxDisease considered eradicated in 1980 but drug development for smallpox is an important component for medical countermeasure response [6/4/2021] The U.S. Food and Drug Administration today approved Tembexa (brincidofovir) to treat smallpox. Although the World Health Organization declared smallpox, a contagious and sometimes fatal infectious disease, eradicated in 1980, there have been longstanding concerns that the virus that causes smallpox, the variola virus, could be used as a bioweapon. Before its eradication in 1980, the variola virus mainly spread by direct contact among people. Symptoms typically began 10 to 14 days after infection and included...

So why did the FDA restrict the use of HCQ to hospitalized patients and those participating in clinical trials, and why does it continue to embargo the 150 million doses in the SNS? The AAPS’s complaint alleges that “through a biased, unlawful process,” FDA officials from “prior administrations” and “contrary to the wishes of President Donald Trump” arbitrarily limited the use of HCQ from the SNS. The complaint specifically references, among others, Rick Bright, the director of the Biomedical Advanced Research & Development Authority (BARDA).

President Donald Trump launched an angry attack Thursday at Dr. Rick Bright ahead of the whistleblower’s highly anticipated congressional testimony — calling the ousted head of the agency tasked with creating a coronavirus vaccine a “disgruntled employee.” “I don’t know the so-called Whistleblower Rick Bright, never met him or even heard of him, but to me he is a disgruntled employee, not liked or respected by people I spoke to and who, with his attitude, should no longer be working for our government!” the president said in a tweet. Bright, who was removed from the Biomedical Advanced Research and Development...

Five years ago, the U.S. Department of Health and Human Services tried to plug a crucial hole in its preparations for a global pandemic, signing a $13.8 million contract with a Pennsylvania manufacturer to create a low-cost, portable, easy-to-use ventilator that could be stockpiled for emergencies.

Bavarian Nordic wins freeze-dried Imvamune contract from US government 20 November, 2009 The Biomedical Advanced Research and Development Authority (BARDA) in the US has awarded a US$40m contract to Bavarian Nordic of Denmark to develop a freeze-dried version of its Imvamune smallpox vaccine. The funds will be used to validate the freeze-dried manufacturing process and the associated pre-clinical and clinical studies to support the development of this version of the vaccine. The funding represents 33% of the total contract value, followed by four additional years of optional funding, which will be triggered by the completion of pre-determined technical milestones. The...

There's Something Fishy About The White House's $433 Million Investment In A Smallpox Vaccine Becket Adams, The Blaze Nov. 15, 2011, 12:21[Editor's note: smallpox is indeed a horrifying and terrible disease; this cannot be overstated. It is not the intent of this article to mitigate the very real and terrible nature of the disease. The point of this article is to question the White Houses’ intentions in this deal.] Several critics believe that the Obama administration’s $433 million investment in the new ST-246 smallpox vaccine reeks of scandal. How could a multimillion dollar investment in an antiviral pill that could...

A measure to shield drug manufacturers from lawsuits in an effort to encourage them to develop new vaccines is likely to be quietly attached to a "must pass" defense appropriation bill within the next few days. If the US Secretary of Health and Human Services declares that vaccines were being distributed during a national health emergency, such as a flu pandemic, the bill would make it very difficult for people who felt they had been harmed by vaccines to pursue legal action against the manufacturer. A broad swath of consumer-rights groups and open-government advocates had succeeded in slowing the progress...

DECEMBER 5, 2005. UPDATE (12/6): During my appearance on the Noory show last night, I also pointed out that, because of the enormous PR and propaganda blitz concerning "the imminent--could be--may be" bird flu pandemic, Senate Bill 1873 has a chance of passing into law. THIS is one of the payoffs from all that propaganda. Establish, on the basis of no fact, the illusion of a pandemic---and then bring this heinous, unconstitutional, and repellent bill into the Congress. snip This is a bad one, folks. It will give the federal government---if Senate Bill 1873 passes---the right to shove drugs and...

<p>WASHINGTON (AP) - By creating a federal agency shielded from public scrutiny, some lawmakers think they can speed the development and testing of new drugs and vaccines needed to respond to a bioterrorist attack or super-flu pandemic.</p>

Some scientists fear resources set aside for a new anti-bioterrorism center will be taken away from existing agencies doing similar work WASHINGTON -- Legislation moving rapidly through the Senate would create a secretive national research center to respond to bioterror threats and natural disease outbreaks. But some scientists cautioned Friday that the new agency could draw money away from the Centers for Disease Control and Prevention and the National Institutes of Health and disrupt their work. The measure, said to be a priority of Senate Majority Leader Bill Frist, R-Tenn., would shift the main responsibility for developing bioterrorism countermeasures out...