The study uses a robot to surgically place a brain-computer interface (BCI) implant in a region of the brain that controls the intention to move, Neuralink said previously, adding that its initial goal is to enable people to control a computer cursor or keyboard using their thoughts alone.
Archiv: Food and Drug Administration (FDA)
Neuralink Is Now Recruiting Human Subjects
(20.09.2023)
It‘s only a tiny incremental step towards Musk‘s sweeping vision for his company‘s brain chip. In 2020, Musk promised Neuralink devices could solve numerous neurological conditions, including addiction or memory loss, or restore movement for people with spinal cord injuries. He‘s even promised that one day, a Neuralink brain chip could allow for human-to-human telepathy.
In short, despite Musk‘s grand ambitions, Neuralink still has a lot of work to do to catch up with its competitors — and isn‘t about to completely revolutionize the field just yet.
Supreme Court protects access to abortion pill
lawyer for the group of doctors who brought the challenge downplayed the order. “As is common practice, the Supreme Court has decided to maintain the status quo,” Erik Baptist, a lawyer for Alliance Defending Freedom, said in a statement.
“Our case seeking to put women’s health above politics continues on an expedited basis in the lower courts,” Baptist added. “We look forward to a final outcome in this case that will hold the FDA accountable.”
Supreme Court pauses abortion pill restrictions from taking effect during appeal
The justices, in a brief order, said they will put on hold a ruling from a Texas federal judge while the Biden administration’s appeal proceeds.
The decision is a temporary victory for the Biden administration that for now, keeps the Food and Drug Administration’s authority on drug approvals.
Justices Clarence Thomas and Samuel Alito, two of the court’s conservatives, said they would have denied the request for a pause.
‚These are serious ethical issues‘: James O‘Keefe demands answers after FDA executive officer is caught on Project Veritas hidden camera admitting Biden will force an ANNUAL Covid shot that would be a ‚recurring fountain of revenue‘ for drug firms
– FDA executive Christopher Cole was secretly recorded by a Project Veritas undercover employee posing as his date during a series of dinner meetings
– He was caught on camera dishing out his thoughts about vaccine mandates, saying he believed they would be become annual requirements
– He also suggested that the Biden administration had financial incentives for pushing the vaccine, saying they‘re a ‚recurring‘ source of income
– During a follow-up Project Veritas interview, Cole said he‘d been tricked during a ‚hack job‘ investigation and that his comments were taken out of context
– He said his office was not involved in the approval of vaccines
– Project Veritas Founder James O‘Keefe is now demanding the FDA answer to the allegations that its officials are motivated by the ‚fountain of revenue‘ it receives from pharmaceutical companies
– O‘Keefe told Sean Hannity Wednesday night: ‚There are serious ethical issues‘
FDA-Beamter vor versteckter Kamera: Politik plant jährliche Covid-Impfung
Die Aussagen sind verstörend, überraschen aber möglicherweise gar nicht so sehr: „Die Arzneimittelhersteller, die Lebensmittelhersteller, die Impfstoffhersteller. Sie zahlen uns also Hunderte von Millionen Dollar pro Jahr, um die Gutachter einzustellen und zu behalten, die ihre Produkte genehmigen“, so Cole im zweiten Teil des Videos.
Coles Aufgabe in der FDA sei es, den Behörden ein Rahmenwerk für Sicherheit und Effektivität zu bieten.
Brisant: Gravierende Mängel in der Zulassungsstudie von BioNTech/Pfizer
Indem man die anderen Zeugen und das Indizien-Material wie Fotos und Emails ignorierte, wurde aus den in Texas festgestellten Mängeln die lokale „Schlamperei“ (ntv, t-online, Focus, RND) eines „Subunternehmens“ (Spiegel, ntv, t-online, Tagesspiegel, RND) von Pfizer/BioNTech. Auf die Effektivität und die Sicherheit des Vikzins wirke sich die texanische Nebengeschichte nach Ansicht von „Experten“ nicht aus.
Beim kollektiven Weichspülen übersahen die großen Medien allerdings eine Quelle in Thackers Bericht – vermutlich, weil man in den Redaktionen dachte, hier ginge es eh nur um Kritik an der US-Zulassungsbehörde FDA und damit um „Ausland“. Liest man allerdings in die Quelle hinein, sieht die Sache schon deutlich anderes aus.
Women’s Periods May Be Late After Coronavirus Vaccination, Study Suggests
A study published on Thursday found that women’s menstrual cycles did indeed change following vaccination against the coronavirus. The authors reported that women who were inoculated had slightly longer menstrual cycles after receiving the vaccine than those who were not vaccinated.
Their periods themselves, which came almost a day later on average, were not prolonged, however, and the effect was transient, with cycle lengths bouncing back to normal within one or two months.
US-Studie: CoV-Impfung verzögert Periode bei Frauen leicht
Laut der gestern in dem Fachjournal „Obstetrics & Gynecology“ veröffentlichten Studie setzte bei geimpften Frauen die Blutung etwa einen Tag später ein als bei ungeimpften Frauen.
Die Dauer der Monatsblutung wurde demnach jedoch nicht beeinflusst. Den Forschern zufolge sind die Auswirkungen der Impfung auf die Periode gering und voraussichtlich nur vorübergehend.
Head of US FDA’s advisory group: ‘We never expected Covid vaccines to be so good, so effective’
(25 Dec 2021)
In an interview with the Guardian, Monto considered both this possible future – in which Covid-19 “is not going away, in spite of how well our vaccines perform” – and an incredible and perplexing year of vaccine distribution.
“The first thing is [that] we never expected our vaccines to be so good, so effective,” said Monto. “This was a very happy surprise to everybody – and it was a surprise.”
Scoop: Lab for coronavirus test kits may have been contaminated
(01.03.2020)
A senior administration official added that the government also moved the manufacturing of the coronavirus tests out of the Atlanta laboratory of CDC.
The official said that the CDC engaged with a third party contractor on Feb. 20 to help manufacture the testing kits. The official added that the FDA regulator, Stenzel, visited the Atlanta laboratory on Feb. 22.
Pfizer asks FDA for broader authorization of vaccine booster
Pfizer and its German partner, BioNTech, on Tuesday asked the Food and Drug Administration to authorize a booster dose of its coronavirus vaccine for people 18 and older.
The FDA could clear the request by the end of the month, according to health officials who spoke on the condition of anonymity because they were not authorized to discuss the issue.
Company That Managed Pfizer Vaccine Trial Sites ‘Falsified Data’: Whistleblower
Despite Jackson repeatedly notifying Ventavia of the problems, the company reportedly took no corrective action. This prompted Jackson to send a complaint by email to the US Food and Drug Administration (FDA) – the country’s top regulatory body – in September 2020. But less than 24 hours later, Ventavia fired her in an apparent reprisal.
In a further surprise, the FDA did not follow up on Jackson’s complaint either.
Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial
In autumn 2020 Pfizer’s chairman and chief executive, Albert Bourla, released an open letter to the billions of people around the world who were investing their hopes in a safe and effective covid-19 vaccine to end the pandemic. “As I’ve said before, we are operating at the speed of science,” Bourla wrote, explaining to the public when they could expect a Pfizer vaccine to be authorised in the United States.1
But, for researchers who were testing Pfizer’s vaccine at several sites in Texas during that autumn, speed may have come at the cost of data integrity and patient safety. A regional director who was employed at the research organisation Ventavia Research Group has told The BMJ that the company falsified data, unblinded patients, employed inadequately trained vaccinators, and was slow to follow up on adverse events reported in Pfizer’s pivotal phase III trial. Staff who conducted quality control checks were overwhelmed by the volume of problems they were finding. After repeatedly notifying Ventavia of these problems, the regional director, Brook Jackson, emailed a complaint to the US Food and Drug Administration (FDA). Ventavia fired her later the same day.
Corona-Impfungen in den USA – FDA lässt Biontech/Pfizer für Kinder zu
Der Impfstoff von Biontech/Pfizer ist in den USA nun auch für Kinder zwischen fünf und elf Jahren zugelassen. Das hat die FDA bekanntgegeben.
FDA-Impf-Hearing: Es wird ernst. Sehr ernst.
Das Hearing vom 17. September hatte es in sich. Über einen der dort vorgetragenen, besonders wichtigen Berichte möchte ich hier kurz berichten und dessen Ergebnisse dann mit dem neuesten Sicherheitsbericht des Paul-Ehrlich-Instituts zu vergleichen.
Der Informatiker und Unternehmer Steve Kirsch hat als externer Berater der FDA ein Modell zu Abschätzung der Impfstofftoxizität vorgestellt. ……….
Have COVID vaccines killed~ 200,000 Americans?
Executive summary
1.CDC, FDA, NIH are spreading misinfo on vax vs. early treatment: Early treatment is being deliberately sabotaged
2.The data is clear: all the “experts” are wrong about vax safety
3.Our medical freedoms are being stripped away
4.Nobody prominent will challenge my conclusions with a better analysis even with large $ incentives
5.Debates → Government-driven censorship and intimidation
6.CDC and FDA won’t engage or investigate fraud.
7.Medical recommendations are now being driven by the White House
8.Vaccines don’t offer an all-cause morbidity or mortality benefit
9.Geert Vanden Bossche was right: vaccinate mid-pandemic → disaster
Public commenter, not FDA, falsely claimed COVID vaccines kill many
(22.09.2021)
Kirsch, an entrepreneur with a background in banking technology who is funding research into COVID-19 treatments unrelated to vaccines, claimed in the meeting that “the vaccines kill more people than they save.”
To support his argument, Kirsch referenced data from the Vaccine Adverse Event Reporting System, a CDC- and FDA-run database of unverified reports of adverse events that occur after receiving a vaccine. The VAERS system does not determine whether a vaccine caused the events that are reported.
FDA advisory panel rejects widespread Pfizer booster shots
(12.09.2021)
Over several hours of discussion, members of the Food and Drug Administration panel of outside experts voiced frustration that Pfizer had provided little data on safety of extra doses.
And they complained that data provided by Israeli researchers about their booster campaign might not be suitable for predicting the U.S. experience.
USA lassen ersten Corona-Impfstoff für dritte Impfung bei Älteren zu
Die Entscheidung der Behörde war so erwartet worden – das Expertengremium der FDA hatte vergangene Woche eine entsprechende Empfehlung abgegeben. Eine grundsätzliche Auffrischungsimpfung für alle ab 16 Jahren hatte die unabhängige Kommission aber abgelehnt.
FDA to Add Warning to Pfizer, Moderna Vax After CDC Finds ‘Likely‘ Link With Rare Heart Condition
(June 24, 2021)
Pfizer and Moderna vaccine fact sheets will soon feature a label from the Food and Drug Administration (FDA) warning of a heart inflammation risk in adolescents and young adults after a Centers for Disease Control and Prevention (CDC) safety panel determined there is a „likely association“ between the vaccines and cases of myocarditis and pericarditis in younger vaccine recipients, according to an analysis presented by the panel Wednesday.
The CDC says the findings do not change the basic recommendation that all people 12 and older should be vaccinated …
BioNTech erhält in USA vollständige Zulassung
Alle Corona-Impfstoffe hatten in den USA bislang nur eine Notfallzulassung. Als erstes Vakzin hat nun das von BioNTech/Pfizer die vollständige Zulassung erhalten. Experten hoffen auf einen Schub für die US-Impfkampagne.
FDA Approves First COVID-19 Vaccine
August 23, 2021
Today, the U.S. Food and Drug Administration approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.
Pfizer, BioNTech stocks rise on report FDA could fully approve COVID-19 vaccine
(20.08.2021)
Late Friday, The Wall Street Journal and The New York Times reported that the FDA could approve the vaccine, which up until now has been distributed on an emergency basis, as early as Monday but could possibly go past that if regulators need more time to review data.
Pressure builds for full FDA approval of vaccines
(11.08.2021)
The latest mandate came Monday, when Defense Secretary Lloyd Austin announced he would move to make the vaccine mandatory for troops by mid-September but would act “immediately” if it received full approval before then.
Anthony Fauci, the government’s top infectious diseases expert, added to the chorus on Sunday, when he expressed hope that the approval would move quickly.
Pentagon will seek to mandate Covid vaccine for 1.4 million troops
(09.08.2021)
DoD officials have made several calls to key lawmakers in recent days to gauge support for the mandate, according to a congressional source and a senior administration official familiar with the talks.
Pentagon to seek approval to make COVID-19 vaccines mandatory
(09.08.2021)
The Pentagon on Monday said that it will seek U.S. President Joe Biden‘s approval by mid-September to require 1.3 million military members to get vaccinated against COVID-19, anticipating full regulatory clearance for a vaccine by then.
Fauci hopeful COVID vaccines get full OK by FDA within weeks
(08.08.2021)
The FDA has only granted emergency-use approval of the Pfizer, Moderna and Johnson & Johnson vaccines, but the agency is expected to soon give full approval to Pfizer.
Why U.S. Approval of the AstraZeneca Covid-19 Vaccine Is Taking So Long
By the morning of March 23, officials at the National Institute of Allergy and Infectious Diseases released a letter from its data and safety monitoring board that‘s been examining the AstraZeneca trial, Andrew Joseph reports for STAT News. The letter stated that AstraZeneca had used outdated data to reach its efficacy number. The move was unprecedented; usually, monitoring boards keep their correspondence with companies private.
“We just felt we could not remain silent. Because if we did remain silent, we could be understandably accused of covering something up. And we definitely didn’t want to be in that position,” says Anthony Fauci, director of the NIAID, to STAT News. “In my mind, it’s an unforced error by the company.”
WHO erteilte Notfallzulassung für AstraZeneca
Für Länder wie Großbritannien, die USA oder die Mitglieder der EU und viele weitere spielt die WHO-Notfallzulassung keine Rolle. Sie machen selbst Risikoanalysen und entscheiden über eine Zulassung.
Is the U.S. Holdup of the Oxford/AstraZeneca Vaccine Justified?
The Oxford/AstraZeneca vaccine has advantages that make it an attractive possibility. It can be stored at normal refrigeration temperatures, and its price is low relative to its competitors. Public health experts have long targeted it as ideal for use in lower and moderate-income countries because of these features.
The problem is that its U.S. Phase III trial was delayed because of an adverse event investigation in the fall, and the data from the international trials used by the U.K. government are difficult to interpret due to unplanned modifications to dosing levels.
Biden administration orders 200 million more doses of Covid-19 vaccines
The government is seeking 100 million doses from Pfizer/BioNTech and 100 million from Moderna, an order that would be made available over the summer. They would be in addition to the 400 million combined doses the companies had already committed to provide the U.S., Biden said. He said he expects to be able to confirm the purchase soon.
Pfizer will supply the US with 200 million COVID-19 vaccine doses 2 months sooner than expected because of ‚extra‘ doses extracted from vials
Pfizer will supply the US with 200 million doses of its coronavirus vaccine two months sooner than expected, according to the firm‘s chief executive.
Pfizer Will Ship Fewer Vaccine Vials to Account for ‘Extra’ Doses
After the surprise discovery of an extra dose in every vial, Pfizer executives successfully lobbied the F.D.A. to change the vaccine’s formal authorization language. The company charges by the dose.
Doctor’s Death After Covid Vaccine Is Being Investigated
Shortly after receiving the vaccine, Dr. Michael developed an extremely serious form of a condition known as acute immune thrombocytopenia, which prevented his blood from clotting properly.
In a statement, Pfizer, the maker of the vaccine, said it was “actively investigating” the case, “but we don’t believe at this time that there is any direct connection to the vaccine.”
AstraZeneca vaccine likely won‘t be authorized in US until April
(30.12.2020)
The coronavirus vaccine developed by AstraZeneca and Oxford University is not likely to be authorized for use in the U.S. until April, a top Trump administration health official said Wednesday.
“We project, if everything goes well, that the readout and emergency use authorization may be granted somewhere early in the month of April,” Moncef Slaoui, the chief science adviser for the administration‘s Operation Warp Speed, told reporters.
U.K. Authorizes Covid-19 Vaccine From Oxford and AstraZeneca
A decision is further off in the United States, where the Food and Drug Administration is waiting for data from a separate clinical trial. The study was halted in September and delayed for nearly seven weeks — much longer than in other countries — as regulators investigated whether an illness in a participant in Britain was related to the vaccine. American regulators ultimately allowed the trial to proceed.
5 Questions Fauci and FDA Need to Answer on Pfizer and Moderna COVID Vaccines
1. Why didn’t the FDA’s Center for Biological Evaluation and Research require Moderna and Pfizer-BioNTech to conduct immunogenicity testing on their COVID-19 vaccines for anti-drug antibodies as recommended in the agencies’ own guidelines for drug development during clinical trials?
(…)
2. Why does the FDA seem surprised by the recent reports of life-threatening anaphylactic reactions after the agency approved emergency use of two mRNA COVID-19 vaccines that contain polyethylene glycol?
(…)
3. Why did FDA officials not acknowledge the valid and scientifically supported concerns regarding the use of PEG in COVID-19 vaccines when CHD first notified them in September?
(…)
4. Why did the FDA abandon its regulatory authority to the pharmaceutical companies developing COVID-19 vaccines?
(…)
5. Will FDA and NIAID now require mRNA vaccine manufacturers to conduct assessments of the immunogenicity of the pegylated lipid nanoparticles used in their COVID-19 vaccines, and will they also consider pre-screening of all mRNA vaccine recipients for the presence and titers of anti-PEG antibodies?
FDA investigating allergic reactions to Pfizer vaccine reported in multiple states
“We are working hand in hand with the Centers for Disease Control and Prevention (CDC), and we’ve actually been working closely with our United Kingdom colleagues, who of course reported the allergic reaction. I think we’ll be looking at all the data we can from each of these reactions to sort out exactly what happened, and we’ll also be looking to try to understand which component of the vaccine might be helping to produce them,” Marks said.
FDA says Pfizer‘s COVID-19 vaccine vials may hold extra ‚obtainable‘ doses, adding to US supply
Pharmacists must throw away any extra amount of the vaccine if it does not consist of the 0.3 mL needed for a full dose, Pfizer said. The remaining amount „must never“ be combined with the vaccine from another vial.
The Pfizer vaccine, green-lighted by the FDA on Dec. 11, was developed in less than a year, a fraction of the time it would usually take as researchers worldwide frantically sought an antidote to a virus discovered in China in December 2019.
Scientist behind Oxford vaccine urges FDA not to delay data review
Professor Adrian Hill, part of the team behind the Oxford-AstraZeneca Covid-19 vaccine, says he hopes the FDA will review the available data in January, because waiting for the trial’s end next year would be “too late.”
It took AstraZeneca researchers 1 month to get vaccine trial data to FDA, source tells CNN
(14.10.2020)
The source said the root of the delay is that the participant was in the United Kingdom, and the European Medicines Agency and the FDA store data differently.
„They had to convert data from one format to another format. It‘s like taking stuff off a PC and putting it onto an Apple. They had to spend a lot of hours to get what they wanted,“ the source said.
Blunders Eroded U.S. Confidence in Early Vaccine Front-Runner
AstraZeneca was in part to blame for the delay, said the people with knowledge of the F.D.A. talks. The company was slow to provide the F.D.A. with all the data that regulators wanted to review before allowing the trial to start up again.
In late October, after 47 days, the F.D.A. cleared the U.S. trial to restart.
It was now even further behind the late-stage trials that Pfizer and Moderna had begun in the United States about a month before AstraZeneca’s trial started.
Covid-19: F.D.A. Clears Pfizer Vaccine and Millions of Doses Will Be Shipped Right Away
The authorization is a historic turning point in a pandemic that has taken more than 290,000 lives in the United States. With the decision, the United States becomes the sixth country — in addition to Britain, Bahrain, Canada, Saudi Arabia and Mexico — to clear the vaccine. Other authorizations, including by the European Union, are expected within weeks.
AstraZeneca to seek FDA authorization for vaccine based on foreign trial data
The company halted its U.S. trial in early September over safety concerns, after a trial participant reported neurological problems. The study resumed earlier this month after FDA concluded that no evidence linked the volunteer‘s symptoms to the shot.
AstraZeneca shares slip after analyst says vaccine will struggle to get green light in US – live updates
SVB Leerink analyst Geoffrey Porges said the treatment may never gain approval from US regulator the FDA, and said Astra had highlighted results from a “relatively small” number of patients.
University Hospitals and CWRU join global study of AstraZeneca’s COVID-19 vaccine
AstraZeneca paused its trial in early September to review safety data because a British trial participant developed a neurological condition.
Last week, the Food and Drug Administration authorized the resumption of the company’s U.S. trials after reviewing global safety data. The trial had already resumed in other countries.
Astra-Oxford Vaccine Stays Near Front of Line Despite U.S. Delay
A seven-week halt to a U.S. trial of the Covid vaccine developed by AstraZeneca Plc and the University of Oxford bumped it from pole position in the race for a protective shot, but it’s still in the leading pack.
It took AstraZeneca researchers 1 month to get vaccine trial data to FDA, source tells CNN
(14.10.2020)
The source said the root of the delay is that the participant was in the United Kingdom, and the European Medicines Agency and the FDA store data differently.
„They had to convert data from one format to another format. It‘s like taking stuff off a PC and putting it onto an Apple. They had to spend a lot of hours to get what they wanted,“ the source said.
As AstraZeneca’s Covid-19 vaccine trial remains on hold in U.S., participants waiting on a second dose are in limbo
(06.10.2020)
Still, such participants occupy an unusual position in a trial shutdown that is being closely watched as a potential indicator of the prospects of a frontrunner in the race to develop a vaccine to curb the devastation of the Covid-19 pandemic.
For the participant who spoke with STAT — and others in his same position who can’t currently get their booster shot — the trial halt has become a waiting game. “Now, we’re waiting as the lab rats in the corner,” said the participant, who requested anonymity because he was worried he could face consequences if study investigators found out he had spoken to the press.