Archiv: Food and Drug Administration (FDA)


05.10.2021 - 04:38 [ Achse des Guten ]

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. ……….

05.10.2021 - 04:13 [ Steve Kirsch ]

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

05.10.2021 - 04:02 [ apnews.com ]

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.

23.09.2021 - 16:42 [ whyy.org ]

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.

23.09.2021 - 16:40 [ BR.de ]

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.

29.08.2021 - 05:40 [ NBC San Diego ]

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 …

24.08.2021 - 07:12 [ Tagesschau.de ]

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.

24.08.2021 - 06:47 [ Food and Drug Administration (FDA) ]

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.

24.08.2021 - 06:33 [ marketwatch.com ]

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.

12.08.2021 - 08:27 [ theHill.com ]

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.

12.08.2021 - 08:06 [ Yahoo.com ]

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.

12.08.2021 - 08:01 [ Yahoo.com ]

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.

12.08.2021 - 07:50 [ apnews.com ]

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.

30.03.2021 - 16:40 [ smithsonianmag.com ]

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.”

15.02.2021 - 22:20 [ ORF.at ]

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.

27.01.2021 - 02:34 [ theDispatch.com/ ]

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.

27.01.2021 - 02:18 [ NBC News ]

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.

27.01.2021 - 02:12 [ businessinsider.com ]

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.

23.01.2021 - 10:05 [ New York Times ]

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.

13.01.2021 - 18:18 [ New York Times ]

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.”

12.01.2021 - 14:15 [ theHill.com ]

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.

30.12.2020 - 17:39 [ New York Times ]

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.

27.12.2020 - 04:30 [ ChildrensHealthDefense.org ]

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?

20.12.2020 - 10:00 [ theHill.com ]

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.

17.12.2020 - 09:19 [ USA Today ]

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.

12.12.2020 - 20:01 [ NBC News ]

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.”

12.12.2020 - 20:00 [ CNN ]

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.

12.12.2020 - 19:43 [ New York Times ]

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.

12.12.2020 - 19:40 [ New York Times ]

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.

23.11.2020 - 17:11 [ Politico.com ]

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.

23.11.2020 - 17:04 [ Telegraph.co.uk ]

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.

30.10.2020 - 12:50 [ Cleveland.com ]

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.

29.10.2020 - 05:31 [ Bloomberg ]

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.

26.10.2020 - 17:19 [ CNN ]

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.

26.10.2020 - 17:17 [ Statnews.com ]

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.

05.07.2020 - 12:13 [ CNN ]

Study finds hydroxychloroquine may have boosted survival, but other researchers have doubts

(03.06.2020)

The US Food and Drug Administration withdrew its emergency use authorization for the drug earlier this month and trials around the world, including trials sponsored by the World Health Organization and the National Institutes of Health, were halted.

10.05.2020 - 05:18 [ CNN ]

FDA commissioner and CDC director will testify remotely in Senate hearing

Dr. Robert Redfield, the head of the Centers for Disease Control and Prevention, and Dr. Stephen Hahn, the commissioner of the Food and Drug Administration, will testify by video conference at a Senate hearing about the coronavirus next week.

10.05.2020 - 03:08 [ 10tv.com ]

Reports: 11 US Secret Service members currently positive for COVID-19

A spokesperson for DHS reportedly declined to comment on the number of cases.

10.05.2020 - 02:59 [ The Hill ]

Fauci to enter ‚modified quarantine‘: report

He will be staying at home and teleworking while wearing a mask continually for 14 days.

10.05.2020 - 02:41 [ Financial Post ]

U.S. CDC, FDA chiefs in self-quarantine following COVID-19 exposure -statement, report

U.S. Food and Drug Administration Commissioner Stephen Hahn is in self-quarantine for a couple of weeks after coming into contact with someone who tested positive for COVID-19, an FDA spokesman told Reuters late on Friday.

22.04.2020 - 15:39 [ New York Times ]

C.D.C. Labs Were Contaminated, Delaying Coronavirus Testing, Officials Say

(18.04.2020)

Those practices made the tests sent to public health labs unusable because they were contaminated with the coronavirus, and produced some inconclusive results.

22.04.2020 - 15:02 [ Alternet.org ]

CDC blocked top FDA scientist dispatched to expedite coronavirus response at critical moment

(05.03.2020)

The FDA’s director of the Office of In Vitro Diagnostics and Radiological Health, Timothy Stenzel, flew to CDC headquarters in Atlanta on the weekend of Feb. 22, but he was immediately forced to wait overnight as health department officials lobbied the CDC to give him access to the agency’s campus, according to Politico. Stenzel was there specifically to work out issues with the CDC’s coronavirus test that had already hobbled more expansive screening for weeks.

22.04.2020 - 14:41 [ Axios ]

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.

07.04.2020 - 19:18 [ Bloomberg ]

Ebola Drug From Japan May Emerge Among Key Candidates

(August 7, 2014)

Favipiravir is in the final stages of human studies in the U.S. as a treatment for flu. A Phase II study in the U.S. using 10 grams of the drug showed the medicine reduced flu symptoms against a placebo. The U.S. phase III study of the treatment for flu is scheduled to be completed around March 2015, the company said last month.

The U.S. Department of Defense funded the trials to improve the country’s response capability and protect the military from flu pandemics, its BioDefense Therapeutics unit said in an October statement.

05.04.2020 - 09:59 [ Forbes ]

FDA Approves Anti-Malarial Drugs Chloroquine And Hydroxychloroquine For Emergency Coronavirus Treatment

(31.01.2020)

The Department of Health and Human Services said Sunday hydroxychloroquine and chloroquine products can be distributed and prescribed by doctors through the Strategic National Stockpile “to hospitalized teen and adult patients with COVID-19, as appropriate, when a clinical trial is not available or feasible.”

HHS said Germany’s Sandoz has already given 30 million doses of hydroxychloroquine to the Strategic National Stockpile, the federal government’s inventory of medical supplies for public health emergencies, while Bayer has donated a million doses of chloroquine.

05.04.2020 - 02:00 [ The Hill ]

Social Security advocate says pharmaceutical companies ‚looking at a pandemic as a massive profit potential‘

Lawson discussed how drugmaker Gilead Sciences asked the Food and Drug administration last week to give it the rare „orphan“ status for remdesivir, the company’s experimental coronavirus treatment.

03.04.2020 - 08:12 [ Yahoo.com ]

Trump touts chloroquine for ‚immediate‘ use treating coronavirus, but FDA wants to see the data first

“It’s shown very encouraging, very, very encouraging early results, and we’re going to be able to make that drug available almost immediately, and that’s where the FDA has been so great,” Trump said. “They’ve gone through the approval process, it’s been approved and they did it, they took it down from many, many months to immediate.”

But moments later, FDA Commissioner Stephen Hahn cautioned that chloroquine had not yet been approved for treating COVID-19.