Archiv: Food and Drug Administration (FDA)


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 The letter stated that AstraZeneca had used outdated data to reach its efficacy number.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.