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.
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.
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.
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.
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.
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.
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.
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.
A spokesperson for DHS reportedly declined to comment on the number of cases.
He will be staying at home and teleworking while wearing a mask continually for 14 days.
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.
Those practices made the tests sent to public health labs unusable because they were contaminated with the coronavirus, and produced some inconclusive results.
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.
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.
(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.
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.
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.
“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.