Tag: FDA

White House faces new obstacles in COVID-19 fight

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President Biden is facing a series of fresh obstacles in getting the coronavirus pandemic under control in the United States.

Several states have seen an uptick in cases even as millions of Americans are vaccinated each day, which can be attributed in part to the lifting of restrictions on masks and businesses and general pandemic fatigue more than a year after the virus began to spread widely. More contagious variants are spreading throughout the country, and experts warn that new variants could pop up until the country reaches a greater degree of immunity.

The Food and Drug Administration (FDA) recommended a pause in the use of the Johnson & Johnson vaccine this week. While many health experts praised it as the right move, an extended pause could drive up vaccine hesitancy, posing yet another challenge for Biden. Continue reading.

FDA vows to move ‘rapidly’ to authorize second coronavirus vaccine

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Agency announcement follows Thursday’s positive review of Moderna’s shot by outside advisers

The Food and Drug Administration said Thursday night that it will “rapidly work toward” emergency authorization of Moderna’s coronavirus vaccine, just hours after agency advisers endorsed the shot. The announcement appeared to pave the way for another weapon against a pandemic that has killed about 310,000 people in the United States.

The FDA statement came after the agency’s vaccine advisory panel voted almost unanimously — 20 in favor, with one abstention — that the benefits of the highly effective vaccine outweighed its risks for people 18 years of age and older. The FDA intends to authorize the vaccine Friday, according to knowledgeable individuals who spoke on the condition of anonymity because they were not authorized to speak publicly about the schedule.

“I just want to make the point of what a remarkable scientific achievement this is, and pay thanks to all the scientists, present and past, who contributed to this,” James E.K. Hildreth, president of Meharry Medical College and a member of the advisory panel, said at the close of the committee meeting on Thursday. “To go from having a [genetic] sequence of a virus in January, to having two vaccines available in December, is a remarkable achievement.” Continue reading.

FDA review clears path for second coronavirus vaccine, this one developed by Moderna

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NOTE: This article is provided free of charge by the Washington Post.

Regulators, who confirmed the vaccine was 94 percent effective and raised no serious safety concerns, could authorize it as early as Friday

By the end of the week, the United States could have two coronavirus vaccines.

A vaccine developed by biotechnology company Moderna appears poised for regulatory clearance after a detailed data review by Food and Drug Administration scientists confirmed the two-shot regimen was “highly effective” in a clinical trial and carried no serious safety concerns.

The FDA is likely to authorize the Moderna vaccine as soon as Friday, according to a person with knowledge of the situation who spoke on the condition of anonymity because they were not authorized to discuss the issue. Anticipating that decision shortly, Gen. Gustave Perna, who is overseeing the federal effort to distribute vaccines, said Monday that the United States was preparing to ship almost 6 million doses of the Moderna vaccines to 3,285 locations in the first week.

FDA clears nation’s first COVID-19 vaccine

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The country’s first coronavirus shots are one step closer to getting injected into the general public after the Food and Drug Administration (FDA) granted emergency authorization late Friday to the vaccine manufactured by Pfizer and BioNTech.

The announcement comes as the country is reeling from a new surge of COVID-19 infections, with deaths now exceeding 3,000 people each day.

Now that the FDA has given the vaccine the green light, the federal government is able to start distributing it to states. However, vaccinations won’t begin until after a Centers for Disease Control and Prevention (CDC) committee recommends the vaccine and the CDC accepts that recommendation. Continue reading.

Moderna to apply for emergency use authorization for COVID-19 vaccine candidate on Monday

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Moderna announced that it will apply for emergency use authorization from the U.S. Food and Drug Administration (FDA) for its COVID-19 vaccine candidate on Monday.

The company said in a statement that testing showed its vaccine candidate was 94.1 percent effective in preventing COVID-19 and was 100 percent effective against severe COVID-19.

It also said “no serious safety concerns” have been identified to date. Some trial participants have experienced reactions like pain at the site of the injection or fatigue. Continue reading.

Trump says without proof that FDA ‘deep state’ slowing COVID trials

WASHINGTON – U.S. President Donald Trump on Saturday accused members of the “deep state” at the Food and Drug Administration, without providing evidence, of working to slow testing of COVID-19 vaccines until after the November presidential election. 

In a Twitter post, Trump said the deep state “or whoever” at the FDA was making it very difficult for drug companies to enroll people in clinical trials to test vaccines and therapies for the novel coronavirus. 

The comment came after Reuters exclusively reported on Thursday that a top FDA official said he would resign if the Trump administration approved a vaccine before it was shown to be safe and effective. Continue reading.

The head of the FDA is forbidden from speaking to press without a Trump ‘minder’

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The New York Times has a long look questioning whether Food and Drug Administration head Stephen Hahn is being forced into giving the nation subpar advice on the demand of the anti-science, anti-reality narcissistic idiot manchild posing as the current president. It is full of the usual back and forth, both-siding quotes while laying out reams of evidence that actually this is not a question at all. The plain history shows that Dr. Hahn has absolutely been mealymouthing FDA pandemic advice to dodge contradicting Donald Trump’s most egregiously ignorant and magic-minded proclamations. It’s the sort of piece where you get the subject, Hahn, assuring the reporter that he is absolutely not feeling “squeezed” before the reporter casually throws in:

“On the line as he spoke was Michael Caputo, a deputy to Dr. Hahn’s boss, Alex M. Azar II, the secretary of the Department of Health and Human Services. […] Dr. Hahn is not allowed to speak to the press without Mr. Caputo or another official on the phone.”

There you go, America. Question answered. The head of the Food and Drug Administration is forbidden from talking to the press about the pandemic, period, unless an administration minder is present. Continue reading.

FDA ends emergency use authorization for hydroxychloroquine

Axios logoThe FDA ended Monday its emergency use authorizations for two controversial drugs, hydroxychloroquine and chloroquine, as a potential coronavirus treatment.

Why it matters: Despite gaining President Trump’s adamant support and use, the drugs have failed in several clinical trials and have been found to possibly cause serious heart problems.

What they’re saying: The FDA said it believes the drugs “are unlikely to be effective in treating COVID-19” under the emergency use authorization. Continue reading.

FDA to authorize emergency use of new coronavirus treatment

The Hill logoThe Trump administration is fast-tracking authorization of the drug remdesivir as a treatment for COVID-19.

The Food and Drug Administration (FDA) on Friday announced the drug will receive an “emergency use authorization” after it showed promising results during a clinical trial.

Early results released this week showed the drug had modest success in reducing the time COVID-19 patients were in the hospital. Continue reading.

A small trial finds that hydroxychloroquine is not effective for treating coronavirus

On Saturday the Food and Drug Administration approved the use of two antimalarial drugs, hydroxychloroquine and a related medication, chloroquine, for emergency use to treat COVID-19. The drugs were touted by President Trump as a “game changer”for COVID-19.

However, a study just published in a French medical journal provides new evidence that hydroxychloroquine does not appear to help the immune system clear the coronavirus from the body. The study comes on the heels of two others – one in France and one in China – that reported some benefits in the combination of hydroxychloroquine and azithromycin for COVID-19 patients who didn’t have severe symptoms of the virus.

I am a medicinal chemist who has specialized in discovery and development of antiviral drugs for the past 30 years, and I have been actively working on coronaviruses for the past seven. I am among a number of researchers who are concerned that this drug has been given too much of a high priority before there is enough evidence to show it is indeed effective. Continue reading.