Tag Archives: Food and Drug Administration

U.S. FDA grants full approval to Pfizer-BioNTech COVID-19 vaccine

(Reuters) -The U.S. drug regulator on Monday granted full approval to the Pfizer Inc/BioNTech SE COVID-19 vaccine that earned emergency-use authorization in December, making it the first to secure such Food and Drug Administration validation as health authorities struggle to win over vaccine skeptics.

The FDA approved the two-dose vaccine for use in people over the age of 16. More than 204 million people in the United States have received the vaccine since it was given emergency authorization, based on data from Sunday.

None of the three COVID-19 vaccines given emergency-use authorization by the FDA – also including those made by Moderna Inc and Johnson & Johnson – had previously received full FDA approval.

Public health officials hope it will convince more unvaccinated Americans that Pfizer’s shot is safe and effective. Vaccine hesitancy among some Americans has hindered the United States response to the COVID-19 pandemic.

“While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated,” said Janet Woodcock, the U.S. Food and Drug Administration’s acting commissioner.

Roughly 51% of Americans have been fully vaccinated so far, even as a recent surge of infections spurred by the contagious Delta variant ravages parts of the country with low vaccination rates.

The FDA’s approval is based on updated data from the company’s clinical trial.

“Based on the longer-term follow-up data that we submitted, today’s approval for those aged 16 and over affirms the efficacy and safety profile of our vaccine at a time when it is urgently needed,” Albert Bourla, CEO of Pfizer, said in a statement.

The Pfizer-BioNTech vaccine will now be marketed under the name Comirnaty, the FDA said.

Some U.S. cities including New York and San Francisco have already imposed rules requiring vaccination to dine at restaurants or work in government offices, among other activities.

(Reporting by Michael Erman in New Jersey and Manas Mishra in Bangalore; Editing by Sriraj Kalluvila and Will Dunham)

U.S. experts to review Biogen drug that could be first new Alzheimer’s treatment in decades

By Deena Beasley

(Reuters) – U.S. health experts this week will decide whether to recommend approval for Biogen Inc’s Alzheimer’s drug, which could become the first new treatment for the mind-wasting disease in decades even as serious questions persist over whether data show if it works.

In a field littered with unrelenting failure, Biogen believes in aducanumab it has the first drug that can treat an underlying cause, and therefore slow progression, of Alzheimer’s. But its path to approval has been anything but smooth or assured.

Biogen abruptly ended clinical trials of aducanumab last year after an early look at trial results showed it was not effective. Last October, the company shocked many Alzheimer’s experts by reversing course, saying that a new analysis showed aducanumab could help patients with early-stage disease preserve their ability to function independently for longer. In July, Biogen filed for approval from the Food and Drug Administration.

Now the agency faces tremendous pressure to approve a treatment option for millions of Americans suffering from Alzheimer’s and the millions more expected to face it in coming years.

Patient advocates say the need for a new Alzheimer’s treatment that could help people remain independent is heightened by the coronavirus pandemic, which has killed more than 229,000 people in the United States, including tens of thousands of seniors in nursing homes.

“The pandemic came and it changed everything,” said Russ Paulsen, chief operating officer at patient advocacy group UsAgainstAlzheimer’s. “We need something to keep people out of nursing homes.”

A committee of outside advisers to the FDA will discuss aducanumab on Nov. 6. The agency’s final decision is expected by March. European health regulators have also accepted the drug for review.

Charles Flagg, a 79-year-old retired minister from Jamestown, Rhode Island, had been enrolled for years in a trial of aducanumab before it was stopped. He started receiving the drug again in August as part of a follow-up study, according to his wife Cynthia Flagg.

“He’s not 100 percent himself, but overall I’m not dealing with someone that needs to be led around or be in a care home,” Flagg said.

Aducanumab, an antibody designed to remove amyloid plaques from the brain – a strategy tried with many failed Alzheimer’s drugs – would reap billions of dollars in sales if approved.

Biogen, along with partner Eisai Co Ltd <4523.T>, is one of the last large drugmakers pursuing treatments for a disease that afflicts nearly 6 million Americans and millions more worldwide. Biogen estimates about 1.5 million people with early Alzheimer’s in the United States could be candidates for the drug.

‘CLINICALLY MEANINGFUL’

Late last year, Biogen said one of its two pivotal studies of aducanumab showed a statistically significant benefit at slowing cognitive and functional decline in patients with early Alzheimer’s. A second trial failed to achieve that goal, but did show a benefit for a subset of patients who were given a high dose for at least 10 months.

In March, it opened a follow-up long-term safety study to 2,400 people who had previously participated in trials of aducanumab, like Flagg.

Many Alzheimer’s researchers say Biogen should conduct a third large study to prove aducanumab works. They worry about its possible side-effects, such as brain-swelling, and the potential cost.

“Aducanumab’s efficacy as a treatment for the cognitive dysfunction in Alzheimer’s disease cannot be proven by clinical trials with divergent outcomes,” said Mayo Clinic neurologist Dr. David Knopman, who was recused from the expert panel because he helped conduct the trials.

Others believe the FDA could approve the drug without another trial.

Previous clinical studies had largely targeted patients in later stages of the disease, while many experts now believe attacking Alzheimer’s as early as possible may be the key to success. But there was a lack of clarity on how to assess a drug’s success when functional deficits are less pronounced.

In 2018, the FDA revised its standard of proof guidance for reviewing Alzheimer’s drugs by essentially combining what had been separate goals for cognition, or memory, and day-to-day function. The new guidance stressed the need for a drug to show “clinically meaningful” benefits, a term it has not clearly defined.

Alzheimer’s advocacy groups are pushing for a broad definition, saying it should include preserving the ability to perform daily activities such as shopping independently or remembering to turn off a stove.

“They have been trying to lower the bar and help any company to get a drug approved,” said Dr. Marwan Sabbagh, from the Cleveland Clinic Lou Ruvo Center for Brain Health in Las Vegas. “How much (improvement) do you need to be clinically meaningful? Naturally this is very subjective.”

The FDA did not immediately respond to a request for comment.

(Reporting by Deena Beasley; Editing by Caroline Humer and Bill Berkrot)

Novartis, U.S. drug regulator agree to malaria drug trial against COVID-19

By John Miller

ZURICH (Reuters) – Novartis has won the go-ahead from the U.S. Food and Drug Administration to conduct a randomized trial of malaria drug hydroxychloroquine against COVID-19 disease, the Swiss drugmaker said on Monday, to see if it helps patients.

The decades-old generic medicine got FDA emergency use authorization this month for its unapproved use for coronavirus disease, but so far there is no scientific proof it works. There are currently no approved COVID-19 medicines.

Novartis plans to start recruiting 440 patients for its Phase III, or late-stage, trial within weeks at more than a dozen U.S. sites. Results will be reported as soon as possible, the company added.

Use of the drug, also approved to treat lupus and rheumatoid arthritis, has soared after having been promoted by President Donald Trump, with some worried the administration’s advocacy for an unproven medicine for COVID-19 has short-circuited the FDA’s oversight process.

“We recognize the importance of answering the scientific question of whether hydroxychloroquine will be beneficial for patients with COVID-19 disease,” said John Tsai, Novartis’s top drug developer. “We mobilized quickly to address this question in a randomized, double-blind, placebo-controlled study.”

Companies such as Novartis, Roche and Gilead Sciences are testing older medicines developed to treat other diseases, for signs they could be repurposed to tackle the coronavirus epidemic. Gilead just expanded a trial of its Ebola drug remdesivir.

Still, some fear the championing of hydroxychloroquine by Trump and others as a potential “game changer” against COVID-19 has overshadowed dangerous side effects like vision loss and heart problems. Novartis CEO Vas Narasimhan has also said the medicine is one of his biggest hopes against the viral epidemic.

There are several additional studies of hydroxychloroquine underway, including at the University of Washington and University of Minnesota, as well as work by the National Institutes of Health in the United States.

Novartis’s Sandoz generics unit has pledged to donate 130 million doses of the medicine for use. Sanofi has also said it will donate 100 million doses of hydroxychloroquine to 50 countries.

(Reporting by John Miller, editing by John Revill)

U.S. officials hopeful about May 1 target date for reopening U.S.

WASHINGTON (Reuters) – The Trump administration views May 1 as a target date for relaxing stay-at-home restrictions across the United States, Food and Drug Administration Commissioner Stephen Hahn said on Sunday, but he cautioned that it was still too early to say that target would be met.

“We see light at the end of the tunnel,” he told ABC’s “This Week.” However, there were many factors to take into account in finally determining when it would be safe to lift restrictions, he said.

(Reporting By Ross Colvin; editing by Diane Craft)

FDA too slow to order food recalls, U.S. watchdog finds

By Julie Steenhuysen

CHICAGO (Reuters) – The Food and Drug Administration is too slow to order companies to recall tainted foods, leaving people at risk of illness and death, a government watchdog said in a review of the agency’s food safety program.

The Department of Health and Human Services’ Office of Inspector General reviewed 30 recalls that occurred between 2012 and 2015, including two in which companies did not recall all affected items until 165 days and 81 days after the FDA became aware of tainted foods. The watchdog issued its report on Wednesday.

“FDA does not have adequate policies and procedures to ensure that firms take prompt and effective action in initiating voluntary food recalls,” the report said. “As a result, consumers remained at risk of illness or death for several weeks after FDA was aware of a potentially hazardous food in the supply chain.”

The watchdog urged the FDA to address the problem immediately.

In a blog post, FDA food safety officials Stephen Ostroff and Howard Sklamberg called the report’s findings “unacceptable” and said the agency is “totally committed” to food safety.

Representative Rosa DeLauro of Connecticut in a statement said it was “mind-boggling” that the FDA does not have policies or procedures to ensure swift voluntary food recalls.

DeLauro, who oversees drug and food safety in her position on the House of Representatives subcommittee responsible for the FDA, pointed to a salmonella outbreak last year in cucumbers, which sickened nearly 900 people, hospitalized 191 and killed six. The outbreak began in July, but it took until September before producers started recalling product.

“Delays like this one – and others found in the report – are completely unacceptable and leave American consumers at risk for illness and death,” DeLauro said.

Ostroff and Sklamberg said the FDA has a plan underway to strengthen compliance and enforcement policies, including both voluntary and mandatory recalls.

But they said recalls must be based on scientific evidence borne out of an outbreak investigation. And while timeframes for recalls need to be set, “they must be done on an individual basis rather than by setting arbitrary deadlines.”

To speed the FDA’s response, Ostroff and Sklamberg said the agency has established a team of experts from different scientific disciplines to oversee outbreak investigations. They also cited FDA’s adoption in 2014 of the use of whole genome sequencing, a more precise technology for determining the genetic fingerprint of foodborne pathogens.

In addition, provisions in the 2011 Food Safety Modernization Act that require companies to minimize food safety risks, and require companies to have a recall plan, will begin to take effect this fall.

(Reporting by Julie Steenhuysen; Editing by Leslie Adler)

Dole recalls packaged salads after multi-state listeria outbreak

Dole is temporarily shutting down one of its production facilities and recalling all of the salads that were made there because the facility has been linked to a multi-state outbreak of listeria.

The recall notice was posted on the Food and Drug Administration website on Friday.

The Centers for Disease Control and Prevention (CDC), which has been investigating the outbreak, said 12 people in six states have been hospitalized since July. One person died.

The CDC determined that salads produced and packaged at Dole’s facility in Springfield, Ohio, were likely behind the illnesses. Dole initiated the recall and decided to temporarily suspend production at the facility “out of an abundance of caution,” according to the recall notice.

The salads in question were sold under a variety of different brand names — including Dole, Fresh Selections, Simple Truth, Marketside, The Little Salad Bar and President’s Choice, the CDC said. However, they all have the letter ‘A’ at the beginning of a product code that appears on the upper-right-hand corner of the package, according to Dole’s recall notice.

Dole said none of its other products or facilities are affected by the recall, and added that packaged salads that have ‘B’ or ‘N’ at the start of their product codes aren’t being recalled. Those salads were produced at different facilities, and the CDC added that it doesn’t currently have any evidence suggesting those salads are linked to the outbreak.

Dole said the recalled salads were sold in Alabama, Connecticut, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Michigan, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Virginia and Wisconsin, as well as the Canadian provinces of Ontario, New Brunswick and Quebec.

The company encouraged consumers and stores who still have packaged salads with product codes beginning with ‘A’ to throw them out without eating them.

According to the CDC, listeria is a bacteria that can lead to listeriosis, a rare but life-threatening condition that is often contracted by eating contaminated food. The organization estimates that listeriosis sickens about 1,600 people annually in the United States, killing about 260 of them.

Newborns, older adults people with weak immune systems and pregnant women are generally at risk, the CDC says, and the bacteria can lead to miscarriages or stillbirths. Common symptoms include fever and muscle aches, though the disease can also cause convulsions in certain people.

This particular outbreak sickened people in Michigan, Indiana, Pennsylvania, New York, New Jersey and Massachusetts, according to the CDC, and killed a person from Michigan.

Trader Joe’s recalls cashews amid salmonella concerns

A possible salmonella contamination has prompted Trader Joe’s to recall some cashews.

The grocery store chain issued a statement about the recall late last week, saying that one particular kind of Trader Joe’s Raw Cashew Pieces could be contaminated with the bacteria.

The cashews are marked “BEST BEFORE 07.17.2016TF4,” the company said, and were distributed to stores in 30 states across the country, as well as the District of Columbia.

It wasn’t clear exactly how many packages were included in the recall.

Trader Joe’s said it learned of the possible contamination from a supplier, but didn’t elaborate.

A recall notice on the Food and Drug Administration website says Heritage International (USA) Inc. was voluntarily recalling the cashew lot after routine lab tests found salmonella in it.

The bacteria can cause people to fall ill.

Trader Joe’s said it hasn’t received any reports of anyone getting sick from the cashews, though it has stopped selling all Trader Joe’s Raw Cashew Pieces in its stores pending an investigation.

The grocery chain encourages anyone who bought the cashews marked “BEST BEFORE 07.17.2016TF4” to return them for a full refund or throw them out without eating them.

According to the CDC, salmonella sickens about 1.2 million Americans every year. Symptoms include diarrhea, fever and abdominal cramps, and most people fully recover in 4 to 7 days. In extreme cases, though, infections can spread beyond the intestines and become more severe.

The bacteria leads to about 450 deaths and 19,000 hospitalizations every year, the CDC says. Children, older adults and people with weak immune systems are particularly at risk.