Food and Drug Administration

FDA Concedes Delays In Response To Baby Formula Shortage

By Associated Press

and Newsy Staff
September 21, 2022

The FDA will also seek new authority to compel companies to turn over key information.

The Food and Drug Administration acknowledged Tuesday that its response to the U.S. infant formula shortage was slowed by delays in processing a whistleblower complaint and test samples from the nation’s largest formula factory.

A 10-page report from the agency offers its first formal account of the factors that led to the ongoing shortage, which has forced the U.S. to airlift millions of pounds of powdered formula from overseas.

The review zeroed in on several key problems at the agency, including outdated data-sharing systems, inadequate staffing and training among its food inspectors, and poor visibility into formula supply chains and manufacturing procedures.

“For things that are critical to the public health, if you don’t have some understanding of how all the pieces fit together, then when you get into a crisis or a shortage you have a real problem,” FDA Commissioner Robert Califf told The Associated Press in an interview. “To a large extent that’s what happened here.”

Califf said the FDA will seek new authority to compel companies to turn over key information.

One consumer advocate said the evaluation doesn’t go far enough to fix the problems.

“This internal evaluation treats the symptoms of the disease rather than offering a cure,” Scott Faber of the Environmental Working Group said in a statement. “Nothing in this evaluation addresses the fragmented leadership structure that led to critical communication failures.”

The FDA report was overseen by a senior official who interviewed dozens of agency staffers. It comes nearly eight months after the FDA shuttered Abbott’s Michigan plant due to safety concerns, quickly slashing domestic production within the highly concentrated formula industry.

A company whistleblower had tried to warn the FDA of problems at the plant in September 2021, but government inspectors didn’t investigate the complaints until February after four infants became sick, resulting in two deaths. The FDA is still investigating links between those illnesses and the formula.

The FDA previously told Congress that top agency officials didn’t learn about the complaint until February because of mail delays and a failure to escalate the Abbott employee’s allegations. The new report stated that FDA’s “inadequate processes and lack of clarity related to whistleblower complaints,” may have delayed getting inspectors to the plant.

“Whistleblower complaints come into the agency in many different ways, from many different sources,” said Dr. Steven Solomon, an FDA veterinary medicine official who oversaw the review. “One of the actions we’ve already taken is to make sure that however they come into the agency, they get triaged and escalated to the right leadership levels.”

FDA inspectors collected bacterial samples from the plant for testing, but shipping issues by “third party delivery companies” delayed the results, according to the report. The FDA also faced challenges ramping up its testing capacity for cronobacter, a rare but potentially deadly bacteria repeatedly linked to outbreaks in baby formula.

The FDA also noted that it had to reschedule its initial inspection of the Abbott plant due to cases of COVID-19 among company staff. That delay came on top of earlier missed inspections because the agency pulled its inspectors from the field during the pandemic.

The report concluded by listing new resources that Congress would need to authorize to improve infant formula inspections and standards, including:

— Increased funding and hiring authority to recruit experts to FDA’s food division;

— Improved information technology to share data on FDA inspections, consumer complaints and testing results;

— New authority to compel manufacturers to turn over samples and records on manufacturing supply chains, manufacturing quality and safety.

U.S. inventories of baby formula have been improving, hitting in-stock rates above 80% last week, according to IRI, a market research firm. That’s up from a low of 69% in mid-July. The U.S. has imported the equivalent of more than 80 million bottles of formula since May, according to White House figures, and the Biden administration is working to help foreign manufacturers stay on the market long term to diversify supply.

Califf has commissioned a separate external review of FDA’s food division citing “fundamental questions about the structure, function, funding and leadership” of the program. That review is being led by former FDA commissioner Dr. Jane Henney, who led the agency during the final years of the Clinton administration.

Additional reporting by The Associated Press.

Source: newsy.com

View Source

>>> Don’t Miss Today’s BEST Amazon Deals! <<<<

Store Shelves Are No Longer Bare, but Baby Formula Remains in Short Supply

More than six months after one of the largest infant formula manufacturing plants in the United States issued a recall and was then shut down because of contamination concerns, a newborn staple remains in short supply.

In parts of the country, parents and their families are scrambling to locate precious containers of formula for their babies and many large retailers remain out of stock of popular brands. Some companies like Walmart and Target are limiting the number of containers that can be purchased at one time.

While the situation has improved since mid-July, the out-of-stock figures for powder formula on store shelves in late August remained at 23 percent, still above the 10 percent it was before the recall and shutdown, according to the Chicago-based market research firm IRI.

infections in four babies — two of them fatal — who had consumed formula manufactured at the plant. On Feb. 17, two days after the shutdown, Abbott recalled batches of three powdered formulas over complaints of serious bacterial contamination. (Abbott has said that there is no “conclusive evidence” to link the company’s formulas to the illnesses.) That disruption made it clear just how dependent Americans were on a few formula manufacturers, and the Biden administration found itself scrambling to figure out how to make more product available.

ending around Nov. 14, the F.D.A. said it would release guidance this month on how the new companies can continue to sell in the United States past this fall.

“Parents in the U.S. have been looking for a better product than what they were being offered,” said Will McMahon, one of the members of the family who owns the British baby formula Kendamil. The company has spent the last three years working through the formal process, including clinical trials, necessary to get its organic infant formula approved by the F.D.A.

Kendamil was one of the earliest formulas to get its application approved by the F.D.A. in the wake of the Sturgis plant shutdown, and the company has begun sending two million cans of formula to the United States.

dropped in early August after it said the F.D.A. had notified it that it was “deferring further consideration” of its application to import formula into the United States.

resume manufacturing of Similac formulas at its plant in Sturgis.

The company also said that it increased production at other U.S.-based manufacturing plants and one in Ireland, and that it would supply the United States with more than eight million pounds of formula in August, an increase from the year before. But it noted it would take six weeks for the Similac product from the Sturgis plant to start to hit store shelves.

But some industry experts say it will take time for Abbott to gain back the market share it once had. “To be frank, there is a lot of consumer mistrust around Similac right now,” said Mr. Dittmeier of the W.I.C. program.

That could be a boon for Reckitt Benckiser, which has been running its formula manufacturing plants at full tilt all summer, hoping to hold on to the market share it has gained at Abbott’s expense. Its market share has climbed to nearly 60 percent from 35 percent before the recall, said Robert Cleveland, who oversees the Mead Johnson nutrition business at Reckitt.

“We remain committed to making as much formula as we can,” Mr. Cleveland said. “We continue to maximize our domestic manufacturing, running overtime and going 24/7.” He added that the company had received approval to bring in formula from its plants in Singapore and specialty formula from its facilities in Mexico.

Still, in late August, when Lori Sharp, a first-time mother in Port Hueneme, Calif., realized she was down to one container of Reckitt’s Enfamil Sensitive infant formula for her 3-month-old daughter, the formula was out of stock on Walmart.com.

Panicking, she scoured more websites and widened her geographic search. She eventually discovered a container of formula at a Target 40 minutes away in Moorpark, Calif. “I went into the store and they actually had four more, but their shelves were so bare,” Ms. Sharp said. “I bought all of them.”

In Georgia, some of the most acute shortages are in rural areas. Jennifer Kelly, who is the family services manager at the early Head Start program in Swainsboro, which is between Macon and Savannah, said trying to find formula earlier this summer had become a “daily chore.”

The 14 babies she watches drink seven different kinds of formula. She and her staff were often driving to Walmart, Walgreens or a local grocery chain or scouring Amazon for some of the more obscure brands.

“It’s not like it was a few months ago when the shelves were bare,” Ms. Kelly said. “I am hoping we are on the other side of this dilemma.”

When the formula shortage was at a crisis point in May, Ms. Robinson of Bucks County, Pa., created a Facebook group that connected parents around the country. The group, called Formula Hunters, does not exchange money to keep out profiteers who have been hoarding formula and seeking to resell it at a markup.

The group operates on the notion that a parent who buys a hard-to-find formula brand and sends it to another parent in the group will eventually be repaid when others do the same for them.

Formula Hunters now has 1,500 members, who are still actively helping each other locate formula. “This has been going on for so many months,” Ms. Robinson said. “The frustration has been high.”

View Source

>>> Don’t Miss Today’s BEST Amazon Deals! <<<<

Juul To Pay Nearly $440M To Settle States’ Teen Vaping Probe

Connecticut Attorney General William Tong announced the deal Tuesday on behalf of the states plus Puerto Rico.

Electronic cigarette maker Juul Labs has agreed to pay nearly $440 million to settle a two-year investigation by 33 states into the marketing of its high-nicotine vaping products, which have long been blamed for sparking a national surge in teen vaping.

Connecticut Attorney General William Tong announced the deal Tuesday on behalf of the states plus Puerto Rico, which joined together in 2020 to probe Juul’s early promotions and claims about the benefits of its technology as a smoking alternative.

The settlement, which includes numerous restrictions on how Juul can market its products, resolves one of the biggest legal threats facing the beleaguered company, which still faces nine separate lawsuits from other states. Additionally, Juul faces hundreds of personal lawsuits brought on behalf of teenagers and others who say they became addicted to the company’s vaping products.

The states’ investigation found that Juul marketed its e-cigarettes to underage teens with launch parties, product giveaways and ads and social media posts using youthful models, according to a statement.

“We think that this will go a long way in stemming the flow of youth vaping,” Tong said at a news conference at his Hartford office.

“I’m under no illusions and cannot claim that it will stop youth vaping,” he said. “It continues to be an epidemic. It continues to be a huge problem. But we have essentially taken a big chunk out of what was once a market leader, and by their conduct, a major offender.”

The $438.5 million will be paid out over a period of six to 10 years. Tong said Connecticut’s payment of at least $16 million will go toward vaping prevention and education efforts. Juul previously settled lawsuits in Arizona, Louisiana, North Carolina and Washington.

The settlement total amounts to about 25% of Juul’s U.S. sales of $1.9 billion last year. Tong said it was an “agreement in principle,” meaning the states will be finalizing the settlement documents over the next several weeks.

Most of the limits imposed by Tuesday’s settlement won’t immediately affect Juul, which halted use of parties, giveaways and other promotions after coming under scrutiny several several years ago.

Teen use of e-cigarettes skyrocketed after Juul’s launch in 2015, leading the U.S. Food and Drug Administration to declare an “epidemic” of underage vaping among teenagers. Health experts said the unprecedented increase risked hooking a generation of young people on nicotine.

But since 2019 Juul has mostly been in retreat, dropping all U.S. advertising and pulling its fruit and candy flavors from store shelves.

The biggest blow came earlier this summer when the FDA moved to ban all Juul e-cigarettes from the market. Juul challenged that ruling in court, and the FDA has since reopened its scientific review of the company’s technology.

The FDA review is part of a sweeping effort by regulators to bring scrutiny to the multibillion-dollar vaping industry after years of delays. The agency has authorized a handful of e-cigarettes from Juul’s competitors for adult smokers looking for a less harmful alternative.

While Juul’s early marketing focused on young, urban consumers, the company has since shifted to pitching its product as an alternative nicotine source for older smokers.

“We remain focused on our future as we fulfill our mission to transition adult smokers away from cigarettes – the number one cause of preventable death – while combating underage use,” the company said in a statement.

Juul has agreed to refrain from a host of marketing practices as part of the settlement. They include not using cartoons, paying social media influencers, depicting people under 35, advertising on billboards and public transportation and placing ads in any outlets unless 85% of their audience are adults.The deal also includes restrictions on where Juul products may be placed in stores, age verification on all sales and limits to online and retail sales.

“These are some of the toughest mandates at any point on any industry,” Tong said, “which is incredibly important because at the end of the day this is about protecting our kids and protecting all of us from a very significant public health risk.”

Juul initially sold its high-nicotine pods in flavors like mango, mint and creme. The products became a scourge in U.S. high schools, with students vaping in bathrooms and hallways between classes.

But recent federal survey data shows that teens have been shifting away from the company. Most teens now prefer disposable e-cigarettes, some of which continue to be sold in sweet, fruity flavors.

Overall, the survey showed a drop of nearly 40% in the teen vaping rate as many kids were forced to learn from home during the pandemic. Still, federal officials cautioned about interpreting the results given they were collected online for the first time, instead of in classrooms.

Additional reporting by The Associated Press.

Source: newsy.com

View Source

>>> Don’t Miss Today’s BEST Amazon Deals! <<<<

The FDA Has Authorized New Omicron Booster Shots

Pfizer and Moderna have released a new COVID booster shot that will target the highly contagious BA.4 and BA.5 omicron variant.

COVID boosters are getting an omicron makeover and could go into arms by the weekend.

“I will be at the front of the line at the pharmacy getting my vaccination. I’m very confident about this,” said Dr. Robert Califf, the FDA commissioner.

The Food and Drug Administration has authorized a formula change to target the highly contagious omicron BA.4 and BA.5 variants.

Anyone at least two months past their last COVID-19 shot is eligible. Moderna is authorized for those age 18 and older. For Pfizer and Biontech’s it’s 12 and up.

Health officials say it’s to get ahead for fall and winter when the virus has mutated and spread because more people are inside.

“The idea here is the more up to date you are, the better chance we have of looking at what may come afterwards,” said Dr. Peter Marks, the FDA vaccine chief.

Pfizer and Moderna can now ship out the omicron formulated boosters.

State and local health departments began placing pre-orders last month.

The decision has faced some criticism though.

Regulators say the new vaccine formula is similar enough that safety is sound.

But how well it works in humans is unclear.

Both Moderna and Pfizer submitted efficacy results from animal studies.

That research did show a better antibody response to all the omicron subvariants compared to the original formula.

Clinical trials on humans are set to begin next month.

“f we wait for those data in human data, not just mice data, in human data we will be using what I would be using what I would consider to be a very outdated vaccine,” said Dr. Rochelle Walensky, the CDCd director.

The CDC still needs to sign off and officially recommend the new booster formula. Their advisors are meeting this week.

Source: newsy.com

View Source

>>> Don’t Miss Today’s BEST Amazon Deals! <<<<

Why Totino’s Needs 25 Ways to Make Pizza Rolls

It takes about 21 ingredients to make a Totino’s pizza roll, the bite-size snack that soared in popularity during the pandemic as people sought easy-to-make meals.

And on any given day since last winter, at least one of those ingredients, if not many, has either been difficult to find or insanely expensive.

The shortages became so bad at one point that General Mills, which makes Totino’s, simply couldn’t produce enough.

sugar and low-calorie sweeteners like erythritol, which is used in products like yogurt and cereal, were tough to pin down. Then palm oil, an odorless and tasteless oil that’s in about half the packaged goods in supermarkets, became hard to find. After Russia invaded Ukraine, global supplies of sunflower oil, produced by both countries, disappeared. And more recently, because of the avian flu that swept across the United States this spring, egg prices soared, leading to shortages.

guidance to allow manufacturers to make “minor formulation changes” because of supply disruptions or shortages without updating the ingredient list.

The leeway doesn’t apply to a change that increases the safety risk because it contains a food allergen or gluten, or that replaces a key ingredient or one featured in the name or marketing. For example, a product that claims to be made with “real butter” cannot now be made with margarine, and raisin bread must contain raisins.

Before the pandemic, Ingredion, a company that makes sweeteners, starches and other ingredients used by large food companies, often had its 500 scientists and 26 labs all over the country working on new products for companies. But in recent months, much more of their time has been spent figuring out what happens to the taste, texture and shelf life of a food when one or two ingredients are switched out.

“The overall reformulation of a product is a very complicated equation,” said Beth Tormey, a vice president and general manager of systems and ingredient solutions at Ingredion. “It has to meet parameters of texture and taste so that consumers like it, but it also has to fit into the regulatory box and the nutrition box. It all sounds simple from a distance, but it’s not.”

Take eggs. They are, explained Leaslie Carr, a senior director at Ingredion, a key source of protein for many products, but they are more than that. For baked goods, for instance, they provide moisture and volume, helping make cakes light and fluffy.

“Salad dressings also use a lot of egg for body and texture,” Ms. Carr said. “So we’re trying to figure out how to use different emulsifiers to reduce the amount of egg used, maybe reduce the egg amount by half, to produce the dressings. That gives you some flexibility to continue to manufacture the product until the egg situation stabilizes.”

General Mills started to notice the supply chain disruptions late last year.

The company’s plant in Wellston, Ohio, which had churned out Totino’s pizza and pizza rolls, working to meet the surge in sales that accompanied the pandemic, suddenly couldn’t get key ingredients.

“First it was the starch that we use for the cheeses,” Mr. Nudi said. “Then certain packaging and oils were hard to find. A lot of the materials that we use for Totino’s were challenged from an ingredient standpoint.”

By February, there weren’t enough Totino’s pizza and pizza rolls to keep grocery freezer sections full.

By then, the company had started daily meetings across its research and development, procurement and supply chain departments to figure out how to revamp and substitute ingredients. For instance when starch became difficult to find, the company began substituting and combining different starches in order to figure out what worked to make the pizza rolls look and taste the same.

In March, the company had filled freezer sections again, Mr. Nudi said.

But the lessons being learned from the “new normal” in the supply chain are being felt across the entire company.

Before the pandemic, the packaged food industry was a stable environment, with a consistent level of growth, Mr. Nudi said. That made having a secure, steady supply of ingredients easier.

Now General Mills is lining up multiple suppliers for each ingredient and keeping more ingredients on hand.

“Just-in-time deliveries don’t work anymore,” Mr. Nudi said. “We’re adding to inventory, holding more dry ingredients and fats and oils, even though that’s tough too right now. We need tanks to store those liquids, and those just aren’t readily available.”

View Source

>>> Don’t Miss Today’s BEST Amazon Deals! <<<<

EU Regulator OKs Plan To Increase Monkeypox Vaccine Supplies

By Associated Press
August 19, 2022

EU authorities could decide “as a temporary measure” to use smaller doses of the vaccine to protect vulnerable people during the ongoing outbreak.

A smaller dose of the monkeypox vaccine appears to still be effective and can be used to stretch the current supply by five times, the European Medicines Agency said Friday, echoing a recommendation made earlier this month by the U.S. Food and Drug Administration.

The EU drug regulator said in a statement that injecting people with just one-fifth the regular dose of the smallpox vaccine made by Bavarian Nordic appeared to produce similar levels of antibodies against monkeypox as a full dose.

The approach calls for administering Bavarian Nordic’s vaccine with an injection just under the skin rather than into deeper tissue, a practice that may stimulate a better immune response. People still need to get two doses, about four weeks apart.

The EMA said national authorities could decide “as a temporary measure” to use smaller doses of the vaccine to protect vulnerable people during the ongoing monkeypox outbreak.

EU health commissioner Stella Kyriakides said the decision would allow the vaccination of five times as many people with the continent’s current supply.

“This ensures greater access to vaccination for citizens at risk and healthcare workers,” she said in a statement.

Earlier this month, the U.S. FDA authorized a similar plan to extend the country’s monkeypox vaccine stocks. The technique has previously been used to stretch supplies of vaccines during other outbreaks, including yellow fever and polio.

The unusual recommendations from both regulators acknowledge the extremely limited global supplies of the Jynneos vaccine, originally developed against smallpox. Bavarian Nordic is the only company that makes it and it expects to have about 16 million doses available this year. On Thursday, the U.S. also announced a new agreement with a Michigan manufacturer to help speed production of 5.5 million vaccine vials recently ordered by the government.

The EMA authorized the vaccine in July based on experimental data that suggested it would work; the World Health Organization has estimated the shot is about 85% effective at preventing monkeypox.

Globally, there are more than 40,000 cases of monkeypox, of which about half are in Europe. Earlier this week, WHO chief Tedros Adhanom Ghebreyesus said there has been a 20% increase in cases reported in the last two weeks and that nearly all infections have been reported in men who are gay, bisexual or have sex with other men.

Tedros said WHO was in talks with vaccine manufacturers and countries to see if any might be willing to share doses. Africa has reported the highest number of suspected monkeypox deaths and although the disease has been endemic in parts of central and west Africa for decades, it has only a small supply of vaccines being used as part of a research study.

About 98% of monkeypox cases beyond Africa have been reported in men who are gay, bisexual or have sex with other men. WHO said there is no sign of sustained transmission beyond men who have sex with men, although a small number of women and children have also been sickened by the disease.

Monkeypox spreads when people have close, physical contact with an infected person’s lesions, their clothing or bedsheets. Most people recover without needing treatment, but the lesions can be extremely painful and more severe cases can result in complications including brain inflammation and death.

In the U.K., which at one point had the biggest outbreak outside Africa, officials said earlier this week they have seen signs the outbreak is slowing down.

Additional reporting by The Associated Press.

Source: newsy.com

View Source

>>> Don’t Miss Today’s BEST Amazon Deals! <<<<

CDC Drops Quarantine, Distancing Recommendations For COVID

The changes are driven by a recognition that an estimated 95% of Americans 16 and older have acquired some level of immunity.

The nation’s top public health agency relaxed its COVID-19 guidelines Thursday, dropping the recommendation that Americans quarantine themselves if they come into close contact with an infected person.

The Centers for Disease Control and Prevention also said people no longer need to stay at least 6 feet away from others.

The changes, which come more than 2 1/2 years after the start of the pandemic, are driven by a recognition that an estimated 95% of Americans 16 and older have acquired some level of immunity, either from being vaccinated or infected, agency officials said.

“The current conditions of this pandemic are very different from those of the last two years,” said the CDC’s Greta Massetti, an author of the guidelines.

Many places around the country long ago abandoned social distancing and other once-common precautions, but some of the changes could be particularly important for schools, which resume classes this month in many parts of the country.

Perhaps the biggest education-related change is the end of the recommendation that schools do routine daily testing, although that practice can be reinstated in certain situations during a surge in infections, officials said.

The CDC also dropped a “test-to-stay” recommendation, which said students exposed to COVID-19 could regularly test — instead of quarantining at home — to keep attending school. With no quarantine recommendation anymore, the testing option disappeared too.

Masks continue to be recommended only in areas where community transmission is deemed high, or if a person is considered at high risk of severe illness.

School districts across the U.S. have scaled back their COVID-19 precautions in recent weeks even before the latest guidance was issued. Some have promised a return to pre-pandemic schooling.

Masks will be optional in most districts when classes resume this fall, and some of the nation’s largest districts have dialed back or eliminated COVID-19 testing requirements.

Public schools in Los Angeles are ending weekly COVID-19 tests, instead making at-home tests available to families, the district announced last week. Schools in North Carolina’s Wake County also dropped weekly testing.

Some others have moved away from test-to-stay programs that became unmanageable during surges of the Omicron variant last school year.

The American Federation of Teachers, one of the nation’s largest teachers unions, said it welcomes the guidance.

“Every educator and every parent starts every school year with great hope, and this year even more so,” President Randi Weingarten said. “After two years of uncertainty and disruption, we need as normal a year as possible so we can focus like a laser on what kids need.”

The new recommendations prioritize keeping children in school as much as possible, said Joseph Allen, director of Harvard University’s healthy building program. Previous isolation policies forced millions of students to stay home from school, he said, even though the virus poses a relatively low risk to young people.

“Entire classrooms of kids had to miss school if they were deemed a close contact,” he said. “The closed schools and learning disruption have been devastating.”

Others say the CDC is going too far in relaxing its guidelines.

Allowing students to return to school five days after infection, without proof of a negative COVID-19 test, could lead to outbreaks in schools, said Anne Sosin, a public health researcher at Dartmouth College. That could force entire schools to close temporarily if teachers get sick in large numbers, a dilemma that some schools faced last year.

“All of us want a stable school year, but wishful thinking is not the strategy for getting there,” she said. “If we want a return to normal in our schools, we have to invest in the conditions for that, not just drop everything haphazardly like we’re seeing across the country.”

The average numbers of reported COVID-19 cases and deaths have been relatively flat this summer, at around 100,000 cases a day and 300 to 400 deaths.

The CDC previously said that if people who are not up to date on their COVID-19 vaccinations come into close contact with a person who tests positive, they should stay home for at least five days. Now the agency says quarantining at home is not necessary, but it urges those people to wear a high-quality mask for 10 days and get tested after five.

The agency continues to say that people who test positive should isolate from others for at least five days, regardless of whether they were vaccinated. CDC officials advise that people can end isolation if they are fever-free for 24 hours without the use of medication and they are without symptoms or the symptoms are improving.

Also on Thursday, the Food and Drug Administration updated its recommendations for how many times people exposed to COVID-19 should test.

Previously, the FDA had advised taking two rapid antigen tests over two or three days to rule out infection. Now the agency recommends three tests.

FDA officials said the change was based on new studies that suggest the old protocol can miss too many infections and result in people spreading the coronavirus, especially if they don’t develop symptoms.

Additional reporting by The Associated Press.

Source: newsy.com

View Source

>>> Don’t Miss Today’s BEST Amazon Deals! <<<<

There Is A Nationwide Shortage Of Monkeypox Vaccines

Health officials are now considering splitting the monkeypox vaccine dose due to a shortage of supply.

There is a shortage of monkeypox vaccines.

Health officials are now considering splitting the doses.

Doctor Eric Cioè Peña is the director of Global Health at Northwell Health in New York City.

“The idea is, is that if you’re able to give someone the smallest amount of dose, that still induces immunity,” Cioè Peña said.

The new plan under consideration is to split one dose into five, an approach the Federal Food and Drug Administration says is safe.

Dr. Cioè Peña doesn’t think there’s enough data available on this approach, called dose sparing.

“Im assuming that it’s based on data that they’re seeing immune response at much lower doses,” he said.

The Biden administration’s move to declare monkeypox a public health emergency is intended to speed up vaccine distribution.

Dr. Ashish Jha is the White House COVID-19 response coordinator.

“About 1.6 million Americans are in that high-risk group that needs to be, and that should get vaccinated,” Jha said.

Health officials across state lines said that only the most vulnerable should be seeking a vaccine.

“We’re also giving it out to groups that are at high risk. Where there’s lots of monkeypox transmission right now, which are primarily men who identify as having sex with other men,” Cioè Peña said.

According to the latest CDC numbers, the U.S. leads the world in infections with more than 7,100 cases.

Monkeypox is now appearing in wastewater in five states: California, Georgia, Michigan, Texas and Idaho. Wastewater samples are often an early warning of community spread.

In Chicago, officials are saying to “use common sense” ahead of this weekend’s Market Days Festival. More than 100,000 people are expected to attend this popular LGBTQ+ event.

The virus is still spreading mostly among men who have sex with men, but health officials advise everyone is at risk because it spreads from close skin-to-skin contact.

Source: newsy.com

View Source

>>> Don’t Miss Today’s BEST Amazon Deals! <<<<

U.S. Signs Off On 800,000 More Doses Of Monkeypox Vaccine

By Associated Press
July 27, 2022

The announcement comes amid growing criticism that authorities have been too slow in deploying the vaccine.

After weeks of delays, nearly 800,000 doses of the monkeypox vaccine will soon be available for distribution, U.S. health regulators said Wednesday.

The announcement comes amid growing criticism that authorities have been too slow in deploying the vaccine, potentially missing the window to contain what could soon become an entrenched infectious disease.

Nearly two weeks ago, the Food and Drug Administration said it had finished the necessary inspections at Bavarian Nordic’s facility in Denmark, where the company fills vials of the vaccine. The FDA said via Twitter on Wednesday that the certification had been finalized. The doses are already in the U.S. “so that they would be ready to be distributed once the manufacturing changes were approved,” the agency said.

The U.S. already has sent more than 310,000 doses of the Jynneos vaccine to state and local health departments. But clinics in San Francisco, New York and other major cities say they still don’t have enough shots to meet demand.

The head of the U.S. Department of Health and Human Services said Wednesday officials would announce more allocations on Thursday.

The monkeypox virus mainly spreads through skin-on-skin contact, but it can also transmit through touching linens used by someone with the infection. The vast majority of cases reported have been in men who have sex with men, though health officials have stressed that anyone can catch the virus.

People with monkeypox may experience fever, body aches, chills and fatigue. Many in the outbreak have developed zit-like bumps on many parts of the body.

The sluggish federal response has drawn comparisons to the initial days of the COVID-19 outbreak, but experts had pointed out that the U.S. had one huge advantage: more than 1 million doses of vaccine in the strategic national stockpile.

But it turned out U.S. officials had only about 2,000 doses on hand when the outbreak was first identified in May. Shipping and regulatory delays have meant only a portion of the rest were deployed.

“There’s not enough doses,” said Dr. Perry Halkitis of Rutgers University. “I think with some quicker action on part of federal government we might not be in the situation we are now.”

The doses previously shipped came from a separate facility in Denmark that already had FDA clearance. Another 786,000 doses made at a newly opened Bavarian Nordic facility were awaiting the U.S. certification announced Wednesday.

The FDA requires inspections of all vaccine manufacturing plants to assure safety, sterility and consistency of production.

U.S. officials announced orders this month for 5 million more doses, though most of those are not expected to arrive until next year

Officials have recommended the shots be given to people who know or suspect they were exposed to monkeypox in the previous two weeks.

The Jynneos vaccine has never been widely used in response to an outbreak like this, and the government will track how well it’s working.

Additional reporting by the Associated Press.

Source: newsy.com

View Source

>>> Don’t Miss Today’s BEST Amazon Deals! <<<<

FDA Weighs Oversight Changes After Formula, Juul Troubles

The FDA’s tobacco center, which regulates traditional cigarettes and vaping products, is facing challenges navigating policy and enforcement issues.

The head of the Food and Drug Administration has asked for a review of the agency’s food and tobacco programs following months of criticism over their handling of the baby formula shortage and e-cigarette reviews.

Tuesday’s announcement comes as FDA Commissioner Robert Califf attempts to push past several controversies that have dominated his second stint running the agency, including the delayed response to contamination problems at the country’s largest infant formula plant.

“Fundamental questions about the structure, function, funding and leadership need to be addressed” in the agency’s food program, Califf said in a statement. The agency’s tobacco center, which regulates traditional cigarettes and vaping products, is facing challenges navigating policy and enforcement issues from “an increasing number of novel products that could potentially have significant consequences for public health,” he said.

Califf said the Reagan-Udall Foundation — a non-governmental research group created by Congress to support FDA’s work — would convene experts to deliver evaluations within 60 business days of both the food and tobacco operations. The experts are expected to consult with FDA staff along with outside groups to gather a broad range of opinions. Califf and his team have already begun meeting with outside stakeholders, the FDA noted.

The review announcement comes one day before Califf is scheduled to testify before the Senate agriculture committee about FDA’s oversight of food safety.

More than two dozen consumer groups have called on Califf to appoint one official to oversee all FDA food operations, which are dispersed across multiple centers responsible for nutrition standards, plant inspections and animal food. But Califf told The Associated Press in an interview that he believes more fundamental changes are needed.

“I don’t think structure alone is really the fix, or that leadership alone is the fix,” Califf said. “There’s a consistent concern out there that we need to really fix the fundamentals, which includes all those elements.”

Califf said he agreed with critiques that the food program has been underfunded compared with FDA’s drug program, which receives more than $1 billion annually in industry user fees. The agency recently sought more food funding and authority to help track supply chains in order to head off future shortages.

Parents and politicians also have expressed frustration over the agency’s handling of a recent decision to ban all e-cigarettes from Juul, the leading U.S. vaping company. A federal court quickly blocked the agency’s order. FDA then backtracked further in court, saying it needed more time to review Juul’s application due to its “unique scientific issues.”

The FDA has also struggled to review millions of other applications from vaping companies, prompting multiple missed regulatory deadlines over the last two years.

Califf again cited funding challenges, pointing out that the FDA cannot collect user fees from vaping companies who submit their products. The agency has asked Congress for that authority.

“I don’t think anyone anticipated that there would be 6.7 million vaping product applications that came rolling in during a pandemic that was stressing the entire agency,” Califf said.

Last week, the FDA announced it would miss another deadline to remove thousands of illegal e-cigarettes that use synthetic nicotine. FDA officials specifically asked Congress to give the agency authority over those products, which had used a legal loophole to skirt regulation.

Sen. Dick Durbin, an Illinois Democrat, suggested Califf should resign if the agency can’t swiftly remove such products.

President Joe Biden tapped Califf for the FDA job largely because of his prior experience at the agency, which he briefly led during the Obama administration. A cardiologist and respected researcher, Califf planned to focus his time at FDA on fighting medical misinformation and streamlining the agency’s data systems.

But those efforts have been eclipsed by newer controversies, including political outrage over the formula shortage, which has forced the U.S. to airlift millions of containers of formula from Europe. Recently, the FDA said it would help foreign manufacturers stay on the U.S. market for the long term, in an effort to diversify the formula supply here.

Califf previously predicted the formula shortage could last until July. He said Tuesday that retail data show that supplies have improved with increases in both U.S. production and imports.

“What you’re going to see is a gradual climbing out of the current situation as more and more formula becomes available,” Califf said.

In May, Califf testified before Congress about missteps that slowed the agency’s response to contamination problems at the Michigan formula plant that triggered the shortage. While many of the problems happened before Califf started on the job, he struggled to explain who was ultimately responsible for food safety within FDA’s bureaucracy.

FDA’s food program has a byzantine leadership structure in which there is a director for food and a separate deputy commissioner for “food policy and response.” The deputy commissioner has more of a safety focus, but has no direct authority over food center staff nor regional personnel who inspect plants.

“You have serious structural leadership issues,” Rep. Rosa DeLauro told Califf during the hearing.

DeLauro, a Connecticut Democrat, said Tuesday the FDA’s evaluation must contain input from non-FDA experts and interest groups to be credible.

“A report that includes recommendations to preserve the status quo is unacceptable,” she said in an emailed statement.

Responding to multiple crises is a standard part of leading the FDA, which regulates industries that account for an estimated one-fifth of all U.S. consumer spending.

Despite the recent controversies, some experts say Califf has done a good job, considering the increasing polarization surrounding the issues and products FDA oversees.

“Leading the FDA is becoming as complicated as, maybe more complicated than, leading a cabinet-level executive department,” said Daniel Carpenter, a professor of government at Harvard University. “I think Califf has navigated a pretty politically fraught environment and he has done it with remarkable skill.”

Additional reporting by The Associated Press.

Source: newsy.com

View Source

>>> Don’t Miss Today’s BEST Amazon Deals! <<<<