Health

(NEW YORK) — When the Food and Drug Administration (FDA) granted full approval of the Pfizer COVID-19 vaccine for people ages 16 and older Monday, it did so with a warning to parents and medical providers.

The vaccine — the first covid-19 vaccine to transition from an emergency authorization status to full FDA approval — should not be given to young children as off-label use, according to FDA commissioner Janet Woodcock.

“We do not have data on the proper dose, nor do we have the full data on the safety in children younger than what is in the EUA, and so that would be a great concern that people would vaccinate children,” Woodcock said. “We are not recommending that children younger than age 12 be vaccinated with this vaccine, it would not be appropriate.”

“They are not just small adults,” she said of kids. “And we’ve learned that time and time again and so we really would have to have the data and the appropriate dose before recommending that children be vaccinated.”

Dr. Robert Frenck, lead investigator of the COVID-19 vaccine trials at Cincinnati Children’s Hospital, emphasized that clinical testing has not yet been done in 5 to 12-year-olds.

It’s likely that young children ages 5 to 12 will get a smaller vaccine dose. That’s not only because children are smaller, but also because they tend to have stronger immune responses than adults, Frenck said.

“In kids 5-12, we found that 10 micrograms, so one-third of the [adult] dose, gives you the same immune response,” Frenck said. “If they give it off label, and they give the 30 mg, I think they’re going to have kids in the 5 to 12-year-olds that are going to have a lot more reactogenicity. That means they’re going to have kids with fevers, headaches, and they’re going to feel bad.”

“As scientists we want to know,” Frenck said. “You don’t want to guess.”

The American Academy of Pediatrics (AAP) also urged caution, noting that while it is now “legally permissible” for doctors to administer the vaccine off-label for kids ages 11 and younger, the AAP “strongly discourages that practice.”

Pfizer’s COVID-19 vaccine was authorized for use in children ages 12 to 15 in May by the U.S. Food and Drug Administration (FDA).

The two other COVID-19 vaccines available in the United States, Moderna and Johnson & Johnson, are currently available for anyone 18 years and older in the U.S. Moderna filed for emergency use authorization with the FDA for its vaccine in adolescents in June but is still awaiting a decision.

Here is what parents may want to know about the COVID-19 vaccines and kids to help them make decisions.

1. What is the science behind the COVID-19 vaccine?

Both the Pfizer and Moderna vaccines use mRNA technology, which does not enter the nucleus of the cells and doesn’t alter human DNA. Instead, it sends a genetic “instruction manual” that prompts cells to create proteins that look like the outside of the virus — a way for the body to learn and develop defenses against future infection.

The Johnson & Johnson vaccine uses an inactivated adenovirus vector, Ad26, that cannot replicate. The Ad26 vector carries a piece of DNA with instructions to make the SARS-CoV-2 spike protein that triggers an immune response.

This same type of vaccine has been authorized for Ebola, and has been studied extensively for other illnesses — and for how it affects women who are pregnant or breastfeeding.

Neither of these vaccine platforms can cause COVID-19.

2. What is the status of vaccine eligibility for kids?

Pfizer has said it will submit vaccine safety data on 5- to 11-year-olds by the end of September. Moderna has said it will do so in the middle of the fall. It will then be up to the FDA on how quickly it grants the authorization.

In general, federal and industry officials said they expect the first vaccine shots for children ages 5-11 could happen by the end of this year or early 2022. Timing on a vaccine for children younger than 5 is less certain, but officials have said they hope a green-light for toddlers and infants will follow soon after.

Clinical trials are however still ongoing, and the FDA has signaled it wants to expand the pool of children signed up as volunteers. A larger pool of volunteers makes it more likely that even the rarest of side effects could be detected before it rolls out nationwide.

3. Why do kids need to be vaccinated against COVID-19?

While have not been as many deaths from COVID-19 among children as adults, particularly adults in high-risk categories, kids can still get the virus and just as importantly, they can transmit the virus to adults.

The American Academy of Pediatrics reported this week that children now make up 22.4% of all new weekly cases, and over 3.7 million children have been diagnosed during the pandemic.

“There are really two big reasons why kids need to get the vaccine,” explained Dr. Jennifer Ashton, ABC News chief medical correspondent.

“One of them is that it is possible that they could be infected and then unknowingly pass COVID-19 to someone with a serious or underlying, pre-existing medical condition,” she said. “And also, though it’s very uncommon and unlikely, it is still possible that children infected with COVID-19 could become seriously ill or worse. We have seen that.”

“It’s important to think in ripple effects, outside the box,” Ashton added. “It’s not just your home environment that you need to worry about.”

4. Will kids experience the same vaccine side effects as adults?

Adolescents experienced a similar range of side effects as seen in older teens and young adults — generally seen as cold-like symptoms in the two to three days after the second dose — and had an “excellent safety profile,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said at a press briefing announcing Pfizer’s authorization.

“Based on all this available information, the FDA determined the Pfizer-BioNTech vaccine has met all of the criteria required to amend the EUA, which concluded that the known and potential benefits of this vaccine in individuals 12 years of age and older outweigh the vaccines known and potential risks,” Marks said.

Marks encouraged parents who were hesitant to vaccinate their children to speak with their pediatricians, urging confidence in the trial and data.

Moderna said its COVID-19 study with teens ages 12 to under 18 identified no “significant safety concerns.” The most common side effects from the vaccine were injection site pain, headache, fatigue, muscle pain and chills, according to the company.

The FDA will scrutinize Moderna’s clinical data before authorizing the use in anyone under 18.

5. Have there been any vaccine side effects for teens and young adults?

There have been more than 300 confirmed cases of heart inflammation in teens and young adults who have received COVID-19 vaccines, but the nation’s leading health experts say the Pfizer and Moderna vaccines remain safe for use.

Dr. Rochelle Walensky, director of the Centers for Disease Control and Prevention (CDC), said on “Good Morning America” in June the benefits of the vaccine for young people “overwhelmingly outweigh the risk,” echoing the findings of researchers at a CDC advisory committee meeting this week on vaccines.

Out of more than 26 million doses given to young people, the CDC has so far confirmed 323 cases of heart inflammation, called myocarditis or pericarditis, and is still monitoring more cases. Of the confirmed cases, the vast majority were temporary and resolved with monitoring and treatment.

“To put this in perspective, if we have a group of 12 to 17-year-olds who we’re working to vaccinate over the next four months and can vaccinate 1 million of them, which would be great strides, over the next four months we could expect 30 to 40 of these mild self-limited cases of myocarditis,” Walensky said on “GMA.” “And for that, if we were to vaccinate all 1 million we would avert 8,000 cases of COVID, 200 hospitalizations, 50 ICU stays and one death.”

The rare instances of heart inflammation occurred about 12.6 times out of every million second dose administered and were mostly among younger males about a week after the second dose of the Pfizer or Moderna vaccines, according to researchers at the CDC advisory committee.

Regulators at the Food and Drug Administration (FDA) say they are preparing a warning to go along with the Pfizer and Moderna vaccines to make young people aware of the very rare risk.

6. How effective are the vaccines in children?

Pfizer announced in late March that its clinical trials showed the vaccine was safe and 100% effective in children ages 12-15, similar to the 95% efficacy among adult clinical trial participants.

Marks confirmed on May 10 that after a trial with over 2,000 children, Pfizer found no cases of infection among the children who had been given the vaccine and 16 cases of infection among the children who received a placebo.

No cases of COVID occurred in the 1,005 adolescents that received the vaccine, while there were 16 cases of COVID among the 978 kids who received the placebo, “thus indicating the vaccine was 100% effective in preventing COVID-19 In this trial,” said Marks.

Moderna’s COVID-19 vaccine is 100% effective in children ages 12 to under 18, the company said last month, in announcing results of their latest clinical trials.

In addition to its efficacy, the vaccine showed “no significant safety concerns” in the trial of more than 3,700 adolescent participants, according to Moderna.

7. Will kids get the same dose of the vaccines as adults?

The FDA has authorized the same dosing for 12- to 15-year-olds as adults with the Pfizer two-dose vaccine.

Pfizer is currently testing smaller doses of the vaccine in children ages 11 and under.

8. Could COVID-19 vaccines impact puberty, menstruation?

There is currently no clinical evidence to suggest the vaccines can have long-term effects on puberty or fertility, according to Ashton, a practicing, board-certified OBGYN.

Ashton noted that while there has been anecdotal discussion of the emotional event of finally receiving the vaccine temporarily impacting menstruation for adult women, the idea of the cause being from the vaccine itself “defies science and biology.”

It is really important to understand basic biology here,” Ashton said. “Women can have changes in their menstrual cycle and also have gotten the vaccine, that does not mean that one caused the other.”

“Right now there is no puberty concern. There is no fertility concern,” she added.

9. Will the Johnson & Johnson COVID-19 vaccine be available for kids?

Johnson & Johnson announced in April that it had begun vaccinating a “small number of adolescents aged 16-17 years” in a Phase 2a clinical trial.

As of April, the trial was enrolling participants only in Spain and the United Kingdom, with plans to expand enrollment to the U.S., the Netherlands and Canada, followed by Brazil and Argentina.

10. Will COVID-19 vaccines be required by schools?

It will be up to each state’s government to decide whether a COVID-19 vaccine is required for school entry. Many colleges and universities in the U.S. have announced they will require students to be vaccinated from COVID-19.

Copyright © 2021, ABC Audio. All rights reserved.

(NEW YORK) — The coronavirus pandemic has upended much of the lives of children, and their diets too, research is showing.

One recent study found that after one year of the pandemic, one in three pediatric patients was above their expected weight, a 41% increase from before the pandemic.

Another study, published this month in the medical journal JAMA, found that two-thirds of U.S. children’s calorie intake comes from ultra-processed foods, defined as ready-to-eat foods that contain “little to no whole foods,” like frozen pizza, chips and cookies.

The greater the intake of processed foods, the more sugar a child is likely consuming, which can lead to lifelong health complications, including obesity and Type 2 diabetes, experts say.

“The added sugars for most kids are going to show up in the packaged, processed foods,” said Maya Feller, a New York-based registered dietitian and nutritionist. “For the most part, you don’t have tablespoons of sugar dumped into their homemade food, so it’s actually in whatever product they’re consuming.”

Kelly LeVeque, a Los Angeles-based holistic nutritionist who works with stars like Jennifer Garner, has focused on blood sugar control with her adult clients for over a decade.

When LeVeque gave birth to her oldest son nearly three years ago, she said she was shocked to see how hard it is to control sugar intake in even young kids.

“I know firsthand that added sugars and too much even natural sugar in something like orange juice wreak havoc on us internally, on our metabolic goals, so when I became a mom, it was mind-blowing,” she said. “Even the [portable food] pouches available to children are all sugar.”

It’s a fight every day to keep the sugar, processed foods and inflammatory oils out of our homes. To the moms, my gatekeepers out there in the trenches….keep fighting the good fight for good health! These little brains, organs and bodies need an adult in the room. #saynotosugar

— Kelly LeVeque (@bewellbykelly) May 10, 2021

LeVeque recently launched a “Fab 4 Under 4” guide for parents that adapts the “Fab 4” principles she created to help adults support blood sugar balance in kids.

“We think that kids are not vulnerable to the effects of sugar, but in fact they’re more vulnerable,” she said, noting that blood sugar spikes caused by sugar can affect everything from a child’s mood to their ability to learn. “These are formative years for children and, in my opinion, they’re drugged with sugar, and it’s not their fault when we look at the increased access to processed foods in their pantry,”

Here are five tips from LeVeque and Feller to help parents reduce the amount of sugar in their children’s diets.

1. Balance sugar with protein, fat or fiber.

Parents can help reduce the impact of sugar kids consume by balancing it with other macronutrients, according to LeVeque.

“If you’re going to have sugar, even natural sugar in the form of fruit, you absolutely have to balance that with protein, fat or fiber,” she said. “That blood sugar response needs to be blended with other foods.”

 

 

 

 

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A post shared by Kelly LeVeque (@bewellbykelly)

A breakfast of pancakes and strawberries, for example, would cause a double spike in blood sugar, where serving pancakes with a protein like peanut butter or turkey sausage would help counter the blood sugar spike brought on by the pancakes.

2. Know what sugar your child is consuming at home .

Both Feller and LeVeque acknowledge it’s inevitable that children will consume sugar at celebrations like birthday parties or at friends’ houses, and that’s okay.

What parents can do, however, is make sure they keep the foods their kids eat daily at home low in sugar.

“Make sure that with every food in your house, you know where the sugar is,” said LeVeque. “My kids are going to have sugar but they’re not going to have sugar in their ketchup or their marinara or granola bars,” “We’re going to pull it out of the everyday things and be very strategic.”

3. Read food labels.

There are more than 70 ways that sugar can be listed on a food label, so parents need to not only read food labels, but read them carefully.

Look out for words that end in “ose” (like glucose, dextrose, sucrose), as well as words like juice concentrate, syrup, honey, maple, coconut sugar and agave, according to LeVeque.

“Sugar is sugar. It doesn’t matter what type it is,” she said. “I don’t care if it’s natural, organic, vegan, paleo, keto, look for the sugar.”

Feller echoes that parents should also be wary of food labels that feature healthy buzz words to advertise a product that nonetheless contains sugar.

“It’s challenging for parents in the current food landscape to figure out what constitutes a healthy pattern of eating,” she said. “When a parent goes to a grocery store and they see 100% carrot juice, sure it is a better choice than a sugar-sweetened beverage, but it would also be great to offer your child a carrot.”

 

 

 

 

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A post shared by Maya Feller MS,RD,CDN(she/her) (@mayafellerrd)

4. Talk to your child about how foods make them feel.

LeVeque said she talks to her sons about what the foods they eat do for their bodies, like building muscle.

“I want my kids to have the foundation of knowing how healthy eating makes them feel and knowing the expectation of their family, that we eat to nourish our bodies,” she said. “So when they’re crying and having a meltdown after a sugar crash, it’s having the conversation, ‘I see that you’re upset now … I bet if you had a little bit of protein and a lot of water, you’d feel a lot better.’”

5. Encourage your child to eat what you eat.

“You don’t need kid foods,” said LeVeque, adding that the kids’ foods nearly always contain more sugar. “People think, ‘Oh, I need to get my kids the kids’ yogurt,’ but that’s just something you’re being told, that kids need kid food and kids need kids’ meals.”

When LeVeque’s sons begin eating solid foods, she serves them a portion of her own meal when they are out to eat, for example.

“I’ll order chicken and a side of veggies or a salad and order extra protein and put a little chicken on his plate with some avocado,” she said. “And when kids get to the age that they need another meal, order a real meal, take half of it home and you have lunch the next day. Not only did your kid eat healthier, but you have a healthier lunch for the next day.”

 

 

 

 

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A post shared by Kelly LeVeque (@bewellbykelly)

6. Allow your child to cook with you.

“Kids love to cook and they’re super capable,” said Feller. “Sometimes it takes time to prepare food with them, but we have to change our mindset and be okay with the idea that there will be times where we’re going to spend time preparing something.”

“You have to get your kids involved,” echoed LeVeque. “And get your kids involved in making the vegetables and the protein and the dip. They don’t care what they’re making with you. You believe that they’re going to be disappointed that they’re not making cookies, but they are so excited to make a vinaigrette with you, a kale salad with you, to barbecue with you.”

When LeVeque does bake with her son, she uses tricks like swapping bananas for sugar in their favorite blueberry muffin recipe.

“Swapping in bananas for even half of the sugar in the recipe helps,” she said. “Because the sugar in banana is wrapped up in fiber, there won’t be as much of a high blood sugar spike and crash.”

Try these low-sugar recipes from LeVeque and Feller

Kelly’s Leveque’s blueberry muffins

 

 

 

 

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A post shared by Kelly LeVeque (@bewellbykelly)

Ingredients:
1/4 cup coconut oil
1/3 cup unsweetened vanilla nut milk
2 bananas (smush them in the peel before placing in a bowl so you don’t have to fork them as long)
2 eggs
1 teaspoon apple cider vinegar
1 teaspoon vanilla extract
2 cups almond flour
1 scoop @bewellbykelly vanilla protein powder (or 1/4 cup coconut flour)
2/3 cup tapioca or arrowroot flour
1 teaspoon baking soda
1/2 teaspoon salt
1 1/2 cups blueberries

Directions:
Mix wet and dry ingredients, and place in a greased muffin tin (can grease with coconut oil).

Bake for 30 minutes at 350 degrees.

“I slather the muffins with almond butter and ghee, yum!” said Leveque.

Maya Feller’s mint chocolate chip green smoothie

 

 

 

 

View this post on Instagram

 

 

 

 

 

 

 

 

 

 

 

A post shared by Maya Feller MS,RD,CDN(she/her) (@mayafellerrd)

Ingredients:
1 cup plain full fat Greek yogurt
1/4 cup baby spinach leaves
1/4 avocado
1 teaspoon ground flax seed
1/2 cup frozen banana
1/2 teaspoon mint extract (alcohol free) or 1 drop BetterStevia® Peppermint Cookie Liquid
cacao nibs for garnish

Directions:
Place all ingredients in a blender and blend for 90 seconds until smooth.

Pour into a glass, garnish with cacao nibs and enjoy.

Copyright © 2021, ABC Audio. All rights reserved.

(WASHINGTON) — The Food and Drug Administration on Monday granted full approval of the Pfizer COVID-19 vaccine, becoming the first covid-19 vaccine to transition from an emergency authorization status to full FDA approval.

The approval comes in a week prior to federal health officials’ earlier estimates that the agency would complete its review by Labor Day.

The full approval indicates that Pfizer has shown enough effectiveness and safety data to meet the stringent Biologics License Application (BLA) requirements, which includes at least six months of safety data from a majority of the volunteers in a large, final stage 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, Pfizer CEO said in a statement to ABC. “Hundreds of millions of doses of our vaccine already have been administered in the U.S. since December 2020, and we look forward to continuing to work with the U.S. government to reach more Americans.”

This prioritized review entailed government scientists pouring over hundreds of thousands of pages of safety and efficacy data at a rapid-fire pace, conducting meticulous inspections of Pfizer’s manufacturing process.

Pfizer’s full and formal approval will now pave the way for further vaccine mandates in both the public and private sector, akin to existing vaccine mandates for other FDA-approved vaccines. Some businesses and state leaders have held off thus far, signaling they’d wait for full approval before imposing tighter requirements.

Federal, state and local health officials have also expressed optimism that full approval will help dissolve some of the lingering hesitancy around taking a shot that until now has been only authorized for emergency use — a forecast recent polling has also reflected.

U.S. Surgeon General Dr. Vivek Murthy, predicting on ABC’s “This Week” Sunday that full approval may “tip” some fence-sitters towards taking the shot, and prompt more workplaces and schools to move forward on requirements.

“I am hopeful this approval will help increase confidence in our vaccine, as vaccination remains the best tool we have to help protect lives and achieve herd immunity,” Bourla said upon Pfizer’s approval.

“Full approval could not come at a more important time, as the highly contagious Delta variant continues to drive up caseloads and deaths across the U.S.,” Dr. Rich Besser, former acting CDC director and president of the Robert Wood Johnson Foundation said. “I am hopeful that full approval will address any remaining concerns and will move many people to a ‘yes’ on vaccination.”

Pfizer was the first to request full approval in the U.S.; other Covid vaccine makers are likely to follow suit. All three authorized vaccines were granted emergency authorization based on massive clinical trials involving tens of thousands of volunteers.

Federal health officials have come under immense political pressure from all sides to get the approval done as soon as possible — as much of the country faces yet another surge, and the Delta variant threatens hard-fought wins in the fight against the virus.

In private calls with the White House Covid team obtained by ABC News, some of nation’s governors have recently expressed waning patience and frustration over the wait for full approval of the vaccine — saying the FDA either needs to act, or be transparent about how much longer there is to wait — given that the lack of full approval is a recurring reason they had heard among the hesitant for not taking the shot yet.

The FDA had made clear getting Pfizer’s vaccine to the approval finish line is a top priority, with an “all hands on deck approach” and “moving forward as rapidly as possible.”

ABC News learned in late July the agency would reprioritize some of its personnel and technology resources from “across the agency” and reshuffling other existing work, in order to finish the review faster, devoting those additional resources towards expediting the process for Pfizer’s approval.

“We recognize that for some, the FDA approval of COVID-19 vaccines may bring additional confidence and encourage them to get vaccinated,” an agency spokesperson told ABC in late July, promising any approved vaccine would meet “rigorous standards for safety, effectiveness, and quality.”

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(NEW YORK) — In the next month, millions of Americans will get ready to roll up their sleeves for a third dose of the COVID-19 vaccine. But when it comes to booster shots, it’s not as simple as ‘more is more’ — it’s also a matter of when.

For severely immunocompromised people, a third dose of the COVID-19 vaccine is available now. Come mid-September, that option is expected to be open for everyone who got Pfizer or Moderna vaccines, at least eight months after their second dose.

Health experts caution not to jump the gun — or the line — on when you might actually need a booster shot.

With patience, a better immune response

“We have to look at both sides of the equation — the benefits to be reaped and the safety of giving an additional dose,” Dr. William Schaffner, professor of preventive medicine and infectious diseases at Vanderbilt University Medical Center, told ABC News. “You’ll get a more robust immune response if you wait a little longer before you get your booster.”

The COVID-19 vaccines continue to be safe and effective against severe disease and hospitalization. And when immunity wanes, it does so gradually, experts say, with current data suggesting all three of the authorized vaccines provide good protection at least six months after initial vaccination and likely longer.

The Biden administration announced availability of booster shots would begin ahead of any ruling from the Food and Drug Administration or Centers for Disease Control and Prevention advisory groups.

Wary of delta’s exponential spread, federal health officials are attempting to preempt the possibility of a greater surge should vaccine efficacy dwindle.

You’re likely still protected, for now

“We are concerned that this pattern of decline we are seeing will continue in the months ahead,” Surgeon General Dr. Vivek Murthy said at a briefing Wednesday.

“You don’t want to find yourself behind playing catch up,” said Dr. Anthony Fauci, chief medical adviser to the White House.

It’s a careful narrative aimed at keeping confidence that vaccines still work — while preparing the public for another round of shots if protection against hospitalization and deaths ebbs.

Even in announcing the step toward boosters, the nation’s top health officials emphasized most fully vaccinated Americans “still have a high degree of protection from the worst outcomes of COVID-19.”

“We are not recommending that you go out and get a booster today,” Murthy said.

“We don’t have data that suggests you benefit from having the additional dose of the vaccine before your immunity drops off,” said Jay Bhatt, an internist, geriatrician and ABC News contributor, adding anxious Americans shouldn’t feel tempted to get a booster earlier than eight months.

Those who got the Johnson & Johnson vaccine will also likely need an additional dose, health experts predict. Since its authorization came later, data is still developing on an additional dose.

Getting a booster shot too soon may be counterproductive. Those who wait extend their “runway” of immune protection further.

“Because of all these breakthrough milder infections, and the diminution in antibody levels, those things combined to make the task force antsy and wanting to not wait,” Schaffner said.

Let the most vulnerable go first

Additional third doses should be prioritized first for the most vulnerable and those who were first given vaccines in December and January, experts say. Those people include nursing home and long-term care facility residents and staff, elderly Americans and front-line health care workers, for whom even a mild case of COVID could risk an entire hospital ward.

“There’s real concern among nursing home residents and their loved ones about getting sick again,” Bhatt said.

The same day federal officials previewed coming boosters, the CDC released several studies showing that although the vaccines are highly effective against severe disease, protection against infection may peter out over time.

Health officials don’t want to wait until the nation gets stuck behind the pandemic eight ball again, but some experts worry the move was premature.

Dr. Jeremy Faust, an emergency medicine physician at Brigham and Women’s Hospital, is skeptical of boosters for the broader population so soon.

“The risks are unknown, and the benefits are unknown. I can’t, as a responsible physician, give someone advice, when I haven’t been able to weigh those two things,” Faust said, cautioning against taking a “shot in the dark.”

Waiting for the data

Pfizer and Moderna have gauged side effects from a third shot tantamount to the primary course — fever, sore arm and fatigue — while the rare risk of more serious side effects, like myocarditis, remains.

Faust points out the clinical trial data and real-world success of the vaccines have been an undeniable “slam dunk” thus far, but third doses are uncharted territory.

“The science on this is unavailable. And that’s not a place where we’ve been before,” Faust said, noting the risk of myocarditis has shown to happen more frequently after the second mRNA dose.

“What’s the third dose going to do?” Faust said. “Is a third dose going to hospitalize more people for myocarditis than we’re actually getting in return for the third dose of vaccine coverage? We literally don’t know.”

Boosters are meant to fortify the vaccine’s still-robust strength over time, but it’s a unique time frame for each individual’s optimized immunity.

“It’s a little bit of a Goldilocks moment. Where do you want to put down your bets?” NIH Director Dr. Francis Collins said in a recent interview on MSNBC. “We think because lives are at stake if we are going a little early, I’d rather be in that space than be a little late.”

“The COVID virus precipitates decision-making, when one has less than an ideal amount of data,” Schaffner said. “You always want more.”

ABC News’ Eric M. Strauss and Sony Salzman contributed to this report.

Jess Dawson, M.D., a masters of public health candidate at Johns Hopkins Bloomberg School of Public Health, is a contributor to the ABC News Medical Unit.

Copyright © 2021, ABC Audio. All rights reserved.

(NEW YORK) — The use of monoclonal antibodies as a way to prevent people from getting very sick with COVID-19 is rapidly increasing — alongside the grim statistics on surging infection rates across the country.

Federal health officials have seen a “significant increase” in the ordering of monoclonal antibodies in recent weeks with the U.S. Department of Health and Human Services telling ABC News orders have increased by more than 1,200%.

HHS said they are currently shipping about 120,000 patient courses of Regeneron’s monoclonal antibody treatment a week.

More than three-quarters of those orders are going to the regions in the country with low vaccination rates and states currently getting clobbered hardest by COVID’s surge — and where intensive care unit capacities are most strained.

Between July 1 and Aug. 17, more than 438,100 one-dose infusions of the treatment were ordered nationally.

In that same time frame, Kentucky, Tennessee, Mississippi, Alabama, Georgia, Florida, South Carolina and North Carolina — designated by HHS as Region 4 — ordered about 198,000 patient courses, or roughly 45% of the national order.

New Mexico, Texas, Oklahoma, Arkansas and Louisiana (Region 6) ordered roughly 144,000 — about 33% of the order.

Monoclonal antibodies are synthetic versions of the body’s natural line of defense against severe infection — a therapy designed to send reinforcements for the immune system.

The antibody treatment is meant for COVID-19 patients early in their infection and who are at high risk of getting even sicker, nipping infections in the bud before it puts people in the hospital.

It can be used for breakthrough COVID cases as well, regardless of symptoms. If a person has tested positive within the last 10 days, and they are at risk for getting sicker — like older Americans, patients with high blood pressure, diabetes, heart disease, asthma or obesity — the treatment is available.

The drug can also now be used for preventative use in some cases. The Food and Drug Administration expanded Regeneron’s authorization in late July, allowing for proactive prophylactic use for people who may have been exposed to COVID, and are at high risk of getting very sick because of health complications, being immunocompromised or because a person wasn’t fully vaccinated.

It can be administered through an intravenous infusion, or a subcutaneous injection, which is less time-consuming and labor-intensive, and more practical in an outbreak situation.

An HHS official told ABC News they are seeing new infusion sites springing up, and sites that had been inactive are coming back online and administering the treatment again.

This new uptick and interest in use of the monoclonals comes after months of mediocre uptake, what then-Operation Warp Speed head Moncef Slaoui lamented last winter as “disappointing.”

It also comes as Govs. Greg Abbott, R-Texas, and Ron DeSantis, R-Fla., have ordered the opening of more infusion centers, and touted the treatment’s promise. Abbott, who tested positive for COVID-19 earlier this week, said he is taking it himself.
 

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(WASHINGTON) — The Biden administration announced on Wednesday that it will roll out COVID-19 booster shots for many Americans starting in mid-September. But there’s another date that many are anticipating.

As early as this coming week, according to The New York Times, the U.S. Food and Drug Administration is expected to give full approval to Pfizer-BioNTech’s coronavirus vaccine — the first COVID-19 vaccine expected to receive that endorsement.

The FDA’s approval might seem like a minor technical move to some. But full approval of all three COVID-19 vaccines is an important step that can make a difference in reducing COVID-19 infection and mortality rates, improving health care delivery and saving lives.

Here’s why:

1. The approval will empower health care professionals to address the myth of “experimental vaccines.”

All three vaccines currently have what’s called “emergency use authorization” (EUA), which the FDA uses as a means to quickly give people access to potentially lifesaving medicines during a national crisis. Somehow, “emergency use” has been confused with “experimental.”

As physicians and epidemiologists who have treated COVID-19 patients, it’s frustrating that what amounts to a rather minor, somewhat bureaucratic detail is being used by people as justification not to get a vaccine that can save their lives and the lives of the people around them. More than 358 million doses of COVID-19 vaccines have been safely administered in the U.S. — and the incidence of complications as a result of the vaccines is minimal.

The good news: According to a recent Kaiser Family Foundation (KFF) study, three in ten unvaccinated adults say they’d be more likely to get vaccinated if the vaccines currently authorized for emergency use were to receive full approval from the FDA. So if full FDA approval is what it takes for millions of people to put away their skepticism and get vaccinated, we’re all for it.

Furthermore, for those for whom FDA approval isn’t the real reason but a convenient excuse, clinicians may uncover more information about what is holding individuals back from getting vaccinated.

2. Approval of the vaccines will get more kids vaccinated.

Schools across the country are open. Millions of school-age children are now learning indoors. According to another KFF study, about one-quarter of parents of kids aged 12-17 say they’ll “wait and see” how the vaccine works before getting their eligible child vaccinated. One in five parents say that their child will “definitely not” get vaccinated.

Again, people’s objections stem largely from distrust of the vaccines and concerns about side effects. To empower educators and health professionals to both counter myths surrounding side effects and confidently enact vaccine requirements in schools, it’s essential that the FDA give full approval to the vaccines. While authorization may initially only apply to those 16 and over, approval could provide reassurance to parents of all children currently eligible for the shot.

3. Approval will provide us with longer-term safety data.

What’s the difference between emergency use and full approval? The simple answer is that for full approval, the FDA will require an additional four months of safety data. The FDA granted the COVID-19 vaccines’ emergency use authorization based on two months of safety data; with any vaccine, nearly all potential safety problems crop up almost immediately after injection, which is why the FDA deemed two months sufficient for emergency authorization. We have now accumulated at least six months of safety data about these vaccines, making them eligible for full approval.

For people with irrational fears of infertility, magnetism and other specious side effects of the vaccines, the extra data probably won’t mean much. But for people who really want to know more about the true long-term consequences of the vaccines, their reported diminished effectiveness over time, and common real-life side effects such as fevers and headaches, the extra information that goes into the full approval process will be yet another way to help them overcome hesitancy and get vaccinated.

4. Approval will provide employers with greater authority to mandate vaccines.

Many employers across the country have mandated that their employees get vaccinated. A number of these mandates have been challenged in court, and so far they’ve been upheld as legal. But Dr. Francis Collins, director of the National Institutes of Health, recently noted that if the vaccines receive full FDA approval, “then the legal ability to mandate becomes a lot stronger.”

No doubt many employers are waiting for full approval before enacting vaccine requirements, and the sooner they get the legal basis to do so, the better.

The idea of a workplace-based vaccine mandate may seem like a new concept, but these mandates are already common for other FDA-approved vaccines. For example, children are required to be vaccinated against diseases like measles and mumps before enrolling in public school. Travelers are required to be vaccinated against diseases like yellow fever before visiting countries where those illnesses are common. And health care workers are required to get annual flu shots to protect themselves and their patients.

5. Approval will allow the prescribing of vaccines for “off-label” use.

When physicians talk about using drugs “off label,” they mean using them for purposes other than those for which they were initially approved. For example, Metformin, which is approved for the treatment of type 2 diabetes, reduces appetite — so it’s often used to help patients who are trying to lose weight.

Off-label prescribing is legal — but only when drugs have received full approval by the FDA. Once this happens with COVID-19 vaccines, doctors will be able to further study their use in treating a variety of other illnesses.

Off-label use includes delivering booster shots outside of the FDA’s fully approved parameters — and while booster shots weren’t initially included in the COVID-19 vaccines’ application for full approval, companies can request an approved product be amended to include boosters. The FDA’s approval could thus make a third shot more palatable to the population.

Despite everything we know about the COVID-19 vaccines’ effectiveness and their ability to prevent serious illness and hospitalizations, just 60% of Americans ages 12 and up are fully vaccinated against the virus, according to data from the Centers for Disease Control and Prevention. The most recent model from the Institute for Health Metrics and Evaluation indicates grave consequences if Americans don’t continue to get vaccinated and follow mask guidance.

Given that the delta variant has led to an uptick in infections and deaths, it’s crucial that Americans use every tool at our disposal to convince every person to get vaccinated. If full FDA approval of vaccines is one of those tools, then the decision can’t come fast enough.

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(BATON ROUGE, La.) — In Louisiana, the COVID-19 crisis is leaving hospitals teetering on the edge of collapse.

The state currently has the nation’s highest case rate, and hospitalization levels — more than 3,000 at last count — are stretching the health system to a breaking point with patients overwhelming intensive care units and staffing in short supply.

“Our volume, over the past couple of weeks, has been outrageously high,” Dr. Jon Michael Cuba, service line chairman for emergency medicine at Ochsner Health in Baton Rouge, told ABC News. “There has been a ton, a ton of COVID. We are built to deal with this, but with this surge, there is a lack of nurses, a lack of beds and it’s hard to get enough physicians to see the onslaught of patients that are coming in.”

In the last month alone, hospital admissions have surged by more than 340%, amidst a steady rise in daily cases over the last seven weeks.

The situation in Louisiana, driven by the highly infectious delta variant, is mirrored in other Southern states where vaccination rates are relatively low.

In Florida, more patients are currently hospitalized than at any other point in the pandemic, and in Alabama, there no remaining ICU beds available statewide.

In Louisiana, less than 39% of the state’s population is fully vaccinated. Nearly all of those currently hospitalized with COVID-9 in the state — 91% — are unvaccinated, according to state data.

“We’re seeing people come in, they’re getting sicker more quickly,” Dr. Ryan Richard, a pulmonary and critical care physician with the Baton Rouge General Hospital told ABC News, adding that “the vast majority of people are unvaccinated.”

Hospitals in crisis mode

Hospitals across the state are struggling to keep up with the rapidly changing pandemic. There is simply not enough staff to deal with the influx of COVID-19 patients, in addition to the non-COVID-19 patients, doctors said, thus greatly straining the healthcare system

“We are seeing crazy outrageous numbers of patients,” Cuba explained.

At the beginning of July, there were 10 COVID-19 patients receiving care at Baton Rouge General Hospital. As of Wednesday, there were more than 200 COVID-19 patients.

The hospital is now at a breaking point, Richard said. “We do have people calling in to try to get to this hospital that we’re unable to accept,” he said, adding that they have had to send patients to other facilities because they simply do not have the means to care for them. “That’s hard on us, because we want to take everybody that we possibly can and do everything we can, but we don’t have the right means. It’s very frustrating.”

With so many patients needing care, and critical care at that, hospitals have been forced to create makeshift ICUs.

Baton Rouge General opened its eighth COVID-19 ward this week, including one unit in the hospital’s burn unit. Other hospitals in the state have been transforming endoscopy suites, or other medical rooms into untraditional places to care for patients.

In addition, the wait time in the emergency rooms is getting increasingly longer, with critically ill patients forced to stand by for care that was once immediate.

“We are getting crushed in our emergency rooms, our hospitals are filled to the brim,” said Cuba. “If somebody is coming in today with a heart attack, there is a wait. Something we aren’t accustomed to, or comfortable with, but it’s just overwhelming and a cold hard fact of the capacity in the hospitals are starting to get to the bursting point.”

Patients getting younger, and sicker

With more than 80% of Americans 65 and older fully vaccinated, the burden of disease has shifted largely to younger Americans. As of Aug. 7, Americans between the ages of 18-49 make up more than 40% of the patients currently hospitalized with COVID-19, across the country.

Many of the patients who are coming in tend to be younger and sicker, Dr. Abdul Khan, pulmonary critical care physician in the COVID ICU at Ochsner Medical Center in New Orleans noted. He recalled a 40-year-old father, who before being placed on a ventilator, told staff that he was the primary caretaker of a 10 year-old son.

There has also been a staggering increase in younger patients being hospitalized.

“The other thing that we didn’t see in the beginning, is parents visiting their kids,” Khan explained. “The thought of having to visit my kids in the hospital is mind numbing. And that’s what we are seeing.”

Even more concerning, added Khan, is the dreadful reality that “we are having to have conversations with people’s parents about end of life care and things like that. These aren’t kids, but they are 20 years old and 30 years old, and the people that are at their bedsides are their parents.”

One of the patients at Baton Rouge General is 39-year-old disaster relief worker Jessica Cooper, of Baton Rouge, who has been hospitalized with the virus for over 12 days. Cooper, who was unvaccinated, told ABC News, she had wanted to wait for the shot until after she completed an upcoming surgery.

Cooper told ABC News that the infection had depleted her, with every breath a battle. At her worst, she had even written out a goodbye text to her 11-year-old daughter, in case she did not make it out of the hospital.

“I had prayed, made my peace with God. And started typing a text message to her, that way if something happened, and I didn’t make it, she knew I loved her,” Cooper said, adding that this virus is “ageless, it’s colorless — what you can do to protect yourself, it’s not even about you, it’s to protect others.”

Richard noted that people who are coming into the hospital appear to be getting sicker, more quickly, and while in the first three waves of COVID-19, the medical staff felt that it could predict, to some degree, who would get sick, and which people were most vulnerable to the disease, it is no longer the case.

“We’re fooled everyday for what we thought and we’re seeing a lot of young people with no medical problems that were significant or it,” he said. “I thought we had kind of turned the corner and on our way out of this thing… but the delta has truly thrown us a curveball.”

Hospital workers overworked and overwhelmed

The nationwide shortage of nurses has also left frontline workers stretching their teams responsibilities, in an effort to meet all patients’ needs.

“The amount of nurses is never enough,” said Khan. “We are redeploying physicians. That’s how sick the patients are, and how fast they are coming in. If we have 5, 10, 15 extra nurses, there will be a job for them. That’s how many people are coming to the hospital.”

Teams are also ultimately facing the burden of the physical and emotional toll yet another wave has placed on the staff.

“We are already stressed in our job with the extra hours covering the surge, and then when you see your patients, and worried about what’s in the lobby, worried about who is in the ambulance, am I going to be able to get this heart attack out to the right place, will I find a place for the patient to land? I worry a lot about our teams,” Cuba concluded.

Copyright © 2021, ABC Audio. All rights reserved.

(NEW YORK) — Rhashonna Cosby’s two children fared very differently during their months of remote learning. Her son thrived working independently, going on to graduate from high school in the spring of 2020. Her 17-year-old daughter, meanwhile, struggled academically without face-to-face instruction, before transferring this past spring to a school where she could go on-site a few days each week.

“She definitely needs in-person,” Cosby, of Linden, New Jersey, told ABC News. “That’s ideal for her because she doesn’t get distracted. She can focus.”

As students head back for a third school year impacted by the pandemic, COVID-19 continues to complicate the education landscape and the impact of remote learning has yet to be fully assessed. As achievement gaps have emerged, many districts are planning to return fully in person learning in hopes of restoring traditional learning, even as safety concerns mount around the highly contagious delta variant.

But remote learning will remain a part of students’ lives for the foreseeable future, experts say, with tens of thousands of students in quarantine just weeks into the school year for some. How schools approach remote learning is varied: While some view it as a Zoom extension of the classroom, others are taking novel and holistic approaches to try to improve the quality of instruction.

For now, in-person learning is the only option for students like Cosby’s daughter, a rising senior, as New Jersey’s governor was among several leaders to require full-time, in-person K-12 instruction this school year. Other large school districts, like New York City, are starting the year without a remote option.

In recent days, however, the New Jersey state education department has issued guidance that “strongly encouraged” schools to provide remote instruction for students during quarantine, NorthJersey.com reported.

In Philadelphia, Maritza Guridy had the option of a fully remote school, though she decided to have her four children in person “as long as it’s safe,” she told ABC News. Once they were able to return to the classroom last school year, her children did better with face-to-face instruction, she said. While working as the secretary for her children’s school, Guridy heard from many parents struggling with remote learning last year.

“I got many phone calls with families telling me that they had to choose between working or being able to help their child, so there are children that didn’t even log on the entire school year, as a result, because their families could not afford to be at home,” said Guridy, who now works as the Northeast Regional Organizer for the education advocacy group National Parents Union. “It was just so many things that I personally experienced, saw, heard about from parents calling the school. It was a lot.”

Achievement gap in math and English

While some students may do well learning remotely, others have fallen disproportionately behind.

A spring report by the think tank Rand Corp. found that fully remote students learned less in mathematics and English language arts and were more likely to be absent than those learning in person. In a new poll from the Kaiser Family Foundation, nearly 40% of parents of school-age children said their child fell behind academically during the pandemic — with Hispanic parents and households with incomes less than $40,000 a year most likely to report that.

Even for those opting for in-person classes, virtual learning will be inevitable this school year, especially in areas of low vaccination, Daniel Domenech, executive director of AASA, the School Superintendents Association, told ABC News.

Case in point: Just a week into the school year, over 10,000 students and staff in one Florida school district were isolating or quarantining due to COVID-19 cases or exposure.

And over 20,000 students in Mississippi, the state with the lowest vaccination rate, were in quarantine after the first week of school.

“Remote learning is not going to disappear,” Domenech said. “It’s going to continue as a major supplement to help us catch up with the learning loss.”

Deliberate about who goes remote

Amid rising worries over the delta variant, Kenny Rodrequez, the superintendent of the Grandview C-4 School District in Grandview, Missouri, has seen a growing interest in remote learning ahead of the first day of school on Aug. 23 — from about 5% of the district’s roughly 4,000 students last month to around 10 to 12%, he told ABC News last week.

“Certainly the variant has many people very concerned,” he said, though the district is encouraging in-person learning if possible.

“We’re trying to do it a little bit more deliberately this time, a little bit more in the student’s best educational interests,” he said. “If your kid was virtual last year and they were not successful, we’re going to have a real, personal conversation with you about, maybe this is not in their best interest.”

For parents concerned about safety, the district has been communicating about its COVID-19 protocols, such as requiring students and staff to wear masks regardless of vaccination status, the superintendent said.

As for remote instruction, the district took a few more lessons to heart. For one, teaching both in-person and remote at the same time was too challenging, so it is looking to have educators who just focus on remote learning. Additionally, teaching kindergarten in particular was too difficult via a screen, so the grade will only be in person this school year, Rodrequez said.

Dedicated virtual staff and a targeted student approach have factored into other school districts’ plans. Georgia’s Bibb County School District marked the debut this month of its virtual school, VIP Academy — an investment in remote learning that was in the works pre-pandemic. About 2% of the 21,000-person student body is enrolled in the school, which serves grades 4 through 12, school officials said.

Students had to apply to the school “to make sure that they are a quality candidate to be successful in virtual learning,” Rose Powell, chief information officer for the school district, told ABC News. “It’s not for everyone.”

In the event students attending school in-person in the district aren’t able to show up — such as due to COVID-19 quarantine or isolation, another illness or a family matter — they can shift virtually at their district school. Classrooms are also equipped with audio and video technology, so teachers can record and upload lessons into the district’s learning management system.

“[This] provides our teachers and our students and our parents access like they’ve never had before,” Powell said.

Communication key in unclear environment

One key component during months of pandemic learning has been, simply, communication.

“You cannot communicate enough, because people do not necessarily know what’s going on,” said Rodrequez, who started posting weekly videos online for families. “I think for us, just trying to be as open and honest as possible and communicate everything that’s going on that we know, knowing that sometimes we’re not gonna know what’s gonna happen — some things will change around us and we’ll have to adapt to that as well.”

That captures what many parents are feeling as the school year starts amid high COVID-19 transmission across most of the United States.

Debra Garrett of Troy, New York, is hoping her four children, who are between the ages of 7 and 11, can safely stay in school after they largely learned remotely last year.

“This year was a struggle, but I think a lot of the sacrifices fell on me as a parent, and of course other parents can vouch for that as well,” said Garrett, who left her job working for the state’s retirement system to be home with her children. She also was in school virtually herself, recently graduating with a bachelor’s in health sciences.

Her children did better academically and socially with face-to-face instruction, especially her 10-year-old, she said. After he went back to the classroom a few days a week to receive speech therapy services, he improved so much he currently doesn’t need them this upcoming school year, she said.

As cases continue to rise in her area, though, Garrett is getting more anxious about both the prospects of staying fully in-person once her children go back to their charter school on Aug. 23, and what it means for their safety.

“I’m nervous, but I really want them back in the building,” she said. “I know that they learn better when they’re there. I also need a sense of normalcy.”

Copyright © 2021, ABC Audio. All rights reserved.

(NEW YORK) — As students across the country head back to school, a top priority for many educators and parents is how to help students who have experienced “learning loss” during the COVID-19 pandemic.

With kids leaning remotely since early 2020, “learning loss” — or gaps in understanding and skill knowledge that prevent academic progress — has been a natural worry for many parents.

But instead of dwelling on how much students may have fallen behind during their time away from school, some educators are focusing on meeting students where they are rather than focusing on what they’ve “lost.”

“Sometimes the phrase ‘learning loss’ doesn’t value and uphold all of the hard work that teachers, students and families did over the last year and a half to really try to stay the course and really keep their students learning,” Juliana Urtubey, the Council of Chief State School Officers’ 2021 national teacher of the year, told Good Morning America.

“One of the things that I like to tell families and my students is that we’re going to be OK. We’re going to work really hard to catch all the kids up,” Urtubey said. “But what we want to focus on is the future and how to meet all the needs of all of our students instead of working, fixating on the pressure of catching up.”

Urtubey, who is a special education teacher at Kermit Booker Elementary School in Las Vegas, said that even if the COVID-19 pandemic didn’t exist, teachers still assess where students stand academically each year. But if learning loss is the main focus this school year, Urtubey said it could put a lot of pressure on students.

“I think that one of the biggest things we can do is really be critical about how we think about this concept and push back on the idea that our students are going to have to be running the whole year to catch up,” said Urtubey.

Urtubey said that in-person learning will provide a support system for students as they return to school and teachers will meet their needs to help them stay engaged and help them get to where they need to be academically.

“We’re going to work really hard to make sure all of our students have the foundational knowledge they need to be able to apply critical thinking,” Urtubey added. “Each student benefits and thrives in different ways, which is why it’s so important for us to have community within our learning spaces no matter what grade you’re in. Students do better when they know that they’re part of a community and that there’s lots of support for them.”

Ahead of the upcoming school year, Urtubey shared some advice for parents to help their kids feel supported as they transition back to in-person learning.

Co-write a letter with your child to the teacher

Urtubey said co-writing a letter with your child to their teacher is a good way for teachers to get to know students, but also a good way for students to introduce themselves to their teacher. Students can talk about anything from their family to their favorite activities. It can also include what they struggle with in school or what they’re excited to learn. Parents can also include their concerns in the letter.

“As a teacher, I loved getting these letters at the beginning of the year,” Urtubey said. “They made me feel like I already knew the child and I already had a first step in terms of building this kind of trust with families.”

Do activities that are both academic and of interest to your child

If your child expresses an interest in certain subjects like art or reading, Urtubey said it’s good to push them to explore the topics more. For example, if a child is interested in space, Urtubey said a trip to the library can help get your child reading books about space.

“You’re carving out time at home for them to read, so that learning is enjoyable, so that learning is self-guided and self-motivated and that the child has some kind of way to share the learning at home,” Urtubey said. “I think that especially during this last year, we have to make sure that all students feel joy in what they’re learning.”

Visit school before the year begins

For big transition years, like kindergarten or the start of middle school, one way to help prepare students for the upcoming year is to visit the school before the year begins. That way students know where they’re having lunch, where their classroom is, who their teacher is and more.

“A lot of schools will already schedule this,” said Urtubey. “I know that this is really helpful in reducing stress before the first days of school.”

Help students practice introductory questions

Urtubey said when she taught fifth grade students, one way to help them prepare for middle school was spend time with them on things like switching classes or practicing opening a locker. Another way they prepared for the school year was to practice social skills to make new friends.

Urtubey suggested practicing different conversations for different scenarios with your student to help them take the stress or anxiety out of forming friendships or meeting new people.

Encourage deeper conversations about school

At the end of each day, Urtubey suggested asking your child questions beyond “How was your day?” since that doesn’t necessarily start a conversation with them about what happened during school.

Instead, Urtubey suggested questions such as, “Tell me about a time that you felt really happy today,” “Tell me about a time you felt challenged today,” or “Tell me a bit about what you learned today,” will help foster more discussions about what they’re feeling.

Copyright © 2021, ABC Audio. All rights reserved.

(NEW YORK) — Time to take stock of what’s in your freezer after a major frozen shrimp producer issued an expanded recall on a range of products due to salmonella concerns.

Avanti Frozen Foods Pvt. Ltd, expanded a voluntarily recall that was first issued June 25, 2021 to now include “certain consignments of various sizes of frozen cooked, peeled, deveined, shrimp (with some packaged with cocktail sauce) sold in various unit sizes, because it has the potential to be contaminated with Salmonella.”

Avanti sells its shrimp under a range of labels. Initially, the recall included frozen shrimp from Censea, CWNO, Chicken of the Sea, Honest Catch, Hannaford, Waterfront Bistro, Open Acres, 365 (Whole Foods), and Meijer. Now it has expanded to include new brands and additional SKUs from the previous brands listed.

Click here for full details on the affected products, codes and labels from the FDA.

The affected frozen raw and cooked shrimp products were distributed nationwide from November 2020 to May 2021, according to the Food and Drug Administration.

According to the recall, there have been nine reports of salmonella-related illness to date associated with these shrimp distributions. Avanti has taken several preventive steps and initiatives to eliminate potential for future contaminations.

Salmonella is an organism that can cause serious illness, especially in young children, elderly people and others with weakened immune systems. Healthy individuals infected with salmonella often experience fever, diarrhea, nausea, vomiting and abdominal pain.

Although a number of product included in the recall has not been associated with any illness, according to Avanti Frozen Foods, this expansion was initiated out of an abundance of precaution after discussions with FDA and CDC.

Consumers who purchased any of the products in question are urged not to eat it and return them to the place of purchase or contact the company by phone with questions.

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