Fall COVID-19 boosters could roll out soon pending green light from FDA, CDC

Fall COVID-19 boosters could roll out soon pending green light from FDA, CDC
Fall COVID-19 boosters could roll out soon pending green light from FDA, CDC
Евгения Матвеец/Getty Images

(NEW YORK) — With the end of summer nearing, and Labor Day around the corner, U.S. health officials are preparing to roll out millions of new COVID-19 boosters as health experts grow concerned over a potential viral resurgence in the fall and winter.

The Food and Drug Administration is expected, as soon as this week, to authorize Pfizer and Moderna’s new bivalent booster shots, which target both the original Wuhan strain that emerged at the onset of the pandemic, as well as the omicron subvariants, BA.4 and BA.5, that are currently dominant globally.

Advisers to the Centers for Disease Control and Prevention (CDC) are set to meet on Thursday and Friday, and if both agencies greenlight the new shots, doses could be shipped out in the days to come and administered soon after Labor Day weekend.

Unlike the original vaccines and boosters, these new shots will not go through a lengthy clinical trial process, where thousands of Americans are dosed with the vaccines to test the safety and long-term effectiveness of the vaccines. However, federal health officials stress that these new shots will still be just as safe as the original vaccines because the underlying vaccine platform, mRNA, is the same.

“Real world evidence from the current mRNA COVID-19 vaccines, which have been administered to millions of individuals, show us that the vaccines are safe. As we know from prior experience, strain changes can be made without affecting safety,” FDA Commissioner Robert Califf tweeted earlier this week.

“When available, new boosters are expected to help provide greater protection against the currently circulating strains. We encourage all who are eligible to consider a booster,” Califf wrote.

Because the vaccines have already been studied and administered in millions of people, and the new boosters use the same foundation but change the targeted variant, the FDA is not requiring the same process for authorization.

Health experts say that the decision not to use time-consuming clinical trials for each new shot is also a strategic move, in an effort to keep vaccines up to date with the rapidly evolving variants — a process that will likely mimic how the flu vaccine is altered each year.

Across the country, 108 million Americans — or more than half of those eligible to be boosted — have yet to receive their first booster shot, according to data from the CDC.

Although the immunity provided by COVID-19 vaccines continues to wane with time, data published by the CDC shows that COVID-19 booster doses are still offering protection against severe forms of disease and death, particularly among older Americans.

Among people ages 50 years and older, the unvaccinated had a risk of dying from COVID-19 that was 14 times higher than their fully vaccinated and double-boosted peers.

In people ages 50 years and older, vaccinated people with one booster dose had a risk of dying from COVID-19 that was three times higher than those fully vaccinated and double boosted.

More than 61 million people over the age of 50 are eligible to receive their second COVID-19 booster shot, but just a third of people have actually done so. Since second booster doses were authorized in mid-March, a total of 23.1 million Americans have received their second booster.

In May, the CDC announced that it was “strengthening” its recommendation for Americans over the age of 12, who are immunocompromised, and those over the age of 50, to receive their second booster shot.

Younger populations are also benefiting from boosters, data shows.

In June, unvaccinated people ages 12 years and older had a risk of dying from COVID-19 that was eight times higher, compared to people who were fully vaccinated and boosted with their first dose.

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Abbott restarting production of its largest, most popular formula after months on hiatus

Abbott restarting production of its largest, most popular formula after months on hiatus
Abbott restarting production of its largest, most popular formula after months on hiatus
Tim Boyle/Getty Images

(STURGIS, Mich.) — Abbott is announcing Friday their Sturgis, Michigan plant is restarting production of their largest and most popular infant formula, Similac.

Previously, the troubled plant had only restarted a fragment of its production, after bacterial contamination concerns inside the facility had prompted a months-long voluntary recall and shutdown.

The closure at the largest formula manufacturer in the country ricocheted across the infant formula industry and exacerbated the supply shortage, forcing families to scramble for alternatives in the hyper-concentrated formula market.

Then in June — less than two weeks after it had finally restarted some of its formula production — severe weather and flooding forced the plant to close once again to “assess damage,” “clean and re-sanitize the plant.”

In July, Abbott announced they were opening the lines for their specialty hypoallergenic formula, EleCare, along with some metabolic formulas — but still, not its most popular and widely used Similac.

The company is now announcing it has restarted Similac production, paving the way for an eventual infusion of formula into the U.S. market, once the plant gets back up to full speed — after what has been a months-long scarcity on American grocery shelves.

The discovery of Cronobacter sakazakii bacteria inside Abbott’s Sturgis plant prompted a massive voluntary formula recall in February, after four babies who had consumed Abbott’s formula contracted a Cronobacter infection. Two of the infants subsequently died, although Abbott maintains there has not been conclusive evidence that its formula caused the infant illnesses, since none of the Cronobacter strains found at their plant matched the two samples genetically sequenced from the sickened infants. Ultimately, it was the combined findings of Cronobacter inside Abbott’s plant — along with a pattern of serious operational deficiencies and consumer complaints — which led to its closure.

Now that they are reopening Similac production, Abbott estimates it will take about six weeks for them to begin shipping it to retail locations “as it enters into production, enhanced pre-and post-production testing, and cycles through shipping and retail distribution networks,” a spokesperson said.

Abbott tells ABC News that during its shutdown and systems overhaul, there have been “a couple” instances where they have again found Cronobacter within batches of their formula. In each case, they say they have found it, addressed the issue, and destroyed the affected product.

This is, essentially, the oversight system at work: Cronobacter can be widely found in the environment — but in infants, it can be deadly — which is why rigorous safety and quality control procedures at plants like these are so important, experts have previously told ABC News.

“Restarting a large manufacturing facility after a several-month shut down is a complex process, and it takes time to ensure that equipment, processes and production are functioning smoothly and sustainably,” an Abbott spokesperson said in a statement to be posted tonight on their site. “It’s taken us time to ramp up production consistently to these high standards. There have been – and likely will be – stops and starts from time to time. We’ve experienced events like severe weather, we’ve had to make mechanical adjustments, and we’ve had to discard some early production batches that didn’t meet our standards.”

“As we’ve said, we have a zero-tolerance policy for Cronobacter or any pathogen in our plants. Cronobacter is naturally and commonly found in the environment and our quality systems are designed to find it and destroy it when it’s present, as it sometimes is with all manufacturers. That is why we test for it regularly and take steps to eliminate it if and when we find it, is why we took the steps we did in Sturgis in February, and is what guides our approach today,” the spokesperson said.

“If our quality systems detect the presence of Cronobacter in product testing, we suspend production while we investigate and coordinate closely with the FDA. Since our restart, this has occurred with a couple of batches, and in those cases we found the issue, addressed it and no affected product has been or will be distributed. This confirms our quality systems work.”

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Introducing your baby to food allergens, according to an expert

Introducing your baby to food allergens, according to an expert
Introducing your baby to food allergens, according to an expert
skaman306/Getty Images

(NEW YORK) — Knowing what to put on a baby’s plate and when can be daunting and nerve-racking for new parents. Now experts recommend regularly offering non-choking forms of foods containing common allergens between 4 and 6 months of age.

“Allergies are a part of a child’s life in the United States today, unfortunately. We know about 8% of American children, by the time they go off to college, carry a diagnosis of food allergy,” Dr. Wendy Sue Swanson, a mother of two and a board-certified pediatrician, told ABC News’ Good Morning America.

“We know that feeding all different kinds of foods, including common allergens in the beginning of life, tends to down regulate or decrease the risk of food allergies dramatically,” added Swanson.

New guideline changes on early allergen exposure

The advice to incorporate common allergens between 4 and 6 months is a dramatic shift from what doctors previously told parents and caregivers. In 2000, the American Academy of Pediatrics advised parents to delay the introduction of common food allergens for the purpose of preventing allergic disease. For example, experts previously recommended delaying cow’s milk until age 1 year; eggs until age 2 years; and peanuts, tree nuts, and fish until age 3 years.

New evidence since 2000 shows that the practice of delaying introduction of highly allergenic foods may actually increase rather than decrease the incidence of food allergies. A research study from 2018 suggested that the increased likelihood of peanut allergy seen in younger siblings of a peanut allergic child may be due in part to the practice of delayed introduction rather than genetics alone.

“For example, when you have food in the tummy, in the gut, those food proteins are exposed to the immune system and a baby’s body grows up exposed to them and tolerant to them,” emphasized Swanson.

Nine types of highly allergic foods

While any food can cause an allergy, knowing common triggers may help parents and caregivers identify a potential food-related allergic reaction.

“In general, you can develop an allergy to any food. In fact, there are more than 200 foods that we know humans are allergic to but there is a certain subset of foods that tend to be more provoking when it comes to allergies,” said Swanson.

The most common food allergy that starts in childhood and persists into adulthood in the United States is peanuts. Contrary to popular belief, peanuts are actually not a tree nut. They are a type of legume.

Besides peanuts, the other common food allergens among children in the U.S. are:

  • Soy beans
  • Tree nuts (cashews, walnuts, pistachios etc.)
  • Cow milk
  • Eggs
  • Wheat
  • Fish
  • Shellfish
  • Sesame seeds

Sesame seeds, which is one of the fastest growing food allergies in the U.S. according to Dr. Swanson, are increasingly recognized as the ninth major food group that causes allergies.

Currently, the first eight food groups mentioned in the list above make up around 90% of all food allergies and must be declared on U.S. product labels.

How to introduce allergens safely

The first step in introducing any “complementary foods,” the term referring to all solid and liquid foods other than breast milk or infant formula, is assessing an infant’s developmental readiness such as adequate ability to hold one’s body upright, ability to indicate desire for food by opening the mouth and leaning forward and the ability to swallow safely.

The next step is making sure the infant tolerates a few of the more “typical” complementary foods such as cereals, fruits and vegetables.

When introducing allergens, “you want to just make sure that you’re creating a texture and a consistency that’s easy and safe for your baby,” said Swanson. “And then making sure if you are using things like nuts or nut butters, that you are just thinning those nut butters to a way that they are not a choking risk.”

For high-risk children, i.e., children with a strong family history or children who have a personal history of moderate-severe eczema or egg allergy, the latest Dietary Guidelines for Americans published by the United States Department of Agriculture (USDA) advise parents to speak with a pediatrician before giving their infants peanuts.

For reasons unrelated to allergies, cow milk or fortified soy beverages should not be offered to infants younger than age 12 months, the USDA says.

What to know and what to do if a baby has a reaction

Reassuringly, “90% or more of babies will never develop an allergy or have any kind of reaction to food,” said Swanson.

“Now, if you are at home and if you think your baby might have a reaction, there are two symptoms that a baby will show if they are likely having a reaction to food: hives, or vomiting, or both within about minutes to two hours,” said Swanson.

Almost always, allergic reactions are not life-threatening and can be managed safely at home. However, if an infant is exhibiting signs of a severe allergic reaction such as mouth or tongue swelling, trouble breathing or wheezing, hoarse voice, or trouble swallowing or drooling, call 911 right away.

“How you feed your baby with all those common allergens in early life will continue to protect them to stay that way,” said Swanson.

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After daughter’s suicide, dad shares emotional message to ‘help at least one person’

After daughter’s suicide, dad shares emotional message to ‘help at least one person’
After daughter’s suicide, dad shares emotional message to ‘help at least one person’
Courtesy Alex Sheats

(NEW YORK) — A dad mourning the loss of his 26-year-old daughter is sharing an emotional message on mental health.

David Sheats shared on Instagram that his daughter, Savannah Sheats, died by suicide.

“I’ve been reluctant to express that, but I think it’s important,” he wrote in a message shared by another daughter, Alex. “With a young child, a skinned knee is one thing. A hug and a band aid will normally cure the tears. As that child becomes a young lady, the task becomes more difficult. There are no cuts, bruises, bumps you can make better. The pain is internal.”

Savannah Sheats, of Atlanta, was reported missing by her family on Aug. 17, and was found by police one day later, according to local ABC affiliate WSB-TV.

Her father described her as a “giver, overachiever, and genuine person,” who “never met a stranger.”

Describing his family’s loss, David Sheats wrote that their hearts are “broken into a million pieces.”

He wrote that while he remembers his daughter and mourns her death, he wants to, “bring awareness for others in similar situations, so that their outcome is a positive one.”

“As a dad and parent, I’ve learned a difficult lesson,” he wrote. “When your child or anyone reaches out for help, take it seriously. I knew there were issues but I could have done more.”

Citing the coronavirus pandemic as a time that people have felt disconnected and anxious, David Sheats also urged people to help one another.

“Help at least one person. Do it today. Don’t wait,” he wrote. “Everyone needs help at points. As the saying goes, ‘no man is an island.’ We need each other.”

In the United States, suicide is the 12th leading cause of death, according to the American Foundation for Suicide Prevention.

Over the last two years, a more widespread focus has been placed on suicide prevention and mental health care in acknowledgment of the pandemic’s impact on Americans’ mental health.

In July, a new three-digit phone number, 988, was launched as a way to make mental health care more accessible.

People can now call or text 988 and access a free and confidential help line, now known as the Suicide and Crisis Lifeline, that is available 24 hours a day, seven days a week.

“988 is easy to remember,” Jessica Rosenworcel, chairwoman of the Federal Communications Commission, said in July when the new number launched. “Now we have to make it clear to the entire country that it is a sign of strength to call it and use it, and not a sign of weakness.”

If you are experiencing suicidal, substance use or other mental health crises please call or text 988. You will reach a trained crisis counselor for free, 24 hours a day, seven days a week. You can also go to 988lifeline.org or dial the current toll free number 800-273-8255 [TALK].

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E. coli outbreak linked to Wendy’s grows to 84 reported cases: CDC

E. coli outbreak linked to Wendy’s grows to 84 reported cases: CDC
E. coli outbreak linked to Wendy’s grows to 84 reported cases: CDC
Dwi Pradnyana/Getty Images

(ATLANTA) — A multi-state E. coli outbreak associated with romaine lettuce in sandwiches from Wendy’s has grown, with dozens more infections reported in the past week, according to federal health officials.

Since Aug. 17, when the outbreak was first publicized, 47 more illnesses in the outbreak have been reported to the U.S. Centers for Disease Control and Prevention — bringing the total number of reported infections to 84, the agency said Thursday.

Among those, 38 people have been hospitalized, including eight people in Michigan who have a type of kidney failure called hemolytic uremic syndrome, the CDC said. No deaths have been reported so far.

The infections have been reported to the CDC from four states: Michigan (53); Ohio (23); Indiana (six); and Pennsylvania (two).

CDC investigators are working to confirm the source of the outbreak, though many of those who became sick reported eating at Wendy’s, the CDC said.

“A specific food has not yet been confirmed as the source of this outbreak, but many sick people reported eating sandwiches with romaine lettuce at Wendy’s restaurants in Indiana, Michigan, Ohio, and Pennsylvania before getting sick,” the CDC said in its notice.

Among 62 people interviewed by investigators, 52 of them (84%) reported eating at a Wendy’s the week before they became sick, the CDC said. Of 17 people with detailed information about what they ate there, 15 (88%) reported eating romaine lettuce served on burgers and sandwiches.

As a precaution, the fast food chain has removed the romaine lettuce used in sandwiches from restaurants in that region. A different type of romaine lettuce is used in salads.

In a statement on its website Friday, Wendy’s confirmed that it was “fully cooperating with public health authorities on their ongoing investigation of the regional E. coli outbreak reported in certain midwestern states,” adding that it was “taking the precaution of discarding and replacing the sandwich lettuce at some restaurants in that region.”

“The lettuce that we use in our salads is different, and is not affected by this action. As a company, we are committed to upholding our high standards of food safety and quality,” the statement read.

The CDC is not advising that people stop eating at Wendy’s or to stop eating romaine lettuce in general.

“At this time, there is no evidence to indicate that romaine lettuce sold in grocery stores, served in other restaurants, or in people’s homes is linked to this outbreak,” the CDC said.

Most people infected with E. coli experience severe stomach cramps, vomiting and often bloody diarrhea, which typically start three to four days after ingesting the bacteria.

The CDC is urging people to call their health care provider immediately if they have severe symptoms, such as diarrhea for more than three days, diarrhea and a fever higher than 102 degrees, vomiting to the point where you can’t keep liquids down and signs of dehydration.

Most recover without treatment within a week, though some people may develop kidney failure.

ABC News’ Eric Strauss contributed to this report.

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Pfizer’s RSV vaccine candidate over 85% effective in older adults, data shows

Pfizer’s RSV vaccine candidate over 85% effective in older adults, data shows
Pfizer’s RSV vaccine candidate over 85% effective in older adults, data shows
ER Productions Limited/Getty Images

(NEW YORK) — Pfizer announced Thursday that its vaccine candidate for respiratory syncytial virus was more than 85% effective in preventing lower respiratory tract illness in older adults.

The New York-based pharmaceutical company released findings from the Phase 3 clinical trial investigating its RSV vaccine candidate when administered to participants ages 60 and up. The investigational vaccine targets both A and B strains of the virus, making it bivalent.

“We are delighted that this first bivalent RSV vaccine candidate, RSVpreF, was demonstrated to be efficacious in our clinical trial against this disease, which is associated with high levels of morbidity and mortality in older adults,” Dr. Annaliesa Anderson, senior vice president and chief scientific officer for vaccine research and development at Pfizer, said in a statement Thursday.

RSV is a common virus that affects the lungs and breathing passages, usually causing mild, cold-like symptoms but sometimes leading to serious conditions. Although most people recover within a week or two, the virus can be dangerous, especially for infants and older adults, according to the Centers for Disease Control and Prevention.

Each year, an estimated 177,000 older adults are hospitalized with RSV across the United States and 14,000 of them die. The virus is the most common cause of bronchiolitis and pneumonia in children under the age of 1 in the U.S. There is currently no approved vaccine for RSV, according to the CDC.

Four companies — Pfizer, GSK, Johnson & Johnson and Moderna — are in late-stage trials for their respective RSV vaccine candidates.

Pfizer said in a press release Thursday that a vaccine efficacy of 85.7% was observed in participants with more severe primary disease endpoint of lower respiratory tract illness, or LRTI-RSV, defined by analysis of three or more RSV-associated symptoms. The investigational vaccine was also well-tolerated, with no safety concerns, according to the press release.

Based on the findings, Pfizer said it plans to seek regulatory approval from the U.S. Food and Drug Administration this fall.

“Scientists and researchers have worked to develop RSV vaccines with little success for over half a century,” Anderson added. “These findings are an important step in our effort to help protect against RSV disease and we look forward to working with the FDA and other regulatory agencies to make this vaccine candidate available to help address the substantial burden of RSV disease in older adults.”

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Three children in Georgia test positive for monkeypox: Officials

Three children in Georgia test positive for monkeypox: Officials
Three children in Georgia test positive for monkeypox: Officials
Jackyenjoyphotography/Getty Images

(ATLANTA) — Three children in Georgia have now tested positive for monkeypox, newly updated state data has revealed.

The Georgia Department of Health did not immediately respond to ABC News’ request for comment on these cases.

Newton County School System, which went back to school in early August, confirmed to ABC News that at least one child at Mansfield Elementary in Mansfield, Georgia, has tested positive for the virus, and one student at Flint Hill Elementary in Oxford, Georgia, is currently undergoing testing.

It is unclear if these cases are at all connected. The schools are located approximately 13 miles apart. Additional information on how the students may have contracted or been exposed to the virus is unavailable at this time, due to privacy concerns, according to school officials.

The school district has notified parents, officials said, and parents of students considered to be close contacts will receive separate communications instructing them on next steps.

“NCSS facilities employees will thoroughly clean and disinfect classrooms and other areas at both schools this afternoon to ensure ongoing safe and healthy learning and work environments for students and staff. Both schools will be open tomorrow,” the school district wrote in a statement on Tuesday.

Across the state of Georgia, at least 15 children, ages 17 years and younger, have received their first monkeypox vaccine dose, state data shows.

Separately, in Texas, officials confirmed that a previously confirmed monkeypox case had actually turned out to be a false positive.

Across the country, at least 13 children have now tested positive for monkeypox. Nine states and jurisdictions have reported pediatric monkeypox cases.

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Tattoo ink is under-regulated, scientists say

Tattoo ink is under-regulated, scientists say
Tattoo ink is under-regulated, scientists say
Alvaro Medina Jurado/Getty Images

(NEW YORK) — Researchers are raising concerns about the quality of tattoo ink, saying the ink isn’t always properly labeled and, in some instances, could contain possible carcinogens. But the biggest problem, researchers say, is that the tattoo ink is relatively unregulated, meaning the ingredients inside this ink are not always known.

A team of researchers at Binghamton University presented their work at the American Chemical Society Fall 2022 meeting and launched a website – What’s in my ink – to assist consumers and artists as it get more information and completes additional research.

Although tattoo inks are injected into the skin, they are not considered medical products. Tattoos are regulated as a cosmetic product in the United States, and cosmetic products and ingredients do not need to be approved by the Food and Drug Administration prior to going on the market for use by the public, with some exceptions.

“Surprisingly, no dye shop makes pigment specific for tattoo ink,” Dr. John Swierk, the principal investigator of the project, said in a press release with the American Chemical Society. “Big companies manufacture pigments for everything, such as paint and textiles. These same pigments are used in tattoo inks.”

This means modern tattoo ink is sometimes made from products that were not manufactured for tattoos – including printer ink.

“Our focus is that we want to understand the science better,” Swierk told ABC News, “We want to empower artists and consumers to be knowledgeable.”

The team of researchers uses multiple techniques to detect the particle size and molecular composition of tattoo pigments, using highly specialized machines that can analyze the inks at a molecular level.

“The most surprising thing we found is just how much inaccuracy there is,” Swierk said. “I won’t say that it’s inaccurate for every single manufacturer … but certainly, we’ve looked at a pretty significant subset, and we’re finding a recurring issue of incorrect labeling.”

The team has been studying both carrier solutions – which Swierk said is the liquid portion that carries the pigment, typically made out of a mix of alcohol and water – and pigments. In 20 of the 24 carrier solutions examined by the team, they found alcohols that were not listed on the label, Swierk said.

Another aspect the team studied was particle size.

“Usually the rule of thumb is that particles with a particle size of around 100 nanometers or less start to become a concern from the human health standpoint,” Swierk said, “because they can penetrate into cell nuclei.”

The team has so far analyzed the particle size of 16 inks, and has found that about half had an average particle size of around 100 nanometers or significantly smaller.

“Having a tattoo with ink does carry some risks,” Dr. Mark Abdelmalek, dermatologist and ABC News Correspondent, told ABC News. “The risks aren’t very common, but they are there.”

Abdelmalek noted the body will sometimes react to tattoo ink as if it’s a foreign substance, causing a granulomatous reaction, which he describes as almost an allergy beneath the skin.

“You have this complex interaction, and this manifests with bumps on the skin or raised areas on the skin,” Abdelmalek said. “It’s a little bit like detective work because you have a person who comes in with a multicolored tattoo, but you might be noticing that only the red ink is reacting.”

Symptoms of an allergic tattoo reaction typically include itching, infiltrated papules, nodules, or plaques that are restricted within one color of a tattoo. From 2004-2018, there was an increase in Google search volumes for “itchy tattoo”, “tattoo bumps”, “raised tattoos”, and “swollen tattoo”.

“If you are a type of person who has had allergic reactions to other things in the past, you really want to think about knowing what kind of dyes are going into your skin,” Abdemalek said.

The red colors, Abdelmalek pointed out, tend to cause the most problems with allergic reactions. Additionally, those with pre-existing skin conditions, such as psoriasis, may have exacerbations or flares after getting a tattoo.

Should someone decide to have their tattoo removed at a later date, Abdelmalek also noted that some colors are harder to remove using laser tattoo removal than others – namely, oranges, yellows, greens, and turquoise.

Tattoos have been around for centuries in many cultures and areas of the globe – archaeologists have found evidence of tattooing from as long as 7,000 years ago. As of 2019, 31.5% of adults in the United States have at least one tattoo.

Dr. Alexandria C Wellman, a resident in the combined Anatomical and Clinical Pathology program at the University of California Los Angeles, is a part of the ABC News Medical Unit.

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Some health officials struggling with new monkeypox vaccine injection method

Some health officials struggling with new monkeypox vaccine injection method
Some health officials struggling with new monkeypox vaccine injection method
Paul Bersebach/MediaNews Group/Orange County Register via Getty Images

(WASHINGTON) — Some states and jurisdictions are hitting early bumps in their rollout of the U.S. government’s new approach to expand access and supply of monkeypox vaccines to more at-risk Americans, local officials have told ABC News, as providers face a steep learning curve with the new inoculation method.

Earlier this month, the Biden administration announced it was launching a new plan to increase the country’s monkeypox vaccine supply by shifting the way the shots were administered from a traditional subcutaneous injection in the arm, to an intradermal technique of smaller, shallower injections.

The new intradermal technique requires just a fraction of a vaccine per shot. Instead of using one vial per vaccination, the approach produces a total of five vaccinations per vial, according to federal officials. At the time, these officials acknowledged that giving shots this way would require more technical skill.

Now, several state and local officials from across the country have told ABC News that some of their clinicians are struggling to extract all five doses from the vial.

“We have also heard reports from some of our providers that they have been only able to extract three or four doses per vial,” Nikki Ostergaard, from the Washington State Department of Health, told ABC News.

Health officials in Texas confirmed to ABC News that although some providers have been able to successfully extract five doses from the vials, others “cannot get five doses.” In Maryland, a representative for the health department also confirmed it has heard anecdotal reports of the issues.

The Association of Immunization Managers (AIM) confirmed to ABC News that its executive director, Claire Hannan, has also heard that some clinicians are running into trouble with the extraction process, and thus, the organization is working to educate health officials to prepare them for the injection process better.

“The needles that are used make a difference. And AIM hopes that as clinicians get more proficient with the ID technique, this will improve,” a representative for the organization said in a statement.

White House National Monkeypox Response Deputy Coordinator Dr. Demetre Daskalakis told Stat News that his team has “definitely” heard of the issues arising from local jurisdictions, adding there has been a range in the number of doses clinicians are able to extract, with most reporting that they are getting between three and five doses.

Concerns about the intradermal approach from local officials

In the weeks after the U.S. government announced the shift in vaccination strategy, local officials have had some initial concerns about training health care providers on how to administer the shots with the new technique.

New York State Health Commissioner Dr. Mary T. Bassett said during a press conference this week, with Gov. Kathy Hochul, that it is “not as pleasant” to get an intradermal injection, as it can scar and is “more painful.”

“They’re more complications at the site, that these aren’t serious, but they’re unpleasant,” Bassett said.

But officials said given the ongoing crisis, vaccinating as many people as possible is crucial.

“We have been struggling with not having enough doses. And our obligation in public health is always to do the most good for the most people and intradermal administration will vastly expand our access to a scarce resource,” Bassett said at the press conference.

Hochul noted this is “an interim approach until the supply chain challenges break,” and when an unlimited number of vaccines becomes available, the state may consider going back to the original way of administering the shots.

In New York City, Health Commissioner Dr. Ashwin Vasan said Wednesday that it will take “some weeks” for the city to transition fully to an intradermal approach as they educate local clinics on the practice, but the transition is necessary because it is “really being mandated by the federal government.”

“It’s not optional,” Vasan said at a city council meeting. “The federal government has made it clear that we won’t get more vaccines until we make the switch and so we’re making the switch.”

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After COVID and monkeypox, experts say outbreaks anywhere threaten citizens everywhere

After COVID and monkeypox, experts say outbreaks anywhere threaten citizens everywhere
After COVID and monkeypox, experts say outbreaks anywhere threaten citizens everywhere
Jasmin Merdan/Getty Images

(NEW YORK) — With the emergence of COVID-19 and the recent surge in monkeypox cases, scientists and doctors who specialize in infectious disease are issuing increasingly dire warnings, saying wealthy countries can no longer afford to ignore small outbreaks abroad.

For decades, diseases that primarily affected lower and lower-middle income countries were relegated as “neglected” diseases, having less funding, fewer resources and little attention. Monkeypox, for example, has been smoldering quietly in Western Africa since 2017. Now, scientists are increasingly warning that global infectious disease outbreaks could become the new normal.

“I think it’s very clear that we’re living in a new age of pandemics,” said Dr. Jay Varma, a professor of population health sciences at Weill Cornell Medicine.

“We’ve been dealing with infectious diseases since we appeared on this planet,” said Dr. Amesh Adalja, a senior scholar at Johns Hopkins Center for Health Security.

Although the advent of antibiotics, vaccines and basic sanitation measures have helped control infectious diseases, the acceleration of international travel in recent decades has unleashed viruses that may have otherwise been contained in one region.

“What’s occurring in one geographic area may not remain in that geographic area [because] a pathogen can travel by the speed of a jetliner,” says Adalja.

Experts say people tend to focus on problems closer to home, and tend to be unaware of diseases spreading beyond their borders.

“There’s sort of this false sense of security, that when something is spreading somewhere where you don’t live and don’t know anyone, it’s easy to think that it will just sort of continue that way,” says Stephen Kissler, Ph.D., a research fellow at the Harvard Department of Immunology and Infectious Diseases.

Oftentimes, officials work to limit travel to slow the spread of disease, as occurred globally during the COVID-19 pandemic or the Zika outbreak in the United States. But that strategy rarely halts the transmission of a virus.

“One of the important lessons of public health is that diseases don’t respect administrative borders and they certainly don’t carry passports or request visas,” said Varma.

Historically, less funding has existed to study viruses that primarily thrived outside U.S. borders.

“Public health [is underfunded]. Infrastructure is underfunded. And that’s especially true in resource poor settings where infectious disease burden is significant,” said John Brownstein, Ph.D., an ABC News contributor and chief innovation officer at Boston Children’s Hospital.

Now, there is evidence that pandemics are picking up pace. In the past 15 years, seven emergency declarations have been made by the organization — H1N1, Ebola (twice), Poliomyelitis, Zika, COVID-19, and just recently, monkeypox.

“Ultimately, these declarations are helpful, because they unlock resources, support, visibility, and education that are important in the sort of response to an emerging infectious disease,” Brownstein said.

But not every virus — or every country — gets such resources. Just this last week, scientists have been monitoring a few dozen cases of a new virus in China called the Langya virus (LayV). Because there’s limited evidence of LayV spreading between people, experts are not overly concerned at this time, but they note that dealing with new infectious diseases is not uncommon.

“We still see the sort of power architecture of the world, to be heavily imbalanced, towards countries that have historically, over the past 200 years, held the most power and political way. And that’s primarily countries in Europe and the United States,” said Varma.

In responding to COVID-19 — a truly global pandemic — governments scrambled to protect their own citizens first. The COVAX initiative aimed to share COVID vaccines equitably around the world, but never reached its full potential, experts say.

“When you have a sort of gift to the world, like the development of highly effective COVID vaccines, they’re immediately gobbled up by the countries that have the most power and wealth, leaving the rest of the populations around the world which don’t benefit from that wealth behind,” said Varma.

Pharmaceutical companies also serve as the lifeline for many that depend on vaccines or medications to protect themselves and their loved ones. Yet, the incentive to combat neglected diseases is limited — especially early in an outbreak, when very few people are sick.

“[Neglected diseases] are a small market compared to what a pharmaceutical company might be going after like high cholesterol or heart disease or something like that, that’s much more lucrative,” said Adalja.

Experts noted that the global health community increasingly works together to stop the spread of emerging diseases. But funding remains a consistent hurdle to ensure that outbreaks are contained quickly and efficiently.

“I do think that there’s always a window of opportunity, with any emerging outbreak, to do something and potentially prevent it from spreading more broadly,” said Kissler.

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