FDA’s move to stretch monkeypox vaccine supplies could pay off, experts say

FDA’s move to stretch monkeypox vaccine supplies could pay off, experts say
FDA’s move to stretch monkeypox vaccine supplies could pay off, experts say
Smith Collection/Gado via Getty Images

(SILVER SPRING, Md.) — The Food and Drug Administration announced an emergency use authorization to move forward with their plan to stretch out the current monkeypox vaccine supply with a new injection method that will try to stretch one dose into five. Vaccine experts say that the scientific rationale behind this decision is sound, but technical challenges with the rollout technique may still be ahead.

“In recent weeks, the monkeypox virus has continued to spread at a rate that has made it clear our current vaccine supply will not meet the current demand,” FDA Commissioner Bob Califf said Tuesday during a press briefing.

But this swift decision has some asking if this way of giving a vaccine that is still experimental.

Dr. Demetre Daskalakis, deputy coordinator for the White House Monkeypox Response, sought to reassure gay, bisexual and men who have sex with men — the group most affected by the outbreak right now — that the new strategy is evidence-based.

“I think that the due diligence done by the FDA, looking into the data, should assure them that the vaccine is immunologically equivalent and safe,” Daskalakis, a leading expert on LGBTQ health, said during a Tuesday briefing.

Experts say the scientific rationale is sound, but the data isn’t robust

The data Daskalakis is referring to comes from a 2015 study that evaluated both ways of administering the vaccine, that found “a similar immune response,” according to the FDA. Other data comes from smallpox and influenza vaccines.

“We look at the totality of the available scientific evidence and we bring that together to try to do the best by public health,” Dr. Peter Marks, FDA’s vaccine chief, said on Tuesday.

Vaccine scientists interviewed by ABC News agreed that the scientific rationale supporting the new injection technique is strong, but note prior studies have been small.

“The data supports this based on the original clinical trial data and their approval from FDA,” Dr. Richard Kuhn, Krenicki Family Director of Inflammation, Immunology, and Infectious Disease at Purdue University, told ABC News.

Dr. Dan Barouch, Director, Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center says it’s crucial to continue collecting data to better understand if the new injection technique will be equally effective in this outbreak.

“There is some data, but it’s a small amount of data — and it needs to be studied in larger numbers with more sophisticated assays that we have today with the actual vaccine that’s being used right now,” Barouch told ABC News.

The National Coalition of STD Directors, a nonprofit representing sexual health clinics that have been on the frontlines of the current outbreak – questioned the decision. Without clear data on efficacy, giving smaller, shallower injections could give people a false sense of security, they argued on Twitter.

Trickier injection method can be taught

Healthcare providers will need to be trained in how to give shots between layers of the skin, instead of the more typical deeper injections below the skin. The technique is not overly complex and has been done in the past with other vaccines. But because it is slightly more difficult, the shallower injection into the skin is not commonly used.

“There is a lot of history of getting vaccines by the intradermal route, but not recently,” Barouch said. “Most people are not trained or experienced in administering vaccines by the intradermal route.”

Despite challenges, vaccine scientists say dose sparing technique could still pay off

“Currently we have a larger demand for monkeypox vaccine than we have doses of the vaccine. I am confident this is why a dose sparing strategy was authorized,” Dr. Robert Frenck, director of the Vaccine Research Center at Cincinnati Children’s Hospital Medical Center, told ABC News.

Kuhn also agrees with FDA’s decision to allow shallower injections to stretch limited vaccine supply.

“The guidance on the intradermal is supported by earlier trials and is meant to increase availability of the current vaccine stocks,” Kuhn said, but warned that we need to be thinking about opening vaccine eligibility.

“I would prefer that we move now with this attenuated non-replicating vaccine,” he continued. “This is not a gay disease, and my concern is that we should be open to larger segments of the population, independent of sexual orientation, for the application of diagnostics and therapeutics.”

“Now is the time to try to get in front of this outbreak since we have a reasonable history of smallpox vaccination and some data on monkeypox,” he added.

But no one can perfectly predict the future of this outbreak.

“Only time will tell if this was the right decision or not,” Barouch said.

Dr. Jade A Cobern, board-eligible in pediatrics, is a member of the ABC News Medical Unit and a general preventive medicine resident at Johns Hopkins.

ABC News’ Cheyenne Haslett and Sony Salzman contributed to this report.

Copyright © 2022, ABC Audio. All rights reserved.

Monkeypox: What public health experts want you to know

Monkeypox: What public health experts want you to know
Monkeypox: What public health experts want you to know
Jasmin Merdan/Getty Images

(NEW YORK) — Since the first case of monkeypox was detected in the United States in mid-May, the outbreak has led to more than 10,300 reported cases across the country as of Wednesday.

The evolving situation moved the Department of Health and Human Services to declare a public health emergency last week.

Many questions have emerged over the last two-and-a-half months including how the disease spreads, how it’s treated and which vaccines can prevent infection.

Experts spoke to ABC News about the primary methods of transmission, why most patients won’t need treatment and what people can do to protect themselves.

How monkeypox spreads

In the current outbreak, monkeypox has been mostly spreading via skin-to-skin contact with a person with monkeypox or through contact with a patient’s rash, lesions, scabs or body fluids.

Although monkeypox can spread during intimate sexual contact, as many cases have during this outbreak, there is no evidence it is a sexually transmitted disease.

It can also spread through prolonged contact with objects or fabrics — including clothes, bed sheets and towels — touched or used by someone with monkeypox, but this brings a lower risk.

Dr. Gabriela Andujar Vazquez, an infectious disease physician and associate hospital epidemiologist at Tufts Medical Center in Boston, told ABC News a person is much less likely to contract monkeypox by brushing past a positive patient or by using shared public spaces such as a swimming pool, gyms, restrooms or public transit compared with skin-to-skin contact.

“We don’t think shared bathrooms, locker rooms, things that are shared publicly — or even within households — are a major mode of transmission,” she said. “It’s really direct contact with a person who is infectious.”

This is different from a previous monkeypox outbreak in 2003, linked to contact with pet prairie dogs, which were infected after being kept near small mammals from Ghana.

Dr. Jessica Justman, an associate professor of medicine in epidemiology at Columbia Mailman School of Public Health, emphasized this could change.

“I think we all learned with COVID that things can change, particularly in public health when we are dealing with an outbreak and we just need to all be prepared for the information to change and the public health messaging to change as we gain more information,” Justman told ABC News. “And COVID was a brand new virus. At least with monkeypox, it’s not a brand-new virus.”

She added, “But the current outbreak has a number of features to it that are different from prior outbreaks.”

Signs and symptoms

The incubation period from the time a person is exposed to when symptoms first appear can range from three days to 17 days, according to the Centers for Disease Control and Prevention.

The most common symptom is a rash that can appear on the arms, legs, chest or face or on or near the genitals, the health agency said.

Lesions start out as dark spots on the skin before progressing to bumps that fill with fluid and/or pus.

Finally, the lesions will scab over and eventually fall off. People may be left with scars or skin discoloration, but health officials say a person is no longer infectious once the scabs are gone and a fresh layer of skin has formed.

Other symptoms include fever, headache, fatigue, chills, muscle aches, backache and swollen lymph nodes.

What treatments are available

Most monkeypox patients recover within two to four weeks without specific treatments and receive “supportive care” such as Tylenol for fever or topical pain relievers for rashes.

However, some patients at high risk of severe illness, such as those with weakened immune systems, may benefit from treatment.

“We have an antiviral medication we can offer to patients if they need a little more help handling the rash,” Andujar Vasquez said. “But that would be for a subset of patients. Not every patient needs to be on antiviral medication.”

Tecovirimat, known under the brand name TPOXX, is a two-week course of pills approved by the U.S. Food and Drug Administration to treat smallpox.

However, TPOXX was made available to treat monkeypox under “compassionate use” by the CDC after animal studies showed it can lower the risk of death.

Vaccines that can protect against infection

There are two vaccines that can be used to prevent monkeypox.

The only one currently being used is JYNNEOS, which is a two-dose vaccine approved by the FDA to prevent smallpox and monkeypox.

“We would give the vaccine ideally by four days from your exposure, but we think it may be still beneficial to do it if it’s been 14 days after you were exposed,” Andujar Vasquez said.

Data from Africa has shown two doses of JYNNEOS are at least 85% effective in preventing monkeypox infection.

The other vaccine, ACAM2000 — which the U.S. has in a stockpile — is not being used because it has been shown to cause side effects in people with certain conditions, such as those who are immunocompromised.

To increase the number of JYNNEOS doses available, health officials announced Tuesday they would be implementing a new strategy to inject the vaccine intradermally, just below the first layer of skin, rather than subcutaneously, or under all the layers of skin.

This will allow one vial of vaccine to be given out as five separate doses rather than a single dose.

Prevention methods

The experts say for most Americans, the risk for monkeypox is still low. However, they recommend proper hand hygiene and following CDC guidelines for practicing safer sex.

“It’s worth it to pay attention to what’s happening with monkeypox, but I would not worry about shaking hands with people [without monkeypox] or opening doors or touching surfaces,” Justman said.

Copyright © 2022, ABC Audio. All rights reserved.

Harvard doctor on study claiming climate change intensifies pathogens

Harvard doctor on study claiming climate change intensifies pathogens
Harvard doctor on study claiming climate change intensifies pathogens
MR.Cole_Photographer/Getty Images

(NEW YORK) — In a new study published in the journal Nature Climate Change, researchers found that climate change is expected to aggravate 58% of the world’s infectious diseases.

“The societal disruption caused by pathogenic diseases, as clearly revealed by the COVID-19 pandemic,” the authors wrote in the study published Monday, “provides worrisome glimpses into the potential consequences of looming health crises driven by climate change.”

Dr. Aaron Bernstein, director of the Climate MD program at the Center for Climate, Health, and the Global Environment at Harvard University’s Chan School of Public Health, sat down with ABC News’ “Start Here” podcast to discuss the study’s findings, as well as its far-reaching implications.

START HERE: Dr. Bernstein can you just explain to me what this study found? How does climate change relate to something like COVID or monkeypox?

BERNSTEIN: Great question, Brad, and thanks so much for having me. Climate change matters to pretty much every infection you can imagine that we already know about. But it’s also true that it matters to things that we have never yet seen, like COVID-19 prior to 2019. And that’s because we know that diseases that are surprises like COVID, or HIV when it first appeared, because usually a virus moves from an animal into a person.

Well, how does that happen? Well, people obviously have to bump into animals, but also animals bumping into other animals. And what climate change does is it makes everything that can head for the hills or the poles get out of the heat. It’s like a big game of bumper cars. So there’s animals that have never touched each other, running into each other, trying to get out of the heat.

So there’s really two issues here. One is how the more intense heat events, the changes in how rain happens with climate change, affect diseases we know. And then there’s how this bumper car problem might affect new things appearing in ways that we don’t really want to see and have been seeing an unfair share of lately.

START HERE: I’m trying to get a sense of what pathogens this would affect. The study says it will aggravate, I think they said, 58 percent [of the world’s infectious diseases]. Are you saying that more than half of the viruses on Earth are basically going to get worse because of this in the coming years?

BERNSTEIN: They looked at all pathogens, it wasn’t just viruses. I mentioned viruses because they’re the ones that tend to be the ugly surprises, like COVID-19 or HIV. But they looked at bacteria, they looked at fungi. And again, what they wanted to answer was does climate change look like it’s going to be overall worse for the infections we know about or overall better?

There are certainly some diseases, and malaria is a good [example]. Malaria has been in west Africa forever. It’s been there so long that the human genome has evolved to cope with the parasites, in the form of sickle cell disease. Many people will know about sickle cell disease, it’s a disease where your red blood cells, [in] a reaction, look like a sickle.

Well, if you have two copies of that gene that are defective, you get sickle cell disease. But if you have one copy, you’re actually protected from malaria. That’s how much malaria has been in the population of West Africa, it’s been there that long. That’s actually selected for, that gene to protect people from malaria. But it’s going to get so warm in west Africa in this century, we expect that malaria is actually going to decrease in incidence because it’s too hot for the mosquitoes.

So there are some diseases like that where we think that climate change is probably going to make them, at least in local situations, less likely. But on balance, what they found is that the majority of things we know are likely to get worse because it’s going to get wetter. Heavy downpours of rain are a major risk for outbreaks of waterborne diseases, particularly for people who get water from wells, which is almost all of the rural U.S.

In a lot of the rest of the world, heat in particular isn’t just an issue for animals bumping into each other and viruses going over, it affects where things like mosquitoes and ticks that transmit disease live. So here in New England, we have the most prevalent insect-transmitted disease in the country, which is Lyme disease. We’ve definitely seen that disease able to live in places it couldn’t [before] because it’s warm enough for the tick to survive.

START HERE: And there’s a shorter winter to kill the thing.

BERNSTEIN: Exactly.

Copyright © 2022, ABC Audio. All rights reserved.

Hundreds of Americans still dying of COVID each day despite signs the latest surge may be slowing

Hundreds of Americans still dying of COVID each day despite signs the latest surge may be slowing
Hundreds of Americans still dying of COVID each day despite signs the latest surge may be slowing
Carol Yepes/Getty Images

(NEW YORK) — After several weeks of steady increases in coronavirus infections and hospitalizations, there are encouraging signs that the latest viral resurgence may be abating in the United States.

The rate of new infections appears to be dropping, with the U.S. now reporting 107,000 new cases each day — an average that has fallen by 12% in the last week, according to data collected by the Centers for Disease Control and Prevention (CDC).

The number of virus-positive Americans currently receiving care in hospitals across the country has plateaued at around 43,000 patients, according to data from the U.S. Department of Health and Human Services. Throughout the summer, hospital admission rates had been rising in many areas of the country, particularly in the South.

Hospitalizations, however, remain significantly lower now than during every other COVID-19 surge. There were more than 160,000 patients hospitalized with the virus during the surge last winter.

On average, nearly 400 American deaths to COVID-19 are reported each day, a daily total that has not seen any significant declines since the spring.

Over the last seven days alone, the U.S. has reported just under 2,700 COVID-19 deaths.

The latest viral surge has been largely driven by highly infectious variants, which continue to infect and reinfect Americans. It has been more than eight months since the original omicron variant emerged, and although the original strain is no longer circulating in the U.S., its subvariants continue to spread.

BA.5, a subvariant of omicron, is currently estimated to account for more than 87% of new COVID-19 cases in the U.S.

Omicron and its subvariants have been better at chipping away at vaccine efficacy, which has caused health experts to reignite their call for Americans to get vaccinated and boosted.

Last week, Dr. Anthony Fauci, the government’s top infectious disease expert, warned that Americans who are not up to date on their COVID-19 vaccinations may be in “trouble” this fall, with immunity waning over time.

Although the burden of hospitalization and death continues to affect primarily individuals who are still unvaccinated, as well as those at highest risk, such as the elderly or the immunocompromised, other people who “don’t fall into those categories” may also find themselves at-risk for severe disease, Fauci said during an interview with KNXAM.

More than 70 million Americans remain unvaccinated. Less than half of eligible Americans have received their first booster and only about one-third of people 50 years and older, who are eligible for a second booster, have received their supplemental shot.

Fauci stressed that in order to “get your arms around” the pandemic, more people must be vaccinated, domestically and globally, “so you don’t give this virus such ample opportunity to freely circulate, and when you do that, the virus has more of an opportunity to mutate, and when you give it an opportunity to mutate, that’s when you get new variants.”

Copyright © 2022, ABC Audio. All rights reserved.

Monkeypox patient speaks out about what it’s like to have the disease

Monkeypox patient speaks out about what it’s like to have the disease
Monkeypox patient speaks out about what it’s like to have the disease
Courtesy Jeffrey Todd

(NEW YORK) — When the first lesion appeared on Jeffrey Todd’s right cheek in mid-July, the 43-year-old didn’t pay too much attention to it.

“I noticed I had like a pimple or like a blemish on my cheek and it had this very odd-looking raised white circle around the outside of the blemish and it felt indented a little bit like a crater,” Todd, who lives in Hollywood, California, told ABC News.

Being aware of the monkeypox outbreak spreading across the U.S., Todd said he did a Google search of what monkeypox rashes look like and “one of the images looked exactly like my blemish.”

He thought, however, the blemish would disappear by morning.

Over the next two days, Todd developed a series of bumps on the back of his right arm and back and a lesion appeared on his neck. He was itchy and had backaches, fatigue and shooting pain down his legs — all telltale signs of monkeypox.

Being diagnosed

Todd was first tested on July 13 but it took a while to get his results. He didn’t know at the time that the first clinic he visited sent the sample to a lab. The sample though was spoiled by the time it got there so it couldn’t be tested, he said.

As his condition continued to worsen, he went to the emergency room at Cedars-Sinai Medical Center, where staff performed an in-house test. The next day, Todd got his test results back and found out he was positive for monkeypox.

He is one of the more than 8,900 Americans who have tested positive for the disease across 48 states, the District of Columbia and Puerto Rico as of Tuesday, according to the Centers for Disease Control and Prevention.

Last week, the U.S. Department of Health and Human Services declared the outbreak a public health emergency, 78 days after the first case was detected in the country in mid-May.

The outbreak has mostly affected men who identify as gay, bisexual or other men who have sex with men, although the CDC has warned it is not a sexually transmitted disease and anyone is at risk of infection.

Todd, who identifies as gay, said he was contacted by the Los Angeles County Department of Public Health. The nurse assigned to his case believes he contracted monkeypox at an event during Pride weekend in Los Angeles in late June.

“I was at a dance party,” he said. “It was enclosed. It was hot, sweaty. I was shirtless. It was really jam-packed — a lot of physical touching and close proximity to people. So that seems very much like where it probably happened.”

The CDC has said most cases in this outbreak have occurred from skin-to-skin contact or direct contact with a patient’s rash, lesions or body fluids.

The disease can also spread from prolonged contact of objects or fabrics used by a monkeypox patient, but it is a lower risk form of transmission, according to the CDC.

‘Traumatizing’ lesions

There are no treatments specifically for monkeypox. The disease is a cousin of smallpox, so antiviral drugs developed to treat smallpox may be used.

Tecovirimat, known as TPOXX, which is a two-week course of pills, can be considered for people at high risk of severe illness, such as those with weakened immune systems.

Todd said he heard about this treatment from friends of his in New York but it was difficult for him to access it.

After being tested for monkeypox the first time, he asked his physician if he could get on the antiviral medication. He said his physician referred him to an infectious disease specialist.

“He called me immediately and was like, ‘You know, I will try to get you on this medication but it’s a lot of red tape. Only the county is able to prescribe it but I’ll do the paperwork and get this going for you,'” Todd said.

After the county received his positive test from Cedars Sinai, Todd said he was approved for TPOXX two weeks after his symptoms first began.

Although his condition has improved since starting treatment, Todd said his lesions have caused him some pain. In late July, the lesion on his face scabbed over and fell off, leaving behind a small hole.

“My doctor said that the lesion was killing the tissue inside of my face,” he said. “It literally was so traumatizing to me.”

He continued, “I was expecting that to happen … I was excited that the scab was falling off and then part of my face was coming out.”

Todd said his doctor told him that hole will eventually heal but he will be left with a scar.

Raising awareness about monkeypox

Todd has made several videos showing the progress of his condition, including the “gruesome” nature of his lesions, which he has shared to social media platforms such as Instagram and TikTok.

While he says some of the messages have not been kind, he said the overwhelming majority have been positive. He’s also encouraged some of his friends to get vaccinated.

Vaccines are recommended for those who have been exposed to monkeypox and for those who may be more likely to get it.

Data from Africa has shown two doses of vaccination with the smallpox vaccine, JYNNEOS, is at least 85% effective in preventing monkeypox infection.

Todd, who is officially ending his 28-day quarantine on Tuesday, said he wants to raise awareness of what it can be like to have a case of monkeypox.

“Please know that this can happen and I think that’s the dialogue that needs to be out there,” he said. “When I see people don’t take it seriously, they think, ‘Oh, it’s like Chickenpox.’ But no, it’s horrible and now I have a hole in my face.”

He went on, “I don’t want anyone else to go through what I’ve been going through.”

Copyright © 2022, ABC Audio. All rights reserved.

Bug bites begone! Experts break down how to treat itchy skin and stings this summer

Bug bites begone! Experts break down how to treat itchy skin and stings this summer
Bug bites begone! Experts break down how to treat itchy skin and stings this summer
Joao Paulo Burini/Getty Images

(NEW YORK) — It’s time to say “bye-bye” to bug bites.

As summer is still in full effect, so are lots of bugs that are ready to bite or sting exposed skin. Whether you are headed on a nature walk or out for a pool dip, everything from mosquitos and ticks to bees and other insects are ready to pounce.

But there are ways to prevent and treat your skin against some of those pesky stings, itches, bumps or marks left behind.

ABC News’ Good Morning America consulted with board-certified medical and cosmetic dermatologist Dr. DiAnne Davis, as well as board-certified pediatrician and expert on Bug Bite Thing’s medical advisory board Dr. Mona Amin to find out how to prevent and treat bug bites this season.

Are there any key indicators that would let someone know that they have a bug bite versus other skin irritations? How are you able to tell the difference?

Amin: With bug bites, you will usually see a lump or bump of redness and surrounding irritation — this is generally where the insect bit you and a telltale sign. Some people report seeing or feeling an insect bite them and then noticing the rash develop. Others have seen the rash begin as a hive, where the skin surrounding the bite looks red and puffy — our bodies create a histamine response to the irritant, which is the saliva of the insect.

What’s the first thing you should do when you have identified that you have a bug bite?

Davis: I know this is easier said than done, but the first thing you should try to do is not scratch the bug bite. For bites that itch, apply an ice pack or an over-the-counter anti-itch cream, such as hydrocortisone. Another option is to take an over-the-counter oral antihistamine.

To reduce swelling, apply an ice pack to the bite. If it’s a painful bite, take an over-the-counter painkiller, such as acetaminophen or ibuprofen.

What’s a top product you recommend when treating a bug bite and why?

Amin: I recommend using Bug Bite Thing immediately after you notice the bite as it will reduce the itching, stinging and swelling within seconds. The product only uses suction and is chemical-free, making it a safe option for people of all ages, including infants and toddlers.

How do you go about getting rid of the sting, itch or pain associated with any bug bites or stings?

Davis: Topical steroids, which also encompass over-the-counter anti-itch creams, can really help to ease the inflammation that occurs with bug bites and reduces the itching.

What are some best practices to help ease inflammation caused by bug bites?

Amin: The best thing is to minimize scratching as soon as you see the bite. When we scratch our skin, this leads to more inflammation. More inflammation leads to more scratching. It’s what we call the “itch-scratch” cycle. Using a cool compress can also help ease inflammation after a bite.

Are most bug bites treatable at home? When is it necessary to seek professional help?

Davis: If you experience any serious symptoms after a bug bite, such as a rash, fever, body aches, difficulty breathing, chest pain, swollen lips, tongue, and/or face, dizziness, vomiting, or a headache, contact your doctor or a board-certified dermatologist immediately. Make sure you tell the doctor about your recent bite so that they can examine you for a transmitted disease.

Copyright © 2022, ABC Audio. All rights reserved.

Vaccine for Lyme disease enters final stage of clinical trial

Vaccine for Lyme disease enters final stage of clinical trial
Vaccine for Lyme disease enters final stage of clinical trial
rbkomar/Getty Images

(NEW YORK) — Researchers are one step closer to developing a vaccine for Lyme disease, which affects nearly half a million people each year in the United States, according to the U.S. Centers for Disease Control and Prevention.

Pfizer, the maker of a COVID-19 vaccine, announced Monday it is starting a phase 3 clinical trial on its Lyme disease vaccine, known as VLA15.

The study will include over 6,000 participants from 50 locations around the world, including the U.S. Children ages 5 and older will also be included in the study, according to Pfizer.

“With increasing global rates of Lyme disease, providing a new option for people to help protect themselves from the disease is more important than ever,” Annaliesa Anderson, Ph.D., senior vice president and head of vaccine research and development at Pfizer, said in a press release announcing the study. “We hope that the data generated from the Phase 3 study will further support the positive evidence for VLA15 to date, and we are looking forward to collaborating with the research sites across the U.S. and Europe on this important trial.”

Lyme disease, the most common vector-borne disease in the U.S., is a tick-borne infectious disease that, if left untreated, can affect the joints, heart and nervous system, according to the CDC.

There has not been a vaccine for the disease for the past 20 years. The most recent vaccine for the disease, LYMErix, was discontinued in the U.S. in 2002.

“This one is protein-based vaccine technology,” ABC News chief medical correspondent Dr. Jennifer Ashton said of the new Pfizer vaccine. “It’s important to prevent not only short-term signs and symptoms of Lyme disease but long term, so we’re talking about things like short-term fever, headache, fatigue, rash, and then if untreated, it can spread to the joints, heart and central nervous system.”

The vaccine is administered through three shots given over a period of several months, followed by a booster dose 12 months later, according to Pfizer, who is developing the vaccine with Valneva, a French biotech firm.

If the trial moves forward as planned, Pfizer said it expects to submit an authorization request to the U.S. Food and Drug Administration in 2025.

Lyme disease, mainly caused by the bacterium Borrelia burgdorferi, is transmitted to humans via tick bites. In most cases, the tick must be attached to the skin for at least 36 hours before the bacterium can be transmitted.

Symptoms generally appear after one week, with approximately 70% to 80% of people experiencing a classic “bull’s eye” rash which expands in size at the site of the bite.

Symptoms in the acute phase include fever, headache and fatigue. If left untreated, the infection can spread to joints, the heart and the nervous system. People also may experience lingering symptoms that last months or even years, such as muscle and joint pain, cognitive defects and sleep disturbances, according to the CDC.

Once confirmed with laboratory testing, most cases can be treated for a few weeks with antibiotics. According to the Mayo Clinic, Lyme disease should be treated immediately and may require intravenous antibiotics if the case is severe.

Lyme disease is most commonly found in the Northeast and upper Midwest, with 96% of all cases in 14 states — Connecticut, Delaware, Maine, Maryland, Massachusetts, Minnesota, New Hampshire, New Jersey, New York, Pennsylvania, Rhode Island, Vermont, Virginia and Wisconsin, according to the CDC.

The CDC recommends preventive measures to avoid ticks including avoiding “wooded and brushy areas with high grass and leaf litter” and walking in the center of trails.

When hiking or in wooded areas, you can also treat your clothes and gear with products containing 0.5% permethrin, according to the CDC. They also recommend always doing a “tick check” after being outside and wearing insect repellent with Deet.

Ticks can also come into the home through clothing and pets, so the CDC recommends checking pets for ticks and tumble drying clothes on high heat for 10 minutes after coming indoors to kill ticks.

If you are ever in a situation where you are bitten by a tick, the Cleveland Clinic recommends tugging gently but firmly near the head of the tick until it releases its hold on the skin.

People who are outdoors in areas that may have ticks should also conduct a full body check when they return, including checking under the arms, in and around the ears, inside the belly button, behind the knees, in and around the hair, between the legs and around the waist, the CDC recommends.

Copyright © 2022, ABC Audio. All rights reserved.

From patient to doctor: One woman’s resilient fight after six brain surgeries, stroke

From patient to doctor: One woman’s resilient fight after six brain surgeries, stroke
From patient to doctor: One woman’s resilient fight after six brain surgeries, stroke
ABC News

(NEW YORK) — A Texas doctor who survived six brain surgeries and a stroke is now treating people at the same hospital where she used to be a patient, bringing a unique perspective to her practice as a physical medicine and rehabilitation (PM&R) physician.

“You learn so many things in medical school but one of the things you don’t learn is how to be a patient,” Dr. Claudia Martinez told ABC News’ Good Morning America. “What they’re feeling, what they’re thinking, what their families are thinking — and we went through that for so many years, me and my mom, just navigating the medical system from the other side and seeing all the barriers we had to go over.”

“I’m very thankful for that experience and getting to now share what I know with patients and better help them,” she added.

Martinez, 31, is a third-year resident physician at TIRR Memorial Hermann hospital, a teaching hospital for Baylor College of Medicine and University of Texas Health Science Center at Houston. But just a few years ago, she was unable to walk or do many everyday tasks by herself. It was at TIRR where Martinez rebuilt her life and where her doctor, Dr. Lisa Wenzel, both treated her and supported her dream of pursuing medicine.

“[Wenzel] was in charge of my entire rehab stay. She’s a spinal cord injury specialist. She’s been my mentor along the way and my advocate, the one who has helped me get my accommodations for medical school and now residency, and just really given me that hope that I could still be a physician even though she saw me at my lowest point,” Martinez said.

Martinez was diagnosed in 2011 with Chiari malformation, an abnormality where portions of the brain “[extend] through the natural opening at the base of the skull,” creating pressure on the brain, according to the National Institute of Neurological Disorders and Stroke.

Often, surgery is the only option for patients.

“So my first brain surgery was for Chiari malformation and many of the subsequent [surgeries],” Martinez said of her experience. “The last two were for a complication that developed from my previous surgeries where my brain stem got tethered to the dura — it’s a pretty rare occurrence but it was causing a lot of issues in regards to my brainstem, and so the surgeon had to go in there and kind of de-tether that area.”

Overall, Martinez had six brain surgeries in the span of five years with her first surgery in 2012 and her last on Feb. 6, 2017.

“The recoveries from each brain surgery got harder each time,” Martinez recalled. “After my first one, it was pretty OK, but then after that second one, the third, the fourth and fifth, every time it was just more and more difficult to bounce back.”

It was during her sixth brain surgery when Martinez said she suffered a stroke.

“It was a very risky surgery. Going in, the neurosurgeon told us there were many complications that could happen, [saying], ‘Expect these things to happen because of the area that we’re going to manipulate; your brain stem controls your breathing, your heart rate, a lot of your autonomic functions,'” Martinez recalled. “…I ended up with a stroke that left me unable to function from the neck down. And of all the things that really could have happened, it was a success in our eyes, but it definitely changed my life for sure.”

After her stroke, Martinez said she couldn’t walk and was “unable to function from the neck down.” She was transferred to TIRR Memorial Hermann where she underwent intensive physical, speech, and occupational therapies for a year.

“There was a point when I was at TIRR that I was like, ‘I didn’t think that I would make it here.’ But I was very persistent, and I wanted to prove not to other people, but just to myself that I could do this. I worked harder than my classmates because I never wanted my disability or my medical illness to define me or have other people let me kind of slide by with doing less, just because I had a disability or was in the hospital so long,” Martinez said.

Despite her difficulties and the long odds, Martinez didn’t give up. With the support of her family and medical team, she took a year off from medical school to focus on recovery. She then returned to finish her degree program and was matched with TIRR in the spring of 2020 for her residency. Martinez graduated from UTHealth Houston McGovern Medical School that May.

Martinez said her health experiences resulted in at least two unexpected outcomes. The first was the need to shift her initial goal of becoming a surgeon to specializing in PM&R.

“Of all the function I’ve regained, [the function in my] hands is the one that has been the biggest limiting factor, so I kind of see it as a blessing in disguise,” Martinez said. “From there, I got redirected and had to look elsewhere. And when I got to TIRR and saw what they do and how they help after these big life-changing events, I just knew I was meant to be here all along.”

The second unexpected outcome from her medical hurdles was meeting her husband Andrew, after local news outlets in Texas, including ABC affiliate KTRK-TV in Houston, shared her journey. The two bonded over their shared experiences undergoing brain surgeries; Andrew had undergone treatment for glioblastoma, a rare type of tumor that can affect the brain or spinal cord.

Today, Martinez wants others to know that “disabilities don’t define the capability of a person.”

“Never underestimate someone with a disability,” she said. “There’s so much that they can do and they have so much worth to bring to the world. Sometimes we just need to have a little compassion and patience and now that I’m here being a physician, there [are] so many things that I do differently than my colleagues just because I have a disability, but that doesn’t mean that I can’t do the things they do.”

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New monkeypox vaccine strategy underway to increase availability

New monkeypox vaccine strategy underway to increase availability
New monkeypox vaccine strategy underway to increase availability
Chris Kleponis/CNP/Bloomberg via Getty Images, FILE

(WASHINGTON) — The Biden administration is moving forward with a plan to increase the U.S. monkeypox vaccine supply by as much as five times.

In an announcement Tuesday, Health and Human Services Secretary Xavier Becerra said he issued a determination, made possible by the public health emergency declared last week, that will allow the Food and Drug Administration to authorize changing the method of injection for the vaccines.

The new approach would produce up to five more doses from each vial by using an injection method that requires less vaccine per shot.

The vaccine would be injected into the second layer of the skin, just below the first, visible layer. Most routine vaccinations are given as intramuscular or subcutaneous shots, which go deeper.

But health experts said the vaccine given intradermally — just under the skin — could be as effective against monkeypox.

“Today’s action will allow FDA to exercise additional authorities that may increase availability of vaccines to prevent monkeypox while continuing to ensure the vaccine meets high standards for safety, effectiveness and manufacturing quality,” Becerra said in a press release.

In another release, FDA Commissioner Robert Califf said the decision was based on a 2015 study and historical data on the smallpox vaccine, which was once administered intradermally.

The FDA issued an emergency use authorization that allows healthcare providers to move forward with administering the vaccine using the new method. The emergency use authorization also allows children under 18 who are at high-risk of monkeypox to get the vaccine.

“In recent weeks the monkeypox virus has continued to spread at a rate that has made it clear our current vaccine supply will not meet the current demand,” Califf said in a statement.

“The FDA quickly explored other scientifically appropriate options to facilitate access to the vaccine for all impacted individuals. By increasing the number of available doses, more individuals who want to be vaccinated against monkeypox will now have the opportunity to do so,” he said.

Dr. Dan Barouch, the director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center, told ABC News the intradermal method “is very effective because there are a lot of immune cells just under the skin, and often lower doses are needed compared with intramuscular vaccination.”

The same technique is already used in tuberculin skin tests, also called a PPD test. More recently, the influenza vaccine against the H1N1 strain that caused a pandemic in 2009 was tested intradermally in many research studies and was shown to be just as effective at one-fifth the dose of the intramuscular shot.

The announcement comes as many state and local officials have been raising the alarm that there are not currently enough monkeypox vaccines to address the emerging crisis.

Between 1.6 and 1.7 million Americans are currently eligible for a vaccine, according to estimates by the Centers for Disease Control and Prevention.

But the U.S. only has enough vaccines to reach around one-third of those people over the next two months, under the current method that doesn’t allow doses to be stretched.

The U.S. has secured a total of 6.9 million doses for an expected delivery of May of 2023, according to Health and Human Services, but to date, 1.1 million of those vaccines have been made available to states for ordering — and because the doses are currently authorized as two-shot regimens, that total only covers about 550,000 people.

This authorization, however, could mean that far more people can be vaccinated with those doses.

It’s part of a heightened approach rolled out by the recent declaration of a public health emergency over the monkeypox outbreak, which Health and Human Services Sec. Xavier Becerra announced last week following widespread calls from health officials and activists across the country.

Globally, more than 30,000 cases of monkeypox have now been reported, including nearly 9,000 cases in the U.S. — the most of any country. All but one U.S. state — Wyoming — has now confirmed at least one positive monkeypox case.

The majority of cases in the current monkeypox outbreak have been detected in gay, bisexual or other men who have sex with men. However, health officials have repeatedly stressed that anyone can contract the virus and there is currently no evidence it is a sexually transmitted disease.

Copyright © 2022, ABC Audio. All rights reserved.

Monkeypox and your skin: How to prevent and treat post-infection scarring

Monkeypox and your skin: How to prevent and treat post-infection scarring
Monkeypox and your skin: How to prevent and treat post-infection scarring
Yuki Iwamura/AFP via Getty Images

(NEW YORK) — Last week monkeypox was declared a public health emergency in the U.S. and now with more than 8,900 confirmed cases of monkeypox, thousands of Americans are struggling with a defining feature of the condition, skin lesions.

The classic skin lesions of monkeypox start with a pimple-like lesion that can look like pus-filled bumps (pustules) with redness around them. After that, the rash goes through phases, including pustules progressing to blisters that eventually scab over.

Unfortunately, the skin lesions can leave an unwanted lasting change on the skin.

Dermatologists say monkeypox lesions should be covered in their active phase, as skin lesions are contagious until the rash has fully healed. The Centers for Disease Control and Prevention said lesions are no longer contagious when the scabs have fallen off and a fresh layer of skin has formed.

Monkeypox lesions inevitably will scab over — and while that is a step in the right direction in terms of the infection, the sores underneath can scar.

What can monkeypox scarring look like?

Once healed, monkeypox lesions can sometimes result in scarring and discoloration, which may be long-lasting or even permanent.

“In some cases, patients may develop depressed or atrophic scars that may resemble those seen following chickenpox infection or with severe acne,” Dr. Trisha Dasgupta, a board-certified dermatologist at Dermatology of Philadelphia, told ABC News.

Monkeypox lesions may also heal with either dark discoloration or lightening of skin color.

“These scars can have varying appearances as well as degrees of severity,” Dasgupta said.

Experts said lesions on the face, while concerning, often heal better than lesions on other parts of the body.

Dermatologists caution that some patients develop scars that can be firm, itchy, and even painful.

How can you minimize monkeypox scarring?

One of the best ways to manage a scar is to prevent a scar with good wound care during the healing process.

“The best way to prevent scarring is to take good care of your skin. Nowadays, we believe healing under moist conditions is better than just letting a scab dry out and become hard,” Dr. Christine Ko, professor of dermatology at Yale University, told ABC News.

Experts describe wound healing as a cascade of events. Scientists who study wound healing at a cellular level describe skin cells that leapfrog over each other in a wound bed — and the skin cells have a much easier time doing this if the wound bed is moist compared to a dry, open wound.

Though scarring from healed monkeypox lesions may not be entirely preventable, there are steps you can take to decrease the risk of scarring, including gentle skin care.

Dermatologists said while the spots can be itchy and irritated, it is important to avoid picking, scratching, or scrubbing monkeypox lesions.

“Consider using a gentle, fragrance-free, dye-free soap or cleanser to avoid any additional irritation when cleansing the area daily,” Dr. Shoshana Grossman, a board-certified dermatologist at Dermatology of Philadelphia, told ABC News.

Sun protection:

“Sun protection is one of the simplest and most effective ways to maximize the appearance of scars after monkeypox lesions have healed,” Grossman said.

Dermatologists recommend a broad-spectrum sunscreen with an SPF of at least 30 to lower the chance of darkening of the skin.

“Sun protection can be important to minimize scarring, especially in patients who have darker skin tones because scars can become quite dark in those patients and using some sun protection might help prevent that,” Ko said.

Topical Treatments:

For fully healed areas, using chemical exfoliants such as alpha-hydroxy acids and topical retinoids can be helpful to lower the chance of some types of scarring by increasing skin cell turnover and by stimulating the growth of healthy collagen.

“The limiting factor with these treatments is tolerability in terms of dryness or irritation; they should not be used on active lesions. The key with using these topical treatments is to start slowly — only a couple of times a week to start, building up gradually to nightly use,” Grossman said.

How to avoid complications that can increase chance of monkeypox scarring

Monkeypox infections are caused by a virus. Sometimes as these viral lesions heal, other infections, including bacterial infections, can arise on top of the original viral infection.

“Preventing a superimposed bacterial infection in areas of existing or healing monkeypox is also crucial in preventing scarring. A good way to prevent a bacterial infection is by introducing an anti-bacterial wash into your shower routine a few times per week.” Grossman said.

Monkeypox scars that are bothersome or symptomatic can be treated with a variety of approaches, including:

Time: Most scars improve on their own with time, especially with good sun protection. It can take six to 12 months for full scar maturation. This is especially true for hyperpigmented scars, which can take many months to fade.

“Ideally, a scar will look closer to the normal skin color around it within four to five weeks, but it can sometimes take longer for scars to remodel and settle, even up to a year,” Ko said.

Silicone containing scar gels: Medical-grade silicone scar gels and sheets may be a good option for scars that are thick or at risk of becoming thick.

“Silicone-based products can create a protective barrier over scars which increases hydration and helps stop excess collagen build up in the skin,” Dasgupta said.

Steroid injections: For thicker, hypertrophic scars or keloids, a steroid medication can be directly injected into the problem areas.

“The goal of the steroid is to calm down any residual inflammation and flatten any raised areas. While systemic steroids such as pills, intravenous or intramuscular injections can have unwanted internal side effects, intralesional steroids remain localized to the skin and are very well tolerated,” Grossman said.

Surgical procedures: Surgically removing a bothersome scar may be the most effective method of treating a scar.

Scars in the skin are sometimes caused by strands of collagen under the skin pulling down on the surface of the skin — often described as stakes of a tent pulling down on the skin. A specific type of minimally invasive procedure called a subcision can help break apart these band-like scars to allow for a smoother appearance on the skin’s surface.

Microneedling is another minimally-invasive procedure in which many tiny needles are used to puncture the affected skin.

“These controlled micro-injuries to the skin help to encourage tissue remodeling by mimicking the skin’s natural healing process,” Grossman said.

Lasers: Depending on the location of the scar and skin type of the patient, lasers can be used to help improve the appearance of scars that are white or lighter in appearance than the surrounding skin. Lasers have to be carefully used in darker skin types and fractionated lasers are a specific laser approach that decreases downtime after lasers and can be safer in patients with darker skin tones.

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