Vaccines For Teens: Answers About The Pfizer COVID-19 Vaccine For The 12 to 15 Set

A Centers for Disease Control and Prevention panel has recommended the Pfizer COVID-19 vaccine for use in children as young as 12. The decision follows the Food and Drug Administration’s extension of the vaccine’s emergency use authorization for children 12 to 15 years old on May 10.

West Virginia announced the state will be offering the vaccine to this group of young Appalachians shortly after the recommendation.

The Ohio Valley ReSource asked Vince Venditto, an expert in vaccine design, about the Pfizer study data collected in participants ages 12 to 15. Venditto previously responded to listener questions about the safety and efficacy of the Pfizer and Moderna vaccines.

ReSource: The FDA press release said that (the Pfizer vaccine) shouldn’t be given to anyone with a known history of severe allergic reaction, including anaphylaxis. Has that changed?

Venditto: It’s really out of an abundance of caution. There are other options. So the allergic response to the Moderna and Pfizer vaccines — we think it’s due to a response to a specific component of the vaccine. So because the Johnson & Johnson vaccine is also available, people who have the anaphylactic response to Pfizer and Moderna would very likely not have the allergic response to Johnson and Johnson. I think it’s really out of an abundance of caution to make sure there’s not that risk there. I’m not aware of a change in the standards based on the FDA and the CDC.

ReSource: In this latest trial of kids 12 to 15, were there any other risks associated with getting the vaccine?

Venditto: No. They are reporting about the same reactogenicity, so the same response that you get when you feel a little achy after the vaccine. So in children ages 12-15, they are reporting about the same response that way. They have a slightly better antibody response, so their immune system looks a little bit stronger compared to the 16 to 25 year-olds, but not really any major difference. And otherwise safe. Now this was only done in about a little more than 2,000 individuals and about 1,100 individuals got the vaccine. It’s smaller than the large-scale study that was done for the initial approval that had 40,000 people in it. So it is smaller, but everything looks like it’s working about the same in the 12 to 15 year-olds as it is in the older population.

ReSource: This study seems small. But obviously it was large enough for the FDA to extend that emergency (use) authorization. Do you know why the study was this size?

Venditto: It has to do with the number of adults in the original study. And then based on the same safety profile, you’re basically running a smaller study just to determine if there’s anything coming up that is unexpected in a younger population. And you should see that in a thousand subjects, if something came up. But you know we have this safety profile in however many millions of adults that have received the vaccine — minus a few examples of anaphylaxis as the most common, rare side effect. The fact that we didn’t see anything in any of the children, it’s really just a continuation. There’s no reason to expect there to be any difference. But they are continuing to monitor the children long term, and so as they monitor the children long term, they’ll be able to still continue to assess safety just like they are in the adults as well.

ReSource: And how long will they follow the children long term?

Venditto: They are following them for an additional two years after their second dose.

ReSource: The FDA release said the vaccine was 100% percent effective in preventing COVID-19. Does that mean the vaccine is more effective in children than it is in adults?

Venditto: That’s a really difficult comparison to make. With the different size of the study, you’re comparing the 20,000 people who got the vaccine in the adult study compared to the 1,100 or so in this one. In the whole trial, which had 2,260 subjects, there were 18 cases of COVID-19. All of them were in the placebo group. And so that’s where this hundred percent comes from. Now, if you expand this number to 40,000, it’s very likely you’re going to have some number of cases in the vaccinated group. The only way to actually compare those is to do an equally sized trial. And so I suspect that after this is approved and after they start administering this to children on a large scale, we will probably see more information about the number of people who are vaccinated who are also getting infected.

ReSource: The CDC also says that in general vaccine breakthrough cases are expected, and no vaccines are 100% effective at preventing illness. So should we expect breakthrough cases in the 12-15 year old age group?

Venditto: We should expect them the same way that we expect them in the adult population. I don’t think that there’s anything different about the 12 to 15 year olds. There’s nothing that I would anticipate that would say there was a difference. Just like in adults who have been vaccinated, some adults have been infected, and I think we should just be expecting the same thing to happen in children.

ReSource: Do we know anything yet about the study in children under the age of 12.

Venditto: I’m not aware of any data yet. I know that those studies are ongoing from both Pfizer and Moderna — they both have studies in younger children.

The Pfizer COVID-19 vaccine study in children younger than 12 is ongoing. To find Pfizer vaccine, visit vaccine.gov.

This conversation has been shortened and edited for clarity.

Biden Administration Releases Drug Control Policy Priorities After Deadliest Year For Overdoses

The Biden administration released its first set of drug policy priorities Thursday after overdose deaths hit record numbers during the pandemic. Office of National Drug Control Policy Acting Director Regina LaBelle discussed the office’s seven priorities, beginning with expanding access to drug treatment services.

“We’ll do this by expanding access to quality treatment and medications for opioid use disorder,” LaBelle said. “This includes removing unnecessary barriers to buprenorphine prescribing and contingency management interventions, modernizing our methadone treatment, expanding access to evidence based treatment options for people who are incarcerated.”

The American Rescue Plan Act set aside $4 billion to broaden access to behavioral services under the Substance Abuse and Mental Health Services Administration and the Health Resources and Services Administration.

Another top priority includes addressing racial inequities within addiction treatment.

“So this includes developing a drug budget that reflects the needs of diverse communities, developing priorities for criminal justice reform and identifying culturally appropriate evidence based practices for Black, Indigenous and People of Color across the continuum of care,” LaBelle said. “And that continuum of care includes prevention, harm reduction, treatment and recovery services.”

From August 2019 to August 2020, more than 88,000 people died from drug overdoses, according to provisional data from the Centers for Disease Control and Prevention. West Virginia and Kentucky both reported more overdose deaths than the national average. The Ohio Valley has long been the epicenter of the addiction crisis, and the isolation and stress of the pandemic appears to have worsened the overdose death rates. The overdose death rate increased 43% year-over-year in Kentucky, by 38% in West Virginia, and by 21% in Ohio. In the three states combined, 8,126 people died of overdoses from 2019 to 2020.

Disability Rights Advocates Question Kentucky Policy On COVID Vaccines

Nathan French signed up for a COVID-19 vaccination and is waiting for an appointment. The 22-year-old Transylvania University senior has had COVID-19 twice.

“The first time it was asymptomatic, and I was thankful,” French said. “But the second time, I was stricken with lung issues, and it felt like my heart rate was faster than normal. I was horrified for my safety because I just didn’t know what was going to happen to me.”

French has a developmental disability, a form of the neuromuscular disease called Charcot-Marie-Tooth disease, which affects his diaphragm and his nerves. French also has a heart condition.

The second coronavirus infection made French feel like he couldn’t breathe, and it landed him in the hospital for a day where he said he didn’t feel like his treatment was a priority.

“They were more concerned with dealing with people who aren’t disabled, so I felt like I was being neglected and not important as a person,” French said.

Courtesy Nathan French
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Kentucky college student Nathan French is unsure if he is eligible for a COVID vaccine.

French said he doesn’t know if he is currently eligible for a vaccine in Kentucky, but hopes to get one soon. Despite appeals from disability advocates, and studies showing that people with intellectual and developmental disabilities are at an increased risk of dying from COVID-19, Kentucky’s plan for prioritizing vaccinations did not clearly include disabilities in the early phases.

Because French has a developmental disability, he would have already qualified for a vaccination if he lived in some other nearby states, such as Ohio and West Virginia, which prioritize people with disabilities.

Kentucky’s vaccination plans have prioritized medical conditions that are considered “high risk” for severe COVID-19 by the Centers for Disease Control and Prevention. Down Syndrome is listed as a qualifying condition for phase 1C of vaccinations, a broad category which recently got underway in the state, but that is the only such disability on the state’s list, according to disability advocates.

During a press conference March 16, Kentucky Gov. Andy Beshear responded to a question on the issue from the Ohio Valley ReSource and said that the commonwealth’s vaccination plans closely follow the CDC’s guidelines.

“And so the reason it’s not included in Kentucky is it’s not in the CDC prioritizations, but with that said, we should consider it,” Beshear said.

Questioned again on the subject on March 18, Beshear still did not have a firm answer.

“There was even an internal disagreement with whether these individuals are in 1C,” Beshear said. “They certainly need to be prioritized and we’ll be providing clarity on that shortly.”

Crystal Staley, communications director for the governor’s office, said later that night in an email, “yes people with intellectual and developmental disabilities are in 1C.”

However, by the end of the week, even advocates who track the issue closely were left uncertain about just what the state’s policy is for people with intellectual and developmental disabilities, or IDD.

“Those with IDD and their family members don’t know they’re in 1C if, in fact, they are,” Kentucky Protection and Advocacy Legal Director Heidi Schissler said in an email. “It definitely needs to be clarified and the website needs to be updated to clearly explain it, especially now that supply is greatly increasing.”

A Push For Change

In 2017, an estimated 101,535 people with intellectual and developmental disabilities received services in Kentucky. Kentucky Protection and Advocacy is a federally mandated, independent state agency that works to protect the rights of people with disabilities.

The group sent a letter to Gov. Beshear in December requesting priority status for vaccinations for those with IDD. Legal Director Schissler said some concerns have been addressed. For example, people with disabilities who live in congregate housing were prioritized in the state’s first vaccine phase, which also focused on long-term care centers. In early February, the agency met with the Cabinet for Health and Family Services over Zoom.

“They said, you know, ‘We’re still listening. We’ll get back with you,’” Schissler said. Since then the agency sent another letter and drew attention to a recent study published in the New England Journal of Medicine that found that people with intellectual and developmental disabilities were more likely to become infected and were nearly six times more likely to die from COVID-19 compared to the general population.

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People waiting at the UK HealthCare vaccination site at Kroger field after being vaccinated.

Schissler said she thought that data would get the state’s attention.

“We thought that (study) was truly a game changer — that that was going to make Kentucky officials and the CDC wake up,” she said.

“Devastating Impact”

On March 5, the New England Journal of Medicine published a commentary with a blunt warning about the “devastating impact” COVID-19 was having on people with IDD. The study found that people with intellectual disabilities “are at substantially increased risk of dying from Covid-19.”

One of the study’s authors, Dr. Wendy Ross, is a developmental and behavioral pediatrician who directs the Center for Autism & Neurodiversity at Jefferson Health in Philadelphia. Since the study’s publication, she said about six states have changed vaccine plans to include intellectual disabilities.

“I think the big differentiator about this study that made it so impactful is that it wasn’t saying that intellectual disability is one of many things that can make you more likely to get COVID and die from COVID,” Ross said. “It said it is literally the top independent risk factor for getting COVID. And second, only to age for dying from COVID.”

The CDC’s vaccination guidelines for people with disabilities state that “disability alone does not put you at higher risk for getting COVID-19.” The agency updates the list of medical conditions regularly, but has not added intellectual or developmental disabilities.

Ross said the data from the study was presented to the CDC.

“They did not question the quality of our data, but they did not change the recommendations, and I honestly cannot explain that,” she said.

Challenges Elsewhere

Ohio listed intellectual and developmental disabilities in phase 1B of its vaccine plan that was slated for distribution on Jan. 25. For people who also have certain medical conditions, county developmental disability boards are in charge of helping them to coordinate a vaccine. People with IDD who do not use county board services should reach out to those boards to plan to get their vaccine.

“Ohio’s decision to vaccinate those with developmental or intellectual disabilities and certain medical conditions was based on the potential severe outcomes these individuals could face if infected with COVID-19, in line with Ohio’s goal to save lives,” Alicia Shoults with the Ohio Department of Health said in an email.

Shoults added that local health departments are vaccinating people who aren’t able to leave their homes.

West Virginia’s vaccine plan lists intellectual and developmental disabilities and care takers in phase 2-A. The state expanded eligibility in phase 2A on March 15.

Anne McDaniel, executive director of the West Virginia Statewide Independent Living Council, said advocates and disability groups have been pushing to make people with disabilities a higher priority within the state’s plans.

“People with disabilities (were) included in phase 2-A all along, but we’ve been in phase one, since vaccination started until just the last week or so,” she said.

McDaniel said it was especially important to focus on people with disabilities living in group settings.

“Because the whole phase structure started with people in nursing homes, people in assisted living, people in prisons,” McDaniel said. “But people with disabilities who are living in group homes, larger group homes, other congregate settings, were not included in that.”

McDaniel said the groups’ continual push for the inclusion of people with disabilities “may have sped up that move to phase two a little bit.”

To ensure people have access to vaccines, ongoing efforts have focused on vaccine registration and pop-up clinics have been set up to reach people who cannot get to vaccination sites.

McDaniel said strategies to have nurses vaccinate people in their homes and in congregate settings are also underway.

“The new vaccine from Johnson & Johnson, I think, is really going to help with that,” she said. ”You don’t have that time frame, from the time it’s thawed, until the time it has to go into an arm,” she said.

Still, identifying people who can’t leave their homes or don’t have access to transportation to reach a vaccine clinic has been a challenge in West Virginia.

Maj. Gen. James A. Hoyer, the Adjutant General of West Virginia, said there isn’t a single way to identify someone who can’t get to a vaccine clinic. Health departments, regional clinics and programs that focus on vaccinating people with disabilities have helped identify about 2,400 individuals so far.

But Hoyer said he’s not sure how many of those 2,400 have been vaccinated in their homes or at health departments.

“It’s probably not something that we have tracked,” Hoyer said.

Hoyer said university health and science programs and pharmacy programs have volunteered to administer shots. “The other group that’s been really exceptionally good is the independent pharmacy folks, because, you know, in some of these small rural communities, it’s not uncommon for pharmacists to go still make a house call for a vaccine.”

A New Advocate

When Nathan French learned that people with IDD weren’t listed as eligible for vaccines in Kentucky, he said he was disappointed.

“I have learned to expect to be disappointed,” he said.

But French wants things to change. He plans to become an advocate for people with disabilities.

“I hope that later in my life I can go into politics to represent people with disabilities and make changes at the state and national scale.”

June Leffler, West Virginia Public Broadcasting’s Appalachian Health News reporter, contributed to this story.

The Ohio Valley ReSource gets support from the Corporation for Public Broadcasting and our partner stations.

Addiction In The Pandemic: The $350M Effort To Heal Communities In Opioid Crisis

The Madison County health department in Kentucky has kept its harm reduction program open throughout the COVID-19 pandemic to continue its work against the other epidemic afflicting the region: the addiction crisis. Through the program, people can exchange needles, receive referrals for addiction treatment services, and get training to use the overdose-reversal drug Narcan.

Laura Nagle, a risk reduction specialist at the department, said they use a van to provide training and doses of Narcan in area communities such as Richmond.

“The mobile unit is a part of Madison County’s harm reduction team, but [the University of Kentucky] provides the Narcan. So we actually couldn’t do this outreach if it weren’t for the HEALling Communities project,” Nagle said.

Abbygail Broughton
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Ohio Valley ReSource
Anyone can request doses of Narcan and receive training from the Madison Co. Health Department’s Narcan mobile unit.

In 2019, the University of Kentucky was awarded the largest grant in its history — $87 million — to reduce opioid overdose deaths. Kentucky is one of four states chosen for the National Institutes of Health’s HEALing Communities Study. HEAL stands for Helping to End Addiction Long-term and communities in Massachusetts, New York and Ohio are also involved.

Although more overdose deaths have occurred during the pandemic compared to any previous year, across the Ohio Valley doctors and health workers have said the numbers of people seeking treatment have grown. Treatment practices like distributing overdose reversal drugs aren’t new. But the scale of efforts have increased and so has the focus on needs at the local level. The pandemic has also prompted new approaches to addiction treatment.

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Big Money, Big Goal

Overall, the HEALing Community Study’s goal is to reduce opioid overdose deaths by 40%. It will look at how evidence-based recovery, treatment and prevention practices work within mental health, primary care, addiction treatment clinics, county health departments and other settings within each community. Sixteen Kentucky counties, a mix of rural and urban, are divided into two waves of the study.

Sharon Walsh is a professor of behavioral science, pharmacology and pharmaceutical sciences and the principal investigator of the UK study. Walsh also directs UK’s Center on Drug and Alcohol Research. Walsh said meetings between researchers and community coalitions were just set to begin last year in order for communities to put treatment and prevention plans in place. That was March 2020. Then the first pandemic shutdown orders were issued.

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Sharon Walsh, principal investigator of the HEALing Communities Study at the University of Kentucky.

But that led to an unexpected benefit — meetings shifted online — which sped things up, Walsh said. More than 500 meetings took place from March to November of 2020.

“In retrospect, if we really thought that we could have done all that in person, we would have been buying campers and sleeping on the side of the road; we would have never been able to achieve so much without having gone virtually,” Walsh said.

Plans to implement addiction treatment vary between communities participating in the study.

“But what they have in common is that they all include evidence-based practices around our three critical elements of preventing opioid overdose deaths,” she said. The plans include ways to expand naloxone distribution and overdose education, make treatment programs more accessible and improve opioid prescribing practices.

Last spring, the pandemic pushed Ohio and Kentucky study participants to fast-track the distribution of the opioid overdose reversal drug naloxone. Walsh said the effort was “to make sure we could get naloxone into people’s hands, who were leaving jails, who are coming to the syringe service programs, who were coming to treatment programs, so that they would have that life saving medication.”

By November 2020, Walsh said, approximately 12,000 doses had been distributed to communities in wave one.

Some counties didn’t have any drug disposal dropboxes — sites where unused or unwanted prescription opioids can be dumped. So Walsh said community and partner agencies installed drug disposal kiosks in pharmacies. That’s one way the study is working within communities.

“We’re having meetings with all of our treatment partners to figure out what it would require of them in order to, for example, be able to treat another 50 people,” Walsh said. “What is it that they need? What are the barriers to doing that?”

Thinking Flexibly

The Ohio State University received $65.9 million to lead Ohio’s HEALing Communities Study. Dr. Rebecca Jackson, the study’s principal investigator, said they’ve used mail to make naloxone more widely available.

To provide information about opioid education and naloxone distribution, Jackson said the team looked at different ways to reach the public. In Athens County, in the southeast of the state, broadband internet is not widely available. So they looked at the heavily traveled thoroughfares instead.

“And so they made a decision to use some of their communication funds and work through that and to use billboards because they could get that message out because, in fact, that was where they knew that the largest number of people would actually see that.”

In addition to the HEALing Communities Study, last August, Ohio received $96 million in State Opioid Response grants from the U.S. Department of Health and Human Services. Of that funding, $58.8 million was granted directly to county Alcohol, Drug Addiction and Mental Health Services boards throughout the state.

Susan Shultz, executive director of ADAMH board of Adams, Lawrence and Scioto counties in southern Ohio, said the $2,051,788 million allows the board to contract with local behavioral health providers that treat substance use disorders.

Four agencies will receive the latest round of funding to provide a range of services: substance use disorder outpatient treatment services; an opioid response team that shows up in the emergency department to offer treatment for anyone treated for an overdose; peer support ; and a vocational training program.

“They have an electrical program, they have plumbing, they have the barge, deckhand program, and they’re going to be adding some new vocational programs to that,” Shultz said. “So that’s a really great thing to get the people certified to be able to then get work once they graduate programs.”

In West Virginia, the state widely distributed Naloxone and organized free rides for people in treatment last summer.

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Ohio Valley ReSource

Federal Changes

When someone decides to get medicated assisted treatment for opioid addiction, usually the first step involves visiting a doctor’s office to be prescribed a medication such as buprenorphine that stabilizes them.

Courtesy FUSIONPHOTOPRO
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Addiction medicine specialist Dr. Kelly Clark.

Dr. Kelly Clark, an addiction medicine specialist and psychiatrist in Kentucky, said that in-person evaluation by a doctor is required to start treatment, but the pandemic has forced some changes.

“There is a temporary relaxation by the federal government of these requirements during the COVID emergency,” Clark said. “So now, if you’re looking for treatment, which the core piece of opioid addiction treatment is medicine, you can call, do audio visual and start medication with buprenorphine using telemedicine.”

Although buprenorphine appointments may be conducted online, methadone intake appointments must still occur in person, Clark said. But the newest rules give doctors the option to let patients have more take-home doses of the medication to reduce the number of in-person appointments.

“The doctors are allowed to say that if patients are stable enough, they can more rapidly get more take-home, Clark said. “So instead of coming every day, for months and months, they might come every week or every two weeks.”

Being able to check in with a doctor or therapist online has also prevented patients who don’t have transportation from missing appointments. But the availability and affordability of the internet is an issue for much of the Ohio Valley.

“We’ve heard stories of people who literally set up their own or patients and communities — literally setting up their own hotspots in fields, in parking lots, so that people can come together and utilize that in order to make the connections to counselors and their prescribers of medication,” Clark said.

Shultz said the reach of telemedicine has helped in Ohio, too.

“Telehealth services have been probably a godsend for our areas. So they’re able to do a lot of their treatment online,” Shultz said.

Dr. Redonna Chandler, with the National Institutes on Drug Abuse, directs the HEALing Communities Study. She said isolation has been a substantial issue since the beginning of the pandemic.

“We were hearing about isolation and relapse of individuals that had not been using drugs, as well as the fact that people who were using drugs, were using in isolation alone in many instances,” Chandler said. “And so we also started to see, as the months went forward in the spring, an increase in overdose events and overdose fatalities.”

A change to telemedicine policy could remedy challenges like isolation and transportation.

“And there is a big push to try to make this something that is permanent,” Clark said. “The genie’s out of the bottle with telemedicine during this pandemic.”

As the HEALing Communities Study continues, ultimately treatment models may serve as blueprints that can be tailored to fit community needs across the country.

“What the study is doing is putting the power in the community to be able to figure out their unique assets, gaps, issues, to address the problem themselves, as opposed to coming in with something and saying, well, this is what you need to do and this is how you need to do it.” Chandler said.

This is the final story in a series about the resurgence of the addiction crisis during the coronavirus pandemic.

If you are struggling with addiction, the Substance Abuse and Mental Health Services helpline operates year round. 1-800-662-HELP (4357) Narcotics Anonymous hosts online meetings year round.

The Ohio Valley ReSource gets support from the Corporation for Public Broadcasting and our partner stations.

Addiction In The Pandemic: An Interview With White House Leader On Drug Control Policy

When the Centers for Disease Control and Prevention released drug overdose death data last December, it warned about the impacts the ongoing pandemic has had on the addiction crisis.

“The disruption to daily life due to the COVID-19 pandemic has hit those with substance use disorder hard,” CDC Director Dr. Robert Redfield said in a statement. “As we continue the fight to end this pandemic, it’s important to not lose sight of different groups being affected in other ways. We need to take care of people suffering from unintended consequences.”

Only four states in the U.S. saw a decline in overdose deaths. Deaths increased in the remaining states. The rate of overdose deaths in Kentucky increased by 27% and in West Virginia by 31.7% — both were higher than the national increase of 21%.

In a series of stories about the addiction crisis during the pandemic, the Ohio Valley ReSource spoke to Acting Director of the White House Office of National Drug Control Policy Regina LaBelle. ONDCP develops and oversees the administration’s National Drug Control Strategy and budget.

Addiction In The Pandemic: Staying In Treatment While Staying COVID Safe
Regina LaBelle was featured in the second part of an Ohio Valley Resource series on addiction in the pandemic.

LaBelle answered questions about barriers to addiction treatment, temporary policy changes during the pandemic, and what actions need to be taken to address overdose deaths.

OVR: The opioid epidemic was declared a public health emergency by the Trump administration. Yet the latest CDC overdose death data published in December showed that over 81,000 people died, making it the highest number of overdose deaths ever recorded in a 12-month period. What immediate action is necessary to address drug overdose deaths?

LaBelle: So I think one of the most important steps we need to take is to recognize that our addiction overdose death problem didn’t happen overnight. And it’s not going to get fixed overnight. We have to develop a treatment infrastructure around this country that makes sure that we can get people the treatment they need, the services they need, when they need it. And we’re just not there yet. I mean, there are 20 million people in this country who have some form of substance use disorder, and only about 11% of people get treatment. So we have this huge gap between where we want to be and where we are today. We have to have a long-term plan to address that huge treatment gap, and also to prevent substance use from ever occurring. And that’s not just not something we can do overnight. I started at ONDCP in 2009, when we were pretty much in the beginning of this opioid epidemic, what was then an opioid overdose epidemic, which has evolved over time. We’re in a better place than we were then. But we still have a long way to go.

OVR: Why do you think that we are in a better place now?

LaBelle: So I think we’re in a better place because number one I think there’s a general acceptance about the types of treatment that work to prevent overdoses, the types of treatment that helped people. We’re much further along in terms of our support and recognition of the importance of recovery— that addiction treatment is not something you go in for 20 days and you come out and you’re transformed. Certainly you’re transformed, but you need support, ongoing support, and it is not ‘one-size-fits-all.’ We have to have cultural competence in our approach to addiction treatment. We have to recognize that people come to addiction treatment with all sorts of other needs — child care, they may have co-occurring conditions. So these are not simple solutions. But we have a lot more money than we did before. And again a greater recognition of the importance of long-term, ongoing recovery support.

OVR: Kentucky, Ohio and West Virginia have rapidly distributed Naloxone during the pandemic. Is that a solution that could immediately help with overdose deaths?

LaBelle: Yeah, getting Naloxone in the hands of at-risk people is very important. And as I said, when we were here when I was here in the office last time, one of our first steps was to get it in the hands of first responders. And we did that because of overdoses. It was primarily in rural areas, and first responders were the first on the scene. And that is often the case, but not always the case. So we need to make sure that Naloxone is readily distributed. Laws have changed around the country to make sure that people can be co-prescribed Naloxone if they’re on high doses of opioids — that it’s available, readily available, without a prescription in a community pharmacy. Drug free community Coalitions often work with local groups to make sure it’s distributed to at-risk groups. So yes, that’s another issue that we have to take on.

OVR: West Virginia was granted federal funding for efforts to combat the opioid crisis and is running deviated bus routes to take people to and from treatment. How will the office address some of the biggest barriers to treatment that have been made worse by the pandemic?

LaBelle: So a really great thing that happened last year, at the beginning of the pandemic was that ONDCP, HHS (U.S. Department of Health and Human Services), DEA (Drug Enforcement Administration) looked at some of the biggest barriers, regulatory barriers, to access to treatment. And those were revised during the public health emergency around the opioid response. Many of those revisions have allowed people access to treatment during this pandemic during times of social distancing. And so, we’ll be looking at which of those, with the interagency, which of those changes should be made permanent. So that we can make sure that, what you’re talking about, you know, that it’s difficult to get transportation to treatment, much of that will be eliminated. Now, I also failed to mention the importance of telehealth. And that is obviously really important in rural areas as well, to get people access to treatment. I’ve spoken with physicians, addiction treatment providers in Tennessee who said that the ability to do telehealth has been kind of a game changer for their ability to connect with their patients. And it’s really helped to retain people in treatment during this very uncertain time.

OVR: Will the temporary telehealth policy become permanent so doctors can continue addiction treatment in that way?

LaBelle: So I think that’s definitely something to look at. One of our preliminary questions is, is it a regulatory change? Do you have to go through the rulemaking process? Is it an administrative change, or does it take legislation? So those are some of the fundamental questions we have to answer initially. However, I know that as of the last congressional session, I’m not sure if it was reintroduced. Senator [Rob] Portman from Ohio had legislation that was introduced that would make some of those telehealth provisions permanent. So, we’ll make sure to stay on top of that in this new congressional year.

OVR: Just so I’m clear, what can the Office of National Drug Control Policy do when it comes to looking at those temporary changes?

LaBelle: The intent of the office is to develop policy, and then to make sure through its statutory authority, that the budget of all of our drug control agencies follow those policies so that they are adequate to support the policy, the strategy that’s in place. Now, we will have a statement of drug policy priorities we have to send to the Hill in the spring. Our strategy is not due till next year, but we will have to work with federal agencies to make sure that their funding lines up with the drug control strategy that we develop.

OVR: Addressing racial inequity associated with current drug policies is one of the office’s top priorities. What does an equitable policy look like? And what policy changes can be expected?

LaBelle: So I want to clarify that these are the first 100 day priorities that were developed over the course of the transition. And in keeping with the Biden-Harris administration’s approach to everything that we do has to have an equity lens. So what that looks like is making sure that we have culturally competent treatment: We have culturally competent prevention, that we recognize that how we treat someone, a person of color, in one part of the country may not be the same as that type of treatment or other services the person needs in another part of the country. So it’s really developing and expanding culturally competent programs.

OVR: I don’t know if this would be something your office looks at, but would that include looking at and reducing jail sentences for people who are arrested with drugs?

LaBelle: In writing the drug strategy, we’ll be looking at how we can look at diversion programs — Diversion programs to help people get treatment. You shouldn’t have to only get treatment because you got arrested and ended up in jail. How can we divert people away from incarceration? And also when they’re incarcerated, how do we make sure that they get the type of treatment that they need so that their condition isn’t something [that] is just held in abeyance while they’re incarcerated, and then, they tend to overdose when they leave because they’re not getting the type of treatment they need? So certainly, the criminal justice aspect of this will be something that we’ll be working on with our interagency partners.

This interview has been edited for length and clarity. The order of some questions has been changed to highlight issues of greatest relevance for the region.

Addiction In The Pandemic: Staying In Treatment While Staying COVID Safe

Since 2012, the 2nd Chance Center for Addiction Treatment has served people in Lexington, Kentucky. The office sits on a busy street on the city’s north side. Similar to the heavy traffic that passes by, clients seeking treatment for substance and opioid use disorders steadily stream in and out of the building.

But in 2020, the clinic had to limit that flow of patients as it changed its protocols to adhere to COVID-19 restrictions. Group therapy and individual counseling meetings stopped. In-person meetings moved to online video calls as telehealth appointments became an alternative.

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For one 2nd Chance client receiving treatment, the pandemic’s disruption has been searing.

“I’m employed, and I do have a stable background and family. But still, the isolation is extremely tough, and it does weigh on you,” he said. (The client asked to remain anonymous because of the stigma associated with addiction.)

In a December interview, Dr. Tuyen T. Tran, CEO of 2nd Chance, said he worried that the pandemic would worsen addiction, relapses and overdoses.

“With the pandemic, we’re going to probably see a surge in the number of cases of patients experiencing suicidal ideation, increased patients with addiction,” Tran said. “And for those who have been stable in treatment, the increased need for isolation will result in multiple relapses.”

A week later, drug overdose death data from the Centers for Disease Control and Prevention affirmed Tran’s prediction. June 2019 through June 2020 was the deadliest year for drug overdoses the country has ever seen.

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Ohio Valley ReSource

The Ohio Valley, an early epicenter of the opioid crisis, saw overdose fatalities soar, and in parts of the region the rate of increase surpassed the national average. But while the pandemic is compounding the addiction crisis, it has also catalyzed additional state and federal responses to the epidemic. From local clinics and state agencies to newly appointed officials in the White House, people are looking for ways to tackle both new and existing barriers to treatment during the pandemic.

Overcoming Barriers

When the pandemic first emerged, many addiction treatment programs went to a virtual setting online. But, as with many aspects of work and education, that shift exposed common barriers people face as economic inequality and infrastructure gaps restricted access to telemedicine visits.

“We take it for granted, everyone has a cell phone, everyone has a laptop or a computer. But that’s not necessarily the case,” Tran said. “And so we experienced many difficulties with getting our patients seen with telehealth.”

The lack of broadband internet access in parts of the region also impeded access to treatment. Tran’s clinic provided Wi-Fi access so people could safely participate in group therapy sessions from their cars in the parking lot. For patients who didn’t have a phone or internet, 2nd chance established isolated space in the clinic with a computer for telehealth visits.

The pandemic’s economic impact also started to affect their clients, as unemployment escalated and people lost income. Some were struggling to pay for rent, food and other necessities. The clinic helped out with unemployment insurance claims, job searches, and even referred some patients to food banks, as well as signing some up for Medicaid as well as signing some up for Medicaid, which, among other things, allows clients to continue to pay for treatment.

In addition to the multifaceted stress caused by the pandemic, stigma still presents a significant barrier to treatment and the acknowledgement of substance and opioid use disorders as chronic diseases.

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Ohio Valley ReSource
2nd Chance Center for Addiction Treatment adjusted its in-person services in 2020 during the COVID-19 pandemic

“It’s not a moral choice, and we’ve been trying to preach that for quite a while.” Tran said. “If we can get everyone to understand that this is a disease, then the treatment of that disease will not be any different. We don’t view the chronicity of other illnesses, such as hypertension, or diabetes, in any other way, but yet for this particular illness, we view it as if it was a poor moral choice.”

Tran said Lexington area hospitals have worked to combat that stigma and treat addiction patients the same as anyone being seen at a hospital.

For a few months during the pandemic, Tran said, the clinic couldn’t monitor patients, which helps hold those in treatment accountable.

“Since they weren’t being monitored, they began to use additional illicit drugs, and we’ve been detecting them when we started monitoring again,” he said.

KY Drug Control Policy Office
Kentucky Drug Control Policy Director Van Ingram.

The danger for those who abuse drugs is now magnified by the increased traffic in more powerful synthetic drugs. Over the past few years, fentanyl, a synthetic opioid, has become more common in Kentucky. Van Ingram, executive director of the Kentucky Office of Drug Control Policy, said the potent drug is used in the manufacturing of other drugs. A person intending to use methamphetamine, cocaine or even a different type of manufactured opioid may unknowingly take a drug laced with fentanyl.

“So all these things cause all kinds of problems in the illicit drug market because people may think they’re injecting methamphetamine when in fact it’s a cocktail of methamphetamine and fentanyl,” Ingram said. “They may think they’re taking a pharmaceutical drug when they’re not.”

Tran fears that the number of fentanyl analogs, or various chemical structures, will complicate drug screenings.

“To detect certain analogs, you have to have the proper reagents,” Tran said. “Well, the new analogs are coming out so rapidly, we can’t keep up with creating reagents to test for them.”

If fentanyl analogs evade drug tests, it can complicate treatment for patients possibly leading to more drug overdose fatalities, Tran said.

State and Federal Efforts

West Virginia has long had some of the nation’s worst rates of addiction and overdose deaths, and federal data show the death toll has surged during the pandemic.

Last year West Virginia was awarded $43.7 million in State Opioid Response grant funding from the U.S. Department of Health and Human Services. So far, that’s assisted in the statewide distribution of approximately 28,000 doses of the overdose-reversal drug Naloxone.

“To be completely honest, our goal was to stop deaths so that we could get people into treatment or back into treatment,” Christina Mullins said. Mullins is Commissioner for the Bureau for Behavioral Health in West Virginia’s Department of Health and Human Resources, “We expect people to relapse. This is a chronic disease where relapse happens.”

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The grant funding also helped her agency tackle one of the biggest barriers for many rural Appalachian people seeking treatment — transportation. The West Virginia Public Transportation Association buses alter routes to pick people up.

“And since the pandemic started, we’ve run over 7,700 of those deviated routes, getting people back and forth to where they need to be,” Mullins said. “That has been one of the biggest challenges in my public health career.”

At the federal level, health officials just beginning their duties in the Biden administration know that more people with substance use disorder need access to treatment. Regina LaBelle is the acting director of the White House Office of National Drug Control Policy, which develops and oversees the administration’s National Drug Control Strategy and budget.

“We have to develop a treatment infrastructure around this country that makes sure that we can get people the treatment they need, the services they need, when they need it,” she said. “And we’re just not there yet. I mean, there are 20 million people in this country who have some form of substance use disorder, and only about 11% of people get treatment.”

LaBelle says the pandemic has allowed for some policy revisions that have improved access to treatment, such as telehealth.

“The ability to do Telehealth has been kind of a game changer for their ability to connect with their patients. And it’s really helped to retain people in treatment during this very uncertain time.”

Courtesy ONDCP
White House Office of National Drug Control Policy Acting Director Regina LaBelle

Racial equity is one of the office’s top five policy priorities. LaBelle said that means striving for “culturally competent” treatment and prevention.

“That we recognize that how we treat someone, a person of color, in one part of the country may not be the same as that type of treatment or other services the person needs in another part of the country,” LaBelle said.

She added that expanding that treatment is part of “the whole government approach to racial equity that the Biden-Harris administration is taking on.”

LaBelle echoed the importance of some of the work already underway in the Ohio Valley, such as expanding the availability of Naloxone and providing transportation assistance for rural patients.

She said her office will be reviewing some of the temporary policy changes that have been made to address needs during the pandemic with an eye toward which of those changes should be made permanent.

In Treatment

The experience of clients at Lexington’s 2nd Chance clinic drive home just how urgent those efforts will be as the pandemic wears on.

The anonymous client who spoke with the ReSource said extended isolation is a challenge for him as he manages his opioid use disorder, and he said it can affect addiction of any kind.

“You’ll probably see a large increase in people with addiction and needing recovery,” he said. “Anytime you have people with addiction, and they’re being forced to stay at home or out of [work], I think it’s going to create a bit of a problem.”

He hasn’t attended recovery meetings like he once did because he helps elderly members of his family. The pandemic has forced him to further limit his contact with others so as to reduce the risk of transmitting the virus to highly vulnerable people.

“By visiting, helping them with groceries, I’m over there taking them to the doctor when they need help,” he said. “Things like that have really kept me from attending meetings, like I would have in the past prior to the pandemic, just because of the fear of me being asymptomatic and transferring the disease to someone and someone I really care about passing away because of me.”

He has stayed in touch with his recovery group and sponsors by using social media, but he doesn’t think the public has “broad knowledge of what people with addiction go through, what the disease is. So I think, definitely, people with addiction are kind of left behind in so many ways.”

This is the second story in a series of reports about the addiction crisis during the pandemic. Part three will examine solutions regional experts are developing to expand treatment and reduce overdose deaths.

The Ohio Valley ReSource gets support from the Corporation for Public Broadcasting and our partner stations.

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