Promising COVID-19 antiviral pill, Paxlovid, in scarce supply, as doctors, patients compete for access

Promising COVID-19 antiviral pill, Paxlovid, in scarce supply, as doctors, patients compete for access
Promising COVID-19 antiviral pill, Paxlovid, in scarce supply, as doctors, patients compete for access
Kobi Wolf/Bloomberg via Getty Images

(NEW YORK) — Dr. Albert Lam, a geriatrician who works with nursing home patients in Palo Alto, California, was excited to be among the first to prescribe the new antiviral pill Paxlovid after one of his patients tested positive for COVID-19.

Hailed as a “game-changer” in the pandemic, Paxlovid is a drug made by Pfizer that if taken within five days of being diagnosed reduces the chance of hospitalization and death by 88% for people who are at high risk of severe illness.

The treatment has proved so promising that President Joe Biden included it in a Jan. 4 televised speech on the omicron variant, announcing that the first batch had shipped on Christmas Eve. While production would take “months,” Biden said it was in “full swing” and promised the drugs were on their way.

“The United States has more pills than any other country in the world, and our supply is going to ramp up over the coming months as more of these pills are manufactured,” Biden said.

Lam’s patient, a woman in her 80s with a history of cancer, got the drug within 24 hours and responded well.

Since then, however, the doctor hasn’t been so lucky.

Whereas nursing homes were first in line to get COVID vaccines last year, Lam now regularly scours a publicly available federal database to see if a Paxlovid prescription pops up near his location. This week, his home state of California got 9,560 doses — about 24 prescriptions for every 100,000 people.

Five weeks after federal regulators approved Paxlovid and began distributing it to states, few people can find it — omicron’s aggressive rise has quickly outstripped supplies.

According to an ABC News analysis of federal data on Paxlovid in more than 3,100 U.S. counties, three-quarters didn’t have any of the drug on hand as of Jan. 27, and about three-fifths had no access to a provider offering Paxlovid.

States are given amounts based on population, but some face more demand than others. Among the states that have the lowest rates of Paxlovid treatment on hand are Alabama, California, Florida, Idaho, New Jersey, New Mexico and Texas, according to data released by the Department of Health and Human Services.

Race also seems to be a factor in access, at least for now: Urban counties with majority nonwhite population have the lowest average of doses on hand, whereas counties with less than 10% of its population being nonwhite have the highest average of treatments on hand.

Scarcity isn’t the only problem. Doctors and pharmacists told ABC News the process of obtaining the drug is opaque, even arbitrary.

In Nevada, for example, Paxlovid primarily goes to long-term care facilities like nursing homes. But in neighboring California, state officials use a complex formula that factors in rising case numbers with other risk factors. In the District of Columbia, a few Safeway grocery stores are the primary distributors, although city health officials have asked doctors to give priority to high-risk individuals.

Dr. Christian Ramers of the Family Health Centers of San Diego, a network of clinics for low-income patients, said his clinic was able to secure its first shipment of 100 treatments of Paxlovid two weeks ago as part of a Biden program aimed at improving health equity.

But the staff also had to set up a system, using federal guidelines, to decide who gets the drugs first because there just weren’t enough. Often, that’s meant prioritizing people who initially refused a vaccination and now are at much greater risk of dying.

“The volume has been just mind-blowing for the last three to four weeks — just absolutely insane,” he said. That spike “to us means hundreds to thousands of people vying for about … 40 to 50 treatment slots per day.”

For now, he said, the reality is “if you’re vaccinated and you’re under age 65 and you don’t have a medical condition, you’re not going to get Paxlovid.”

Adding to the confusion is that many doctors are nervous about prescribing the drug for many high-risk patients because of potentially dangerous interactions with other commonly used medications, including cholesterol-lowering drugs and certain anti-depressants. Advocates say more data should be collected on people in their 80s and 90s.

But there aren’t a lot of other options.

“It is a little disappointing, and it makes me wonder: Could we do more?” said Erin Karara, a pharmacy consultant who works with nursing homes and long-term care facilities. “I mean, we’re seeing entire wings of nursing homes or facilities converted to COVID units. … It’s a lot of people affected by it.”

For its part, both the White House and Pfizer said the drug was never expected to roll out in large numbers right away, in part because of the time it takes to secure raw materials and to scale up manufacturing.

The current plan calls for 265,000 courses of treatment in January, gradually ramping up to 10 million by the end of June and 20 million by the end of September.

This week, Pfizer told ABC News it plans to increase its production of Paxlovid overall to 120 million courses of treatment globally — some 3.6 billion pills total.

Pfizer CEO Albert Bourla said producing the drug can’t be compared to its COVID vaccine.

“It is very different, the situation,” Bourla said at anindustry conference. “Any decent manufacturer of medicines can make it. But the chemistry, it is complicated, and it takes time to synthesize the active substance.”

Some conservatives still have been quick to criticize Biden’s handling of the rollout, with The Wall Street Journal’s editorial board deriding it as “Biden’s Operation Snail Speed,” writing, “Why didn’t it order more treatments sooner?”

According to one senior administration official, the White House did everything it could, including promising to Pfizer last July it would spend at least $1 billion on the drugs if it worked. This informal “handshake agreement” was intended to be a powerful incentive for the company, which doesn’t use government money to develop new products, the official said, speaking on condition of anonymity.

By then, Pfizer had already spent months preparing its supply chain and developing the drug. It agreed to allow the U.S. to receive the world’s first shipments.

A company official declined to confirm details of private discussions with the White House before the drug became available.

“Thanks to this at-risk preparation — drawing on our deep expertise — we have already shipped hundreds of thousands of Paxlovid courses in the U.S.,” a spokesperson told ABC. “We continue to work quickly to ship courses in accordance with our agreed delivery schedule.”

Two years into the pandemic, doctors still have few ways to treat COVID-19 with vaccines as the most effective option. Treatment options dwindled further this week when federal regulators pulled authorization of two types of monoclonal antibodies that had been widely used in the pandemic, including the kind given to then-President Donald Trump.

The antibody cocktails, made by Eli Lilly and Regeneron, were found to be useless against omicron, now 99.9% of all U.S. cases.

Two remaining drugs, Remdesivir and Sotrovimab, have to be administered intravenously at a medical facility. Molnupiravir, the new antiviral pill from Merck and Ridgeback Therapeutics, found to be 30% effective at preventing hospitalization and death, is authorized only for high-risk patients who can’t access other treatments.

That leaves Paxlovid — if a person can find it and take it early enough, and if the medication doesn’t put them at risk because of other drugs they are taking.

This week, the Southern Nevada Health District in Las Vegas announced it received 120 prescriptions last week and was willing to offer the medication to anyone older than 12 who is at high risk of COVID and tests positive through their clinic.

“If we can identify and treat people early in the course of their illness who otherwise may have ended up in the emergency department or hospital … we can potentially reduce the impact on our hospital system,” said Dr. Cort Lohff, chief medical officer of the public health agency.

Lam, the doctor in northern California, said he’s hopeful access will improve, particularly for nursing homes and long-term care residents.

“Frankly,” he added, “I think that if we were able to target those advanced therapeutics for the most at-risk populations, I think we would really make a bigger difference in terms of our death rate.”

Copyright © 2022, ABC Audio. All rights reserved.

COVID-19 live updates: US cases down nearly 25%

COVID-19 live updates: US cases down nearly 25%
COVID-19 live updates: US cases down nearly 25%
Morsa Images/Getty Images

(NEW YORK) — As the COVID-19 pandemic has swept the globe, more than 5.6 million people have died from the disease worldwide, including over 879,000 Americans, according to real-time data compiled by Johns Hopkins University’s Center for Systems Science and Engineering.

About 63.6% of the population in the United States is fully vaccinated against COVID-19, according to data from the Centers for Disease Control and Prevention.

Latest headlines:
-US cases down nearly 25%
-New Hampshire to sell rapid COVID-19 tests at liquor stores
-NIH trial finds mixing and matching boosters is safe and effective

Here’s how the news is developing. All times Eastern.

Jan 28, 8:22 pm
Sen. Romney tests positive for COVID-19

Utah Sen. Mitt Romney tested positive for COVID-19 Friday, his office said.

“He is currently asymptomatic and will be isolating and working remotely for the recommended period of time,” his office said.

His wife, Ann Romney, has tested negative for the virus. Both are fully vaccinated and boosted, his office said.

Jan 28, 5:06 pm
240 million free at-home tests ordered so far: White House

About 60 million American households have ordered 240 million free at-home COVID rapid tests since they became available on Jan. 18, White House officials said Friday.

The Biden administration plans to ultimately mail 1 billion free at-home rapid tests to Americans.

Additionally, the federal government has sent out “tens of millions of masks” since Biden announced last week that the government would provide 400 million N95 masks for free at pharmacies and community health centers across the country, White House principal deputy press secretary Karine Jean-Pierre said.

ABC News’ Ben Gittleson

Jan 28, 1:32 pm
US cases down nearly 25%

Federal data shows that the U.S. is now reporting an average of almost 600,000 new cases per day — a nearly 25% drop in the last two weeks, according to federal data.

Just nine states are reporting at least a 10% increase in cases: Alaska, Idaho, Kentucky, Maine, Minnesota, Montana, North Dakota, Washington and West Virginia.

All other states and territories are reporting a decrease in new cases or are at a plateau.

Nationwide, hospitalization rates are also declining, according to federal data. Just under 145,000 COVID-19-positive patients are currently in U.S. hospitals, down from 160,000 patients reported last week.

It’s not clear how many of these patients were admitted to the hospital for COVID-19 and how many coincidentally tested positive for the virus after they were admitted for other reasons.

The national daily death average now stands at nearly 2,300 — a 30% jump in the last two weeks.

ABC News’ Arielle Mitropoulos

Jan 27, 3:54 pm
San Francisco dropping masks in ‘stable cohorts’

San Francisco officials are ending indoor mask mandates for “stable cohorts” where everyone is up to date on vaccinations, like people in an office or gym setting.

The city’s health officer Dr. Susan Philip called this change, which begins Feb. 1, doable due to San Francisco’s highly vaccinated and boosted population.

“Other COVID-19 safety guidelines in these settings remain in effect and include a means for others who do not or cannot meet the vaccination requirements to join the group with the added safety of showing a negative test and wearing a mask,” San Francisco’s health department said.

ABC News’ Matt Fuhrman

 

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Boston risks losing ‘disproportionate’ number of educators of color with city’s vaccine mandate

Boston risks losing ‘disproportionate’ number of educators of color with city’s vaccine mandate
Boston risks losing ‘disproportionate’ number of educators of color with city’s vaccine mandate
iStock/Pornpak Khunatorn

(NEW YORK) — There’s growing concern among union leaders in Boston that a “disproportionate” number of educators of color may leave their jobs because of a vaccine mandate for city employees.

“We are very concerned about the possibility of losing a disproportionate number of educators of color in Boston over the vaccine policy,” Boston Teachers Union President Jessica Tang told ABC News.

Last month, Boston Mayor Michelle Wu announced that all city employees would be required to have their first shot of COVID-19 vaccine by Jan. 15 and complete the cycle by Feb. 15, unless granted a dispensation for medical or religious reasons. However, the Jan. 15 deadline was subsequently extended to Jan. 24 and again to Jan. 30.

City employees who refuse to comply will be placed on unpaid leave.

But with the vaccination policy set to go into effect next week, the Massachusetts Appeals Court on Thursday issued a temporary pause of Boston’s requirement for city workers after serious pushback from unions.

Over the past several months, teachers unions across the country, including in Chicago and New York City, have pushed back on similar mandates.

In a statement released Thursday, the BTU said it will not enforce Boston’s mandate by putting teachers on leave — at least until there’s a decision on the appeal. According to the union, over 96% of all members are vaccinated, including over 98% of teachers.

As of Friday, about 367 BTU members remained unvaccinated — disproportionately, Tang told ABC News, educators of color.

“Our union has worked extensively with the school department and community groups, especially over the last few years, to attract and retain a diverse staff that is reflective of the community that our schools serve,” Tang added.

According to city data, more than three-quarters (75.3%) of Boston’s students are Black or Latinx, compared with just over a third (33.7%) of teachers.

“Losing educators, especially in the middle of the school year, presents major difficulties across a wide array of issues,” Tang said. “We are committed to working with the district as best we can to not lose any educators.”

The union has proposed another extension on implementing the mandate, and it’s filed a formal complaint against Boston Public Schools and the city for “failing to bargain in good faith.”

A representative from Boston Public Schools pointed to the more than 80 clinics hosted by the district to help vaccinate staff and students.

“We have been working hard to ensure all of our employees understand the city’s policy and to increase access to vaccines,” a representative told ABC News.

Several other Boston unions, including those representing police and firefighters, also have pushed back on the mandate.

But Wu has repeatedly stood by that decision, insisting it’s necessary for the safety of the city, where about 95% of city employees have been vaccinated.

“Vaccination is our most powerful tool in this ongoing public health emergency, and we look forward to filing our response with the court,” Wu’s office said in a statement to ABC News.

 

Copyright © 2022, ABC Audio. All rights reserved.

US COVID-19 vaccine booster drive slows, with 85 million eligible Americans still without their extra shot

COVID-19 live updates: US cases down nearly 25%
COVID-19 live updates: US cases down nearly 25%
Morsa Images/Getty Images

(NEW YORK) — With the highly infectious omicron COVID-19 variant spreading rapidly across the country and overwhelming the health care system, health officials have been pleading with Americans to get vaccinated and boosted.

“The doctors and data have made crystal clear, vaccinations and boosters provide the best protection,” White House COVID-19 coordinator Jeff Zients said during a press briefing on Wednesday. “Vaccines remain our single most powerful tool.”

But despite continued public urgings from the White House and the Centers for Disease Control and Prevention, the nation’s vaccination initiation and COVID-19 booster rate continues to lag, which experts say is particularly worrisome, as efficacy continues to wane overtime.

“Booster shots are effective against both infection and serious disease,” Dr. David Dowdy, an infectious disease epidemiologist at Johns Hopkins Bloomberg School of Public Health, told ABC News. “If people don’t get boosted, we as a population are more vulnerable to the virus. To my mind, the biggest concern is that people who are vaccinated but not boosted may infect people who haven’t been vaccinated.”

As of Wednesday, just under half of those who are eligible to receive a booster — about 85 million Americans — have yet to receive their additional shot, and data shows that each day, fewer and fewer Americans are getting vaccinated. Since mid-December, the number of Americans receiving their booster every day has been cut in half — falling from more than 1 million people boosted every day to just over half a million people. In addition, 63 million eligible Americans remain totally unvaccinated.

Experts say several factors are to blame for the nation’s drop in booster shots being administered, including confusion with the CDC’s messaging and an uncertainty and lack of understanding from many about the urgency and need for boosters.

Last week, CDC Director Dr. Rochelle Walensky shared three new studies, all of which clearly demonstrated that unvaccinated individuals are at greater risk of severe illness, and even death, from COVID-19, compared to those who are vaccinated. The studies found that booster shots significantly increased protection against severe disease, both during the delta wave and at the beginning of the omicron wave.

“Protection against infection and hospitalization with the omicron variant is highest for those who are up to date with their vaccination, meaning those who are boosted when they’re eligible. There are still millions of people who are eligible for booster doses and have not yet received one,” Walensky said during a White House COVID-19 press briefing last week.

The first study found a third shot slashed the risk of visiting the ER or urgent care by 94% during delta and 82% during omicron. A second study found that the unvaccinated were nearly 14 times more likely to be infected and 53 times more likely to die, compared to the vaccinated and boosted, and a third study reported that although omicron was more likely to cause breakthrough infections compared to delta, even among the boosted, protection against more severe illness remained high.

“There may be a bit more pain and suffering with hospitalizations in those areas of the country that have not been fully vaccinated or have not gotten boosters,” Dr. Anthony Fauci told Martha Raddatz during an appearance on ABC News’ This Week on Sunday.

Messaging on vaccinations cause confusion

Health experts suggest the nation’s slowing booster campaign and the CDC’s unclear messaging and guidance are the reasons many Americans haven’t felt the need to get boosted.

“While the initial vaccination drive was met with clear communications, incentives and mandates, the booster campaign has had far less organization,” said John Brownstein, Ph.D., an epidemiologist at Boston Children’s Hospital and an ABC News contributor.

Complicating matters is the fact that the virus has already mutated several times, with new variants emerging, creating additional confusion.

“The changing science of variants and boosters has required real-time adapting of public health messaging and guidance, providing less time to prepare and convince people on the value of a third shot,” Brownstein said.

Further muddling the messaging is the discussion about whether a fourth dose of a coronavirus vaccine shot will be needed to offer protection against omicron. Israel is currently administering additional boosters to residents over the age of 60, and immunocompromised individuals, among others.

When asked whether a fourth shot will be necessary, Fauci told ABC’s This Week that it is still unclear whether an additional booster shot will be recommended, as scientists are still trying to determine how much protection is provided by the first booster.

Fauci added that it’s “quite conceivable, and I hope it’s true, that the third shot boost will give a much greater durability of protection.”

Some Americans may not understand the urgency for boosters, experts say

Although researchers report that the science behind the benefit of boosters is clear, some experts say many Americans still do not fully understand the urgency of getting boosted.

“There are many who may not yet understand the importance of [the] third dose of vaccine,” said Creech. “By giving an additional dose, particularly of an mRNA vaccine several months after those initial doses, we leverage the immune system’s ability to create long-term memory. That 1-2 punch is the best way to protect quickly and protect for a longer period of time.”

For other fully vaccinated Americans, a booster may seem unnecessary, for the time being, Dowdy said.

“For those who want protection against serious disease, but don’t care if they get a mild infection, the first series is probably sufficient. For those who want to avoid any infection at all costs, they’ve come to realize that a booster shot – while helpful – is not a ‘get out of jail free’ card,” Dowdy explained.

Despite the fact that omicron has been shown to cause less severe disease, Walensky stressed this week that as a nation, we are still facing a high overall burden of disease.

“Importantly, ‘milder’ does not mean ‘mild.’ And we cannot look past the strain on our health systems and substantial number of deaths — nearing 2,200 a day — as a result of the extremely transmissible omicron variant,” Walensky said.

Hospital officials have repeatedly stressed that the sheer number of infections caused by the new variant could still overwhelm the health care system. Nationwide, there are just under 150,000 COVID-19-positive Americans receiving care — a total which has just begun to fall after hitting a record high of 160,000 patients earlier this month.

When asked whether the C.D.C. might consider changing the definition of “fully vaccinated” to encourage more Americans to get the additional shot, Walensky reiterated that at this time, the agency is working to ensure people are “up to date” with their vaccinations.

“Right now, we’re pivoting our language, we really want to make sure people are up to date. That means if you recently got your second dose, you’re not eligible for a booster, you’re up to date. If you are eligible for a booster and you haven’t gotten it, you’re not up to date,” Walensky said.

Vaccination campaign must target both the unvaccinated and the unboosted

Experts stress the vaccination campaign must not only focus on the unboosted, but also on the 63 million eligible Americans who remain completely unvaccinated.The efforts should not be perceived as an “either/or situation, but rather a “both/and,” said Creech.

“While we want to respect the personal choices that individuals wish to make, we certainly need to invest resources to address misunderstandings or misconceptions that have led them to the decision not to vaccinate,” Creech said.

Strategies to increase overall vaccine confidence, as well as to raise awareness about the value of boosters, will also be applicable to vaccines as a whole, Creech said.

“It’s not about whether we should be prioritizing boosters over the primary vaccine series, it’s about how we message these in a way that prioritizes both,” Dowdy added.

Although the omicron surge seems to be sharply declining in many areas of the country, Americans must realize the pandemic is not over yet, Fauci stressed.

“It’s vital that we all remain vigilant in the face of this virus,” Fauci said. “It’s been a long two years. However, please now do your part to lean into this current moment. Now is the time to do what we know works: Wear a mask, get vaccinated and get boosted.”

Copyright © 2022, ABC Audio. All rights reserved.

Moderna launches clinical trial for HIV vaccine that uses mRNA technology

Moderna launches clinical trial for HIV vaccine that uses mRNA technology
Moderna launches clinical trial for HIV vaccine that uses mRNA technology
Gado/Getty Images

(WASHINGTON) — Moderna announced Thursday that it’s launched early-stage clinical trials of an HIV mRNA vaccine.

The biotechnology company has teamed up with the nonprofit ​​International AIDS Vaccine Initiative to develop the shot, which uses the same technology as Moderna’s successful COVID-19 vaccine.

The first participants in the Phase I trial were given doses at George Washington University School of Medicine and Health Sciences in Washington, D.C., according to a company statement.

“We are tremendously excited to be advancing this new direction in HIV vaccine design with Moderna’s mRNA platform,” Dr. Mark Feinberg, president and CEO of IAVI, said in a statement. “The search for an HIV vaccine has been long and challenging, and having new tools in terms of immunogens and platforms could be the key to making rapid progress toward an urgently needed, effective HIV vaccine.”

Nearly 38 million people worldwide — including about 1.3 million in the U.S — are living with HIV, or human immunodeficiency virus, which can lead to the potentially fatal disease AIDS.

Being diagnosed with HIV was once considered a death sentence. During the height of the U.S. AIDS epidemic in the mid-1990s, more than 50,000 deaths occurred every year, according to the Centers for Disease Control and Prevention.

Today, HIV is much more manageable with medications that can reduce viral loads to undetectable so the virus can’t be transmitted, as well as pills that can be taken to prevent infecting those who are HIV-negative.

But despite decades of research, no vaccine has ever been developed. Several candidates have entered clinical trials but failed in later stages.

The new vaccine uses mRNA, or messenger RNA, which teaches the body’s cells how to make proteins that trigger immune responses.

Researchers have developed not only a primary vaccine but also a booster to deliver HIV immunogens — molecules that elicit an immune response — via mRNA.

The hope is this process can induce specific white blood cells, called B cells, which can then turn into what are known as broadly neutralizing antibodies that can neutralize the virus.

According to the statement, Phase I of the trial will enroll 56 healthy, HIV-negative adult participants at GWU and three additional sites: Hope Clinic of Emory Vaccine Center in Atlanta; Fred Hutchinson Cancer Research Center in Seattle; and the University of Texas-Health Science Center at San Antonio.

Of the volunteers, 48 will receive one or two doses of the mRNA vaccine, and 32 also will receive the booster. The remaining eight will receive just the booster.

Researchers will then monitor for safety and efficacy of the new vaccine for up to six months after participants receive their final dose.

Moderna did not immediately respond to ABC News’ request for comment.

ABC News’ Sony Salzman contributed to this report.

Copyright © 2022, ABC Audio. All rights reserved.

California bill would allow kids 12 and up to get vaccines without parents

California bill would allow kids 12 and up to get vaccines without parents
California bill would allow kids 12 and up to get vaccines without parents
EFF KOWALSKY/AFP via Getty Images

(SACRAMENTO, Calif.) — A new bill in California would allow children to get vaccinated against diseases including COVID-19 without their parents’ consent.

Currently, kids in the state between ages 12 and 17 must receive permission from a parent or a guardian to get a vaccine, unless it is to prevent a sexually transmitted infection.

However, the new bill — introduced Friday by state Sens. Scott Wiener (D-San Francisco) and Richard Pan (D-Sacramento) — would allow Californians aged 12 and older to receive vaccines that meet specific federal agency criteria on their own.

Under the bill, adolescents could get vaccinated as long as the shots are approved by the U.S. Food and Drug Administration and recommended by the Centers for Disease Control and Prevention’s advisory committee.

As of Wednesday, about 63% of Californians aged 12-17 are fully vaccinated, according to the state department of health — but at least 28% are not.

“There are nearly 1 million teenagers in California who are not vaccinated against COVID-19, and that jeopardizes their own health. It makes our schools less safe,” Wiener told ABC News. “A lot of these teenagers would like to get vaccinated, but their parents either won’t let them or their parents aren’t making the time to go with them to get vaccinated.”

He added, “This legislation will allow teens to protect their own health and to get vaccinated against COVID-19, against the flu and other serious diseases.”

Washington, D.C., currently allows minors to receive vaccines on their own starting at age 11. San Francisco also allows kids aged 12 and older to receive COVID-19 shots without parental consent when consent is unavailable.

Additionally, five states allow minors to get vaccinated without parental consent. Alabama allows teens to receive vaccines on their own starting at age 14; Oregon at age 15; and Rhode Island, North Carolina and South Carolina at age 16.

Elizabeth Tobin-Tyler, an associate professor of health services, policy and practice at Brown University, said these laws are often the result of a “mature minor” doctrine, which allows minors to give consent provided they can show they are mature enough to make decisions on their own.

“The idea is there are minors that might be quite mature at age 12 or 14 and have the capacity to make their own decision,” she told ABC News. “States have recognized there are situations where we don’t want to have someone make a decision at just 18.”

Dr. Georges Benjamin, executive director of the American Public Health Association, said most kids of that age are mature enough to understand medical information that is given to them.

“When you’re dealing with kids and medical care, you want to be able to give them with some graduated autonomy about their health,” he told ABC News.

If the bill passes, California would become the state with the youngest age for children to get vaccinated on their own without permission from an adult.

“It will serve as an example for other states,” Benjamin said. “California has often been on the cutting edge of legislation that has become law in other parts of the country. So it will certainly be an exemplar in that area and it will serve as a model for other states, particularly as we see the numbers of kids vaccinated grow.”

However, not everyone is in favor of the bill.

​​”It just seems like this is part of this ongoing war against parents by some Democratic elected officials,” California Republican Assemblyman James Gallagher told ABC News. “This bill is not about letting children make some sort of decision in a vacuum whether or not they want to get vaccinated. It’s about eliminating parents from that decision-making process.”

He described the bill as a “slippery slope” and said it could lead to kids having autonomy to take other medications without parental consent.

“What other drugs, what other things would a child be able to decide at school or some other place without their parents’ consent?” Gallagher asked.

Under California law, minors aged 12 and older are already allowed to be vaccinated against hepatitis B and human papillomavirus (HPV) and to receive birth control and treatments for STIs, mental health disorders and substance abuse.

But Wiener said he doesn’t believe the new bill would curb parents’ input when it comes to their children’s health because most teens speak to their parents when it comes to making medical decisions.

“The vast majority of teens — even if they have the ability to get a vaccine — will talk to their parents about the issue,” Wiener said. “We want parents to be involved in their kids’ health care, and I am confident that many, many teens will talk to parents about it.”

He continued, “Sadly there are some teens who are not in a position to talk to their parents about it. For whatever reason, they can’t have those conversations and in those situations, a teenager should be able to protect their own health.”

Benjamin said the idea of providing teens with autonomy is not new or radical and could actually help teenagers think critically and analytically.

“We do this a lot in other areas in our lives,” he said. “We give them driver’s licenses as they are able to mature both emotionally and physically. Parents should think of this as part of allowing their kids to have more control over their health decision-making. From a mental health and psychological perspective, this should be thought of as giving kids more responsibility, and I think overall it’s a good thing.”

ABC News’ Ivan Pereira contributed to this report.

Copyright © 2022, ABC Audio. All rights reserved.

Boston hospital denies heart transplant to man who hasn’t gotten COVID-19 vaccine

Boston hospital denies heart transplant to man who hasn’t gotten COVID-19 vaccine
Boston hospital denies heart transplant to man who hasn’t gotten COVID-19 vaccine
Boston Globe via Getty Images

(BOSTON) — The family of a Boston man is speaking out after they say their 31-year-old son was struck from a waitlist for a heart transplant because he was not vaccinated against COVID-19.

DJ Ferguson, who was diagnosed with arrhythmia four years ago, was admitted to Brigham and Women’s Hospital after suffering heart failure this winter, his parents told ABC News. But after reviewing Ferguson’s medical history, which showed he had not received a coronavirus shot, hospital staff told Ferguson that his vaccination status made him ineligible for a new heart, according to his parents.

Tracey and David Ferguson insisted their son does not oppose vaccines; he just worries the COVID-19 shot would complicate his heart condition, they said.

“He’s not an anti-vaxxer. He has all of his vaccines, and he’s an informed patient who is concerned because of his current cardiac crisis,” Tracey Ferguson said.

However, doctors say the risk of severe illness and inflammation of the heart from contracting COVID-19 is much more likely than the low risk of heart inflammation from the vaccine, which is usually temporary.

National transplant associations recommend the COVID-19 vaccines before transplants, as do many medical centers, because after a transplant, the patient’s immune system can become compromised from medications necessary to keep the organ and the patient alive, making the individual at risk for severe illness and death if they become infected with COVID-19.

The coronavirus vaccine is just one of several vaccinations required for patients who receive a transplant at Brigham and Women’s Hospital, a spokesperson at the facility told ABC News. These requirements “create both the best chance for a successful operation and optimize the patient’s survival after transplantation, given that their immune system is dramatically suppressed,” spokesperson Serena Bronda wrote in an email.

Since only about half of people waiting for an organ transplant will receive one, according to the hospital, doctors try to ensure that the organs go to people with the best chance of survival after the operation.

While the hospital could not comment on Ferguson’s case, citing HIPAA privacy law, Bronda said that all patients seeking transplants undergo a “comprehensive evaluation” to determine if they are eligible for the operation.

Transplant seekers are also screened for certain “lifestyle behaviors” that might disqualify them, such as substance use and active smoking, she added.

Evaluating patients seeking organ transplants is a common practice in most hospitals — and a necessary one, experts told ABC News, as there are not enough organs for everyone who needs one.

“You’re trying to get the most life saved with a very, very scarce resource,” Dr. Arthur Caplan, a professor of bioethics at New York University, said. “This is not about discrimination.”

Jennifer Miller, a bioethicist at Yale, told ABC News that hospitals must “allocate prudently” when it comes to organ transplants. “If you end up giving a heart to somebody who then dies, not only that person died, another person didn’t get that heart,” she said.

On Tuesday, DJ Ferguson was in open-heart surgery to receive a mechanical heart pump, called a left ventricular assist device, which should keep him alive for up to five years, according to his parents, who worry about the toll the device will have on their son’s quality of life.

“For the foreseeable future, he won’t be able to shower, he won’t be able to swim. He won’t be able to have a life,” David Ferguson said.

Tracey Ferguson said it was “devastating” when she learned that her son was not eligible to receive a new heart.

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Scientists monitoring new omicron subvariant BA.2

Scientists monitoring new omicron subvariant BA.2
Scientists monitoring new omicron subvariant BA.2
Win McNamee/Getty Images

(GENEVA) — Even as the omicron COVID-19 variant continues to sweep the globe, scientists are now monitoring a new mutation of omicron, dubbed BA.2.

The World Health Organization maintains that BA.2 is not a “variant of concern,” meaning there is no current evidence to suggest this new subvariant will worsen COVID-19 transmission, illness severity, or efficacy of vaccines and public health efforts like masking and social distancing.

BA.2 numbers around the world are rising, with at least 40 countries reporting cases to a global variant tracking database, but the subvariant has spread rapidly in Denmark and the UK, with almost half of recent cases in Denmark attributed to BA.2.

The subvariant has already been detected in several U.S. states, with Washington State confirming two cases Monday.

While over 8,000 BA.2 cases have been identified since November 2021, it is unclear where BA.2 originated. Even though the first sequences were submitted from the Philippines, numerous cases have since been detected in various places, from Europe to South Asia.

Given the rising numbers, health care organizations, like the WHO, are asking scientists to watch and study the new subvariant separately from omicron, to see if it behaves differently.

“It is the nature of viruses to evolve and mutate, so it’s to be expected that we will continue to see new variants emerge as the pandemic goes on,” said Dr. Meera Chand, the COVID-19 incident director at the UK Health Security Agency, in prepared remarks. “So far, there is insufficient evidence to determine whether BA.2 causes more severe illness than Omicron BA.1, but data is limited.”

The evolution of COVID-19 subvariants is not new. The delta variant also had several subvariants, but scientists referred to all of them as delta. BA.2, however, has earned its own designation due to rising numbers across several nations.

Although it’s been called the “stealth” omicron variant, the new subvariant, “can absolutely be detected through traditional surveillance mechanisms whether through rapid testing or PCR,” said Dr. John Brownstein, chief innovation officer at Harvard University’s Boston Children’s Hospital and ABC Medical Correspondent.

Conventional COVID-19 tests can show a positive or a negative result, but they can’t determine specific variants. For that, scientists need to do additional genetic sequencing. Conveniently, the omicron variant has a particular genetic signature that allows scientists to quickly and easily determine if the sample is omicron or not.

The new BA.2 subvariant does not have that feature, meaning scientists can no longer use this shortcut — though they can still identify the subvariant using genetic sequencing technology. Because of this, the BA.2 subvariant has sometimes been referred to as the “stealth” variant. But for the general public, conventional COVID-19 tests will still work to detect the new subvariant.

Ultimately, while scientists and public health officials are urging continued research and surveillance, experts say there is little reason to worry.

“BA.2 is important from a public health perspective, but it doesn’t fundamentally change at this moment, how we think about the impact in the population,” Brownstein said. “A lot more work needs to be done to understand severity, breakthrough infections, and immunizations before you can make any statement about clinical relevance.”

“While it’s important to understand that in the family of omicron, there is a sub-lineage that is potentially more transmissible, it’s not necessarily a cause for panic,” Brownstein added.

Nitya Rajeshuni, M.D., M.S., a pediatrics resident at the Children’s Hospital of Philadelphia, University of Pennsylvania, is a contributor to the ABC News Medical Unit.

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‘Don’t Weigh Me’ cards designed to empower people to skip the scale at the doctor’s office

‘Don’t Weigh Me’ cards designed to empower people to skip the scale at the doctor’s office
‘Don’t Weigh Me’ cards designed to empower people to skip the scale at the doctor’s office
Ginny Jones

(OMAHA, Neb.) — Dani Donovan, a 30-year-old woman from Omaha, Nebraska, said she spent the better part of a decade going to different doctors to seek help for chronic pain.

At each visit, according to Donovan, she would be told she needed to lose weight, a discouraging cycle that she said kept her from seeking more medical care.

“I was in pain and all doctors would say to me is that I need to lose weight,” Donovan told “Good Morning America,” noting the experience would often lead her down a cycle of binge eating due to her frustration and pain.” “I felt like doctors wouldn’t listen to me and it was making me not go to want to see the doctors.”

That changed in December, according to Donovan, when she went to a new primary care physician.

While in the waiting room at that doctor’s office, Donovan saw what are called “Don’t Weigh Me” cards, business cards that are designed for a patient to hand to a nurse or doctor.

The cards read on the front, “Please don’t weigh me unless it’s (really) medically necessary. If you really need my weight, please tell me why so that I can give you my informed consent.”

On the back of the card is a list of reasons why a person may not want to be weighed, including the risk of weight stigma and stress and that “most health conditions can be addressed” without knowing a patient’s weight, according to the card.

The cards were a game-changer for Donovan, who said she felt empowered to stand up for herself and not have her weight be the focus of the doctor’s appointment.

“I had heard online that you could ask doctors not to weigh you, but I still felt really intimidated to say that out loud,” said Donovan. “You’re used to going to the doctor’s office and them herding you onto the scale. It’s just part of the routine.”

“I was able to just show the card to the woman who was bringing me back and it was like OK and we continued on,” she said.

Donovan said she went onto have an hourlong appointment with the doctor, who sent her to a specialist, whom Donovan said ultimately diagnosed her with Ehlers Danlos syndromes, a a group of inherited connective tissue disorders, according to the National Institutes of Health.

“It just made a huge difference to have been heard,” said Donovan, adding that she now feels comfortable going to see her doctors.

It was a similar experience with weight stigma at doctors’ offices that led Ginny Jones to create the “Don’t Weigh Me” cards nearly four years ago.

Jones, the founder of More-Love.org, an eating disorder-focused resource for parents, said she suffered from an eating disorder and began asking to not be weighed at doctors’ offices when she started her recovery.

“I decided I would not be weighed unless it was necessary,” said Jones, explaining that at first she told her doctors verbally. “Very interestingly, in many, many years of asking not to be weighed, it’s never been required for my care.”

“I’m open to it if it is required for my care, but so far it really hasn’t been an issue for me,” she said.

Jones said that as she began working with parents and people in recovery from eating disorders, she saw she was not alone in not wanting weight to be the focus of doctors’ appointments. She launched the cards as a way for people to have something in their pocket they could just easily hand to a doctor or nurse.

“I posted them on my website kind of thinking maybe a couple people would be interested,” said Jones. “And they have had a huge demand.”

The cards, which are available for sale on Jones’s website, have been purchased by not just individuals but also therapists, dietitians and doctors, according to Jones.

Dr. Lesley Williams-Blackwell, an Arizona-based family medicine physician and eating disorder specialist, carries the cards in her office so that patients can take them and use them with other doctors.

Williams-Blackwell said she started doing automatic blind weights — meaning the patient is weighed but the number on the scale is not shown to them — after one incident in which a patient fled the office after being weighed.

“She was so upset that she fled the office,” said Williams-Blackwell. “That just illustrated for me that you don’t know, especially if it’s your first time meeting someone, how [weight] being the first piece of data that they’re presented with, even before you have an opportunity to meet them, could be very triggering or upsetting.”

Williams-Blackwell said when she takes her three children, ages 9 to 12, to doctors’ appointments, she asks that their weights not be shown or discussed.

She said, in her experience, it is important for doctors and patients to look beyond a single number when it comes to someone’s health.

“I really would challenge people to look at health in a more holistic way and to not feel that they have to get so pigeonholed into weight as the sole marker of how healthy someone is,” said Williams-Blackwell. “Because the reality is that there’s so much more to health.”

Chelsea Kronengold, a spokeswoman for the National Eating Disorders Association, said doctors’ focus on weight can often not only miss other conditions that may be present, but can also lead to weight stigma and eating disorder behaviors.

“Weight stigma is discriminating or stereotyping someone based on their weight, which we know that medical providers frequently do, as well as the general public,” said Kronengold. “And weight stigma can increase body dissatisfaction, which is a leading risk factor in the development of eating disorders.”

Nearly 30 million Americans will have an eating disorder in their lifetime, and over the past two years of the coronavirus pandemic, eating disorders have been on the rise in the U.S., according to NEDA.

Jones said she hopes the conversation around weight changes in society to the point that it puts her “Don’t Weigh Me” cards venture out of business.

“My dream and my vision is that we actually live in a society that respects bodies regardless of weight, and that being weighed at the doctor’s office is not an assumed first step,” she said. “I don’t want to be in business in 10 years selling cards. My vision is actually that we change the conversations at a much deeper level, and that doctors start to recognize the harm that being weighed [in their offices] can cause.”

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COVID-19 vaccines do not affect fertility for women or men, study finds

COVID-19 vaccines do not affect fertility for women or men, study finds
COVID-19 vaccines do not affect fertility for women or men, study finds
Andriy Onufriyenko/Getty Images

(NEW YORK) — A new study adds to the growing evidence that COVID-19 vaccines are safe for both pregnant people and people hoping to become pregnant.

The study, which looked at more than 2,000 couples in the United States and Canada, found “no adverse association” between getting vaccinated against COVID-19 and fertility, for both men and women.

On the other hand, men who contract COVID-19 may experience a temporary reduction in fertility. Couples who had a male partner test positive for COVID-19 within 60 days of their partner’s menstrual cycle were 18% less likely to conceive in that cycle, according to the study, published on Jan. 20 in the American Journal of Epidemiology.

“The findings provide reassurance that vaccination for couples seeking pregnancy does not appear to impair fertility,” Dr. Diana Bianchi, director of the National Institute of Health’s Eunice Kennedy Shriver National Institute of Child Health and Human Development, which funded the study, said in a statement. “They also provide information for physicians who counsel patients hoping to conceive.”

The myth that COVID-19 vaccines may negatively impact fertility was one that was spread largely on social media.

More and more research has now shown that not only do the vaccines not affect fertility, they also do not impact pregnancy.

A study released Jan. 4 by the Centers for Disease Control and Prevention (CDC) found no increased risk of preterm or low-weight birth among babies born to pregnant people who got a COVID-19 vaccine shot, compared to babies born to unvaccinated pregnant people.

The study’s researchers at Yale University looked at the health data of more than 40,000 pregnant women and did not identify any safety issues with getting vaccinated while pregnant, no matter which trimester a woman was in when vaccinated, or how many vaccine doses she got during her pregnancy. Researchers noted most of the women included in the analysis were vaccinated in the second or third trimester, and the study didn’t include booster doses.

In a health warning issued in September urging pregnant people to get vaccinated, the CDC said data shows there is also no increased risk for miscarriage linked to receiving a COVID-19 vaccine.

“Miscarriage rates after receiving a COVID-19 vaccine were similar to the expected rate of miscarriage,” the CDC said at the time. “Additionally, previous findings from three safety monitoring systems did not find any safety concerns for pregnant people who were vaccinated late in pregnancy or for their babies.”

In addition, two studies released last summer found Pfizer and Moderna’s COVID-19 vaccines appear to be safe and effective for pregnant people, and were also found to likely offer protection to infants born to a vaccinated person.

In August, the CDC strengthened its recommendation for COVID-19 vaccination during pregnancy, citing new evidence of safety with the vaccines.

The nation’s two leading health organizations focused on the care of pregnant people — American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (SMFM) — also issued new guidelines calling on all pregnant people to get vaccinated against COVID-19.

The World Health Organization (WHO) also says pregnant people can be vaccinated against COVID-19.

“Limited data are currently available to assess the safety of COVID-19 vaccines in pregnancy. However, based on what we know about the kinds of vaccines being used, there is no specific reason for concern,” the WHO says on its website. “None of the COVID-19 vaccines authorized to date use live viruses, which are more likely to pose risks during pregnancy.”

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

They are the first mRNA vaccines, which are theoretically safe during pregnancy, because they do not contain a live virus.

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

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

The CDC has concluded that pregnant people can receive the Johnson & Johnson one-shot vaccine after reviewing more than 200 pages of data provided by the company and the U.S. Food and Drug Administration (FDA).

Vaccine experts interviewed by ABC News said although pregnant women are advised against getting live-attenuated virus vaccines, such as the one for measles, mumps and rubella, because they can pose a theoretical risk of infection to the fetus, the Johnson & Johnson vaccine doesn’t contain live virus and should be safe.

The COVID-19 virus has also proven to be more dangerous for pregnant people, especially if they are not vaccinated.

According to the CDC, COVID-19 causes a two-fold risk of admission into intensive care and a 70% increased risk of death for pregnant people.

A study led by researchers in Scotland, and published this month in Nature Medicine, found that unvaccinated pregnant people who contracted COVID-19 not only were at risk of more severe illness themselves, but also were more likely to experience pregnancy loss or preterm birth compared to other women.

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