US men sicker than those abroad, study says

US men sicker than those abroad, study says
US men sicker than those abroad, study says
Thomas Barwick/Getty Images

(NEW YORK) — American men are sicker and die earlier than men living in other developed nations, according to a new report from The Commonwealth Fund, a non-profit organization focusing on public health issues.

The study looked at men from the U.S, Switzerland, Norway, New Zealand, Germany, Australia, the U.K., France, the Netherlands, Canada and Sweden and found that rates of avoidable deaths, chronic conditions and mental health needs are among the highest with American men.

Around 29% of American men reported they have multiple chronic illnesses, followed closely by Australian men at 25%, according to the study. Men living in France and Norway were the lowest at 17%.

Experts reveal how likely reinfection is from COVID with spread of omicron subvariant BA.5
“Whether it’s stubbornness, an aversion to appearing weak or vulnerable, or other reasons, men go to the doctor far less than women do,” the study’s authors wrote.

Men in the U.S. also die from avoidable deaths, classified as deaths before 75 years old, at a higher rate than men from the 10 other countries listed in the report.

The study showed that income disparities also play a factor in one’s health. Men with lower incomes tend to partake in unhealthy habits more frequently, such as drinking and smoking, leading to chronic conditions such as diabetes, obesity and heart disease.

Low-income earners are least likely to afford adequate care and can’t visit the doctor regularly, which contributes to worsening health issues, the study added. Men stressed because they are low-income earners were less likely to have a regular doctor.

The U.S. remains an outlier being the only industrialized nation without universal healthcare and has led to men avoiding getting the care they need because costs are too high, researchers noted.

Long Island school district found to have higher rates of cancer cases: Study
“Roughly 16 million U.S. men are without health insurance and affordability is the reason that people most often cite for why they do not enroll in a health plan,” they wrote.

American men also don’t think highly of the U.S. health care system, with only 37% giving it a high rating. It’s even worse among men with a below-average income, with only 32% approving the healthcare system.

There was a silver lining among men in the U.S. They have the lowest rate of prostate cancer-related deaths among the other countries studied, largely because the U.S. offers wide-ranging cancer testing and advanced treatments, the authors of the study said.

ABC News reached out to the authors of the study for comment but have not heard back.

Copyright © 2022, ABC Audio. All rights reserved.

With an incoming COVID surge, health officials push urgently for boosters. Do you need one?

With an incoming COVID surge, health officials push urgently for boosters. Do you need one?
With an incoming COVID surge, health officials push urgently for boosters. Do you need one?
Jessica Rinaldi/The Boston Globe via Getty Images

(NEW YORK) — Early cases of COVID-19 are believed to be linked to a live-animal market in Wuhan, China.
Facing yet another COVID-19 variant, this one said to be faster and stealthier than those before it, health officials say the calculus has changed and are urging booster shots even more strongly to buck up the country’s armor.

There is a renewed push for everyone over 5 to go out and get a first booster shot if they haven’t yet. That’s the majority of Americans since despite evidence of significant improvements in protection against hospitalization and death from the third shot since only 48% of Americans have gotten a third shot, according to data from the Centers for Disease Control and Prevention.

Officials are also urging a second booster shot, about four months after the first booster shot, for people who have received their first boosters but are considered high-risk, including people 50 and older and the immunocompromised.

“For people who are 50 years of age or older, my message is simple. If you have not gotten a vaccine shot in the year 2022 — if you have not gotten one this year, please go get another vaccine shot,” White House COVID-19 Response Coordinator Dr. Ashish Jha said during a press briefing on Tuesday.

“If you’ve not gotten a vaccine shot this year, go get one now. It could save your life,” he said.

The Food and Drug Administration and the Centers for Disease Control are also considering widening that eligibility to include all adults in the next few weeks, Jha said.

But the newfound urgency to offer second boosters to younger populations has been met with confusion, particularly after federal officials previously suggested that shots for people who weren’t high risk wouldn’t be necessary until the fall.

And even for those over the age of 50, prior guidance on the CDC’s website stated that if getting a shot now would make you hesitant to get one in the fall, you should wait until fall to get a second booster. The emergence of the omicron subvariant BA.5 appears to have changed that calculus, however.

Why does BA.5 change the urgency of booster shots?

BA.5, which is now estimated to account for 65% of new COVID-19 cases in the U.S. according to CDC data, became dominant earlier this month. It brought with it a surge of cases and hospitalizations, which will likely be followed by deaths.

It seems to be the most immune-evasive variant the world has seen so far, in terms of its ability to get around past protection from bouts with COVID and from the vaccines.

That means people who have already had COVID-19 are still at risk of becoming reinfected.

And that decline in protection, paired with a new variant that’s better at getting around the vaccine, poses a renewed threat.

“The frequency of BA.5 infections are rising across the US, for those that have not been vaccinated in several months, immunity has likely waned,” C. Buddy Creech, director of the Vanderbilt Vaccine Research Program and associate professor of pediatric infectious diseases, told ABC News.

So who should get one?

Even if you’ve already had COVID-19 and even if you plan to get a booster this fall, when variant-specific vaccines are expected to be available, experts who spoke with ABC News widely agreed that eligible people should still ensure they are up to date with their COVID-19 vaccinations and booster shots.

“If I had not gotten booster number two already, I would get it today,” Dr. Bob Wachter, chair of the department of medicine at the University of California, San Francisco, told ABC News.

“You can get a painless, free, and essentially risk-free intervention that will lower the probability of mortality, hospitalization and, at least for a while, infection, at a time when the virus is absolutely rampant,” Wachter said. “That seems like a pretty easy call to me.”

Wachter said the risks of another booster shot is less than most of the procedures he does daily in his job at the hospital, and carries a big benefit.

“The booster is about as safe as anything we do. So my threshold to give it when I think there might be benefit is pretty low,” he said.

What if you’ve recently had COVID?

Though the CDC recommends waiting about three months after having COVID-19 to get vaccinated, experts watching BA.5 said they thought people should consider getting a shot one or two months after recovering.

“I have shortened up my timeline. If you got infected a month or more ago, and you’re eligible for a booster now, I would go ahead and get it,” Wachter said.

Because BA.5 may better can evade prior infection compared to previous variants, people who got COVID recently shouldn’t consider that to be as strong of protection as it once was.

“For anybody who was infected prior to a month ago, an educated guess would be that it wasn’t BA.5, and therefore, your immunity is not good for as long as it used to be,” Wachter said.

Dr. Anna Durbin, director of Center for Immunization Research at Johns Hopkins University, said she would also wait a month, or perhaps two months for people who are lower risk.

“You want your immune system to cool down a bit before you give another vaccine because once it’s cooled down, then you get the biggest effect from that vaccination,” she told ABC News.

“That recent infection is going to provide you with an immune response that will keep you out of the hospital. It is a better booster than the vaccine because it is more aligned with what’s currently circulating,” added Durbin.

Dr. David Dowdy, an infectious disease epidemiologist at Johns Hopkins Bloomberg School of Public Health, agreed that the need for a booster shortly after infection is not pressing, as the added value of a booster shot that soon is “relatively small.”

What about the boosters coming this fall?

Even though the U.S. is expecting a new booster campaign this fall with updated, variant-specific vaccines, several experts encouraged getting a booster now, in light of BA.5, and then again in a few months, when the new vaccines arrive.

“There’s this theoretical risk of over-boosting but we’ve been at this now for two years, we have people having gotten two, three, even four shots — and I think it remains a theoretical risk,” he told ABC News. “I don’t think there’s any strong evidence that is true.”

Durbin said she thinks people who get a booster now would also have enough of an interval between shots for another booster this fall or winter to still have a strong impact.

“Because it’s July now, there’s enough of a window between that booster and then the Omicron-specific booster that you should get a really good benefit from that in the fall,” she said.

If health agencies recommend a booster for younger people, should they get one?

For younger people, if the FDA and CDC decide to open up eligibility for second booster shots, experts agreed that it would be worth it to re-up protection in certain cases.

“I would say the benefit outweighs the risk, certainly,” Durbin said.

It won’t eliminate the chance of getting COVID, though, and people shouldn’t expect it to because of how fast the virus has evolved since the original vaccines were created.

“We have to really be careful in our messaging and manage people’s expectations, otherwise they’re not going to want to get boosters in the fall that are more specific for Omicron and may prevent infection far better than the current vaccine does,” Durbin said.

That said, other experts were more conservative in their recommendations for young people.

“While the benefits of vaccination certainly outweigh the risks, I’m not sure that it’s more urgent now than before to get younger people yet another booster,” said Dowdy.

“If anything, hospitalizations in the BA.5 era are increasingly among people 70 and older, so the focus on people under 50 isn’t really following what we see in the data.”

And particularly for young people who have recently had COVID, Wachter, too, said it would be reasonable to wait until the fall.

“I’d say for a truly low-risk person, a healthy young person with three shots and gets COVID now, then I’d be on the fence and I probably wait until the fall,” Wachter said.

Creech added that although some younger Americans may feel hesitant to get the booster now and in the fall, most people will understand the continued threat of COVID-19 and the need to maintain protection.

“I think people recognize that a new COVID variant seems to always be lurking around the corner and vaccines are the best prevention we have,” Creech said.

Copyright © 2022, ABC Audio. All rights reserved.

Patients being barred from medication no longer used for abortion post Roe

Patients being barred from medication no longer used for abortion post Roe
Patients being barred from medication no longer used for abortion post Roe
Phil Walter/Getty Images

(NEW YORK) — The Department of Health and Human Services announced it is investigating reports of women being denied vital medication for chronic medical conditions unrelated to abortion in states that have banned abortion after the Supreme Court overturned Roe v. Wade.

It will also be issuing guidance to 60,000 retail pharmacies, reminding them of their obligations under federal civil rights laws, the agency said.

“We are committed to ensuring that everyone can access health care, free of discrimination,” HHS Secretary Xavier Becerra said in a statement Wednesday. “This includes access to prescription medications for reproductive health and other types of care.”

One example of the fallout has been reports of several women diagnosed with an autoimmune disease in states with abortion bans that have reported not being able to obtain a medication called methotrexate from their pharmacies.

“I’m a 48-year-old woman without a uterus,” Jennifer Crow from Tennessee, where there is a six-week abortion ban in place, told ABC News. “I didn’t think the abortion ban would affect me.”

She said she has been taking methotrexate for her inflammatory arthritis since April. On July 1, for the first time since getting her prescription, her pharmacy required her to call her doctor to access a refill she was already prescribed, she said.

Crow said she was without medication for three days until she could speak to her doctor after the long July Fourth holiday weekend. She said, “During those three days, the inflammation returned. I was immediately put back into a flare.”

Crow said she’s spoken to many other people on Twitter with chronic diseases requiring methotrexate treatment with similar experiences to hers. She said that “many of them reached out to their doctor preemptively. Many doctors said that they had a blanket hold on all methotrexate until it gets worked out.”

Becky Schwartz, 28, who suffers from lupus, told Stat News her doctor in Virginia said he had to pause prescribing the medication by orders of the health system he worked for.

She told Stat News the medication was dramatically effective and she feared what would happen without it.

“Before I started taking it, I was not able to do much at all, I was pretty immobile,” she said. “Within a month, I was feeling great. Not perfect, but I could take a shower unassisted.”

“I have gotten some reports where children have been denied methotrexate for their juvenile arthritis until they’ve proven they’re not pregnant,” Dr. Cuoghi Edens, an assistant professor of internal medicine and pediatrics at University of Chicago Medicine told the Los Angeles Times. That included an 8-year-old, Edens said.

The pharmacy’s reluctance to fill a standing prescription or a doctor’s reluctance to prescribe it may be due to fear of legal retaliation via felony charges on providers for aiding or abetting abortions.

“The concern that physicians and pharmacists are experiencing is, ‘Is there a legal implication based on the SCOTUS ruling for continuing to prescribe or fill prescriptions for methotrexate?'” Dr. Kenneth Saag, president of the American College of Rheumatology, told ABC News.

The American College of Rheumatology, the Arthritis Foundation, the Crohn’s and Colitis Foundation and the advocacy group CreakyJoints have all issued statements since the recent decision in Dobbs v. Jackson Women’s Health Organization opposing the restriction of methotrexate access and have developed educational materials, as well as offered avenues through helplines and email to help support those who are not able to obtain their treatment.

Methotrexate is no longer used for abortions.

Medication abortion is the use of a combination of hormonally-active drugs to evacuate the contents of the uterus. Before the FDA approval of mifepristone in 2016 for medication abortion, methotrexate was paired with misoprostol. The abortion process on this older regimen was less effective, more prone to causing adverse side effects and took a substantially longer time to complete.

Methotrexate is still used to treat ectopic pregnancies, which occur when the embryo implants outside of the uterus. These pregnancies are not viable in any circumstance and only pose a significant risk to the mother, including future infertility and death, according to the American College of Obstetricians and Gynecologists. A study found that deaths from ectopic pregnancy decreased from 1.15 to 0.50 per 100,000 from 1980 to 2007, presumably due to improved treatment options and guidelines.

The issue of methotrexate access in outpatient pharmacies makes some providers worried about the future of access in other health care settings.

“Methotrexate has been revolutionary in women’s health care for ectopic pregnancies, as most ectopic pregnancies don’t go to the OR anymore. My take-home is, what’s next? Let people die from a ruptured ectopic if methotrexate is restricted? Do women then have to wait until ectopic pregnancies rupture so that they can then get a lifesaving procedure in the OR?” said Dr. Jacques Moritz, a board-certified OB-GYN.

When women who can become pregnant are prescribed methotrexate, there are already safeguards to prevent adverse events related to pregnancy.

The American Academy of Family Physicians strongly recommends that women using this medication must use birth control in the form of hormonal contraceptives, condoms and/or abstinence. If a woman is ready to become pregnant, the American Academy of Rheumatology recommends that methotrexate be stopped at least three months before conception.

For those already using methotrexate, it’s not as simple as finding another medication.

Methotrexate is a drug that also works to suppress the immune system. This treatment can be essential for people diagnosed with cancer as part of a chemotherapy regimen, some autoimmune diseases such as lupus, rheumatoid arthritis, psoriasis and Crohn’s disease, or for those who have received an organ transplant.

“These are chronically ill patients who spend oftentimes years from the first date of the onset of the illness through diagnosis through a trial-and-error period to get themselves onto a medication where they’re able to live their lives,” Steven Newmark, chief legal office and director of policy for CreakyJoints, told ABC News. “And to see any kind of impediment put in place is horrific to say the least.”

Without access to this treatment, disease flares are more likely, which can prevent people from maintaining their daily responsibilities and negatively impact their quality of life.

Restricting methotrexate from women could mean that the standard of care will not be met for those experiencing a range of diseases beyond reproductive care in states where abortion is banned.

“In arthritis, women are disproportionately impacted by the disease, so it’s more likely that you’re going to see a woman show up to the pharmacy counter for a methotrexate prescription than a man. So, it’s kind of like this double whammy in that there are a few layers to this particular issue,” Anna Hyde, the vice president of advocacy and access, and Alisa Vidulich, the policy director for the Arthritis Foundation, told ABC News.

Alternative medications are not necessarily the answer.

Newmark told ABC News, “There are concerns that alternative medications, which is not always a proper one-to-one substitute, but even if you look at other medications, they may not be covered in the same manner by insurance and may be more expensive.”

“It’s a shame that other diseases are being affected by this,” Moritz added. “The doctor-patient relationship is sacred and now it’s being desecrated.”

Dr. Jade Cobern contributed to this article and is a resident in preventive medicine and pediatrics in Baltimore, Maryland, and a member of the ABC News Medical Unit.

Dr. Erica Jalal is an internal medicine resident physician at George Washington University and a member of the ABC News Medical Unit.

Copyright © 2022, ABC Audio. All rights reserved.

Biden to announce appointees to Cancer Panel, part of initiative to cut death rate

Biden to announce appointees to Cancer Panel, part of initiative to cut death rate
Biden to announce appointees to Cancer Panel, part of initiative to cut death rate
Official White House Photo by Adam Schultz

(WASHINGTON) — President Joe Biden will announce Wednesday his appointees to the President’s Cancer Panel, ABC News can exclusively reveal.

The Cancer Panel is part of Biden’s Cancer Moonshot Initiative, which was relaunched in February, with a goal of slashing the national cancer death rate by 50% over the next 25 years.

Biden will appoint Dr. Elizabeth Jaffee, Dr. Mitchel Berger and Dr. Carol Brown to the panel, which will advise him and the White House on how to use resources of the federal government to advance cancer research and reduce the burden of cancer in the United States.

Jaffee, who will serve as chair of the panel, is an expert in cancer immunology and pancreatic cancer, according to the White House. She is currently the deputy director of the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University and previously led the American Association for Cancer Research.

Berger, a neurological surgeon, directs the University of California, San Francisco Brain Tumor Center and previously spent 23 years at the school as a professor of neurological surgery.

Brown, a gynecologic oncologist, is the senior vice president and chief health equity officer at Memorial Sloan Kettering Cancer Center in New York City. According to the White House, much of her career has been focused on eliminating cancer care disparities due to racial, ethnic, cultural or socioeconomic factors.

Additionally, First Lady Jill Biden, members of the Cabinet and other administration officials are holding a meeting Wednesday of the Cancer Cabinet, made up of officials across several governmental departments and agencies, the White House said.

The Cabinet will introduce new members and discuss priorities in the battle against cancer including closing the screening gap, addressing potential environmental exposures, reducing the number of preventable cancer and expanding access to cancer research.

It is the second meeting of the cabinet since Biden relaunched the initiative in February, which he originally began in 2016 when he was vice president.

Both Jaffee and Berger were members of the Blue Ribbon Panel for the Cancer Moonshot Initiative led by Biden.

The initiative has personal meaning for Biden, whose son, Beau, died of glioblastoma — one of the most aggressive forms of brain cancer — in 2015.

“I committed to this fight when I was vice president,” Biden said at the time, during an event at the White House announcing the relaunch. “It’s one of the reasons why, quite frankly, I ran for president. Let there be no doubt, now that I am president, this is a presidential, White House priority. Period.”

The initiative has several priority actions including diagnosing cancer sooner; preventing cancer; addressing inequities; and supporting patients, caregivers and survivors.

The White House has also issued a call to action to get cancer screenings back to pre-pandemic levels.

More than 9.5 million cancer screenings that would have taken place in 2020 were missed due to the COVID-19 pandemic, according to the National Institutes of Health.

“We have to get cancer screenings back on track and make sure they’re accessible to all Americans,” Biden said at the time.

Since the first meeting of the Cancer Cabinet, the Centers for Disease Control and Prevention has issued more than $200 million in grants to cancer prevention programs, the Centers for Medicaid & Medicare Services implemented a new model to reduce the cost of cancer care, and the U.S. Patent and Trademark Office said it will fast-track applications for cancer immunotherapies.

ABC News’ Sasha Pezenik contributed to this report.

Copyright © 2022, ABC Audio. All rights reserved.

Experts reveal how likely reinfection is from COVID with spread of omicron subvariant BA.5

Experts reveal how likely reinfection is from COVID with spread of omicron subvariant BA.5
Experts reveal how likely reinfection is from COVID with spread of omicron subvariant BA.5
VALERIE MACON/AFP via Getty Images

(NEW YORK) — Early in the COVID-19 pandemic, the prevailing theory was that if someone was infected with the virus, they were immune — at least for a while.

But a growing number of Americans seem to be contracting the virus more than once.

A recent ABC News analysis of state data found that, as of June 8, there have been more than 1.6 million reinfections across 24 states, but experts say the number is likely much higher.

“These are not the real numbers because many people are not reporting cases,” Dr. Ali Mokdad, an epidemiologist with the University of Washington’s Institute for Health Metrics and Evaluation in Seattle, told ABC News.

The latest variant, BA.5, has become the dominant strain in the U.S., making up more than 65% of all COVID-19 cases as of Wednesday, according to data from the Centers for Disease Control and Prevention.

What’s more, studies have suggested that vaccines and previous infection do not offer as much protection against BA.5 compared to past variants.

However, there is little evidence to suggest that BA.5 causes more serious disease or is more deadly than previous variants.

Experts say the risk of reinfection has also increased due to the sheer number of Americans who’ve had a first infection and the dropping of mitigation measures, like mask-wearing, across the country.

Risk of reinfection was different pre-omicron

Before the omicron variant arrived in the U.S., experts said reinfection was far less likely.

“I would say that before the omicron variant, it was pretty rare for me to see reinfection,” Dr. Shira Doron, an infectious disease physician and hospital epidemiologist at Tufts Medical Center in Boston, told ABC News. “Sometimes we would see someone who appeared to have reinfection and we’d repeat the test and it turned out that the new test was a false positive.

“And PCR tests can stay positive for months so sometimes clinicians would say a patient had reinfection, but it was a persistent positive from their infection a few months earlier,” Doron said.

In fact, an April 2021 study from England published in The Lancet found that people with a previous history of COVID-19 infection were 84% less likely to be reinfected.

But that changed post-omicron. A March 2022 study from South Africa found an increased risk of reinfection with the emergence of omicron, BA.1, due to the variant’s “marked ability to evade immunity from prior infection.”

This has also rung true for the original omicron variant’s several offshoots, including BA.5.

“There are two things going for BA.5,” Mokdad said. “One is, it evades protection from vaccines and previous infection due to its mutation and it’s a super-spreader.”

“When you look at BA.5 specifically, your antibodies from BA.1 and BA.2 are not great at neutralizing BA.5,” Doron added.

However, she did point to a preprint study from researchers in Qatar, which has not yet been peer-reviewed, suggesting effectiveness from infection with pre-omicron strains was only about 15.1-28.3% effective against reinfection with omicron.

“I still believe from what I’ve seen that if you were infected with omicron — sure, you can get reinfected — but it’s much less likely you will” than if you were previously infected with delta, Doron said.

More people infected means higher chance of reinfection

Experts told ABC News the risk of reinfection hasn’t just risen because of the emergence of the BA.5 variant. It’s also because the total number of overall infections has increased.

In April, a CDC analysis estimated 58% of all Americans had antibodies indicating a prior COVID infection, meaning people never sickened by the virus are in the minority.

Doron said that by the nature of more people infected, especially two-and-a-half years into the pandemic, it means there will be more reinfections as well.

“In the pre-omicron era, the proportion of people who were infected is smaller than the proportion today, which is the majority of people,” Doron said. “As you increase the proportion of people who have been infected, you’re going to — by definition — increase the proportion of reinfections.”

People have changed their behaviors

Mokdad said another reason that the risk of reinfection is higher is because people’s behaviors have changed.

He said after the initial omicron wave in winter 2021-22, most Americans stopped wearing masks indoors and all states lifted their remaining mitigation measures.

The IHME, where Mokdad works, has tracked mask use over time and as of May 30, 2022 — the latest date for which data is available — found that just 18% of Americans say they always wear a mask in public. At the same time one year ago, that figure was 44%.

“Mask-wearing is the lowest since we started tracking it,” he said. “Even on planes, people don’t wear them. And now you have an invasive and an immune-escape variant and people not wearing a mask indoors.”

He said previous waves from different COVID strains — including alpha, delta and the original omicron variant — were likely mitigated due to a higher percentage of the public wearing masks in indoor spaces.

Copyright © 2022, ABC Audio. All rights reserved.

FDA authorizes Novavax COVID-19 vaccine for emergency use in US

FDA authorizes Novavax COVID-19 vaccine for emergency use in US
FDA authorizes Novavax COVID-19 vaccine for emergency use in US
Pavlo Gonchar/SOPA Images/LightRocket via Getty Images

(WASHINGTON) — Americans will likely have one more COVID-19 vaccine to choose from after the Food and Drug Administration issued an emergency use authorization for Novavax’s COVID-19 vaccine Wednesday.

The two-shot vaccine was authorized for use in people 18 years and older.

Novavax is the fourth COVID-19 vaccine to receive emergency use authorization in the U.S. by the FDA. The Centers for Disease Control and Prevention is now expected to review data on the vaccine before providing its recommendation for authorization.

“Authorizing an additional COVID-19 vaccine expands the available vaccine options for the prevention of COVID-19, including the most severe outcomes that can occur such as hospitalization and death,” FDA Commissioner Dr. Robert M. Califf said in a statement on Wednesday. “Today’s authorization offers adults in the United States who have not yet received a COVID-19 vaccine another option that meets the FDA’s rigorous standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization.”

The FDA said it had determined that the Novavax vaccine met the criteria for authorization, and that the data showed that the potential benefits of the vaccine outweighed any potential risks.

“The American public can trust that this vaccine, like all vaccines that are used in the United States, has undergone the FDA’s rigorous and comprehensive scientific and regulatory review,” said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.

Some health experts have suggested that some hesitant Americans may be more inclined to get the Novavax vaccine, as it is based on a more traditional protein-based technology, one already used for the flu vaccine and other shots, while Pfizer, Moderna and Johnson & Johnson’s vaccine platforms use more modern genetic technology.

The company applauded the agency’s decision to authorize the vaccine for emergency use.

“Today’s FDA emergency use authorization of our COVID-19 vaccine provides the U.S. with access to the first protein-based COVID-19 vaccine,” Stanley C. Erck, president and chief executive officer of Novavax, said in a statement. “This authorization reflects the strength of our COVID-19 vaccine’s efficacy and safety data, and it underscores the critical need to offer another vaccine option for the U.S. population while the pandemic continues.”

On Monday, the U.S. Department of Health and Human Services announced that the Biden administration had secured 3.2 million doses of Novavax’s COVID-19 vaccine. The vaccine will be made available for free to U.S. states and jurisdictions.

If the CDC signs off on use of the vaccine, the shots could be made available shortly thereafter.

To date, approximately two-thirds of the U.S. population has been fully vaccinated against COVID-19, according to federal data. However, more than 26.5 million American adults remain completely unvaccinated.

Copyright © 2022, ABC Audio. All rights reserved.

COVID hospitalizations forecast to increase amid concerns over new omicron subvariants

COVID hospitalizations forecast to increase amid concerns over new omicron subvariants
COVID hospitalizations forecast to increase amid concerns over new omicron subvariants
VioletaStoimenova/Getty Images

(NEW YORK) — For the first time since May, COVID-19-related hospital admissions are forecasted to increase again in the U.S., as highly infectious omicron subvariants continue to spread, according to updated forecasting models used by the Centers for Disease Control and Prevention.

The models show that nearly 40 states and territories are currently projected to see increases in new hospitalizations over the next two weeks. States in the South, including Arkansas, Louisiana, Mississippi and Texas, are expected to see the greatest increases in hospitalizations.

Nationally, between 3,200 to 13,800 daily confirmed COVID-19 hospital admissions are expected to be reported on Aug. 5. As of Wednesday, the U.S. is reporting nearly 5,800 virus-related hospital admissions each day, according to the CDC.

Hospitalization levels have already been increasing, with nearly 40,000 virus-positive Americans currently hospitalized, according to federal data. Totals are more than double the level they were at this time last summer, when the delta surge was beginning to emerge, and a growing number of COVID-19 positive people are also showing up to emergency departments, data shows.

In the South, where many states are forecasted to see notable increases, hospital admissions have risen by more than 20% in the last week.

Although the overall total remains significantly lower than at the nation’s peak, when more than 160,000 patients were hospitalized with the virus, hospitalizations are still at their highest point since early March.

The forecast also predicts that virus-related deaths will have either a stable or an uncertain trend in the next four weeks.

Even so, more than 5,700 deaths are still expected to occur nationally over the next two weeks. Texas, Oklahoma and California are projected to see the largest death tolls in the weeks to come.

“Deaths are still around 300, but hospitalizations are ticking up. This is something you don’t want to panic about, but we really need to pay attention to it because there are things that we can do to blunt that,” Dr. Anthony Fauci, a senior adviser to the president on the pandemic, told CNN on Wednesday.

Fauci and other federal health officials have been raising the alarm about omicron subvariant BA.5, which they say has been causing a resurgence of infections.

The U.S. is currently reporting more than 118,000 new cases a day, marking the country’s highest daily infection average since mid-February.

Fauci said the current reported case total is likely a “gross underestimate” as the majority of Americans are testing with home kits and not reporting their results to their local jurisdictions.

BA.5 is now the dominant variant in the U.S, accounting for an estimated 65% of new cases in the country. Scientists say it does appear to have a transmission advantage over the original omicron strain, although they do not believe it is more severe than prior strains.

“[BA.5] is certainly the most immune evasive. What we’re seeing is people who were previously infected getting reinfected at high rates, people who were vaccinated last year having a ton of breakthrough infections. It’s something we’re paying a lot of attention to,” White House COVID-19 Response Coordinator Dr. Ashish Jha told ABC News’ George Stephanopoulos on Good Morning America Wednesday.

However, Jha said the vaccines and boosters are still helping blunt the impact of severe disease.

Copyright © 2022, ABC Audio. All rights reserved.

Agencies weigh second COVID booster for more people; admin urges shots for those over 50

Agencies weigh second COVID booster for more people; admin urges shots for those over 50
Agencies weigh second COVID booster for more people; admin urges shots for those over 50
SDI Productions/Getty Images

(WASHINGTON) — Scientists at the nation’s top health agencies are looking into expanding vaccine eligibility so that more Americans can get a second booster shot during the latest COVID-19 wave, White House officials said on Tuesday.

“I know that the [Food and Drug Administration] is considering this, looking at it. And I know [Centers for Disease Control and Prevention] scientists are thinking about this and looking at the data as well. The decision is purely up to them,” Dr. Ashish Jha, the White House COVID coordinator, said at a briefing with reporters on Tuesday morning.

Dr. Anthony Fauci, chief medical adviser to the White House, said conversations about booster eligibility have been going on for a while. But he also reiterated that the final call lies with the FDA and CDC.

“We always talked about it, it’s not something new, but we all recognize what the lines of authority are and that’s what we’ll be depending on,” he said.

In May, FDA vaccine chief Dr. Peter Marks told ABC News that internal discussions were underway about second boosters for all adults.

Currently, everyone over 5 is eligible for an initial booster shot at least five months after their initial vaccination series. Everyone over 50 is recommended to get a second booster shot four months after their first, as is anyone who is immunocompromised.

But officials were clear on Tuesday that despite the potential for opening up second boosters to a wider population, there has been very low uptake among the older Americans who are already eligible — a problem because they are the most vulnerable to the virus.

“For people who are 50 years of age or older, my message is simple: If you have not gotten a vaccine shot in the year 2022 — if you have not gotten one this year — please go get another vaccine shot,” Jha said. “It could save your life.”

Jha also pushed people to start testing before gathering at big events, getting treatment like Paxlovid or monoclonal antibodies if infected with COVID and upping their use of face masks.

BA.4 and BA.5, the latest dominant COVID strains to spread in the U.S., are substantially more evasive of prior immunity, both from infection and from vaccines. Together, they currently account for around 80% of cases.

“The vaccine effectiveness against severe disease, fortunately for us, is not reduced substantially or at all compared to other omicron subvariants,” Fauci said Tuesday.

Jha said the White House was closely monitoring the subvariants and their impact.

“We’re encouraged that serious illness, hospitalizations and deaths have remained relatively low based on the level of infections. That’s not by coincidence, by the way. It’s not random,” Jha said, going on to tout “our successful vaccination program, our efforts to get people boosted and our incredibly focused effort on making sure that treatments and testing are widely available.” (The administration had faced criticism last year that testing wasn’t easily accessible nationwide.)

Still, Jha noted Tuesday that hundreds of people — far too many — were dying every day.

“We are experiencing about 300 to 350 deaths a day. That is unacceptable. It’s too high. And we will continue to use the infrastructure we have built and the tools we have to lower suffering and death as we manage BA.5,” he said, “and it is clear that with every American doing their part, we can get through the BA.5 infections together.”

What Americans can do to protect themselves

While Jha, Fauci and CDC Director Rochelle Walensky were all clear in their recommendations on Tuesday for the public to get up-to-date on their vaccines and boosters to fend off variants, the reality is murky for many Americans who have recently had COVID.

The CDC’s guidance is that people can wait up to three months after infection to get a shot — but reinfection with BA.5 could happen sooner than three months. Because the omicron subvariant is still new, there’s a lot scientists are still scrambling to learn.

“The overall principle is that we know immunity wanes with coronaviruses, whether that is infection or vaccination, and so if you’ve been infected or vaccinated and your time comes for a boost, that’s when you should go and get the boost,” said Fauci, who recently recovered from COVID.

“And I might say myself, having been someone who’s been vaccinated and infected, when we get the next round of having vaccines available, months later, I will be in line to get another boost after that,” he added.

The other factor many Americans are weighing is the new, omicron-specific vaccine that will be available beginning in October. Officials were adamant that anyone who gets a booster now will again be able to get one in the fall. But booster fatigue or hesitancy to get boosted twice within a span of a few months might prevent people from making that decision.

To that, officials said the benefit was worth it.

“People say, ‘Well, why do I want to get a prototype vaccine booster now, when I’m gonna have a variant-specific vaccine in four months or five months?'” Jha said.

“The biggest thing, and the data on this is very clear, is if you’re over 50, that extra booster dramatically lowers your risk of getting into the hospital, going into the ICU and dying. And there are very few things we do in medicine that have the kind of benefit that we see from that extra shot,” Jha said.

“And let me be clear: If you get vaccinated today, you’re not going to be ineligible to get the variant-specific vaccine as we get into the later part of fall and winter. So this is not a trade off,” he said. “We’ve got plenty. It’s a great way to protect yourself.”

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How Plan B works and why it’s not abortion

How Plan B works and why it’s not abortion
How Plan B works and why it’s not abortion
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(NEW YORK) — Since the U.S. Supreme Court’s overturning of Roe v. Wade, ending nearly five decades of a precedent that protected the constitutional right to an abortion, there has been a lot of public debate and confusion over what constitutes an abortion and what is considered legal.

Emergency contraceptive medications such as Plan B, also known as the morning-after pill, taken to prevent pregnancy after unprotected intercourse, have also been falsely interpreted by some as a form of abortion.

With no exact consensus, some states have defined “life” as beginning at conception or fertilization — the moment egg meets sperm. Meanwhile, the American College of Obstetricians and Gynecologists (ACOG) — the nation’s leading physician group for OB-GYNs — says complex medical concepts are being “misused” by state legislators.

“Conception and pregnancy are not the same thing,” said Dr. Elizabeth Schmidt, assistant professor of obstetrics and gynecology and director of family planning at North Shore University Hospital in New York. “Conception is not a medically recognized term.”

But doctors say the debate about when life begins shouldn’t have any bearing on Plan B, which works to stop pregnancy even earlier in the process — before fertilization, or conception.

What is Plan B?

Plan B is a progesterone hormone, which prevents ovulation or the release of an egg when taken at the appropriate time. This effectively prevents fertilization or the meeting of the sperm and egg for pregnancy. If taken after ovulation has already occurred, Plan B has no effect and there is no evidence that it harms an already established pregnancy, according to ACOG.

“Pregnant people make progesterone, and Plan B is a type of progesterone, so it makes sense that it would have no effect on a developing embryo,” Schmidt told ABC News.

Why is it confused with abortion?

Some of the confusion may stem from the Food and Drug Administration’s own website, which explains that Plan B “may prevent a fertilized egg from attaching to the womb (implantation).” The problem, experts say, is that this description is not accurate.

When the FDA first approved emergency contraception back in the late 1990s, it wasn’t totally clear how the pills prevented pregnancy, said Susan F. Wood, Ph.D., George Washington University professor and former director of the FDA’s Office of Women’s Health.

Now, she said, “new evidence [that has] been around for about 10 years now has shown that actually, Plan B works, probably essentially only through that first mechanism — blocking ovulation.”

Still, the FDA’s statement has been interpreted by some to imply abortion, resulting in objections to Plan B.

How does Plan B work?

“When used as emergency contraception, Plan B only affects ovulation,” Schmidt said. “Studies have failed to show any effect from levonorgestrel on the uterine lining when used as a one-time dose in emergency contraception.”

In a 2001 study published in Contraception, scientists looked at 45 women who were treated with short-term levonorgestrel administration — the same hormone found in Plan B — and observed no impairment in the lining of the uterus whether levonorgestrel was administered around or after ovulation. Previous studies on monkeys and rats have also failed to show a significant effect of the levonorgestrel hormone on uterine lining to prevent the implantation of a fertilized egg.

Taken collectively, this evidence suggests Plan B works primarily on the first step in the process — preventing the body from releasing an egg in the first place, or ovulating.

If the body has already released an egg prior to taking Plan B, the drug does not stop an egg from meeting sperm, and it does nothing to prevent a fertilized egg from implanting in the uterus.

Wood said given the current legal environment, the FDA should consider updating the language on its website “to pull Plan B out of the line of fire” from anti-abortion groups.

When reached for comment by ABC News, an FDA spokesperson did not comment directly on the language on its website but emphasized that “emergency contraception is used to reduce the chance of pregnancy after unprotected sex.”

“Plan B is an extremely safe medication and there are no medical contraindications to its use. It is safer than Tylenol — which is sold over the counter without restriction,” Schmidt said.

Although contraception currently remains legal throughout the U.S., the growing abortion restrictions in the country are now bringing some forms of contraception into question.

In his concurring opinion on the overturning of Roe v. Wade, Supreme Court Justice Clarence Thomas wrote that in the future, the court should reconsider other “demonstrably erroneous” precedents, including the 1965 ruling in Griswold v. Connecticut, which protects the right of married couples to buy and use contraception without government restriction.

“Limiting access to any medical care can have disastrous effects on communities,” Schmidt said. “It has been shown that states with restricted access to abortion also have higher rates of maternal and infant mortality. The situation is going to get even worse by prohibiting access to emergency contraception and abortion, which will disproportionately affect the most vulnerable and disadvantaged.”

Dr. Esra Demirel is a fellow in Minimally Invasive Gynecologic Surgery at NYU Langone Health and is a contributor to the ABC News Medical Unit.

ABC News’ Anne Flaherty contributed to this report.

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Drug company asks FDA for approval for OTC birth control pills

Drug company asks FDA for approval for OTC birth control pills
Drug company asks FDA for approval for OTC birth control pills
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(NEW YORK) — A French-based pharmaceutical company announced Monday that it has asked the Food and Drug Administration to sell over-the-counter birth control pills in the U.S., making it the first business to file an official application.

Perrigo’s HRA Pharma said it hopes that regulatory approval comes early next year.

“This historic application marks a groundbreaking moment in contraceptive access and reproductive equity,” Frédérique Welgryn, chief strategic operations and innovation officer at HRA Pharma, said in a statement.

“More than 60 years ago, prescription birth control pills in the U.S. empowered women to plan if and when they want to get pregnant,” Welgryn said. “Moving a safe and effective prescription birth control pill to OTC will help even more women and people access contraception without facing unnecessary barriers.”

Currently, hormone-based birth control pills require a doctor’s prescription because of health concerns such as blood clotting in some women. But most doctors say the risk is minimal for the vast majority of the population and note that pregnancy can carry its own significant health risks.

Reproductive rights advocates say an over-the-counter pill would make it easier for women without access to health care to obtain contraceptives.

“In the wake of the overturn of Roe v. Wade, we must pull out all the stops to make it easier and more affordable for everyone to secure contraception and take bold steps to protect women by ensuring that health — not politics — guides medical decisions,” said Michigan Gov. Gretchen Whitmer, a Democrat.

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

According to the Centers for Disease Control and Prevention, 65.3% of women aged 15 to 49 use contraception, with 14% taking pills.

The move comes weeks after the U.S. Supreme Court overturned Roe v. Wade, which granted people a constitutional right to an abortion for nearly 50 years.

Senate Republican Leader Mitch McConnell had said it was a relief, calling Roe v. Wade “one of the most egregious legal and moral mistakes of the 20th century.”

The fallout from Roe’s reversal has many people worried that the Supreme Court will overturn other constitutionally protected rights.

In his concurrent opinion, Supreme Court Justice Clarence Thomas called for the court to reconsider other cases, including Griswold v. Connecticut, which gave married couples the right to use contraception.

He also asked the court to reconsider Lawrence v. Texas, which protects the right to same-sex romantic relationships; and Obergefell v. Hodges, which establishes the right to same-sex marriage.

“In future cases, we should reconsider all of this Court’s substantive due process precedents, including Griswold, Lawrence, and Obergefell. Because any substantive due process decision is “demonstrably erroneous,” we have a duty to “correct the error” established in those precedents,” Thomas wrote.

ABC News’ Kiara Alfonseca contributed to this report.

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