(NEW YORK) — In yet another setback in the decadeslong scientific quest for an HIV vaccine, a Johnson & Johnson HIV vaccine candidate failed to reduce the risk of infection in a clinical trial among women in southern Africa. The would-be vaccine uses the same underlying technology used successfully for COVID-19 and Ebola viruses, but this recent high-profile failure is another example of immense challenge of creating a vaccine against HIV.
The trial, called Imbokodo, was co-sponsored by the Bill & Melinda Gates Foundation and the U.S. National Institutes of Health. It included more than 2,600 women living in five African countries where women and girls have a high risk of HIV infection.
The vaccine was safe, researchers said, but ultimately, efficacy was only 25% — meaning people who received the vaccine had a slightly smaller risk of developing HIV, but the difference was so slight that the result might be chalked up to random chance.
Prominent scientists, including Dr. Anthony Fauci, have been searching for an effective HIV vaccine since the virus, which attacks the immune system and leads to a disease called AIDS if left untreated, was first identified in the 1980s. Today, nearly 38 million people are living with HIV worldwide. Although effective treatments can now help people infected with HIV live long and healthy lives, there is still no vaccine that can prevent infection.
Still, scientists say they aren’t giving up.
“The development of a safe and effective vaccine to prevent HIV infection has proven to be a formidable scientific challenge,” Fauci said in prepared remarks. “Although this is certainly not the study outcome for which we had hoped, we must apply the knowledge learned from the Imbokodo trial and continue our efforts to find a vaccine that will be protective against HIV.”
“The challenges associated with the development of an HIV vaccine are unprecedented in the history of vaccinology. After 40 years of global efforts, we still do not have an HIV vaccine,” said Dr. Dan Barouch, director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center.
“This trial was not a home run but hopefully will guide the HIV field moving forward,” said Barouch, whose laboratory contributed significantly to the initial development of the investigational vaccine.
Despite the setback, the Imbokodo trial showed the vaccine was safe among people who received it — a hopeful sign. Imbokodo means “rock” in the South African language isiZulu, referring to a proverb about women’s strength and community.
“We are extremely grateful to the women who volunteered for the Imbokodo study, and to our partners, including the people on the front lines, all of whom are contributing every day to this enduring quest to make HIV history.” Dr. Paul Stoffels, vice chairman of the executive committee and chief scientific officer at Johnson & Johnson, said in prepared remarks.
The Johnson & Johnson HIV vaccine uses the same underlying “viral vector” technology used in its current COVID-19 vaccine. Scientists say the recent failure has no bearing on the technology itself, which has been used successfully for other viruses, including Ebola and SARS-CoV-2, the virus that causes COVID-19. Rather, HIV itself is a unique virus. It evades the body’s immune system, making it very difficult to create a vaccine that generates immunity against infection.
HIV activists and scientists alike say this result shouldn’t slow down other efforts to find an effective HIV vaccine.
“It is very disappointing that this particular vaccine candidate did not work in this trial, but the trial was well-conducted and got an answer quickly. HIV remains a global threat, and a safe, efficacious and accessible HIV vaccine is still needed to contribute towards curbing new infections and providing a durable end to the pandemic,” Mitchell Warren, executive director of HIV prevention advocacy organization AVAC, said in prepared remarks.
Another late-stage trial called Mosaico, which uses a slightly different vaccine approach and is being tested among men who have sex with men and transgender people in Europe and North America, will continue. Another study called PrEPVacc is combining HIV vaccine candidates with a once-daily pill called PrEP, which reduces the risk of HIV infection. Meanwhile, Moderna has said it will begin early-stage clinical trials of its own HIV vaccine candidate, which uses its mRNA technology, this year.
“This is in no way the end of the search for an HIV vaccine,” Warren said.
(NEW YORK) — From popular sayings like mommy juice, wine down, rose all day and happy hour to T-shirts that read “Mama needs wine,” the marketing of alcohol towards women in America is omnipresent.
And while women have historically consumed less alcohol than men, that trend is changing, increasingly to the detriment of women’s health, data shows.
The increases in alcohol consumption, binge drinking, and alcohol-related health issues are largely driven by women in their 30s and 40s. Over the past 20 years, as alcohol consumption among women has increased, the rates of death involving alcohol increased 85% among women, according to the National Institute on Alcohol Abuse and Alcoholism (NIAAA).
And this spring, amid the coronavirus pandemic, doctors across the country warned of anecdotal evidence showing increases in the number of hospitalizations and deaths caused by alcohol-related liver disease over the past year, particularly among young women.
Women have increased their consumption of alcohol during the coronavirus pandemic, data shows.
The increase in drinking among women comes as research shows that even one alcoholic drink per day can contribute to an increased risk of breast cancer for women. Women are also, research shows, at greater risk than men for health risks like alcohol-related cardiovascular diseases, liver disease and alcohol use disorder.
While the impacts of marketing and societal pressures have combined to make alcohol a common topic among women, talking honestly about how much they may be drinking and how it is affecting their bodies is still taboo, according to Dr. Jennifer Ashton, ABC News chief medical correspondent and a board-certified OBGYN.
“This is something that is really, really ripe with questions, emotions, myths, misconceptions, and unfortunately, stigma and taboo,” said Ashton. “There is a taboo about alcohol for women that is oftentimes not spoken about at all, or if it is spoken about, it’s whispered about.”
“Alcohol is, in fact, a type of drug, and yet, it is socially acceptable in our country, in our society, in our culture,” she added. “That can set up a potentially precarious situation, or relationship, for anyone.”
Here are six things women should know and talk about with their friends when it comes to alcohol, according to Ashton.
1. Serving size matters.
For women, a moderate alcohol intake per week is defined as seven servings of alcohol or less, according to the Centers for Disease Control and Prevention.
One serving of alcohol is defined as five ounces for wine and just one-and-a-half ounces for hard alcohol, far less than what is typically served in bars, restaurants and at home.
“You can do this experiment for yourself at home with water or wine, but let’s start with water,” explained Ashton. “You can take water, pour it into your wine glass to the amount that you think that you would serve yourself.”
“If you were having a glass of rose, for example, and then pour that water into a measuring cup, chances are it is going to be significantly more than five ounces. It might even be twice that amount,” she said. “So what you think is one drink, i.e., one serving, could actually be one-and-a-half or even two servings.”
Ashton continued, “It doesn’t matter whether it is one [alcoholic drink] a day or all on the weekends or spread out over a couple of days. If you’re drinking let’s say a margarita that’s made with three ounces of tequila, because it’s served in a giant, supersize, pretty glass, your seven drinks might actually be 21 drinks, 21 servings, and that qualifies as heavy alcohol consumption for a woman.”
For women, even eight or more drinks qualify as heavy alcohol consumption.
The National Institute on Alcohol Abuse and Alcoholism shares this graphic on how much alcohol a drink contains.
Ashton said that participating in Dry January — not consuming any alcohol for the month of January — for several years herself has taught her to keep a “mental tally” of the servings of alcohol she has per week.
“Now I kind of keep a mental tally of my servings per week so that I’m under that seven number that’s recommended, or acceptable, in the medical literature for alcohol consumption for women,” she said. “I just am aware of it very much like I would be aware of spending habits or my cardio exercise.”
2. Drinking alcohol can cause cancer.
Drinking alcohol is listed by the Department of Health and Human Services as a known human carcinogen.
“That means it’s known to be a contributing agent in the formation or development of various types of cancers,” said Ashton, noting that those cancers include cancer of the esophagus, liver cancer, colon cancer and breast cancer.
Women who consume about one alcoholic drink per day have a 5 to 9% higher chance of developing breast cancer than women who do not drink at all, and that risk increases for every additional drink a woman has per day, according to NIAAA.
3. Alcohol affects women differently than men.
Men can drink double the servings of alcohol each week and still stay within the moderate alcohol intake limits because their bodies metabolize alcohol differently than women, according to Ashton.
“Generally, women are smaller, the body fat distribution in a woman is different and their metabolism is different,” Ashton said. “So in general, two drinks for a woman could give you the blood alcohol level equivalent of one drink for a man.”
“That’s [why] it’s important to take a gender-specific approach to this issue and not lump men and women together,” she said.
4. The health effects of alcohol are worse than a hangover.
While women may talk or joke about the hangovers they have after drinking too much alcohol, what often goes unsaid, or even unknown, is what alcohol is doing inside their bodies.
“When you look at the possible effects of excessive alcohol consumption or heavy alcohol consumption for women, it ranges from head to toe,” said Ashton, citing health consequences including brain atrophy, cognitive issues, weight gain, negative effects on the heart and cardiovascular system, increased risk of alcoholic liver disease and fatty liver, increased risk of cancers and increased risks of accidents based on alcohol intoxication.
And just as women metabolize alcohol differently than men, they also face more serious health consequences, research shows.
Women are more susceptible to alcohol-related heart disease than men; alcohol misuse produces brain damage more quickly in women than in men; women may be more susceptible than men to alcohol-related blackouts, or gaps in memory; and women who regularly misuse alcohol are more likely than men who drink the same amount to develop alcoholic hepatitis, a potentially deadly condition, according to the NIAAA.
“We have to remember that almost anything, if done to excess, has the potential to be bad for us,” said Ashton.
5. Not all women may safely consume alcohol.
For women especially, there are times in their lives when it is not medically safe to consume alcohol.
Women who should completely avoid alcohol are those who are under age 21, the legal drinking age, those who are pregnant and those taking medications that can interact negatively with alcohol.
When it comes to pregnancy, research has proven that any amount of alcohol intake at any point in pregnancy can be harmful, according to the CDC. Still, CDC data shows that as many as one in nine women report drinking while pregnant.
Doctors advise against drinking while pregnant because alcohol in the mom’s blood passes through the umbilical cord to the baby and can cause everything from miscarriage and stillbirth and can increase the risk of fetal alcohol spectrum disorders which can cause physical, cognitive, and behavioral problems in children, according to the CDC.
Drinking during pregnancy is also associated with an increased risk of premature, or early, birth.
6. There are flags women can look for to know when drinking is too much.
“At this point, it’s pretty well known that it was a strategic marketing campaign on the part of the alcohol industry to target women, in particular moms, to make alcohol consumption cooler, more hip, more current,” said Ashton. “In terms of the medical, physical, psychological and societal implications of that, I think it’s really up to women that we have to be able to look in the mirror and ask ourselves, ‘Why am I reaching for this glass? Why am I reaching for this drink?'”
As a physician, Ashton said a red flag for her would be if a woman is answering that question all the time, “I feel so tense. I feel so stressed. I need it to help calm me down.”
Another “glaring red flag” for Ashton is if women find themselves drinking alone, looking to drink in more covert or hidden or cryptic environments or in situations where they’re hiding it from people.
For both of those red flag cases, Ashton suggests seeking medical help.
A “pink flag” for Ashton as a physician is if a woman answered the question of why she reached for an alcoholic drink by saying, “‘Because I feel like I deserve it. Because it’s been a tough year-and-a-half. Because it’s just the low-hanging fruit for me, and it’s better than doing something else.”
“That may be a time to say, ‘Is there something else going on emotionally, psychologically, in your environment, behaviorally, that could be targeted so that there are less potentially negative behaviors involved,” she said.
The good news for women is that help is available, and it starts by talking about their drinking, be it with a doctor, with a friend, with a loved one or with a mental health professional, according to Ashton.
“I can’t encourage women enough to speak up and seek help,” she said. “It takes massive courage. It can be incredibly scary. But the health consequences will sneak up on someone who is consuming too much alcohol.”
Describing the dangers of waiting too long to get help for drinking, Ashton continued, “Ultimately, it’s like a marble rolling off the edge of a table. Once it gets to that edge, it’s much harder to stop it.”
If you or someone close to you needs help for a substance use disorder, call the Substance Abuse and Mental Health Services Administration (SAMHSA) National Helpline at 1-800-662-HELP (4357) or visit FindTreatment.gov, SAMHSA’s Behavioral Health Treatment Services Locator.
(WASHINGTON) — The United States is facing a COVID-19 surge this summer as the more contagious delta variant spreads. More than 637,000 Americans have died from COVID-19 while over 4.5 million people have died from the disease worldwide, according to real-time data compiled by the Center for Systems Science and Engineering at Johns Hopkins University.
Just 61.2% of Americans ages 12 and up are fully vaccinated against COVID-19, according to data from the Centers for Disease Control and Prevention.
Latest headlines:
Here’s how the news is developing today. All times Eastern.
Aug 30, 11:48 am
Vaccine effectiveness against hospitalization drops, CDC says
The COVID-19 vaccines’ ability to keep people out of the hospital appears to be dropping slightly, particularly for those 75 and older, the Centers for Disease Control and Prevention announced Monday during an advisory panel.
The CDC has previously estimated that 97% of people in the hospital being treated for COVID-19 are unvaccinated, but that data was collected before the spread of delta, a hyper-transmissible variant that many doctors have warned appears to be making people sicker.
The latest CDC analysis estimates that the ability of the COVID vaccines to keep a person out of the hospital is now between 75% to 95%.
For people older than 75 in particular, vaccine effectiveness against hospitalization experienced the steepest decline, from more than 90% to 80% between June and July.
Health experts are also concerned that a person’s immunity could be waning over time, particularly among older people whose bodies are less likely than younger people to develop a strong immune response to the vaccines.
However, the vaccine still remains highly effective at preventing serious illness, according to the briefing.
(NEW YORK) — As many parents wait for COVID-19 vaccines to be authorized for children younger than 12, doctors increasingly are alarmed at the rising number of kids who are missing routine vaccinations — a trend that’s had a domino effect from last year, when so many families were confined to their homes.
Now, a new analysis finds that to catch up, community health centers may need to increase the number of childhood vaccinations by 265% — and maintain that pace for at least six months.
“The decline in routine pediatric immunizations is very concerning because measles, pertussis and chickenpox still remain threats to child health,” said Dr. Josh Sharfstein, a pediatrician and vice dean for public health practice and community engagement at the Johns Hopkins Bloomberg School of Public Health.
With in-person schooling restarting this fall, a growing chorus of doctors is now urging parents to make sure their children receive their routine pediatric vaccinations, which run along a specific schedule. For example, babies are supposed to get their measles, mumps, rubella vaccination near their first birthday. By age 11, it’s time to be vaccinated against human papilloma virus.
But with so many children missing these routine immunizations, doctors are now warning of a potentially sharp uptick in vaccine-preventable diseases, which may coincide with a potentially difficult flu season if children also are receiving fewer flu shots.
“We now face the double challenge of keeping children safe from the delta variant and making sure they’re not falling ill from other preventable diseases as they return to in-person schooling,” Sharfstein said. “The next year will be an immense challenge for parents, pediatricians, teachers and school administrators to protect children.”
HealthEfficient, a not-for-profit organization in New York that supports community health centers nationwide, has been tracking childhood immunization rates since the beginning of the pandemic.
“Our data shows a substantial and persistent drop in the number of childhood immunizations occurring over the last two years,” Alan Mitchell, the group’s executive director, told ABC News. “The numbers in 2021 are in some cases even lower than 2020, and 2020 already represented a large drop-off from 2019.”
Analysis by the Centers for Disease Control and Prevention of high-performing immunization information systems from 10 jurisdictions in the U.S. showed that administered doses of routine childhood and adolescent vaccines were substantially lower from March to May 2020 compared with that same time period in 2018 and 2019.
A study conducted by a team at the Institute for Health Metrics and Evaluation at the University of Washington found a similar drop-off in vaccination rates throughout the world, with the most significant decrease seen in April 2020. Data from the World Health Organization and UNICEF shows that at least 23 million children missed routine vaccinations in 2020 because of the disruption in health services.
“Any time there is a decrease in vaccination rates, this lowers herd immunity and increases the potential for an outbreak, as we saw for measles in Minnesota in 2017 and in New York in 2018-2019,” said Dr. Keila Lopez, an associate professor of pediatrics at Baylor College of Medicine/ Texas Children’s Hospital.
“These declining immunization rates risk reversing years of gains via public health efforts to improve pediatric immunization trends,” Mitchell said. “In our view, a sustained, coordinated public health initiative is needed to drive these rates back up to pre-pandemic levels.”
Experts recommend restoring vaccination services and campaigns, helping health care workers and community leaders educate the public about the importance of vaccinations, identifying and rectifying vaccination gaps in individual communities, making sure COVID-19 vaccinations don’t affect the routine childhood vaccination drive, and implementing plans to prevent and respond to outbreaks of vaccine-preventable diseases.
The impact of the pandemic can be felt as a ripple through other serious conditions that make catching up even more critical.
Health care providers and schools should assess the vaccination status of all pediatric patients, including adolescents, and contact those who are behind schedule to ensure all children are fully vaccinated, experts told ABC News. Furthermore, more public health campaigns to combat misinformation and reinforce the overwhelming value of vaccines also could help, and community health centers have a critical role to play.
“Based on the current delta surge impacting higher numbers of children, school reopening’s with varied public health practices and more frequent quarantines,” Lopez said, “I fear that routine and flu vaccine acquisition will fall even lower this season.”
Tushar Garg, M.D., an incoming postdoctoral research fellow at Johns Hopkins Hospital, is a contributor to the ABC News Medical Unit. Jay Bhatt, D.O., an internist and adjunct faculty at the UIC School of Public Health, is an ABC News contributor.
(WASHINGTON) — Public health officials are sticking with the recommendation that people get booster shots eight months after getting the COVID-19 vaccine, but that could change based on reviewing the data, Dr. Anthony Fauci said on Sunday.
“We’re still sticking with the eight months,” the chief medical adviser for the White House told ABC “This Week” co-anchor Martha Raddatz. “However, as we’ve said, even in the original statement that came out, we’re gonna have to go through the standard way of the (Food and Drug Administration) looking at the data and then the Advisory Committee on Immunization Practices. So although we’re sticking with eight, we’re remaining flexible, that if the data tells us differently, we’ll make adjustments accordingly. But for now, we’re sticking with the eight.”
As the U.S. prepares a COVID-19 vaccine booster shot program, President Joe Biden said on Friday that the administration is considering whether booster shots should be given as early as five months after vaccination. Biden was meeting with the Israeli prime minister and credited his advice that the U.S. should start earlier.
The new daily COVID-19 case average in the U.S. has risen to 142,000, and is 130,000 daily cases higher than the average was about two months ago, as of Thursday. The U.S. has also continued to experience its steepest rise in COVID-19 related hospitalizations since the winter of 2020, with more than 101,000 patients hospitalized across the country with COVID-19. This marked the highest number of patients hospitalized with the virus in seven months.
Pediatric hospital admissions for children under 18 with COVID-19 were also up by 514% since July Fourth, as of Friday.
Regarding when children under 12 will be eligible to receive the COVID-19 vaccine, Fauci said that the FDA should be examining the data toward the middle or end of September.
“Hopefully we’ll be acting quickly, depending on the data, and their assessment of the risk-benefit ratio,” Fauci said.
But the nation’s top infectious disease doctor also emphasized that there are other ways to protect unvaccinated children as they head back to school amid a surge in COVID-19 cases, fueled by the delta variant of the virus.
“You can protect children who can’t get vaccinated because of their age. Yes, we can protect them by surrounding them with a community of people who are vaccinated. That’s how you protect children. And you also do it by complying with the CDC guidance about masking, particularly masking in school, even though you have vaccinated teachers and vaccinated personnel. You want to give that extra, added level of protection for the children.”
Fauci also addressed an unclassified report released on Friday by the intelligence community that did not come to any definitive conclusion over the origins of the coronavirus first detected in Wuhan, China. The agencies that worked on the report wrote that two hypotheses are still possible: “natural exposure to an infected animal” or “a laboratory-associated incident.”
When asked if the origins will ever be known, Fauci said, “You know, I hope so … because it will help us to avoid this in the future. But we will need the cooperation of Chinese scientists and Chinese public health officials, if we’re gonna do the proper surveillance serologically of people who were infected in China, as well as the animals; being able to asses whether or not animals had viruses that are closely related to SARS-COV-2. We’ll need to do that in China with the cooperation of the Chinese,” Fauci said.
ABC News’ Arielle Mitropoulos contributed to this report.
This is a developing news story. Please check back for updates.
(NEW YORK) — A new, peer reviewed study estimates that the delta variant of COVID-19 doubles the risk of being hospitalized compared to the prior alpha variant among unvaccinated people.
The delta variant is the most highly transmissible strain seen yet, first emerging in India in late 2020 and quickly sweeping the globe. But scientists have debated whether this variant is also deadlier.
Preliminary studies from Scotland and Canada hinted that this version of the virus might be making people sicker, but some researchers said this could also be explained by the variant’s hyper-transmissibility, which leads to massive COVID surges that overwhelm hospitals.
This new study, published in the peer-reviewed journal Lancet Infectious Diseases, adds increased evidence that the delta variant is more likely to send people to the hospital than the previously dominant alpha variant.
This doesn’t apply if you’re vaccinated, researchers say. Vaccines dramatically reduce the risk of hospitalization and death for both the alpha and delta variants. Most of the people in the U.K. study were unvaccinated.
“Our analysis highlights that in the absence of vaccination, any Delta outbreaks will impose a greater burden on healthcare than an Alpha epidemic,” said Dr. Anne Presanis, one of the study’s lead authors and senior statistician, MRC Biostatistics Unit, University of Cambridge, in prepared remarks.
In one of the largest studies yet looking at this question, U.K. researchers analyzed medical records of more than 40,000 COVID cases from March to May, roughly 20% of which were delta variant infections. By measuring what happened to people within 14 days of testing positive, researchers found that people infected with delta were more likely to seek medical care at a hospital or emergency room compared to people infected with the alpha variant.
“This is a large study that suggests a slight increase in [emergency department] visits and hospitalizations among unvaccinated persons infected with delta versus alpha,” said Dr. Carlos Del Rio, executive associate dean of the Emory School of Medicine and Grady Health System in Atlanta.
“But to me, what the paper says more about delta is the fact that vaccines work,” Del Rio said.
In the United States, the delta variant was first identified in March and had become the dominant variant by July. It has led to a massive surge among mostly unvaccinated people, including many young adults and children, who are less likely to be vaccinated than older adults.
“I know from anecdotal reports here in the U.S. that we are seeing more serious infections with the delta variant than the alpha variant, and these data support that,” said Dr. Anna Durbin, an associate professor at the Johns Hopkins University School of Medicine.
“I think this is a trend we are seeing in the U.S. where pediatric ICUs are filling up and we are seeing young adults requiring intubation at a much higher rate than with the alpha peak in early 2021,” Durbin said. “I am confident that we are seeing more severe illness in younger people with the delta variant.”
In early August, National Institutes of Health Director Dr. Francis Collins said there wasn’t enough data yet to be confident that the delta variant is more serious for children, but preliminary evidence so far is “tipping in that direction.”
The Pfizer vaccine is currently authorized for children ages 12 and older, with authorization for children 5 to 11 expected sometime this winter. Roughly half of children ages 12 to 17 have received their first shot, according to White House Coronavirus Response Coordinator Jeff Zients, speaking at Friday press briefing.
-ABC News’ Cheyenne Haslett contributed to this report.
(WASHINGTON) — U.S. intelligence agencies remain “divided on the most likely origins of COVID-19,” after President Joe Biden’s 90-day push for his intel community to “redouble their efforts” to find a more definitive conclusion regarding the source of the virus.
In a declassified summary released late Friday afternoon, the agencies said that two hypotheses for the virus’ origin remain possible: either natural exposure to an infected animal, or an accidental lab leak.
Four elements of the U.S. intelligence community said with “low confidence” that COVID-19 was initially spread from an animal to a human, while one element assessed with “moderate confidence” that the first human infection was the result of a “laboratory-associated incident, probably involving experimentation, animal handling, or sampling by the Wuhan Institute of Virology,” and pointing to the “inherently risky nature of work on Coronaviruses.”
The agencies, however, generally agreed that the virus was most likely not developed as a biological weapon, and that China’s leaders did not know about the virus before the start of the global pandemic.
Barring new information, said the report, a more definitive explanation will not be possible without Beijing’s cooperation.
Biden, responding to the report, said that efforts to identify the cause of the virus will continue.
“While this review has concluded, our efforts to understand the origins of this pandemic will not rest,” Biden said. “We will do everything we can to trace the roots of this outbreak that has caused so much pain and death around the world, so that we can take every necessary precaution to prevent it from happening again.”
Referring to China, the president said, “Responsible nations do not shirk these kinds of responsibilities to the rest of the world. Pandemics do not respect international borders, and we all must better understand how COVID-19 came to be in order to prevent further pandemics.”
But international scientists tasked with studying the virus’ origins warned Wednesday that a crucial window is “closing fast”: the shrinking opportunity for any thorough scientific study to be completed. As time wears on, potential evidence wanes, and tracing back biologic breadcrumbs will yield diminishing returns, said more than ten of the authors of a World Health Organization-led report that is urging action to “fast-track the follow-up scientific work required” for better answers by the WHO.
Assessing the intelligence and raw data available this spring, it became apparent to Biden and his top officials that a large cache of information had yet to be fully analyzed, officials told ABC News — including potential evidence that could hold clues to the virus that has now claimed more than four million lives worldwide.
Consensus among top officials in the Biden administration has been that the pandemic originated in one of two ways: The virus emerged from human contact with an infected animal, or from a laboratory accident.
But with no “smoking gun” and limited access to raw data, discussion of the science has played out in a haze of circumstantial evidence.
Following Biden’s call for clarity in May, intelligence agencies have spent the last three months poring over an untapped trove of information, and have amassed classified records and communications, genomic fingerprints of the virus, and early signals as to where and when the virus may have flared up first.
Biden’s August deadline marks zero hour for the next phase of a larger international quest: to trace back the virus in order to hold the responsible parties to account, and to understand its inception in order to prevent the next one.
Any emerging answers, however, come amid a roiling geopolitical debate, as COVID-19’s origins have become a contentious wedge issue at home — while abroad, the Chinese government vehemently denies the virus could have come from one of its labs.
“What the U.S. cares about is not facts and truth, but how to consume and malign China,” Chinese Foreign Ministry Spokesperson Zhao Lijian said Wednesday ahead of the U.S. report, claiming that China had welcomed collaborative research which “laid the foundation for the next-phase global origins tracing work.”
The Chinese government rejected the World Health Organization’s proposed audits of Wuhan’s labs in July, part of the UN agency’s recommended phase two study — saying they could not accept needless “repetitive research” when “clear conclusions” had already been reached.
But there have been no definitive conclusions as to where COVID-19 came from. The joint WHO-led team presented a range of options in their March report, calling a lab leak “extremely unlikely,” but offering pathways for further investigation. Team members have voiced frustration with the lack of cooperation from the Chinese government — echoed in international criticism that politics had stymied science.
Since then, the WHO has become increasingly receptive to the possibility that the virus resulted from a lab leak. In July, WHO Director-General Tedros Adhanom Ghebreyesus acknowledged that ruling out a lab leak theory was “premature” and recommended audits of the Wuhan labs in further studies. China’s subsequent rebuff left the WHO to proceed without them.
White House National Security Adviser Jake Sullivan has underscored that the U.S. will continue the “diplomatic spadework” of rallying support for the WHO-led study — while warning that the administration will not accept Beijing’s stonewalling.
“Either they will allow, in a responsible way, investigators in to do the real work of figuring out where [COVID-19] came from, or they will face isolation in the international community,” Sullivan told Fox News in June.
A group of bipartisan lawmakers urged Biden not to let this month’s deadline hamstring a thorough investigation.
“If the 90-day effort you have announced does not yield conclusions in which the United States has a high degree of confidence, we urge you to direct the intelligence community to continue prioritizing this inquiry until such conclusions are possible,” Sens. Mark Warner (D-Virginia) and Marco Rubio (R-Fla.) of the Senate Intelligence Committee and Jim Risch (R-Idaho) and Bob Menendez (D-N.J.) of the Senate Foreign Relations Committee wrote in a late July letter to the president.
Asked about the report’s release, White House Press Secretary Jen Psaki said it would take “several days” for an unclassified and collated version to come together, but that agencies were working “expeditiously to prepare that.”
With no definitive proof of the virus’ origin, scientists and policymakers alike have been left to speculate. Some of the first COVID-19 clusters occurred around Wuhan’s wet markets, where exotic wild fare was sold in close quarters, offering ample opportunity for the virus to jump from animals to humans, as in past epidemics.
No direct animal host for COVID-19 has been identified, and if there is one, it could take years to find, experts say. While environmental samples from the Wuhan markets tested positive, animal samples that were tested did not. Transmission earlier on and within the wider community would suggest the market was not the original source of the pandemic, experts say.
In late summer and early autumn of 2019, satellite imagery shared exclusively with ABC showed dramatic spikes in auto traffic around major Wuhan hospitals — suggesting the virus may have been spreading long before the world was alerted. U.S. intelligence officials had already been warning that a contagion was sweeping through the region as far back as late November 2019, changing patterns of life and business and posing a threat to the populations, according to sources briefed on the matter.
Proponents of the lab-leak theory point to gain-of-function research conducted at the Wuhan Institute of Virology, a controversial study that amplifies a virus’ potency to understand how to neutralize it better. They also point to concerns over biosafety at the WIV’s facilities, where researchers had worked with bat coronavirus samples 96% similar to SARS-CoV-2 — as well as workers at the lab who were hospitalized with “symptoms consistent with both COVID-19 and common seasonal illnesses” in November 2019.
Advocates of zoonotic origin, however, emphasize that the 4% discrepancy means a world of genetic difference — and WIV lead researcher Shi Zhengli insists that she tested all her workers for COVID-19 antibodies, and all tests came back negative.
Despite pressure to approach the “high degree of confidence” desired by the public and requested in the lawmakers’ July letter, such certainty remains elusive — something presaged by Director of National Intelligence Avril Haines in an interview with Yahoo News earlier this summer.
“We’re hoping to find a smoking gun,” Haines said. “It’s challenging to do that.”
-ABC News’ Josh Margolin, Karson Yiu, James Gordon Meek, Eric M. Strauss, Ben Gittleson and Molly Nagle contributed to this report.
(NEW YORK) — As many children return to in-person learning and adults end a period of working from home, experts are concerned about the upcoming flu season and its implications for hospitals that are already pushed to the limits of capacity due to the COVID-19 delta variant.
Flu season usually runs from October to May, with experts suggesting the best time to get vaccinated is from early September to the end of October, although some major retail pharmacies have already begun advertising this year’s supply.
“We should always prepare for the flu season by planning to get vaccinated. This fall and winter there is likely to be circulation of COVID, influenza as well as other respiratory viruses,” said Dr. David Hirschwerk, an infectious disease specialist at Northwell Health in New York.
For some, that might mean getting vaccines for the flu and COVID-19 at the same time — either a booster shot or primary COVID-19 vaccination. Either way, the Centers for Disease Control and Prevention say it is safe to get the COVID and flu vaccines during the same visit.
“There is currently no contraindication to receiving both at the same time and for many people, this will be the most convenient way to handle it,” said Hirschwerk.
Experts say that with multiple viruses now circulating, every bit of protection helps.
Other seasonal respiratory viruses — such as RSV and adenovirus — have proven unpredictable, surging during the summer, a time typically outside their regular season.
By the same token, it’s not possible to predict the severity of the 2021-2022 flu season. Public health officials like to say if you’ve seen one flu season, you’ve seen one flu season — meaning every year starts and ends at different times, with different strains and different severities. Some worry the low number of cases last year during remote learning and work from home situations — as well as people wearing masks when they were in public — could be the calm before a very severe flu season this year.
Influenza activity during the 2020-2021 season was at a record low despite high levels of testing. Less than 1% of tested respiratory samples were positive for the flu. For comparison, the prior three flu seasons showed positive tests for influenza between 26% and 30%.
During the 2019-2020 season, 38 million people became sick with flu, resulting in more than 400,000 hospitalizations and 22,000 deaths.
A major contributor to the low cases of flu during 2020-2021 was a record number of flu vaccinations. An estimated 193.8 million doses were distributed in the U.S. during the 2020-2021 season.
Many primary care doctors, especially pediatricians, are playing catch-up when it comes to making sure that everyone is getting their routine vaccinations as the COVID pandemic resulted in many maintenance visits being canceled or rescheduled.
While children under 12 are not yet eligible for the COVID vaccine, those ages 6 months and older are strongly encouraged to get the flu vaccine. Many school districts insist on it.
“The first time a child gets the flu vaccine, it’s two doses, not just one, so people should plan for that,” said Dr. Eric Cioe-Pena, emergency medicine specialist at Staten Island University Hospital.
Annual flu vaccines are especially important for children ages 6 months to 4 years, adults aged 50 and older, nursing home residents, people with underlying health conditions such as heart disease and lung disease, people who are immunosuppressed and people who are pregnant.
By now, most people are aware that vaccines prevent serious illness for the individual getting the vaccine and for those around them who are more vulnerable to severe illness. In a typical year, hundreds of children die from the flu. The CDC estimates that an average of 36,000 adults have died of the flu each year over the past decade. The worst recent flu season was 2017-2018, when 61,000 people died, according to the CDC.
“It is very important that all children (6 months and older) receive the flu vaccine. This helps to reduce risk of infection, of severe complications from flu, and it protects the entire household and communities by reducing transmission to others,” said Hirschwerk.
To vaccinate as many individuals as possible, vaccine makers are producing large quantities of several types of flu vaccine. Flu vaccines are typically made using a process that involves eggs, but alternative vaccines will be available for people who have egg allergies.
Getting vaccination is a key step in preventing the flu and decreasing transmission, experts say. Continuing mitigation measures are also likely to keep any influenza surges at bay, especially as the country to struggles to cope with the devastation caused by COVID-19.
“Mask-wearing has significantly curbed the spread of influenza,” said Cioe-Pena. “Wash your hands, wipe down commonly touched surfaces like keyboards, phones and door knobs. Stay home when you are sick, and wear a mask.”
(NEW YORK) — The Centers for Disease Control and Prevention announced an investigation into an outbreak of Salmonella that may be linked to Italian-style meats.
They reported 36 illnesses and 12 hospitalizations across 17 states and found that most people ate Fratelli Beretta brand uncured antipasto trays before they became ill, according to a release on Thursday.
This does not include Italian-style meats sliced at a deli.
No deaths have been reported.
The CDC is advising people not to eat Fratelli Beretta brand pre-packaged uncured antipasto trays, including uncured salami, prosciutto, coppa or soppressata. The trays were sold nationwide and have “best by” dates on or before Feb. 11, 2022.
The investigation is ongoing to determine if additional products are linked to illness. ABC News has reached out to Fratelli Beretta for comment, but has not heard back at this time.
(CHESTERFIELD, Mo.) — Dr. Steven Brown is on the front line of the battle against the surge of COVID-19 cases. But for him, the front line is also the home front.
Working overnights, the 66-year-old critical care specialist manages hundreds of intensive care unit patients in hospitals across the Midwest, more than half of them COVID cases, many on ventilators. And he does it from his living room in suburban St. Louis.
Sitting before an array of four large computer screens and two laptops, he compares his work to that of an air traffic controller. He can read charts, scans, X-rays and even look in on patients with the help of sophisticated cameras in the ICUs.
“Each room has its own camera in it and I’m remotely operating it,” he told ABC News.
So despite being distant from his patients, his care is intimate. “I can look in a throat. I can look at how they’re using their muscles of respiration and whether they have disordered breathing. I’m able to do extreme fine-tuning of the ventilator settings for patients.”
And lately, more and more of his cases are COVID patients on ventilators. On his regular 12-hour shifts, he reports that the “amount of disease I am seeing is amplified. While some critical care doctors on a night shift might be managing eight or 10 patients with COVID-19 who are on ventilators for their shift, I’m managing 10 times as many because I’m managing patients in multiple sites.”
Remote care is not new for Brown, who had been working that way alongside colleagues at Mercy Virtual Care Center for more than 12 years. However, age and other factors put him at higher risk for COVID-19. So, when the pandemic struck, he got installed in his home the equipment needed to continue working there and has done so now for more than a year and a half.
“There are a lot of telemedicine physicians and providers and vendors out there,” Bethany Pope, spokesperson for Mercy Virtual, told ABC News. “There are likely very few who are doing critical care medicine from home.”
Working from home, however, does not mean working less. Brown forecasts that the surge in the disease will mean a surge in his already grueling work schedule, from 10 straight days of 7 p.m. to 7 a.m shifts to 12 days in a row or more.
But while the current situation is grim, he thinks a good outcome is still possible, perhaps even a Hollywood ending. “Initially this felt, at the end of 2020, as being like the end of the first original Star Wars movie,” he said. “We’re in the ‘Empire Strikes Back’ right now with the delta variant. And we’re going to have a happy sequel, but there’s a lot of work ahead for us.”
