As booster shots roll out nationwide, scientists stress original vaccines are still working

As booster shots roll out nationwide, scientists stress original vaccines are still working
As booster shots roll out nationwide, scientists stress original vaccines are still working
carmengabriela/iStock

(NEW YORK) — Amid a nationwide campaign to promote COVID-19 booster shots, vaccine scientists and public health experts say vaccines are still holding up remarkably well for most people — depending on how effectiveness is measured.

In fact, many scientists now worry that the recent booster shot authorization could give the false impression that existing vaccines are no longer offering protection.

“They all work well,” said Dr. Paul Goepfert, an infectious disease physician and director of the Alabama Vaccine Research Clinic. “They aren’t perfect by any means. But if your bar is prevention of hospitalizations in the United States, they still work incredibly well.”

A vaccine’s effectiveness can be measured in several different ways. One is their ability to protect people from mild infections. When first authorized, Pfizer and Moderna’s vaccines proved 95% and 94% effective using this threshold, and Johnson & Johnson’s single-shot vaccine proved 75% effective.

“No vaccine entirely prevents disease,” said Dr. Anna Durbin, an associate professor at the Johns Hopkins University School of Medicine.

Even protecting from mild infections is “a high bar for a vaccine,” said Dr. Paul Offit, an FDA advisory panel member and director of the Vaccine Education Center at Children’s Hospital of Philadelphia.

And even if a vaccine achieves that high bar, t quickly starts waning. Antibodies, which protect against infection, surge after vaccination — but then rapidly fade. Other parts of the immune system, like T cells and B cells, remain more stable over time, protecting against severe disease and death.

Scientists and public health experts say what really matters is a vaccine’s ability to prevent severe illness and hospitalization. And on that metric, all three vaccines performed well from the start — each more than 90% effective — and have remained relatively stable, even through the emergence of a new delta variant

“It’s the unusual vaccine that protects you against mild illness,” Offit said. “It’s OK to get infected. It really is. You just don’t want to get seriously infected.”

A comprehensive study from New York state offers a glimpse of this phenomenon, finding that all three vaccines remained roughly 86% effective when it came to reducing the risk of being hospitalized with COVID-19 from May to August.

But over the same time frame, all three lost some ability to protect against breakthrough infection. Though vaccine efficacy started from a high point, from May to August, efficacy of the Pfizer vaccine declined by 25% to 14% depending on age, the Moderna vaccine declined 18% to 9% and the Johnson & Johnson vaccine declined 19% to 11%.

When it comes to booster shots, experts agree there are some people who clearly need them — chiefly, people with weakened immune systems and the elderly, who also mount a less robust immune response.

Today, more than 13 million people in the United States have already received a booster shot. Moderna and Pfizer vaccines are authorized six months after the first shot for those 65 and older, and those at high risk of developing COVID-19. Johnson & Johnson boosters, meanwhile, are authorized for anyone at least two months after the first shot. After the Pfizer booster shots were authorized, CDC director Rochelle Walensky said it was a “walk, don’t run” situation, during a conversation with The Atlantic.

“There is no doubt that if you were to get a booster every two months or so, you may prevent all symptoms,” Durbin said. “But there’s a cost to that.”

It’s expensive, for one. And there are concerns that frequent boosting could dull the immune system’s ability to fight future variants, because the boosters could focus the immune response on the COVID-19 strain used to make the current vaccines.

Widely publicized concerns about breakthrough infections may have “focused the conversation prematurely on the need for boosters,” said Dr. John Brownstein, an epidemiologist at Boston Children’s Hospital and an ABC News contributor.

“Concerns about waning immunity and breakthrough cases have likely been overblown,” Brownstein said.

And boosters for the vaccinated — while offering a temporary shield against mild infection — are unlikely to dramatically turn the tide of the pandemic.

“Boosting is not going to be what’s going to be the issue for us as a country,” said Goepfert. “It’s finding the people who are still unvaccinated.”

Copyright © 2021, ABC Audio. All rights reserved.

How schools plan to keep students safe from COVID as cold weather arrives

How schools plan to keep students safe from COVID as cold weather arrives
How schools plan to keep students safe from COVID as cold weather arrives
kali9/iStock

(NEW YORK) — As colder temperatures begin to settle in for many parts of the nation, schools are set to lose critical tools to keep students and staff safe from coronavirus spread, such as extended outdoor time and open windows.

Despite this disadvantage, medical experts and physicians say elementary and middle school administrators can still limit the spread of the virus during the next couple of months as the vaccine rollout begins for younger age groups.

“Hopefully this year will not lead to the surge we saw last winter,” Dr. Anne Liu, clinical associate professor of medicine and pediatrics at Stanford Health, told ABC News.

Liu and other experts said the best thing schools can do is to maintain masking indoors, consistent testing, proper hand-washing practices and social distancing where applicable.

While not all schools will have up-to-date ventilation systems, masking indoors will ensure that the virus doesn’t spread among students, she said. Testing will also help keep any potential cases and outbreaks from spreading, according to medical experts.

Dr. Allison Bartlett, associate professor of pediatric infectious diseases at the University of Chicago Medicine, told ABC News that schools have already gotten into the habit of implementing these measures and, most importantly, kids have become accustomed to wearing masks.

“We now have months of experience in the real world in school settings in terms of COVID transmission and how effectively masking in schools works,” she said.

Dr. John Brownstein, an epidemiologist at Boston Children’s Hospital and an ABC News contributor, noted that mass rapid testing has also helped schools stop the spread and will be essential to keeping schools open during the winter.

“This allows kids that may have had an exposure to test and stay in school as long as they have daily negative test results,” Brownstein said.

Bartlett and other medical experts who have been studying pediatric coronavirus cases said the best tool against coronavirus spread in schools during the winter will be the approval of COVID-19 vaccines for younger students.

The U.S. Food and Drug Administration voted Tuesday to allow the Pfizer mRNA vaccine to be used for 5-to 11-year-olds. The U.S. Centers for Disease Control and Prevention are slated to vote on approving the vaccine for that age group as early as next week.

The Pfizer vaccine has been available to anyone over 12 since the spring after it was given an emergency use authorization. The FDA fully approved the Pfizer vaccine for anyone 16 and older in August.

Liu, who reviewed the data Pfizer sent to the FDA last week on 5- to 11-year-olds, said the clinical trials have shown the vaccine to be very effective at preventing severe illness, hospitalizations and deaths among that age group, so as more kids receive their doses, the safer classrooms will be in the winter.

Although it will take about five weeks for a student to be fully vaccinated from both doses, including the two-week period to build immunity after their second dose, Liu said that young students will be in a better place the minute they start their vaccination process.

“One shot alone provided strong protection based on that data,” she said.

Bartlett, who has three sons, two of whom are under 12, said that if the vaccines are approved in November, it would ensure that students have that protection preceding the holidays when they are likely to be celebrating indoors with large groups of people.

Coming back from winter break, schools will be able to mitigate any loss of outdoor space and or decreased ventilation if more of their students are vaccinated, Bartlett said. And the vaccinations could help ease class interruptions in another way, she said.

“We’ll hopefully be able to manage vaccinated children in a way that they could probably stay in school if exposed to someone with COVID and not have that disruption in their learning,” she said.

Bartlett warned that it will take a while before schools can start rolling back masking requirements because that will depend on vaccination rates among students.

“As eager as I am to get kids out of masks, I’m really in the mind to go slow,” Bartlett said. “Kids are doing an amazing job dealing with wearing masks and getting our kids able to get vaccinated will be a big motivator to get the pandemic under control.”

Bartlett added that parents must also be aware of the overall COVID-19 transmission rates within their community during the winter, because it will impact the number of cases in schools.

“I think it all could be enough, but the major contributor among kids in schools is what goes on outside the schools in the community,” she said. “If we don’t do a good job in controlling transmissions for adults it will bleed into the schools.”

Copyright © 2021, ABC Audio. All rights reserved.

FDA panel greenlights COVID-19 vaccines for kids ages 5 to 11: Five things to know

FDA panel greenlights COVID-19 vaccines for kids ages 5 to 11: Five things to know
FDA panel greenlights COVID-19 vaccines for kids ages 5 to 11: Five things to know
andreswd/iStock

(NEW YORK) — COVID-19 vaccine shots for kids ages 5 to 11 may be available as soon as November after a Food and Drug Administration advisory panel voted Tuesday in support of the Pfizer vaccine for kids.

The vote is the first step in the authorization process that would make the Pfizer/BioNTech vaccine available for the approximately 28 million children in the United States ages 5 to 11.

Dr. Francis Collins, director of the National Institutes of Health, said on “Good Morning America” Tuesday that getting more kids vaccinated will be key to ending the pandemic in the U.S.

“If we can create a situation where more of these kids are not getting infected, we should be able to drive this pandemic down, which is what we really hope to do, even as we face the cold [weather] and other concerns about whether we might see another surge,” said Collins. “We don’t want that, and this would be one significant step forward in getting our country really in a better place.”

As the countdown begins, here are five things parents should know about COVID-19 vaccines and kids under the age of 12.

1. Kids ages 5 to 11 are still not yet eligible for a COVID-19 vaccine.

The FDA panel’s approval Tuesday does not mean that children ages 5 to 11 will immediately be eligible to get a COVID-19 vaccine.

The leaders of the FDA need to sign off on the advisory panel’s decision, and then the decision will move to the Centers for Disease Control and Prevention’s vaccine advisory group.

That group, the Advisory Committee on Immunization Practices, is scheduled to meet next Tuesday to review the same data reviewed by the FDA advisers.

Then, once the ACIP recommends the vaccine, the CDC director must sign off on it, the final step in the authorization process.

Once that decision is made, the vaccine would be able to be administered relatively quickly to children across the country.

At the same time, the FDA will continue to review data to decide whether to grant full FDA approval for the vaccine in kids ages 5 to 11.

The FDA approved the Pfizer vaccine for people ages 16 and older in August. It is currently authorized for emergency use in children ages 12 to 15.

The two other vaccines currently available in the U.S., Moderna and Johnson & Johnson, are currently available only for people 18 years and older.

Moderna said Monday it plans to submit data to the FDA soon showing its vaccine for children ages 6 to 11 produces a strong immune response and appears safe.

2. The Pfizer dose is different for kids under age 12.

In Pfizer and BioNTech’s clinical trial of more than 2,200 children, the COVID-19 vaccine was administered in two doses, but the doses were one-third the amount given to adults.

The clinical trial results, which have not yet been peer-reviewed, showed the antibody response in children at that dose was at least as strong as the full adult dose in patients ages 16 to 25.

Pfizer and BioNTech say the vaccine produced minimal side effects in children ages 5 to 11, and the side effects were similar to those experienced by adults and older children.

For 12- to 15-year-olds, the FDA has authorized the same dosing as adults with the Pfizer two-dose vaccine.

3. The vaccine’s focus is on kids’ immune systems.

Children have different immune systems than adults, so it should be reassuring for parents that the Pfizer/BioNTech vaccine has been shown to be safe in kids.

Differing immune systems among people of different ages also help explain why the cutoffs for vaccine eligibility rest on age and not body size.

In addition to the COVID-19 vaccine, other immunizations are also scheduled and administered based on age and not weight. This is partially due to the fact that the body’s immune responses to vaccinations and infection are known to be different based on age.

4. The vaccine will be distributed to kids through pediatricians, pharmacies, health clinics and more.

Once greenlighted, the pediatric doses of the vaccine will be sent to thousands of sites across the country, including more than 25,000 pediatricians’ offices, more than 100 children’s hospitals, tens of thousands of pharmacies and hundreds of school- and community-based clinics, the White House announced Oct. 20.

Within days, more than 15 million doses are set to begin distribution across the country.

Though the White House has purchased 65 million Pfizer pediatric vaccine doses — more than enough to fully vaccine all children ages 5 to 11 in America — the first launch will dole out doses in waves based on states’ eligible population of kids. Shipments can be recalibrated based on shifting demand.

The distribution plan will also include a national public education campaign to “reach parents and guardians with accurate and culturally-responsive information about the vaccine and the risks that COVID-19 poses to children,” according to the White House.

White House officials told the nation’s governors on Oct. 12 that it has enough pediatric doses on hand for the 28 million children ages 5 through 11 expected to become eligible once the CDC gives the green light.

To troubleshoot any confusion in distribution, federal health officials are outlining a new color-coded cap system for each formulation of the vaccine, though still “preliminary.” Purple-capped vials will contain doses for adult and older adolescents, a chart offered to states said; orange-capped vials will contain doses for kids aged 5 to 11.

5. Families need to remain vigilant against COVID-19.

While there is a light at the end of the tunnel with younger kids having access to a COVID-19 vaccine, families need to stay vigilant against the virus as they wait for authorization.

Unvaccinated children can not only become ill from COVID-19 themselves, but they can also spread the virus to more vulnerable family members and other adults with whom they interact.

Both the CDC and the American Academy of Pediatrics recommend universal mask-wearing in schools to help slow the spread of COVID-19.

Experts said that in addition to unvaccinated children wearing face masks, parents and siblings who are vaccinated should also continue to wear face masks indoors because of the rates of breakthrough infections in the U.S.

Families should also continue to follow other safety guidelines shared throughout the pandemic, including social distancing and hand-washing.

Copyright © 2021, ABC Audio. All rights reserved.

FDA panel meets on COVID-19 vaccine shots for kids under 12: Five things to know

FDA panel greenlights COVID-19 vaccines for kids ages 5 to 11: Five things to know
FDA panel greenlights COVID-19 vaccines for kids ages 5 to 11: Five things to know
andreswd/iStock

(NEW YORK) — COVID-19 vaccine shots for kids ages 5 to 11 may be available as soon as November, depending on the outcome of a Food and Drug Administration (FDA) advisory panel hearing happening Tuesday.

At the hearing, the FDA’s independent advisory committee is expected to have a public discussion and hold a non-binding vote on whether to authorize the Pfizer/BioNTech vaccine for the approximately 28 million children in the United States ages 5 to 11.

Once the FDA decides to authorize the vaccine, the issue goes before the Centers for Disease Control and Prevention’s vaccine advisory group.

That group, the Advisory Committee on Immunization Practices, is set to meet on Nov. 2 and 3, and from there, the CDC director must sign off on the recommendation.

Dr. Francis Collins, director of the National Institutes of Health (NIH), said on “Good Morning America” Tuesday that getting more kids vaccinated will be key to ending the pandemic.

“If we can create a situation where more of these kids are not getting infected, we should be able to drive this pandemic down which is what we really hope to do, even as we face the cold other and other concerns about whether we might see another surge,” said Collins. “We don’t want that, and this would be one significant step forward in getting our country really in a better place.”

As the countdown begins, here are five things parents should know about COVID-19 vaccines and kids under the age of 12.

1. Kids ages 5 to 11 are still not yet eligible for a COVID-19 vaccine.

Tuesday’s public hearing does not mean that children under age 12 will immediately be eligible to get a COVID-19 vaccine.

The final vote on whether the vaccine is authorized for use in kids ages 5 to 11 will happen in early November, and will come from the CDC director.

Once that decision is made, the vaccine would be able to be administered relatively quickly to children across the country.

At the same time, the FDA will continue to review data to decide whether to grant full FDA approval for the vaccine in kids ages 5 to 11.

The FDA approved the Pfizer vaccine for people ages 16 and older in August. It is currently authorized for emergency use in children ages 12 to 15.

The two other vaccines currently available in the U.S., Moderna and Johnson & Johnson, are currently available only for people 18 years and older.

Moderna said Monday it plans to submit data to the FDA soon showing its vaccine for children ages 6 to 11 produces a strong immune response and appears safe.

2. The Pfizer dose is different for kids under age 12.

In Pfizer and BioNTech’s clinical trial of more than 2,200 children, the COVID-19 vaccine was administered in two doses, but the doses were one-third the amount given to adults.

The clinical trial results, which have not yet been peer-reviewed, showed the antibody response in children at that dose was at least as strong as the full adult does in patients ages 16 to 25.

Pfizer and BioNTech say the vaccine produced minimal side effects in children ages 5 to 11, and the side effects were similar to those experienced by adults and older children.

For 12- to 15-year-olds, the FDA has authorized the same dosing as adults with the Pfizer two-dose vaccine.

3. The vaccine’s focus is on kids’ immune systems.

Children have different immune systems than adults, so it should be reassuring for parents that the Pfizer BioNTech vaccine has been shown to be safe in kids.

Differing immune systems among people of different ages also help explain why the cutoffs for vaccine eligibility rest on age and not body size.

In addition to the COVID-19 vaccine, other immunizations are also scheduled and administered based on age and not weight. This is partially due to the fact that the body’s immune responses to vaccinations and infection are known to be different based on age.

4. The vaccine will be distributed to kids through pediatricians, pharmacies, health clinics and more.

Once greenlighted, the pediatric doses of the vaccine will be sent to thousands of sites across the country, including more than 25,000 pediatricians’ offices, more than 100 children’s hospitals, tens of thousands of pharmacies, and hundreds of school and community-based clinics, the White House announced Oct. 20th.

Within days, more than 15 million doses are set to begin distribution across the country.

Though the White House has purchased 65 million Pfizer pediatric vaccine doses — more than enough to fully vaccine all children ages 5-11 in America — the first launch will dole doses out in waves based on states’ eligible population of kids. Shipments can recalibrate based on shifting demand.

The distribution plan will also include a national public education campaign to “reach parents and guardians with accurate and culturally-responsive information about the vaccine and the risks that COVID-19 poses to children,” according to the White House.

White House officials told the nation’s governors on Oct. 12th that it has enough pediatric doses on hand for the 28 million children ages 5 through 11 expected to become eligible once the FDA gives the green light.

To troubleshoot any confusion in distribution, federal health officials are outlining a new color-coded cap system for each formulation of the vaccine, though still “preliminary.” Purple-capped vials will contain doses for adult and older adolescents, a chart offered to states said; orange-capped vials will contain doses for kids aged 5-11.

5. Families need to remain vigilant against COVID-19.

While there is a light at the end of the tunnel with younger kids having access to a COVID-19 vaccine, families need to stay vigilant against the virus as they wait for FDA authorization.

Unvaccinated children can not only become ill from COVID-19 themselves, but they can also spread the virus to more vulnerable family members and other adults with whom they interact.

Both the CDC and the American Academy of Pediatrics recommend universal mask-wearing in schools to help slow the spread of COVID-19.

Experts said that in addition to unvaccinated children wearing face masks, parents and siblings who are vaccinated should also continue to wear face masks indoors because of the rates of breakthrough infections in the U.S.

Families should also continue to follow other safety guidelines shared throughout the pandemic, including social distancing and hand washing.

Copyright © 2021, ABC Audio. All rights reserved.

How did California go from the epicenter of the US pandemic to the lowest statewide transmission rate?

How did California go from the epicenter of the US pandemic to the lowest statewide transmission rate?
How did California go from the epicenter of the US pandemic to the lowest statewide transmission rate?
Diy13/iStock

(ATLANTA) — With the lowest COVID-19 infection rate among all states as of Friday, California, which has some of the strictest mask and vaccination mandates in the country, has managed to flip the script as the former U.S. epicenter of the pandemic.

“They’ve been very much forward-thinking in terms of policies around vaccination requirements and mandates,” said epidemiologist Dr. John Brownstein, chief innovation officer at Boston Children’s Hospital and an ABC News contributor.

As of Friday evening, California had an infection rate of 61.1 cases per 100,000 over the past week, according to data from the Centers for Disease Control and Prevention. The state was briefly the only to be classified with a “moderate” rate of transmission — 10 to 49.99 cases per 100,000 over seven days — before it went back up to “substantial,” meaning 50 to 99.99 cases per 100,000 over seven days.

Over the previous week, Hawaii, Florida, Louisiana, Connecticut, New Jersey, Mississippi, Maryland, Georgia and Washington, D.C., each also reported “substantial” rates.

A rate of at least 100 cases per 100,000 is labeled as “high.” Montana, Wyoming, Idaho and Alaska, as of Friday, had the highest rates over the previous seven days, with each above 450 cases per 100,000 people. The U.S. average over that span was 150.9.

Experts said California’s journey from worst to first is likely due to a combination of things.

“We can’t know for sure which factors are responsible,” Brownstein added, “but we know that the combination of interventions and policies can play a really strong role in driving transmission.”

‘Ending this pandemic’

More than 70% of California’s population has received at least one dose of vaccine, according to the CDC, and the state also leads in total vaccinations administered, roughly 53 million doses. As of Friday, the national average rate was 66.2%.

Being the first state to announce a COVID-19 vaccine requirement for schools, California has some of the strictest mandates in the U.S. The state has mandated vaccines for state employees, health care workers, teachers and at large indoor gatherings.

“The more aggressive the vaccination campaign, the better,” Dr. Todd Ellerin, director of infectious diseases at South Shore Health, told ABC News.

Given that vaccines are the most powerful tool we have in curbing the spread of COVID-19, experts said they believe California’s emphasis on immunizations has provided big dividends.

“These results show quite clearly that vaccines offer protection for individuals who lack immunity, with important implications for finally ending this pandemic,” Dr. Francis Collins, director of the National Institutes of Health, wrote in a blog post Tuesday.

Idaho and Wyoming have some of the lowest vaccination rates and the highest transmission rates.

All three COVID-19 vaccines available in the U.S. have since shown high effectiveness in preventing death due to COVID-19, and as of Friday, California boasted the lowest death rate in the country, with 0.3 per 100,000 over the previous week. The U.S. average over that span was 2.7 per 100,000.

Additionally, experts told ABC News, having endured the harshest waves of infections last winter and the delta surge in July, formerly infected Californians may have acquired antibodies and more of a natural immunity to COVID-19 — both factors that, in concert with vaccines, could be driving down case numbers.

‘More work to do’

In addition to strict vaccine mandates, California has been unwavering on face-coverings, testing and social distancing policies.

“While California has administered more vaccines than any other state, we have more work to do,” the California Department of Public Health said in a statement to ABC News.

Everyone, regardless of vaccination status, is required to wear a mask on public transit, in health care settings and at educational and correctional facilities. Masks are required for all unvaccinated people and recommended for vaccinated people in settings such as theaters, retail stores, restaurants and bars.

Despite having a higher vaccination rate than California, states like Vermont are still falling behind on transmission rate rankings, which experts said points to the importance of distancing and masking. Breakthrough cases seen in Vermont can be further explained by its higher proportion of residents 65 and older.

Mobility

Research shows mobility, or movement in populations, can be a predictor of disease spread, especially via air travel or mass transit. This became evident through the surge of COVID-19 cases the U.S. saw during holiday season.

Gov. Gavin Newsom pleaded with California residents on Christmas Eve to avoid holiday gatherings at a time when hospitals in the state were under “unprecedented pressure.”

Californian cities experienced a huge surge of cases and hospitalizations following the holidays, although rates have since declined.

No stranger to stay-at-home orders, the California government imposed several lockdowns and restrictions to curb the spread of the virus. It celebrated its most recent reopening in mid-June, which replaced 15-month-long public health restrictions with conditions more akin to “business as usual.”

“In the height of the pandemic, people were locked down, they weren’t moving at all, they were staying at home,” Brownstein told ABC News. “The more people move around, that’s usually an indicator for increased transmission.”

The great outdoors

The virus has been shown to spread more indoors and with people in close proximity to one another. California’s sunny climate means more people spend more time outside.

“When we spend most of our time indoors, that’s when transmission is greatest,” Ellerin said.

Added Brownstein: “More close contacts with people outside your household indoors is what creates additional risk.”

This effect is also compounded by the rise in the virus’ effective reproductive number during the winter season with research suggesting that a drop in temperature encourages virus growth.

Compared to many other states, especially as winter draws nearer, California is in “quite a good spot,” Brownstein said. “In all likelihood, the trends that we’re seeing are realistic and very much driven by compliance with masking and other interventions, plus the well-covered vaccination strategy in the state.”

Copyright © 2021, ABC Audio. All rights reserved.

Pediatric vaccines will ‘very likely’ be available first or second week of November: Fauci

Pediatric vaccines will ‘very likely’ be available first or second week of November: Fauci
Pediatric vaccines will ‘very likely’ be available first or second week of November: Fauci
Halfpoint/iStock

(NEW YORK) — Vaccines for children will “very likely” be available the first or second week of November, White House Chief Medical Adviser Dr. Anthony Fauci said Sunday.

“If all goes well, and we get the regulatory approval and the recommendation from the CDC [Centers for Disease Control and Prevention], it’s entirely possible if not very likely that vaccines will be available for children from 5 to 11 within the first week or two of November,” Fauci told ABC This Week anchor George Stephanopoulos.

Pfizer’s COVID-19 vaccine is nearly 91% effective against symptomatic illness in children ages 5-11, according to new data. A Food and Drug Administration advisory panel will meet Tuesday to discuss authorizing the vaccine for children, which is currently only available to those ages 12 and older.

The CDC issued recommendations for both Moderna and Johnson & Johnson vaccine boosters for certain populations on Thursday evening, clearing the way for millions of Americans to receive additional shots. The CDC’s authorization followed the FDA’s, which it issued Wednesday.

The CDC is also permitting mix-and-match booster doses — allowing people to get a different booster brand than was used for a primary vaccination.

Fauci said Sunday the new recommendations should not cause confusion, as they allow for flexibility in booster selection.

“We would hope that people, if available, would get the boost from the original product,” Fauci said. “But if not, there’s the flexibility of what we’re calling ‘mixing and matching.'”

Stephanopoulos pressed Fauci on whether receiving a different brand shot from the original dose yields better protection.

“I have read some studies that suggest that it’s actually better to mix. Like, say, if you got the Johnson & Johnson the first time around, it’s better to get Moderna the second time,” Stephanopoulos asked.

“If you look at the level of antibodies that are induced — if you originally had J&J, and you get, for example, a Moderna or a Pfizer, the level of antibodies, namely, the proteins that you would predict would protect you, those levels go up higher with the Moderna boost to J&J than the J&J boost,” Fauci responded. “However, it’s a little bit more complicated, because, in the clinical trial that J&J did, the clinical effect of the second dose of J&J was quite substantial.”

“So, it really becomes an issue of, what’s the most convenient? What do you feel is best for you?” Fauci added, recommending that people consult their physician.

Stephanopoulos also pressed Fauci on the controversy over to what extent the U.S. was funding bat coronavirus research in Wuhan after the NIH released a letter this week about a New York City-based nonprofit’s research on bat coronavirus spike proteins. The letter states that the subcontractor had not disclosed some results in a timely manner.

“Now, some critics and analysts have seized on that to say you and others have misled the public about U.S. funding of this so-called gain-of-function research. The NIH says that’s false. Our medical unit backs that up,” Stephanopoulos said. Sen. Rand Paul, R-Ky., has called for Fauci’s firing over the controversy.

“Well, I obviously totally disagree with Senator Paul. He’s absolutely incorrect. Neither I nor Dr. Francis Collins, the director of the NIH lied or misled about what we’ve done,” Fauci responded.

“What did we learn from the letter? Does it show that some of the research we were finding was riskier than we know?” Stephanopoulos pressed.

Fauci said they knew what the risk was and there’s “no denial” that they should have put their progress report in a timely manner, but that the implication that the research led to COVID-19 is “unconscionable” and “molecularly impossible.”

“There’s all of this concern about what’s gain-of-function or what’s not, with the implication that that research led to SARS-CoV-2, and COVID-19, which, George, unequivocally anybody that knows anything about viral biology and phylogeny of viruses know that it is molecularly impossible for those viruses that were worked on to turn into SARS-CoV-2 because they were distant enough molecularly that no matter what you did to them, they could never, ever become SARS-CoV-2,” Fauci explained.

“And yet when people talk about gain-of-function, they make that implication which I think is unconscionable to do, to say, ‘Well, maybe that research led to SARS-CoV-2’,” Fauci added. “You can ask any person of good faith who’s a virologist, and they will tell you, absolutely clearly, that that would be molecularly impossible.”

Copyright © 2021, ABC Audio. All rights reserved.

Ukraine’s black market in COVID vaccine certificates

Ukraine’s black market in COVID vaccine certificates
Ukraine’s black market in COVID vaccine certificates
solarseven/iStock

(KYIV, Ukraine) — It doesn’t take long to buy a fake COVID-19 vaccine certificate in Ukraine. Just typing the words into Google brings up a slew of advertisements offering a certificate “without visiting a doctor.”

A would-be customer sends their passport details, address and a phone number through the Telegram messenger app, and the next day, a document showing fake proof of vaccination with Pfizer’s coronavirus vaccine arrives in the post, according to several people who have bought one of the fake certificates, and who spoke to ABC News on condition of anonymity because the practice is illegal. They said prices for the certificates can vary anywhere from $20 to $200 (USD) with some fetching as much as $380.

The COVID vaccination certificate black market is becoming a growing concern in Ukraine, which is suffering from a worsening third wave of the pandemic amid low vaccination numbers and as the government tries to impose restrictions on the unvaccinated. The number of people who have already bought fake certificates is unknown, but some Telegram app channel advertising them have thousands of subscribers.

Svitlana is one of them. She said she bought a fake certificate in September showing she was inoculated with Pfizer/BionTech’s vaccine.

“I don’t trust neither vaccines nor the government,” she told ABC News, explaining her decision and declining to give her last name.

The demand for fake vaccine certificates exists despite the ease of getting a free COVID vaccine in Ukraine. As of late September there are over 11 million doses of different coronavirus vaccines in Ukraine now for a population of 44.1 million, according to Ukraine’s health ministry. The vaccine is free for all Ukrainians and in Kyiv, walk-in vaccination centers are even open in some shopping malls.

But despite the availability of vaccines, Ukraine is among one of the least vaccinated countries in Europe, with only around 30.2% of the population having received one dose and 14.7% fully vaccinated, according to a vaccine tracker published by Bloomberg. In late September the health minister Viktor Lyashko said 34,000 doses of Pfizer would be dumped because they had expired.

The low numbers are the product of widespread vaccine hesitancy among Ukrainians: 56% don’t plan to get vaccinated at all, according to a poll from the Ilko Kucheriv Foundation, a well-known independent think tank that conducts sociological studies.

“We observe this trend globally, however in Ukraine, misinformation about vaccination is extremely politicized and is spread both among the general public and the medical community,” Murat Shahin, head of the UNICEF office in Ukraine told ABC News this month.

Another problem is lack of quality medical education on vaccination which leads to incorrect practices and confuses patients, Shahin said.

“We also observe a suboptimal level of trust to state institutions,” he said. “Meanwhile, people trust their relatives, local leaders and their doctors and nurses.”

Some of the social media channels offering fake vaccine certificates are part of that ecosystem pushing anti-vaccine sentiment, sharing anti-vax information and news stories, while urging people to buy fake certificates to avoid getting the shot.

According to the same Ilko Kucheriv Foundation poll, some are reluctant because they are not sure about the safety of the vaccines. Some of those who spoke to ABC News said they resist just because they are forced to vaccinate.

There is no mandatory vaccination in Ukraine, except for teachers and civil servants, meaning there is little pressure to vaccinate. But some companies are pressing their employees to vaccinate, threatening to cut salaries or reduce vacation days.

And a vaccine certificate is necessary to travel. Ukraine has created its own digital certificate in an app, called Diya (“Action”) that is valid in EU countries.

Wanting to go abroad, some Ukrainians are refusing the free shot of the real vaccine and instead are paying money for a fake certificate. On a site listing the phone number of one seller, users reviewed the service.

“We’ve just crossed the border in Rava Russka [in Poland], our border service scanned the certificate and let us go without any problems,” one wrote. “I took it to Germany. All worked,” another said.

Some services provide paper certificates. A fake official stamp is applied using the real names of doctors and clinics, based on samples posted by some of the Telegram channels offering them.

Getting the digital proof of vaccination without being vaccinated is more difficult. It is still possible for a bribe, according to some people ABC News talked to on condition of anonymity.

Some Ukrainians are simply paying doctors to sign off on their digital vaccine certificates, by entering them as vaccinated in Ukraine’s state vaccination register. After that, a digital certificate appears in the official Diya app, which is also valid in the EU.

Oleksiy Vyskyb, Ukraine’s deputy minister for digital transformation, told ABC News that some doctors were charging a fee to falsely enter people’s name into the state register showing vaccinated citizens.

One of the sellers confirmed that in a Telegram chat with an ABC reporter posing as a potential customer. ABC News did not actually purchase a fake certificate.

“We put the data into the register,” a person who identified themselves as a support manager responded when asked by the reporter how it would work.

Another channel said that the clinic where the false vaccination happens “dumps” two real doses of Pfizer and VaxZevria after pretending the client has received them.. They also offer “to save” these doses for the client to be vaccinated later if they change their mind before the vaccine expires two months later. Both options cost around $60.

According to some advertisements you can get a forged vaccination certificate even if you’re a foreigner. It will cost a bit more than for a Ukrainian citizen — $380 if you’re abroad, according to one ad.

Besides becoming part of a dangerous invisible pool of unvaccinated people that undermine restrictions and spread infection, those buying fake certificates may be unable to get a real shot later on since they are already recorded as having received one in the state registry, Shahin said.

Ukraine’s authorities say they are now trying to crackdown on the practice. Ukraine’s security service, the SBU, together with the country’s cyberpolice, said they have opened nearly 500 criminal proceedings relating to the selling of forged paper vaccination certificates and that more than 50 web resources have been blocked. So far, only three cases have been opened against doctors for allegedly entering false information into the register. Those detained face up to six years in prison. But government says it wants to increase the punishment.

This week, Ukraine imposed a full lockdown in four regions as Ukraine’s daily numbers continue to worsen, recently hitting its highest level since the country’s second wave in the spring. Ukrainian authorities reported 22,415 new confirmed infections and 546 deaths in the past 24 hours, the highest numbers since the start of the pandemic. Most experts also believe the real number of cases and deaths are likely higher, since not all are recorded with testing.

“People who use fake certificates create a dangerous space for others,” Maria Karchevych, Ukraine’s deputy health minister said at a press conference in Kyiv last week.

She said the fake COVID vaccine certificate industry also threatens Ukraine’s international image since Ukraine was among the first non-European Union countries to have its national vaccine pass recognized by the EU for travel.

“EU countries expect transparency and honesty in using such documents,” she said.
 

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Walmart recalls aromatherapy spray linked to rare bacterial illness, 2 deaths

Walmart recalls aromatherapy spray linked to rare bacterial illness, 2 deaths
Walmart recalls aromatherapy spray linked to rare bacterial illness, 2 deaths
Sundry Photography/iStock

(NEW YORK) — Walmart has recalled an aromatherapy spray after it identified a bacteria in the product that has now been linked to four illnesses and two deaths.

The Centers for Disease Control and Prevention announced Friday that it had identified the bacteria Burkholderia pseudomallei in the aromatherapy spray.

The spray, “Better Homes & Gardens Lavender & Chamomile Essential Oil Infused Aromatherapy Room Spray with Gemstones,” was found Oct. 6 in the home of a Georgia resident who became ill with melioidosis in late July, according to the CDC.

The CDC said it will continue to test the bacteria in the bottle to potentially match the bacteria identified in the four patients. The symptoms of melioidosis are similar to that of a cold or flu, according to the CDC.

The contaminated spray was sold at about 55 Walmart stores and on Walmart’s websites between February and Oct. 21.

Walmart has pulled the remaining bottles of this spray and related products from the shelves and its websites.

“Our hearts go out to the families that have been impacted by this situation,” Inger Damon, director of the CDC’s Division of High-Consequence Pathogens and Pathology, said in a statement. “We at CDC have been very concerned to see these serious related illness spread across time and geography. That is why our scientists have continued to work tirelessly to try to find the potential source for the melioidosis infections in these patients. We hope this work can help protect other people who may have used this spray.”

The Consumer Product Safety Commission and Walmart issued a recall for the lavender and chamomile room spray along with five other scents in the same product line.

The CDC will continue to investigate whether other related aromatherapy scents and brands may pose a risk.

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More disease, more suicide: Study shows human cost of climate change

More disease, more suicide: Study shows human cost of climate change
More disease, more suicide: Study shows human cost of climate change
Halfpoint/iStock

(NEW YORK) — Climate change is not only warming the planet, it’s negatively affecting human health in myriad ways, with researchers reporting surges in heat-related illnesses, infectious diseases, poor sleep and an increase in suicides, according to a major report by The Lancet Countdown that’s been cosigned by health experts from more than 70 institutions worldwide.

“There is no safe temperature rise from a health standpoint,” Dr. Renee Salas, an author of the report and an assistant professor of emergency medicine at Harvard, said at a press briefing on Tuesday. “The take-home message of this year’s brief is clear: Climate change is first and foremost a health crisis.”

Additionally, the report shows how decades of racial inequity has deepened divides when it comes to health outcomes, especially in the U.S. over the last few decades, as researchers have observed an increase in the intensity, duration and frequency of heat waves, wildfires and droughts.

We could be investing in a healthier future. This is a pivotal moment in history.
More than a third of urban heat-related deaths in the 1990s and early 2000s can be attributed to climate change, and extensive research also has shown that exposure to heat waves poses a range of health risks, from heat rashes to heat exhaustion to heatstroke.

“During the last heat wave, I saw paramedics with burns on their knees from kneeling down on the sidewalk to take care of patients with heatstrokes,” said Dr. Jeremy Hess, a co-author of the report and a professor of environmental and occupational health services at the University of Washington. “I have seen patients die of heatstroke this year. These are preventable problems.”

Warmer temperatures also contribute to people sleeping less and observable increases in suicide and crime.

“Patients tend to complain more about sleep disturbances during heat waves, which generally go away once the weather passes,” said Dr. Shehram Majid, a New York City-based psychiatrist. “I have seen a rise in patients struggling with mood and anxiety disorders during periods of extreme weather in NYC.”

One study estimates that in the U.S., suicide rates rise 0.7% for every 1 degree Celsius increase in average temperature.

Climate change also creates and exacerbates droughts, which can lead to more wildfires that burn for much longer, which means more dust and smoke that destroys air quality. Agriculture suffers. Pollen levels can increase, affecting those with allergies.

And poor air quality can be felt thousands of miles away from fires. In July 2021, smoke from California’s Dixie Fire reached the Eastern Seaboard, contributing to the worst air quality in New York City in 15 years.

“September 2020, we saw the max wildfires to date, with about 80,000 wildfires in the U.S., which is eight times greater than 2001,” Salas added.

Emerging evidence, cited in the report, also shows that wildfire smoke may be more harmful than many other types of smoke, especially for children. Exposure has been linked to an increased risk of heart and pulmonary disease, premature death, worsened mental health and greater risk of preterm birth.

More flooding can create conditions that lead to increased mosquito breeding, which means diseases such as Dengue fever, a dangerous viral infection, can spreader wider more quickly via the insects.

“New Dengue transmission potential is five times higher than 1950,” Salas added.

Longer warm seasons also means more ticks are spreading Lyme disease.

“We spent many years talking about the pandemic, yet we were not prepared. We are bound to make the same mistake again with climate change. We have not invested in the mitigation and adaptation necessary,” said Dr. Georges Benjamin, executive director of the American Public Health Association. “The health sector is already stressed, and when you add these natural disasters it pushes things to the breaking point.”

Policymakers need to get serious about taxing carbon and reaching zero-emission targets, said Benjamin, adding: “This is an opportunity to invest differently in a green recovery that isn’t fueled by fossil fuels. We could be investing in a healthier future. This is a pivotal moment in history.”

Yalda Safai, M.D., M.P.H., a psychiatry resident in New York City, is a contributor to ABC News Medical Unit.

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Northern states see uptick in COVID-19 infections and hospitalizations as weather gets colder

Northern states see uptick in COVID-19 infections and hospitalizations as weather gets colder
Northern states see uptick in COVID-19 infections and hospitalizations as weather gets colder
Ergin Yalcin/iStock

(NEW YORK) — There is a growing sense of optimism across the country, with national coronavirus infection rates steadily falling, booster shots available for many Americans and pending vaccine approval on the horizon for young children.

In southern states like Florida, Mississippi, Louisiana and Georgia, which were hit early on by the delta surge, hospitalizations are on the decline.

But despite the good news, experts are pleading with Americans to remain alert, as the highly infectious delta variant continues to circulate.

Despite vaccination rollouts, several states, particularly those in colder climates, are beginning to see a rise in infections.

“You’re starting to see an uptick in cases in the colder parts of the country and as people are driven indoors without masks on,” former Food and Drug Administration Commissioner Dr. Scott Gottlieb told CNN earlier this month. “The delta wave has not run through the United States… I think we have a couple of months to go.”

Experts have been warning for weeks that colder areas may see an uptick in cases this winter.

“We may be starting to see the delta surge in the northern parts of the country that were relatively spared over the summer,” said John Brownstein, Ph.D., an epidemiologist at Boston Children’s Hospital and an ABC News contributor.

In recently released forecasts, the PolicyLab at Children’s Hospital of Philadelphia reported that infection rates in parts of the Midwest and Mountain states remained “stubbornly high,” and that despite declining transmission in the Southeast, Mid-Atlantic and in California, a period of resurgence may be on the horizon for northern regions of the country.

“We can take some comfort this week in the fact that national daily case counts have dropped below 100,000 and national adult and pediatric hospital censuses have declined by 50% since late summer,” the group wrote, adding that the country must still be prepared to see a resurgence.

In the Midwest, many counties throughout Minnesota and Michigan have had a significant rise in cases, while other states (Delaware, Maine, Montana, New Mexico, Ohio, Pennsylvania, Vermont, Washington, Wisconsin, West Virginia and Wyoming) are reporting high transmission in nearly every county, according to federal data.

“Coronaviruses tend to thrive in winter months and colder weather,” Centers for Disease Control and Prevention Director Rochelle Walensky said. “Right now is not the time, as cases are coming down to become complacent because we do know colder weather is ahead of us.”

These local increases in cases are being accompanied by an uptick in hospitalizations. Ten states (Alaska, Colorado, Maine, Michigan, Minnesota, New Hampshire, North Dakota, Pennsylvania, Vermont, and Wyoming) are already seeing a higher number of hospital admissions.

In Montana, forecasters noted that cities are experiencing the highest rates of case incidence and hospitalizations they have seen throughout the pandemic, mirroring what happened in Idaho last month. Similarly, in Utah, the outlook continues to worsen, specifically in the Salt Lake City region, as resurgence spreads to a wider geographic area.

According to the PolicyLab, the regional variation across the country makes predicting the trajectory of this period of the pandemic challenging. While the team wrote that the likelihood of a fall and winter resurgence in northern areas “seems more probable,” there is “uncertainty about the magnitude, duration and breadth of geographic regions that will be impacted.”

“We need to expect that, as we enter a season of shorter, colder days that will push more people to gather indoors, we will soon see a widening geographic distribution of resurgent transmission in many locations,” forecasters wrote.

The group noted that the Northeast did not experience a significant surge last year, until the holiday season in November and December, and added that nationally, case incidence increased rapidly just after Halloween last year, surging through the New Year.

“As winter approaches, indoor mixing, especially among the remaining unvaccinated populations, means that we will likely continue to see increases in cases. The biggest remaining question is whether we have vaccinated enough of the population to see a decoupling with hospitalizations and deaths,” added Brownstein.

People who have not been fully vaccinated are 6.1 times more likely to test positive with the virus and 11.3 times more likely to die from it, compared with people who are vaccinated, according to federal data.

Although nearly two-thirds of Americans have now received at least one shot of a COVID-19 vaccine, more than 112 million Americans remain completely unvaccinated. Approximately 64 million of those unvaccinated Americans are people over the age of 12, and thus, are currently eligible to get the shot.

PolicyLab experts say it is therefore critical for communities to act now in order to “maximize vaccinations among children and adults so that we can prevent local surges in all regions this winter and finally move toward the waning days of the pandemic.”

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