(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.”
(WASHINGTON) — Jessica Rosenworcel is in line to make history as the first woman to head the Federal Communications Commission, after President Joe Biden announced on Tuesday his intent to officially nominate her as a commissioner and designate her as chair of the agency tasked with regulating telecommunications technology.
Rosenworcel has served as acting chair of the FCC since January, but would need to be confirmed by the Senate to assume her new role as chair in an official capacity. She has been a commissioner since 2012.
Her nomination could also mean the end to Trump-era clampdowns on net neutrality, as Rosenworcel has been a fierce advocate for an internet that is “open and available for all.”
“The internet should be open and available for all. That’s what net neutrality is about,” Rosenworcel said in an October 2020 statement. “It’s why people from across this country rose up to voice their frustration and anger with the Federal Communications Commission when it decided to ignore their wishes and roll back net neutrality.”
She added that she views the rollbacks to net neutrality as a way to “make it easier for broadband companies to block websites, slow speeds, and dictate what we can do and where we can go online.”
During her brief stint as acting chair, Rosenworcel has focused on closing the digital divide at a time when the COVID-19 pandemic resulted in an abrupt dependence on internet access for millions of Americans in order to go to school or do their jobs.
Rosenworcel’s policy approach and the historic nature of her nomination has also been lauded for representing the needs of women in a sector where they remain underrepresented in leadership positions.
“Every issue is a gender issue, even broadband access,” Rosenworcel wrote in a July op-ed she co-authored with Valerie Jarrett, a former senior adviser to President Barack Obama.
The op-ed cited how 31% of women have worried about paying their broadband bill during the pandemic, and delved into the issues working mothers especially faced when schools shuttered for in-person learning. The piece promoted the Emergency Connectivity Fund, which aims to support students who need internet access at home in order to participate in virtual schooling during the health crisis.
The White House also recognized her inclusive approach to telecommunications policy, especially for low-income communities, in a statement Tuesday.
“During her time at the agency, she has worked to promote greater opportunity, accessibility, and affordability in our communications services in order to ensure that all Americans get a fair shot at 21st century success,” a statement from the White House announcing her nomination Tuesday said. “From fighting to protect an open internet, to ensuring broadband access for students caught in the Homework Gap through the FCC’s Emergency Connectivity Fund, to making sure that households struggling to afford internet service stay connected through the Emergency Broadband Benefit program, she has been a champion for connectivity for all.”
She has also led a fight against illegal robocalls, the statement added, and worked to enhance consumer protections.
Rosenworcel previously worked as a senior communications counsel for the Senate Committee on Commerce, Science, and Transportation, and before that practiced communications law after graduating from the New York University School of Law.
The mother of two is originally from Hartford, Connecticut, but currently lives in Washington, D.C., with her husband.
In addition to announcing Rosenworcel’s nomination, the Biden administration said Tuesday that it plans to nominate fellow net neutrality advocate Gigi Sohn as an FCC commissioner. If both the new nominees are confirmed, it would give the FCC a Democratic majority. If their confirmations are delayed until Rosenworcel’s term expires at the end of the year, Republicans would hold a majority on the commission — setting up a potential political showdown over their confirmations.
(WASHINGTON) — A Senate panel on Tuesday grilled executives from YouTube, TikTok and Snapchat on what the social media companies are doing to ensure young users’ safety in the wake of revelations about Facebook’s practices and allegations the platforms need to do more to prevent potentially harmful effects on kids.
“They have deepened America’s concern and outrage and have led to increasing calls for accountability, and there will be accountability,” Senate Commerce subcommittee Chair Richard Blumenthal, D-Conn., said in his opening remarks regarding the newly exposed details on the inner workings of social media giants.
“We’re hearing the same stories of harm” caused by YouTube, TikTok and Snapchat, Blumenthal said, calling this, “for Big Tech, a Big Tobacco moment.”
“This time is different,” he said.
The subcommittee is seeking information from executives at TikTok, Snap Inc. and YouTube on how critics say algorithms can magnify harm to children, with the goal of passing legislation aimed to protect kids.
“You’re parents,” said Ranking Member Sen. Marsha Blackburn, R-Tenn., to the witnesses in her opening statement. “What would you do to protect your child?”
Tuesday’s hearing comes as the subcommittee expands its scope after hearing from Facebook whistleblower Frances Haugen earlier this month. She alleged that executives blatant disregarded concerns when they learned their platforms could have harmful effects on foreign democracies and the mental health of children.
The hearing also marked the first time TikTok and Snapchat have testified before lawmakers, while Facebook has been called to more than 30 congressional hearings through the years and YouTube executives have already appeared in front this Congress earlier in the year.
The social media executives on Tuesday vigorously defended how their platforms protect children from inappropriate content.
Here are some key takeaways:
Tech companies blasted for alleged lack of transparency
Different from a normally polarized Washington, senators on both sides of the aisle came together to drill the social media executives on transparency and focused on whether they’d allow access to independent researchers to study their algorithms, which some allege have exposed kids to harmful behavior and fueled eating disorders in young girls.
All three platforms said they have studied the potential negative impacts on children’s mental health.
Blumenthal asked, “If an academic researcher comes to you on child psychology and wants to determine whether one of your products causes teen mental health issues or addiction, they get access to raw data from you without interference?”
Jennifer Stout, vice president for global public policy of Snapchat parent Snap Inc., said her company’s algorithms “operate very differently” from those of the other platforms under scrutiny, but ultimately signaled a willingness to support outside researchers, as did TikTok’s executive.
“Yes, senator, we believe transparency for the average is incredibly important. We’re one of the first companies to publish publicly, a deep dive in how our algorithm works,” said Michael Beckerman, a TikTok vice president and head of public policy for the Americas.
Leslie Miller, vice president for government affairs and public policy of YouTube’s owner Google, skirted the question and said that outside research “would depend on the details” — an answer that frustrated Blumenthal.
“I’m going to cite the difference between your response between Mister Beckerman’s and Ms. Stout’s, which indicates certainly a strong hesitancy if not resistance,” Blumenthal said to Miller.
Overall, the executives defended what senators deemed was a lack of transparency.
Stout said in her closing statement that the protection of children is the “highest priority,” and Miller also said at YouTube there “no more important thing than the safety of kids online.”
But Tiktok appeared to be most willing for congressional oversight with Beckerman saying squarely in his closing statement, “We support stronger privacy rules to be put in place.”
Push for privacy legislation
While millions of young users log into the platforms every day, the bipartisan panel of senators appeared to agree that not enough is being done to protect them from harmful content.
Sen. Ed Markey, D-Mass., used the moment to push the companies to say whether they support his proposed privacy laws banning the use of targeted ads on kids and other potentially harmful features.
One piece of legislation he’s introduced, the Children’s Online Privacy Protection Act, or COPPA, would prohibit internet companies from collecting personal information from anyone under the age of 13 without parental consent.
“Do you support it or not?” he asked the Snap executive.
“I think, senator, we’d love to talk to you a bit more about this,” Stout said.
“This is just what drives us crazy,” a heated Markey responded. “We want to talk, we want to talk, we want to talk. This bill’s been out there for years, and you still don’t have a view on it?”
“We like your approach,” Beckerman, from TikTok, said. “However, I think a piece that should be included is a better way to verify age across the Internet across apps rather than the system that is in place now. And I think with that improvement, it would be something that we’d be happy to support.”
Miller said wouldn’t commit on the record but said executives at YouTube have had “constructive” conversations internally.
He also pressed them on the Kids Internet Design and Safety Act, or KIDS Act, another piece of legislation he’s introduced to stop online practices such as manipulative marketing, noting the impact of social media influencers on children.
“They’re inherently manipulative to young kids who often cannot tell that they’re really paid advertisements that their heroes pushing that the hero is getting a monetary kickback,” Markey said. “Should we make it illegal?”
Miller said they would “need to stare at the details of such a bill” to which Markey, again, noted,” It’s been around for a while.”
The TikTok executive said they agree that there should be additional transparency and additional privacy laws, which Snap mirrored, but added the caveat, “We would be happy to look at them.”
After Miller said YouTube executives “support the goals of comprehensive privacy legislation,” when Blumenthal raised the Eliminating Abusive and Rampant Neglect of Interactive Technologies, or EARN IT, Act, which has bipartisan Senate support, he said back, “This is the topic that we’ve seen again and again and again, and again. ‘We support the goals, but that’s meaningless unless you support the legislation.”
Focus on potential real-world harm on kids
With the momentum of the findings from the Facebook hearing, the panel argued that social media platforms have been allowed to promote and glorify dangerous content, and it especially harms the nation’s most vulnerable: children.
While executives defended their platforms and listed actions that they’ve taken internally, senators on the committee highlighted several examples of inappropriate content slipping past those safeguards and getting in front of children.
Sen. Mike Lee, R-Utah, said his staff opened an account saying it was for a teenage girl, and when they opened the “Discover” page with its default settings, found concerning videos.
“They were immediately bombarded with content that I can most politely describe as wildly inappropriate for a child, including recommendations for among other things an invite to play an online sexualized video game, tips on why you shouldn’t go to bars alone,” he said, waving his hands with concern.
The Snap executive said guidelines prevent sexual content to 18 and above, “so I’m unclear as to why that content would’ve shown up for an account that was for a 14-year-old.”
Senators reminded the witnesses that Snapchat’s speed filter allowed users to add their speeds and it took eight years for the company to remove the filter following catastrophic car crashes associated with the app.
Sen. Amy Klobuchar, D-Minn., pressed Snapchat over the use of illegal drugs being used on its platform in an argument for greater liability on tech companies, citing the case of Devin Norring, who authorities said died in Minnesota after taking Percocet laced with Fentanyl from a drug dealer on Snapchat.
“They can get on your platform and just find a way to buy it, and that is the problem,” she said. “Are you going to get drugs off Snapchat?”
Stout said it was a “top priority” and that it’s happening on other platforms, too.
“I think there are other ways to do this too as creating liability when this happened, so maybe that’ll make you work even faster, so we don’t lose another kid,” Klobuchar replied.
Citing a recent investigation by the Wall Street Journal which found that Tik Tok algorithm can put young users into content glorifying eating disorders, drug violence, Klobuchar asked blankly, “Have you stopped that?”
Beckerman said it’s something they’ve taken action on are “constantly working on” and repeated their support for the Children and Media Research Advancement Act or CAMRA Act.
Blumenthal pressed TikTok on its effects on teens, saying his staff created TikTok accounts intended for dance videos and within a week those accounts were flooded with content of suicidal ideation, self-injury, sex and eating disorders.
Beckerman suggested some of those challenged are overblown by the press and said that’s “not the typical TikTok experience.”
“We found pass-out videos,” Blumenthal said, pausing for dramatic effect. “We found them, so I have a lot of trouble crediting your response on that score.”
“This is stuff occurring in the real world,” he added later.
(NEW YORK) — As the COVID-19 pandemic has swept the globe, more than 4.9 million people have died from the disease worldwide, including over 738,000 Americans, according to real-time data compiled by Johns Hopkins University’s Center for Systems Science and Engineering.
Just 67.2% of Americans ages 12 and up are fully vaccinated against COVID-19, according to data from the U.S. Centers for Disease Control and Prevention.
Here’s how the news is developing. All times Eastern:
Oct 27, 3:41 am
Australia to lift ban on citizens leaving the country
After more than 18 months, Australia announced Wednesday that it will lift a ban on its own people from leaving the country without permission.
Starting Nov. 1, citizens and permanent residents of Australia who are fully vaccinated against COVID-19 will no longer require an exemption to travel abroad. Australia has imposed some of the world’s strictest border rules amid the pandemic, which Home Affairs Minister Karen Andrews said has kept the country “free from widespread COVID transmission.”
“The easing of these restrictions is possible thanks to our impressive national vaccination rates, and I thank all those who have done the right thing and rolled up their sleeve,” Andrews said in a statement Wednesday.
While Australian citizens and permanent residents are currently the “first priority,” Andrews said, more travel restrictions — including for some foreigners — will be relaxed as the national vaccination rate “continues to climb.” As of Wednesday, nearly 75% of people aged 16 and over in the country are fully vaccinated against COVID-19, according to data posted by the Australian Department of Health.
“I look forward to further easing restrictions over coming weeks and months as more and more Australians become fully vaccinated,” Andrews said. “Before the end of the year, we anticipate welcoming fully vaccinated skilled workers and international students.”
Oct 26, 8:53 pm
Immunocompromised may need 4th dose: CDC
Immunocompromised people may need a fourth dose of the vaccine, according to newly issued guidance from the U.S. Centers for Disease Control and Prevention.
Those patients may end up needing an additional shot six months after their third dose of the Moderna or Pfizer vaccines, the CDC said. The fourth dose can be of any of the three available vaccines, according to the agency.
This is in line with what the CDC has said before regarding immunocompromised adults. A third shot is considered necessary to establish vaccination for those patients and a boost would need to come six months later, according to the agency.
Oct 26, 4:26 pm
FDA panel greenlights vaccines for kids
An advisory panel at the Food and Drug Administration voted Tuesday in support of the Pfizer vaccine for kids 5 ages 11.
Seventeen people voted “yes” and one person abstained.
Next, the FDA will make a decision. Then, the matter heads to the CDC’s independent advisory panel to deliberate and vote next week, and after that, the CDC director is expected to make the final signoff.
The earliest shots could be in arms is the first week of November.
Oct 26, 2:37 pm
Biden administration to ship vaccines for children as soon as FDA approves them
The Biden administration will begin shipping vaccine doses for kids ages 5 to 11 as soon as the Food and Drug Administration gives the green light in coming days, White House officials told governors on a private phone call Tuesday.
Doing so will allow children to begin receiving shots as soon as the Centers for Disease Control and Prevention signs off, which is expected around Nov. 4.
Jeff Zients, the White House coordinator on the federal response to COVID-19, said one big concern is the shorter shelf life for pediatric doses. In trying to make the vaccine easier for pediatricians to handle, the doses for kids 5 to 11 can be kept for only 10 weeks, compared with six to nine months for adult doses.
“We don’t want to have wastage, so we encourage you to build flexibility into your distribution systems you can move around within your state or territory,” he told the governors. Audio of the call was obtained by ABC News. “Just order what you need. We have plenty of supply. We can always get you doses on short notice.”
(ARLINGTON, Va.) — Headlining a rally Tuesday evening, President Joe Biden was the latest national Democrat to campaign in Virginia for gubernatorial nominee Terry McAuliffe, joining a long list of prominent figures in the party who’ve descended on the commonwealth to mobilize voters against Republican nominee Glenn Youngkin.
“You all know the stakes,” Biden told a crowd of supporters at the Virginia Highlands Park in Arlington, just outside the nation’s capital. “You don’t have to wonder what kind of governor Terry will be because you know what a great governor he was. It wasn’t just because of what he promised, it’s what he delivered.”
This marked the president’s second time stumping for McAuliffe; he first campaigned with him in late July.
Always falling the year after a presidential election, Virginia’s off-year elections, in particular the gubernatorial race, are considered a bellwether for politics heading into the midterm elections. Virginia trended increasingly blue over the four years of Donald Trump’s presidency, but this election will be the first measure of how lasting that rebuke of the GOP is in what used to be a presidential battleground. A loss for McAuliffe, or even a narrow win, will also serve as a warning shot for Democrats in Washington that an unpopular president and stalled agenda defined by intraparty differences could cost them their slim majorities in Congress next year.
Biden’s approval is not only underwater nationally, but also in Virginia, where a Monmouth poll out last week showed more than half of voters disapprove of the job he is doing as president.
Trump endorsed Youngkin after he secured the Republican nomination in May, but he has not done any events with the candidate. He called into a rally in support of the statewide GOP ticket where attendees pledged allegiance to a flag said to be carried at the rally preceding the Jan. 6 insurrection, but Youngkin was not there and denounced the pledge as “weird and wrong.” The Republican has had to toe the thin line between being too pro- or anti-Trump so as not to alienate voters on either end of the political spectrum, and he’s fired back at McAuliffe’s Trump attacks by reminding his opponent that Trump is not on the ballot, trying to keep the focus on Virginia-specific issues.
The state rejected the former president twice (and by a 10-point margin in 2020), Democrats flipped the state legislature in 2019 and Republicans haven’t won statewide office in over a decade — all indications Trump is politically toxic in Virginia. McAuliffe and other Democrats have tried to use Trump’s toxicity to drag down Youngkin, tying him to the former president at every opportunity.
But during Tuesday night’s rally, Biden borrowed McAuliffe’s playbook, closely tying Youngkin to the former president.
“How well do you know Terry’s opponent? Well, just remember this, I ran against Donald Trump. Terry is running against an acolyte of Donald Trump,” Biden said, claiming Youngkin has embraced Trump’s “bad ideas and bad record.”
The president also comment on how Youngkin hasn’t done any campaign events with Trump, claiming the GOP nominee “won’t allow Donald Trump to campaign for him in this state.”
“What’s he trying to hide? Is there a problem with Trump being here? Is he embarrassed?” Biden rhetorically asked the crowd.
Despite the race tightening over the last few weeks, McAuliffe is confident he’ll once again break the so-called “Virginia curse” of candidates losing Virginia’s off-year gubernatorial race if they have the same party affiliation as the current occupant of the White House. He broke it in 2013 when Barack Obama was president.
Barred by Virginia law from seeking a consecutive term, McAuliffe is vying for a comeback eight years after first winning the governor’s mansion, and despite Democrats’ recent gains, he’s locked in a tight race with Youngkin, a former private equity executive running his first campaign for political office. According to FiveThirtyEight’s polling average, the McAuliffe’s lead is under two points one week out from Election Day — down from a nearly eight-point peak over Youngkin he had in early August.
Biden touted McAuliffe first term in office, even saying he’s “taking a page” from the Democrat’s book by including an expansion of pre-K in his Build Back Better bill that Congress and the White House are still negotiating. Biden also plugged McAuliffe’s record on the economy and creating new jobs, saying, “If you’re looking for someone who’s going to keep your economy going and growing, the man behind me’s the guy to get it done.”
Calling in help from national politicians is in line with how McAuliffe and other Democrats have nationalized the stakes of this race.
“This election is about the next chapter of Virginia — and our country,” McAuliffe said at a rally in Richmond with Obama Saturday.
“What happens here, I promise you is about people in these state and the people of our country,” Vice President Kamala Harris said at a rally in Prince William County Thursday.
In addition to Obama and Harris, who will be back in the state Friday for a concert rally in Norfolk with Virginia Beach native Pharrell Williams, McAuliffe has had first lady Jill Biden, second gentleman Doug Emhoff, Sen. Amy Klobuchar, Stacey Abrams and Atlanta Mayor Keisha Lance Bottoms campaign for him. Sens. Cory Booker, D-N.J., and Alex Padilla, D-Calif., are campaigning for him in Northern Virginia Wednesday night.
Youngkin has taken a different approach as the campaign ends, touting his 10-day, 50-stop “Win with Glenn” bus tour around the commonwealth and mocking his opponent for relying “on big name surrogates to draw paltry, apathetic crowds.”
“Nobody’s coming to campaign with me,” Youngkin told CBS last week. “I mean, this is a race about Virginians and about the Virginia challenges.”
Polls show Republicans are more enthusiastic about participating in this election than Democrats. How heavily Washington’s woes weigh on McAuliffe, and whether enough Virginia voters buy the Democrats’ attempts to paint Youngkin and Trump as one in the same, and in turn, vote against him in this race, won’t be known until the votes are counted.
Mark Rozell, dean of George Mason University’s Schar School of Policy and Government, told ABC News Tuesday that the number of national surrogates stumping for McAuliffe is indicative of Democrats’ concerns.
“I think a lot of that has to do with the McAuliffe campaign being worried that the Democratic base is asleep right now, that the Democratic brand right now is suffering because of the declining popularity of the president, what happened in Afghanistan, the perception that the party just can’t get it together in Washington to get things done,” said Rozell, who’s covered this race in the Washington Post’s opinion section.
McAuliffe himself has acknowledged the president’s falling support in Virginia.
“We got to get Democrats out to vote. We are facing a lot of headwinds from Washington, as you know. The president is unpopular today, unfortunately, here in Virginia, so we have got to plow through,” he said during a virtual rally on Oct. 5 that was clipped by the Republican National Committee and posted on social media.
In a statement ahead of Biden’s quick trip across the river, RNC Chairwoman Ronna McDaniel said McAuliffe knows the president “is failing Virginians.”
“With an unprecedented amount of Republican enthusiasm, Virginians are ready to reject Terry McAuliffe and Joe Biden this November and turn out for Glenn Youngkin and Republicans up and down the ballot,” she said.
(WASHINGTON) — Vaccines for 28 million American children are on the way to authorization after an advisory panel at the Food and Drug Administration voted in support of the Pfizer vaccine for kids ages 5-11 on Tuesday afternoon.
The vote was the first step in a regulatory process for the two-shot Pfizer vaccine that could allow kids to get their first shots in early November and become fully immunized by early December.
Next, leaders of the FDA have the chance to officially sign off, potentially as soon as Tuesday night. If and when that happens, the White House will begin shipping doses, senior officials told governors on a call Tuesday afternoon that was obtained by ABC News.
But there are still more steps before shots go into arms: If authorized by the FDA, the process would move to the Centers for Disease Control and Prevention next Tuesday, when a CDC panel meets to discuss the same data reviewed by the FDA advisers.
“If all goes well, and we get the regulatory approval, and the recommendations from the CDC, 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,” Dr. Anthony Fauci, chief medical adviser for the White House, said in an interview on Sunday on ABC’s “This Week.”
Many parents are desperate to protect their children after the delta surge over the summer led to increased cases and hospitalizations among kids. Though the variant is not more deadly, it is more transmissible — and because kids are unvaccinated, the variant rocketed through schools and camps.
The most recent data from Pfizer’s clinical trials found that the vaccine for 5-11 year olds was nearly 91% effective against symptomatic illness.
For kids, the vaccine will be given at a smaller, one-third dose.
The vaccine also appeared safe. None of the children in the clinical trials experienced a rare heart inflammation side effect known as myocarditis, which has been associated with the mRNA vaccines in very rare cases, mostly among young men.
And in a review of the data that assumed the worst — that kids could experience myocarditis at the same rates as young men, which many experts don’t believe will be the case — the FDA’s senior adviser for benefit-risk assessment, Hong Yang, still found that in the majority of scenarios, kids will still be safer once vaccinated.
Dr. Matthew Oster, a pediatric cardiologist, told the panel during his presentation on myocarditis that one of the leading theories is that the heart inflammation is linked to testosterone and hormones, which is why it has occurred more often in teenage boys and young men. Oster also said people tend to recover quickly from the kind of myocarditis experienced after vaccination.
But he noted that long-term study of myocarditis is still needed.
“We really need to see what the long-term outcomes for these kids will be. So far, the data for follow-up results is sparse but ongoing follow-up is in progress,” Oster said.
Despite the near-unanimous vote, Oster and Yang’s presentations were among the most debated.
The FDA experts ultimately agreed all children should have the opportunity to get vaccinated, but many also voiced concern over the remaining unknowns about adverse effects, weighing that against the relatively low risk of hospitalization or death from COVID for kids.
Most FDA advisers felt very clearly that the benefits outweighed the risk.
“To me the question is pretty clear. We don’t want children to be dying in COVID, even if it is far fewer children than adults, and we don’t want them in the ICU,” said Dr. Amanda Cohn, chief medical officer for the National Center for Immunization and Respiratory Diseases.
Although children are less likely to die of COVID-19 than older adults, nearly 2 million kids in the 5-11 age group have gotten COVID. Of those, 8,300 have been hospitalized, about one-third of whom have been in the intensive care unit, and almost 100 kids have died.
Cohn said if adverse events like myocarditis increase among kids, the safety systems in place will flag and address the problem.
Dr. Jeannette Lee, a biostatistician at the University of Arkansas, also agreed.
“Obviously, the adverse events are always a concern, but they don’t seem to be overwhelming really, at this point,” Lee said. “I will say that the school closures and the disruption, I think has been enormous.”
But some, though they voted in favor, also felt there should be caveats to the authorization.
“I’m just worried that if we say yes, that the states are going to mandate administration of this vaccine to children in order to go to school, and I do not agree with that. I think that would be an error at this time, until we get more information about the safety,” Dr. Cody Meissner, chief of pediatric infectious diseases at Tufts Children’s Hospital, told his colleagues on the panel.
For his part, FDA’s vaccine chief Dr. Peter Marks said the experts should trust that any adverse effects would be closely monitored and acted on if necessary.
The safety teams at the FDA and CDC “are incredibly committed and devoted to making sure that we understand the nature of the safety events and that we catch these signals as soon as we possibly can,” Marks said. “That’s what we’re here to do.”
The White House has purchased enough pediatric doses to vaccinate all 28 million children ages 5 to 11. If authorized, it will be distributed to thousands of sites, including pediatricians, family doctors, hospitals, health clinics and pharmacies enrolled in a federal program that guarantees the shots are provided for free.
Some states are planning to provide the vaccine through schools as well.
The 5-11 age group would be the youngest and latest to receive eligibility. The Pfizer vaccine has already been authorized for adolescents 12 and up, and everyone 18 and older is eligible for all three vaccines: Pfizer, Moderna and J&J.
Whether parents will embrace the vaccines for their kids is still a question. In a September poll, the Kaiser Family Foundation found that about a third of parents with kids ages 5-11 were willing to vaccinate their kids right away, while another third wanted to “wait and see.” The figures represented a slight uptick in vaccine acceptance among parents of elementary-school-aged kids since July.
Trials for children 2 years and up, the next age group that could become eligible, are ongoing. Data from the clinical trials is expected sometime this winter.
(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.
(HOUSTON) — The boyfriend of the mother of an 8-year-old boy has been charged with murder after the child’s remains were discovered in a Houston home along with his three abandoned siblings, authorities said.
One of the children, a 15-year-old, called the authorities and said his brother had been dead for one year and his body was in the room next to his, Harris County Sheriff Ed Gonzalez said Monday.
The Harris County Medical Examiner’s Office said the boy’s manner of death was a homicide, according to Houston ABC station KTRK.
His mother, Gloria Williams, 35, now faces multiple charges, including injury to a child by omission and tampering with evidence (human corpse), Gonzalez announced Tuesday night.
Her boyfriend, Brian Coulter, 31, has been charged in the murder of her son, who was 8 years old at the time of his death in 2020, the sheriff said.
Both Williams and Coulter are in custody and additional charges are expected, he said.
The 15-year-old and the other two children — boys under the age of 10 — were found home alone on Sunday, the sheriff said.
Both younger kids “appeared malnourished and showed signs of physical injury,” he tweeted.
Deputies also “found skeletal remains of a small child,” the sheriff said.
All three children were taken to the hospital, he said. Their conditions were not released.
Authorities believe the parents hadn’t lived in the home for several months, Gonzalez said.
Prior to their arrest, the children’s mother and her boyfriend were found late Sunday night and had been interviewed and released, Gonzalez said Monday.
The investigation is ongoing, the sheriff said.
At a news conference Sunday, Gonzalez called it a “horrific situation.”
“I have been in this business for a long time and I had never heard of a scenario like this,” he said.
(WASHINGTON) — “I don’t know where in the hell I belong,” Sen. Joe Manchin, the West Virginia Democrat, said Tuesday when when asked about possibly switching parties amid his stubborn bargaining with frustrated fellow Democrats and President Joe Biden.
Manchin said people approach him “every day” about doing so, and that it would be an easy decision. But he insisted he won’t, speaking out in a revealing interview with Economic Club for Growth Chairman David Rubenstein.
“Is that the purpose of being involved in public service? Because it’s easy?” Manchin asked. “Do you think by having a “D” or an “R” or an “I” is going to change who I am?” he said, adding he didn’t believe Republicans would be any more pleased with him than Democrats are right now.
He called being the only statewide Democratic public official in his home state “very lonely,” but said he understands why his constituents mostly vote for Republicans.
“My little state has never complained. We’ve done all the heavy lifting — we’ve done the mining, we’ve made the steel, we’ve done everything it took for this country to be a the superpower of the world,” Manchin said. “And all of a sudden they took a breath and looked back and we’re not good enough, we’re not clean enough, we’re not green enough, we’re not smart enough, so to hell with you. So, they said, ‘Well, to hell with you, too.'”
With Democrats holding onto a razor-thin margin in the Senate, Manchin has emerged as a pivotal player in Democratic efforts to pass the president’s agenda.
He said he doesn’t think there is anything “fun” about being the decisive vote in the Senate — but it’s led to breakfast meetings at Biden’s Delaware home and given him the upper hand in driving the direction of the massive social spending package, including what amounts to a veto power over provisions he doesn’t like.
That includes sticking to a much lower $1.5 top-line price tag for the social spending package he set at the start — something Democrats and Biden are still negotiating with him about this week, months later.
He commented on Majority Leader Chuck Schumer’s decision in June to use the fast-track budget process known as reconciliation to bypass Republican blocking efforts.
“I don’t think we should be running the government through reconciliation, because it’s not lasting,” Manchin said he told Schumer.
He also reaffirmed Tuesday that he’s opposed to changing the Senate’s filibuster rule — just days after Biden himself suggested he could support exceptions for fundamental Democratic priorities such as voting rights and election reform — and maybe more.
While that would give Democrats breathing room to pass key agenda items, without Republicans keeping the measures from even getting a vote, Manchin said it’s important that the minority party retains some political power and that all sides pursue bipartisanship.
And he offered some behind-the-scenes color about how he’s been bargaining with Biden, who’s eager to secured his support.
“The president and I had this conversation, I said, ‘Mister President, I don’t know who put this out, but that’s screwed up,'” Manchin said, speaking about a proposal to help pay for his spending plan by having the IRS track annual transactions of $600 or more from individual bank accounts. After GOP backlash, the administration last week backed off the idea to catch tax evaders, raising the triggering amount to more than $10,000.
Manchin wasn’t happy.
“Do you understand how messed up that is?” he said he told the president. “This cannot happen. It’s screwed up.”
“He says, ‘I think Joe’s right on that,’ Manchin told Rubenstein. “So, I think that one’s going to be gone.”
(WASHINGTON) — Three of President Joe Biden’s major nominees were confirmed to ambassadorships by the Senate on Tuesday.
Former Sen. Jeff Flake, an Arizona Republican who left office in 2019, was confirmed as ambassador to Turkey, while former Democratic Sen. Tom Udall of New Mexico was confirmed to be ambassador to New Zealand.
Cindy McCain, the wife of late GOP Sen. John McCain, was confirmed to the rank of ambassador during her tenure of service as U.S. Representative to the United Nations Agencies for Food and Agriculture.
All three nominees were confirmed unanimously.
Arizona Sen. Mark Kelly, a Democrat, asked for unanimous consent to confirm Cindy McCain. Kelly was mentored by John McCain prior to his death in 2018 and won his Senate seat last year. Democratic Sen. Kyrsten Sinema, also of Arizona, was presiding over the Senate when the nomination was confirmed and was visibly excited.
Flake and McCain were some of Biden’s most ardent Republican supporters during the 2020 presidential election. They were censured by the Arizona Republican Party in January for their staunch criticism of former President Donald Trump.
“When I began in the Republican Party officially, the Republican party was the party of inclusion. It was the party of generosity. It was the party of ‘country first,'” Cindy McCain said of the censure. “We have lost our way and it’s time that we get back on track.”
“I truly hope that as things progress on, and we get further away from this mess that occurred, that we can do just that,” she added. “We can get back on track and remind everyone that we are here for the country and not our party.”
