Al Drago/Bloomberg via Getty ImagesBy ALLIE YANG, ABC News
(WASHINGTON) — Less than 24 hours after Moderna’s COVID-19 vaccine was approved by the FDA, Operation Warp Speed’s chief operating officer Gen. Gus Perna said the second vaccine to be approved in the U.S. is being packed and loaded and will be ready to be administered to patients Sunday.
Perna said Saturday that amid snowstorms and the holiday shipping rush, 2.9 million doses of the previously-approved Pfizer COVID-19 vaccine have been delivered over the last week across the country, to every state.
He expects in the coming week, with both the Pfizer and Moderna vaccines going out for distribution, there will be 7.9 million doses delivered across 3,700-plus locations, including hospitals, doctor offices and pharmacies.
In addition to private companies like Pfizer, Moderna, FedEx and UPS, the OWS collaboration includes the Centers for Disease Control and Prevention, the National Institutes of Health, the Biomedical Advanced Research and Development Authority and the Department of Defense.
Perna says he feels “confident” about their goal of processing 20 million vaccines by the end of December and finishing distribution across the U.S. by the first week of January.
Perna also addressed allegations that vaccine doses were cut, explaining he took complete personal responsibility in approving a larger number of vaccines that were actually releasable, in part because of the FDA’s rigorous checks for safety, as well as a non-stop production line from manufacturing to processing to distribution.
He said he has spoken to governors from several states to personally apologize for the error.
“At the end of the day, this is all about enabling the governors and the states to ensure that their people receive the vaccine in a fair and equitable process — and that when they receive it, they can have confidence that the vaccine is safe and ready to be administered in their arms,” Perna said.
On Friday, a board of independent advisers overwhelmingly voted to recommend the Moderna vaccine for people over the age of 18. Shortly after, the U.S. Food and Drug Administration approved the vaccine, triggering the shipping of 5.9 million doses.
The Pfizer and Moderna vaccines are similar in several ways, including using messenger RNA technology, and both have been shown to be more than 94% effective in protecting against COVID-19 across race, gender and underlying medical conditions.
Side effects for both vaccines have been shown to be mild and temporary, including symptoms of pain at the injection site, headache, fever, fatigue, chills and muscle and joint pain.
The two vaccines have subtle differences, but it will be ultimately unlikely Americans will be able to choose which shot they get as it will depend on which is available in their area.
The two differ in part because Moderna’s vaccine can be kept in a conventional freezer at minus 4 degrees, while Pfizer’s requires a special freezer to maintain a minus 94 degree environment.
While they both have two-dose timelines, Moderna’s is slightly longer at a 28-day schedule between shots, and Pfizer’s is 21 days.
The companies’ vaccines are also authorized for slightly different age groups. Pfizer’s vaccine is authorized for people 16 years old and up, while Moderna’s authorization request includes people 18 and older.
A third vaccine also is on the horizon. Johnson & Johnson was expected by early January to know whether its vaccine was effective. If that vaccine comes online as well, that “will help us accelerate even faster coverage of that population,” Moncef Slaoui, Trump’s top science adviser in the vaccine effort, told CNBC.
ABC News’ Erin Schumaker contributed to this report.
(NEW YORK) — In April, a month after the World Health Organization declared the coronavirus outbreak a global pandemic, the Rape, Abuse & Incest National Network (RAINN) reported that, for the first time, half of the victims receiving help from its National Sexual Assault Hotline were minors.
Eight months later, the anti-sexual violence organization is still finding that to be the case.
“We are seeing a lot of what we saw in the spring,” RAINN President Scott Berkowitz told ABC News this month. In fall 2019, about 40% of hotline users were minors; since the spring, that number has consistently been around 53%, Berkowitz said.
At the same time, reports of child abuse and neglect to state agencies and interventions by child advocacy centers have declined.
A recent report by the National Children’s Alliance, which represents a national network of 900 children’s advocacy centers, found that the centers helped some 33,000 fewer children in the first half of the year than they did over the same period last year — a 17% drop — the organization told ABC News.
“We have every reason to believe that those kids are still out there, that they still need service, and we simply haven’t been able to identify them to this point,” Teresa Huizar, executive director of the National Children’s Alliance, told ABC News.
Most abusers tend to be an immediate family member, according to the alliance. During the pandemic, children have lost access to people outside the home — such as a teacher, doctor or friend’s parent — who could report possible physical abuse or neglect. Instead, they may turn to a service like RAINN’s hotline, which could be helping to fill the gap, or go unhelped, which child abuse prevention advocates like Huizar have feared to be the case.
The National Children’s Alliance says it plans to follow up on data from children’s advocacy centers to see how many children they served in the second half of the year. Though “we really have no reason to think that it will be very much different” from the first half, Huizar said, as many students have continued to learn remotely and surging COVID-19 cases have renewed stay-at-home orders.
The pandemic has continued to put some children at an increased risk of abuse, Huizar said. Not only have they had less contact with people they could turn to during this time, families have endured financial stress for months on end. The boosted $600 in federal unemployment insurance ran out in late July, and several pandemic relief programs are set to expire at the end of the year.
“Families that might not have been in immediate crisis at the beginning of the pandemic then came into crisis,” Huizar said. “As those circumstances worsen, we know from research that the more economic stressors there are in a family, the more likelihood that we are increasing the possibility of domestic violence and physical abuse.”
A lack of social support is another stressor that may increase the risk of child abuse, Lisa Specter-Dunaway, the CEO and president of Families Forward Virginia, a Richmond-based nonprofit that provides services to help disrupt cycles of child abuse, neglect and poverty, told ABC News.
“Having access to high-quality care is a child abuse prevention strategy,” she said, though the pandemic “has underscored the fragility of the child care system.”
One in four child care centers and one in three child care homes say that if enrollment stays the same and no additional financial support comes forward, they will have to close in the next three months, according to a survey released last week by the National Association for the Education of Young Children. There is an emergency need for $50 billion to stabilize and support the sector, the organization said, as funding from the CARES Act, the Paycheck Protection Program and other sources runs out.
After months of stalled negotiations, congressional leaders Friday night were still working out a nearly $900 billion COVID-19 relief deal that could include child care funding, as well as a second round of stimulus checks for lower-income Americans.
Over the past nine months, service providers have adapted to help reach children and offer support.
Children’s advocacy centers have moved the mandatory reporter training they offer to teachers online to continue to teach educators the signs of abuse and neglect. Some have also worked with schools to include safety messaging in homework packages and do unintrusive welfare checks on families such as through pizza dropoffs, Huizar said.
Families Forward Virginia’s programs have held home visits virtually or socially-distanced on porches and in playgrounds. Teachers have also conducted online polls to gauge how children are feeling, Specter-Dunaway said. Though if children don’t have consistent internet access, they could be missed.
“There are a lot of organizations that are conscious of it and are doing everything they can,” Berkowitz said. “But it’s so hard to have direct access to kids.”
In July, RAINN launched a new app, through which users can access its National Sexual Assault Hotline. It has also brought on 30 additional hotline staffers to keep up with demand.
The full impact of the pandemic on incidences of child abuse remains to be seen, though Berkowitz is sure of one thing.
“I think we’re going to see a lot more ongoing assaults,” he said. “In a different world they might have been able to get help early; this year, they’re going to suffer for a longer period.”
Jimi Celeste/Patrick McMullan via Getty ImagesBy JAMES HILL and AARON KATERSKY, ABC News
(NEW YORK) — Federal prosecutors in New York are urging a judge to reject Ghislaine Maxwell’s second attempt to be released on bail in advance of her trial, arguing that she remains an “extreme flight risk” because of her foreign ties, her alleged “lack of candor” and her “demonstrated willingness and sophisticated ability to live in hiding,” according to court documents made public on Friday.
Maxwell, who has pleaded not guilty to enabling and, in some cases, participating in deceased sex-offender Jeffrey Epstein’s alleged sexual abuse of three minors in the mid-1990s, argued again for release on bail in a motion earlier this month. Maxwell’s submission included letters from her previously undisclosed husband and more than a dozen relatives and friends attesting to her “forthright character” and their confidence she would not flee.
“Ms. Maxwell would never destroy those closest to her by fleeing, after they have risked so much to support her,” Maxwell’s attorneys wrote in the renewed motion for bail.
But prosecutors cast Maxwell’s pitch for a $28 million bail package as a rehash of arguments previously rejected by the court at a detention hearing in July, two weeks after Maxwell’s arrest.
“The offense conduct outlined in the indictment remains incredibly serious, the evidence against the defendant remains strong, and the defendant continues to have extensive financial resources and foreign ties, as well as the demonstrated ability to live in hiding for the long term,” wrote prosecutors.
Maxwell revealed in her renewed bail application that she has been married for four years, but prosecutors balked at the notion that would keep her from fleeing the country and faulted Maxwell for an “apparent willingness to deceive” the court initially about her assets and her marital status after her arrest.
“Although the defendant now claims her marriage would keep her in the United States, her motion does not address the plainly inconsistent statements she made to Pretrial Services at the time of her arrest, when, as documented in the Pretrial Services Report, the defendant said she was ‘in the process of divorcing her husband,'” acting U.S. Attorney Audrey Strauss wrote.
“On this point, it bears noting that the defendant’s motion asks that she be permitted to live with [name redacted] if granted bail, not her spouse,” Strauss added.
Maxwell’s spouse, whose name has been redacted from the public version of the court filings, told the court in a letter earlier this month that the person described in the federal government’s criminal charges is “not the person we know.” He said he did not come forward as a co-signer to Maxwell’s initial bail application because they were trying to protect their family “from ferocious media aggression.”
“I have never witnessed anything close to inappropriate with Ghislaine; quite to the contrary, the Ghislaine I know is a wonderful and loving person,” he wrote in a letter accompanying the motion for bail.
A person familiar with Maxwell’s thinking said that divorce was an option she had considered immediately after her arrest in order to protect the privacy of her husband and family, but that it was not pursued.
Prosecutors noted in their response to the new bail application that all three of the alleged victims listed in the indictment continue to oppose her release. The government included in their filing a letter to the judge from Annie Farmer, 41, who has publicly identified herself as one of the three alleged victims. Farmer’s letter expresses her doubts that Maxwell would show up for trial if she’s granted release on bail.
“She has lived a life of privilege, abusing her position of power to live beyond the rules. Fleeing the country in order to escape once more would fit with her long history of anti-social behavior,” Farmer wrote.
“Maxwell has repeatedly demonstrated that her primary concern is her own welfare, and that she is willing to harm others if it benefits her,” Farmer continued. “She is quite capable of doing so once more. She will not hesitate to leave the country irrespective of whether others will be on the hook financially for her actions because she lacks empathy, and therefore simply does not care about hurting others.”
At Maxwell’s initial detention hearing in July, prosecutors conceded that they were not alleging Maxwell presented a danger to society if released on bail, but argued that her finances were “opaque” and that she was the “very definition of a flight risk.”
More than $22 million of the assets Maxwell has pledged to secure the proposed bond would come from the combined resources of Maxwell and her husband, with the remainder to be posted by a handful of close family and friends, according to Maxwell’s court filing earlier this month.
Maxwell’s lawyers noted in their motion for bail that she and her husband have filed joint federal tax returns since 2016. Prosecutors did not challenge the accuracy of the couple’s tax filings, but argued in their opposition that most of the couple’s reported assets were Maxwell’s to begin with, and that she had “slowly funneled the majority of her wealth to trusts and into her husband’s name over the last five years.”
As a result, the government contends, if Maxwell were to flee she would “largely be sacrificing her own money and assets, thereby limiting the moral suasion of her spouse co-signing the bond,” prosecutors wrote.
The government also alleged that Maxwell’s proposed bail package would still leave her with substantial resources to flee the country. Maxwell’s proposal “does not change the government’s position that the defendant has considerable financial resources and could live a comfortable life as a fugitive,” prosecutors wrote.
Maxwell, 58, is the Oxford-educated daughter of Robert Maxwell, the larger-than-life publishing baron whose rags-to-riches story captivated England. She lived an extravagant life among the British elite until her father’s business empire collapsed in the wake of his death in 1991. She decamped to New York looking for a fresh start and was soon seen in the company of the mysterious multimillionaire Epstein.
Following Epstein’s death in August 2019, prosecutors vowed to hold accountable anyone who allegedly conspired with him or participated in his alleged child-sex trafficking crimes. Their attention quickly turned to Maxwell, who had previously been accused in civil lawsuits of facilitating Epstein’s abuse of young women and girls, allegations that she has long denied. She was arrested on July 2 in a surprise early morning raid at a secluded 156-acre property in New Hampshire that had been purchased by a shell company in an all-cash transaction, according to court records and public documents.
Maxwell’s lawyers have argued that she went into seclusion after Epstein’s death in order to avoid media scrutiny on her and her family rather than to avoid arrest. But prosecutors argued in their opposition that, whatever the reason, “her time in isolation makes clear that, even to the extent she has loved ones and property in this country, she has proven her willingness to cut herself off entirely from them and her ability to live in hiding.”
If granted bail under her proposed conditions, Maxwell would be restricted to a New York residence with round-the-clock security and GPS monitoring. She would also irrevocably waive her rights to contest extradition from France or England, the two countries other than the U.S. where Maxwell holds citizenship.
Prosecutors countered that GPS monitoring would offer “little value for a defendant who poses such a significant flight risk because it does nothing to prevent the defendant’s flight once it has been removed. At best, home confinement and electronic monitoring would reduce a defendant’s head start after cutting the bracelet.” And they contended that her proposed waivers to contest extradition would likely be “unenforceable and effectively meaningless” if she were to flee.
Maxwell’s lawyers will have one more opportunity to counter the prosecution’s argument for her continued detention. They’ve asked U.S. District Judge Alison Nathan to schedule a hearing next week on her renewed bail package. Nathan has not yet committed to a hearing and may issue her decision solely on the written arguments.
(WASHINGTON) — The U.S. Food and Drug Administration has authorized use of a second COVID-19 vaccine for people age of 18 and over, a move that will trigger the shipment of millions more doses to hospitals and nursing homes next week.
Like its competitor Pfizer, the Moderna vaccine was believed to be both safe and highly effective. After tracking some 30,000 volunteers, Moderna estimated it as 94% effective in preventing COVID-19 illness with few serious side effects.
“With the availability of two vaccines now for the prevention of COVID-19, the FDA has taken another crucial step in the fight against this global pandemic that is causing vast numbers of hospitalizations and deaths in the United States each day,” said FDA Commissioner Dr. Stephen M. Hahn.
The Moderna vaccine though does not require the same ultra-cold storage, making it more user-friendly, particularly in rural areas that might be less equipped.
The authorization comes after federal advisers — an independent group of infectious disease experts, doctors and scientists — agreed overwhelmingly on Thursday that the benefits of the Moderna vaccine outweighed any potential risks based on trial data. The vote was 20-0 with one abstention.
As with volunteers who took the Pfizer vaccine, fatigue, headaches and swelling at the injection site were noted.
Unknown still is whether the vaccine stops transmission. The study only looked at whether people became serious ill.
Also unclear is the potential for allergic reactions. A few incidents have been reported following shots of the Pfizer vaccine.
At Thursday’s meeting on Moderna, Dr. Doran Fink, a senior vaccine official at the FDA, said researchers didn’t have all the information. But he noted that “these cases underscore the need to be vigilant during the early stage of the campaign” and communicate those findings to the public.
Fink said the FDA was working with Pfizer to further revise fact sheets and warnings to health care providers to make clear that any facility administering it “should ensure that medical treatment for managing serious allergic reactions is immediately available.” He said the FDA plans to do the same for Moderna.
“I have never been more hopeful that we will eventually turn the corner on this pandemic,” said Rich Besser, a former director of the Centers for Disease Control and Prevention and head of the Robert Wood Johnson Foundation.
The 5.9 million doses shipped from Moderna would be in addition to the 6.4 million doses provided by Pfizer-BioNTech.
Dr. Anthony Fauci, the nation’s top infectious disease expert, said Wednesday that people shouldn’t be concerned about having to choose between Moderna and Pfizer. An internal assessment by the FDA already found that the Moderna data showed the benefits likely outweigh the risks.
ABC/Randy Holmes(LOS ANGELES) — Fans of the TheFresh Prince of Bel-Air were reunited with the beloved Banks family last month for a reunion special and, on Thursday, Will Smith shared a seven-minute video detailing everything they didn’t see.
When asked about what makes the Emmy and Golden Globe-nominated show stand out, the Aladdin star credited “the casting.”
“You cannot buy or fake chemistry,” said Smith, who was 21 when the series started production. “When people vibe, when people are in sync and in tune and in harmony, you can’t fake that. And when you have it, it creates magic.”
“I think we could all sense that something special was bubbling,” he added of the show, which celebrated its 30th anniversary this year.
Another behind the scenes look showed an emotional Smith sitting at the reconstructed set and gushing, “This is crazy! Dude, big chunk of my life on this set!”
Alfonso Ribeiro, who played Carlton, winced when reviewing his audition tape and exclaimed to his laughing cast mates, “Everybody in that cast has more experience than me… and they picked me?!”
The video also showed more about Smith and Janet Hubert’s emotional reunion, with the actor admitting the two hadn’t spoken for 27 years.
“I have to say, after 27 years, being here today and having the conversation Will and I had together, the moments that we shared the other day, it’s healing,” said Hubert after a large sigh. Hubert played Aunt Viv before being replaced by Daphne Maxwell Reid in the third season.
The Fresh Prince ran from 1990 to 1996 on NBC. The 30th anniversary reunion special is streaming now on HBO Max.
Al Drago/Bloomberg via Getty ImagesBy ALLIE YANG, ABC News
