(WASHINGTON) — The Food and Drug Administration on Friday postponed its review of Pfizer’s COVID-19 vaccine for kids under 5.
“We realized now, in data that came in very rapidly because of the large number of cases of Omicron, that at this time, it makes sense for us to wait until we have the data from the evaluation of a third dose before taking action,” Dr. Peter Marks, the FDA’s vaccine chief, told reporters.
Marks acknowledged the change was “late breaking” — the FDA’s committee of independent advisors was scheduled to review and vote on authorizing the vaccine next Tuesday — but said the job of the FDA was to “adjust” to new data amid an unpredictable virus.
Pfizer applied for an emergency use authorization for its vaccine for kids ages 6 months to 4 years nearly two weeks ago. Studies on a three-shot regimen continue, which Pfizer ultimately expects will be the most effective dosage for the youngest age group.
The shot for kids under 5 is about one-tenth the dose for adults.
Submitting the data on a rolling basis was intended to get young children started on their vaccinations sooner in the face of the omicron variant and any potential new variants that arise.
But Pfizer said omicron advanced the study “at a rapid pace” and it was now going to wait for the three-dose data that “may provide a higher level of protection in this age group.”
“This is also supported by recent observations of three dose booster data in several other age groups that seems to meaningfully augment neutralizing antibody levels and real world vaccine protection for omicron compared to the two-dose regimen,” Pfizer said in a press release, referring to the heightened protection booster shots have shown to give.
Marks said the FDA needed to see the full data on three doses before it could proceed and he couldn’t comment on the specifics.
“The data that we saw made us realize that we needed to see data from a third dose … to make the determination that we could proceed with doing an authorization,” Marks said.
Pfizer predicts it will be able to submit data on the third dose by early April. Marks, in the briefing, also said it would be about two months before there is more movement from the FDA.
“For the next two months, while the additional data are gathered, parents will have to rely on what they’ve come to do well, which is they’re using masking procedures, and they are making sure that they’re vaccinated and taking those types of precautions with their youngest children,” Marks said.
He went on, “We will do our part obviously, to move as fast as we can when we have the data, but for now we’ll have to ask parents to help to continue to do what they’ve been doing.”
He also sought to reassure parents and their children that this postponement was a sign that the scientific process was working.
Pfizer may have only recently informed the FDA of this new data because it takes time to review clinical studies run by an independent monitoring board.
The latest omicron surge hit children harder than previous variants largely because of their unvaccinated status.
The Backstreet Boys helped define the boy band craze of the late ’90s and aughts, but member Nick Carter recalls how awkward it was for him and his band mates before they hit the big time.
Speaking to USA Today, the singer recalled, “In my late teens, I’d go and try to play basketball on the basketball court with friends, and there’d be kids mocking you and singing your songs like, ‘Backstreet’s back,’ ‘I want it that way’…At that time, I remember it was like, ‘Oh, this pop, boy band music.'”
Nick also gave a shout-out to those who fell in love with their music before they became a global phenomenon, saying he attributes that early attention to “the most incredible fans in the world, who are resilient, who don’t care about what anybody else out there says, and love what they love.”
He added, “Sometimes it was like you were an outsider. We recognize that our fans are the most incredible people in the world.”
Those early fans have certainly been vindicated. The Backstreet Boys have sold over 100 million albums globally and are now considered not just the best-selling boy band of all time — they are one of the best-selling artists in the world.
Backstreet is still going all these years later. Nick and his fellow band mates are getting ready to start their pandemic-delayed world tour, which starts June 4 in California.
In the meantime, Nick has released a new solo single “Easy,” which features country star Jimmie Allen. “I’d been just doing normal, everyday husband and fatherhood duties at home and got inspired to write a song that was about my life,” he explained, noting the song has “too literal” lyrics about waking up in a house full of young kids.
Zedd has accomplished many impressive feats — he’s won a Grammy, collaborated with A-list artists such as Selena Gomez and Ariana Grande, launched countless world tours and played five Vegas residencies — but all that pales in comparison to what he’ll be doing this Sunday.
The Russian-born artist is the Super Bowl’s official pre-game DJ this year, and he tells Entertainment Tonight that he’s beyond amped up for the tremendous opportunity because he honestly thought this was something that was never going to be in the cards.
“To be able to perform it myself…at the Super Bowl, [it] was definitely not something I thought I would ever get to do,” Zedd admitted. “I got a missed call from my team and a lot of text messages, so usually when that happens I know something’s going on — hopefully something good! And then I was like, ‘Oh s***, I gotta call back!’ I found out it’s happening and I didn’t want to be too happy until I knew it was happening, because sometimes something happens and then it doesn’t. But yeah, this one is actually happening, so I’m super excited!”
The “Clarity” artist added that he has “a rough idea of what I wanna do,” but is taking his time putting together the perfect set list. “There’s definitely a possibility that I’ll mix in some of the songs that will for sure make some of the players take their headphones off,” he hinted. “I think my plan is to play…just a bunch of classics and a lot of songs that get people hyped, just to keep the energy up.”
Zedd also dropped a major hint that fans should keep their ears trained on the SoFi Stadium speakers during his set, because he’ll “maybe [play] something that isn’t released yet.”
Just in time for Valentine’s Day, the latest episode of Cardi Tries features Cardi B and her husband Offset getting matching tattoos to commemorate their relationship.
Under the guidance of celebrity tattoo artist Nikko Hurtado, the two took turns inking each other with their wedding date. They each got 9/20/17 on their hands above their thumbs, so that when they’re holding hands, the dates line up.
(NEW YORK) — About 4,000 New York City municipal workers are facing termination Friday for not being vaccinated against COVID-19.
Less than 1% of the city’s workforce will lose their jobs if they don’t show proof of vaccination — potentially the country’s largest workforce reduction linked to COVID vaccines.
The 4,000 employees include 3,000 workers who are on unpaid leave and 1,000 new workers who were hired after Aug. 2, 2021, who were told they had to be vaccinated as a condition of employment.
“I want them to stay, I want them to be employees of the city, but they have to follow the rules that were made before my administration,” Mayor Eric Adams said during a press conference Thursday. “We have to be very clear. People have to be vaccinated if they are a New York City employee. Everyone understood that and we have to follow that.”
The mandate was first announced in October 2021 by then-New York City Mayor Bill de Blasio for roughly 370,000 city employees — including police officers, firefighters, corrections officers and teachers — to either be vaccinated by the end of month or be placed on unpaid leave.
When the mandate was first announced, about 84% had received at least one dose, according to City Hall, which rose to 95% by January. Several exemptions have also been granted.
The unpaid workers must submit proof of their first dose by day’s end and then have 45 days to receive a second dose. The new workers, on the other hand, submitted proof of an initial dose when they were hired and now must show they’ve completed their vaccine series.
Adams said some workers who were facing termination have since submitted their proof of vaccination so it’s not clear how many employees will be fired.
During the press conference, Adams stressed that any workers who have not yet been vaccinated weren’t being fired, but are rather “quitting” on the city.
“We are not firing them. People are quitting,” he said. “The responsibility is clear. We said it, ‘If you were hired, if you get this job, you have to be vaccinated. If you are not following the rules, you are making that decision. You are making the decision that you are not going to follow the rules of getting vaccinated and that is a decision they are making.'”
Hundreds of workers protested the mandate earlier this week, marching across the Brooklyn Bridge.
Additionally, a religious rights group filed a lawsuit in Brooklyn Federal Court Thursday on behalf of unvaccinated city workers, claiming the mandate violates their religious and constitutional rights.
The plaintiffs, which include firefighters, a corrections officer, a sanitation worker, a social worker and a police officer, say the mandate is “openly discriminatory” against “people with personally held religious beliefs or unorthodox religious beliefs.”
ABC News’ Mark Crudele contributed to this report.
Kingsley Ben-Adir, who starred as Malcolm X in One Night in Miami, will reportedly play another iconic figure, reggae legend Bob Marley, in an as-yet-untitled biopic.
Marley, who influenced generations of other musical acts, with songs like “Get Up, Stand Up,” “I Shot the Sheriff” and “One Love,” died of cancer at 36 in 1981.
Deadline reports that the producers of the project, including Marley’s widow Rita, son Ziggy and daughter Cedella, staged an exhaustive search with director Reinaldo Marcus Green to find the right actor to portay the influential Jamaican-born music star.
It appears Marley’s life story is certainly in good hands: Green’s King Richard — a film about sibling tennis stars Venus and Serena Williams, and their tennis-coach father, Richard Williams — just earned five Oscar nominations.
(WASHINGTON) — Ahead of his promised intent to name his nominee to the Supreme Court by the end of the month, and sticking to his pledge to name the court’s first Black woman, President Joe Biden has indicated to Senate Democrats he will start interviewing prospective candidates for the upcoming vacancy next week, according to two sources with direct knowledge of the meeting.
Emerging from a meeting with Biden on Thursday, Senate Judiciary Chairman Dick Durbin, D-Ill., said they are all “anxious to get started” with the process and confirmed that Biden would be “going to take up a meeting with the nominees soon.” Sen. Sheldon Whitehouse, D-R.I., added they’re “aware of the historic nature of this appointment,” and Richard Blumenthal, D-Conn., said that whomever Biden names will give Republicans “no choice” but to support her nomination.
“I came away from this conversation looking forward more than ever, to bipartisan support because I think the president will nominate someone of such compelling personal story, of character and intellect that Republicans will have no choice in effect, but to support her in some number,” Blumenthal said.
Biden and Harris also told the Senate Democrats, according to a White House readout, that there are a “wealth of extraordinarily qualified potential nominees under consideration” and that “any of the candidates” under review would be “deserving of bipartisan support.”
In an interview with NBC’s Lester Holt taped Thursday, Biden said he’s done a “deep dive” on “about four people” who have already seen “thorough background checks” as he keeps an eye on replicating the qualities of Justice Stephen Breyer on the bench.
“I’m not looking to make an ideological choice here,” Biden said. “I’m looking for someone to replace Judge Breyer with the same kind of capacity Judge Breyer had, with an open mind, who understands the Constitution, interprets it in a way that is consistent with the mainstream interpretation of the Constitution.”
Court watchers expect those under closest consideration include Judge Ketanji Brown Jackson of the U.S. Court of Appeals in Washington, Judge Leondra Kruger of the California Supreme Court and Judge J. Michelle Childs of the U.S. District Court in South Carolina.
Biden told Holt the candidates are “incredibly well qualified and documented. They are the honor students that come from the best universities they have experience, some on the bench, some in the practice of law.”
White House press secretary Jen Psaki also said earlier in the week that the president has reviewed “binders of cases” authored by the potential picks.
“He is receiving and engaging with a range of people as he considers this process. I would note also that as he’s looking at the process, he’s reviewing not just bios, but he’s also reviewing cases. And he is looking at binders of cases,” Psaki said. “He’s taking a very thorough approach to it.”
Once Biden names his nominee, she will go before the Senate Judiciary Committee for public hearings. If confirmed out of the committee, her nomination will see a full floor vote in the Senate.
While Harris, as vice president and president of the Senate, could potentially serve as a tie-breaking vote to Biden’s pick since 51 votes are needed to confirm Supreme Court nominees — there is not a single Black woman in the Senate to vote to confirm the first Black woman nominated to the high court.
A group of 14 Black female lawmakers in the House led by Rep. Cori Bush sent a letter to Biden Thursday morning outlining what they are looking for – and there’s a split within the Congressional Black Caucus as to whether it’s appropriate to publicly push for one Black woman over another.
“I just don’t think it’s our place to pit Black women against each other who are trying to get this spot,” Bush told ABC News Congressional Correspondent Rachel Scott.
Bush’s comments mark a clear break from the highest-ranking Black member of the Congress, Rep. Jim Clyburn, D-S.C., who has launched an aggressive campaign to persuade the president to nominate Childs of South Carolina. Childs already has at least one Republican vote if picked.
“If this happens, it will be because of the power of Jim Clyburn in the Democratic world. I think I can get some of my Republican colleagues to follow my lead, and wouldn’t it be something if the first African-American woman on the court was a South Carolinian,” Republican Sen. Lindsey Graham of South Carolina told WYFF earlier this week.
Biden met last week with Durbin and the top Republican on the Senate Judiciary Committee, Sen. Chuck Grassley, R-Iowa, as the president nears his own self-imposed deadline for the historic Supreme Court pick.
At the formal announcement of Breyer’s retirement, Biden said he was seeking a candidate “with character” and a judicial philosophy that “suggests that there are unenumerated rights to the Constitution and all the amendments mean something, including the Ninth Amendment,” which states that “certain rights, shall not be construed to deny or disparage others retained by the people.”
(LOS ANGELES) — Homeland Security Investigations has seized nearly $100 million in fake goods, including counterfeit Super Bowl merchandise, ahead of Sunday’s big game, a top HSI official told reporters on Thursday.
HSI is the Department of Homeland Security’s investigative arm.
Steve Francis, who serves as the agency’s executive associate director, said at a press conference at the Los Angeles Convention Center that stealing intellectual property is not a “victimless crime.”
“The illicit proceeds resulting from the sale of counterfeit or unlicensed products are more often than not funneled back to smart other criminal organizations,” Francis said. “But more importantly, the illegal manufacture and sale of these counterfeit goods represent predatory trade practices that endanger the public health and economy and restrict competitiveness of the United States products in the global market.”
“Millions” of dollars of merchandise from 261 vendors have already been seized leading up to the game, according to Lt. Geoff Deedrick with the LA County Sheriff’s Department.
Deedrick told consumers to be alert about counterfeit goods — look for official NFL holograms on the products and if it’s too good to be true than it is.
Pete Flores, the executive assistant commissioner at U.S. Customers and Border Protection, told ABC News that not only are counterfeit goods dangerous for national security but could cause bodily harm. He said the consumer doesn’t know what the product is made of and where the product is coming from,
Flores said there isn’t one particular place where it is coming from.
“It comes from multiple countries,” he said. “So multiple importers, it comes from all over the world. So it’s it’s an issue and it’s not only arriving here, it’s a no by sea by air by land. It’s coming across in different modes of transportation.”
(NEW YORK) — As the COVID-19 pandemic has swept the globe, more than 5.7 million people have died from the disease worldwide, including over 915,000 Americans, according to real-time data compiled by Johns Hopkins University’s Center for Systems Science and Engineering.
About 64.3% of the population in the United States is fully vaccinated against COVID-19, according to data from the Centers for Disease Control and Prevention.
Here’s how the news is developing. All times Eastern:
Feb 11, 3:10 pm
Pfizer delays request for vaccine for kids under 5
Pfizer said it has postponed its application to the FDA to expand the use of its COVID-19 vaccine for kids under 5.
Pfizer instead will continue with its study on the three-dose vaccine and seek authorization when that data is available.
“We believe additional information regarding the ongoing evaluation of a third dose should be considered as part of our decision-making for potential authorization,” Pfizer said.
Dr. Peter Marks, the FDA’s vaccine chief, told reporters Friday, “We realized now, in data that came in very rapidly because of the large number of cases of omicron, that at this time, it makes sense for us to wait until we have the data from the evaluation of a third dose before taking action.”
Marks acknowledged that the change was “late breaking” — the FDA’s committee of independent advisers was scheduled to review and vote on authorizing the vaccine next week — but said the job of the FDA was to “adjust” to new data amid an unpredictable virus.
“The data that we saw made us realize that we needed to see data from a third dose as in the ongoing trial in order to make the term determination that we could proceed with doing an authorization,” Marks said.
Pfizer has predicted it will be able to submit data on the third dose in early April.
-ABC News’ Eric M. Strauss, Cheyenne Haslett
Feb 11, 3:07 pm
FDA authorizes new monoclonal treatment that works against omicron
The FDA has authorized a new monoclonal antibody treatment from Eli Lilly called bebtelovimab, which has shown to hold up against omicron and the BA.2 subvariant.
As with other monoclonal therapies, this is for COVID-19 patients early on in their infection who are at high risk for getting severely ill, to help keep them from getting sicker and help keep them out of the hospital.
The Biden administration said it has purchased 600,000 doses for roughly $720 million in anticipation of bebtelovimab getting an emergency use authorization from the FDA.
The plan is to get about 300,000 doses this month and another 300,000 in March. The contract also includes a future option for 500,000 more doses if necessary.
-ABC News’ Sasha Pezenik
Feb 11, 1:55 pm
Pfizer delays request for vaccine for kids under 5
Pfizer said it has postponed its application to the FDA to expand the use of its COVID-19 vaccine for kids under 5.
Pfizer instead will continue with its study on the three-dose vaccine and seek authorization when that data is available.
“We believe additional information regarding the ongoing evaluation of a third dose should be considered as part of our decision-making for potential authorization,” Pfizer said.
FDA independent advisors will no longer meet on Tuesday.
-ABC News’ Eric M. Strauss
Feb 11, 12:09 pm
US cases at lowest point since Christmas
The daily case average in the U.S. has dropped to its lowest point since Christmas, with the nation now reporting an average of 215,000 new cases each day — a 71% drop in the last three weeks, according to federal data.
However, even with the declines, nearly 99% of U.S. counties are reporting high transmission. Also, many Americans are taking at-home tests and not submitting their results, so case totals may be higher than reported.
U.S. hospitalization rates are also declining.
On average, about 12,100 Americans are being admitted to the hospital with COVID-19 each day, down by about 25% in the last week, according to federal data.
The national average continues to plateau around 2,300 new COVID-19-related deaths per day.
Feb 11, 6:56 am
New York City’s unvaccinated workers face termination
About 3,000 municipal workers in New York City — less than 1% of the city’s workforce — face termination Friday after refusing to abide by a COVID-19 vaccine mandate.
The requirement, established under former New York City Mayor Bill de Blasio, applies to municipal employees hired after Aug. 2, 2021, who were told to be vaccinated against COVID-19 as a condition of employment and to unvaccinated police officers, correction officers, firefighters and others who opted to forego city health benefits and are currently on leave because they are not vaccinated.
The mandate achieved a vaccination rate among municipal workers of more than 95%. A number of exceptions were approved in recent months.
New York City Mayor Eric Adams said Thursday that some workers initially facing termination had submitted their proof of vaccination, so the final number wasn’t yet clear. He reiterated that the stragglers aren’t being fired but are “quitting.”
“The responsibility is clear,” Adams told reporters Thursday. “We said it. If you were hired, you get this job, you have to be vaccinated. If you are not following the rules, you are making that decision. You are making the decision that you are not going to follow the rules of getting vaccinated. And that is a decision they are making.”
“I want them to stay, I want them to be employees of the city,” he added. “But they have to follow the rules.”
-ABC News’ Mark Crudele and Aaron Katersky
Feb 10, 3:24 pm
1st vaccine shipments for kids under 5 could be as soon as Feb. 21, pending FDA authorization
The first vaccine shipments for children under 5 could arrive at pediatricians’ doors as soon as Feb. 21, according to a planning guide sent to states from federal health officials and obtained by ABC News.
Doses can ship once the FDA signs off.
The FDA’s independent advisory committee will meet on Tuesday and after that the FDA can issue an emergency use authorization.
The CDC’s independent advisory panel is expected to meet within days of the FDA’s authorization. Once the CDC signs off on its panel’s recommendations, vaccinations for kids under 5 can start.
-ABC News’ Sasha Pezenik
Feb 10, 2:18 pm
Walensky: Difficult to release guidance that works everywhere from NYC to rural Montana
CDC Director Rochelle Walensky acknowledged that it’s tough to make national guidelines to ease restrictions that will fit every different city and town.
“One of the challenging pieces has been how we make guidance that is general enough so that it can be applied to New York City and rural Montana and Indian country, which is our responsibility, and yet have it be specific enough so that people can get their questions answered,” Walensky said in a webinar in hosted by the COVID-19 Vaccine Education and Equity Project.
Looking to the future, Dr. Peter Marks, the FDA’s vaccine chief, said “Obviously the hope is — and I think it’s probably the 90% scenario — is that we’re going to now move into a period where … the virus becomes endemic. And we will be living alongside it probably in a period where we will start to get yearly boosters for it.”
But Dr. Sara Oliver, an epidemic intelligence service officer for the CDC, noted that, although there’s a drop in cases, the same hasn’t happened yet in hospitals.
“It’s difficult to envision a time point where we can say COVID is over if we’re still in a time period where our hospitals and ICUs are feeling the strain,” Oliver said.
-ABC News’ Cheyenne Haslett
Feb 10, 1:51 pm
Nevada lifting indoor mask mandate, including for schools
Nevada Gov. Steve Sisolak on Thursday announced an immediate end to the state’s indoor mask mandate — including for schools — citing a rapid decline in cases and a drop in hospitalizations.
“Teachers & schools will no longer be required to wear masks but school districts will need to work with their local health authorities to have plans in place to deal with outbreaks,” the governor tweeted.
He added, “Employers and organizations, including school districts, may set their own policies, and I encourage them to work with their employees and communities to ensure that policies are in place.”
Masks in Nevada will only be required on public transit per federal law, or in special facilities like hospitals or long-term care facilities.
Lester Cohen/Getty Images for The Recording Academy12
Miley Cyrus‘ new Super Bowl commercial is finally here, which finds her teaming with godmother Dolly Parton.
The two-part commercial for T-Mobile made its debut on Friday and was all about 5G phone technology. The ad is a complete spoof on public-service announcements, with Dolly raising awareness about 5G phones with a little help from the “Midnight Sky” singer.
Dolly aims to solve America’s “serious problem” with current 5G networks, saying they are “limited,” and she declares that she wants phones to “be able to shine their brightest like me. I have my own theme park!” That’s when she tells Miley to “use” her voice, which the two teased in Thursday’s trailer.
Miley embarks on a music writing montage and whips up a cheesy song about phones, which is a total spoof on how some causes use inspiring music to get their message across. “Let’s do it for the phones, they do so much for you/ When they’re out there all alone, there’s something we can do,” Miley and a group of backup singers belt out in the ultra campy commercial.
The ad will air during the Super Bowl, which kicks off Sunday at 6:30 p.m. ET on NBC.
