(RED WING, Minn.) — Years after two infants were discovered dead along a stretch of the Mississippi River in Minnesota, police have identified and arrested their mother in connection with one of their deaths.
Jennifer Lynn Matter, 50, is charged with two counts of second degree murder in connection with the December 2003 death of her newborn son.
Four years before the body of her son was discovered, police had found a female infant’s body in the river. Investigators had suspected the two infants were siblings and their DNA profiles were run against criminal databases over the years to find their parents, but no match had been found, Drew Evans, the superintendent of the Minnesota Bureau of Criminal Apprehension, told reporters during a press conference.
Genetic genealogy ultimately provided the lead that led to Matter’s arrest by connecting officers to two persons of interest, Evans said. Investigators learned of a relative of the children in Goodhue County, Minnesota, and then worked to narrow their search, identifying Matter as the most “logical and likely” mother, he said.
Matter of Red Wing, Minnesota, had declined to voluntarily provide police with a DNA sample, according to the complaint. After obtaining a search warrant for the sample, police were able to identify Matter as the mother of the two children, the complaint says.
Charges have not been filed against Matter in connection with the 1999 death of Matter’s infant daughter, Stephen O’Keefe, the Goodhue County attorney, said at a press conference Monday. He declined to give a reason, but said the investigation is ongoing. Charges could be added or amended at a later time as more evidence comes to light, he said.
Information on an attorney for Matter was not immediately available.
During a bail hearing on Tuesday, a judge denied Matter’s application for a public defender, according to ABC affiliate KSTP in St. Paul, Minnesota. Her bail was set at $1.5 million without conditions, according to court records.
Investigators interviewed Matter on May 5, which is when she admitted the child born in November 1999 was hers, according to the criminal complaint. Matter told investigators she was in a bad mental state that year saying she was “in and out of jail, drinking too much, doing a lot of stupid things and had experienced chaotic life circumstances for a long time,” the complaint says.
Matter said that she was not aware she was pregnant when she started bleeding after dropping off her two other children. When she returned home, she said she began giving birth in the bathroom, according to the complaint.
She said the baby was born blue, was not breathing and was not crying so she “freaked out,” according to the complaint. Matter said she wrapped the child in a towel while she tried to figure out what to do. She said she was drinking heavily, according to the complaint.
Matter told investigators that a day later she drove the baby to Bay Point Park in Red Wing in the middle of the night and put her in the water, the complaint says.
A boater found the baby wrapped in a towel in the water, according to the complaint.
An autopsy of the newborn concluded that the manner of death was homicide, but the cause of death was undetermined, the complaint shows.
Matter said she gave birth to the second baby on a beach in nearby Florence Township in December 2003 while she was “laying low” because there was a warrant out for her arrest and she believed cops were looking for her, the complaint revealed.
Matter told investigators she did not remember whether she wrapped the second baby in a towel or a blanket and said she did not look to see the gender of the child. Matter said she remembered leaving the baby on the beach before driving away.
Matter later told investigators the child was breathing and may have been crying, but she did not remember it. Matter said she did not call 911 and hoped someone in the houses nearby would find the baby, according to the complaint.
A group of teenagers found the infant’s body along the shoreline of the river, the complaint shows.
An autopsy found that the male infant had force head injuries, “possibly due to the birth process,” according to the complaint. The infant’s manner of death was determined to be homicide, but the cause of death was undetermined, according to the complaint.
(PHILADELPHIA) — Philadelphia police are seeking a suspect in a recent string of sexual assaults that they believe may be the work of a serial rapist.
Authorities have identified a “pattern of sexual assaults” that occurred in the Kensington neighborhood and involved a man who sexually assaulted women in his car, according to Captain James Kearney, commanding officer of the Philadelphia Police Special Victims Unit.
“We’ve got three cases,” Kearney told reporters during a briefing Tuesday. “We have a pattern going on here.”
The incidents occurred in the early morning hours of March 15, April 5 and April 21, police said. Two victims were approached by the suspect and got in his car, one after being offered a ride, police said. A third victim was forced into the car, police said.
Philadelphia Police Department
In all three cases, the suspect drove to a location, pulled out a handgun and demanded oral sex from the women, police said. In the most recently reported assault, the suspect also punched and raped the victim and stole her cellphone, Kearney said. A rape kit was conducted, where DNA evidence was collected and is in the process of being compared to other cases, he said. The iPhone was recovered as well, he said.
Police described the suspect’s car as a 2016 to 2020 charcoal gray Dodge Charger four-door sedan, with tinted windows and “distinct rims.” Detectives were able to locate surveillance video of the car but were unable to pick up a license plate, Kearny said.
The victims ranged in age from 28 to 35 and were all Black women, police said. Kearney described them as “the most vulnerable people out there,” and noted that the area is known for sex work.
“He’s preying on these women who we believe he feels that’s not going to report it,” he said.
Authorities believe that additional assaults involving other women may have occurred and are asking potential survivors to step forward.
“For one reason or another, these survivors, these women are not coming in to talk to us,” said Kearney. “We need to talk to people and stop it from happening again.”
ABC News’ Victoria Arancio contributed to this report.
(BOSTON) — Celebrity chef Mario Batali has been found not guilty of indecent assault and battery for a 2017 incident in Boston.
“It’s an understatement to say that Mr. Batali did not cover himself in glory on the night in question. His conduct and his appearance and his demeanor are not befitting of a public person of his stature at that time,” Boston Municipal Court Justice Judge James Stanton said Tuesday.
But the judge added, “This case is about credibility. And it’s the court’s job to adapt to assess the credibility of the witnesses. … The complaining witness has significant credibility issues.”
Natalie Tene, 32, said Batali forcibly kissed her and grabbed her breasts, buttocks and groin after meeting him in a Boston bar while having a drink with a friend in March 2017.
Under cross-examination, Tene repeatedly said she did not remember text messages she sent to friends that described her meeting Batali as “exciting.” In one message, she suggested to a friend she could “hopefully” get $10,000 for photos of the encounter.
After two days of testimony and two hours of deliberation Stanton ruled that the defendant had a financial motive for making the accusations. Stanton rendered the verdict directly as the sole decider of the case since Batali waived his right to a jury trial.
On Monday, at the start of the trial, Tene said she was speaking out “to be able to take control of what happened,” while a defense attorney for Batali called her a liar who is twisting the truth “for money and for fun.”
Tene claimed Batali was “grabbing me in ways I had never been touched before, squeezing between my legs … pulling me closer to him.”
Batali maintained that he was not guilty of the allegations.
Mario Batali takes leave of absence, apologizes to those ‘I have mistreated and hurt’
The alleged assault took place after the accuser asked the chef for a selfie. He smelled of alcohol and appeared intoxicated, she alleged. Tene has also filed a civil complaint for unspecified damages based on the same allegations that will be tried separately from this case.
Though this case was the only one to go to criminal trial, four women accused Batali of inappropriate touching in December 2017, which prompted him to leave the ABC daytime cooking show “The Chew” and remove himself from his restaurant business. In a statement at the time, Batali said he was “so very sorry” for disappointing his friends, family, co-workers and fans.
ABC News’ Mark Guarino contributed to this report.
(SAN FRANCISCO) — Former world heavyweight boxing champ Mike Tyson will not face charges in an incident last month in which he was recorded getting into a physical altercation with a fellow passenger on a flight at San Francisco International Airport, a California prosecutor announced Tuesday.
San Mateo County District Attorney Steve Wagstaffe said he decided not to charge the 55-year-old Tyson after reviewing police reports and videos of the confrontation.
“Our decision is that we will not file any charges against Mr. Tyson based on the circumstances surrounding the confrontation,” Wagstaffe said in a statement. “These include the conduct of the victim leading up to the incident, the interaction between Mr. Tyson and the victim, as well as the requests of both the victim and Mr. Tyson that no charges be filed in this case. We now deem this case closed.”
The incident unfolded on April 20 while Tyson was seated in first-class on a JetBlue flight at San Francisco International Airport waiting to take off for Florida.
A video obtained by the website TMZ Sports appeared to show a passenger seated behind Tyson repeatedly attempting to speak to the boxer, who became annoyed and told the man to “chill.”
“Unfortunately, Mr. Tyson had an incident on a flight with an aggressive passenger who began harassing him and threw a water bottle at him while he was in his seat,” representatives for Tyson said in a statement to The Associated Press.
The video showed Tyson standing up, leaning over the back of his seat and repeatedly punching the passenger, who was later video recorded with blood on his forehead.
San Francisco police officers detained Tyson and the passenger, and opened an investigation.
Wagstaffe said he reviewed the case and determined that allegations Tyson committed misdemeanor battery were not founded.
Tyson’s attorneys David Z. Chesnoff, Richard A. Schonfeld and Martin A. Sabelli issued a joint statement thanking Wagstaffe for conducting a thorough investigation and praising all law enforcement agencies involved in the probe for their “careful, diligent and professional work.”
(NEW YORK) — The parents of a 6-year-old marathoner are speaking out after they say child protective services paid their family an unannounced visit and questioned their children at home.
Ben and Kami Crawford shared a photo on Instagram Sunday purportedly of one of their children being interviewed by a CPS staffer. In the accompanying caption, they wrote in part, “Yesterday Child Protective Services (CPS) arrived at our home unannounced and interviewed our children, parents & grandmother. This is a scary process because usually children are interrogated away from parents, against their will, and their answers determine the agency’s legal right to take away the kids.”
The Crawfords made headlines last week after they let their children, including their son Rainier, 6, run the Flying Pig Marathon in Cincinnati on May 1 and shared it online. Their May 3 Instagram post in particular sparked outcry from social media users, with some critics going so far as to accuse the Crawfords of child abuse.
Campbell County, Kentucky, District Attorney Steve Franzen confirmed to “Good Morning America” that child services had visited the Crawfords, but said no determination had been made yet in the investigation.
Ben and Kami Crawford addressed critics’ accusations in a lengthy Instagram video Saturday.
“The real stuff that we got accused of was dragging Rainier, like physically dragging him on the marathon course after mile 13 and across the finish line,” Ben Crawford said.
“If you guys have seen our finish line picture, we all held hands for like the last probably, like, .2, .3 miles,” he added. “We talked about it ahead of time, like that’s what we’re going to do.”
The Crawfords maintain their 6-year-old wanted to run all along and stand by their decision to let the young boy run 26.2 miles.
“I don’t know if I should be angry. I like to believe that people are doing the best that they can. They’re not trying to ruin our life or, you know, they probably are legit afraid for our kids. But also, it’s like, where’s the line?” Ben Crawford asked.
“I feel like we’re doing what we feel passionate about,” Kami Crawford said. “It would be kind of tragic to stop all that.”
Experts say a marathon is a serious physical feat for anyone and it can take a toll on a child.
“If a young child were to run a marathon, I’m worried about electrolyte abnormalities, nausea, vomiting, heatstroke, all these signs and symptoms that may not be that clear in a young child,” Dr. Alok Patel previously told “GMA.”
Children may have a harder time recognizing warning signs of dehydration, exhaustion or other red flags. Parents and caregivers should consult with a child’s pediatrician before a child is permitted to engage in any strenuous exercise.
(MONTGOMERY, Ala.) — Alabama’s gender-affirming care ban went into effect on May 8, and physicians in the state say they’re scrambling to figure out how provide care for their young transgender patients.
S.B. 184, the Vulnerable Child Protection Act, states that anyone who provides gender-affirming care to anyone under 19 could be convicted of a felony and face up to 10 years in prison and a $15,000 fine.
This type of care includes providing puberty blockers, hormone therapy or physical gender-affirming surgeries.
Pediatric endocrinologist Hussein Abdul-Latif, who provides gender-affirming care for trans youth, told ABC News that before the ban went into effect, he was rushing to see his patients and refill the necessary prescriptions to continue their treatment in the meantime.
He has already seen the fear this legislation has caused as patients prepare for an end to healthcare.
“It was a scramble, trying to gather as many names as possible of the kids that we see in our clinic and make sure that they do have refills called in before the law took effect,” Abdul-Latif said.
Abdul-Latif says patients have attempted suicide due to discrimination, bullying and anti-trans sentiment. With this new law in place, he fears the worst.
“Physicians and the patient and the family [typically] walk through the different options that they have and come to the best solution that works for that particular context,” Abdul-Latif said. “By having a law, it took all that dialogue and that discussion that’s deep and that’s heartfelt … now, there’s no discussion. You just abide by the law or I will put you guys in jail. That is not how medicine is effective, but this is also not how civil society reacts.”
He’s had to cancel in-person appointments with trans patients who live too far away and would waste their time and money just to leave empty-handed, without the gender-affirming treatments they were traveling to him for.
He also said that some patients fell through the cracks and did not receive their prescription refills in time.
Now, Abdul-Latif says he and his fellow physicians that provide such care are left hoping that a federal judge will block the ban following a lawsuit filed by GLBTQ Legal Advocates & Defenders (GLAD) and other civil rights organizations against Alabama Gov. Kay Ivey and other state officials seeking an injunction against the law. The judge is expected to issue a decision by the end of the week.
“We’re trying to prepare for the worst-case scenario while we’re hoping for the best-case scenario,” he said.
The governor’s office did not immediately respond to ABC News’ request for comment Tuesday.
The bill’s sponsor, Republican state Sen. Shay Shelnutt, has called gender-affirming health care, “child abuse.”
“We don’t want parents to be abusing their children. We don’t want to make that an option because that’s what it is, it’s child abuse. This is just to protect children,” Shelnutt said on the state Senate floor in February.
After signing the bill into law last month, Ivey said, “I believe very strongly that if the Good Lord made you a boy, you are a boy, and if he made you a girl, you are a girl.”
She continued, “We should especially protect our children from these radical, life-altering drugs and surgeries when they are at such a vulnerable stage in life. Instead, let us all focus on helping them to properly develop into the adults God intended them to be.”
The law was panned by physicians, including Abdullatif, who say it is riddled with misinformation about gender-affirming care.
The legislation makes the claim that puberty blockers can cause infertility or other health risks.
According to physicians, these potential side effects only present real risks after puberty and are not a risk to youth taking puberty blockers.
The bill also cites the higher rate of mental health conditions among transgender people as a reason to ban care — though many medical organizations say poor mental health conditions is due to anti-trans discrimination and lack of gender-affirming care.
“I know that I am a girl and I always have been,” said a 15-year-old transgender girl in a statement from LGBTQ legal advocacy group Lambda Legal. “The possibility of losing access to my medical care because of this law causes me deep anxiety. I would not feel like myself anymore if this lifesaving medication was criminalized.”
Several medical organizations, including American Academy of Child and Adolescent Psychiatry and American Academy of Pediatrics, have spoken out against the bill.
“The American Academy of Pediatrics recommends that youth who identify as transgender have access to comprehensive, gender-affirming, and developmentally appropriate health care that is provided in a safe and inclusive clinical space,” the American Academy of Pediatrics said in a statement.
It continued, “These bills not only ignore these recommendations, they undermine them.”
(NEW YORK) — The woman accused of fatally pushing an 87-year-old woman on a New York City street was indicted on a manslaughter charge and ordered held without bail on Tuesday.
Lauren Pazienza, 26, pleaded not guilty in New York State Supreme Court to charges stemming from the March 10 attack, including one count of first-degree manslaughter and two counts of second-degree assault. She was remanded into custody, with the judge citing a recent bail reform change that allows judges to consider the seriousness of harm caused, according to New York ABC station WABC.
Prosecutors allege that on the evening of March 10, Pazienza crossed the street in Manhattan’s Chelsea neighborhood and “shouted obscenities” at the victim, Barbara Maier Gustern, a well-known and beloved member of the city’s cabaret scene and a vocal coach. Pazienza then “intentionally shoved her to the ground,” prosecutors allege.
Gustern hit her head on the ground, causing a hemorrhage to the left side of her brain, and died five days later in the hospital after she was removed from life support, according to prosecutors.
“This was a senseless and unprovoked attack,” Manhattan District Attorney Alvin L. Bragg, Jr., said in a statement. “Barbara Gustern was a beloved vocal coach who lived a vibrant and active life at the age of 87, and her loss was felt deeply by many throughout the city.”
Prosecutors allege Pazienza “went to great lengths to avoid accountability for her actions,” including leaving the scene as Gustern lay bleeding on the ground. The suspect stayed in the area for about 20 minutes, during which time video footage showed her have a “physical altercation” with her fiance and watch the ambulance arrive, before they headed back to their apartment in Astoria, Queens, according to prosecutors.
Following the incident, Pazienza deleted her social media accounts, took down her wedding website and “eventually fled to Long Island to stay with family,” according to prosecutors.
Pazienza allegedly admitted to her fiance that she pushed Gustern, prosecutors said. She turned herself in to police on March 22, nearly two weeks after the incident, and was arrested on manslaughter and assault charges. She was initially released on $500,000 cash bail.
A motive for the attack remains unclear.
Following her arrest, her attorney called the victim’s death a “tragedy.”
“We’re just going to get to the bottom of what really happened that day after we have all the evidence that’s in possession of the prosecutors because we don’t have any evidence,” her attorney, Arthur Aidala, said in a statement at the time.
Pazienza is next due in court on July 26.
ABC News’ Aaron Katersky contributed to this report.
(ATLANTA) — Gun homicides increased 35% across the country during the pandemic to the highest level in 25 years, according to newly released data from the Centers for Disease Control and Prevention (CDC).
“Unfortunately I am not surprised,” Debra Houry, acting principal deputy director of CDC and director of the National Center for Injury Prevention and Control, told ABC News, “but it is heartbreaking.”
Firearm murders increased most markedly among youth and young adults — 40% for those 10 to 24, the CDC data shows. The increases were also highest for people of color: rates of gun homicide involving Black males aged 10 to 24 years — which were already 21-times has high as white males of the same age — increased further still in 2020.
The study suggests that the rise in violence could be attributed to the social and economic pressures stemming from the pandemic that reinforced “longstanding” inequities between communities.
The report also found that while the increase in firearm suicides was less than firearm homicides, the sheer number of suicides involving guns continued to outpace homicides. There were 24,245 suicides involving firearms in 2020, the report found, compared to 19,350 firearm homicides.
“These stats have devastating effects on families, schools, and entire communities, and have lasting consequences on us as individuals and as a society,” Thomas Simon, associate director for science at the CDC’s Division of Violence Prevention, said during a press briefing on Tuesday.
“Our reports contain statistics and numbers, but it’s also important to reflect on the individual lives lost,” he added, “and even one homicide or suicide is too many.”
The new CDC data confirms trends identified by ABC News as it studied data compiled by the Gun Violence Archive over the past year. It also builds upon other research demonstrating rising rates of gun purchasing and gun violence during the pandemic.
Guns remained available for purchase throughout the pandemic — even during intermittent stay-at-home orders — due to exemptions designating firearm retailers (and shooting ranges) as “essential businesses” in all but four states. A December study found that 7.5 million Americans became new gun owners during the pandemic — 5 million of whom lived in a household that previously hadn’t had guns.
The purchasing patterns aren’t showing any sign of letting up, either. The FBI has conducted over 10 million firearm background checks — which are frequently used as a proxy for purchases — in 2022 through April.
Gun violence has picked up alongside the increase in purchases, other studies found. According to an October study, gun violence increased in 28 states during the pandemic; another found that firearm incidents increased 15% — and non-fatal firearm injuries increased 34% — during the pandemic.
The youngest Americans have, increasingly, been collateral damage of this violence. Firearm deaths in children between 1 and 4 years old have increased 5% annually since 1999. And in the first six months of the pandemic, the risk of firearm injuries in children less than 12 years was 90% higher than in the pre-pandemic period.
Monika Goyal, a pediatric emergency medicine specialist at Children’s National Hospital in Washington, D.C., called the statistics “sobering” — adding that they reinforce what she’s been seeing clinically: that children are increasingly finding themselves in the crosshairs.
The pandemic uptick in firearm purchasing, violence and homicide has been attributed in part, to intensifying economic pressures like unemployment, housing insecurity and childcare.
“Longstanding systemic inequities and structural racism have resulted in limited economic, housing, and educational opportunities associated with inequities in risk for violence,” the authors of the new CDC study wrote, “the COVID-19 pandemic might have exacerbated existing social and economic stressors.”
Social factors like decreases in mutual aid, pausing in-person harm-reduction initiatives and political unrest may have also fueled these patterns, researchers say.
“Stay-at-home orders and physical distancing likely increased the guardianship people had over their homes and property,” the authors of a February report wrote, which could “help explain the observed relationship with violence” and the fact that “interpersonal interactions — despite happening with lesser frequency during the pandemic — may have been increasingly violence-prone.”
According to Houry, policy changes to halt the worrisome and worsening trends in gun violence are urgently necessary.
“[Gun] violence is not inevitable,” she told ABC News, “it’s preventable.”
The authors of the CDC offered various recommendations to that end, which included expanded welfare policies, empowering community-based harm reduction efforts, and promoting strategies for urban renewal among other initiatives.
“The findings of this study underscore the importance of comprehensive strategies that can stop violence,” they wrote. “Now and in the future.”
(PALO ALTO, Calif.) — A hate crimes investigation has been launched at Stanford University after a noose was found hanging in a tree outside a student residence hall, officials said.
It was the third time in four years that a noose has been discovered on the Palo Alto, California, campus, and the second since November, according to university officials.
Susie Brubaker-Cole, the school’s vice provost for student affairs, and Patrick Dunkley, vice provost for institutional equity, access and community, issued a joint statement condemning the act.
“We cannot state strongly enough that a noose is a reprehensible symbol of anti-Black racism and violence that will not be tolerated on our campus. As a community, we must stand united against such conduct and those who perpetrate it,” Brubaker-Cole and Dunkley wrote in their statement to The Stanford Daily student newspaper.
The noose was discovered at about 7:45 p.m. Sunday hanging on a tree outside Branner Hall, an undergraduate residence hall, and was reported to the university’s Department of Public Safety, school officials said.
Campus police immediately launched a hate crimes investigation that included interviewing maintenance staff, students and school staff in an effort to narrow down the time frame for the incident and identify a suspect or suspects, according to a statement on the Stanford’s Protected Identity Harm Reporting website.
It was not immediately clear if any campus security video captured the culprit hanging the noose.
Brubaker-Cole and Dunkley thanked the people who saw the noose and reported it to the campus police.
“We are sharing this message with the full university community so that everyone is informed and we can move forward as one committed to ending anti-Black racism,” Brubaker-Cole and Dunkley said in their statement.
It was the second noose found on the campus in six months. On Nov. 29, a student reported seeing two long cords that appeared to be fashioned into a noose hanging from a tree along a campus walking trail. Campus police investigated the incident but could not determine if the cords were deliberately fashioned into a noose or were part of an abandoned swing or rope ladder, according to school officials.
In July 2019, campus police investigated the discovery of a noose near a residence for summer students.
No arrests have been made in any of the incidents.
(NEW YORK) — Between March 2020 and February 2022, vaccine-maker Emergent BioSolutions was forced to discard or destroy up to 400 million coronavirus vaccine doses due to the contamination of ingredients, according to a congressional report published Tuesday — a figure that reflects more than five times what was previously disclosed by the beleaguered firm.
Congressional investigators probing the Maryland-based biotech company found that Emergent executives had privately raised urgent quality-control concerns even before the company began manufacturing the vaccines’ key ingredient — despite publicly expressing confidence in their ability to deliver on their multimillion-dollar government contract.
Meanwhile, according to the report, Emergent lab workers intentionally sought to mislead government inspectors about issues at its Bayview, Maryland, plant, and repeatedly “rebuffed” efforts by AstraZeneca and Johnson & Johnson to inspect their facilities.
“Despite major red flags at its vaccine manufacturing facility, Emergent’s executives swept these problems under the rug and continued to rake in taxpayer dollars,” House Oversight and Reform Committee Chairwoman Carolyn Maloney, D-N.Y., said of the report, which determined that the company’s “manufacturing failures and deceptive tactics” led to the largescale waste of ingredients that could have helped make millions of vaccine doses.
None of the compromised batches of the ingredient in question made it into finished vaccine doses released from Emergent’s plant, the committees said.
An Emergent spokesperson said the firm learned of the congressional report from news outlets who reached out seeking comment, and did not address a list of detailed questions from ABC News.
“Emergent has been open and forthcoming with the FDA, Congress and our partners about the work at our Bayview site and the challenges that were encountered, including providing thousands of documents, willingly participating in a congressional hearing and inviting them to visit our facilities,” the spokesperson said.
Tuesday’s joint report from the House Oversight Committee and the House Subcommittee on the Coronavirus Crisis aggregates the findings of their yearlong probe into Emergent’s quality control issues. As part of their efforts, committee investigators secured internal Emergent emails and interviewed several key witnesses, including senior officials from the U.S. Food and Drug Administration.
Emergent landed a $628 million contract from the Food and Drug Administration in June 2020 to help develop Johnson & Johnson and AstraZeneca vaccines at its Bayview facility as part of Operation Warp Speed, the Trump administration’s rapid vaccine development program.
But according to the committees’ report, issues at Bayview arose even before the firm secured its vaccine-development deal. In a flurry of internal emails during the spring of 2020, executives and managers expressed a growing concern with the firm’s response to an April 2020 FDA audit that identified troubling safety deficiencies.
Sean Kirk, at the time an Emergent executive, wrote in a June 2020 email to a quality-control manager that the situation was “deeply concerning” and demanded that he “fix this.” In email correspondence with another colleague that same day, Kirk wrote that “room for improvement” in the Bayview plant’s quality control systems “is a huge understatement.”
Outwardly, however, the firm claimed its longstanding relationship with U.S. government agencies — which included multiple contracts to develop anthrax vaccines — was evidence of its competence. But internally, said the report, alarm bells continued to sound — and anxiety over Bayview’s readiness grew.
“Of all the things we have to deliver on [Operation Warp Speed], the thing that keeps me up at night is overall perception of state of quality systems at bayview [sic],” Kirk wrote to Emergent CEO Robert Kramer in late June 2020.
The drumbeat of concern over quality control at Bayview reached a fever pitch in the fall of 2020, as internal memos ahead of a September 2020 FDA inspection indicated that executives were fully aware of gaps in quality control measures for months after vaccine development began, according to the congressional report.
“We are not in full compliance yet — BUT — we are making [vaccine] batches NOW,” Emergent’s senior director of quality wrote in an internal email, according to the report. “Our risk is high!”
In November 2020, according to an email obtained by the committees, a consultant with an outside firm warned the company that “ultimately Emergent will have to decide what level of risk they are willing to accept, but this is one of those where you really better listen to me and do exactly what I tell you to.”
“I am stating very loudly that this work is NON-compliant,” the consultant said. “And a direct regulatory risk.”
AstraZeneca representatives who visited Bayview in November 2020 complained that “a lack of fundamentals [was] contributing to bioburden issue,” and that “poor cleaning was part of the root cause” of the persistent contaminations, per the report.
Emergent executives acknowledged in internal emails that, in its rush to ramp up production, it hired temporary employees with “little or no pharmaceutical experience,” and described trash “piling up” in its facilities, said the report. FDA leaders told the committees that Emergent “hired a lot of individuals not as familiar with vaccine manufacturing, that did not have adequate training to do so” — a message it conveyed directly to Emergent as early as April 2020.
The committee found that despite these red flags, Emergent “did not remediate the issues, and problems persisted at the [Bayview] facility for months.” And from late 2020 to early 2021, the committee wrote, a series of contaminations at Bayview led to the disposal of enough vaccine drug ingredients to produce 240 million doses.
“The investigation has revealed that the impact of these issues is larger than previously known,” the committee said in its report, “with more incidents of contamination and millions more vaccines [ingredients] destroyed than previously revealed by Emergent.”
In February 2021, under pressure from manufacturers to tighten up quality controls, Emergent apparently “rebuffed multiple requests from Johnson & Johnson’s quality staff to access Bayview,” the committee wrote. Around the same time, the committee found that Bayview lab workers sought to hide the extent of their failures prior to an FDA site visit.
According to an email written by one of Emergent’s external consultants and obtained by the committees, Emergent employees removed quality-assurance “hold tags” from two batches of Johnson & Johnson vaccine drug ingredients just one hour before FDA inspectors began their tour of the facility. The “hold tags” were bright yellow and indicated that those batches may have quality issues.
“Since the tags were deemed necessary before and after the FDA’s visit, it is my understanding, based on the entirety of what I observed and was told, that the purpose of removing the QA [quality assurance] hold tags was to avoid drawing attention to the two subject containers during the tour by the FDA inspectors,” the consultant wrote.
In their report, the committees indicated that senior leaders at Emergent were aware of the removal of the tags, and that the incident amounted to an “apparent attempt to impede oversight.” The FDA inspectors “still identified serious concerns” during their visit to the site in February 2021, but did not halt production at the facility until April 2021, after Emergent alerted the Biden administration to its cross-contamination incidents.
Dr. Peter Marks, director of FDA’s Center for Biologics Evaluation and Research, told the committees in a briefing that FDA leaders and inspectors bore some responsibility for the extent of leniency they granted Emergent.
“Shame on us for thinking that [Emergent’s] experience in manufacturing would mean they would be able to move ahead and make the vaccines in a high-quality manner that we would expect for an experienced vaccine manufacturer,” Marks told committee members, according to the report.
In May 2021, during a hearing before the Congress, Emergent executives said the company hoped to resume production of the vaccines “in the coming days.” According to the committees, that didn’t happen; three months passed before regulators allowed Emergent to resume vaccine manufacturing in August 2021. But even then, the problems persisted.
From August 2021 to February 2022, the committee found that Emergent manufactured 15 new batches of Johnson & Johnson vaccine, six of which — the equivalent of 90 million vaccine doses — “were either aborted or rejected by Johnson & Johnson.”
All told, Emergent was forced to discard or destroy up to 400 million doses’ worth of the ingredient that helps make the coronavirus vaccine. Company executives had previously pegged the number at 75 million.
In November 2021, the Biden administration canceled Emergent’s contract to continue developing vaccines, which at the time would have paid the company an estimated additional $320 million.
But the real victims, according to the committees, are those who would have benefited from the 400 million doses that failed to materialize.
“Emergent’s failures wasted hundreds of millions of taxpayer dollars and impacted our country’s ability to meet the urgent, global need for coronavirus vaccines,” the report concludes.
The Emergent spokesperson told ABC News that the company “remains committed to being a trusted partner of the U.S. and allied governments … [and] will continue to use our more than 20 years of public health preparedness experience to help inform an all-of-the-above approach to help prepare for the public health challenges to come.”
On Feb. 7 of this year, Emergent told the committees that its Bayview plant was entering a “maintenance shutdown period.” The company said it hopes to resume manufacturing in August 2022.
Emergent still maintains a federal contract to develop anthrax vaccines.
