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COVID-19 vaccine testing turns to kids

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The 9-year-old twins didn’t flinch as each received test doses of Pfizer’s COVID-19 vaccine — and then a sparkly bandage to cover the spot.

“Sparkles make everything better,” declared Marisol Gerardo as she hopped off an exam table at Duke University to make way for her sister Alejandra.

Researchers in the U.S. and abroad are beginning to test younger and younger kids to make sure COVID-19 vaccines are safe and work for each age. The first shots are going to adults who are most at risk from the coronavirus, but ending the pandemic will require vaccinating children too.

“Kids should get the shot,” Marisol told The Associated Press this week after the sisters participated in Pfizer’s new study of children under age 12. “So that everything might be a bit more normal.” She’s looking forward to when she can have sleepovers with friends again.

So far in the U.S., teen testing is furthest along: Pfizer and Moderna expect to release results soon showing how two doses of their vaccines performed in the 12 and older crowd. Pfizer is currently authorized for use starting at age 16; Moderna is for people 18 and older.

Syringes are seen filled with the Moderna COVID-19 vaccine at a Queens vaccine hub.
Syringes are seen filled with the Moderna COVID-19 vaccine at a Queens vaccine hub.
Mary Altaffer/AP

But younger children may need different doses than teens and adults. Moderna recently began a study similar to Pfizer’s new trial, as both companies hunt the right dosage of each shot for each age group as they work toward eventually vaccinating babies as young as 6 months.

Last month in Britain, AstraZeneca began a study of its vaccine among 6- to 17-year-olds. Johnson & Johnson is planning its own pediatric studies. And in China, Sinovac recently announced it has submitted preliminary data to Chinese regulators showing its vaccine is safe in children as young as 3.

Getting this data, for all the vaccines being rolled out, is critical because countries must vaccinate children to achieve herd immunity, noted Duke pediatric and vaccine specialist Dr. Emmanuel “Chip” Walter, who is helping to lead the Pfizer study.

Most COVID-19 vaccines being used around the world were first studied in tens of thousands of adults. Studies in children won’t need to be nearly as large: Researchers have safety information from those studies and subsequent vaccinations of millions of adults.

And because children’s infection rates are so low — they make up about 13 percent of COVID-19 cases documented in the U.S. — the main focus of pediatric studies isn’t counting numbers of illnesses. Instead researchers are measuring whether the vaccines rev up youngsters’ immune systems much like they do adults’ — suggesting they’ll offer similar protection.

Proving that is important because while children are far less likely than adults to get seriously ill, at least 268 have died from COVID-19 in the U.S. alone and more than 13,500 have been hospitalized, according to a tally by the American Academy of Pediatrics. That’s more than die from the flu in an average year. Additionally, a small number have developed a serious inflammatory condition linked to the coronavirus.

Apart from their own health risks, there still are questions about how easily children can spread the virus, something that has complicated efforts to reopen schools.

Earlier this month, Dr. Anthony Fauci, the top U.S. infectious disease expert, told Congress he expected that high school students likely would begin getting vaccinated in the fall. The elementary students, he said, may not be eligible until early 2022.

In North Carolina, Marisol and Alejandra made their own choice to volunteer after their parents explained the opportunity, said their mother, Dr. Susanna Naggie, an infectious disease specialist at Duke. Long before the pandemic, she and her husband, emergency physician Dr. Charles Gerardo, regularly discussed their own research projects with the girls.

In the first phase of the Pfizer study, a small number of children receive different doses of vaccine as scientists winnow out the best dosage to test in several thousand kids in the next phase.

“We really trust the research process and understand that they may get a dose that doesn’t work at all but may have side effects,” said Naggie, describing the decision-making that parents face in signing up their children.

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, testifies during a Senate Health, Education, Labor and Pensions Committee hearing on the federal coronavirus response on Capitol Hill.
Dr. Anthony Fauci has previously said he expects high school-aged students to be able to get vaccinated in the fall.
Susan Walsh, Pool/AP

But 9-year-olds have some understanding of the pandemic’s devastation and “it’s nice to participate in something where it’s not just about yourself but it’s about learning,” Naggie added. “They do worry about others and I think this is something that really, you know, struck home for them.”

For Marisol, the only part that was “a bit nerve-wracking and scary” was having to give a blood sample first.

The vaccination itself was “really easy. If you just sit still during the shot, it’s just going to be simple,” she said.

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FDA finds peeling paint, debris at US plant making J&J’s COVID vaccine

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A US plant that was making Johnson & Johnson’s COVID-19 vaccine must fix a long list of problems including peeling paint and unsanitary conditions and practices to resume operation, according to a highly critical report by the Food and Drug Administration.

Experts said addressing the issues raised in the scathing FDA inspection report could take months.

Neither J&J nor the FDA has said when they expect vaccine production to restart at the Baltimore plant owned by Emergent Biosolutions. Only two other plants are currently equipped to supply the world with the key drug substance for J&J’s vaccine.

“It may take many months to make these changes,” said Prashant Yadav, a global health care supply chain expert at the Center for Global Development. He described some of the issues raised by the FDA as “quite significant.”

No vaccine manufactured at the Emergent plant has been distributed for use in the United States. However, J&J said it will exercise its oversight authority to ensure that all of the FDA observations are addressed promptly and comprehensively.

The Johnson & Johnson vaccine was put on a pause in the US over a potential link to a blood clotting condition.
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The health care conglomerate has drawn scrutiny for months over its halting process to scale up production of a vaccine that is easier to handle and, by virtue of being a single shot, easier to use than other authorized vaccines.

Its use in the United States has been paused since last week as health officials study a possible link to a very rare but serious blood clot condition.

Emergent has been seeking regulatory authorization to make the J&J vaccine in the United States. It stopped production at the plant recently, saying the FDA had asked it to do so after an inspection.

J&J’s plant in Leiden, the Netherlands, is still producing doses for the world. It has another facility in India, which is currently curtailing exports of the shot as it struggles to vaccinate its own population.

Johnson & Johnson reiterated on Wednesday that it was working to establish a global supply chain in which 10 manufacturing sites would be involved in the production of its COVID-19 vaccine, in addition to the Leiden plant.

The company has a US government-brokered agreement with rival drugmaker Merck, which is preparing to make doses of J&J’s vaccine.

Failure to train personnel

The FDA in its final 12-page inspection report said it had reviewed security camera footage in addition to an in-person site visit to the Emergent plant.

It found a failure to train personnel to avoid cross-contamination of COVID-19 vaccines from Johnson & Johnson and AstraZeneca, which had also been produced at the site. The agency also cited staff carrying unsealed bags of medical waste in the facility, bringing it in contact with containers of material used in manufacturing.

The FDA reviewed security camera footage and visited the Emergent BioSolutions plant in Baltimore.
Getty Images

Earlier this week, the House launched an investigation into whether Emergent used its relationship with a Trump administration official to get a vaccine manufacturing contract despite a record of not delivering on contracts.

Emergent said in a statement that it is working with the FDA and J&J to quickly resolve the issues outlined in the report.

Production of the AstraZeneca vaccine, which is not yet authorized for use in the United States, was previously stopped at the Emergent plant after ingredients from that shot contaminated a batch of J&J vaccine, ruining millions of doses.

The FDA also noted that Emergent did not produce adequate reports showing that the vaccines it was producing met quality standards.

The inspection, carried out between April 12 and April 20, also found the building not of suitable size or design to facilitate cleaning, maintenance or proper operations.

J&J said it was redoubling its efforts to get authorization for the facility as quickly as possible.

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One dead after pair of fires breaks out in Manhattan

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One person was killed and several others were injured in a pair of Manhattan fires Wednesday morning, officials said.

The first blaze erupted in Midtown around 8:15 a.m. inside a DSW Designer Shoe Warehouse at 213 W. 34th St., where an escalator became fully engulfed in flames — sending smoke billowing into the first and second floor and the interconnected 40-story hotel building, fire officials said.

It was not immediately clear which hotel it was.

Five firefighters suffered minor injuries putting out the blaze.

“The fire went out, but we have a smoke condition that we’re trying to alleviate,” FDNY Battalion Chief John Porretto said at the scene. “Units are going to remain on scene until all the smoke alleviates.”

The fire marshal will determine the causes of the fire.

A second blaze broke out 15 minutes later on the Upper East Side at 1576 2nd Ave., officials said.

A three-alarm fire at 213 W. 34th Street in Manhattan that left one dead
A three-alarm fire at 213 W. 34th St. in Manhattan left one dead.
NYFD

One man died in the fire and a second man was in serious condition at Lenox Hill Hospital, police said.

A firefighter suffered minor injuries battling the blaze and was taken to Cornell Hospital, fire officials said.

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NYC school leaders react to Derek Chauvin guilty verdict

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The leaders of the city’s public schools and largest charter network both weighed in on the Derek Chauvin verdict with passionate statements about how there is still a long way to go to reach systemic equality.

Department of Education Chancellor Meisha Ross-Porter issued a personal commentary Tuesday night after the murder conviction of former Minnesota cop Chauvin.

“I felt pain and rage, deep in my bones,” she said of her initial reaction to George Floyd’s death. “It wasn’t a new feeling. I have felt that many times in my life, as a Black woman, sister, daughter, and mother to Black children—and as an educator who has served children of color in this city for more than 20 years.”

Ross-Porter said the Department of Education would be issuing guidance for teachers and families to help them process the verdict.

Eva Moskowitz with two students, the CEO and Founder of the Success Academy
Success Academy CEO Eva Moskowitz issued a statement on the Derek Chauvin verdict.
Brigitte Stelzer

“For our Black and brown children to know that they matter, the accountability this verdict represents is so important,” she stated. “In a world that too often tells them otherwise, accountability in this moment tells the Black and brown children in our schools that their lives matter, and lifts up the importance of their futures.”

Several teachers told The Post on Wednesday morning that they planned to broach the topic with their students to allow them to discuss Floyd’s death and Chauvin’s conviction.

Schools Chancellor Meisha Ross-Porter said the Department of Education would issue guidance to help teachers and families process the verdict.
Schools Chancellor Meisha Ross-Porter said the Department of Education would issue guidance to help teachers and families process the verdict.
Mark Lennihan/AP

“Because while the individual who took George Floyd’s life will be held accountable, we recognize that systemic racism, and the violence it fuels, is still creating tragedy and inequality across our country every single day,” Ross-Porter said. “We are all part of the work to undo this harm and reach true justice.”

Success Academy CEO Eva Moskowitz, who oversees the city’s largest charter school network, also issued a statement.

People react after the verdict was read in the Derek Chauvin trial in Minneapolis.
People react after the verdict was read in the Derek Chauvin trial in Minneapolis.
Scott Olson/Getty Images

“We are grateful that justice has been served and that the judicial process has worked as intended,” she wrote. “We recognize, however, that this verdict does not resolve the systemic inequities that led to Floyd’s death; nor does it heal the anguish we feel witnessing our fellow citizens die at the hands of the public servants tasked with protecting us.”

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