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FDA Paves Way for Pfizer COVID-19 Vaccinations in Young Kids

Angelo Moretti

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FDA Paves Way for Pfizer COVID-19 Vaccinations in Young Kids



The Food and Drug Administration on Friday paved the way for children ages 5 to 11 to get Pfizer’s COVID-19 vaccine.

The FDA cleared kid-size doses — just a third of the amount given to teens and adults — for emergency use, and up to 28 million more American children could be eligible for vaccinations as early as next week.

One more regulatory hurdle remains: On Tuesday, advisers to the Centers for Disease Control and Prevention will make more detailed recommendations on which youngsters should get vaccinated, with a final decision by the agency’s director expected shortly afterwards.

“With this vaccine kids can go back to something that’s better than being locked at home on remote schooling, not being able to see their friends,” said Dr. Kawsar Talaat of Johns Hopkins University. “The vaccine will protect them and also protect our communities.”

A few countries have begun using other COVID-19 vaccines in children under 12, including China, which just began vaccinations for 3-year-olds. But many that use the vaccine made by Pfizer and its partner BioNTech are watching the U.S. decision, and European regulators just began considering the companies’ kid-size doses.

With FDA’s action, Pfizer plans to begin shipping millions of vials of the pediatric vaccine — in orange caps to avoid mix-ups with the purple-capped doses for everyone else — to doctors’ offices, pharmacies and other vaccination sites. Kids will get two shots, three weeks apart.

While children are at lower risk of severe illness or death from COVID-19 than older people, 5- to 11-year-olds still have been seriously affected — including over 8,300 hospitalizations, about a third requiring intensive care, and nearly 100 deaths since the start of the coronavirus pandemic, according to the FDA.

And with the extra-contagious delta variant circulating, the government has counted more than 2,000 coronavirus-related school closings just since the start of the school year, affecting more than a million children.

Earlier this week, FDA’s independent scientific advisers voted that the pediatric vaccine’s promised benefits outweigh any risks. But several panelists said not all youngsters will need to be vaccinated, and that they preferred the shots be targeted to those at higher risk from the virus.

The coronavirus pandemic caused people to buy more goods to replace services they weren’t accessing (like buying workout equipment instead of going to the gym, or buying kitchen equipment instead of eating out). Now many products are out of stock, with shortages affecting millennials the most, according to a poll from the Morning Consult.

Nearly 70% of 5- to 11-year-olds hospitalized for COVID-19 in the U.S. have other serious medical conditions, including asthma and obesity, according to federal tracking. Additionally, more than two-thirds of youngsters hospitalized are Black or Hispanic, mirroring long-standing disparities in the disease’s impact.

The question of how broadly Pfizer’s vaccine should be used will be a key consideration for the CDC and its advisers, who set formal recommendations for pediatricians and other medical professionals.

A Pfizer study of 2,268 schoolchildren found the vaccine was nearly 91% effective at preventing symptomatic COVID-19 infections, based on 16 cases of COVID-19 among kids given dummy shots compared to just three who got vaccinated.

The kid dosage also proved safe, with similar or fewer temporary reactions — such as sore arms, fever or achiness — that teens experience.

But the study wasn’t large enough to detect any extremely rare side effects, such as the heart inflammation that occasionally occurs after the second full-strength dose, mostly in young men and teen boys. It’s unclear if younger children getting a smaller dose also will face that rare risk.

Some parents are expected to vaccinate their children ahead of family holiday gatherings and the winter cold season.

But a recent Kaiser Family Foundation survey suggests most parents won’t rush to get the shots. About 25% of parents polled earlier this month said they would get their children vaccinated “right away.” But the remaining majority of parents were roughly split between those who said they will to wait to see how the vaccine performs and those who said they “definitely” won’t have their children vaccinated.

The similarly made Moderna vaccine also is being studied in young children, and both Pfizer and Moderna also are testing shots for babies and preschoolers.

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Biden Tries to Reassure on COVID as He Sells Spending Plan

Angelo Moretti

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Biden Tries to Reassure on COVID as He Sells Spending Plan



President Joe Biden on Tuesday went to Minnesota to pitch his completed infrastructure deal and a giant social spending bill that he’s still trying to get passed, but also found himself reassuring the nation he would fight the evolving COVID-19 threat without resorting to “shutdowns and lockdowns.”

Biden met with students at Dakota County Technical College in Rosemount in a garage space with a bulldozer, backhoe and cargo truck before delivering a speech criticizing GOP lawmakers for opposing his social services and climate spending bill that would expand health care coverage, enhance job training for students at community colleges, and offer child care benefits for middle and low income Americans.

The pill from drug maker Merck could become the first U.S. authorized at-home treatment for the coronavirus.

Biden has been eager to build momentum for his agenda, but he finds himself once again forced to divert attention to battling the virus—this time because of global concerns about the spread of the omicron strain of the virus.

“This new variant is a cause of concern, but not a cause to panic,” Biden said.

He said that on Thursday, he would detail his plan for how “we’re going to fight COVID this winter, not with shutdowns and lockdowns” but “with more widespread vaccination, boosters, testing and much more.”

Biden came to the suburban Minneapolis tech college looking to tout his $1 trillion infrastructure plan and making the case for an addition $1.75 trillion spending bill, which he is still trying to get through the Senate. The legislation includes $5 billion for community colleges to expand workforce training programs.

“Technology moves so rapidly,” Biden told students. “You’ve got to get an education to make it work.”

The trip came as Biden, who in addition to facing the threat of the new omicron strain of the coronavirus is also batting high levels of inflation as vital parts of his agenda are still await congressional approval. Biden also needs to get Congress to move to temporarily fund the government and preserve its ability to borrow as the debt limit could be breached in December.

Biden holds out the infrastructure package, containing money for roads, bridges, broadband, water systems and a shift to electrical vehicles, as evidence that he can work across the political aisle. The measure passed with solid Republican support..

Biden won Minnesota in last year’s presidential election with 52.6% of the vote. He’s visited the state’s second congressional district, a potentially vulnerable seat in the midterms that narrowly went to Democratic Rep. Angie Craig in 2020.

The president noted that Minnesotans saw first-hand the need to invest in rebuilding the nation’s infrastructure in August 2007 when a portion of the I-35 bridge in Minneapolis collapsed, killing 13 and injuring more than 140 more.

“No more talking, time for action,” Biden said. “This law makes significant investments in our roads and bridges.′

The president has recently been in close contact with the heads of several major retailers, including Target, which is headquartered in the state, as he attempts to resolve supply chain challenges that have clogged ports and caused consumers to wait longer for electronics, furniture and other goods.

The supply chain challenges have contributed to prices in October rising 6.2% from 12 months ago, the highest pace in 31 years. The White House National Economic Council issued a report Monday suggesting that there has been progress on addressing the problems, with a decrease in long-dwelling containers waiting at ports and an increase in retail inventories.

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CDC Strengthens Advice for Boosters as Omicron Variant Spreads Globally

Angelo Moretti

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Boosters for All Adults in US Closer With CDC Panel Meeting Set



All adults should get COVID-19 booster shots when they’re eligible, the Centers for Disease Control and Prevention said Monday, striking a much stronger tone than its recommendations just a few weeks ago.

The new advice was issued days after the new omicron variant of the coronavirus was detected in southern Africa. The variant’s constellation of mutations suggests the virus could evade the immune system or spread more easily than previous variants do, although it will take time to determine its impact.

“Everyone ages 18 and older should get a booster shot … when they are 6 months after their initial Pfizer or Moderna series,” the CDC’s director, Dr. Rochelle Walensky, said in a statement. Anyone who got the single-dose Johnson & Johnson vaccine shot at least two months ago would also qualify.

The CDC only earlier this month recommended that people ages 50 and up, as well as those in long-term care facilities, should get a booster. The agency said at the time adults ages 18 to 49 may choose to get a booster, based on their risk.

Read the full story at NBCNews.com.

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US Expected to Toughen Testing Requirement for Travelers

Angelo Moretti

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US to Require Vaccines for All Nonresident Border Crossers in January



The Biden administration is expected to take steps in the coming days to toughen testing requirements for international travelers to the U.S., including both vaccinated and unvaccinated people, amid the spread of the new omicron variant of the coronavirus.

The precise testing protocols were still being finalized ahead of a speech by President Joe Biden planned for Thursday on the nation’s plans to control the COVID-19 pandemic during the winter season, according to a senior administration official who said some details could still change. Among the policies being considered is a requirement that all air travelers to the U.S. be tested for COVID-19 within a day of boarding their flight. Currently those who are fully vaccinated may present a test taken within three days of boarding.

“CDC is evaluating how to make international travel as safe as possible, including pre-departure testing closer to the time of flight and considerations around additional post-arrival testing and self-quarantines,” Centers for Disease Control and Prevention Director Dr. Rochelle Walensky said Tuesday.

The official, who spoke on the condition of anonymity to discuss the administration’s plans before the announcement, said options under consideration also include post-arrival testing requirements or even self-quarantines.

The expected move comes just weeks after the U.S. largely reopened its borders to fully vaccinated foreign travelers on Nov. 8.

Much remains unknown about the new variant, which has been identified in more than 20 countries but not yet in the U.S., including whether it is more contagious, whether it makes people more seriously ill, and whether it can thwart the vaccine. Dr. Anthony Fauci, the top U.S. infectious disease expert, said more would be known about the omicron strain in two to four weeks as scientists grow and test lab samples of the virus.

The pill from drug maker Merck could become the first U.S. authorized at-home treatment for the coronavirus.

On Monday, as he sought to quell public concern about the new variant, Biden on said that in his Thursday remarks, “I’ll be putting forward a detailed strategy outlining how we’re going to fight COVID this winter — not with shutdowns or lockdowns but with more widespread vaccinations, boosters, testing, and more.”

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