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FDA Panel to Review Pfizer’s COVID-19 Vaccine for Kids 5-11

Angelo Moretti

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FDA Panel to Review Pfizer's COVID-19 Vaccine for Kids 5-11



U.S. health advisers are meeting Tuesday to debate whether the Food and Drug Administration should grant emergency authorization to Pfizer’s COVID-19 vaccine for children ages 5 to 11.

The Vaccines and Related Biological Products Advisory Committee will review Pfizer’s data and hear from regulators in an all-day meeting on the safety and efficacy of the vaccine, and to vote on whether the vaccine’s benefits outweigh any serious potential side effects in children.

If the panel votes in favor and the FDA authorizes the shots, the Centers for Disease Control and Prevention will make additional recommendations on who should receive them the first week of November. Children could begin vaccinations early next month — with the first youngsters in line fully protected by Christmas.

Full-strength Pfizer shots already are recommended for anyone 12 or older, but pediatricians and many parents are anxiously awaiting protection for younger children to stem infections from the extra-contagious delta variant and help keep kids in school.

On Friday, the FDA posted its analysis of Pfizer’s data ahead Tuesday’s meeting. Federal health regulators said that kid-size doses of Pfizer’s COVID-19 vaccine appear highly effective at preventing symptomatic infections in elementary school children and caused no unexpected safety issues.

The FDA review affirmed results from Pfizer posted earlier in the day showing the two-dose shot was nearly 91% effective at preventing symptomatic infection in young children. Researchers calculated the figure based on 16 COVID-19 cases in youngsters given dummy shots versus three cases among vaccinated children. There were no severe illnesses reported among any of the youngsters, but the vaccinated ones had much milder symptoms than their unvaccinated counterparts.

Most of the study data was collected in the U.S. during August and September, when the delta variant had become the dominant COVID-19 strain.

The FDA review found no new or unexpected side effects. Those that did occur mostly consisted of sore arms, fever or achiness.

However, FDA scientists noted that the study wasn’t large enough to detect extremely rare side effects, including myocarditis, a type of heart inflammation that occasionally occurs after the second dose.

9-year-old Daemo Gregorie-Cradick is one of the 250 kids ages 5 to 11 who are participating in a trial of the Pfizer coronavirus vaccine at the Children’s Hospital Colorado. If the trial is successful, experts say vaccines for kids under 12 could be just months away.

The agency used statistical modeling to try to predict how many hospitalizations and deaths from COVID-19 the vaccine would prevent versus the number of potential heart side effects it might cause. In four scenarios of the pandemic, the vaccine clearly prevented more hospitalizations than would be expected from the heart side effect. Only when virus cases were extremely low could the vaccine cause more hospitalizations than it would prevent. But overall, regulators concluded that the vaccine’s protective benefits “would clearly outweigh” its risks.

While children run a lower risk of severe illness or death than older people, COVID-19 has killed more than 630 Americans 18 and under, according to the CDC. Nearly 6.2 million children have been infected with the coronavirus, more than 1.1 million in the last six weeks as the delta variant surged, the American Academy of Pediatrics says.

The Biden administration has purchased enough kid-size doses — in special orange-capped vials to distinguish them from adult vaccine — for the nation’s 5- to 11-year-olds. If the vaccine is cleared, millions of doses will be promptly shipped around the country, along with kid-size needles.

More than 25,000 pediatricians and primary care providers already have signed up to get the shots into little arms.

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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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