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Exclusive: CDC panel recommends Moderna two-dose Covid vaccine for kids ages 6 to 17

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FDA committee recommends Moderna two-dose Covid vaccine for kids ages 6 to 17

#CDC #panel #recommends #Moderna #twodose #Covid #vaccine #kids #ages

The Centers for Disease Control and Prevention is expected to clear Moderna’s two-dose Covid-19 vaccine for kindergartners through high schoolers for public distribution this week after the agency’s panel of independent vaccine experts unanimously voted Thursday to recommend the shots.

The committee endorsed Moderna’s vaccine for kids ages 6 to 17 after examining its safety and effectiveness during a public meeting. CDC Director Dr. Rochelle Walensky is expected to sign off on the recommendation later Thursday, the final step before pharmacies and doctor’s offices can start administering the shots.

The CDC endorsed Moderna’s vaccines for infants through preschoolers, ages six months to 5-years-old, on Saturday. Vaccinations started this week for that age group.

Moderna’s shots for older kids won’t have an immediate impact on the U.S. vaccination campaign, other than providing parents with another option to choose from. Previously, only Pfizer’s vaccine was authorized for kindergartners through high schoolers, though uptake has been lackluster. Two-thirds of kids ages 5 to 11 and 30% of adolescents ages 12 to 17 haven’t been vaccinated against Covid yet.

More than 600 kids in those age groups have died from Covid during the pandemic and more than 45,000 have been hospitalized, according to the CDC.  Nearly 11 million kids ages 5 to 17 have caught Covid during the pandemic.

Kids ages 6 to 11 receive smaller 50 microgram Moderna shots, while adolescents ages 12 to 17 would receive the same dosage as adults at 100 micrograms.

Moderna originally asked the Food and Drug Administration to authorize its vaccine for adolescents ages 12 to 17 more than a year ago, but the regulator held off after other countries raised concern the company’s shots might be associated with a higher risk of heart inflammation, or myocarditis, than Pfizer’s vaccine.

There are no head-to-head comparisons in the U.S. of heart inflammation in kids who get Pfizer’s or Moderna’s shots because Moderna’s vaccine was only authorized for adults until this month. However, comparisons between Pfizer and Moderna shots in young adults appears to show that the rate of myocarditis is slightly higher in Moderna recipients, though data is not consistent across the various U.S. surveillance systems.

“Some evidence suggests that myocarditis and pericarditis risks may be higher after Moderna than after Pfizer. However, the findings are not consistent in all US monitoring systems,” Dr. Tom Shimabukuro, an official at the CDC vaccine safety unit, told the committee.

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The available U.S. data on myocarditis among kids ages 6 to 17 is based on side effects reported from Pfizer’s vaccine because Moderna’s shots hadn’t been authorized for this age group yet. Pfizer and Moderna’s shots use similar messenger RNA technology.

The CDC has identified 635 cases of myocarditis among children ages 5 to 17 after vaccination out of 54 million Pfizer doses administered. The risk of myocarditis after Pfizer vaccination is highest after the second shot among boys ages 12 to 17. Myocarditis is slightly elevated among boys ages 5 to 11 after the second dose of Pfizer’s vaccine, though it is much lower than adolescents.

Boys ages 16 to 17 reported 75 myocarditis cases per 1 million second Pfizer doses administered while boys ages 12 to 15 reported about 46 myocarditis cases, according to CDC data. Boys ages 5 to 11 reported 2.6 myocarditis cases per million second Pfizer doses administered.

People who have develop myocarditis after vaccination are generally hospitalized for a few days as a precaution before being sent home. Most patients made a full recovery 90 days after their diagnosis, according to a CDC survey of health-care providers.

The CDC has found that the risk of myocarditis is higher from Covid infection than vaccination. Myocarditis in children is typically caused by viral infections.

Dr. Sara Oliver, a CDC official, said the risk of myocarditis after Moderna vaccination in children and adolescents is unknown, though data from adults suggests the risk could be higher than Pfizer’s shots. However, Oliver said extending the interval between the first and second dose to eight weeks may lower the risk of myocarditis based on data shared by health officials in Canada.

The most common side effects among kids ages 6 to 17 during Moderna’s clinical trials were pain at the injection site, fatigue, headache, chills, muscle pain and nausea. There were no confirmed cases of myocarditis during the trials.

It’s unclear how effective the shots will be against the omicron variant. The clinical trials were conducted during periods when other Covid strains were dominant. The shots for adolescents ages 12 to 17 were about 90% effective at preventing illness from the original Covid strain and the alpha variant, while the shots for kids ages 6 to 11 were more than 76% effective at preventing illness from the delta variant, according to the Food and Drug Administration’s review of clinical trial data.

However, the Covid vaccines have trouble fighting the omicron variant, which is now dominant, because it has so many mutations. Third shots have significantly increased protection in other age groups. Moderna is studying booster shots for kids that target omicron with data expected later this summer.

“We would expect to be addressing this gap in booster dose recommendations over the summer and into early fall,” said Dr. Doran Fink, a senior official at the FDA’s vaccine division.

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Exclusive: Spirit delays shareholder vote on merger hours before meeting to continue deal talks with Frontier, JetBlue – TalkOfNews.com

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Spirit Airlines says it will decide on competing JetBlue, Frontier bids before the end of June

#Spirit #delays #shareholder #vote #merger #hours #meeting #continue #deal #talks #Frontier #JetBlue

A Spirit Airlines plane on the tarmac at the Fort Lauderdale-Hollywood International Airport on February 07, 2022 in Fort Lauderdale, Florida.

Joe Raedle | Getty Images

Spirit Airlines on Wednesday delayed shareholder vote on its proposed merger with Frontier Airlines until July 8, hours before a meeting scheduled for Thursday so it can further discuss options with Frontier and rival suitor JetBlue Airways.

It is the second time Spirit has delayed a vote on its planned combination with Frontier and extends the most contentious battle for a U.S. airline in years.

Spirit originally scheduled Thursday’s vote for June 10 but had delayed that for the same reasons.

Both Frontier and JetBlue have upped their offers in the week before the scheduled vote approached.

“Spirit would not have postponed tomorrow’s meeting if they felt they had the votes,” said Henry Harteveldt, a travel industry consultant and president of Atmosphere Research Group. Spirit didn’t comment on whether that is the case.

“We compliment the Spirit Board for listening to their shareholders, who clearly were not supportive of the Frontier transaction, and adjourning the Special Meeting,” JetBlue CEO Robin Hayes said in a statement later Wednesday.

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“It’s clear that Spirit shareholders have now handed the Spirit Board an undeniable mandate to reach an agreement with JetBlue.”

“This is like the end of a soap opera episode,” Harteveldt added.

Frontier and Spirit first announced their intent to merge in February. In April, JetBlue made an all-cash, surprise bid for Spirit, but Spirit’s board has repeatedly rejected JetBlue’s offers, arguing a JetBlue takeover wouldn’t pass muster with regulators.

Either combination would create the United States’ fifth-largest carrier.

JetBlue has fired back at Spirit, saying it did not negotiate in good faith, setting off a war of words between the airlines as they competed for shareholder support ahead of the vote.

Frontier didn’t immediately comment about the postponed vote.

Spirit shares were up about 2% in afterhours trading, while Frontier was up more than 1% and JetBlue was down 1%.

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Exclusive: Get hype for the first images from NASA’s James Webb Space Telescope – TalkOfNews.com

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Get hype for the first images from NASA’s James Webb Space Telescope

#hype #images #NASAs #James #Webb #Space #Telescope

Very soon, humanity will get to view the deepest images of the universe that have ever been captured. In two weeks, the $10 billion James Webb Space Telescope (JWST) — NASA’s super expensive, super powerful deep space optical imager — will release its first full-color images, and agency officials today suggested that they could just be the beginning.

“This is farther than humanity has ever looked before,” NASA Administrator Bill Nelson said during a media briefing Wednesday (he was calling in, as he had tested positive for COVID-19 the night before). “We’re only beginning to understand what Webb can and will do.”

NASA launched James Webb last December; ever since, it’s been conducting a specialized startup process that involves delicately tuning all 18 of its huge mirror segments. A few months ago, NASA shared a “selfie” marking the successful operations of the IR camera and primary mirrors. Earlier this month, the agency said the telescope’s first images will be ready for public debut at 10:30 AM ET on July 12.

One aspect of the universe that JWST will unveil is exoplanets, or planets outside our Solar System — specifically, their atmospheres. This is key to understanding whether there are other planets similar to ours in the universe, or if life can be found on planets under atmospheric conditions that differ from those found on Earth. And Thomas Zurbuchen, associate administrator for NASA’s Science Mission Directorate, confirmed that images of an exoplanet’s atmospheric spectrum will be shared with the public on July 12.

Essentially, James Webb’s extraordinary capacity to capture the infrared spectrum means that it will be able to detect small molecules like carbon dioxide. This will enable scientists to actually examine whether and how atmospheric compositions shape the capacity for life to emerge and develop on a planet.

NASA officials also shared more good news: The agency’s estimates of the excess fuel capability of the telescope were spot on, and JWST will be able to capture images of space for around 20 years.

“Not only will those 20 years allow us to go deeper into history and time, but we will go deeper into science because we will have the opportunity to learn and grow and make new observations,” NASA deputy administrator Pam Melroy said.

JWST has not had an easy ride to deep space. The entire project came very close to not happening at all, Nelson said, after it started running out of money and Congress considered canceling it entirely. It also faced numerous delays due to technical issues. Then, when it reached space, it was promptly pinged by a micrometeoroid, an event that surely made every NASA official shudder.

But overall, “it’s been an amazing six months,” Webb project manager Bill Ochs confirmed.

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Exclusive: Fight for Spirit Airlines goes down to the wire with competing bids from Frontier and JetBlue – TalkOfNews.com

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Fight for Spirit Airlines goes down to the wire with competing bids from Frontier and JetBlue

#Fight #Spirit #Airlines #wire #competing #bids #Frontier #JetBlue

The most heated airline battle in recent years comes to a head on Thursday when Spirit Airlines’ shareholders vote on a proposed tie-up with fellow discount carrier Frontier Airlines while rival suitor JetBlue Airways circles with increasingly sweetened takeover bids.

Spirit has repeatedly rebuffed sweetened, all-cash bids from JetBlue, arguing that such a takeover wouldn’t pass muster with regulators, and has stuck with its plan to combine in an also-sweetened cash-and-stock deal to combine with Frontier, first announced in February.

JetBlue’s surprise all-cash bid in April set off a fight over Spirit that last month turned hostile.

If Spirit shareholders vote in favor of the tie-up with Frontier, it would put the carriers on the path to creating a budget airline behemoth. The two carriers share a similar business model based on low fares and fees for almost everything else from seat selection to carry-on bags.

A Frontier Airlines plane near a Spirit Airlines plane at the Fort Lauderdale-Hollywood International Airport on May 16, 2022 in Fort Lauderdale, Florida.

Joe Raedle | Getty Images

If shareholders vote against the deal it opens the door for a takeover by JetBlue, which would retrofit Spirit’s yellow planes to look like JetBlue’s, including cabins with seatback screens and more legroom.

“JetBlue does not have many options to achieve a step-change in growth, and that explains why JetBlue has pursued this deal so doggedly,” said Samuel Engel, aviation consultant at ICF.

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JetBlue and Frontier have each argued their proposed transactions are key to their future growth, helping them better compete with large U.S. carriers and get fast access to Airbus narrow-body planes and pilots.

Either deal would create the fifth-largest U.S. airline.

Late Monday, JetBlue said it would raise the reverse breakup fee if regulators don’t approve a JetBlue takeover of Spirit to $400 million from $350 million. It also raised the amount it would pay up in advance to $2.50 a share, from $1.50 and added a 10 cent-a-share monthly payment to shareholders starting next year until the deal is consummated or terminated.

JetBlue previously offered to divest some assets in crowded markets to calm antitrust fears, but hasn’t said it would give up its alliance with American Airlines in the Northeast U.S., which Spirit has called out as a sticking point in that deal.

JetBlue’s latest offer came after Frontier late Friday raised the cash portion of its offer by $2 per share to $4.13 and increased the reverse breakup fee to $350 million to match JetBlue’s then-offer.

Spirit has stuck with the Frontier deal. CEO Ted Christie on Tuesday called the Frontier offer “very compelling” and told CNBC the airline wants to “focus our efforts on convincing the shareholders it’s the right thing to do.”

Proxy advisory firm Institutional Shareholder Services on Tuesday said that “the enhancements by JetBlue may be enough to offset the potential upside of the proposed merger with Frontier” but said it didn’t want to change its recommendation in favor of the deal with so little time before the vote.

Spirit postponed the vote from June 10 to continue deal talks with Frontier and JetBlue.

War of words

For weeks, JetBlue has argued that Spirit’s board hasn’t negotiated in good faith or fully considered its offer. It has repeatedly urged the budget airline’s shareholders to vote against the Frontier deal.

“The Spirit Board consistently ignored or refused to engage with JetBlue until faced with certain defeat on the original shareholder meeting date and then, in an attempt to avoid the widespread perception of its poor corporate governance, pretended to engage with JetBlue,” JetBlue said in a letter Wednesday again urging Spirit shareholders to vote against the Frontier deal.

Spirit has repeatedly denied claims that it hasn’t engaged with JetBlue in good faith.

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“Our board believes [the Frontier merger] is the most financially and strategically compelling path forward for Spirit with a greater likelihood of closing,” Christie said in a video message addressing shareholders on Wednesday.

All three carriers have traded heated words as they try to win over Spirit shareholders before the shareholder vote.

JetBlue late Monday wrote a letter to Spirit shareholders detailing its latest sweetened bid and accusing Spirit of making “misleading statements” regarding its antitrust doubts.

Frontier fired back in a lengthy news release Tuesday saying that “a Spirit acquisition by JetBlue would lead to a dead end — a fact that no amount of money, bluster, or misdirection will change.”

The high drama is coming from an already-consolidated industry that hasn’t seen a major airline deal since 2016, when JetBlue lost out to Alaska Airlines for Virgin America.

“This is as much as a potboiler for the summer than any trashy novel,” said Henry Harteveldt, a former airline manager and president of of Atmosphere Research Group.

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