Medical syringes and Novavax logo displayed in the background are seen in this illustration photo taken in Krakow, Poland on December 2, 2021.
Jakub Porzycki | NurPhoto | Getty Images
The Food and Drug Administration’s independent advisors will meet in June to discuss Novavax’s Covid vaccine for adults as well as Pfizer and Moderna’s shots for younger kids, a sign that the vaccines are moving a step closer to authorization.
The FDA committee will review Novavax’s vaccine for adults ages 18 and over on June 7. The FDA has selected three possible dates – June 8, 21 and 22 – to discuss Moderna and Pfizer’s shots for children under age 5 who are not yet eligible for vaccination. The drug regulator, in a press release Friday, said the dates are tentative because none of the companies have completed their submissions.
The FDA committee will also meet on June 28 to discuss whether the current Covid vaccines need to be redesigned to target mutations of the virus. FDA officials have said the U.S. needs to rapidly make a decision about whether the shots should be changed to have them ready ahead of a possible fall wave of infection. Pfizer and Moderna are both studying shots that target the omicron variant as well as the original strain that emerged in Wuhan, China in 2019.
The FDA panel, the Vaccines and Related Biological Products Advisory Committee, holds meetings open to the public where independent physicians and scientists discuss the data supporting a company’s vaccine. The panel then makes recommendations to the FDA about whether the vaccine should receive authorization. The FDA is not bound to follow the committee’s recommendations, though it usually does.
The FDA committee’s busy June schedule comes a day after Moderna asked the drug regulator to authorize its two-dose Covid vaccine for children six months to 5-years-old. Parents have been waiting months for the FDA to clear a vaccine for this age group.
The FDA had sought to fast track the first two doses of Pfizer’s three-shot vaccine for kids under age 5 in February, but the company decided to postpone its application because the data wasn’t good enough. Pfizer CEO Albert Bourla has said a third shot should provide much higher protection against omicron.
During the winter omicron wave, children under age 5 were hospitalized with Covid at five times the rate of the peak when the delta variant was predominant, according to the Centers for Disease Control and Prevention. About 75% of children in the U.S. have been infected by the virus at some point during the pandemic, according to data from national blood sample survey from the CDC.
Some Americans have also been waiting for the authorization of Novavax’s vaccine. If authorized by the FDA, Novavax’s shot will be the first new Covid vaccine to hit the market in more than a year.
Novavax was an early participant in Operation Warp Speed, the U.S. government’s race to develop a vaccine against Covid in 2020. However, Moderna and Pfizer ultimately beat Novavax to the punch because the company struggled with manufacturing issues.
Novavax’s vaccine uses different technology than Pfizer’s and Moderna’s shots, which rely on messenger RNA to turn human cells into factories that produce copies of the virus spike protein, inducing an immune response that fights Covid. The spike is the part of the virus that latches onto and invades human cells.
Novavax produces the virus spike outside the human body. The genetic code for the spike is put into a baculovirus that infects insect cells, which then produce copies of the spike that are purified and extracted for the shots. The vaccine also uses an adjuvant, an extract purified from the bark of a tree in South America, to induce a broader immune response.
While mRNA vaccines were first authorized during the pandemic, the protein technology that underlies Novavax’s shots has been used in past vaccines. Novavax’s adjuvant has been used in licensed vaccines against malaria and shingles.
Novavax has said some people who are hesitant to take mRNA vaccines might be more willing to use its shots.
‘Minions: The Rise of Gru’ tops $108 million as parents flock back to cinemas, kids in tow
“Minions: The Rise of Gru” is the sequel to the 2015 film, “Minions,” and spin-off/prequel to the main “Despicable Me” film series.
Families have gone bananas for “Minions: The Rise of Gru.”
Over the weekend, the Universal and Illumination animated feature tallied more than $108 million in ticket sales.
The fifth film in the Despicable Me franchise generated an additional $93.7 million from international markets, bringing its estimated opening weekend haul to $202 million globally.
“With the incredible success of ‘Minions,’ the notion that family audiences were avoiding movie theaters due to Covid concerns can be shelved,” said Paul Dergarabedian, senior media analyst at Comscore.
Box office analysts had wondered if this segment of moviegoers was still avoiding cinemas after Disney and Pixar’s “Lightyear” took in just $51 million during its domestic debut last month, below expectations of $70 million and $85 million.
It was unclear if tough box office competition led to “Lightyear’s” less than stellar debut or if consumers were confused about the film’s release. After all, there has not been a theatrical release of a Pixar film since 2020′s “Onward.” The last three from the animation studio, “Soul,” “Luca” and “Turning Red,” were all released on streaming service Disney+.
“Minions: The Rise of Gru” represented 54% of all domestic moviegoers over the weekend, with 68% of ticket holders being part of family groups, according to data from EntTelligence.
“What this weekend has showcased is a triumphant return to cinemas by families, laying to rest any lingering and outdated pandemic narrative that parents and kids only want to watch movies at home,” said Shawn Robbins, chief analyst at BoxOffice.com. “When the right content is out there, people will show up.”
The film is expected to add another $20 million in ticket sales in the U.S. and Canada on Monday, bringing its holiday weekend total to $128 million.
Disclosure: Comcast is the parent company of NBCUniversal and CNBC. NBCUniversal is the distributor of “Minions: The Rise of Gru.”
American Airlines scheduling glitch allows pilots to drop thousands of July flights
An American Airlines Boeing 787-9 Dreamliner approaches for a landing at the Miami International Airport on December 10, 2021 in Miami, Florida.
Joe Raedle | Getty Images
A glitch in a scheduling platform allowed American Airlines pilots to drop thousands of July assignments overnight Saturday, their union said, a headache for the airline as it tries to minimize flight disruptions during a booming travel season.
American said it didn’t expect the problem to affect its operation, including during the busy July Fourth holiday weekend. The union and airline are now discussing additional pay for pilots whose dropped trips the airline reinstated, the Allied Pilots Association said.
“As a result of this technical glitch, certain trip trading transactions were able to be processed when it shouldn’t have been permitted,” the airline said in a statement. “We already have restored the vast majority of the affected trips and do not anticipate any operational impact because of this issue.”
More than 12,000 July flights lacked either a captain, first officer, or both, after pilots dropped assignments, the Allied Pilots Association said Saturday. APA said the airline reinstated about 80% of the trips.
Pilots can routinely drop or pick up trips, but time off in the summer or holidays is hard to come by for airline employees as schedules peak to cater to strong demand.
On Saturday alone, American had more than 3,000 mainline flights scheduled and they were 93% full, according to an internal tally. Flights left unstaffed, however, are an additional strain on any airline.
The glitch occurred during a rocky start to the Fourth of July weekend when thunderstorms and staffing issues caused thousands of U.S. flight delays and hundreds of cancellations.
A similar issue occurred in 2017, when a technology problem let American’s pilots take vacation during the busy December holiday period. The carrier offered pilots 150% pay for pilots that picked up assignments.
American and its pilots’ union, whose relationship has been fraught, are in the middle of contract negotiations and the airline most recently offered nearly 17% raises through 2024.
Union president Capt. Ed Sicher, who started his term Friday, told American’s roughly 15,000 pilots Saturday night that American Airlines CEO Robert Isom said he is committed to paying an “inconvenience premium” to aviators whose trips American put back on their schedules after the glitch.
“To Mr. Isom’s credit, he called me four times today to commit to mitigating the damage from this debacle,” Sicher wrote late Saturday. “We started at a 200% override, although the details of this pay are still the subject of negotiations and there is no guarantee of the details or the amounts.”
American Airlines declined to comment on Sicher’s message to pilots.
American’s pilots have picketed recently against grueling schedules, something they want to be addressed in a new contract. Pilots at Delta and Southwest have picketed in recent weeks for similar reasons.
Sicher also struck an upbeat tone about contract talks with American, particularly about quality-of-life issues.
“Please understand that no firm commitments have yet been made, but I feel that we have, at least for the first time since negotiations began, received positive indications that management is motivated to achieve collaborative solutions to longstanding problems with our current contract that will greatly enhance our ability to trade our trips and consequently enhance our quality of life,” he wrote.
Trump media company subpoenaed in federal criminal probe of SPAC deal
Former U.S. President Donald Trump gives the keynote address at the Faith & Freedom Coalition during their annual “Road To Majority Policy Conference” at the Gaylord Opryland Resort & Convention Center June 17, 2022 in Nashville, Tennessee.
Seth Herald | Getty Images
Donald Trump’s media company was subpoenaed by a federal grand jury in connection with a criminal probe, according to the company with which the former president’s firm plans to merge.
Digital World Acquisition Corp. said in a filing Friday that Trump Media and Technology Group received a subpoena from the grand jury in Manhattan on Thursday. The Trump company also received a subpoena from the Securities and Exchange Commission regarding a civil probe on Monday, DWAC said.
DWAC also said some current and former TMTG employees have also recently received grand jury subpoenas.
The filing came days after DWAC said the government investigations could delay or even prevent its merger with Trump’s newly formed company, which includes Truth Social, a social media app intended to be an alternative to Twitter.
Neither TMTG nor a spokeswoman for Trump immediately responded to CNBC’s requests for comment.
The Justice Department and the SEC, which regulates the stock market, are investigating the deal between DWAC and Trump Media. By merging with DWAC, which is a kind of shell company called a special purpose acquisition company, or SPAC, Trump’s firm would gain access to potentially billions of dollars on public equities markets.
Trump established Truth Social months after Twitter banned him for his tweets on Jan. 6, 2021, when hundreds of his supporters stormed the U.S. Capitol in a bid to overturn Joe Biden’s victory in the presidential election. Trump Media’s CEO is former Rep. Devin Nunes, one of the former president’s most ardent loyalists in the Republican Party. Trump is also considering whether to run for president in the 2024 election.
Trump has continued to spread the lie that the election was stolen from him. His alleged involvement in the Jan. 6 insurrection is being probed by a House select committee that has accused the former president of being at the center of a multipronged conspiracy to block the peaceful transfer of power to Biden.
Early criticism of the Trump-DWAC deal came from Sen. Elizabeth Warren, D-Mass. In calling for an investigation, she wrote to SEC Chair Gary Gensler in November, telling him that DWAC “may have committed securities violations by holding private and undisclosed discussions about the merger as early as May 2021, while omitting this information in [SEC] filing and other public statements.”
DWAC shares are far off their highs, closing Friday at $24.20. The stock had surged above $90 in October, after the deal with Trump’s group was announced.
DWAC on Monday revealed in a securities filing that it learned June 16 that each member of its board of directors received subpoenas from the same federal grand jury.
The grand jury sought documents similar to those the SEC already requested as part of its civil probe, DWAC said. The company itself was served with a subpoena a week ago with similar requests, along with other requests relating to communications, individuals and information involving Rocket One Capital.
DWAC also revealed Monday that a board member, Bruce J. Garelick, had told management that he would quit the board during the previous week. Garelick said his resignation “was not the result of any disagreement with Digital World’s operations, policies or practices,” according to the company filing.
— CNBC’s Kevin Breuninger and Thomas Franck contributed to this story.
This is breaking news. Please check back for updates.
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