Raphael Stevens

The Manhattan district attorney in an unusual statement sought to assure the public that his criminal investigation of former President Donald Trump and the Trump Organization is continuing despite the resignations of two prosecutors who were leading that probe.
“The team working on this investigation is comprised of dedicated, experienced career prosecutors,” said DA Alvin Bragg.
Bragg’s statement came two weeks after the disclosure of a letter to him by Mark Pomerantz, who with Carey Dunne resigned in February from leading the Trump probe after Bragg reportedly told them he had doubts about indicting Trump.

Former U.S. President Donald Trump speaks during a rally at Florence Regional Airport in Florence, South Carolina, U.S., March 12, 2022. 
Randall Hill | Reuters

The Manhattan district attorney, in an unusual statement Thursday, sought to assure the public that his criminal investigation of former President Donald Trump and the Trump Organization is continuing despite the resignations of two prosecutors who were leading that probe.
“The team working on this investigation is comprised of dedicated, experienced career prosecutors,” said DA Alvin Bragg.

“They are going through documents, interviewing witnesses, and exploring evidence not previously explored,” Bragg said.”
“In the long and proud tradition of white-collar prosecutions at the Manhattan D.A.’s Office, we are investigating thoroughly and following the facts without fear or favor.”
Bragg’s statement came two weeks after the disclosure of a letter to him by Mark Pomerantz, who with Carey Dunne, resigned in February from leading the Trump probe after Bragg reportedly told them he had doubts about indicting Trump.

“The team that has been investigating Mr. Trump harbors no doubt about whether he committed crimes — he did,” Pomerantz wrote in that letter.
Pomerantz said those were felonies related to the “preparation and use of his annual Statements of Financial Condition,” which “were false.”

Pomerantz wrote Bragg that the DA’s decision not to seek charges against Trump, and to “indefinitely” suspend the 3-year-old probe was “contrary to the public interest.”
In his statement Thursday, Bragg said, “In recent weeks, the Manhattan District Attorney’s Office has been repeatedly asked whether our investigation concerning former President Donald J. Trump, the Trump Organization, and its leadership is continuing.”
“It is,” Bragg wrote.

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He also brushed aside reports that he was allowing a grand jury that was hearing evidence in the case to lapse without bringing an indictment.
“As anyone who has worked on criminal cases in New York knows, New York County has grand juries sitting all the time,” the DA said.
Bragg also said that while he understands “the public desire to know more about our investigative steps … the law requires secrecy during an investigation.”Bragg also said, “While the law constrains me from commenting further at this time, I pledge that the Office will publicly state the conclusion of our investigation — whether we conclude our work without bringing charges, or move forward with an indictment.”
The DA also said, that, “As a state prosecutor and a federal prosecutor in the Southern District of New York, I successfully brought cases involving money laundering, witness tampering, mortgage fraud, official misconduct, and bribery.”
“And, I went wherever the facts took me, prosecuting two mayors, a city council member, an FBI agent, a former Senate Majority Leader, a District Attorney, and business executives.
“Indeed, litigation involving the former president himself is not foreign to me. As the Chief Deputy at the New York State Attorney General’s Office, I oversaw the successful litigation against the former president, his family, and the Trump Foundation.”

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CNBC’s Jim Cramer said Thursday that he expects the market to pivot to a bull market for recession-proof stocks rather than expensive growth names.
When the Federal Reserve decides to combat an “inflationary spiral with higher [interest] rates, you’re not supposed to buy expensive growth stocks,” the “Mad Money” host said.

CNBC’s Jim Cramer said Thursday that he expects the market to pivot to a bull market for recession-proof stocks rather than expensive growth names.
When the Federal Reserve decides to combat an “inflationary spiral with higher [interest] rates, you’re not supposed to buy expensive growth stocks. The hedge fund playbook says that you should sell stocks like Amazon until the tightening cycle is nearly over,” the “Mad Money” host said.

“We’ve got a new bull market in recession-proof names that can keep putting up good numbers even in the face of a slowdown,” he added.
The Dow Jones Industrial Average gained 0.25% on Thursday while the S&P 500 rose 0.43%. The tech-heavy Nasdaq Composite increased 0.06%.
Cramer also said that he believes investors should generally avoid buying stock of the biggest names in tech in the current market.
“I am adamant that you need to be very conservative with the FAANG names and their ilk,” Cramer said. “Of all of these growth names, the only two that I would put fresh money into” are Google-parent Alphabet and Facebook-parent Meta because they aren’t expensive on next year’s earnings, he added.
FAANG is an acronym for Facebook, Amazon, Apple, Netflix and Google.

Cramer warned that a pivot to a bull market won’t happen right away.
“Pivots don’t happen on a dime, even if it feels that way. This one’s very hard because for a long time, the whole stock market has bowed to FAANG and friends,” Cramer said. “It was a bull market in a handful of stocks, a bear market in hundreds, if not thousands of others. Now, the bear is changing to a bull, and most of that will happen over the course of the next month.” 
Disclosure: Cramer’s Charitable Trust owns shares of Meta, Amazon, Apple and Alphabet.

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House of Representatives Speaker Nancy Pelosi has tested positive for Covid but does not have any symptoms.
Pelosi, a California Democrat, stood next to President Joe Biden at a signing event at the White House.
She follows Vice President Kamala Harris in the order of presidential succession.
On Wednesday, Attorney General Merrick Garland and Commerce Secretary Gina Raimondo tested positive for the coronavirus. Both Cabinet officials attended the Gridiron dinner over the past weekend, which has been linked to other cases.

US President Joe Biden signs H.R. 3076, the Postal Service Reform Act of 2022, during a ceremony in the State Dining Room of the White House in Washington, DC, on April 6, 2022.
Mandel Ngan | AFP | Getty Images

House of Representatives Speaker Nancy Pelosi has tested positive for Covid but is not showing any symptoms, her office said Thursday.
“After testing negative this week, Speaker Pelosi received a positive test result for Covid-19 and is currently asymptomatic,” her deputy chief of staff Drew Hammill said in a Twitter post.

Pelosi’s positive test is the latest in a series of Covid diagnoses among high-ranking government officials, including those who attended Washington’s Gridiron Club and Foundation dinner last Saturday.
While Pelosi didn’t attend the annual gala, Hammill told CNBC, more than a dozen D.C. power brokers who were there have since tested positive. Among them are Attorney General Merrick Garland, Commerce Secretary Gina Raimondo and Reps. Joaquin Castro and Adam Schiff, and Sen. Susan Collins, the Maine Republican whose office later Thursday revealed she was positive and had mild symptoms.
Pelosi’s test result also comes a day after the California Democrat stood next to President Joe Biden at a bill-signing event at the White House;
Biden on Wednesday night tested negative for Covid “as part of his regular-testing cadence,” the White House said in a statement.
“The president is not considered a close contact of Speaker Pelosi as defined by the” Centers for Disease Control and Prevention, the statement said. “The president saw Speaker Pelosi at White House events and had brief interactions over the course of the last two days.”

“He will continue to be tested regularly. The president wishes Speaker Pelosi a speedy recovery,” the White House said.
The 82-year-old Pelosi follows Vice President Kamala Harris Vice President Kamala Harris in the order of presidential succession.
“The Speaker is fully vaccinated and boosted, and is thankful for the robust protection the vaccine has provided,” Hammill wrote on Twitter.
“The Speaker will quarantine consistent with CDC guidance, and encourages everyone to get vaccinated, boosted and test regularly.”
Politico reported Wednesday that several journalists who attended the Gridiron dinner also had tested positive.
In addition, CIA Director William Burns tested positive for the virus last week.
– Additional reporting by Kevin Breuninger

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Global methane emissions jumped by a record amount in 2021, the National Oceanic and Atmospheric Administration said Thursday.
Methane, a key component of natural gas, is 84 times more potent than carbon dioxide but doesn’t last as long in the atmosphere before it breaks down.
NOAA said the annual increase in atmospheric methane last year was 17 parts per billion, the largest amount recorded since systematic measurements began in 1983.

A broken oil well pipeline gauge near Depew, Oklahoma
J Pat Carter/Getty Images

Global emissions of methane, the second-biggest contributor to human-caused climate change after carbon dioxide, surged by a record amount in 2021, the National Oceanic and Atmospheric Administration said on Thursday.
Methane, a key component of natural gas, is 84 times more potent than carbon dioxide but doesn’t last as long in the atmosphere before it breaks down. Major contributors to methane emissions include oil and gas extraction, landfills and wastewater, and farming of livestock.

“Our data show that global emissions continue to move in the wrong direction at a rapid pace,” Rick Spinrad, the NOAA administrator, said in a statement. “The evidence is consistent, alarming and undeniable.”
NOAA said the annual increase in atmospheric methane last year was 17 parts per billion, the largest amount recorded since systematic measurements began in 1983. The increase in methane during 2020 was 15.3 parts per billion. In 2021, atmospheric methane levels averaged 1,895.7 parts per billion, or roughly 162% greater than preindustrial levels, NOAA said.
The report comes after more than 100 countries joined a coalition to cut 30% of methane gas emissions by 2030 from 2020 levels. The Global Methane Pledge of 2021 includes six of the world’s 10 biggest methane emitters — the U.S., Brazil, Indonesia, Nigeria, Pakistan and Mexico. China, Russia, India and Iran did not join the pledge.
Last year, a landmark United Nations report declared that drastically slashing methane is necessary to avoid the worst outcomes of global warming. The report said if the world could cut methane emissions by up to 45% through 2030, it would prevent 255,000 premature deaths and 775,000 asthma-related hospital visits on an annual basis.
Kassie Siegel, director of the Center for Biological Diversity’s Climate Law Institute, said reducing methane is a relatively cheap and easy way to achieve significant climate benefits.

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“Methane reductions have to be one part of a transformative global effort to phase out deadly fossil fuels in favor of truly clean renewable energy,” Siegel said in a statement. “Anything less puts us on a catastrophic path to an unrecognizable world.”
A study published in the journal Environmental Research Letters also found that slashing methane emissions from the oil and gas industry, agriculture and other human sources could slow climate change by as much as 30%.
NOAA also warned that carbon dioxide is continuing to rise at historically high rates.
The global surface average for carbon dioxide last year was 414.7 parts per million, an increase of 2.66 parts per million over the 2020 average, the agency said. The measurement marks the 10th consecutive year that carbon dioxide rose by more than two parts per million, the fastest rate of increase since monitoring began 63 years ago.
While there’s been some debate on the cause of the ongoing rise in methane emissions, carbon dioxide emissions are the main driver of human-caused climate change, NOAA said.
“The effect of carbon dioxide emissions is cumulative,” Pieter Tans, a senior scientist with the Global Monitoring Laboratory, said in a statement.
“About 40% of the Ford Model T emissions from 1911 are still in the air today,” Tans said. “We’re halfway to doubling the abundance of carbon dioxide that was in the atmosphere at the start of the Industrial Revolution.”

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JetBlue Airways made an unsolicited bid to Spirit Airlines for $3.6 billion.
Spirit Airlines’ no-frills model has spawned punchlines for comedians over the years.
Major airlines have emulated some of Spirit’s fees to drive revenue.

Travelers check in for a Spirit Airlines flight at Orlando International Airport on the Friday before Memorial Day.
Paul Hennessy | Lightrocket | Getty Images

JetBlue’s surprise $3.6 billion cash bid for Spirit is threatening the latter’s plan to merge with Frontier into a discount airline behemoth. It’s also threatening one of comedians’ favorite sources of material.
“It’s kind of a bummer for me. If there’s no Spirit anymore who are we going to make fun of?” Jimmy Kimmel quipped Wednesday in his “Jimmy Kimmel Live!” monologue. “Look out, Allegiant. You’re on deck.”

New York-based JetBlue wants to absorb Florida-headquartered Spirit and change Spirit’s bright-yellow planes, which feature seats that don’t recline, to match JetBlue’s jets, which offer roomier seating, seatback screens and free snacks.
Spirit’s rock-bottom airfare and fees for everything including seat selection and carry-on bags have provided comedians with years of fodder and become a go-to reference for the indignities of air travel. Major airlines have taken a cue from discounters with basic economy fares, which don’t include advance seat selection and force passengers to board last.
Spirit accounted for just under 5% of passengers carried by U.S. airlines last year. Yet it was mentioned 40 times on late-night talk shows in 2021, representing 20% of total airline mentions on those programs, according to an analysis conducted for the airline, which was seen by CNBC.
Kimmel said Wednesday that JetBlue wants to buy Spirit for $3.6 billion “plus $55 extra for carry-on luggage.”
“Tonight Show” host Jimmy Fallon also cited JetBlue’s offer in Wednesday monologue. “Right now Spirit is like, ‘Guys, we better open a bank account. I think it’s time.'”

‘You have to have thick skin’

No airline has gone unscathed from late-night shows’ spotlight. Spirit’s analysis showed American had 77 mentions last year, while Southwest had 50 and Delta had 34. There are also countless standup clips and memes poking fun at airlines and air travel.
“Every airline has a story at some point that becomes a joke on some show,” said Ross Feinstein, a former spokesperson for American Airlines and for the Transportation Security Administration. “You have to have thick skin to work in the airline industry.”
After reports that a man was kicked off a JetBlue flight for trying to bring a possum on board in late 2019, co-host of “Saturday Night Live” star Colin Jost said on the “Weekend Update” segment: “while at Spirit Airlines that’s what falls down when you need an oxygen mask.”
Spirit said that “contrary to the late-night narrative our airline is focused on providing Guests with an excellent experience, with affordable fares that allow them to venture further and discover more than ever before.”
It said it has reached out to shows before and hasn’t had any luck with a response.
Spirit said it understood airlines are a target “because the air-travel-related jokes consistently get laughs” and added: “We promise possums never popped out of the bulkhead.”
Spirit has made strides in improving punctuality in recent years and came in sixth among U.S. airlines last year, above JetBlue’s ninth place, according to Transportation Department data. The rate of complaints also fell in the years before the pandemic. It enrolled staff at the Disney Institute to improve customer service.
In 2019, Spirit unveiled new curved seats that it says were designed to give passengers more personal space, but still didn’t escape ridicule from late-night hosts.
“Congratulations, Spirit. We diss them a lot on the show, but this is a big improvement over their old seats, which were just a dirty couch they found on the street,” said Trevor Noah on a December 2019 episode of “The Daily Show.”
Representatives for Kimmel, Fallon, Noah and “Saturday Night Live” didn’t immediately respond for comment.

Pandemic problems

The pandemic hasn’t been easy. Staffing shortages and technical problems forced Spirit to cancel more than 2,800 flights in late July and early August 2021, a debacle that cost it some $50 million. American Airlines and Southwest Airlines faced similar issues in the fall.
The problems drove up passenger complaints about Spirit to the Transportation Department to 11.45 per 100,000 passengers, the most of the U.S. airlines, while DOT logged 6.38 about JetBlue and 5.78 about Frontier.
Spirit said it’s evaluating JetBlue’s “unsolicited” offer. A deal, just like the planned merger of Frontier and Spirit, would have to pass muster with regulators at a time when President Joe Biden has tasked his administration with scrutinizing competition. Frontier and Spirit earlier this year said they haven’t decided which airline’s branding would last.
That still hasn’t stopped comedians from taking digs at Spirit.
JetBlue has “a real bathroom instead of a bucket that everyone is passing around,” Kimmel said Wednesday.
Spirit told CNBC that it welcomes any late-night hosts and their families to fly the airline.
“The Roots might even be inclined to write a love song about us after they fly Spirit!” the airline wrote, referring to the house band for “The Tonight Show.”
Disclosure: Comcast is the parent company of NBCUniversal and CNBC. NBCUniversal airs “The Tonight Show with Jimmy Fallon” and “Saturday Night Live.”

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New York Attorney General Letitia James asked a judge to hold former President Donald Trump in contempt of court for refusing to comply with an order to turn over documents for her investigation of his company.
James also asked the judge to fine Trump $10,000 for every day he fails to surrender those documents.
The AG’s office says in a court filing that Trump is in violation of a court order to give her investigators the documents by March 31.
James is investigating the Trump Organization in connection with how that company reported the values of various real estate assets.

New York State Attorney General, Letitia James, speaks during a news conference, to announce criminal justice reform in New York City, U.S., May 21, 2021.
Brendan McDermid | Reuters

New York Attorney General Letitia James asked a judge Thursday to hold former President Donald Trump in contempt of court for refusing to comply with a judge’s order to turn over documents for her investigation of his company.
James also asked Manhattan Supreme Court Judge Arthur Engoron to fine Trump $10,000 for every day he fails to surrender those documents.

The attorney general also says in a court filing that Trump is in violation of Engoron’s order to give the state’s investigators the documents by March 31 pursuant to a subpoena, a deadline that had previously been extended from March 3.
James is investigating allegations that the Trump Organization manipulated the stated values of various real estate assets to get better financial terms when applying for loans and insurance, and for tax purposes.
“The judge’s order was crystal clear: Donald J. Trump must comply with our subpoena and turn over relevant documents to my office,” James said in a statement.
“Instead of obeying a court order, Mr. Trump is trying to evade it. We are seeking the court’s immediate intervention because no one is above the law.”
Trump’s lawyer Alina Habba, in an emailed statement to CNBC, wrote, “We are prepared to adamantly oppose the frivolous and baseless motion filed by the Attorney General’s office today.”

“Our client has consistently complied with the many discovery requests served by the Attorney General’s office over the years,” Habba wrote. 
Engoron in February ordered Trump, Donald Trump Jr. and Ivanka Trump to answer questions under oath from James’ investigators and ordered Trump individually to give James’ office additional documents.
While Trump appealed the order that he submit to questioning, he did not appeal the order to surrender the documents.
And “rather than ‘comply in full’ with the Court’s unambiguous directive by producing all responsive documents by March 31, Mr. Trump did not comply at all,” James said in her filing.
Instead, Trump raised objections to “each of the eight document requests in the subpoena based on grounds such as overbreadth, burden, and lack of particularity,” the filing said.
Trump also said that subject to his objections he “would not produce any documents” responsive to the subpoena because his lawyer said that none of the documents could be found, the filing said.
Trump also claimed that his lawyer believed that even if the documents existed “the Trump Organization has them” and the attorney general “will just have to wait until the Trump Organization completes its production to get them,” the filing said.
Last week, in another court filing, James said her investigation has “uncovered significant evidence” that financial statements by the Trump Organization relied on misleading valuations of its real estate assets for more than a decade.
Those potentially misleading valuations “and other misrepresentations” were used by the company “to secure economic benefits — including loans, insurance coverage, and tax deductions — on terms more favorable than the true facts warranted,” that earlier filing said.
This is breaking news. Please check back for updates.

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Box has been on a roller coaster since its 2015 IPO, including a protracted battle with activist investor Starboard Value.
Revenue growth finally picked up in fiscal 2022 after slowing for eight straight years.
While cloud stocks have gotten crushed in the first few months of the year, Box is trading near a record.

Box CEO Aaron Levie speaking at BoxWorks in 2018

In this weekly series, CNBC takes a look at companies that made the inaugural Disruptor 50 list, 10 years later.
At age 37, Aaron Levie has been at the same job for almost half his life. He’s the CEO of collaboration software vendor Box, a business he started as a sophomore at the University of Southern California.

Far from its days as a fledgling dorm room start-up, Box now employs more than 2,100 people and generates close to $900 million in annual revenue. Levie, despite his relative youth, is a grizzled veteran of cloud software, an industry that consisted of Salesforce and little else at the time Box was getting started.
Levie is also a seasoned vet when it comes to Wall Street drama, and he has the scars to prove it.
In the decade since Box made CNBC’s very first Disruptor 50 list, the company has reckoned with a delayed IPO to rightsize its economics, an extended stretch of stock underperformance and last year had to manage through a heated battle with activist investor Starboard Value, which was demanding the company either find a buyer or oust its CEO.
Levie kept his job, and an independent Box was ultimately victorious in its proxy fight with Starboard. At long last, investors seem to be liking what they see.
The company recently surpassed its all-time high stock price from 2018, and Box has turned out to be a safe haven during the tech market’s nosedive to start 2022. Among the 76 companies in the Bessemer Venture Partners Cloud Index, Box is the fourth-best performer and one of only seven members that’s up so far this year.

“It’s a weird claim to fame,” Levie said in a recent interview. “I’ve literally come around to the other side of this thing, which is having a healthy balance of growth and profit is actually a really good thing.”

Arrows pointing outwards

Box’s outperformance this year

Box shares have climbed over 5% this year through Wednesday’s close, while the Nasdaq has dropped more than 11% over that stretch. The stock rallied on March 17, after Box issued a forecast at its analyst day that called for fiscal 2025 revenue growth of 15% to 17%, alongside an operating margin of 25% to 28%.
Analysts at JMP said in a report that the updated guidance “reflected the company’s strong execution, leadership in a large market, and prospects for continued financial improvement.”
Even with the recent momentum, this isn’t where Levie thought he would be, given the hype around his company 10 years ago, when it was a scorching Silicon Valley start-up. Its market cap today is just shy of $4 billion, up from about $1.7 billion at the time of its 2015 IPO. Venture investors valued the company at $2 billion in 2013, the year Inc. Magazine put Levie on the cover as its entrepreneur of the year.
Compare that to some of the top names that joined Box on the first Disruptor 50 list. Airbnb is worth $106 billion, Shopify is at $83 billion, Square (now Block) is at $75 billion and Atlassian is worth $73 billion. Also on the list that year was Box rival Dropbox, which has struggled since its 2018 IPO and now has a market cap of under $9 billion.
“Categorically, we believe we’re undervalued,” Levie said. To prove it, the company has been buying back shares and, at its analyst day, increased its repurchase plan by $150 million over the next year.

Box co-counders Aaron Levie (C) and Dylan Smith (2nd R) celebrate their company’s IPO on the floor of the New York Stock Exchange, Jan. 23, 2015.
Brendan McDermid | Reuters

“That’s our message,” said Levie. “We think the shares are very attractive for us to own” and that “we have substantial upside going forward.”
Some of that potential upside comes from revenue growth, which is finally accelerating. Revenue in the fiscal year that ended in January increased 13%, up from 11% the prior year. Before that, growth had slowed for eight consecutive years, as improving collaboration and file storage tools were getting baked into low-cost productivity suites from Google and Microsoft.
To reach growth of up to 17% in three years, Box is counting on a strategic shift that involves providing more stuff to its customers.

When Microsoft was a punching bag

In Box’s early days, the company played the role of upstart taking a direct shot at Microsoft, which was then an easy target. The software giant had yet to go all in on cloud and its SharePoint product was a clunky collaboration tool that didn’t work across the array of mobile devices consumers were adopting.
Box’s app made it easy for people to store and share documents in the cloud and access them from anywhere. It was fun while the venture capitalists were subsidizing growth. But competition was everywhere, leaving Box with no pricing power.
When Box’s IPO prospectus landed in March 2014, investors saw signs of a flawed business model. Operating costs in the most recent quarter were almost twice as high as revenue. So Box delayed its offering, raised $150 million in private financing, and 10 months later hit the market with its financials pointing in a more sustainable direction.

The original CNBC disruptors: Where are they now?

In subsequent years, Box invested heavily to move from product to platform. Instead of selling collaboration software, it’s now offering what it calls the content cloud — a full suite of services for storing and sharing documents, managing workflow, securing files and integrating third-party tools. In early 2021, Box spent $55 million on start-up SignRequest, adding e-signature technology across its cloud.
“A decade ago all we talked about was collaboration,” Levie said. Now, he said, the company is “building out a complete suite as opposed to one capability that was driving all of the growth.”
Of its 100,000-plus customers, Box says 120 are spending at least $1 million a year. Within its client base, the company sees a “7x user expansion opportunity” as its products become relevant to more people in the workplace, according to to its analyst day presentation.
In the world of software as a service, or SaaS, investors have heard plenty of companies tout the “land and expand” model, selling to a small team of developers or marketers and then using that footprint to get wider adoption inside an organization.

Box made it work with collaboration, but it has a long way to go to prove that its platform can be a key piece in the enterprise stack of the future. While the stock has outperformed of late, it still trades at about four times forward revenue, putting it in the bottom fifth of the BVP cloud Index.
The good news for Levie is that the activists are off his back, and metrics are improving where it matters most: free cash flow jumped 41% in 2022 to to $170.2 million.
“I would tell all founders to get more focused on cash flow,” Levie said.
With two little kids at home, Levie doesn’t have much time anymore to provide coaching to young entrepreneurs who are trying to navigate the current market choppiness. But he has learned some things going through the types of battles that many tech entrepreneurs have thus far avoided.
And if he has any sage advice, it’s this:
“Silicon Valley has ebbs and flows,” Levie said. Always look at long-term economics, and “how you’re going to generate cash flow in the future,” he added, “because that future might come faster than you think.”

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Top FDA official Dr. Peter Marks told the drug regulator’s advisory committee that a decision needs to be made by June on updating Covid vaccines to target variants.
Marks said it’s possible the U.S. could face another wave of infection in the fall as the virus evolves and immunity wanes.
Physicians and scientists are divided on whether more shots are needed right now.

A volunteer is injected with a vaccine as he participates in a coronavirus disease (COVID-19) vaccination study at the Research Centers of America, in Hollywood, Florida, September 24, 2020.
Marco Bello | Reuters

The FDA has until the early summer to decide whether vaccine makers need to change existing Covid shots to target different virus variants to avoid another possible surge in cases this fall, according to a top official at the drug regulator.
Dr. Peter Marks, who leads the Food and Drug Administration office responsible for vaccine safety and efficacy, told the agency’s advisory committee Wednesday that a decision would need to be made by June in order to have shots available in the fall. Marks said the U.S. could face another wave of infection at that time because the virus will continue to evolve as immunity from the current vaccines wanes.

Robert Johnson, a senior official at the Biomedical Advanced Research and Development Authority, said at the meeting that the biggest challenge in updating the shots will be coordinating across the vaccine makers to make sure they are focusing on the correct Covid variants.
Pfizer, Moderna and other vaccine makers are conducting clinical trials on omicron-based shots. However, the companies aren’t currently coordinating on their new vaccine formulas, according to Jerry Weir, head of the FDA’s division of viral products. Several FDA advisory panel members said public health authorities need to develop a unified approach across vaccine makers, similar to their work updating the flu vaccine to target new strains every year.
Dr. Paul Offit, an FDA committee member, said the CDC needs to take the lead in deciding when the vaccines are no longer effective against severe illness, so the FDA and National Institutes of Health can then work with the companies to determine the best path forward on a new shot.
“At some level, the companies kind of dictate the conversation here,” Offit said. “You often hear that the company now has an omicron-specific vaccine, or vaccine they can now link with the influenza vaccine. It shouldn’t come from them, it really has to come from us.”
FDA officials proposed using the process for developing new flu vaccines as a guide for changing the Covid shots. Every year, the World Health Organization makes a recommendation about the composition of the flu vaccine. The FDA then makes its own determination, based on a recommendation from its committee, about which strain should go into shots for the U.S.

The uncertainty over the trajectory of Covid’s evolution, unlike the predictability of the flu, makes it difficult to determine how the vaccines should be updated — or if they even need a change at all.
Three doses of Pfizer’s or Moderna’s vaccines were more than 80% effective at preventing hospitalization among healthy adults during the omicron wave, according to Centers for Disease Control and Prevention data presented at the meeting. But the companies’ vaccines are still based on the original version of the virus that emerged in Wuhan, China, and their effectiveness against infection has substantially dropped since the beginning of the pandemic.
Covid has mutated two to 10 times faster than the flu, depending on the strain of the latter virus, according to Trevor Bedford, a virologist at the Fred Hutchinson Cancer Research Center. Bedford said he expects that the spike protein, which the Covid virus uses to invade human cells, will keep evolving. The vaccines target the spike and as the protein mutates, the effectiveness of the shots can diminish.
Bedford said the most likely scenario over the next year is omicron and its subvariants will evolve to become more transmissible and further escape immunity from vaccination and infection. However, he said it’s difficult to predict whether another heavily mutated variant will come along that upends the pandemic response as omicron did over the winter.
“We really don’t know whether these wildly divergent viruses will be a common feature, or a rare feature of endemic SARS-CoV-2 evolution,” Bedford said, using the scientific name for the virus that causes Covid.
Johnson noted that in the case of the flu, the vaccine makers are able to develop production plans in advance based on a stable seasonal market. However, it’s not yet clear if Covid will follow a predictable seasonal pattern similar to the flu, according to Dr. Kanta Subbarao, a virologist who works on the flu for the WHO.

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FDA committee members said the central question in updating a vaccine is determining what metric public health authorities should use to determine when the shots have lost their effectiveness. Scientists have not yet determined if a certain antibody level generated by a vaccine translates to clear protection against the virus, according to Dr. Cody Meissner, an infectious disease experts at Tufts University School of Medicine.
As a consequence, public health authorities will have to rely on hospitalization rates to determine if the vaccine is losing its effectiveness, Meissner said. However, it’s also not clear if national hospitalization data is primarily made up of patients admitted due to the virus, or people who tested positive after admission for other reasons. Meissner pointed to data from Massachusetts that showed 65% of the 219 people hospitalized with Covid as of April 5 were actually admitted for reasons other than the virus.
Dr. Amanda Cohn, a CDC official, told the committee that repeated boosting is not a sustainable public health strategy. Cohn said the vaccines effectiveness against hospitalization remains high, and society may have to accept a certain level of infection which it can then treat with antiviral pills that are now on the market.
The FDA authorized fourth shots for adults ages 50 and older last week without consulting the committee, a decision that has divided scientists and physicians, some of whom believe that there isn’t sufficient data to support additional shots. Marks said the FDA didn’t consult the committee because the drug regulator viewed the authorization as a way to give people more vulnerable to severe disease additional protection until a broader decision is made for the rest of the population.
“I think we’re very much on board and with the idea that we simply can’t be boosting people as frequently as we are,” Marks told the committee. “I’m the first to acknowledge that this additional fourth booster dose that was authorized was a stopgap measure until we got things in place for the potential next booster given the emerging data,” Marks said.

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