Raphael Stevens

The Food and Drug Administration’s advisory committee voted unanimously to recommend Novavax’s Covid-19 vaccine for use in the U.S.
The FDA usually follows the committee’s recommendations, though it is not obligated to do so.
The agency could clear Novavax’s vaccine for distribution in the U.S. as soon as this week.
FDA officials and committee members raised concerns about a risk of heart inflammation with Novavax’s shot that are similar to the Pfizer and Moderna vaccines.

Novavax’s two-dose Covid-19 vaccine for adults ages 18 and older cleared a key step on the path toward Food and Drug Administration authorization on Tuesday.
The FDA’s committee of independent vaccine experts voted 21 to 0 with one abstention at the end of an all-day meeting to recommend authorizing the shot for use in the U.S. after an all-day public meeting in which it weighed safety and effectiveness data. The FDA usually follows the committee’s recommendations, though it is not obligated to do so. The agency could clear Novavax’s vaccine for distribution in the U.S. as soon as this week.

The Centers for Disease Control Prevention would still need to sign off on the shots before pharmacies and other health-care providers can start administering them to people.
Novavax’s shot would be the fourth Covid vaccine authorized for use in the U.S. and the first new one since the Johnson & Johnson vaccine was cleared in February 2021.
Novavax was one of the early participants in the U.S. government’s race to develop a Covid vaccine in 2020, receiving $1.8 billion in taxpayer funding from Operation Warp Speed. However, the company struggled for more than a year to get manufacturing in place and its clinical trial data appeared much later than Pfizer and Moderna.

Known technology

The Maryland biotech company’s shots are based on protein technology that’s been in use for decades in vaccines against hepatitis B and HPV. The technology differs from Pfizer and Moderna’s shots, which were the first ones using messenger RNA technology to receive FDA approval.
Dr. Peter Marks, who leads the FDA office responsible for reviewing vaccine safety and effectiveness, said Novavax’s vaccine would potentially appeal to unimmunized people who would prefer a shot that is not based on the mRNA technology used by Pfizer and Moderna. Though Johnson & Johnson’s shot is also available, the CDC has restricted its use due to a risk of blood clots, primarily in women.

In this photo illustration the Food and Drug Administration (FDA) and Novavax logos are seen behind a medical syringe and vials.
Pavlo Gonchar | LightRocket | Getty Images

About 76% of adults ages 18 and older have already received two doses in the U.S., primarily with Pfizer and Moderna’s vaccines, according to data from the CDC. However, about 27 million adults in the U.S. have not received their first dose yet, according to Heather Scobie, an official on the CDC’s Covid emergency response team. Novavax executives believe their vaccine will appeal to some people in this group who are not against vaccination, but want an option that uses technology with a longer track record than mRNA.
Novavax’s vaccine was 90% effective at preventing illness from Covid across the board and 100% effective at preventing severe illness, according to the company’s clinical trial results from the U.S. and Mexico. However, the trial was conducted from December 2020 through September of 2021, months before the highly contagious omicron variant and its various sublineages became dominant in the U.S.

Omicron

In briefing documents published ahead of Tuesday’s meeting, FDA officials said there is no data available on the effectiveness of the Novavax vaccine against omicron, though the shots would likely still protect against severe illness from the variant. Novavax, like every Covid vaccine, was designed to target the original strain of the virus that first emerged in Wuhan, China, in 2019. However, the virus has mutated dramatically over the past two years. The effectiveness of all the vaccines against mild illness from Covid has declined substantially as the virus has evolved.
“The study was conducted quite a while ago and said the cases that accrued were not during the time that omicron was circulating,” Dr. Lucia Lee, an official with the FDA’s division of vaccine research, said during her presentation to the committee.
Committee member Dr. Eric Rubin, an infectious disease expert at Harvard, said he was disappointed the company didn’t present data on Novavax’s effectiveness against omicron. However, Rubin said the data the company did submit meets the same standard used to authorize Pfizer and Moderna’s vaccines in December 2020.
Novavax’s Chief Medical Officer Dr. Filip Dubovsky told the panel that data from the company’s trials showed that two doses induced an immune response against omicron, though it was lower than against the Wuhan strain. A third dose boosted the immune response against omicron to levels comparable to the first two doses which had 90% effectiveness against illness, Dubovsky said. Novavax plans to ask the FDA to authorize a third dose if the agency clears the primary series for use in the U.S., he said.
“It’s factual that we don’t have efficacy data against omicron, what we do have is a technology that we think generates a broad immune response, demonstrated against a broad array of variants,” Dubosvky said. 

Side effects

The most common side effects of Novavax’s shots were injection site pain, fatigue, headache and muscle pain, according to FDA briefing documents. However, FDA officials also raised a red flag that Novavax’s vaccine might be associated with a risk of heart inflammation as is the case with Pfizer and Moderna’s shots.
In a safety database of 40,000 Novavax vaccine recipients, four young men who ranged in age from 16 to 28 reported myocarditis or pericarditis within 20 days of receiving a shot, though one of them had a viral illness that could have caused the symptoms. Myocarditis is an inflammation of the heart muscle and pericarditis is inflammation of the outer lining of the heart.
Lee said these cases were concerning because the patients reported their symptoms within days of receiving a Novavax shot, and there is already an established link between mRNA vaccination and heart inflammation among younger men. In the case of the mRNA shots, the CDC has found that the risk of myocarditis is higher from Covid infection than vaccination.

Myocarditis

Novavax’s chief safety officer Dr. Denny Kim said the rates of myocarditis were essentially the same between people who did and did not receive the vaccine in the clinical study, though it was slightly higher among people who received the shots.
“We believe that the totality of the clinical evidence here is not enough to establish an overall causal relationship with the vaccine,” Kim told the committee. He said Novavax is monitoring for cases of heart inflammation in the accumulating data from its clinical trials and real world use of the shots where they are already authorized.
Panel member Dr. Arthur Reingold, an epidemiologist at UC Berkeley, said he was skeptical that large numbers of vaccine-hesitant people would get Novavax’s shot, given there’s evidence the company’s vaccine might be associated with a risk of heart inflammation at comparable levels to the Pfizer and Moderna shots. 
Dr. Cody Meissner, a pediatrician at Tufts University who also sits on the committee, said there’s clearly a link between Covid vaccines and myocarditis, though there’s not enough data to say whether one company’s shot carries a higher risk.
Novavax’s vaccine technology differs in a number of ways from Pfizer and Moderna’s shots. The latter rely on messenger RNA to turn human cells into factories that produce copies of Covid’s spike protein to induce an immune response that fights the virus. The spike protein is the part of the virus that latches on to and invades human cells.
Novavax produces copies of the virus’ spike protein outside the human body. The genetic code for the spike is put into a baculovirus that infects moth cells, which then produce copies of the spike that are then purified and extracted. The spike copy, which can’t replicate or cause Covid, is injected into people inducing an immune response against the virus.
The vaccine also uses another ingredient called an adjuvant, which is an extract purified from the bark of a tree in South America, to induce a broader immune response against the virus. The shots consist of 5 micrograms of the spike copy and 50 micrograms of the adjuvant.
Novavax’s vaccine can also be stored at refrigerator temperatures, while Pfizer and Moderna’s shots require deep subzero cold temperatures.

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Lyft’s vehicle fleet will remain largely commandeered by drivers even as the company continues to develop its autonomous driving capabilities, co-founder and president John Zimmer told CNBC’s Jim Cramer on Tuesday.
“It’ll do five percent of the trips. 95% of the time you’re going to rely on a rideshare driver. So that’s all going to happen within the Lyft network, and we’ll scale up with our autonomous partners,” he said.

Lyft’s vehicle fleet will remain largely commandeered by drivers even as the company continues to develop its autonomous driving capabilities, co-founder and president John Zimmer told CNBC’s Jim Cramer on Tuesday.
“What we see happening is that there will be a hybrid network, meaning on day 1, just like what happened with phones, you didn’t have 3G go to 4G go to 5G on separate networks. You still needed to be able to make a 3G call when 4G wasn’t available,” Zimmer said in an interview on “Mad Money.”

“The same thing’s going to be true with autonomous vehicles. … It’ll do five percent of the trips. 95% of the time you’re going to rely on a rideshare driver. So that’s all going to happen within the Lyft network, and we’ll scale up with our autonomous partners,” he added.
Lyft Autonomous’ AV partners include Ford Motor and Argo AI, Motional and Waymo. Lyft announced in 2021 that it will launch a driverless robotaxi service in Las Vegas next year through its partnership with Motional.
Zimmer also told Cramer that the rideshare platform has seen “a 40% active drivers year-over-year improvement,” and that productivity has been higher, with Lyft facilitating 20% more rides per driver compared to during the first quarter in 2019.
Soaring gas prices led to a shortage of rideshare drivers earlier in the year, and the Covid pandemic kept Lyft drivers off the road before that.
Disclosure: Cramer’s Charitable Trust owns shares of Ford.

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It’s that time again! “Mad Money” host Jim Cramer rings the lightning round bell, which means he’s giving his answers to callers’ stock questions at rapid speed.

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Blackline Inc: “They’re losing money. … We can just not go with it.”

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MetLife Inc: “I’m going to have to say yes to that, even as I’m not a great fan of the insurers. … That is too cheap a stock.”

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Farfetch Ltd: “I say, buy Target down here.”
Disclosure: Cramer’s Charitable Trust owns shares of Johnson & Johnson.

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CNBC’s Jim Cramer on Tuesday gave investors his blessing to consider purchasing beaten-down tech stocks after Target’s latest quarter indicated good news for the Federal Reserve’s fight against inflation.
“The real greenlight here is on the beaten down tech. … They might deserve a bit of a resurgence if they have profits and a total romp if they have buybacks and dividends,” he said.

CNBC’s Jim Cramer on Tuesday gave investors his blessing to consider purchasing beaten-down tech stocks after Target’s latest quarter indicated good news for the Federal Reserve’s fight against inflation.
“The real greenlight here is on the beaten-down tech. … They might deserve a bit of a resurgence if they have profits and a total romp if they have buybacks and dividends,” he said.

“This is not a subtle market. I don’t want you to overthink it because sometimes it can be easy,” he added.
Cramer’s comments come after Target said in its latest quarter that it will need to shed its excess inventory, which will in turn constrain the company’s profits. 
The “Mad Money” host, who the day before advised investors to buy the dip only on oil stocks, said that Target’s news suggests that inflation is peaking. This opens up the door for investors to buy stocks that were previously untouchable in a high interest rate environment, he said. 
Listing ServiceNow, Broadcom and Salesforce as names that are more attractive after Target’s news, Cramer said he’s still staying away from retail stocks short-term.
He also warned investors that this change in the market could go away as fast as it came, due to the economy’s volatility.

“Of course, this market’s so darned fickle that this whole move could reverse when we get the big consumer price index number at the end of the week. … That could drive long-term interest rates higher again, putting this whole move on ice,” he said.
Disclosure: Cramer’s Charitable Trust owns shares of Salesforce.

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Club holding Eli Lilly (LLY) offered fresh insight Tuesday into its new type 2 diabetes drug Mounjaro and the exciting prospects of using it to treat obesity. The FDA-approved diabetes drug is an important product for Lilly as it works to commercialize its strong innovation pipeline. That pipeline is a big reason why we own the drugmaker. Mounjaro deepens Eli Lilly’s presence in diabetes treatment, while potentially creating a new market for Lilly in obesity care. Mizuho estimates Mounjaro sales of more than $14 billion by 2030 and sees more upside potential than downside risk to that estimate given the drug’s performance so far. LLY shares rose nearly 3% Tuesday, outperforming the S & P 500’s roughly 1% advance. What’s new Over the weekend, Eli Lilly presented data from its phase 3 Surmount-1 trial at the annual meeting for the American Diabetes Association, showing robust weight loss among participants and solid tolerability. Results also were published in the New England Journal of Medicine. Executives in the company’s diabetes division discussed those obesity-trial results Tuesday on a call with analysts. They also offered details about the rollout of Mounjaro since it received Food and Drug Administration approval to treat diabetes in May. The big takeaway The phase 3 trial data confirms what we already knew from the top-line weight loss results in April. The drug — which also is called tirzepatide — offers tremendous promise as a way to treat obesity, a common disease among Americans that also increases risk of other health conditions such as high blood pressure, heart disease and type 2 diabetes. The number of Americans who are technically considered obese is expected to grow in the coming years. Here’s what Eli Lilly’s trial found: Participants on the highest dose (15 mg) of the drug lost an average 22.5% of their baseline body weight, equal to about 52 pounds, after 72 weeks. What’s more, about 40% of patients on the 15-mg dose lost at least 25% of their body weight compared to under 1% of those in the placebo group. Patients on the middle dose (10 mg) saw a 21.4% average weight reduction, or a 49-pound reduction. Those in the placebo group reported a 2.4% reduction, on average, or about 5 pounds. The baseline weight for participants, on average, was 231 pounds. Another important result relates to the drug’s tolerability. On the Tuesday analyst call, Jeffrey Emmick, Lilly’s vice president of diabetes product development, said tirzepatide’s safety profile is similar to obesity drugs in the same category that have been approved. The side effects, which include nausea and vomiting, also are similar to what Lilly saw during the drug’s type 2 diabetes trial called Surpass, according to Emmick. He said it is “noteworthy” that discontinuation rates for trial participants on the drug ranged between 14% to 16%, depending on dosage, while those in the placebo had a discontinuation rate north of 26%. That goes to show “the limited efficacy of diet and exercise alone” in generating weight loss that participants find satisfying enough to remain in the trial, Emmick said. What to look for next Investors want information on when the company will ask U.S. regulators to approve the drug specifically for obesity, and Eli Lilly said Tuesday to expect an update in the second half of the year. Michael Mason, president of Lilly Diabetes, told analysts the company intends to speak with regulators about the possibility of submitting for approval using both data from the Surmount-1 trial along with data from the Surpass trial. Mason said that while weight loss was not the main goal of the Surpass trial, it was a secondary endpoint given 80% of participants had a body mass index (BMI) of 27 and a comorbidity, or a BMI greater than 30. A BMI above 30 is considered obese. “So we have a large data set,” Mason said. To us, this appears to suggest Lilly may not have to wait for additional results from other phase 3 trials involving the drug before submitting a supplemental Biologics License Application to the FDA. Eli Lilly execs declined to share any of their thinking into potential pricing for tirzepatide as an obesity treatment, saying Tuesday it was too early to get into that. What analysts are saying A number of Wall Street analysts expressed satisfaction with the data Lilly presented at the ADA conference over weekend. Morgan Stanley analysts titled their note to clients, “Tirzepatide ushering in a new era of obesity treatment,” while reiterating their overweight rating on shares of Eli Lilly. Morgan Stanley projects sales of tirzepatide to reach $17.2 billion in 2030, with about $12.2 billion of that being for diabetes and $5 billion for obesity. Goldman Sachs analysts now project peak sales of tirzepatide for obesity to be $7 billion — raising their forecast upward from $6.5 billion “based primarily on an increase to our probability of success factoring for the product, based on the recent approval for type 2 diabetes.” After reviewing Eli Lilly’s full data, Goldman analysts said they still believe tirzepatide looks more effective than a similar obesity drug already on the market, Novo Nordisk ‘s Wegovy. (Jim Cramer’s Charitable Trust is long LLY. See here for a full list of the stocks.) As a subscriber to the CNBC Investing Club with Jim Cramer, you will receive a trade alert before Jim makes a trade. Jim waits 45 minutes after sending a trade alert before buying or selling a stock in his charitable trust’s portfolio. If Jim has talked about a stock on CNBC TV, he waits 72 hours after issuing the trade alert before executing the trade. THE ABOVE INVESTING CLUB INFORMATION IS SUBJECT TO OUR TERMS AND CONDITIONS AND PRIVACY POLICY , TOGETHER WITH OUR DISCLAIMER . NO FIDUCIARY OBLIGATION OR DUTY EXISTS, OR IS CREATED, BY VIRTUE OF YOUR RECEIPT OF ANY INFORMATION PROVIDED IN CONNECTION WITH THE INVESTING CLUB. NO SPECIFIC OUTCOME OR PROFIT IS GUARANTEED.

The Eli Lilly logo is shown on one of the company’s offices in San Diego, California, September 17, 2020.
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Actor Matthew McConaughey delivered an emotional White House appeal for gun regulations in the wake of last month’s mass shooting in his hometown of Uvalde, Texas.
Through misty eyes, McConaughey recalled his recent travel to Uvalde, where he and his wife met with victims’ families.
The mass shooting on May 24, carried out by a lone teenage gunman, left 19 children and two teachers dead.

In an emotional speech at the White House on Tuesday, actor Matthew McConaughey called for new gun regulations in the wake of last month’s mass shooting in his hometown of Uvalde, Texas, and urged federal lawmakers to honor their moral obligations instead of party affiliations.
Through misty eyes, McConaughey recalled his recent travel to Uvalde, where he and his wife met with victims’ families, local law enforcement and morticians who were tasked with preparing some of the bodies of the school-aged children who were shot to death on May 24.

He also recounted his younger years in Uvalde, where he said he learned what it means to be a responsible gun owner and to revere the Second Amendment.
“We heard from so many people: Families of the deceased, mothers, fathers, sisters, brothers, Texas Rangers, hunters, border patrol and responsible gun owners who won’t give up their Second Amendment rights,” he said. “They all said, ‘We want secure and safe schools and we want gun laws that won’t make it so easy for the bad guys to get these damn guns.’ ”

Actor Matthew McConaughey, a native of Uvalde, Texas as well as a father and a gun owner, becomes emotional as he holds up a picture of a young victim of the school shooting in Uvalde as he speaks to reporters about mass shootings in the United States during a press briefing at the White House in Washington, U.S., June 7, 2022. 
Kevin Lamarque | Reuters

McConaughey specifically called on U.S. lawmakers to pass legislation to raise the minimum age gun owners can purchase an assault rifle to 21 from 18, bulk up background checks and institute red flag provisions.
His White House appearance came a day after the actor, known for films like “The Wedding Planner” and his Oscar-winning role in “Dallas Buyers Club,” wrote an op-ed in the The Austin American-Statesman titled “It’s Time to Act on Gun Responsibility.”
In that op-ed, the actor pressed Congress to appreciate the difference between gun “control” and “responsibility” in the wake of the gruesome mass shooting in Uvalde that left 19 children and two teachers dead.

“I believe that responsible, law-abiding Americans have a Second Amendment right, enshrined by our founders, to bear arms. I also believe we have a cultural obligation to take steps toward slowing down the senseless killing of our children,” he wrote.
“There is no constitutional barrier to gun responsibility,” McConaughey continued. “Keeping firearms out of the hands of dangerous people is not only the responsible thing to do, it is the best way to protect the Second Amendment. We can do both.”
The Biden administration has called on Congress to pass gun control measures in the wake of two high-profile mass shootings last month: The massacre in Uvalde and a racist attack at a supermarket in Buffalo, New York, that left 10 slain.
President Joe Biden met with Sen. Chris Murphy, a Democrat from Connecticut leading bipartisan gun control talks, earlier Tuesday to discuss the latest debate on Capitol Hill.
Murphy, perhaps the chamber’s biggest advocate for tighter gun laws, is working with Texas Republican Sen. John Cornyn on efforts to improve school security, strengthen background checks and introduce red flag laws that would allow families to petition courts to seize guns from a person suspected of posing a public health threat.

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