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Health

Moderna says its RNA vaccine was nearly 84% effective in preventing symptoms in adults 60 and older

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Moderna Inc. announced on Tuesday that a late-stage trial found that its experimental messenger RNA vaccine for respiratory syncytial virus was 83.7% effective in preventing at least two symptoms in adults ages 60 and older.

RSV produces symptoms similar to a cold and can lead to death for young children and older adults. It results in about 14,000 deaths per year in adults who are at least 65-years-old. RSV, the flu and coronavirus all soared in the U.S. and Europe this fall.

There is no vaccine for adults currently on the market, but Moderna, Pfizer Inc. and GSK Plc. are each looking to be the first to release their RSV vaccines.

Pfizer and GSK filed applications for U.S. regulatory approval at the end of last year. Pfizer’s RSV vaccine was reported to be 66.7% effective against two or more symptoms in late-stage trials.

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Moderna Inc. said a late-stage trial found that its experimental messenger RNA vaccine for respiratory syncytial virus was 83.7% effective in preventing at least two symptoms in adults ages 60 and older.
(REUTERS/Brian Snyder)

Meanwhile, Sanofi and partner AstraZeneca Plc’s antibody treatment nirsevimab has received marketing approval from the European Commission for the prevention of RSV in newborns and infants. It is currently under review by the U.S. Food and Drug Administration.

Moderna said it plans to submit its vaccine, mRNA-1345, for regulatory approval consideration globally in the first half of this year. Company president Stephen Hoge said its vaccine compares favorably to the experimental Pfizer and GSK shots.

“It’s very exciting to see progress in RSV vaccines in older adults, and I think both of those vaccines have shown pretty remarkable results as well,” he said. “We really think we’re in that top class – 84% is a terrific efficacy number.”

There is no vaccine for adults currently on the market, but Moderna, Pfizer Inc. and GSK Plc. are each looking to be the first to release their RSV vaccines.

According to Cowen analyst Tyler Van Buren, The RSV vaccine market could be worth more than $10 billion globally, and half of that would come from the U.S.

Moderna’s study included about 37,000 participants ages 60 years and older. The data analysis was performed after 64 participants became infected with RSV. Moderna said it intends to release the complete data at a medical meeting.

Hoge said the company began secondary analysis on the vaccine’s efficacy against more severe disease and hospitalization and that it was too early to give a potential price range for the vaccine. The vaccine is expected to be administered on an annual basis.

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RSV, the flu and coronavirus all soared in the U.S. and Europe this fall.
(AP)

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The vaccine was generally found safe, with the most common side effects being injection-site pain, fatigue and headache. Hoge said the company had no concerns about myocarditis, a type of heart inflammation linked to mRNA COVID vaccines.

Reuters contributed to this report.

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Business

Market Rally Pauses, Tesla Jumps, Moderna Pops Late; What Investors Need Now

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Dow Jones futures fell slightly after hours, along with S&P 500 futures and Nasdaq futures. United Airlines headlined overnight earnings, while Moderna stock rose on RSV vaccine trial data. Microsoft job cuts and a Bank of Japan policy shift could come Wednesday.




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The stock market rally had a relatively quiet session, despite a solid drop for the Dow Jones.

Tesla (TSLA) continued its rebound from bear-market lows, jumping 7.4% to 131.49. Shares moved slightly above the 21-day line, but remain well below the 50-day and especially the 200-day line. Tesla China EV registrations bounced in the latest week following recent big price cuts there. But it may be some time before investors get a clear picture of the impact of Tesla’s global price cuts and demand. Tesla earnings for Q4 are due on Jan. 25.

A pause for a few days would let more stocks set up. That includes stocks that rallied from early entries and could use handles.

Chevron (CVX), Vertex Pharmaceuticals (VRTX) and TJX Cos. (TJX) are three stocks that are actionable now.

But overall, investors should be patient.

Key Earnings

United Airlines (UAL) and Interactive Brokers (IBKR) reported Tuesday night.

United Airlines earnings comfortably beat Q4 views while the carrier also gave bullish guidance. UAL stock ascended modestly after hours. Shares dipped 0.9% to 51.20 on Tuesday, but after running sharply higher over eight sessions.

Interactive Brokers earnings topped views as well. IBKR stock rose slightly in overnight action. Shares slipped 2 cents to 77.19 on Tuesday, working on an 80.95 buy point from a double-bottom base. Friday’s move over the 50-day line offered an early entry, but just before earnings.

Charles Schwab (SCHW) and trucking firm J.B. Hunt Transport Services (JBHT) are due early Wednesday. SCHW stock inched up 0.6% to 83.49 on Tuesday, holding in a buy zone. JBHT stock dipped 0.3% to 176.29, between the 50-day and 200-day lines.

UAL stock is on the IBD 50. VRTX stock is on the IBD Big Cap 20.

Moderna RSV Vaccine

Moderna late Tuesday reported strong results for respiratory syncytial virus, or RSV, vaccine. The biotech’s RSV vaccine uses its mRNA technology. MRNA stock rose solidly in extended trading, signaling a strong bounce from around the 10-week line. The Moderna RSV vaccine follows positive RSV results from Pfizer (PFE) and GlaxoSmithKline (GSK).

Microsoft Job Cuts Loom

Meanwhile, Microsoft (MSFT) may announce new job cuts as soon as Wednesday, Bloomberg reported, citing sources. The cuts could be “significantly higher” than in prior layoffs. Sky News reported that the Dow Jones software giant could cut up to 5% of staff, which would be 11,000 jobs. In October, Microsoft cut about 1,000 positions.

MSFT stock rose 0.5% to 240.35 on Tuesday, its seventh straight advance and just below its 50-day line. Microsoft earnings are due Jan. 24.

The video embedded in the article reviewed CVX stock, Eli Lilly (LLY) and MercadoLibre (MELI).

Dow Jones Futures Today

Dow Jones futures fell 0.2% vs. fair value. S&P 500 futures dipped 0.25% and Nasdaq 100 futures declined 0.3%.

Crude oil prices rose slightly.

The Bank of Japan could signal the end of its long-term policy of keeping official rates and Japanese sovereign debt near 0%. In December, the BoJ effectively hiked, by letting the 10-year Japanese yield rise to 0.5%.

Remember that overnight action in Dow futures and elsewhere doesn’t necessarily translate into actual trading in the next regular stock market session.

Join IBD experts as they analyze actionable stocks in the stock market rally on IBD Live

Stock Market Rally

The stock market rally had a mixed session Tuesday, generally showing modest intraday swings.

The Dow Jones Industrial Average slumped 1.1% in Tuesday’s stock market trading, but that was largely due to Goldman Sachs (GS) and Travelers (TRV) weighing on blue chips. The S&P 500 index dipped 0.2%, with Tesla stock and Morgan Stanley (MS) the top performers. The Nasdaq composite advanced 0.1%. The small-cap Russell 2000 edged down 0.1%.

U.S. crude oil prices edged up 0.4% to $80.18 a barrel, closing above $80 for the first time in two weeks. Crude futures hit $81.23 intraday.

The 10-year Treasury yield rose 2 basis points to 3.53%.

ETFs

Among growth ETFs, the Innovator IBD 50 ETF (FFTY) dipped 0.2%. The iShares Expanded Tech-Software Sector ETF (IGV) edged up 0.3%, with Microsoft stock a major holding. The VanEck Vectors Semiconductor ETF (SMH) climbed 0.6%.

Reflecting more-speculative story stocks, ARK Innovation ETF (ARKK) popped 2.9% and ARK Genomics ETF (ARKG) 1.8%, both extending gains from the 50-day line and moving toward their 200-day averages. TSLA stock remains a top holding across Ark Invest’s ETFs, with Cathie Wood adding a lot more shares in recent weeks.

SPDR S&P Metals & Mining ETF (XME) fell 1%. U.S. Global Jets ETF (JETS) edged up 0.4%, with UAL stock a big holding. SPDR S&P Homebuilders ETF (XHB) declined 0.8%. The Energy Select SPDR ETF (XLE) tilted up 0.2%, with CVX stock a major holding. The Financial Select SPDR ETF (XLF) retreated 0.7%. The Health Care Select Sector SPDR Fund (XLV) slipped 0.5%.

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Stocks In Buy Zones

Chevron climbed advanced 1.65% to 180.49, moving above the 50-day line and a short-term high of 180.23. CVX stock has a 189.78 flat-base buy point, according to MarketSmith analysis.

VRTX stock popped 3.7% to 311.58, rebounding above the 50-day line in above-average trade. That offers an early entry for Vertex, which has a 324.85 flat-base buy point. VRTX stock also has retaken a prior buy point of 306.05. The biotech hit a record 324.75 on Dec. 8, but then tumbled to the 200-day line by year-end. Vertex stock rebounded from there last week. Investors could wait to see if shares pause around the 50-day line.

TJX stock closed up 2 cents to 81.55, rebounding intraday from a test of an 81.29 flat-base buy point cleared on Jan. 6. Since then shares have been consolidating in the buy zone. The 5%-deep flat base is just above a long, 31%-deep cup consolidation.

Market Rally Analysis

The stock market rally had a relatively quiet session after last week’s big gains.

The S&P 500 briefly retook the 4,000 level and pulled back, but only holding above the 200-day.

The Russell 2000, which ran past its 50-day and 200-day lines last week, backed off after coming within 1% of its November highs.

The Nasdaq composite is holding above its 50-day line, with the December highs and 200-day line the big resistance areas on the horizon. A lot of Tuesday’s strength came from Tesla, chips and beaten-down cloud software names.

The Dow Jones fell solidly, largely on GS stock and Travelers. The blue-chip index is comfortably above its moving averages, with only its December highs to watch.

The market rally still looks healthy. A number of trends, including the Nasdaq advance-decline line and new highs vs. lows, have improved in the past several sessions.

A pause or modest pullback here would be normal or even healthy. The S&P 500 decisively breaking below the 200-day line, perhaps undercutting the 50-day, would be more worrisome. On the upside, the late 2022 highs are the next key level.

While Chevron, TJX and Vertex and a few other names are arguably actionable, there’s not a lot to buy right now. A few stocks that looked promising Tuesday morning, such as Monster Beverage (MNST), wilted by the close.

Many stocks already moved up over the past several sessions, such as Medpace (MEDP) and MercadoLibre. A pause would let many of these names form handles or shelves. Meanwhile, other stocks are coming into the picture.

Time The Market With IBD’s ETF Market Strategy

What To Do Now

Patience is important. With the market ready possibly pausing and not many stocks flashing buy signals, resist the temptation to buy extended stocks. If this uptrend works, you’ll have safer opportunities ahead. That include recently hot stocks if the form handles or touch support levels.

Definitely run your screens of leading stocks to find those that are showing promising action.

If the market offers more stocks flashing buying signals, you can exposure gradually over time. In addition to a variety of economic and Fed crosscurrents, earnings season is underway, with the upcoming two weeks likely the heaviest releases.

Read The Big Picture every day to stay in sync with the market direction and leading stocks and sectors.

Please follow Ed Carson on Twitter at @IBD_ECarson for stock market updates and more.

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Health

Moderna jumps into pivotal pack with promising RSV data as big rivals face off in megablockbuster race – Endpoints News

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David Kessler, the Biden administration’s chief science officer for Covid-19, will step down this week amid question marks about what the next iteration of the Covid vaccine (from booster to price) will look like moving forward, and shortly after the admin’s other long-time chief medical advisor, Tony Fauci, stepped down.

Buttressed by his FDA commissioner experience from 1990-1997, Kessler stood atop the reincarnated version of Operation Warp Speed, helping to bring the bivalent booster to millions, as well as millions of new doses of oral antivirals.

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Business

Dow Jones Rises, But Tesla, Moderna Lead Growth Sell-Off; 5 Stocks Near Buy Points

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Dow Jones futures were little changed after hours, along with S&P 500 futures and Nasdaq futures.




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The stock market rally showed divergent action Tuesday, with the Dow rallying, the Nasdaq slumping and S&P 500 somewhere between.

Tesla (TSLA), Moderna (MRNA), Nvidia (NVDA) and Enphase Energy (ENPH) were notable losers, with Apple (AAPL) setting a new bear market low.

On the positive side, Dow Jones giant Caterpillar (CAT), Deere (DE), ATI (ATI), Freeport-McMoRan (FCX) and Schlumberger (SLB) are industrial, metal, mining and energy plays in or near buy points. Underlying commodity prices rose solidly Tuesday, helped by China continuing to roll back Covid restrictions.

Dow Jones Futures Today

Dow Jones futures rose 0.1% vs. fair value. S&P 500 futures edged higher. Nasdaq 100 futures were flat, with TSLA stock extending losses overnight.

Remember that overnight action in Dow futures and elsewhere doesn’t necessarily translate into actual trading in the next regular stock market session.

Join IBD experts as they analyze actionable stocks in the stock market rally on IBD Live

Stock Market Rally

The stock market rally had a mixed session, with industrial and metal stocks holding up or rising while growth plays struggled.

The Dow Jones Industrial Average inched up 0.1% in Tuesday’s stock market trading. The S&P 500 index fell 0.4%, with Tesla stock the day’s worst performer, followed by Moderna and Nvidia. The Nasdaq composite declined 1.4%. The small-cap Russell 2000 gave up 0.7%.

Apple stock sank 1.4% to 130.03. Intraday, AAPL hit 128.76, just undercutting its bear market low.

Tesla stock plunged 11.4% to 109.01, its worst one-day loss in 11 months, amid a Shanghai plant shutdown, weak China sales data and other news. TSLA stock has now crashed 44% just this month to the lowest levels since August 2020. Volume has been very high all month, signaling institutional selling. TSLA stock fell slightly in extended trade.

Nvidia stock slumped 7.1% to 141.21, breaking below its 50-day line. NVDA stock has tumbled 19% from its Dec. 13 intraday high of 187.90.

MRNA stock sank 9.5% to 180.17, tumbling below a 188.75 cup-with-handle buy point, according to MarketSmith analysis. Moderna blasted out of that base on Dec. 13 on bullish cancer vaccine trial data, soaring 20% that day and hitting 217.25 the following session. But MRNA stock has round-tripped a 15% gain and more.

ENPH stock tumbled 6.6% to 274.54, now well below the 50-day line after undercutting that level on Friday.

U.S. crude oil prices fell 3 cents to $79.53 a barrel after topping $80 Tuesday morning.

The 10-year Treasury yield jumped 11 basis points to 3.86% after soaring 27 basis points last week.

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ETFs

Among the best ETFs, the Innovator IBD 50 ETF (FFTY) fell 0.5%, while the Innovator IBD Breakout Opportunities ETF (BOUT) climbed 0.7%. The iShares Expanded Tech-Software Sector ETF (IGV) retreated 0.6%. The VanEck Vectors Semiconductor ETF (SMH) slumped 1.8%. NVDA stock is a major SMH holding.

The SPDR S&P Metals & Mining ETF (XME) rose 0.8%. FCX stock and ATI are XME components. The Industrial Select Sector SPDR Fund ETF (XLI) edged up 0.3%, with Caterpillar and DE stock both top 10 holdings.

The U.S. Global Jets ETF (JETS) descended 1.3%. SPDR S&P Homebuilders (XHB) dipped 0.3%. The Energy Select SPDR ETF (XLE) advanced 1.1%, with SLB stock a key component. The Financial Select SPDR ETF (XLF) was just below break-even. The Health Care Select Sector SPDR Fund (XLV) gave up 0.3%.

Reflecting stocks with more speculative stories, ARK Innovation ETF (ARKK) tumbled 4.15%, hitting a fresh five-year low. ARK Genomics (ARKG) slumped 3.8%, closing in on June’s bear market low. Tesla stock remains a major holding across Ark Invest’s ETFs.

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Stocks To Watch

Caterpillar stock rose 1.4% to 243.14, clearing a 239.95 buy point from a flat base right next to a deep cup base. Breakouts have struggled over the past year, but the 6%-deep base lowers the risk somewhat. The relative strength line is at its best level in nearly 10 years.

Deere stock edged down 0.2% to 436.15, still close to its 21-day line with the 10-week line catching up. DE stock has been trading tightly after a strong run. It’s on track to have a shallow flat base at the end of the week with a 448.50 buy point. A move above the Dec. 21 high of 444.51 would offer an early entry in Deere stock. The RS line for DE stock is at a record high.

ATI stock popped 3.8% to 31.45, rebounding from the 10-week line and hitting a trendline entry. The official buy point is 31.84 from a handle. The RS line for ATI is at a three-year high.

Freeport-McMoRan stock rose just over 2% to 38.88, bouncing from the 21-day and 10-week lines. That offers an early entry from a long, deep cup-with-handle base with a 41.26 buy point. FCX stock is not yet extended from its 50-day line, which has just crossed the 200-day

Schlumberger stock climbed 1% to 53.50, working on a 56.14 buy point from a short base. SLB stock has broken a trendline entry and is still close to its 21-day and 50-day lines.

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Market Rally Analysis

The stock market rally showed split, divergent action in Tuesday’s session.

The Dow Jones again found support at its 50-day line, but hit resistance at its 21-day line.

The S&P 500 lost a little more ground vs. a rising 50-day line.

The Invesco S&P 500 Equal Weight ETF (RSP) rose fractionally, briefly topping its 50-day line, with the impact of Tesla, Nvidia, Moderna and Enphase lessened.

The Nasdaq skidded Tuesday, approaching Thursday’s intraday lows. The composite flirted with a bear-market closing low.

In addition to industrial, metal, mining and energy plays such as Caterpillar, Schlumberger and FCX stock, many medical plays are acting well. Housing stocks, from builders to materials to retailers, also are showing strength, along with some retailers. Chinese internets are rebounding as the economy opens up.

But growth stocks and techs generally look terrible.

An uptrend under pressure that is also a divergent market rally amid huge macroeconomic uncertainty is unstable and highly risky. And that’s before individual stock risk.

It’s possible that real economy names pull up techs in a 2023 stock market rally, especially if Federal Reserve and economic headwinds recede. Or tech and growth stocks could drag the broad market back toward bear lows. Or the major indexes could whipsaw sideways with significant sector rotation for an extended stretch.

Time The Market With IBD’s ETF Market Strategy

What To Do Now

The stock market rally is still hanging on. Parts of the market are doing well, as the uptrend shows increasing divergence.

A nimble investor could try buying, say, CAT stock, ATI or Schlumberger. But exposure should be light, and any new positions should be small. Investors also could play the sector or theme via ETFs such as XME, XLE, OIH or XLI.

There’s nothing wrong with taking no new positions, or even being entirely in cash.

Read The Big Picture every day to stay in sync with the market direction and leading stocks and sectors.

Please follow Ed Carson on Twitter at @IBD_ECarson for stock market updates and more.

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Business

Covid-19 vaccine boosters for kids age 5 and under

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CNN
 — 

Last week, the US Food and Drug Administration authorized the bivalent Covid-19 booster for children 6 months to 5 years old. The US Centers for Disease Control and Prevention has since recommended the booster, and now everyone 6 months and older is able to receive the updated coronavirus vaccine except kids who got three doses produced by Pfizer/BioNTech.

Which young children are now eligible to receive the booster? What if kids haven’t started or completed the full series — do they now get the updated booster or the original monovalent vaccine? Can parents and guardians choose between the updated booster and the original shot? What are possible side effects? What if kids had Covid-19 already? And which families should consider the updated booster now and who could wait?

To help us answer these questions, I spoke with CNN Medical Analyst Dr. Leana Wen, an emergency physician, public health expert, and professor of health policy and management at the George Washington University Milken Institute School of Public Health. She is also author of “Lifelines: A Doctor’s Journey in the Fight for Public Health” and the mother of two young children, ages 2 and 5.

CNN: Let’s start with what has just changed in the recommendations: Which young children who received either the Pfizer or Moderna vaccine are now eligible to receive the booster?

Dr. Leana Wen: There are two vaccines authorized for young children: Moderna and Pfizer. For the youngest age group, the Moderna vaccine was designed to be a two-dose primary vaccine, while the Pfizer version was designed to be a three-dose primary vaccine. That means young children are considered to have completed their primary series if they completed two doses of the Moderna vaccine or if they completed three doses of Pfizer.

As a reminder, there is now a bivalent booster available for older children and adults. This combines the original (also called monovalent) vaccine with a vaccine that specifically targets the BA.4 and BA.5 Omicron subvariants. Because Omicron subvariants constitute virtually all new infections, the hope is that the bivalent booster will provide better, more directed protection.

What federal health officials have now said is that children 6 months through 5 years old who received both doses of the original Moderna vaccine are able to get the updated bivalent vaccine — if it has been at least two months since they completed the primary vaccine series.

For children who received the Pfizer vaccine, the guidance is a little different, because the primary series already involves three doses. Federal health officials have said that children 6 months through 4 years old who have not yet completed their three vaccine doses can receive the third dose as the bivalent vaccine. Let’s say a child has started this series and has had one or two doses of the original Pfizer vaccine. The third dose can now be the updated booster.

CNN: What if kids haven’t started or completed the full series — do they now get the updated booster or the original monovalent vaccine?

Wen: The answer is different for Moderna vs. Pfizer. For Moderna, the primary series is two doses, so a child needs to complete the two initial shots with the original formulation. The booster — the third dose — is the bivalent vaccine. For Pfizer, the primary series is three doses. The first two doses still need to be the original formulation, but the third shot is now the bivalent vaccine.

CNN: What about young children who completed three doses of the Pfizer vaccine — are they eligible for a fourth dose?

Wen: No. The FDA explicitly says that children 6 months through 4 years old who have completed their three-dose primary series with the original Pfizer vaccine are not eligible for a fourth shot of the bivalent booster. That’s because the primary series of three vaccine doses is still expected to have strong protection against severe illness to Omicron. This recommendation will be reevaluated as new data comes out.

CNN: Can parents and caregivers who have not completed the primary series of Moderna choose the bivalent vaccine as their second dose?

Wen: No. The FDA authorization for the adult primary series for Moderna — the two doses — is for the original monovalent vaccine. Similarly, there is no choice for which vaccine formulation is administered as the booster for Pfizer in adults. Only the bivalent booster is available as the third shot, not the original monovalent, which is still given as doses one and two. This mirrors the authorization given for adults — the primary series is the monovalent vaccine, with the only booster for Pfizer and Moderna for adults being the updated booster.

CNN: What are possible side effects from the updated booster?

Wen: It’s expected that children who get the updated booster will have similar types of side effects to the original vaccines. These side effects tend to be mild and short-lasting, usually resolving in the first 24 hours after inoculation. Adverse reactions can include pain and swelling in the injection site, fatigue, crankiness, sleepiness, headache, muscle aches and sometimes fever. Many children experience no side effects. The risk of serious side effects, such as myocarditis (an inflammation of the heart muscle), is expected to be exceedingly rare in this younger age group.

CNN: What if kids had Covid-19 already?

Wen: People who had Covid-19 can wait three months until after they have recovered from the coronavirus to receive another vaccine dose, according to the CDC. They probably have very good protection against infection in this period.

Many studies have shown that hybrid immunity — recovery from Covid-19 combined with vaccination — conveys very strong protection, arguably even more so than vaccination and boosters alone. In my opinion, I believe a case can be made that if a young child received the primary series and already had Covid, they could wait to receive another booster dose. This is especially true if they had Covid recently, in the last year. To my knowledge, there is no research that shows additional benefit of boosters to young children who recently had Covid-19 infection and who have received their primary vaccinations.

CNN: Which families should consider the updated booster now and who should wait?

Wen: First, I think it’s important to point out that the uptake of the primary series of the Covid-19 vaccines among young children is very low. According to the CDC, less than 5% of kids 5 and younger are fully vaccinated. That means we are referring to a very small pool of kids newly eligible for the updated boosters.

There’s one group that I would definitely recommend getting the updated booster. That’s the group of kids who received their first one or two doses of the Pfizer vaccine. These kids need to complete their primary series. The third dose of that series is now the updated bivalent booster. There’s no reason for families of these children to wait; they should complete the primary series, and it’s a bonus that the third dose is updated to target Omicron.

For children who received the two doses of the Moderna vaccine, I think the decision-making is different and will depend on families’ individual circumstances. Some families are very concerned about Covid-19 infection. Perhaps their child has underlying medical conditions, or they live with someone who is elderly, immunocompromised or otherwise very vulnerable to severe outcomes from Covid-19. Perhaps the family is welcoming a newborn soon, and that baby will be particularly vulnerable to coronavirus infection. I think it’s reasonable to decide that, since Covid-19 cases are rising, this is the time to get their young child the updated booster.

I also think it’s reasonable to wait. My children (ages 2 and 5) received the Moderna vaccines over the summer. They are eligible to be boosted, but I am holding off because the protection that they have against severe illness remains strong. The booster will convey additional protection against symptomatic infection, but that effect is probably short-lasting, according to a June study.

To be clear, I believe it’s crucial for older adults and vulnerable individuals to receive the updated booster. I also think it’s generally a good thing that people can choose the booster if they wish, as there are compelling individual reasons for different households.

Parents and caregivers who have questions should consult their pediatrician to decide the best course of action for their family’s specific circumstances. Finally, families whose children have yet to receive any Covid-19 vaccines should consider starting, especially if their kids are not known to have had Covid-19.

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Business

Positive Moderna, Merck cancer vaccine data advances mRNA promise, shares rise

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CHICAGO, Dec 13 (Reuters) – An experimental cancer vaccine from Moderna Inc (MRNA.O) based on the messenger RNA (MRNA) technology used in successful COVID-19 vaccines has been shown to work against melanoma, sending Moderna shares more than 20% higher and driving up of other biotechs working on similar treatments.

A combination of Moderna’s personalized cancer vaccine and Merck & Co’s (MRK.N) blockbuster immunotherapy Keytruda cut the risk of recurrence or death of the most deadly skin cancer by 44% compared with Keytruda alone in a mid-stage trial, the companies said on Tuesday.

The result was considered a “statistically significant and clinically meaningful improvement,” the companies said.

Moderna shares were up nearly 23% at $202.80 on Tuesday, while Merck’s shares rose 1%. Shares of BioNTech SE (22UAy.DE), which also has successful mRNA vaccine technology, were up 6%, and tiny Gritstone Bio Inc (GRTS.O), which has a cancer vaccine in development, jumped 20% to $3.09.

The study is the first randomized trial to show that combining mRNA vaccine technology with a drug that revs up the immune response would offer a better result for melanoma patients and potentially for other cancers.

“It’s a tremendous step forward in immunotherapy,” Eliav Barr, Merck’s head of global clinical development and chief medical officer, said in an interview.

Paul Burton, Moderna’s chief medical officer, said in a separate interview that the combination “has the capacity to be a new paradigm in the treatment of cancer.”

The ongoing study involved 157 patients with stage III/IV melanoma whose tumors were surgically removed before being treated with either the drug/vaccine combo or Keytruda alone with the aim of delaying disease recurrence.

The combination was generally safe and demonstrated the benefit compared with Keytruda alone after a year of treatment. Serious drug-related side effects occurred in 14.4% of patients who received the combination compared with 10% with Keytruda alone.

A PROMISING FIELD

In October, Merck exercised an option to jointly develop and commercialize the treatment, known as mRNA-4157/V940, sharing costs and any profits equally. Merck and Moderna plan to discuss the results with regulatory authorities and start a large Phase III study in melanoma patients in 2023.

The Merck/Moderna collaboration is one of several combining powerful drugs that unleash the immune system to target cancers with mRNA vaccine technology. They are designed to target highly mutated tumors.

The personalized vaccine works in concert with Merck’s Keytruda, a so-called checkpoint inhibitor designed to disable a protein called programmed death 1, or PD-1, that helps tumors to evade the immune system.

To build the vaccine, researchers took samples of patients’ tumors and healthy tissue. After analyzing the samples to decode their genetic sequence and isolate mutant proteins associated only with the cancer, that information was used to design a tailor-made cancer vaccine.

When injected into a patient, the patient’s cells act as a manufacturing plant, producing perfect copies of the mutations for the immune system to recognize and destroy.

Moderna’s personalized vaccine can be made in about eight weeks, a time frame the company eventually hopes to halve, Burton said.

Barr said the companies intend to study the approach in other highly mutated cancers, such as lung cancer. Other such cancers include bladder cancers and some breast cancers.

Moderna mRNA rival BioNTech has several cancer vaccine trials in the works including one with Memorial Sloan Kettering Cancer Center in New York testing a personalized vaccine in combination with Roche’s (ROG.S) Tecentriq in patients with pancreatic cancer.

Gritstone is testing a personalized, self-amplifying mRNA vaccine in combination with Bristol Myers Squibb’s (BMY.N) immunotherapies Opdivo and Yervoy in a midstage trial in patients with advanced solid tumors.

Experts said the personalized vaccines were among several promising cancer vaccine ideas in the works after many failures in the field.

“In general, I think cancer vaccines are kind of at a tipping point, and there are going to probably be a lot of vaccines coming down the pipeline in the next five years,” said Dr. Mary Lenora Disis, director of the UW Medicine Cancer Vaccine Institute in Seattle.

Although the COVID-19 pandemic demonstrated the speed, ease and safety of mRNA vaccines, they came out of years of cancer vaccine research, Disis said.

Reporting by Julie Steenhuysen in Chicago, Michael Erman in New Jersey and Aditya Samal in Bengaluru; Editing by Caroline Humer, Edwina Gibbs and Bill Berkrot

Our Standards: The Thomson Reuters Trust Principles.

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Moderna says new booster increases protection against omicron subvariants

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Vaccine maker Moderna announced Monday that its new omicron-targeted booster shot reinforces a key line of immune defense by increasing levels of coronavirus-fighting antibodies that block BA.5. This omicron subvariant dominated in the United States until recently and still accounts for nearly a third of reported cases.

In blood drawn from people who received the bivalent booster, omicron-blocking antibody levels shot up 15 times higher than their pre-booster levels, Moderna said in a news release. The findings, which are not yet peer-reviewed, are similar to results Pfizer and its German partner, BioNTech, presented this month about their bivalent coronavirus vaccine booster.

The data is encouraging because it shows that the bivalent booster shots, which were updated to match the BA.4 and BA.5 versions of the omicron variant and began to roll out in September, are providing protection against newer coronavirus variants ahead of a possible winter surge of cases.

Moderna also said a preliminary analysis with a small number of subjects showed that the antibodies generated by the bivalent booster lost some potency against the challenging and rapidly growing BQ.1.1 subvariant — but could still block it. BQ.1.1 makes up about a quarter of the cases in the United States, according to the Centers for Disease Control and Prevention.

“Evolution is a dangerous thing to bet against. The virus keeps surprising us, and we need to be ready to update the vaccine,” said Stephen Hoge, Moderna’s president. But he added that he was encouraged by the high antibody levels induced by the booster shot as the country heads into winter.

“I think we’re optimistic this BA.4/BA.5-containing bivalent is going to be sufficient to get us through,” Hoge said.

Moderna’s announcement will intrigue scientists thinking about future booster strategies because the makers of both messenger RNA coronavirus vaccines have now presented convergent results showing their bivalent shots trigger a stronger response than their original formulations.

But the news is somewhat of an artificial comparison to the general public because those original boosters are no longer available. The decision to switch was made over the summer to ensure enough supply to vaccinate people with the updated shots ahead of a potential winter surge of cases.

It is also unclear whether the data will help ignite public interest in the boosters. Only about 10 percent of people 5 and older in the United States have gotten a bivalent booster, according to CDC data.

To measure the effect of the additional shot, scientists compared the virus-blocking antibodies in the blood of 511 people, before and after the bivalent booster or the original one. What these kinds of laboratory experiments cannot predict is how well or how long the higher antibody levels will protect people against infections or severe illness. Most scientists expect the boosters will help shore up protection against the worst outcomes but will not provide as robust protection against infections.

Moderna reported that its bivalent booster created five to six times the level of antibodies compared with the older booster. That is a stronger advantage than the effects of a previous bivalent booster tuned to fight the BA.1 variant. But some scientists have questioned whether differences between the two groups of people that received each type of shot could be partially responsible for some of the advantage.

By contrast, Novavax, a latecomer in the vaccine race, presented data last week suggesting that a bivalent booster of its shot that included the omicron BA.1 subvariant did not offer an advantage over its original booster.

The company did not present data on a BA.4/BA.5-containing bivalent vaccine, but argued that its original shot could continue to offer protection, instead of updating the formula. It is unclear why there are divergent results. Novavax’s chief medical officer, Filip Dubovsky, said last week that the company’s shot may induce a broader response to the variants, which is then strengthened by repeated boosts of the older formulation. Unlike the widely used messenger RNA vaccines from Pfizer-BioNTech and Moderna, the Novavax shot is a protein-based vaccine with an added substance called an adjuvant that’s designed to rev the immune system.

Novavax has said it could update its shot if required by regulatory agencies.

“We’re kind of ready to respond to whatever is required,” Dubovsky said. “But we actually think we have a case that sticking with what we have now, and appears to be working now, is the way to go into the future.”

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Moderna Shot May Cause Double To Triple As Many Heart Problems As Pfizer, New Study Finds

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Moderna Shot May Cause Double To Triple As Many Heart Problems As Pfizer, New Study Finds








© (Photo by RINGO CHIU/AFP via Getty Images)
This photo shows a vial of the Moderna Covid-19 vaccine, Bivalent, at AltaMed Medical clinic in Los Angeles, California, on October 6, 2022.(Photo by RINGO CHIU/AFP via Getty Images)

Moderna’s COVID-19 shot may cause two to three times as many heart-related side effects as Pfizer’s, according to a new Canadian study.

The rates of myocarditis and pericarditis in individuals within 21 days of getting their second shot were 35.6 and 22.9 per million doses, respectively, for Moderna compared to 12.6 and 9.4 per million for Pfizer, the research found. The connection between the mRNA vaccines and heart complications was most pronounced in men and younger vaccine recipients.

The study’s authors were quick to caution that incidences of heart inflammation were still fairly rare and that catching COVID-19 appears to carry a greater risk of myocarditis or pericarditis than receiving an mRNA vaccine.

Potential recipients should “consider the self-limiting and mild nature of most myocarditis events, benefits provided by vaccination, higher effectiveness of the Moderna vaccine against infection and hospitalization [found in prior studies], and the apparent higher risk of myocarditis following COVID-19 infection than with mRNA vaccination,” lead study author Dr. Naveed Janjua said in the American College of Cardiology news release accompanying the findings.

The authors also said the research should help inform policymakers and individuals choose between Pfizer and Moderna. Those with a propensity for heart conditions may be better off choosing the former, they said.

A number of medical bodies and health professionals have raised concerns about the association between mRNA vaccines and heart conditions. Some have pulled back on recommending the mRNA vaccines for young men in particular due to the less favorable risk-reward balance compared to other demographic groups.

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Epstein-Barr: Researchers speed efforts for vaccine against virus linked with mono, MS

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Maybe you’ve never heard of the Epstein-Barr virus. But it knows all about you.

Chances are, it’s living inside you right now. About 95% of American adults are infected sometime in their lives. And once infected, the virus stays with you.

Most viruses, such as influenza, just come and go. A healthy immune system attacks them, kills them, and prevents them from sickening you again. Epstein-Barr and its cousins, including the viruses that cause chickenpox and herpes, can hibernate inside your cells for decades.

This viral family has “evolved with us for millions of years,” said Blossom Damania, a virologist at the University of North Carolina-Chapel Hill. “They know all your body’s secrets.”

Although childhood Epstein-Barr infections are typically mild, exposure in teens and young adults can lead to infectious mononucleosis, a weeks-long illness that sickens 125,000 Americans a year, causing sore throats, swollen glands, and extreme fatigue. And while Epstein-Barr spends most of its time sleeping, it can reawaken during times of stress or when the immune system is off its game. Those reactivations are linked to a long list of serious health conditions, including several types of cancer and autoimmune diseases.

Scientists have spent years trying to develop vaccines against Epstein-Barr, or EBV. But recently several leaps in medical research have provided more urgency to the quest — and more hope for success. In just the past year, two experimental vaccine efforts have made it to human clinical trials.

What’s changed?

First, the Epstein-Barr virus has been shown to present an even greater threat. New research firmly links it to multiple sclerosis, or MS, a potentially disabling chronic disease that afflicts more than 900,000 Americans and 2.8 million people worldwide.

The journal Science in January published results from a landmark 20-year study of 10 million military personnel that offers the strongest evidence yet that Epstein-Barr can trigger MS. The new study found that people infected with Epstein-Barr are 32 times as likely as people not infected to develop MS.

And shedding new light on the mechanisms that could explain that correlation, a separate group of scientists published a study in Nature describing how the virus can cause an autoimmune reaction that leads to MS. The disease, which usually strikes between ages 20 and 40, disrupts communication between the brain and other parts of the body and is often marked by recurring episodes of extreme fatigue, blurred vision, muscle weakness, and difficulty with balance and coordination. At its worst, MS can lead to impaired speech and paralysis.

Amplifying that newfound urgency, several new studies suggest that reactivation of the Epstein-Barr virus also is involved with some cases of long covid, a little-understood condition in which patients experience lingering symptoms that often resemble mononucleosis.

And just as crucial to the momentum: Advances in vaccine science spurred by the pandemic, including the mRNA technology used in some covid vaccines, could accelerate development of other vaccines, including ones against Epstein-Barr, said Dr. Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine. Hotez co-created a low-cost, patent-free covid vaccine called Corbevax.

Some researchers question the need for a vaccine that targets a disease like MS that, while debilitating, remains relatively rare.

Eliminating Epstein-Barr would require vaccinating all healthy children even though their risk of developing cancer or multiple sclerosis is small, said Dr. Ralph Horwitz, a professor at the Lewis Katz School of Medicine at Temple University.

Before exposing children to the potential risks of a new vaccine, he said, scientists need to answer basic questions about MS. For example, why does a virus that affects nearly everyone cause disease in a small fraction? And what roles do stress and other environmental conditions play in that equation?

The answer appears to be that Epstein-Barr is “necessary but not sufficient” to cause disease, said immunologist Bruce Bebo, executive vice president for research at the National MS Society, adding that the virus “may be the first in a string of dominoes.”

Hotez said researchers could continue to probe the mysteries surrounding Epstein-Barr and MS even as the vaccine efforts proceed. Further study is required to understand which populations might benefit most from a vaccine, and once more is known, Hotez said, such a vaccine possibly could be used in patients found to be at highest risk, such as organ transplant recipients, rather than administered universally to all young people.

“Now that we know that Epstein-Barr is very tightly linked to MS, we could save a lot of lives if we develop the vaccine now,” Damania said, “rather than wait 10 years” until every question is answered.

Moderna and the National Institute of Allergy and Infectious Diseases launched separate clinical trials of Epstein-Barr vaccines over the past year. Epstein-Barr vaccines also are in early stages of testing at Opko Health, a Miami-based biotech company; Seattle’s Fred Hutchinson Cancer Center; and California’s City of Hope National Medical Center.

Scientists have sought to develop vaccines against Epstein-Barr for decades only to be thwarted by the complexities of the virus. Epstein-Barr “is a master of evading the immune system,” said Dr. Jessica Durkee-Shock, a clinical immunologist and principal investigator for NIAID’s trial.

Both MS and the cancers linked to Epstein-Barr develop many years after people are infected. So a trial designed to learn whether a vaccine can prevent these diseases would take decades and a lot of money.

Moderna researchers initially are focusing on a goal more easily measured: the prevention of mononucleosis, which doubles the risk of multiple sclerosis. Mono develops only a month or so after people are infected with Epstein-Barr, so scientists won’t have to wait as long for results.

Mono can be incredibly disruptive on its own, keeping students out of class and military recruits out of training for weeks. In about 10% of cases, the crippling fatigue lasts six months or more. In 1% of cases, patients develop complications, including hepatitis and neurological problems.

For now, the clinical trials for Epstein-Barr immunizations are enrolling only adults. “In the future, the perfect vaccine would be given to a small child,” Durkee-Shock said. “And it would protect them their whole life, and prevent them from getting mono or any other complication from the Epstein-Barr virus.”

The NIAID vaccine, being tested for safety in 40 volunteers, is built around ferritin, an iron-storage protein that can be manipulated to display a key viral protein to the immune system. Like a cartoon Transformer, the ferritin nanoparticle self-assembles into what looks like a “little iron soccer ball,” Durkee-Shock said. “This approach, in which many copies of the EBV protein are displayed on a single particle, has proved successful for other vaccines, including the HPV and hepatitis B vaccine.”

Moderna’s experimental vaccine, being tested in about 270 people, works more like the company’s covid shot. Both deliver snippets of a virus’s genetic information in molecules called mRNA inside a lipid nanoparticle, or tiny bubble of fat. Moderna, which has dozens of mRNA vaccines in development, hopes to learn from each and apply those lessons to Epstein-Barr, said Sumana Chandramouli, senior director and research program leader for infectious diseases at Moderna.

“What the covid vaccine has shown us is that the mRNA technology is well tolerated, very safe, and highly efficacious,” Chandramouli said.

But mRNA vaccines have limitations.

Although they have saved millions of lives during the covid pandemic, the antibody levels generated in response to the mRNA vaccines wane after a few months. It’s possible this rapid loss of antibodies is related specifically to the coronavirus and its rapidly evolving new strains, Hotez said. But if waning immunity is inherent in the mRNA technology, that could seriously limit future vaccines.

Designing vaccines against Epstein-Barr is also more complicated than for covid. The Epstein-Barr virus and other herpesviruses are comparatively huge, four to five times as large as SARS-CoV-2, the coronavirus that causes covid. And while the coronavirus uses just one protein to infect human cells, the Epstein-Barr virus uses many, four of which are included in the Moderna vaccine.

Earlier experimental Epstein-Barr vaccines targeting one viral protein lowered the rate of infectious mononucleosis but failed to prevent viral infection. Targeting multiple viral proteins may be more effective at preventing infection, said Damania, the UNC virologist.

“If you close one door, the other door is still open,” Damania said. “You have to block infection in all cell types to have a successful vaccine that prevents future infections.”

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Why it’s easier to find Pfizer’s updated COVID boosters than Moderna’s

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Vaccinators around the country are reporting weeks-long delays in shipments of Moderna’s updated COVID-19 vaccine boosters. The delays come after the Food and Drug Administration flagged concerns at a facility contracted to fill the Moderna’s new shots into vials. 

The wait stems from an Indiana plant operated by Catalent, which is one of two firms that has been bottling Moderna’s vaccine in the U.S. 

Following an inspection, the FDA this month faulted the Moderna contractor for falling short in its quality control procedures, and failing to “thoroughly investigate” batches discovered to be contaminated. Since September 2020, the company had received 179 complaints over impurities in its vials.

The FDA’s inspection had tied up emergency use authorization of all the updated doses filled and finished by Catalent for Moderna.

However, citing “potential supply limitations,” Moderna submitted additional data to the regulator asking to clear 10 batches of its vaccine from Catalent’s plant. 

The FDA granted that request on Tuesday. Moderna told the regulator it plans to “submit similar requests for additional batches on a rolling basis” to free up millions more doses.

“This authorization was based on FDA’s determination that the batches met all applicable specifications, following a careful review of information provided by Moderna about the manufacture of these batches. The agency has no concerns with the safety, effectiveness, or quality of these batches,” FDA spokesperson Michael Felberbaum said in a statement.

News of the FDA’s move was reported first by The Washington Post. 

“We anticipate that these availability constraints will be resolved in the coming days. We continue to be on track to meet our committed delivery of 70 million doses of our updated, bivalent vaccine by the end of this year,” Moderna spokesperson Christopher Ridley said in a statement.

Chris Halling, a spokesperson for Catalent, said the FDA had “found no issues related to the safety or efficacy of the Moderna product” during its routine inspection, adding that production of the vaccines “has continued without interruption.”

“Catalent takes all observations very seriously, and we have already begun employing all necessary steps to address each observation as quickly as possible,” Halling said.

The delays have resulted in a lopsided rollout of the updated boosters since they were formally cleared for use on September 1. 

Some states have moved to suspend ordering for the Moderna doses, citing the delays. Others have urged residents not to wait for the Moderna shots.

A spokesperson for the Department of Health and Human Services says 26 million doses of the updated shots have been distributed. Americans are eligible to receive either shot, “regardless of which primary vaccine they received.” 

“We anticipate that Moderna supply will continue to increase in the coming days and weeks. Pfizer’s updated COVID-19 vaccine is already widely available across the country,” said the HHS spokesperson.

A spokesperson for Pfizer said the company has supplied “more than 21 million doses,” which works out to some 80% of the U.S. supply so far. The company plans to ship “up to 100 million” doses by the end of November.

“Pfizer’s Kalamazoo, MI site alone is currently manufacturing 10-15 million doses per week with capacity to increase this considerably,” said Julia Michelle Cohen, the Pfizer spokesperson.

Nationwide data on how many the shipped doses of vaccine have gone into arms is expected to be released this Thursday, a Centers for Disease Control and Prevention official said at a recent webinar hosted by the COVID-19 Vaccine and Equity Project.

Early figures from the agency posted last week suggested vaccinations climbed to the highest levels since early May, as the updated boosters began to roll out.

The FDA’s move also comes as the regulator has said it is working to vet data submitted by Moderna as well as Pfizer and its partner BioNTech on updating booster shots for younger children. 

In planning documents shared with health departments this week, the CDC said it expects the bivalent shots could soon be cleared for use “in early to mid-October” for younger age groups.

Moderna’s shots could be a simpler option for family doctors and pharmacies, given the company plans to use the same vaccine vials as adults for children down to six years old.

“One question that I’ll answer right now, that may come up is, when are we going to have these vaccines for younger children? And I think we can say that, for the age range of five and up, that’s a couple of weeks away,” the FDA’s Dr. Peter Marks told a virtual event with the National Foundation for Infectious Diseases on Monday.

“And for the youngest children, it’s probably later this fall to early winter as the data come in and we can review it,” said Marks.

Alexander Tin

CBS News reporter covering public health and the pandemic.



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