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BioNTech says it will start cancer vaccine trials in the UK from September

A NHS vaccinator administers the Pfizer-BioNTech Covid-19 booster jab to a woman, at a vaccination centre in London. BioNTech is launching a large-scale trial of mRNA therapies to treat cancer and other diseases in the U.K.

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LONDON — The U.K. government on Friday announced a partnership with German firm BioNTech to test potential vaccines for cancer and other diseases, as campaigners warned any breakthrough must remain affordable and accessible.

Cancer patients in England will get early access to trials involving personalized mRNA therapies, including cancer vaccines, which aim to spur the immune system to attack harmful cells.

They will be administered to early and late-stage patients and target both active cancer cells and preventing their return.

BioNTech will set up new research and development centers in the U.K., with a lab in Cambridge and headquarters in London, and aim to deliver 10,000 therapies to patients from September 2023 until the end of the decade.

The company developed one of the most widely-distributed Covid-19 vaccines alongside U.S. pharma firm Pfizer. Its CEO, Ugur Sahin, said it had learned lessons from the coronavirus pandemic about collaboration between the British National Health Service, academics, regulators and the private sector in the development of drugs that it was applying now.

“Our goal is to accelerate the development of immunotherapies and vaccines using technologies we have been researching for over 20 years,” he said in a statement. “The collaboration will cover various cancer types and infectious diseases affecting collectively hundreds of millions of people worldwide.”

Peter Johnson, Britain’s National Clinical Director for Cancer, said mRNA technology had the potential to transform approaches to a number of illnesses.

The government confirmed to CNBC the announcement represented a private investment into the U.K., but would be supported by a new Cancer Vaccine Launch Pad funded by the NHS.

Other mRNA cancer vaccines, including a collaboration between U.S. firms Moderna and Merck, are also being trialed.

Tim Bierley, a campaigner at U.K.-based group Global Justice Now, said big pharmaceutical companies had “terrible record of price gouging on new medicines, even where public money has played a key role in bringing them to the market.”

“The government has a moral duty to push BioNtech to set the price of this potentially life-saving vaccine so it is accessible to all,” he said.

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Mohga Kamal-Yanni, policy co-lead for the People’s Vaccine Alliance — a global group of health organizations, economists and activists — said news of the trial was good, but that any outcome “belongs to the people” due to the amount of public funding involved.

“The U.K. government must say how it will ensure any new medicine, vaccine or technology will be made available and affordable to developing countries,” Kamal-Yanni said.

A government spokesperson told CNBC the research was at too early a stage to discuss pricing and distribution, but pointed to its record in distributing free Covid-19 vaccines.

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BioNTech says it will start cancer vaccine trials in the UK from September

A NHS vaccinator administers the Pfizer-BioNTech Covid-19 booster jab to a woman, at a vaccination centre in London. BioNTech is launching a large-scale trial of mRNA therapies to treat cancer and other diseases in the U.K.

Sopa Images | Lightrocket | Getty Images

LONDON — The U.K. government on Friday announced a partnership with German firm BioNTech to test potential vaccines for cancer and other diseases, as campaigners warned any breakthrough must remain affordable and accessible.

Cancer patients in England will get early access to trials involving personalized mRNA therapies, including cancer vaccines, which aim to spur the immune system to attack harmful cells.

They will be administered to early and late-stage patients and target both active cancer cells and preventing their return.

BioNTech will set up new research and development centers in the U.K., with a lab in Cambridge and headquarters in London, and aim to deliver 10,000 therapies to patients from September 2023 until the end of the decade.

The company developed one of the most widely-distributed Covid-19 vaccines alongside U.S. pharma firm Pfizer. Its CEO, Ugur Sahin, said it had learned lessons from the coronavirus pandemic about collaboration between the British National Health Service, academics, regulators and the private sector in the development of drugs that it was applying now.

“Our goal is to accelerate the development of immunotherapies and vaccines using technologies we have been researching for over 20 years,” he said in a statement. “The collaboration will cover various cancer types and infectious diseases affecting collectively hundreds of millions of people worldwide.”

Peter Johnson, Britain’s National Clinical Director for Cancer, said mRNA technology had the potential to transform approaches to a number of illnesses.

The government confirmed to CNBC the announcement represented a private investment into the U.K., but would be supported by a new Cancer Vaccine Launch Pad funded by the NHS.

Other mRNA cancer vaccines, including a collaboration between U.S. firms Moderna and Merck, are also being trialed.

Tim Bierley, a campaigner at U.K.-based group Global Justice Now, said big pharmaceutical companies had “terrible record of price gouging on new medicines, even where public money has played a key role in bringing them to the market.”

“The government has a moral duty to push BioNtech to set the price of this potentially life-saving vaccine so it is accessible to all,” he said.

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Mohga Kamal-Yanni, policy co-lead for the People’s Vaccine Alliance — a global group of health organizations, economists and activists — said news of the trial was good, but that any outcome “belongs to the people” due to the amount of public funding involved.

“The U.K. government must say how it will ensure any new medicine, vaccine or technology will be made available and affordable to developing countries,” Kamal-Yanni said.

A government spokesperson told CNBC the research was at too early a stage to discuss pricing and distribution, but pointed to its record in distributing free Covid-19 vaccines.

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Omicron Covid boosters appear to work, regardless of side effects

If you already got your omicron-specific Covid booster, you might have experienced some side effects. Maybe even ones that were more intense than your previous shot.

But there’s no need to worry: Experts and new data say the new shots appear to work — regardless of whether you experience moderate, mild or no side effects at all.

“Don’t focus too much on side effects, because I really think that the main objective here is to get people to be protected. So focus on that benefit of the new vaccines,” Dr. Yvonne Maldonado, a professor of pediatric infectious diseases at Stanford University’s School of Medicine, tells CNBC Make It.

The new boosters gained approval from the U.S. Food and Drug Administration and the CDC before they finished clinical trials. But newly released data from Pfizer and BioNTech’s ongoing clinical trial gives a first glimpse of how well its new shots work on humans, showing that the new boosters generated a strong immune response against omicron’s BA.4 and BA.5 subvariants.

About 11.5 million Americans have rolled up their sleeves to get the booster since they were first sent out at the beginning of September, according to the latest data from the Centers for Disease Control and Prevention. More Americans could follow: Roughly a third of U.S. adults say they’ve already gotten one or intend to “as soon as possible,” according to a Kaiser Family Foundation poll released Sept. 30. 

Here’s what you need to know about the protection the new boosters provide, and where side effects fit into the equation:

The new booster appears to give you protection

Pfizer and Moderna’s redesigned shots are bivalent, meaning they’re tailored to the original Covid strain and omicron BA.4 and BA.5. All Americans ages 5 and older are eligible for one if they’ve completed their primary vaccination series.

Like previous Covid vaccines, the new boosters are designed to help you fight the virus by triggering an immune response in your body. When you get a vaccine, your immune system recognizes it as something foreign because it mimics a Covid infection without causing the “full-blown sickness,” Maldonado says.

Your immune system responds by producing an arsenal of weapons — including antibodies, memory B cells and T cells — that work together to hunt down the “foreign object” and remember how to fend it off in the future, she adds. 

Pfizer says its clinical trials were successful in inducing that immune response: A week after injection, participants had higher levels of antibodies against BA.4 and BA.5 in their blood than they did pre-injection. The drugmaker didn’t specify how much higher those antibody counts were, but said it expects to release data measuring antibody levels one-month post-booster “in the coming weeks.”

Such data might better measure the full protection Pfizer’s new booster can provide against omicron’s subvariants. Covid vaccines typically take two to three weeks to fully ramp up your immunity, which can help your body stop an infection from happening or keep it from progressing to severe disease.

“We know the data isn’t complete, but it’s also reassuring that after seven days you’re already seeing an increase in antibodies,” Maldanado says. “The response is very consistent with what we’ve seen in the past with other vaccines.”

What does it mean if your side effects are more intense than others?

Side effects — in this case, the now-familiar set of muscle aches, fatigue, headaches and more — are a natural part of our immune response to a vaccine, Maldonado says. Clinical trials on earlier versions of bivalent boosters targeting omicron’s BA.1 subvariant found that most participants experienced “mild” side effects, with much smaller percentages reporting “moderate” or “severe” ones.

Out in the real world, the severity seems to be “kind of a mixed bag,” Maldonado says: Some people may have a worse, similar or more mild experience compared to their prior vaccine doses. “There’s going to be some risk of side effects. For most people, you’re going to feel something, but that doesn’t mean vaccines aren’t safe or won’t protect you,” she adds.

Dr. Peter Chin-Hong, an infectious disease professor from UC San Francisco, says he certainly felt some “adverse side effects” after he received his updated booster. He notes that he got a flu shot at the same time, and while the side effects from both shots are nothing new, he suggests they may have “conflated” to cause a more an intense experience for him.

Some studies show that the chances of experiencing side effects after receiving both shots at the same time are similar or only slightly higher than when receiving a Covid vaccine alone. So, there’s really no concrete explanation for cases where your side effects from the new booster are more or less severe than others.

But you shouldn’t worry, emphasizes Dr. Helen Chu, an assistant professor of infectious diseases at the University of Washington: Your side effects don’t correlate with how much protection a Covid shot gives you. Having mild or moderate side effects doesn’t mean you’re mounting a stronger immune response than people with no side effects, she says.

“You’re still going to have a nice rise to your antibody levels, you’re still very much protected either way,” Chu says.

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Stocks rise as investors look ahead to key consumer inflation data

Stocks rose Wednesday as investors shook off inflation data that came in higher than expected and looked ahead to a key consumer report that will inform the pace of the Federal Reserve’s rate hikes going forward.

The Dow Jones Industrial Average gained 169 points, or 0.58%. The S&P 500 rose 0.28%, bolstered by a 10% jump in shares of Moderna, the top gaining stock in the index. The Nasdaq Composite ticked up 0.12%.

Stocks whiplashed between gains and losses earlier in the morning when the September producer price index, a gauge of final-demand wholesale prices, came in higher than expected. The print was up 0.4% in September, more than the consensus estimate of a 0.2% increase, according to Dow Jones.

The PPI number is one of the inflation gauges investors are watching alongside the Federal Reserve. If inflation stays high, the central bank is more likely to continue its aggressive path of interest rate hikes to bring it back into check. That means rates will continue to rise and may stay high for longer than markets expect, weighing on stocks.

Investors will get more inflation data on Thursday, when the September consumer price index report is released. The CPI number is a measure of price changes in a basket of common consumer goods and services.

“Prices remain elevated so it shouldn’t be a surprise to see producer goods and services rise. Keep in mind the increase is still below what we were seeing consistently month after month earlier this year,” said Mike Loewengart, head of model portfolio construction at Morgan Stanley Global Investment Office. “No doubt the Fed still has its work cut out for them, and if tomorrow’s CPI read is hot, don’t be surprised to see some investors come to grips with how long the road to tamer inflation may be.”

The minutes from the Federal Reserve’s September meeting will also be released Wednesday. While Fed Chairman Jerome Powell has acknowledged that aggressive interest rate increases could be painful, the central bank will continue to charge forward in its fight to lower inflation.

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New minimum tax could hit Berkshire Hathaway and Amazon hardest, study shows

Berkshire Hathaway Chairman Warren Buffett seen at the annual Berkshire shareholder shopping day in Omaha, Nebraska, U.S., May 3, 2019.

Scott Morgan | Reuters

Researchers applied the Inflation Reduction Act’s new 15% corporate minimum tax onto 2021 company earnings and found that the burden would only be felt by about 78 companies, with Berkshire Hathaway and Amazon paying up the most.

The study from the University of North Carolina Tax Center used past securities filings to map the tax, which goes into effect in January, onto companies’ 2021 earnings.

The researchers found that the 15% minimum would have taken a total of $31.8 billion from 78 firms in 2021. Berkshire led the estimated payout with $8.33 billion, and Amazon follows behind with $2.77 billion owed based on its 2021 earnings.

The study notes the limitations of looking solely at public company data within a single year. The researchers recognized that these estimates may be subject to change, especially as company operations change under the tax in 2023.

President Joe Biden signed the minimum book tax into law, along with the rest of the Inflation Reduction Act, in August. The tax is specifically meant to target companies earning more than $1 billion per year.

The Joint Committee on Taxation had previously estimated that it would affect around 150 firms, with the costs falling specifically on the manufacturing industry. The bipartisan JCT also predicted $34 billion in revenue in the first year of the tax, slightly more than the theoretical 2021 revenue estimated at UNC.

According to the study, the next-highest taxes would be paid by Ford, AT&T, eBay and Moderna, all of which would owe more than $1.2 billion in payments based on their 2021 financials.

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FDA authorizes emergency use for Novavax Covid-19 vaccine for ages 12 to 17

A box of the Novavax Covid-19 vaccine arranged at a pharmacy in Schwenksville, Pennsylvania, US, on Monday, Aug. 1, 2022.

Bloomberg | Bloomberg | Getty Images

Biotechnology company Novavax announced on Friday that its Covid-19 vaccine has been authorized for emergency use by the U.S Food and Drug Administration for adolescents between the ages of 12 and 17.

In July, Novavax’s two-dose Covid-19 vaccine for adults ages 18 and over got its emergency approval from the FDA.

Having more vaccine options for adults and children will “hopefully help increase vaccination rates, particularly as we prepare for ongoing surges of Covid-19 with the start of fall and the back-to-school season,” Stanley C. Erck, president and CEO of Novavax, said in a statement.

Novavax was one of the original 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 small Maryland biotech company struggled to quickly get manufacturing in place and its clinical trial data read out much later than rivals Pfizer or Moderna.

Dr. Peter Marks, a senior FDA official, has said that Novavax’s vaccine would potentially appeal to unvaccinated people who would prefer a shot that is not based on the messenger RNA technology used by Pfizer and Moderna.

How Novavax is different

The Novavax shot is based on more conventional protein technology used for decades in hepatitis B and HPV vaccines, while Pfizer and Moderna are the first FDA-approved vaccines to use mRNA.

Pfizer and Moderna’s vaccines use mRNA, a molecule encoded with genetic instructions, to tell human cells to produce copies of a virus particle called the spike protein. The immune system responds to these copies of the spike, which prepares the human body to attack the actual virus.

Novavax makes copies of the virus spike outside human cells. The genetic code for the spike is put into an insect virus that infects moth cells, which produce copies that are then purified and extracted during the manufacturing process. The finished spike copies are injected into the human body, inducing an immune response against Covid.

The Novavax vaccine also uses an additional ingredient called an adjuvant, which is extracted and purified from the bark of a tree in South America, to induce a broader immune response. The shots consist of 5 micrograms of the spike copy and 50 micrograms of the adjuvant.

Effectiveness and safety

Two doses of the Novavax vaccine were 90% effective at preventing illness from Covid across the board and 100% effective at preventing severe illness, according to clinical trial data from the U.S. and Mexico. However, the trial was conducted from December 2020 through September 2021, months before the omicron variant became dominant.

Novavax did not present any data on the shot’s effectiveness against the variant at the FDA committee meeting in June. However, the vaccine will likely have lower effectiveness against omicron as is the case with Pfizer and Moderna’s shots. Omicron is so distinct from the original strain of Covid that the antibodies produced by the vaccines have trouble recognizing and attacking the variant.

Novavax published data in December showing that a third shot boosted the immune response to levels comparable to the first two doses which had 90% effectiveness against illness. The company plans to ask the FDA to authorize a third dose of its vaccine.

FDA authorization of Novavax’s vaccines comes as the U.S. is preparing to update Covid shots to target the omicron BA.4 and BA.5 variants to increase protection against the virus. Novavax’s vaccine, like all the other shots, is based on the original version of the virus that first emerged in Wuhan, China. The effectiveness of Covid vaccines against mild illness has slipped substantially as the virus has evolved, though they still generally protect against severe disease.

Novavax presented data at an FDA committee meeting in late June demonstrating that a third dose of its vaccine produced a strong immune response against omicron and its subvariants. Committee members were impressed by the company’s data on omicron.

The Novavax vaccine also appears to carry a risk of heart inflammation for younger men, known as myocarditis and pericarditis, similar to Pfizer and Moderna’s shots. Myocarditis is an inflammation of the heart muscle and pericarditis is inflammation of the outer lining of the heart.

FDA officials flagged four cases of myocarditis and pericarditis from Novavax’s clinical trial in young men ages 16 to 28. People who develop heart inflammation as a side effect of Covid vaccines are usually hospitalized for several days as a precaution but then recover.

The FDA has issued a fact sheet for health-care providers warning that clinical trial data indicates there is an increased risk of myocarditis with the Novavax vaccine. People who experience chest pain, shortness of breath and feelings of a fluttering or pounding heart should immediately seek medical attention, according to the FDA.

In the case of the mRNA shots, the CDC has found that the risk of myocarditis is higher from Covid infection than vaccination. Myocarditis is usually caused by viral infections.

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Why new Novavax Covid vaccine won’t win over unvaccinated Americans

Unvaccinated Americans will soon be able to opt for a new kind of shot to protect themselves from the ever-evolving Covid-19 virus: the Novavax vaccine.

The latecomer Covid shot has raised hopes of wider acceptance among vaccine skeptics. It uses traditional protein-based technology, unlike its mRNA counterparts. But experts say it still may not convince a large number of unwilling holdouts to roll up their sleeves and get vaccinated.

“I don’t think a shot like Novavax with well-worn technology is suddenly going to convince unvaccinated people to say, ‘Now, I want to get a vaccine, now I believe a vaccine will keep me out of the hospital and ICU,'” Dr. Paul Offit, the director of the Vaccine Education Center at Children’s Hospital of Philadelphia and member of an independent advisory group to the U.S. Food and Drug Administration, tells CNBC Make It. 

On Wednesday, the FDA authorized the Novavax shot for adults ages 18 and up. Once approved by the Centers for Disease Control and Prevention, it’ll only be available as a two-dose primary series, rather than a booster — which means only unvaccinated Americans will be able to receive it.

According to CDC data from early June, roughly 27 million U.S. adults still haven’t received a single Covid shot, posing a significant obstacle for American efforts to finally force Covid into a manageable, endemic phase. The U.S. is already grappling with yet another surge in Covid cases — this time, driven by highly transmissible omicron subvariants like BA.5 — and unless the country’s vaccination rate improves, a more severe variant of concern may soon emerge.

Here’s how Novavax’s Covid vaccine could help, and why many unvaccinated people might still pass on it.

The new vaccine’s appeal to people afraid of mRNA tech

The Novavax shot is the fourth Covid shot to earn FDA clearance in the U.S. and the first to use protein technology — a decades-old method of virus-fighting used in multiple routine vaccinations, like those against hepatitis B and shingles.

It’s highly effective, according to clinical data: Two doses were 90% effective at preventing illness from Covid when tested in a study involving about 30,000 adults ages 18 and older, according to the FDA. Notably, the research was conducted from December 2020 through September 2021, a few months before the emergence of Covid’s omicron variant.

Novavax’s shot works differently than its mRNA counterparts, but achieves the same outcome: teaching your body how to fight Covid. It injects copies of the spike protein — a molecule found on the coronavirus — and an ingredient called adjuvant into your body’s cells, which induces an immune response to the virus.

“Novavax essentially uses the same approach as mRNA vaccines, but they make the protein in a factory. So they’re giving you the protein itself, rather than instructions for your cells to make a protein,” says Dr. Robert Schooley, an infectious disease specialist at UC San Diego Health.

Guy Palmer, a professor of pathology and infectious diseases at Washington State University, says the Novavax vaccine could potentially appeal to Americans who falsely believe that mRNA vaccines are unsafe, due to the technology’s perceived newness and a misconception that they could alter human DNA.

“There’s a slight open door there for a non-mRNA vaccine like Novavax,” Palmer says.

Vaccine denialism is a cultural issue 

Unvaccinated Americans may perceive protein-based shots as safer than mRNA ones: In a Morning Consult poll last week, about 28% of unvaccinated people surveyed said they viewed protein-based shots as safe, while only 17% said the same about mRNA vaccines.

But 77% still said they wouldn’t get a protein-based Covid shot if it were authorized in the U.S.

Offit points to a larger problem at hand: Vaccine denialism has become a cultural issue, no matter the technology behind the shots. He says many unvaccinated Americans, especially those who are politically right-leaning, are now fueled by hardwired ideas like government distrust.

In a Kaiser Family Foundation poll released in May, only 14% of Republicans surveyed said they had a “great deal or fair amount of trust” in President Joe Biden to provide reliable information about Covid vaccines. The poll also notes that Republicans are among those with the lowest vaccination rates, at just 55%.

Even today’s most common anti-vaccination argument — that the vaccines are pointless, because they can’t always prevent breakthrough infections — may be a cover for those types of hardwired ideas. (No vaccine is ever 100% effective, and staying up-to-date on your Covid vaccines can significantly lower your chances of severe illness, hospitalization or death.)

“Some say they don’t want an mRNA vaccine, so this protein vaccine can be an alternative. But other people might say I just don’t like vaccines, period. Or I don’t trust the FDA or the government,” Schooley says. “Providing rational explanations and alternatives like Novavax that address some concerns doesn’t necessarily get you past the fact that there’s just an aversion to being vaccinated.”

The Novavax vaccine is still good news

The shot’s entrance into the U.S. market could still be good news, says Dr. Dean Blumberg, chief of the division of pediatric infectious diseases at UC Davis Health.

Another source of vaccine supply is “always good to have” in case other companies have manufacturing difficulties, Blumberg says. It can ensure that an event similar to the recent baby formula shortage won’t happen with Covid vaccines, he adds. 

Blumberg also emphasizes that any progress in getting holdouts vaccinated should be celebrated. 

“I’m not sure how many of the remaining unvaccinated people in the U.S. are going to be interested in getting this Novavax vaccine — but it’s one more tool in the toolbox,” he says. “Even if just a few people take advantage of getting vaccinated with it, that’s great.”

Offit says Novavax may have a larger impact down the road: Its omicron-specific booster shots may be ready for federal approval this fall or winter, and pre-clinical data shows they could potentially provide enhanced immunity against omicron and its subvariants.

“You have a certain part of the population that is clearly interested in getting as many doses as possible,” Offit says, adding that people could view a Novavax booster as “an advantage” over a shot that’s the same as their previous doses.

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Omicron-specific Covid vaccines could finally be here this fall—here’s what you need to know

Timing, side effects, vaccine selection: Everything you need to know about Covid vaccinations for kids under 5

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Treasury yields fall as traders track economic data, Fed remarks

U.S. Treasury yields slipped Wednesday as investors continue to assess the economic outlook amid rising recession fears.

At around 5:48 a.m. ET, the yield on the benchmark 10-year Treasury note was down at 3.173%, while the yield on the 30-year Treasury bond dropped to 3.285%. Yields move inversely to prices.

As the second quarter draws to a close on Thursday, concern over a slowing economy and aggressive interest rate hikes from the Federal Reserve continue to dominate market sentiment.

An attempted rally for risk assets fizzled out on Tuesday after a disappointing consumer confidence reading, which came in at 98.7, below Dow Jones’ consensus estimates of 100.

The Conference Board’s one-year ahead inflation expectations hit a record high of 8.0%, exceeding the 7.7% seen in June 2008, while the Richmond Fed’s manufacturing index came in at -19, its lowest since May 2020 and well below consensus expectations of -7.

Fed Chairman Jerome Powell is due to give a speech at the European Central Bank forum at 9 a.m. ET. Powell acknowledged in a testimony to the Senate banking committee last week that steep rate hikes may tip the U.S. economy into recession, but reiterated the central bank’s commitment to reining in inflation.

On the economic data front, final first-quarter GDP figures are due at 8:30 a.m., along with PCE prices, corporate profits and consumer spending data.

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FDA authorizes Pfizer, Moderna vaccines for children as young as 6 months

The Food and Drug Administration on Friday authorized Moderna’s and Pfizer’s Covid-19 shots for children as young as 6 months old, which makes nearly every person in the U.S. now eligible for vaccination.

The FDA decision comes after its committee of independent vaccine experts voted unanimously to recommend the shots after weighing their safety and effectiveness during an all-day meeting Wednesday that was open to the public.

The FDA authorized Pfizer’s three-dose vaccine for children 6 months to 4 years old, and Moderna’s two-dose vaccine for children 6 months to 5 years old. Children under age 5 were the only people left in the U.S. not eligible for vaccination. Many parents have been waiting months for the FDA to authorize the vaccines for their kids.

The FDA on Friday also authorized Moderna’s vaccines for kindergarteners through high schoolers. Previously, Pfizer’s vaccine was the only Covid shot available for this age group.

However, there is still one more step left before vaccinations of children under age 5 can begin. The Centers for Disease Control and Prevention’s committee will meet on Saturday to vote on guidelines for pharmacies and doctor’s offices. CDC Director Dr. Rochelle Walensky then has to sign off on those guidelines before kids can start receiving the shots.

The White House expects vaccinations to begin as soon as Tuesday. Appointments might be limited initially but every parent who wants to get their child vaccinated should be able to do so within weeks, according to Dr. Ashish Jha, who oversees the Biden administration’s Covid response.

The federal government has made 10 million Pfizer and Moderna doses available to state and local authorities.

Dr. Arnold Monto, acting chair of the FDA committee, said it took longer for the agency to authorize the shots for infants through preschoolers than for other ages because they are a vulnerable group that requires special care to make sure the shots were safe and effective.

Although Covid is generally less severe in children than adults, hospitalizations of kids under age 5 spiked during the winter omicron wave, hitting the highest level of the pandemic. Covid has killed more than 200 six-month- to 5-year-olds since January 2020, according to the CDC.

Pfizer vs. Moderna shots

Pfizer’s and Moderna’s vaccines for infants through preschoolers differ in the number of shots they use, the dosage level and the eligibility age to receive them. Pfizer’s vaccine also appeared more effective than Moderna’s shots with children under 5, though the data is preliminary.

Pfizer’s vaccine is administered in three doses for children 6 months to 4 years old. The shots are dosed at 3 micrograms, one-tenth the level of what adults receive. Three shots were about 75% effective at preventing infection from omicron in 6-month- to 2-year-olds and 82% effective in 2- to 4-year-olds.

However, it is crucial that parents who opt for Pfizer make sure their kids get the third shot to have protection against the virus. Two doses were only about 14% effective at preventing infection for kids under age 2, and 33% effective for those ages 2 to 4.

Moderna’s vaccine is administered in two doses for children 6 months to 5 years old. The shots are dosed at 25 micrograms, one-fourth the level that adults receive.

Moderna’s vaccine was about 51% effective at preventing infection from omicron for kids 6 months to 2 years old, and about 37% effective for kids ages 2 to 5 years old. However, the company expects the vaccine to provide strong protection against severe illness because the kids had higher antibody levels than adults who received two doses.

The most common side effects from the vaccines were pain at the injection site, irritability and crying, loss of appetite and sleepiness, according to the FDA. Very few children who received either shot developed a fever higher than 102 degrees Fahrenheit, and there were no cases of myocarditis, a type of heart inflammation, in Pfizer’s or Moderna’s trials.

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Baidu, MicroStrategy, Moderna and more

Check out the companies making headlines before the bell:

Baidu (BIDU) – Baidu shares jumped 4.1% in premarket trading after Reuters reported the China-based internet search giant is in talks to sell its controlling stake in the video streaming company iQIYI (IQ). iQIYI fell 3.4%.

MicroStrategy (MSTR) – MicroStrategy lost 2.2% in the premarket as the price of bitcoin touched an 18-month low. The business analytics company has extensive bitcoin holdings.

Moderna (MRNA) – Moderna won the recommendation of an FDA panel for use of its Covid-19 vaccine in children aged 6 to 17 years. A vote by the full FDA could come within a few days. Moderna rose 1% in premarket action.

Stellantis (STLA) – Stellantis will begin indefinite layoffs next week at its Sterling Heights, Michigan stamping plant. The world’s fourth-largest automaker did not specify how many workers would be impacted. Stellantis rallied 3.4% in the premarket.

Zendesk (ZEN) – Zendesk is in settlement talks with activist investor Jana Partners after ending an unsuccessful effort to sell the software company, according to people familiar with the matter who spoke to the Wall Street Journal. The paper said proposed changes could involve CEO Mikkel Svane stepping down as well as changes to the board of directors. Zendesk added 1% in premarket trading.

Robinhood Markets (HOOD) – The trading platform operator was downgraded to “underweight” from “neutral” at Atlantic Equities, which cited Robinhood’s revenue trends. Robinhood slid 4.2% in premarket action.

Snowflake (SNOW) – The cloud computing company was upgraded to “buy” from “hold” at Canaccord Genuity. Shares have fallen more than 65% in 2022, but Canaccord said the stock is now at an attractive entry point, given growing demand and promising new products. Snowflake gained 3.6% in the premarket.

Wheels Up (UP) – The private jet company’s stock rose 2.1% in premarket trading after Goldman began coverage with a “buy” rating, saying Wheels Up is a leading company in an established and growing end market.

Sonos (SONO) – The high-end speaker maker was downgraded to “equal-weight” from “overweight” at Morgan Stanley, which is concerned about the impact of more cautious consumer spending. Sonos fell 3.1% in the premarket.

— CNBC’s Peter Schacknow contributed reporting.

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