The Food and Drug Administration on Monday approved Merck‘s new vaccine designed to protect adults from a bacteria known as pneumococcus that can cause serious illnesses and a lung infection called pneumonia, the drugmaker said.

Merck’s shot, called Capvaxive, specifically protects against 21 strains of that bacteria to prevent a severe form of pneumococcal disease that can spread to other parts of the body and lead to pneumonia. It’s the first pneumococcal conjugate vaccine designed specifically for adults and aims to provide broader protection than the available shots on the market, according to the drugmaker.

Healthy adults can suffer from pneumococcal disease. But older patients and those with chronic or immunocompromising health conditions are at increased risk for the illness, especially the more serious or so-called “invasive” form. 

Invasive pneumococcal disease can lead to meningitis, an infection that causes inflammation in the area surrounding the brain and spinal cord, and an infection in the bloodstream called bacteremia. 

“If you have chronic lung disease, even asthma, you have a higher risk of getting sick with pneumococcal disease, and then being in the hospital, losing out on work,” Heather Platt, Merck’s product development team lead for the newly cleared vaccine, told CNBC in an interview. “Those are things that have a real impact on adults and children, their quality of life.”

Around 150,000 U.S. adults are hospitalized with pneumococcal pneumonia each year, Platt said. Death from the more serious form of the disease is highest among adults 50 and above, Merck said in a release in December.

Even after the FDA approval, the company’s single-dose vaccine won’t reach patients just yet. An advisory panel to the Centers for Disease Control and Prevention will meet on June 27 to discuss who should be eligible for the shot.

Platt said Merck will support the committee’s decision and is ready to supply the vaccine by late summer. 

Some analysts view Capvaxive as a key growth driver for Merck as it prepares to offset losses from its blockbuster cancer drug Keytruda, which will lose exclusivity in the U.S. in 2028. 

The market for pneumococcal conjugate vaccines is currently around $7 billion and could grow to be worth more than $10 billion over the next several years, according to a November note from Cantor Fitzgerald analysts. 

Merck’s newly approved shot could boost its competitive edge in that space, which includes drugmaker Pfizer. Merck currently markets two pneumococcal shots, but neither is specifically designed for adults. For example, the company’s existing shot Vaxneuvance is approved in the U.S. for patients 6 weeks of age and older.

Pfizer’s single-dose pneumococcal vaccine, Prevnar 20, is the current leader in the market for adults. But Merck expects its new shot to capture the majority of market share among adults, Platt said. 

“We do expect there to be rapid uptake of” Capvaxive, she said, adding that the company is confident that data on the shot will “really resonate” with clinicians and policymakers. 

Merck’s pneumococcal vaccine protects against eight strains of the bacteria that are not included in any other approved shot for the disease. Those eight strains account for roughly 30% of invasive pneumococcal disease cases in patients 65 and above, according to a release from Merck, citing CDC data from 2018 to 2021. 

The 21 strains included in Merck’s shot account for roughly 85% of invasive pneumococcal disease cases in adults 65 and above, Merck, citing the CDC data. Meanwhile, Pfizer’s Prevnar targets strains that only account for roughly 51% of cases in that age group, based on the same CDC data. 

The FDA’s approval is partly based on Merck’s late-stage trial called STRIDE-3 that pitted the vaccine against Pfizer’s Prevnar 20 in adults 18 and up who had not previously received a pneumococcal vaccine.

Correction: This story has been updated to reflect 150,000 U.S. adults are hospitalized with pneumococcal pneumonia each year.

In-space manufacturing may sound like science fiction but it’s happening already, albeit on a very small scale. It’s a fledgling market that analysts and several startups are projecting will take off. 

“If you look at pharma, semiconductors, beauty and health products and potentially food in the sense of like new crops, we estimated the market to be above $10 billion at some point in 2030, depending on the speed of maturation,” said Ilan Rozenkopf, a partner at McKinsey.

Space offers a unique environment for research and development because its higher levels of radiation, microgravity and near vacuumless state allows companies to come up with new manufacturing methods or materials that are not possible on Earth.

The practice is not entirely new. The International Space Station has hosted several experiments from academics, government agencies and commercial customers for things such as growing human tissue, making purer semiconductors and developing new or better drugs. In the 2024 fiscal-year budget, President Joe Biden even set aside $5 million for NASA to pursue cancer-related research on the ISS.

But access to the ISS has always been competitive and interest continues to grow. Now, several space startups see an opportunity to satisfy in-space manufacturing demand using compact space factories. One company is Varda Space Industries in Southern California. Varda’s mission is to help pharmaceutical companies improve their drugs or come up with new drug therapies by taking advantage of the unique properties of space, and then return those materials back to Earth.

Key to Varda’s business proposition is a phenomenon known as protein crystallization. 

This occurs when super-saturated protein solutions are essentially evaporated to form a solid so scientists can study a protein’s structure. Understanding the crystal structure of a protein can help scientists get a better idea of disease mechanisms, identify drug targets and optimize drug design. Think drugs that have less side effects, are more effective or can withstand a greater array of conditions such as not needing to be refrigerated.

Years of research have shown that protein crystals grown in space are much higher quality than those grown on Earth. The plan is not to make the entire drug in outer space, just what is known as the primary active pharmaceutical ingredient, or the portion responsible for the therapeutic effects of a drug.

“You’re not going to see us making penicillin or ibuprofen or these types of very generic mass consumption targets, given the amount of crystalline you need to create is far beyond our current capabilities,” said Delian Asparouhov, co-founder and president of Varda Space Industries. “But there is a wide set of drugs that do billions and billions of dollars a year of revenue that actively fit within the manufacturing size that we can do even on our current manufacturing facility.”

Asparouhov said that in the U.S. in 2021 and 2022, of the hundreds and millions of doses of the Pfizer Covid vaccine administered, “the actual total amount of consumable primary pharmaceutical ingredient of the actual crystalline mRNA, it effectively was less than two milk gallon jugs.”

Across the Atlantic in Cardiff, Wales, Space Forge is working on designing its own in-space factory to manufacture next-generation semiconductors. Space Forge’s goal is to make semiconductor substrates using materials other than silicon to manufacture more efficient, higher performing chips. 

“This next generation of materials is going to allow us to create an efficiency that we’ve never seen before,” said Andrew Parlock, managing director of Space Forge’s U.S. operations. “We’re talking about 10 to 100 X improvement in semiconductor performance.”

Just like with pharmaceuticals, the secret sauce to achieving this type of performance improvement in semiconductors lies in creating the perfect crystals in space. These types of advanced chips are important for industries such as 5G and electric vehicles. Similar to Varda, Space Forge plans to manufacture only part of the chips in space.

“Once we’ve created these crystals in space, we can bring them back down to the ground and we can effectively replicate that growth on Earth,” said Josh Western, CEO and co-founder of Space Forge. “So we don’t need to go to space countless times to build up pretty good scale operating with our FAB partners and customers on the ground.”

To learn more about in-space manufacturing as well as Varda and Space Forge’s plans to make the practice a viable business, watch the video.

The Food and Drug Administration’s independent panel of advisers recommended full approval of Pfizer’s Covid-19 antiviral pill Paxlovid for high-risk adults on Thursday, but noted potentially harmful drug interactions.

The treatment is recommended for people over 50 or those who suffer from medical conditions such as high blood pressure or diabetes that put them at higher risk of being hospitalized or dying from Covid.

The FDA first made Paxlovid available in December 2021 for emergency use in high-risk individuals age 12 and older. Pfizer filed for full approval of the drug in June 2022, but the FDA extended the review period for the application in December.

The Agency will normally follow the advice of its advisory committees, but is not required to do so. A final decision is expected to be made in May.

“I would say, other than oxygen, Paxlovid has probably been the most important treatment tool during this outbreak and continues to be,” said Richard Murphy, chief of infectious diseases at White River Junction Veterans Affairs Medical Center.

The panel, which voted 16-1 to recommend full approval, was based on three of Pfizer’s mid-to-late-stage clinical trials of Paxlovid, which enrolled more than 6,000 patients in 21 countries.

One study, called EPIC-HR, looked at high-risk adults who had not been vaccinated and had no previous Covid infection. The study found that Paxlovid reduced the risk of hospitalization or death by 86% in adults treated within five days of symptom onset and 89% in those treated within three days of symptom onset, according to an FDA review of company data.

“I thought the efficacy data were clear and convincing,” said Dr. Sankar Swaminathan, chief of the Division of Infectious Diseases at the University of Utah School of Medicine.

Dr. Adaora Adimora, a professor in the department of infectious diseases at the University of North Carolina School of Medicine, called the reduction in risk in the Pfizer trials “clinically meaningful” for most people and the broader population at a time when the U.S. still has thousands of Covid cases every week. About 200,000 cases of Covid are reported each week nationwide, according to the Centers for Disease Control and Prevention.

But advisers agreed that serious side effects due to interactions between Paxlovid and other drugs were a key safety concern.

“I would just like to emphasize that we emphasize the importance of risk reduction for the prescriber, the primary care physician, the physician and other prescribers regarding drug interactions,” said Dr. David Hardy, assistant clinical professor of medicine at the University of Southern California.

“That’s where I think we can get into trouble, I have to say, they’re going to get into trouble prescribing this drug without really knowing what ritonavir is [one of the medications in Paxlovid] does with other drugs,” he said.

More than half of Paxlovid-eligible Medicare and Veterans Affairs patients are on drugs that have drug interactions with Paxlovid, according to an FDA review of safety monitoring data. Approximately 74 percent of Paxlovid prescriptions were from senior primary care physicians who may not have experience managing potential adverse drug interactions, the FDA review added.

The FDA said its Office of Surveillance and Epidemiology had recorded 271 reports of serious adverse events potentially related to drug interactions with Paxlovid, including 147 hospitalizations and six deaths as of late January. The most common drugs causing problems are immunosuppressants, which are often used to treat HIV and organ transplant patients, the FDA said.

But Swaminathan noted that drug interactions should be “addressable and minimized.” FDA staff said earlier in the meeting that interactions could potentially be managed by adjusting the dosage of certain drugs, increasing patient monitoring and ensuring that product labeling informs prescribers and patients of potential drug interactions.

Paxlovid consists of two drugs: nirmatrelvir, which blocks a key enzyme that the Covid virus needs to replicate, and ritonavir, which increases the first drug’s ability to fight infection.

Patients take Paxlovid within five days of the onset of Covid symptoms to reduce the risk of hospitalization or death. To complete a full course of the drug, patients must take three Paxlovid pills twice daily for five days.

More than 12 million courses of Paxlovid have been delivered to U.S. pharmacies, and 1.3 million doses are available nationwide, according to federal data. About 10 million patients in the U.S. and 14 million worldwide have been treated with the drug, according to Jim Rusnak, Pfizer’s chief internal medicine officer.

Sales of Paxlovid jumped to $18.9 billion in 2022, the first year it was available, but Pfizer expects that revenue to fall 58% to $8 billion in 2023.

The only vote against Paxlovid was from Terry Gillespie, a patient advocate from Plainfield, Illinois. Gillespie raised concerns about doctors not knowing when to prescribe the drug, noting that they had a Covid infection four to five times “but not once” were they offered Paxlovid.

“I don’t think doctors really know how to use it,” Gillespie said.

After the vote, Swaminathan said there was an “alarmingly large number of patients” whose doctors had dissuaded them from taking Paxlovid because of fears of reoccurrence of Covid. Patients then see their Covid symptoms return or test positive after initially recovering.

“I am concerned that there is not a good understanding in the medical community and a real disincentive for patients to take an effective drug that could save their lives,” he said.

Reports of these cases emerged shortly after Paxlovid hit the market in 2021, with President Joe Biden and his former chief medical adviser, Dr Anthony Fauci, appearing to have recovered from Covid after taking the antiviral cocktail before testing positive again result.

Swaminathan said there was a “dramatic acceptance” among the media that Paxlovid caused rebound cases and that they were “potentially worse” than patients had before taking the drug, despite a lack of data to support that belief.

Dr. Lindsey Baden, chair of the group and director of Brigham and Women’s Hospital, added that emerging data show that Paxlovid-induced rebound cases “are not the biology of what’s going on.”

“Until very recently, and even some of the data shared today helped me understand what that means.” So we see real-time data that is systematic and informative,” Baden said.

An FDA review of Pfizer’s clinical trials found that overall recovery rates ranged from 10% to 16%, “with no evidence of a higher rate of symptom recovery or moderate symptom recovery” in patients who received Paxlovid, in compared to patients who received a placebo. It is also independent of patients’ risk of severe disease or whether the omicron variant or an earlier strain is dominant, according to agency staff.

Before the panel’s vote, FDA officials said more data are needed to determine whether immunocompromised people need a longer course of Paxlovid that goes beyond the traditional five days. They cited a complete lack of clinical trial data on the use of Paxlovid in these people, noting that only 13 of more than 2,000 patients in the EPIC-HR study had weakened immune systems.

FDA staff said immunocompromised people may benefit more from longer courses of Paxlovid because they are more likely to have prolonged Covid infections. The Centers for Disease Control and Prevention says that immunocompromised patients can remain infectious after 20 days from the onset of symptoms and recommends that these patients isolate themselves for at least 20 days. Approximately 7 million U.S. adults are immunocompromised, the CDC estimates.

Pfizer officials emphasized the company’s ongoing efforts to study the use of Paxlovid in immunocompromised patients. In September, the company began enrolling these patients in a clinical trial examining different course lengths of Paxlovid, including 10- and 15-day courses.

Dr. Paula Carvalho, a professor at the University of Washington, said she was “quite happy” with the company’s plan, but noted that she hoped the HIV population would be included in the clinical trials.

“I hope the studies can be done in a timely manner because we need this information pretty badly,” Carvalho said.

Semaphore, a new digital media company focused on global news for college-educated readers, debuted Tuesday with the intention of bringing transparency and clarity to a news business that its founders believe has become highly polarized.

Semaphore has been preparing to launch since January, when it was previously The New York Times Media columnist Ben Smith and former Bloomberg Media CEO Justin Smith quit their jobs to start the project. Semafor.com and its mobile site will have a distinct yellow background to match coverage in the US and Sub-Saharan Africa. The news company will provide regional and national coverage in the Middle East, Asia, Europe and other countries.

The Smiths will take lessons learned from more than 20 years in digital media to guide Semafor into what they hope will be a profitable global business.

Recent sales to Axios (to Cox Enterprises), The Athletic (to The New York Times) and Politico (to Axel Springer) have given way to building and selling a company for hundreds of millions of dollars, although Justin Smith said he hasn’t had any conversations about Selling at a specific valuation with Semaphore investors. These include Sam Bankman-Fried, founder of cryptocurrency exchange FTX, and Jessica Lisin, founder of tech news site The Information.

However, ad-supported digital media is still a sector known for stagnation, drought, and low growth – with plenty of cautionary tales. BuzzFeed Its value has seen a sharp drop of 80% since it went public. Vice’s bid to go public failed as investors fretted about its future prospects. He has been trying to find a buyer for several years.

Semaphore will immediately stand out from older news publications such as The New York Times, Wall Steet Journal or CNN.com through its unique article structure. All stories, except for potential breaking news, will adhere to the Semaform, which has five sections: “News,” “Reporter’s Perspective,” “Area of ​​Difference,” “View From” and “Notable.”

Each story will give reporters a chance to influence the news themselves, in a specific section, including paragraphs about why what they’re doing is wrong. The stories will also include a section that gives a holistic/global perspective to reduce local bias.

To solve the information overload problem, there is a major flaw in the current media ecosystem, according to Justin Smith, the analysis of external media will be truncated and found in the notable section. “Semaform” stems from Justin Smith’s experience managing newsrooms at Bloomberg, The Atlantic, Quartz, and The Week, along with Ben Smith’s time as editor-in-chief at BuzzFeed News and his time at The New York Times.

It’s an evolution of Axios’s news distillation into bullet points, the “Bloomberg Way” (a style guide focused on clarity) and the week’s focus on a wide range of viewpoints.

“We started trying to isolate and deconstruct individual issues, like polarization and information overload,” Smith said. “We went to different segments of users with meaningful conversations, and asked them about some of the ideas we had developed. There was a real sense of frustration but also amazed that the basic unit of journalism – the article – hadn’t really developed in hundreds and hundreds of years.”

Justin Smith said Semafor will start out as a free ad-supported media site, but will evolve into a paywalled subscription site in about 12 to 18 months, as it gains brand recognition. Despite being launched at a time of economic uncertainty when brands are cautious about how they spend on digital media advertising, Semaphore will launch with partnerships with companies including Verizon And the Pfizer.

“We are definitely ahead of what we expected in terms of revenue and monetization,” said Rachel Oppenheim, chief revenue officer at Semaphore. “We operate in a specific segment of the advertising market, which is corporate reputation and brand advertising. And while brands are under pressure from a financial perspective, they are also under huge pressure to enhance their reputation and reach key stakeholders. One of the hallmarks of many of the conversations we’ve had is, ” I’ve never seen anything like this before.’ It was so fun and encouraging.”

Justin Smith said Semaphore raised $25 million and had not had any discussions with its investors about evaluating a potential exit, despite sharing a five-year business plan with investors. He added that it will spend its initial investment and gauge how the business is going before setting firm profitability goals or raising more money.

Ben and Justin Smith named the company semaphore after the word “simaphore,” a visual signaling device, which sounds the same in about 35 different languages. The media company will have about 60 employees, more than half of whom will be reporters.

WATCH: Ben Smith at Facebook’s censorship panel

The Centers for Disease Control and Prevention has authorized reformulated Covid vaccines that target the latest omicron subvariants for the fall, making it possible for many people to get an extra booster within days.

The agency’s independent vaccine committee voted 13 to 1 earlier Thursday in favor of the vaccines after reviewing available safety and effectiveness data during a nearly seven-hour meeting. CDC Director Dr. Rochelle Walensky signed off on the shots a few hours later, clearing the way for pharmacies to begin implementing the shots soon.

Pfizer’s omicron boosters were approved for people 12 years of age and older, while Moderna’s updated shots were approved for people 18 years of age and older. Eligible age groups can receive boosters at least two months after completing their main series or their most recent booster with the old vaccines.

Walensky said her decision followed a “comprehensive scientific assessment and robust scientific discussion.”

“If you’re eligible, there’s no bad time to get your Covid-19 booster, and I strongly encourage you to get it,” she said in a statement.

Pfizer plans to ask the Food and Drug Administration to also approve the new boosters for children ages 5 to 11 in early October, company executives told the committee Thursday.

The original vaccines will no longer be used as a booster in people aged 12 and over after the reformulated vaccines come online.

Public health officials are expecting a new wave of Covd infection this fall as immunity from old vaccines wanes, more contagious sub-variants of omicron spread and people spend more time indoors as the weather turns colder and families gather for the holidays.

The CDC and FDA hope the new boosters will provide more durable protection against infections, mild and severe illnesses. The reformulated injections target omicron BA.5, the dominant variant of Covid, as well as the strain that emerged in China more than two years ago.

So far, the US has provided 171 million doses of Pfizer and Moderna’s new boosters. More than 200 million people are eligible for the shots, according to the CDC. Dr. Sarah Oliver, a CDC official, told the committee Thursday that there should be enough vaccine to meet demand this fall.

There’s no human trial data on the new BA.5 boosters, so it’s unclear how they’ll perform in the real world. The CDC and FDA used human data from clinical trials of injections targeting the original version of omicron, BA.1, which elicited a stronger immune response than the old vaccines.

Pfizer and Moderna were initially developing omicron boosters to target BA.1, but the FDA asked the companies to switch gears in June and instead develop BA.5 injections after the subvariant became dominant. The decision to focus on BA.5 did not leave enough time to wait for data from human trials before the fall vaccine launch.

The lack of human data on the BA.5 vaccines has caused some controversy, but Dr. Peter Marks, a senior FDA official, said the agency followed the same process used for years with strain changes for flu vaccines. Marks said Wednesday that flu vaccine strains are also changing without clinical data in humans.

Dr. Pablo Sanchez, the only panel member to vote against vaccines, called the recommendation premature and said the U.S. should have waited for human data before proceeding with boosters.

“There’s already a lot of hesitation about vaccines — we need the human data,” said Sanchez, professor of pediatrics at Ohio State University. But Sanchez said he believes the new boosters are safe and will likely get one himself.

Panel member Dr. Oliver Brooks, chief medical officer at Watts HealthCare Corporation in Los Angeles, asked why the FDA decided to use the BA.5 vaccine when there was clinical data on the BA.1 vaccines that the vaccine manufacturers were originally developing. In the end, Brooks voted in favor of the photos.

But Dr Sarah Long, also a member of the panel, said there was no reason to expect BA.5 boosters to be worse than the old vaccines as they also included the original strain of Covid and had the potential to reduce hospitalisations. and deaths heading into fall and winter. Long also voted yes.

FDA and CDC officials said the omicron BA.1 and omicron BA.5 boosters are similar enough that the immune response data from the BA.1 vaccine should give a good indication of how the BA.5 injections will perform. Omicron BA.1 and BA.5 are closely related with a difference of four mutations, according to Dr. Jacqueline Miller, who works on vaccine development at Moderna.

Moderna completed enrollment in clinical trials of the BA.5 injections last week and should have results by the end of the year, Miller told the CDC committee Thursday. Pfizer’s clinical trial is also ongoing, although the company has not said when it expects results.

The health agencies also reviewed data on BA.5 shots from mouse studies. Moderna presented data showing that BA.5 injections boosted antibodies in mice more than four times compared to the old injections. Mice express the same cellular protein as humans that the virus latches onto. Pfizer’s BA.5 booster boosted antibodies 2.6-fold in mice compared to the original vaccine.

The most common side effects from human trials of BA.1 injections are pain, redness, swelling at the injection site, fatigue, headache, muscle pain, joint pain, chills, nausea, vomiting and fever, according to the FDA.

Oliver, the CDC official, told the committee that health officials do not expect any difference in the safety profile of the BA.1 and BA.5 vaccines, given that the subvariants differ by only a few mutations.

But Oliver noted that the risk of myocarditis after a BA.5 booster is unknown. There is an increased risk of myocarditis among young men and adolescents after the second dose of the Pfizer and Moderna vaccines, but the risk of myocarditis from a Covid infection is higher, according to the CDC.

“We know the risk of myocarditis is unknown, but we expect a risk similar to that seen after monovalent vaccines,” Oliver said. Monovalent vaccines are the old vaccines that have been given to millions of people in the US for the past two years.

The original vaccines, which were first authorized in December 2020, no longer provide meaningful protection against infection because the virus has mutated so much over the past two years. The injections were developed against the first strain that appeared in China, so they are no longer suitable for targeting the omicron sub-variants that are spreading.

Infections, hospitalizations and deaths fell dramatically after last winter’s massive wave of omicron infection, but have remained stubbornly high this summer. Omicron BA.5 is the most infectious and immune-resistant variant to date, and breakthrough infections are becoming more common as a result.

The effectiveness of old vaccines against hospitalization also decreased after omicron BA.5 became dominant. A third dose was 77 percent effective in preventing hospitalization four months after receiving the shot, but protection declined after 120 days to 34 percent, according to CDC data. The fourth dose in people aged 50 and over was 56% effective in preventing hospitalization after four months.

Covid deaths and hospitalizations among people age 65 and older have increased since April, according to Heather Scobie, a CDC epidemiologist who presented data at Thursday’s meeting. Deaths have increased especially among people age 75 and older, Scobie said.

CDC has shifted to a more targeted public health response with an emphasis on protecting the most vulnerable — the elderly, people with serious medical conditions and those with weakened immune systems. Although there is no data on the actual effectiveness of the new boosters, the US is moving quickly to roll them out in hopes that they will protect people this fall.

Here are the most important news that investors need to start their trading day:

So much for a fresh start in September. US stock markets braced for another sell-off Thursday morning after the August close in a losing streak. Things looked promising for stocks this summer after a terrible first half of the year. Inflation eased, but only slightly – and that made the Fed ready to raise interest rates even more. Currently, the Fed’s benchmark interest rate is in the 2.25% to 2.5% range, but Cleveland Fed President Loretta Meester said Wednesday she sees rates rising significantly to more than 4%. Nor does it expect the central bank to cut interest rates next year. The Fed is expected to raise interest rates by another three-quarters of a point later this month.

Nvidia shares fell in off-hours trading after the chip maker said the US government is restricting sales to China over concerns about the company’s products being used by the Chinese military. Nvidia said it expects to lose about $400 million in revenue from China during the current quarter. In recent years, the United States has sought to crack down on China from exploiting American-made technology. Last month, President Joe Biden signed a bipartisan bill aimed at boosting America’s chip-making sector in an effort to bolster the country’s competitive strength in its economic struggle with China.

Even Sam’s Club, a Walmart warehouse chain, isn’t immune to inflation. The company said Wednesday that it has raised entry-level membership fees for Sam’s Club for the first time in nine years. Starting October 17, members will pay $50 annually, up from $45. Warehouse stores have been doing well lately, with inflation-weary shoppers buying in bulk to save on essentials. Walmart’s decision could put pressure on Costco, Sam’s Club competitor, which charges $60 a year for its basic membership. In July, Costco CEO Craig Jelinek told CNBC he didn’t think it was a “right time” to raise the club’s fee — or the price it charges for the popular and inexpensive sausage.

The US Food and Drug Administration (FDA) has approved a new round of Covid-boosted shots targeting the highly pathogenic omicron BA.5 variant. The decision came as children returned to school and many companies pushed their employees back to the office in earnest. Experts expect COVID-19 cases to rise this fall and winter, despite lower death rates. Officials also said that the new boosters – Pfizer are licensed to people 12 and older; Moderna for 18 years and over – must provide lasting protection while keeping hospitalization rates low.

United Nations inspectors have postponed their inspection of Ukraine’s Zaporizhzhya nuclear power plant amid close fighting between Russian and Ukrainian forces. Ukraine’s state nuclear power company said the plant’s fifth reactor was also shut down due to the nearby bombing. The Russians are occupying the facility, and Ukrainian officials have accused them of trying to spoil the inspectors’ visit. Ukrainian President Volodymyr Zelensky, who welcomed the UN team Wednesday, warned that the plant was vulnerable to nuclear disaster as his forces seek to fend off the invading forces of Russian President Vladimir Putin.

Sarah Maine, Kev Lesswing, Melissa Rybko, Spencer Kimball, and CNBC’s Holly Eliat contributed to this report.

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Biotech company Novavax announced Friday that its Covid-19 vaccine has been approved for emergency use by the US Food and Drug Administration for adolescents between the ages of 12 and 17.

In July, Novavax’s two-dose Covid-19 vaccine for adults 18 and older received emergency approval from the FDA.

Having more vaccine options for adults and children “will hopefully help increase vaccination rates, especially as we prepare for continued spikes in Covid-19 as fall and the back-to-school season begin,” Stanley S. Erk , president and CEO of Novavax, said in a statement.

Novavax was one of the early entrants in the US government’s 2020 race to develop a Covid vaccine, receiving $1.8 billion in taxpayer funding from Operation Warp Speed. However, the small Maryland biotech company struggled to get into production quickly, and data from its clinical trials was read much later than rivals Pfizer or Moderna.

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

The Novavax injection is based on a 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.

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

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

The Novavax vaccine also uses an additional ingredient called an adjuvant that is extracted and purified from the bark of a tree in South America to induce a broader immune response. The injections consisted of 5 micrograms of spiked lance and 50 micrograms of adjuvant.

Two doses of the Novavax vaccine were 90% effective in preventing Covid disease everywhere and 100% effective in preventing severe disease, according to data from clinical trials in the US and Mexico. However, the trial was conducted from December 2020 to September 2021, months before the omicron variant became dominant.

Novavax did not present any data on the injection’s effectiveness against the variant at an FDA committee meeting in June. However, the vaccine is likely to be less effective against omicron, as is the case with the Pfizer and Moderna vaccines. Omicron is so different 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 injection boosted the immune response to levels comparable to the first two doses, which were 90 percent effective against disease. The company plans to ask the FDA to authorize a third dose of its vaccine.

The FDA approval of Novavax’s vaccines comes as the US prepares to update its Covid vaccines to target the omicron BA.4 and BA.5 variants to increase protection against the virus. The Novavax vaccine, like all other vaccines, is based on the original version of the virus that first appeared in Wuhan, China. The effectiveness of Covid vaccines against mild disease has declined significantly as the virus has evolved, although they still generally protect against severe disease.

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

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

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

The FDA has issued an information sheet for healthcare providers warning that clinical trial data show an increased risk of myocarditis with the Novavax vaccine. People who experience chest pain, shortness of breath, and a fluttering or pounding heart should seek immediate medical attention, according to the FDA.

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

Shares of GlaxoSmithKline, Sanofi and Haleon sold sharply this week, shedding tens of billions of market value, as investors feared potential US litigation fees focused on the popular heartburn drug Zantac.

This has been a known issue in the background for years, but investor anxiety exploded this week in the run-up to the first scheduled legal action on August 22.

Zantac is the brand name for a drug called ranitidine, which is a drug used to relieve heartburn. It was originally invented and sold by Glaxo as a prescription drug in the 1980s before moving on to over-the-counter medications.

In 2019, regulators launched a safety review amid concerns that the drug contained a possible carcinogen called NDMA, prompting manufacturers to pull it off shelves. By 2020, the US Food and Drug Administration and the European Medicines Agency have requested that all versions of the treatment be withdrawn from the market.

Since then, more than 2,000 cases have been filed in the United States with plaintiffs alleging that Zantac consumption can generate NDMA.

The first trial begins in August. 22 with major cases starting in early 2023.

Litigation is particularly complex because many pharmaceutical companies are involved in drugs.

The drug’s patent expired in 1997, so there are many manufacturers, retailers and distributors of the drug being defendants in the lawsuits.

There have been several OTC rights holders in the United States since 1998, including GSK, Sanofi, Pfizer and Boehringer Ingelheim.

Haleon, the consumer health company that spun off from GlaxoSmithKline last month, is not primarily responsible for the claims, according to the company, but they may be tangentially related.

In response to violent moves in stock prices this week, GlaxoSmithKline, Sanofi and Haleon have all issued statements in their own defense.

Pharmaceutical company shares stabilized on Friday morning.

A GlaxoSmithKline spokesperson said: “The enormous weight of scientific evidence supports the conclusion that there is no increased cancer risk associated with the use of [of] Ranitidine… Suggestions to the contrary are inconsistent with the science and GSK will vigorously defend itself against all baseless allegations.”

A Sanofi spokesperson said: “There is no credible evidence that Zantac caused any of the alleged injuries under real-world conditions, and Sanofi remains fully confident in its defences. Given the strength of our case and the uncertainty about future actions, no emergencies have been established.” “

Haleon’s involvement and possible responsibility are less clear.

Haleon stresses that it is not a party to any of Zantac’s claims, saying that it “never marketed Zantac in any way in the United States” and “is not primarily responsible for any OTC or prescription claims.”

However, according to GSK Mark in its June 1 prospectus, “To the extent that GSK and/or Pfizer assume liability with respect to OTC Zantac, Haleon may be required to indemnify GSK and/or Pfizer” under certain circumstances.

Pfizer was not immediately available for comment when contacted by CNBC on Friday.

“As with all legal outcomes, there is a significant amount of uncertainty,” Credit Suisse’s European pharmaceutical team said in a note. “This is particularly true in this case where four companies have shared ownership of the Zantac rights over time.”

As the brand’s builder, GSK could be on the hook for the bulk of the commitments, rather than OTC manufacturers, according to the team.

Redburn said in a research note that because there are several drug manufacturers in addition to the defendant’s retailers and distributors, this would likely reduce the absolute impact at the company level.

Deutsche Bank’s pharmaceutical research team on Thursday raised its recommendation for Sanofi from “Hold” to “Buy” on the grounds that “Zantac knee-jerk is starting to look somewhat exaggerated.”

The German bank doesn’t think it’s a clear buying opportunity but argues that “to maintain selling at these levels is terrible”.

The team adds, “Both GSK/SAN now appears to present a classic puzzle: they are trapped in worrying about an impending burden of responsibility that they cannot fully assess yet.”

Credit Suisse says this depends on the strength the court sees of any link between NDMA and cancer and any evidence of wrongdoing.

Previous drug settlements ranged from $30,000 to $270,000 per claimant based on evidence of wrongdoing.

There are currently over 2,000 known claimants, but this is expected to increase as trials progress.

For many investors and analysts, this ordeal brings back memories of the saga of the Bayer Roundup.

Soon after Bayer took charge of Monsanto in 2018, lawsuits related to the press report swelled rapidly, ultimately costing Bayer billions of dollars and years of legal and financial uncertainty.

As in the case of Bayer’s acquisition of Monsanto where the risk of litigation was reported to investors prior to the completion of the transaction, GSK indicated that Zantac’s lawsuit represented a major risk to Haleon in its prospectus issued to investors in June.

In the nearly 500-page document, GSK warned, “The group has indemnity obligations in favor of the GSK Group and the Pfizer Group, which may be significant and have a material adverse impact” on the group’s finances.

Contrary to the Bayer report, Zantac has been pulled by regulators around the world. Furthermore, there are currently more than 2,000 claims related to Zantac and other ranitidine products compared to Bayer, which has faced 130,000 cases related to glyphosate.

Deutsche Bank wrote: “We don’t believe the evidence points to this as another glyphosate, but it is very possible that we could see a billion-dollar liability.”

Check out some of the biggest movers in the premarket:

Palantir ( PLTR ) — Shares of the data analytics company tumbled 15.6% in premarket trading after it reported an unexpected quarterly loss and lowered its full-year forecast due to the uncertain timing of some government contracts.

Signify Health ( SGFY ) — CVS Health ( CVS ) is planning a bid for Signify in an effort to expand home health services, according to people familiar with the matter who spoke to The Wall Street Journal. The newspaper reported last week that Signify was exploring strategic alternatives, including a sale. Its shares jumped 16.7% in premarket trading.

Global Blood Therapeutics ( GBT ) — The maker of drugs for blood disorders will be bought by Pfizer ( PFE ) for $5.4 billion, or $68.50 per share in cash. Shares of Global Blood jumped 88% in the past two sessions on reports that a deal was close, and gained another 4.2% in premarket trading.

Tyson Foods (TSN) — The beef and poultry producer reported quarterly earnings of $1.94 per share, 4 cents per share short of estimates. However, revenue beat forecasts as demand for beef remained strong. Chicken volume fell 2.1 percent, but Tyson said business continued to improve. Tyson shares fell 2.5% in premarket trading.

Barrick Gold (GOLD) – The miner’s shares added 3.2% in premarket trade after better-than-expected quarterly results, helped by higher copper production.

Baidu ( BIDU ) – The China-based search engine company has won approval to operate driverless taxi services in two Chinese cities, the first such approvals in the country. Baidu added 1.2% in premarket action.

First Solar (FSLR) — The solar company was upgraded to “buy” at Guggenheim and “overweight” at JP Morgan Securities, both of which said First Solar is among those poised to benefit the most many of the Senate-passed Inflation Reduction Act. First Solar gained 4.2% in premarket action, with other solar stocks also rising.

Emerson Electric ( EMR ) – The manufacturing company is selling its InSinkErator garbage disposal business to appliance maker Whirlpool ( WHR ) for $3 billion.

Avalara ( AVLR ) – The tax software provider has agreed to be acquired by private equity firm Vista Partners for $8.4 billion, including debt, or $93.50 per share. Avalara fell 4% in premarket trading but has risen 30% since reports of a potential deal surfaced in early July.

President Joe Biden may have BA.5 Covid-19 but his symptoms “continue to improve,” according to the White House.

“His initial symptoms, albeit less bothersome, now include sore throat, runny nose, loose cough and body aches,” White House physician Kevin O’Connor said in a note on Saturday.

On Friday, O’Connor said the president completed his second full day of Pfizer’s Paxlovid pills, an antiviral pill that could reduce the risk of Covid-19 patients being hospitalized.

While the president is responding to treatment “as expected,” he likely contracted Covid-19 type BA.5, which is currently responsible for 70% to 85% of infections in the United States.

Biden, who is fully vaccinated and has received two doses of the vaccines, tested positive for Covid-19 on Thursday and reported “very mild symptoms.”