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FDA says two studies showing omicron boosters weren’t much better than old Covid shots were too small to come to any conclusions
Published
5 months agoon
By
ironity
Scientists at Columbia and Harvard, in two independent studies, found that the new boosters and the old shots basically performed the same against omicron BA.5, raising doubts about whether the vaccines will live up to high expectations set by the Biden administration. The antibody responses were slightly higher with the omicron boosters, though the studies concluded the difference wasn’t significant.
Dr. Peter Marks, head of the FDA’s vaccine division, said the studies are small and subject to limitations. Data from larger well-controlled studies are expected in the near future, he said. Pfizer and Moderna are conducting clinical trials on the new boosters and are expected to provide data later this year.
“It is important to note that even the data from these initial small studies indicate that the bivalent vaccines are generally at least as good or better as the original vaccines in generating an immune response, particularly to BA.4/BA.5 and other newer variants,” Marks said in a statement.
Even modest increases in immune response could have positive consequences for public health, he added.
“FDA continues to encourage eligible individuals to consider receiving an updated vaccine to help protect against the currently circulating COVID-19 variants and the wave of COVID-19 that appears to be coming,” Marks said.
Top U.S. health officials have said the new boosters should perform better because they are now matched to the dominant circulating strain, omicron BA.5, for the first time since the pandemic began as well as the original strain of Covid that emerged in China. These are called bivalent shots.
The old shots, called monovalent, were designed against the first strain of Covid. Their effectiveness has declined over time as the virus has mutated away from the original strain.
“It is reasonable to expect based on what we know about immunology and the science of this virus that these new vaccines will provide better protection against infection, better protection against transmission and ongoing and better protection against serious illness,” Dr. Ashish Jha, head of the White House Covid taskforce, told reporters in September.
The Columbia and Harvard studies clearly demonstrate that the boosters work, it’s just a question of whether they’re going to do a much better job preventing disease, particularly infection and mild illness, than the old shots.
“The take home lesson is the people who were in high risk groups and benefit from booster doses as we enter this late fall and early winter – those who are immunocompromised, who have high risk medical conditions, who are elderly — they should get thisbooster dose,” said Dr. Paul Offit, a member of the FDA’s independent vaccine advisory committee.
But Offit said public health officials should be cautious about overselling the shots as a major upgrade.
“We have to be careful when we get in front of the American public and try and sell this vaccine as something that’s significantly better when all the evidence we have so far doesn’t support that,” said Offit.
The Columbia study looked at 21 people who received the new booster while the Harvard study looked at 18 who got the new shot. Both studies are preprints, which means they haven’t undergone peer review by others in the field.
The Columbia study found that antibody levels were about 1.2 times higher with a bivalent booster compared with a fourth dose of the old shots, while the Harvard study found they were 1.3 times higher. Though the antibody levels were slightly higher with the bivalent booster, the studies both concluded the difference was not significant.
Dr. Dan Barouch, the lead author of the Harvard study, said the preprints are small but emphasized that they were conducted independently and basically came to the same conclusion, which is noteworthy.
“It’s important to note that the two studies were done independently. They’re small studies but there are two of them — it’s not just a fluke,” said Barouch, whose lab played a pivotal role in the development of the Johnson & Johnson Covid vaccine.
Dr. Peter Hotez, co-director of vaccine development at Texas Children’s Hospital, said the studies were conducted by two of the best virology labs in the country and the methodology was sound. But the findings should be viewed as preliminary until more data comes in, Hotez said.
“We have to be careful not to draw too many conclusions from it,” said Hotez, who also co-led a team that developed a patent-free vaccine called Corbevax that India authorized for use last December.
The studies are of public interest because there’s very limited human data on how the omicron BA.5 boosters perform right now. The FDA authorized the shots in September based on clinical trial from a similar shot developed against the first version of omicron, BA.1.
Pfizer and Moderna were originally developing their new boosters against BA.1, but the FDA asked the companies to switch gears over the summer and target BA.5 instead because that subvariant had become dominant. As a consequence, there wasn’t enough time for Pfizer and Moderna to run clinical trials and present direct human data on the shots before authorization.
The FDA also looked at data directly on the BA.5 shots that came from animal studies. The agency was acting urgently to get the shots out by the fall in the hope they’d do a better job heading off a Covid wave.
But new subvariants are also now gaining ground in the U.S., particularly BQ.1 and BQ.1.1 which now represent about 27% of new infections in the U.S. It’s unclear how the boosters will perform against these subvariants. Health officials expect the shots to continue to provide protection because the subvariants are descended from BA.5.
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Business
Secondhand resale is getting cutthroat as platforms such as Depop and Poshmark boom
Published
21 mins agoon
March 25, 2023By
ironity
Gabby Jones | Bloomberg | Getty Images
It came via Instagram, from someone who had not received her purchase in time for Christmas. Â
“Nothing happened, but I don’t know, it just opened my eyes to the fact that some people, they just really want their items,” said Robertson.
Demand for secondhand resale online has been booming since the early days of the pandemic, generating a culture shift within the indie marketplaces where it began. Customers, many of whom have been feeling the squeeze of inflation, are fiending for lower prices, leading to more heated negotiations and occasionally ruthless bidding wars.
Meanwhile, independent resellers are turning their onetime hobby into a job, sometimes even upselling items to take advantage of demand spikes. Users on platforms such as Depop and Poshmark set up online shops to list vintage, secondhand or unique items for sale and generate notable followings of loyal shoppers.
Robertson is now 17 and says the growth of resale has allowed him to turn his Depop shop, which now has more than 19,000 followers, into a part-time gig. He told CNBC he juggles the hustle of reselling with his high school studies.
Blake Robertson, 17, poses with his closet, some of which is up for resale on his Depop shop.
Courtesy:Â Blake Robertson
He’s become accustomed to the occasional hate message or dayslong negotiations over a single item. More than anything, he has been pleasantly surprised by the growing reach of his shop, which used to just serve his friends as patrons.
“I get these messages from total and complete strangers, which just makes me think how much this app genuinely has grown,” Robertson said.
The back-and-forth
To be sure, death threats against resellers are not the norm. Beaux Abington, 49, says that overall, she’s had “really fantastic, phenomenal customers.”
But she’s also noticed more buyers hunting deals and has felt insulted by recent offers for her products that are sometimes less than half her asking price.
“There’s definitely a price-consciousness that wasn’t always there,” said Abington.
About 53% of people polled in an October 2022 Depop survey of more than 2,000 U.K. consumers said that they have been turning to secondhand shopping more in order to save money as living costs rise. The result, sellers say, is more frequent negotiations and intensified bidding wars.
“There’s a lot more negotiation happening. Even in the last year, I’d say it’s kind of skyrocketed for me,” said Josefina Munroe, 27, a Depop seller with more than 30,000 followers. She started her shop five years ago and decided to make it a full-time job after she graduated college in 2020 and demand for online resale expanded.
Then there are the de facto bidding wars. Munroe recalls purchasing an item on Depop only to have the seller cancel her order after realizing that another customer was willing to pay more. Other Depop shoppers say that is not an uncommon experience.
“It’s completely separate from real-world shopping because that would never happen in a store,” said Munroe. “I think people have gotten very comfortable with the whole back-and-forth.”
Beaux Abington, 49, models some of her own Depop items.
Courtesy: Beaux Abington
Platforms such as Depop and Poshmark are leaning into the competitive consumer zeitgeist.
Last January, Depop launched a new “Make Offer” option — a feature that has streamlined the negotiation process, which used to take place informally via direct messages. Resellers say that the new button has made customers more comfortable haggling.
“The offer feature on Depop has definitely created a new dynamic in terms of being hounded with low-ballers and also being expected to sell things cheaply,” said Pascale Davies, 28, who runs a Depop shop with 59,000 followers.
But Depop has yet to institute a formal function for bidding battles — like the original online reseller, eBay, offers. Depop also shut down comment sections on product pages where customers used to ask questions and sometimes get in arguments, according to users.
“We found that comments on an item did not directly help buyers with their decision-making,” a Depop spokesperson told CNBC when asked about the change.
Going bigger
In September, Poshmark launched “Posh Shows,” which allows sellers to hold livestreamed auctions to sell and promote their inventory.
Stephanie Dionne, 44, who has been selling on Poshmark for about two years, said the live shows are “all kinds of crazy and chaotic,” generating a fast-paced, ruthless selling environment.
“When it comes to the live shows, people will kind of steal it out from under you at the last second,” she said.
Since she launched her secondhand market with her two sisters, Dionne’s business keeps getting bigger and bigger — so much so that one of her sisters reduced her full-time day job to part-time in order to focus on the Poshmark shop.
Last year, the Dionnes made between $4,000 and $5,000 in profit. Just a couple months into this year, they have already surpassed that.
But now, sellers such as the Dionnes are not only competing with Poshmark and Depop peers but also major retailers such as Target and H&M that are trying to cash in on the resale boom.
Last week, H&M announced its most recent collaboration with the online thrift store ThredUp, which will now cross-list about 30,000 pieces of secondhand clothing on H&M’s website. Target has launched several ThredUp partnerships of its own, and Etsy bought Depop in 2021. In January, Poshmark was acquired by South Korean web giant Naver.
But some independent resellers doubt that the unique, curated experience of indie resale can be scaled.
“Although bigger companies are trying to occupy this space, I think they miss the mark when it comes to the personal element of vintage,” Finn Thomas, a London-based Depop seller, told CNBC.
“Part of the charm of buying vintage is the one-on-one interaction between the buyer and seller, the unique story behind each piece and the general curation behind a store, something I can’t see the larger companies like H&M achieving,” Thomas added.
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Business
Blue Origin says an overheated engine part caused last year’s cargo rocket failure
Published
3 hours agoon
March 24, 2023By
ironity
Blue Origin
The company’s New Shepard rocket, flying the NS-23 mission carrying science and research payloads, suffered a failure in September 2022. No people were onboard, and Blue Origin says its capsule’s emergency escape system functioned properly, but the rocket’s reusable booster was destroyed.
Bezos’ company had previously said little about its investigation over the past six months, which was conducted with Federal Aviation Administration oversight.
In a blog post on Friday, Blue Origin said it identified “a thermo-structural failure of the engine nozzle” as the direct cause of the issue, and is now modifying the engine, including design changes to account for higher-than-expected temperatures during the flight.
“Blue Origin expects to return to flight soon, with a re-flight of the NS-23 payloads,” the company said.
The New Shepard rocket launches from Blue Origin’s private facility in West Texas, carrying people and payloads above 100 kilometers — or more than 340,000 feet — for a couple minutes of weightlessness. The capsule is flown autonomously, with no human pilot, and floats down with the assistance of a set of parachutes to land in the Texas desert. The New Shepard rocket booster is reusable, returning to land on a concrete pad near the launch site.
Blue Origin said its investigation found that NS-23 flight’s engine failure was due to “operational temperatures that exceeded the expected and analyzed values of the nozzle material.” The company recovered fragments of the BE-3PM engine’s nozzle, finding “clear evidence of thermal damage and hot streaks resulting from increased operating temperatures.”
The company noted that its design changes are intended to improve the engine’s performance at high temperature, as well as strengthen the engine’s nozzle.

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Business
Chewy and Petco earnings make it clear: Pet health care is their future
Published
6 hours agoon
March 24, 2023By
ironity
The retailers, which both released their quarterly earnings on Wednesday, began investing heavily into pet health when the pandemic-fueled pet boom saw 23 million American households welcome a new animal into their homes.Â
The boom turned the overall U.S. pet market into a $123.6 billion dollar powerhouse in 2021, and it’s expected to grow to $200 billion by the end of the decade, according to the American Pet Products Association and new research from Bloomberg Intelligence.
Pet health care – and the high margins that come with it – is a crucial component to that overall market and is driving the growth in spending in the U.S., according to Bloomberg Intelligence.
“Increased pet nutrition is leading to longer pet lives around the world,” said Ann-Hunter Van Kirk, a senior biopharmaceutical analyst with Bloomberg Intelligence who co-authored the report. “With this comes an increased need for spending relating to expensive healthcare for aging pets, and we project that this spending on lasting health for pets will continue to swell over the next decade.”
The companies may still have to win over investors with the approach, though, as shares of both companies fell Thursday.
Chewy, the ecommerce giant known for its convenient auto-ship services and generous customer service policies, has focused on building out its pharmacy, insurance and telehealth verticals while partnering with veterinarians to get a cut of their consumables revenues.Â
The company, founded by Ryan Cohen in 2011, now operates the largest pet pharmacy in the U.S., CEO Sumit Singh told investors on an earnings call.Â
“Non-discretionary categories, including consumables and health care, remain the pillars of strength,” Singh, a former Amazon executive, said on the call.Â
A dog hi-fives it’s owner in front of the New York Stock Exchange (NYSE) during Chewy Inc.’s initial public offering (IPO) in New York, U.S., on Friday, June 14, 2019.
Michael Nagle | Getty Images
Petco, on the other hand, has also invested into insurance and pharmacy but has focused on leveraging its brick-and-mortar footprint to set up veterinary hospitals. It changed its name to Petco Health and Wellness Company in 2020.
The longtime pet retailer now has a total of 247 hospitals across the country, up from 10 at the beginning of 2018, bringing a veterinary presence to 90% of Petco’s stores, chairman and CEO Ron Coughlin said during an earnings call.Â
“Petco’s hospitals and clinics saw nearly 1.9 million pets in 2022, positioning us as one of the leading providers of veterinary services in the United States,” Coughlin told investors, adding Petco is among the top 10 in the nation from a hospital unit standpoint.Â
“Vet customers are also demonstrating a 2.3 times higher lifetime value than non-vet customers,” he said.
Against the backdrop of a tough veterinary job market and a dearth of pet doctors, Petco hired 1,100 veterinarians in 2022, a 40% year-over-year increase.
Chewy has not shared how many veterinarians or vet techs it employs for its veterinary telehealth service, Connect With a Vet.
Long-term growth
The fruits of these labors haven’t quite materialized just yet for both of the companies. The nascent initiatives are costly to build. But in the long term, they could provide a durable runway for growth and profitability.Â
Pet adoptions surged during the pandemic, triggering a surge in demand for pet goods. With uncertainty in the macroeconomic environment and an increasingly cautious consumer, sales from high margin hard goods such as toys and leashes have been trending down at both companies.
At Petco, where discretionary supplies and companion animals account for about 38% of sales, the category suffered a 9% decline for the full year, the company said.Â
A Petco store in Louisville, Kentucky, U.S., on Tuesday, Aug. 23, 2022.
Luke Sharrett | Bloomberg | Getty Images
At Chewy, which is not nearly as reliant on hard goods, the company celebrated its first annual profit in its history Wednesday. But executives also repeatedly noted softness in the discretionary and hard goods categories during the company’s earnings call. Singh said he doesn’t expect hard goods sales to accelerate in 2023.
Plus, there’s now more competition in the hardgoods market, making it harder for Chewy and Petco to hang on to their market share, said Jessica Ramirez, a senior analyst at Jane Hali and Associates.Â
“Off-price retailers have a really good category and those categories continue to grow,” she told CNBC.Â
However, when it comes to pet care, there are far more avenues for growth and longevity.Â
“A puppy that was, you know, adopted or bought, during 2020 is now three years old. As they get older, they’re only going to require more health care,” said Anna Andreeva, a senior equity research analyst and managing director at Needham and Company. “And I think both companies are being smart in developing those verticals.”Â
Pet insurance has very little penetration in the U.S. compared to other markets, such as the UK, which can “definitely” be changed moving forward and will be another driver in the space, Andreeva said.
In addition, the footprint of independent veterinary providers is dwindling, which is creating an “interesting” market share opportunity, said Andreeva.
“There’s definitely been, you know, share donation out of that channel,” she said.
Obstacles and opportunities
The two companies share many similarities in the items that they sell and the customers they cater to but have taken different approaches to pet health.Â
Chewy, which has no brick-and-mortar stores, has focused on building out its virtual telehealth capabilities but has run into obstacles because of state and federal regulations that, in some locations, forbid veterinarians from treating an animal if they haven’t met it in person.Â
“That is a bit of a complication and when you look to Petco, they are at a better advantage because they have stores,” said Ramirez.
CNBC previously reported that Chewy, along with other pet companies, have sponsored a lobbying organization that’s working to change those regulations and some veterinarians are concerned that veterinary telehealth could be unsafe and problematic for pets.Â
Petco hasn’t faced the same issues because they haven’t yet branched into telehealth, and all of their veterinarians practice in physical locations. However, it will take some time before the hospitals are profitable.
“The margins on our services business are growing. It’s a three year payback on those vet hospitals and we’re ahead of our model on that,” Coughlin, Petco’s CEO, told CNBC in an interview.
Either way, as the consumer continues to focus on wellness and seek more ease to meet all of its needs, branching into pet health is a positive avenue for growth for both of the companies, said Ramirez, the Jane Hali analyst.Â
“As wellness continues to be a key category for us the consumer, it’s also being reflected into pet,” said Ramirez. “It only makes sense that sort of lifestyle is extended to our furry animals at home because again, it makes everything much more streamlined, much easier, so I think that’s something that makes sense on both sides.”
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