CDC Approves COVID-19 Vaccines For Children Under 5

U.S. health advisers on Saturday recommended COVID-19 vaccines for infants, toddlers and preschoolers — the last group without the shots.The advisers to the Centers for Disease Control and Prevention unanimously decided that coronavirus vaccines should be opened to children as young as 6 months. On Saturday afternoon, CDC Director Rochelle Walensky signed off on the panel’s recommendation.

“Together, with science leading the charge, we have taken another important step forward in our nation’s fight against COVID-19,” Walensky said in a statement. “We know millions of parents and caregivers are eager to get their young children vaccinated, and with today’s decision, they can. I encourage parents and caregivers with questions to talk to their doctor, nurse, or local pharmacist to learn more about the benefits of vaccinations and the importance of protecting their children by getting them vaccinated.”

HHS Secretary Xavier Becerra released a statement calling the CDC’s move a “major milestone.”

“Thanks to the FDA and CDC’s rigorous, comprehensive, and independent review of the data, and their strict commitment to following the science, we are reaching another major milestone in our efforts to protect more children, their families, and our communities as we work to end the pandemic,” Becerra said. “We are following the data and science as we make sure all Americans are eligible and have access to COVID-19 vaccines and boosters to prevent severe disease and save lives. Based on CDC and FDA actions, we now know that vaccination for our children 6 months through 5 years old is safe and effective and we are ready to get millions of children vaccinated.”

The White House also weighed in on the decision in a statement calling the CDC’s decision a “monumental step forward in our nation’s fight against the virus.””For parents all over the country, this is a day of relief and celebration,” President Biden said in the statemente. “As the first country to protect our youngest children with COVID-19 vaccines, my Administration has been planning and preparing for this moment for months, effectively securing doses and offering safe and highly effective mRNA vaccines for all children as young as six months old.

“While the Food and Drug Administration OKs vaccines, it’s the CDC that decides who should get them. The government has been gearing up for the start of the shots early next week, with millions of doses ordered for distribution to doctors, hospitals and community health clinics around the country. Roughly 18 million kids will be eligible, but it remains to be seen how many will ultimately get the vaccines. Less than a third of children ages 5 to 11 have done so since vaccination opened up to them last November.

Two brands — Pfizer and Moderna — got the green light Friday from the FDA. The vaccines use the same technology but are being offered at different dose sizes and number of shots for the youngest kids.

Ticker Security Last Change Change %
PFD FLAHERTY & CRUMRINE PREFERRED INC 12.30 -0.07 -0.57%
MRNA MODERNA INC. 128.03 +6.95 +5.74%

Pfizer’s vaccine is for 6 months through 4 years. The dose is one-tenth of the adult dose, and three shots are needed. The first two are given three weeks apart, and the last at least two months later. Moderna’s is two shots, each a quarter of its adult dose, given about four weeks apart for kids 6 months through 5. The FDA also approved a third dose, at least a month after the second shot, for kids with immune conditions that make them more vulnerable to serious illness.

Two doses of Moderna appeared to be only about 40% effective at preventing milder infections at a time when the omicron variant was causing most COVID-19 illnesses. Pfizer presented study information suggesting the company saw 80% with its three shots. But the Pfizer data was so limited — and based on such a small number of cases — that experts and federal officials say they don’t feel there is a reliable estimate yet.

Hospitalizations surged during the omicron wave. Since the start of the pandemic, about 480 children under age 5 are counted among the nation’s more than 1 million COVID-19 deaths, federal data show. “It is worth vaccinating, even though the number of deaths are relatively rare, because these deaths are preventable through vaccination,” said Dr. Matthew Daley, a Kaiser Permanente Colorado researcher who sits on the advisory committee.

U.S. officials expect most shots to take place at pediatricians’ offices. Many parents may be more comfortable getting the vaccine for their kids at their regular doctor, White House COVID-19 coordinator Dr. Ashish Jha said. He predicted the pace of vaccination to be far slower than it was for older populations.

Pediatricians, other primary care physicians and children’s hospitals are planning to provide the vaccines. Limited drugstores will offer them for at least some of the under-5 group. U.S. officials expect most shots to take place at pediatricians’ offices. Many parents may be more comfortable getting the vaccine for their kids at their regular doctor, White House COVID-19 coordinator Dr. Ashish Jha said. He predicted the pace of vaccination to be far slower than it was for older populations.

“We’re going see vaccinations ramp up over weeks and even potentially over a couple of months,” Jha said. It’s common for little kids to get more than one vaccine during a doctor’s visit. In studies of the Moderna and Pfizer shots in infants and toddlers, other vaccinations were not given at the same time so there is no data on potential side effects when that happens. But problems have not been identified in older children or adults when COVID-19 shots and other vaccinations were given together, and the CDC is advising that it’s safe for younger children as well.

About three-quarters of children of all ages are estimated to have been infected at some point. For older ages, the CDC has recommended vaccination anyway to lower the chances of reinfection.Experts have noted re-infections among previously infected people and say the highest levels of protection occur in those who were both vaccinated and previously infected. The CDC has said people may consider waiting about three months after an infection to be vaccinated.

Source: CDC approves COVID-19 vaccines for children under 5 | Fox Business

Related contents:

Moderna COVID Vaccine May Pose Higher Heart Inflammation Risk

Source: Moderna COVID vaccine may pose higher heart inflammation risk – U.S. CDC

More contents:

Moderna Data Shows mRNA Isn’t a Quick Fix For The Flu Vaccine

The first data from clinical trials of Moderna’s mRNA-based seasonal flu vaccine, released by the company Friday morning, were underwhelming — a finding that shows gene-based vaccines might not be a fix for all the problems with vaccine development.

The overwhelming success of the mRNA COVID-19 vaccines, made by Moderna and Pfizer / BioNTech, supercharged interest in that strategy for developing shots. The shots inject people with tiny snippets of the gene for a virus, which the body builds and then uses to learn how to fight the virus.

Current flu shots contain inactivated copies of the influenza virus. mRNA vaccines are faster to design and produce because manufacturers don’t have to grow copies of the virus, which is why experts have for years seen them as the future of vaccines.

Moderna launched a clinical trial of an mRNA seasonal flu vaccine this summer, hoping to capture the same success as it did with its COVID-19 vaccine. Typically, seasonal flu shots are around 40 to 60 percent effective, and pharmaceutical companies want to make that better. Three other companies are also working on mRNA flu shots.

Moderna released its first results during an investor phone call and presented slides showing that the mRNA flu shots did generate antibodies — but the levels of those antibodies weren’t higher than those for other flu shots already on the market. They also had more side effects than existing shots.

The findings don’t necessarily mean that mRNA flu shots aren’t any better than what we have now. Because mRNA vaccines are faster to design and make, the shots don’t have to be developed as far in advance. Companies may not have to do as much guesswork around what strain of the flu to target them against each year because they can wait to make the shots until they see what strains are circulating.

And as far as efficacy goes, there’s still a lot more data to collect: Moderna is preparing to conduct larger trials that would test how well the shots actually keep people from getting sick in the real world (not just testing antibody levels)..

Still, this early data shows that the immune system is tricky and that mRNA vaccines probably aren’t an easy shortcut for stopping a virus as persistent as the flu. More studies will be needed to figure out if there is a specific benefit to using mRNA vaccines to fight the flu, wrote chemist and writer Derek Lowe in Science. But it’s not a sure thing.

Nicole Wetsman

Source: Moderna data shows mRNA isn’t a quick fix for the flu vaccine – The Verge

.

More contents:

At-Home Covid Tests Are Getting Better

As many of us rush around trying to find the perfect Thanksgiving turkey and holiday gifts, there’s another thing experts recommend we stock up on: at-home tests for Covid-19.

“At-home testing will be essential over the next few months,” said Leana Wen, an emergency physician and professor of health policy at George Washington University.

The most common form of at-home testing is the rapid antigen test — think BinaxNOW, QuickVue, or Ellume — where you swab your own nostrils and get results back in around 15 minutes. These can be found at your local pharmacy, though supply has been erratic (more on this below). Antigen tests are typically contrasted with molecular tests — think lab-based PCR — which are better at picking up the virus, though you have to get swabbed by a professional and then wait, sometimes several days, until results come back.

Now, however, companies like Cue Health and Detect are selling a new class of tests: molecular tests that can be performed entirely at home. They promise PCR-quality results in under an hour — all without ever having to get up off your couch.

If you can find and afford at-home tests — whether they’re the relatively cheap antigen tests or their more expensive molecular cousins — experts say it will be particularly useful for you to have them on hand this fall and winter, for a few reasons.

For Americans who got their first two doses this spring, immunity may well be waning. Data so far shows the vaccines’ effectiveness against infection tapers off around the six-month mark. And so far, only 18 percent of Americans have gotten a booster shot (though that may well rise now that all adults are eligible). That, together with the fact that infection rates are climbing in the US, means breakthrough cases are likely to rise here, as they’ve already begun to do in Europe. And with the weather getting colder and the holidays coming, we’re all going to be spending more time indoors with others.

To be clear, if you’re fully vaccinated, the data shows you’re still well protected from severe disease or death from Covid-19, and reported infections in the US are so far still mainly among unvaccinated people. But should you get a breakthrough infection, you could infect others who are unvaccinated, have waning immunity, or are elderly and thus more at risk for severe illness even if they are vaccinated. That’s what testing can prevent.

“We need to shift from thinking about at-home testing as just a diagnostic tool to thinking about it as a preventative tool,” said Wen, who recommends taking a test before an indoor social gathering even if you’re not feeling symptoms.

Neil Sehgal, a health policy professor at the University of Maryland School of Public Health, told me he’s about to fly from Washington, DC, to California to spend Thanksgiving with relatives there. Everyone in his family plans to take a rapid test before the holiday meal, he said, to help ensure they don’t pose a risk to others.

“The challenge right now is that even if you are vaccinated, your breakthrough infection is a link in a chain that may end up infecting somebody for whom consequences may be more serious than for you,” Sehgal told me. “We all have to make a decision about whether or not we want to participate in those chains of transmission.”

Likewise, Wen said she’s planning to use rapid tests for holiday get-togethers. She also finds them useful for birthday parties and dinner parties; now that it’s getting too cold for outdoor meals, her family and her invited guests test before gathering in her home.

Both experts noted that there’s an additional reason why it’s useful to keep a few tests in your house in the coming months: Antiviral pills for Covid-19, produced by Merck and Pfizer, will probably soon be available in the US under an emergency use authorization. But these treatments are most effective if you take them soon after you’ve become infected. That means it’s in your interest to catch the virus early on — and having a test close to hand can help you do that.

It shouldn’t be so hard to get at-home tests. Here’s what went wrong.

One issue clouds these expert recommendations: The availability of at-home test kits has been spotty at best.

An American, looking at how easy it is to snag a rapid test across the pond in the UK or Germany, could be forgiven for feeling a pang of envy — and a hefty dose of frustration. More than a year and a half into the pandemic, over-the-counter antigen tests are often sold out at stores like CVS or Walgreens.

Despite the Biden administration’s decision to invest $1 billion in rapid tests, the market remains constrained, in part because of regulatory hurdles. Early on, the US decided to categorize these tests as medical devices, which means they needed to pass a stringent FDA approval process, Sehgal explained. As a result, only a few companies’ tests squeezed through to market in 2021.

“We’ve been slow to adopt and approve them in the US because they’re not as sensitive as PCR tests,” Sehgal said. But even though antigen tests are not foolproof at detecting the virus, “they are sensitive enough to give you a pretty realistic sense of whether you pose a risk to the people you’re gathering with” — that is, of whether you’re actively contagious.

“I do think a more public-health-minded mental model would have led to quicker approval of more rapid antigen testing options,” Sehgal continued. In other words, the US should have conceived of the tests as a harm reduction measure: We know they’re not perfect, but if we deploy them at scale, they’ll reduce harm overall.

“The FDA would still have to approve them under an emergency use authorization to make it to market, but the urgency with which the FDA has acted with vaccines could have been similarly applied to testing. If so, I think we’d have seen earlier approvals for more domestic manufacturers of rapid tests,” he added.

Another reason for the low stock is simply that bigger purchasers snapped up a lot of the tests early on. Companies, sports teams, and school systems placed bulk orders in the spring and ate up a lot of the stock before the general public could get to it. “They made contracts because they knew that to resume in-person activity, this would be a good strategy,” Sehgal said.

The upshot is that when regular individuals walk into their drugstores to try and buy a couple boxes, there’s not much left on the shelf.

Under the Trump administration, officials at times appeared to discourage testing, for fear that it would reveal more positive cases. Instead, the US focused on developing vaccines at warp speed, thinking of them as the silver bullet that would destroy the pandemic.

But this fall, the Biden administration decided to make testing a more integral part of its pandemic strategy. White House coronavirus response coordinator Jeff Zients said in October that the $1 billion investment “puts us on track to quadruple the amount of at-home, rapid tests available for Americans by December. So that means we’ll have available supply of 200 million rapid, at-home tests per month starting in December.”

Many experts hailed it as a welcome, if overdue, commitment.

“What rapid tests do is they allow us to live more peacefully with this virus — to actually be able to not have it be so disruptive to society,” Michael Mina, an epidemiologist who’s been one of the most vocal proponents of rapid tests, told the Washington Post. These tests can make quarantines unnecessary, allowing us “to keep students in school, to keep businesses running and to stop the need for shutdowns, even amid outbreaks.”

The next generation of at-home tests

Up till now, at-home testing has been pretty much synonymous with antigen tests, such as BinaxNOW or QuickVue. Overall, these tests’ sensitivity tends to be in the range of 85 percent, meaning they miss about 15 percent of people who are infected. That said, they’re very good at detecting an infection when people have high viral loads, which is when they’re likeliest to infect others.

Molecular tests are considered the gold standard in Covid-19 testing. They take your sample and amplify the genetic material in it many times over, so if there’s even a tiny shred of virus in it, they will almost certainly detect it. Traditionally, the downside has been that you need a professional to swab you and a lab to process your results.

At-home molecular testing is starting to change that. This month, the health tech company Cue Health began selling directly to consumers a molecular test that can be performed entirely at home. You can buy it online, no prescription needed, and get lab-quality results without leaving home, according to the company. The Cue test shows results in line with lab PCR results 97.8 percent of the time, as verified in an independent study conducted by the Mayo Clinic.

And it’s quick, offering results in 20 minutes, similar to the wait time for antigen tests. There’s a catch, though: It’s not cheap. A three-pack of single-use tests will run you $225, and that’s not counting the reusable reader, which costs $250. At that price point, it’s far from ripe for equitable access. (For comparison, antigen tests are priced from about $10 to $40 per test.)

“We’re not priced like an antigen test, but we don’t perform like an antigen test,” said Clint Sever, Cue’s co-founder and chief product officer, adding that the test is used by the likes of Google, NASA, and the NBA. “It’s a breakthrough technology.”

Detect is another health tech company offering an at-home molecular test (the product will be available soon). This one will also come with a reusable hub and single-use individual tests. With the hub priced at $39 and each test at $49, Detect’s system will be more affordable than Cue’s, though still pricier than an antigen test. The Detect test is 97.3 percent accurate, similar to a PCR lab test, according to Axios. It returns results in one hour.

Both Cue’s and Detect’s tests have earned an emergency use authorization from the FDA, and both companies have their sights set on much more than just Covid-19 testing. With a bit of tweaking, their platforms should be able to test for other health issues, too.

Detect’s plan “is that you’ll be able to get a flu test or a Covid test or whatever you need, at home,” Owen Kaye-Kauderer, the company’s chief business officer, told Axios.

Cue envisions a future where its reader will be able to test you for everything from the flu and strep throat to chlamydia and gonorrhea. “Covid has basically accelerated the transition to virtual care services and connected diagnostics,” Sever told me.

The fundamental innovation here — giving your humble home the diagnostic capabilities of a professional lab — will likely become popular in many areas of health care over the next few years. That helps explain why companies like Cue and Detect are eager to get into the game, even though many experts say that as we approach springtime, Covid-19 will likely be entering the endemic phase: It’ll keep circulating in parts of the population, but its prevalence and impact will come down to relatively manageable levels, so it becomes more like the flu than a world-stopping disease.

“When we get to the point where transmission has slowed and we enter the endemic phase,” Sehgal said, “at-home testing becomes much less important.”

In the meantime, Wen recommends that each family keep a few at-home tests in the house. Don’t fret too much about whether they’re antigen or molecular; get what you can find and afford.

“This is a case of ‘don’t let the perfect be the enemy of the good,’” she said. “These tests can allow us to go from Covid-19 as a threat that feels almost existential to just another risk among all the risks we take into account every day. They can let us get back the normalcy we’re craving.”

Sigal Samuel

Source: At-home Covid tests are getting better. Stock up for winter holidays. – Vox

.

More Contents:

Pfizer Sues Employee, Alleging She Stole Covid-19 Vaccine Documents

Pfizer is suing one of its employees after she allegedly stole thousands of the company’s files with the intent to take a job with one of its competitors, with some of the files including information about the Covid-19 vaccine.

Key Facts

In a complaint filed Tuesday in San Diego federal court, Pfizer alleged one of its associate directors of statistics, Chun Xiao Li, uploaded over 12,000 files to her personal devices from a company issued laptop without permission.

Pfizer said it believes Li was offered a job at one of its competitors—Xencor Inc., a biopharmaceutical company. Pfizer claims Li is still in possession of a laptop containing documents “potentially related to numerous Pfizer vaccines, drugs, and other innovations,” with the complaint specifically focusing on information she allegedly has pertaining to the Covid-19 vaccine and monoclonal antibodies.

The drug company claimed Li tried to mislead it by providing a “decoy” laptop when they confronted her about the issue.

A U.S. district judge ordered a temporary block on Tuesday, halting Li from using any of Pfizer’s trade secrets, according to Reuters. Li did not respond to Reuters’ request for comment.

Crucial Quote

“Had Ms. Li left Pfizer honorably, she would not be named in this Complaint. But she made a different choice,” Pfizer wrote.

Key Background

Pfizer noted in the complaint that competitors have been trying “relentlessly” to recruvaccineit its employees, particularly in 2021.

Tangent

On Monday, the company announced its Covid-19 vaccine demonstrated 100% efficacy in adolescents ages 12-15. It plans to submit the vaccine for full regulatory approval in the age group in the U.S. and internationally.

I’m a Los Angeles-based news desk reporter for Forbes. Please feel free to contact me via email (mbissada [@] forbes.com) or Twitter (@masonbissada).

Source: Pfizer Sues Employee, Alleging She Stole Covid-19 Vaccine Documents

.

More contents:

%d bloggers like this: