Moderna, Pfizer vaccines for under 5s overwhelmingly endorsed by FDA advisors

A woman in protective gear leans over a toddler in a bed.

Enlarge / Boston Medical Center Child Life Specialist Karlie Bittrich sees to a baby while in a pediatrics tent set up outside of Boston Medical Center in Boston on April 29, 2020. (credit: Getty | Boston Globe)

A committee of experts advising the Food and Drug Administration voiced unanimous support Wednesday for the authorization of two COVID-19 vaccines for children under the age of 5. If the FDA authorizes the vaccines, it will mark the first time during the more than two-year pandemic that vaccines against COVID-19 will be available for this age group—the last group yet to be eligible for vaccination.

Although children in this young age group have a relatively lower risk of severe disease and death from COVID-19 compared with older groups, they can and do become severely ill and die from the infection. As of last month, 45,000 children under 5 have been hospitalized for COVID-19 during the pandemic; roughly 50 percent of those hospitalizations occurred during the omicron wave. Of the children who land in the hospital, about 63 percent have no underlying medical conditions that put them at greater risk of severe COVID-19. And about a quarter of those hospitalized require intensive care.

So far, 475 children under the age of 5 have died from COVID-19 during the pandemic, making COVID-19 far deadlier than other diseases we routinely vaccinate young children against, including influenza, measles, chickenpox, hepatitis A, and rotavirus.

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COVID Vaccines for Kids Younger Than Five Get Green Light from Regulators

An advisory committee voted unanimously to recommend authorizing the Moderna and Pfizer shots for the youngest children

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EU warns of BA.4/BA.5 uprising, braces for next wave of cases

Members of the public queue outside a pharmacy to receive COVID-19 antigen tests in Paris on January 6, 2022.

Enlarge / Members of the public queue outside a pharmacy to receive COVID-19 antigen tests in Paris on January 6, 2022. (credit: Getty | LUDOVIC MARIN)

Omicron subvariants BA.4 and BA.5 are on the rise in the European Union, spurring officials there to warn that a surge of COVID-19 cases will likely follow in the coming weeks.

In an alert Monday, the European Center for Disease Prevention and Control cautioned that various factors would influence how bad the expected BA.4/BA.5 wave will be. Those factors include the extent of vaccination and past infection in the population, as well as timing since those events because protection from both wanes over time.

BA.4 and BA.5 are clumped together because they share the same mutations in the genetic coding for their spike proteins, though they have differing mutations elsewhere in their genome. Both have a transmission advantage over the initial omicron subvariant, BA.1, as well as subvariants BA.2 and BA.2.12.1.

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COVID Death Rates Explained, Dismal Booster Stats and New Vaccines

On this episode of the COVID, Quickly podcast, we clear up some data misconceptions, get to the bottom of the booster uptake issue and talk Novavax.

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US can’t afford fall boosters for all—even after cuts to test and PPE spending

A sign for a vaccine site stands in Staten Island on November 29, 2021, in New York City.

Enlarge / A sign for a vaccine site stands in Staten Island on November 29, 2021, in New York City. (credit: Getty | Spence Platt)

With pandemic funding running out, the Biden administration is repurposing $10 billion to buy next-generation COVID-19 booster doses for the fall, as well as treatments, including the anti-viral Paxlovid and monoclonal antibodies.

The funding will be pilfered from federal programs that support COVID-19 test availability and domestic production, as well as stockpiles of essential resources, such as personal protective equipment (PPE) and ventilators. Funding for research on coronavirus vaccines and new treatments will also take a hit.

“These were incredibly painful decisions,” White House COVID-19 Response Coordinator Ashish Jha said in a press briefing Thursday.

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June 21 is expected start date of COVID vaccination for kids under 5

White House COVID-19 Response Coordinator Dr. Ashish Jha speaks alongside White House Press Secretary Karine Jean-Pierre during the daily press briefing at the White House on June 02, 2022 in Washington, DC.

Enlarge / White House COVID-19 Response Coordinator Dr. Ashish Jha speaks alongside White House Press Secretary Karine Jean-Pierre during the daily press briefing at the White House on June 02, 2022 in Washington, DC. (credit: Getty | Kevin Dietsch)

COVID-19 vaccination for children ages 6 months to under five years—the only age group yet to be eligible for vaccination—is expected to get underway on June 21, White House COVID-19 response coordinator Ashish Jha said in a press briefing Thursday.

The Food and Drug Administration is now reviewing data from Moderna and Pfizer-BioNTech on their respective vaccines for the young age group. The agency will convene its panel of independent expert advisors to review the data on June 15 and vote on whether the vaccines should be granted emergency use authorization.

If the panel votes in favor of authorization, the FDA will likely grant authorization quickly. Once that happens, shipments of federal supplies of the vaccines will begin going out to states for distribution. But, before they can go into little arms, the Centers for Disease Control and Prevention will need to have its own advisory committee meeting to review the data and vote on a recommendation. And for the final step, the CDC Director Rochelle Walensky will need to endorse the recommendation.

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Where Are Vaccines for Little Kids, and the Latest on Long COVID

Today we bring you a new episode in our podcast series COVID, Quickly. Every two weeks, Scientific American’s senior health editors Tanya Lewis and Josh…

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Pfizer warns of “constant waves” of COVID as complacency grows

A woman wears a facemask as she walks by the Pfizer world headquarters in New York on November 9, 2020.

Enlarge / A woman wears a facemask as she walks by the Pfizer world headquarters in New York on November 9, 2020. (credit: Getty | KENA BETANCUR )

Growing complacency about COVID-19 and politicization of the pandemic response will cost lives as the world is hit by new waves of the virus in the coming months, Pfizer’s chief executive has warned.

Albert Bourla said people were growing “tired” of the measures introduced to slow the spread of the virus, while “politicians want to claim victory.” Compliance with authorities’ requests for people to get booster shots would fall even among those who are already vaccinated, he predicted.

This, combined with waning immunity from previous infections and vaccinations, was likely to lead to “constant waves” of COVID variants and deaths, he said.

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‘When Will Kids under Five Get COVID Vaccines?’ and Other Questions

Experts address when the youngest children could be eligible for the shots, why that has taken so long, and more

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Pfizer says 3-dose COVID vaccine for under 5s produces strong immune response

Vials of the Pfizer COVID-19 vaccine.

Enlarge / Vials of the Pfizer COVID-19 vaccine. (credit: SOPA images)

Pfizer and BioNTech will request authorization from the US Food and Drug Administration this week for their three-dose COVID-19 vaccine for children ages 6 months to under 5 years, the companies announced this morning.

Top-line clinical trial results indicate that the vaccine series is safe and produces a strong immune response against the pandemic virus, according to the companies.

“The study suggests that a low 3-[microgram] dose of our vaccine…  provides young children with a high level of protection against the recent COVID-19 strains,” BioNTech CEO Ugur Sahin said in a statement.

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What the U.S. Can Learn from Brazil’s Successful COVID Vaccination Campaign

Despite similar leadership at the start of the pandemic, Brazilians are more trusting of government and view vaccination as a necessity and a right

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Kids 5 to 11 get FDA OK for COVID-19 booster doses

A boy gives a nurse a high five before receiving a shot of the Pfizer COVID-19 vaccine at a vaccination site for 5-11 year-olds at Eastmonte Park in Altamonte Springs, Florida.

Enlarge / A boy gives a nurse a high five before receiving a shot of the Pfizer COVID-19 vaccine at a vaccination site for 5-11 year-olds at Eastmonte Park in Altamonte Springs, Florida. (credit: Getty | SOPA)

The Food and Drug Administration on Tuesday authorized booster doses of the Pfizer-BioNTech COVID-19 vaccine for children ages 5 through 11, the first booster dose for the age group intended to revive waning immune protection.

The authorization comes as the US continues to see COVID-19 cases rise due to the extremely transmissible omicron coronavirus subvariants, specifically BA.2 and BA.2.12.1, which now account for an estimated 51 percent and 47.5 percent of all reported cases, respectively. Transmission levels are considered high in just over 50 percent of US counties, according to the latest data from the Centers for Disease Control and Prevention. The seven-day average of new daily cases is nearly 96,000, up 57 percent in the last two weeks, according to data tracking by The New York Times. Hospitalizations are around 22,000, up 26 percent. Daily deaths are averaging around 300.

But some experts highlight that data on the current omicron-subvariant wave is muted because testing sites have shuttered, and many people are relying on at-home testing results that are largely not reported. Peter Hotez, a vaccine expert at Baylor College of Medicine, tweeted over the weekend that the current wave could rival that of the original omicron wave in January. He strongly urged Americans to get vaccinated and boosted and to vaccinate their children.

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North Korea: Six dead, 350,000 “fevers” as coronavirus spreads “explosively”

North Korea's leader Kim Jong Un on June 30, 2019.

Enlarge / North Korea’s leader Kim Jong Un on June 30, 2019. (credit: Getty | BRENDAN SMIALOWSKI)

At least six people in North Korea have died and more than 350,000 have contracted an unusual fever since late April in an outbreak that “explosively spread nationwide,” North Korean state media said Friday.

On Thursday, 18,000 new cases were reported, 187,800 people were in quarantine, and 162,200 had reportedly recovered. The cases are being defined by “a fever whose cause couldn’t be identified,” according to The New York Times.

The numbers come just a day after the authoritarian country acknowledged for the first time during the pandemic that the coronavirus was spreading within its borders.

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Unvaccinated North Korea reports omicron outbreak, raising fears of new variants

People watch a television broadcast showing a file image of North Korean leader Kim Jong Un during a military parade at the Seoul Railway Station on May 4, 2022 in Seoul, South Korea.

Enlarge / People watch a television broadcast showing a file image of North Korean leader Kim Jong Un during a military parade at the Seoul Railway Station on May 4, 2022 in Seoul, South Korea. (credit: Getty | Chung Sung-Jun)

North Korea instituted a nationwide lockdown Thursday after reporting an omicron coronavirus variant outbreak in its capital, Pyongyang. The report marks the first time during the pandemic that the secretive, authoritarian country has acknowledged coronavirus cases within its borders, though outside experts have doubted the country’s previous claims of zero infections.

Acknowledging omicron cases in Pyongyang raises questions over whether the admission is a sign of deteriorating public health conditions and/or a signal that the country is willing to accept pandemic aid, including vaccines.

So far, North Korea’s government has rejected offers of COVID-19 vaccine supplies from the United Nation’s global vaccination effort, COVAX, and China’s domestically produced vaccines. North Korea is one of the few countries that has not run a public vaccination effort, and its 26 million people are believed to be largely unvaccinated.

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Despite unknowns, FDA officials make the case for annual fall COVID shots

Dr. Peter Marks, Director of the Center for Biologics Evaluation and Research within the Food and Drug Administration, testifies during a Senate Health, Education, Labor and Pensions Committee hearing on the federal coronavirus response on Capitol Hill on March 18, 2021 in Washington, DC.

Enlarge / Dr. Peter Marks, Director of the Center for Biologics Evaluation and Research within the Food and Drug Administration, testifies during a Senate Health, Education, Labor and Pensions Committee hearing on the federal coronavirus response on Capitol Hill on March 18, 2021 in Washington, DC. (credit: Getty | Pool)

The pandemic coronavirus will likely become a seasonal respiratory virus, much like influenza, requiring annual booster shots each fall, according to three top officials at the US Food and Drug Administration.

In a commentary piece published this week in the medical journal JAMA, the officials make a case for seasonal shots and caution that preparation for this winter’s potential surge needs to begin no later than next month.

“The timeframe to determine the composition of the COVID-19 vaccine for the 2022-2023 season, to use alongside the seasonal influenza vaccine for administration in the Northern Hemisphere beginning in about October, is compressed because of the time required for manufacturing the necessary doses,” the officials write. “A decision on composition will need to be made in the US by June 2022.”

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Nose Spray Vaccines Could Quash COVID Virus Variants

Three nasal spritzes, now in advanced trials, could trigger stronger immunity than shots in the arm

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Here’s Who Should Get a Second COVID Booster

An individual’s health risks, treatment access and local case levels come into play for those who are eligible

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Musk has “huge responsibility” to fight health misinfo on Twitter, WHO says

Tesla and SpaceX CEO Elon Musk presents a vaccine production device during a meeting September 2, 2020 in Berlin, Germany. Musk met with vaccine maker CureVac, with which Tesla has a cooperation to build devices for producing RNA vaccines.

Enlarge / Tesla and SpaceX CEO Elon Musk presents a vaccine production device during a meeting September 2, 2020 in Berlin, Germany. Musk met with vaccine maker CureVac, with which Tesla has a cooperation to build devices for producing RNA vaccines. (credit: Getty | Filip Singer)

Elon Musk has a “huge responsibility” to combat dangerous, potentially life-threatening health misinformation on Twitter, the World Health Organization said Tuesday.

The United Nation’s health agency commented on Monday’s news that the tech billionaire has struck a deal to purchase Twitter for $44 billion. WHO officials stressed how damaging misinformation and disinformation could be when it’s widely spread in digital spaces like Twitter.

“In cases like this pandemic, good information is life-saving,” Mike Ryan, executive director of the WHO’s Health Emergencies Programme, said. “In some cases, [it’s] more life-saving than having a vaccine in the sense that bad information sends you to some very, very bad places.”

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75% of US children have now had COVID, up from 44% due to omicron

A child arrives at an elementary school vaccination site for children ages 5 to 11 in Miami in November 2021.

Enlarge / A child arrives at an elementary school vaccination site for children ages 5 to 11 in Miami in November 2021. (credit: Getty | Bloomberg)

At least 75 percent of US children have now been infected with the pandemic coronavirus, up from roughly 44 percent before the omicron wave, according to a new study by the Centers for Disease Control and Prevention.

Children in the age groups of 0 to 11 and 12 to 17 have the highest infection rates and saw the most significant increases during the omicron wave compared with any other age group. About a third of all children in the country were newly infected during the omicron wave. Together, the data showcase just how poorly the country has done at shielding children—including those not yet eligible for vaccination—from the pandemic virus.

The new data dovetails with a study published by the CDC in February, which found that the peak rate of pediatric hospitalizations during the omicron wave was four times higher than the peak seen during the delta wave last fall. The largest increase was seen in children ages 0 to 4, who had a peak hospitalization rate five times higher than the peak amid delta.

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The Benefits of Hybrid Immunity, and Venturing Back to the Office: COVID Quickly, Episode 28

Today we bring you a new episode in our podcast series COVID, Quickly. Every two weeks, Scientific American’s senior health editors Tanya Lewis and Josh Fischman catch you up on the…

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#health, #public-health, #vaccines

Venturing Back to the Office and the Benefits of Hybrid Immunity: COVID Quickly, Episode 28

Today we bring you a new episode in our podcast series COVID, Quickly. Every two weeks, Scientific American’s senior health editors Tanya Lewis and Josh Fischman catch you up on the…

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#health, #public-health, #vaccines

New Vaccine Could Save Rabbits from Fatal Disease

Veterinarians and rabbit owners are racing to protect bunnies as a hemorrhagic disease spreads

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#animals, #conservation, #ecology, #endangered-species, #environment, #vaccines

COVID Vaccines plus Infection Can Lead to Months of Immunity

New research counters high-profile claims that people who had COVID don’t benefit from vaccination

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#health, #vaccines

Second Boosters, Masks in the Next Wave, and Smart Risk Decisions: COVID Quickly, Episode 27

Today we bring you a new episode in our podcast series COVID, Quickly. Every two weeks, Scientific American’s senior health editors Tanya Lewis and Josh Fischman catch you up on the…

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#health, #public-health, #vaccines

Pfizer, Moderna vaccines aren’t the same; study finds antibody differences

A vial of COMIRNATY (Pfizer/BioNTech) and a vial of Moderna COVID-19 vaccines.

Enlarge / A vial of COMIRNATY (Pfizer/BioNTech) and a vial of Moderna COVID-19 vaccines. (credit: Getty | Marcos del Mazo)

The mRNA-based COVID-19 vaccines made by Pfizer/BioNTech and Moderna have proven highly effective at priming our immune systems to fight the pandemic coronavirus—preventing substantial amounts of infection, severe disease, and death throughout several waves of variants. But, despite their similar design and efficacy, the two vaccines are not exactly the same—and our immune systems don’t respond to them in the same way.

An early hint of this was some real-world data that found startling differences in the effectiveness of the two vaccines, despite both shots performing nearly identically in Phase III clinical trials—95 percent and 94 percent. Amid last year’s delta wave, a Mayo Clinic study found that Pfizer’s effectiveness against infection dipped to 42 percent while Moderna’s only fell to 76 percent.

According to a new study in Science Translational Medicine, such differences might be explained by evidence that the two vaccines spur the immune system to produce slightly different antibodies against SARS-CoV-2.

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With a second booster now authorized for some, the question is when to get it

A health worker administers a third dose of the Pfizer-BioNTech COVID-19 vaccine to an elderly resident at Ichilov medical center in Tel Aviv, Israel, on Monday, Aug. 2, 2021.

Enlarge / A health worker administers a third dose of the Pfizer-BioNTech COVID-19 vaccine to an elderly resident at Ichilov medical center in Tel Aviv, Israel, on Monday, Aug. 2, 2021. (credit: Getty | Bloomberg)

The US Food and Drug Administration on Tuesday announced the authorization of second booster doses of both the Pfizer/BioNTech and Moderna COVID-19 vaccines for people ages 50 and above, as well as certain immunocompromised people.

The FDA’s decision, which was made without consulting its panel of independent expert advisers, was expected this week.

“Current evidence suggests some waning of protection over time against serious outcomes from COVID-19 in older and immunocompromised individuals,” Peter Marks, the FDA’s top vaccine regulator, said in a statement. “Based on an analysis of emerging data, a second booster dose of either the Pfizer-BioNTech or Moderna COVID-19 vaccine could help increase protection levels for these higher-risk individuals.”

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Shanghai in lockdown as officials work to test all 26M residents

Medical workers in hazmat suits talk to a stopped driver.

Enlarge / A closed viaduct and tunnel leading to Pudong is seen in Shanghai, China, March 28, 2022. (credit: Getty | Future Publishing)

Coronavirus cases in China are spiking to record highs, leading officials in the Chinese financial hub of Shanghai to make the snap decision late Sunday to lock down the city of around 26 million people. For weeks, officials denied that they would institute lockdowns in response to rising cases.

But this month, the spread of the ultratransmissible omicron variant has driven China’s highest case rise in the pandemic, and Shanghai has seen some of the highest numbers. On Sunday, the country reported more than 6,000 new cases, with 3,500 of those in Shanghai. According to data tracking by The New York Times, the number of daily new cases has increased 233 percent in the past 14 days. The current case count is the highest yet for the country, which saw its previous peak in February 2020 when new cases reached just above 3,000 a day.

Starting March 28, Shanghai residents on the east side of Huangpu River entered a four-day home lockdown and mass testing campaign. From April 1 to 5, people on the west side will take their turn locking down and testing. Officials are aiming to test the entire population during the sequential lockdowns, sending health workers in white hazmat suits to residents’ front doors.

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Vaccines Remain Effective against BA.2, but Protection from Infection Wanes over Time

Such protection declines within months of the mRNA COVID vaccines’ third dose. Yet the vaccines continue to ward off severe disease

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Pfizer CEO pushes for fourth shots as anxiety over BA.2 subvariant rises

A man in an open-collared suit addresses a woman in a matching chair.

Enlarge / Pfizer Chairman and CEO Dr. Albert Bourla speaks onstage at the 2022 SXSW Conference at JW Marriott Austin on March 14, 2022 in Austin. (credit: Getty | Chris Saucedo)

While US health experts closely monitor upticks of COVID-19 cases in Europe as well as the global rise of the omicron subvariant BA.2, Pfizer is renewing calls for fourth doses of COVID-19 vaccine.

In an interview Sunday on CBS’ Face the Nation, Pfizer CEO Albert Bourla said that a fourth dose—aka a second booster—is “necessary.”

“The protection what we are getting from the third [doses], it is good enough—actually, quite good for hospitalizations and deaths,” Dr. Bourla said. But, “it’s not that good against infections” with omicron, and “it doesn’t last very long.” He reported that Pfizer is “working very diligently” to come up with a new dose that will protect against all variants and provide longer-lasting protection.

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People Are Getting COVID Shots Despite Hesitation

Recent findings blow up assumptions about who chooses to get vaccinated against the disease

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#health, #health-care, #public-health, #vaccines

Florida’s latest anti-health political stunt is to cast doubt on kids’ vaccines

Florida Gov. Ron DeSantis speaks at the Conservative Political Action Conference (CPAC) at the Rosen Shingle Creek on February 24, 2022, in Orlando, Florida.

Enlarge / Florida Gov. Ron DeSantis speaks at the Conservative Political Action Conference (CPAC) at the Rosen Shingle Creek on February 24, 2022, in Orlando, Florida. (credit: Getty| Joe Raedle)

Sometimes fighting a common enemy can unite a country, inspiring solidarity, bravery, and sacrifice. Ordinary citizens become heroes; leaders become icons. But sometimes—like in the United States right now—a common enemy wins by exploiting divisions.

As the US faced down a global viral threat two years ago, its people and leaders couldn’t seem more factious and impotent against a shared foe. Most Americans seemed to embrace the evolving consensus of public health experts, heeding advice to follow basic and simple measures, like getting a safe and effective vaccine and wearing a mask. These measures might otherwise seem uncontroversial and like minor inconveniences. A vocal minority of Americans, however, leaned hard in the opposite direction, claiming that joining the fight against a deadly enemy infringed on their freedom—as if the US Constitution enshrined the right to freely spread disease and suffering to family, friends, and fellow Americans.

Two years later, the US has tallied nearly 80 million cases. Nearly 960,000 people—grandparents, parents, siblings, children, infants, precious loved ones all—are dead. Nine hundred and sixty thousand. It’s an unfathomable loss—a toll one might at least hope would stir reconsideration in those not fighting for the greater good. Yet, here we are two years and nearly 1 million deaths later, and many have not changed their positions. Some Americans still deny the devastating realities of the pandemic. Some spread dangerous misinformation, twist facts, and squabble over trivial points as lives hang in the balance.

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These Vaccines May Be Ready to Take On New COVID Variants

Novel types of jabs could enhance T-cell immunity or protect against emerging strains

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#health, #public-health, #vaccines

Tracking Outbreaks Through Sewers, and Kids’ Vaccines on Hold Again | COVID Quickly, Episode 24

Today we bring you a new episode in our podcast series COVID, Quickly. Every two weeks, Scientific American’s senior health editors Tanya Lewis and Josh Fischman catch you up on the…

— Read more on ScientificAmerican.com

#health, #vaccines

Why covering anti-evolution laws has me worried about the future of vaccines

Why covering anti-evolution laws has me worried about the future of vaccines

Enlarge (credit: Aurich Lawson)

Prior to the pandemic, the opposition to vaccines was apolitical. The true believers were a small population and confined to the fringes of both major parties, with no significant representation in the political mainstream. But over the past year, political opposition to vaccine mandates has solidified, with a steady stream of bills introduced attempting to block various ways of encouraging or requiring COVID vaccinations.

This naturally led vaccine proponents to ask why these same lawmakers weren’t up in arms in the many decades that schools, the military, and other organizations required vaccines against things like the measles and polio. After all, pointing out logical inconsistencies like that makes for a powerful argument, right?

Be careful what you wish for. Vaccine mandate opponents have started trying to eliminate their logical inconsistency. Unfortunately, they’re doing it by trying to get rid of all mandates.

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#behavioral-science, #evolution, #science, #social-science, #vaccines

COVID Vaccines Can Be Safe for People with Prior Allergic Reactions

My colleagues and I use a protocol to inoculate safely, and the CDC needs to revise its recommendations

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For T-cells, omicron is nothing unusual

Image of two spherical objects with a set of processes between them.

Enlarge / False-color image of a T-cell (orange) latching on to a cell in preparation for killing it. (credit: Getty Images)

From the start, the omicron variant had people worried because its version of the spike protein carried mutations in many of the sites that are recognized by antibodies. This meant that antibodies generated to combat earlier variants like delta were less likely to recognize the newcomer. These fears have played out in the form of lowered immunity to omicron, along with the failure of some antibody-based therapies.

But all those fears were focused on the immune system’s antibody response; the immune system also produces T-cells that recognize the virus, and it’s not clear how omicron affected their response. Based on two recently published papers, the answer is “not much at all,” which could help explain why the vaccines continue to protect from severe disease.

Those other cells

The T-cell-based immune response works very differently from that of antibody-producing cells. It relies on the fact that all cells chop up a small fraction of the proteins they make. Specialized proteins then grab on to some of the resulting protein fragments and display them on the cell’s surface. Once on the surface, they can be recognized by a receptor on the surface of T-cells.

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#biology, #covid-19, #immunology, #medicine, #pandemic, #sars-cov-2, #science, #t-cells, #vaccines

Omicron may have FDA rethinking vaccine strategy for kids under 5

A small person looks at the band-aid being applied to their arm.

Enlarge / A child getting a vaccination on February 19, 2021, in Bonn, Germany. (credit: Getty | Ute Grabowsky)

The Food and Drug Administration may be reconsidering its criteria for authorizing COVID-19 vaccine doses for children under age five, according to Scott Gottlieb, a former FDA commissioner and a current board member of vaccine-maker Pfizer. This opens the possibility that vaccine-ineligible youngsters could get protection from severe COVID-19 sooner than anticipated.

In an interview Sunday, Dr. Gottlieb told CBS’s Face the Nation that he sensed a shift in federal health officials’ thinking on the younger group. “And I’m hopeful that you could see some movement on trying to entertain that application earlier,” he said. “Ultimately, the decision resides with FDA, but there is some indication that there may be an early reaction on that application.”

If Gottlieb’s inkling is correct, vaccines could begin going into little arms as soon as March.

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#children, #covid-19, #fda, #science, #scott-gottlieb, #vaccines

How Many COVID Vaccine Boosters Will We Need?

Endless boosting might not be a practical or sustainable strategy, scientists say

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OSHA will try a different route to a vaccine mandate for businesses

Image of a gloved hand holding a cotton ball to a person's arm.

Enlarge (credit: OSHA)

On Tuesday, the Occupational Safety and Health Administration (OSHA) announced it was withdrawing its planned vaccine mandate for businesses with 100 or more employees. The decision comes in the wake of a Supreme Court ruling that blocked OSHA from implementing the mandate while lawsuits opposing it made their way through lower courts.

But the agency also indicated it as still working on getting the mandate implemented via a completely different, albeit slower, mechanism.

OSHA’s initial attempt to implement a vaccine mandate was done under a clause of US law that allows the agency to issue temporary emergency standards in response to “new hazards.” Reasoning that SARS-CoV-2 represents a new hazard, the emergency standard would require vaccination or testing and apply to companies with 100 or more employees, provided those employees were not consistently working outdoors.

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Up to 76% of COVID vaccine side effects are just in people’s heads, study finds

Signage indicates a post-vaccination recovery area to monitor for any immediate side effects.

Enlarge / A drive-up COVID-19 vaccination site from Renown Health on December 17, 2020, in Reno, Nevada. (credit: Getty | Patrick Fallon)

Even before their rollout, a distinct feature of safe and effective COVID-19 vaccines has been their “reactogenicity“—that is, their tendency to cause mild symptoms that signal immune responses firing up after a shot, particularly the second one. As vaccine supplies unfurled in the US last year, families, friends, and coworkers swapped stories of their harrowing post-jab days, often recalling fevers, chills, fatigue, and general crumminess.

Although those experiences are unquestionably real, their connection to the vaccines may not be. As more and more results from randomized-controlled vaccine trials hit science journals, researchers kept noting that, while trial participants often reported mild symptoms after shots, so too did the participants who received placebos—and not at trivial levels.

People are often familiar with “placebo effects,” which is when an inert intervention leads people to report health benefits that couldn’t possibly have been caused by the faux treatment. Placebo effects are well-documented and real—in that people can indeed experience a certain extent of psychosomatic benefits. A placebo will not treat serious medical conditions, such as cancer, but it could, for example, lead people to feel they have more energy or less general discomfort.

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COVID Quickly, Episode 21: Colds Build COVID Immunity, and the Omicron Vaccine Delay

Today we bring you a new episode in our podcast series COVID, Quickly. Every two weeks, Scientific American’s senior health editors Tanya Lewis and Josh Fischman catch you up on the…

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Pfizer and Moderna expect seasonal booster shots after omicron wave

EINDHOVEN, NETHERLANDS - 2022/01/08: A vial containing Moderna COVID-19 booster vaccine at a vaccination centre.

Enlarge / EINDHOVEN, NETHERLANDS – 2022/01/08: A vial containing Moderna COVID-19 booster vaccine at a vaccination centre. (credit: Getty | SOPA Images)

As the US weathers record COVID-19 cases from the ultra-transmissible omicron variant, vaccine makers are thinking about future waves—and the shots that could help prevent them.

Leading mRNA vaccine makers Moderna and Pfizer/BioNTech are currently working up omicron-specific versions of their vaccines, which could be ready in a matter of months. And according to recent interviews, they expect that such boosters will be used as annual shots, which could be given in the fall for the next several years until global transmission dies down.

“I think the reality is that this is going to become an annual vaccination, at least for a period of time,” Scott Gottlieb, former Food and Drug Administration commissioner and Pfizer board member, said Sunday on CBS’s Face the Nation. “We don’t know what the epidemiology of this infection is going to be over the long run, but certainly over the next couple of years, you can envision boosters becoming an annual affair.”

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What’s Holding Up New Omicron Vaccines?

Vaccine makers worry yet another variant will start dominating in the months it takes to roll out shots against this one

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Supreme Court on vaccine mandates: Hospitals OK, general employment a no

Statuary and facade outside neoclassical federal building.

(credit: Getty Images)

The Biden administration has made vaccine mandates central to its attempts to limit the impact of the COVID-19 pandemic. Or at least it has tried to; various states and other organizations have used the courts to challenge the federal government’s authority to impose these mandates. Last week, the Supreme Court heard arguments regarding two of the most significant mandates: one for all hospital workers issued by the Department of Health and Human Services (HHS), and a second for all employees of large companies issued by the Occupational Safety and Health Administration (OSHA).

By the time the cases were argued before the Supreme Court, the HHS rule was already blocked by a stay issued by a lower court. By contrast, the OSHA rules had seen a lower court lift earlier stays, leaving it on the verge of enforcement.

On Thursday, the Supreme Court issued expedited rules that reflected the tone of the questioning the week before. The OSHA rule is now subject to a stay that blocks its implementation, a decision that saw the court’s three liberal justices issue a dissent. The stay against the HHS rules, by contrast, was lifted, but only by a close 5-4 ruling.

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Immune system vs. virus: Why omicron had experts worried from the start

Illustration of antibodies responding to an infection of SARS-CoV-2.

Enlarge / Illustration of antibodies responding to an infection of SARS-CoV-2. (credit: Getty Images/Kateryna Kon/Science Photo Library)

Right from omicron’s first description, researchers were concerned about the variant of the SARS-CoV-2 virus. Looking over the list of mutations it carried, scientists could identify a number that would likely make the variant more infectious. Other mutations were even more worrying, as they would likely interfere with the immune system’s ability to recognize the virus, allowing it to pose a risk to those who had been vaccinated or suffered from previous infections.

Buried in the subtext of these worries was a clear implication: Scientists could simply look at the sequence of amino acids in the spike protein of a coronavirus and get a sense of how well the immune system would respond to it.

That knowledge is based on years of studying how the immune system operates, combined with a lot of specific information regarding its interactions with SARS-CoV-2. What follows is a description of these interactions, along with their implications for viral evolution and present and future variants.

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Biden’s vaccine mandates come before the Supreme Court

The US Supreme Court building in Washington DC.

Enlarge / The US Supreme Court building in Washington, DC. (credit: Getty Images | Mike Kline)

On Friday, the Supreme Court heard arguments in two cases that could severely limit the federal government’s ability to set public health policy during the pandemic. At issue is whether existing health and safety authority given to federal agencies by Congress is broad enough to cover the pandemic or whether Congress needs to step in and explicitly authorize the agencies’ actions.

The arguments occur as the US sees an unprecedented surge in COVID-19 cases. Indeed, two of the state lawyers arguing against these new public health measures were caught up in that surge and had to participate in the hearings remotely.

For and against

Two separate cases are being heard today, both regarding executive actions taken by the Biden administration. The first case involves a rule, issued by the Department of Health and Human Services (HHS), covering all health care workers at facilities that accept Medicare and Medicaid. The rule requires these workers to be vaccinated unless they are exempted on medical or religious grounds. The second case involves a vaccine-or-test mandate issued by the Occupational Safety and Health Administration (OSHA); the mandate would apply to any businesses with 100 or more employees.

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Tracking Facebook connections between parent groups and vaccine misinfo

Tracking Facebook connections between parent groups and vaccine misinfo

Enlarge (credit: Getty | Joe Amon)

Misinformation about the pandemic and the health measures that are effective against SARS-CoV-2 has been a significant problem in the US. It’s led to organized resistance against everything from mask use to vaccines and has undoubtedly ended up killing people.

Plenty of factors have contributed to this surge of misinformation, but social media clearly helps enable its spread. While the companies behind major networks have taken some actions to limit the spread of misinformation, internal documents indicate that a lot more could be done.

Taking more effective action, however, would benefit from more clearly identifying what the problems are. And, to that end, a recent analysis of the network of vaccine misinformation provides information that might be helpful. It finds that most of the worst misinformation sources are probably too small to stand out as being in need of moderation. The analysis also shows that the pandemic has brought mainstream parenting groups noticeably closer to groups devoted to conspiracy theories.

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FDA authorizes booster doses for 12- to 15-year-olds, shortens interval for adults

A health worker administers a third dose of the Pfizer-BioNTech COVID-19 vaccine to an elderly resident at Ichilov medical center in Tel Aviv, Israel, on Monday, Aug. 2, 2021.

Enlarge / A health worker administers a third dose of the Pfizer-BioNTech COVID-19 vaccine to an elderly resident at Ichilov medical center in Tel Aviv, Israel, on Monday, Aug. 2, 2021. (credit: Getty | Bloomberg)

As the ultra-transmissible omicron coronavirus variant bears down on the US, the Food and Drug Administration on Monday announced a set of sweeping changes to the availability of Pfizer-BioNTech booster doses.

The regulator expanded access to third doses by authorizing their use for kids 12 to 15 years old. The agency also shortened the interval at which adults and children 12 and up can get a booster after their second dose—moving the time from six months to only five months. Last, the FDA made third doses available to immunocompromised children ages 5 to 11 who may not mount a strong response from only the first two doses.

The FDA’s moves are motivated by omicron and backed by data from Israel, which has a booster program further along than that of the US. In fact, Israeli officials on Monday began offering fourth doses (second booster doses) of the Pfizer-BioNTech vaccine to people ages 60 and over in an effort to sustain high levels of protection in the population. The omicron variant, which is currently powering a vertical rise in cases in the US, has been found to thwart protection from only two vaccine doses, but it can still be defeated with booster doses.

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#biontech, #booster, #cases, #cdc, #coronavirus, #covid-19, #fda, #infectious-disease, #omicron, #pfizer, #science, #vaccines

New data on using J&J vaccine to boost itself

Image of injection syringes.

Enlarge (credit: RAJESH JANTILAL / GETTY IMAGES)

Based on various measures, the Johnson & Johnson COVID-19 vaccine has appeared to be less effective than those based on mRNA technology. It has also been associated with some rare blood clotting complications that recently caused the CDC to revise its endorsement of the vaccine. Still, the vaccine is easy to produce, transport, and store, and there have been some indications that it provides longer-lasting protection than some alternatives. And there have also been indications that at least some of the efficacy differences came from its use as a single-dose vaccine.

With all vaccines now expected to include a booster significantly after the initial vaccine dose, we’re starting to get a sense of how the J&J vaccine performs in more than one dose. Early results indicated that a J&J vaccine boosted by an mRNA dose provides a big increase in protective antibodies. But a J&J/J&J combination didn’t look to be as effective.

Recent research preprints, however, may indicate that the protection continues to increase over time, engages non-antibody-producing immune cells, and provides some protection against the omicron variant.

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A COVID Vaccine for All

With proved technology and no-frills tech transfer, CORBEVAX is poised to reach hundreds of millions in the coming weeks

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