On the brink of ruin, Juul files emergency petition to fight FDA ban

Packages of Juul e-cigarettes are displayed for sale in the Brazil Outlet shop on June 22, 2022 in Los Angeles, California.

Enlarge / Packages of Juul e-cigarettes are displayed for sale in the Brazil Outlet shop on June 22, 2022 in Los Angeles, California. (credit: Getty | Mario Tama)

With its business going up in smoke, e-cigarette giant Juul filed an emergency motion Monday to halt the Food and Drug Administration’s decision to deny the company authorization to market any of its products in the US, effectively forcing it out of business.

The decision was leaked to The Wall Street Journal last Wednesday, June 22, and the regulator publicly announced the decision Thursday. On Friday, a panel of federal appeals court judges granted Juul a temporary administrative stay, allowing the company to continue to sell its products while the court reviews Juul’s emergency petition to halt the FDA’s decision. Juul had until noon Monday to submit its petition. The administrative stay is not based on the merits of Juul’s argument in any way, the judges noted.

Meanwhile, The Wall Street Journal reported Friday that in addition to fighting the FDA denial, Juul is also considering filing for bankruptcy. The report cited unnamed people familiar with the matter. Juul did not immediately respond to Ars’ request for comment regarding a possible bankruptcy filing.

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#e-cigarettes, #fda, #juul, #medicine, #nicotine, #policy, #science

FDA reportedly preparing to force Juul products off the US market

Mint and menthol pods for Juul Labs Inc. e-cigarettes are displayed for sale at a store in Princeton, Illinois, in September 2019.

Enlarge / Mint and menthol pods for Juul Labs Inc. e-cigarettes are displayed for sale at a store in Princeton, Illinois, in September 2019. (credit: Getty | Bloomberg)

The Food and Drug Administration is reportedly preparing to deny authorization of Juul’s tobacco- and menthol-flavored products, effectively forcing the e-cigarette giant out of the US market, according to a report by The Wall Street Journal.

In their reporting, the Journal cited unnamed people familiar with the matter, who also said the FDA could announce its denial as early as today, Wednesday, June 22.

If the report is accurate, the move will come on the heels of an FDA announcement on Tuesday that the regulator is working on plans to establish a maximum nicotine level for cigarettes and other combusted tobacco products. It’s a move aimed at making the products less appealing to youth, less addictive, and less deadly.

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#biology, #e-cigarettes, #fda, #juul, #medicine, #nicotine, #science, #tobacco, #vaping

As US crawls out of baby formula crisis, troubled plant floods, shuts down again

The Abbott manufacturing facility in Sturgis, Michigan, on May 13, 2022.

Enlarge / The Abbott manufacturing facility in Sturgis, Michigan, on May 13, 2022. (credit: Getty | Jeff Kowalsky)

As the US struggles to recover from a dire infant formula shortage, the Abbott formula plant at the center of the crisis has again shut down—this time due to flooding from heavy rain on Monday.

The plant in Sturgis, Michigan, is the largest formula factory in the US and is operated by Abbott, one of the largest formula manufacturers in the county. The facility had previously shut down in February, driving a nationwide shortage of infant and specialty formulas to a critical point, but had managed to reopen on June 4.

The February closure occurred as the Food and Drug Administration investigated severe bacterial infections in four infants, two of whom died. All of the infants had consumed formula from the plant, and FDA investigators found that the same kind of bacteria infecting the infants—Cronobacter sakazakii—was also lurking in multiple areas of the plant. Although data was limited on each of the infants’ cases, at least one container of formula from the plant tested positive for the strain of Cronobacter sakazakii infecting one of the infants.

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#abbott, #fda, #formula, #science

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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#children-under-5, #covid-19, #fda, #infants, #infectious-disease, #moderna, #pfizer, #pfizer-biontech, #public-health, #science, #toddlers, #vaccines

Moderna’s omicron-combo booster outcompetes current booster

Extreme close-up photo of a gloved hand holding a tiny jar.

Enlarge / A vial of the current Moderna COVID-19 vaccine. (credit: Getty | Ivan Romano)

A combination COVID-19 booster dose that targets the ancestral strain of SARS-CoV-2 and the initial omicron variant, BA.1, appears to outperform the current booster against both of those versions of the virus, Moderna reported Wednesday.

Specifically, Moderna says the combination booster increased neutralizing antibodies against omicron 8-fold, while the original booster only increased antibody levels around 4.4-fold.

The vaccine maker is angling to have this bivalent shot—dubbed mRNA-1273.214—be the go-to booster for seasonal shots this fall. The company will be submitting its data to the Food and Drug Administration in the coming weeks and says it hopes to have the bivalent booster available by late summer, if not early fall.

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#bivalent, #booster, #covid-19, #fda, #infectious-disease, #moderna, #omicron, #science, #subvariants, #vaccine, #variants

FDA advisors overwhelmingly endorse Novavax COVID-19 vaccine

Empty vials of the Novavax Inc. Nuvaxovid COVID-19 vaccine arranged at the Tegel Vaccine Center in Berlin, Germany, on Monday, March 7, 2022.

Enlarge / Empty vials of the Novavax Inc. Nuvaxovid COVID-19 vaccine arranged at the Tegel Vaccine Center in Berlin, Germany, on Monday, March 7, 2022. (credit: Getty | Bloomberg )

A committee of independent, expert advisors for the Food and Drug Administration voted overwhelmingly to authorize the two-dose Novavax COVID-19 vaccine Tuesday, with 21 of 22 committee members voting in favor of the vaccine and one member abstaining.

The endorsement is only for a two-dose primary series in adults, not for boosters. The FDA is not obligated to follow the advice of its committee—the Vaccines and Related Biological Products Advisory Committee (VRBPAC)—but the agency typically heeds its advice. If the FDA authorizes the vaccine, the Centers for Disease Control and Prevention will need to sign off on use before it becomes available.

The decision regarding the Novavax vaccine, which is already authorized in dozens of other countries, is not a straightforward one in the US. The vaccine has some advantages over currently approved vaccines but has several strikes against it.

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#biology, #clinical-trial, #covid-19, #fda, #infectious-disease, #medicine, #novavax, #public-health, #sars-cov-2, #science, #vaccine

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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#biology, #children-under-5, #covid-19, #fda, #medicine, #science, #vaccines

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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#authorization, #biontech, #children-under-5, #children-under-6, #clinical-trial, #covid-19, #fda, #omicron, #pfizer, #sars-cov-2, #science, #vaccines

FDA obliterates formula maker’s defense of contamination linked to baby deaths

The Abbott manufacturing facility in Sturgis, Michigan, on May 13, 2022.

Enlarge / The Abbott manufacturing facility in Sturgis, Michigan, on May 13, 2022. (credit: Getty | Jeff Kowalsky)

Formula maker Abbott continues to firmly deny that its infant formulas sickened four babies, killing two. The denial is despite the same dangerous bacteria that sickened the infants—Cronobacter sakazakii—being found at the company’s formula factory in Sturgis, Michigan, which the Food and Drug Administration alleges was producing formula “under insanitary conditions.” And at least one container of Abbott’s formula tested positive for the same Cronobacter sakazakii strain found infecting one of the infants.

Still, Abbott argues that the link hasn’t been confirmed, and its formula isn’t to blame. In a lengthy Twitter thread on May 13, the company made the blunt assertion: “The formula from this plant did not cause these infant illnesses.”

But that is a brazen and misleading claim, according to the Food and Drug Administration. In a press briefing Monday evening, agency officials thoroughly dismantled Abbott’s defense.

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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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#booster, #cdc, #children, #children-5-to-11, #covid-19, #fda, #pandemic, #pfizer-biontech, #sars-cov-2, #science, #vaccines

Baby formula shortage worsens as national out-of-stock rate hits 43%

A nearly empty baby formula display shelf is seen at a Walgreens pharmacy on May 9, 2022 in New York City.

Enlarge / A nearly empty baby formula display shelf is seen at a Walgreens pharmacy on May 9, 2022 in New York City. (credit: Getty | China News Service)

Shortages of infant and specialty formulas continue to worsen in the US, with the national out-of-stock rate hitting a high of 43 percent in the first week of May, according to data released this week from Datasembly, which tracks retail information.

With bare shelves in stores, purchase limits, and online price gouging and scams, parents across the country are struggling to feed formula-fed babies and children with medical conditions that necessitate specialized formulas. News reports are filled with parents driving hours to search stores for formula or posting pleas online. Some are even watering down formula or turning to recalled batches contaminated with dangerous bacteria.

The dire shortage is due to a combination of factors, including pandemic-related supply chain issues, product recalls, and inflation, according to Datasembly CEO Ben Reich.

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#abbott, #baby-formula, #cdc, #cronobacter, #fda, #formula, #infant-formula, #recall, #science, #shortage, #supply-chain

FDA puts the brakes on J&J vaccine after 9th clotting death reported

Boxes of Johnson & Johnson's Janssen COVID-19 vaccine at a vaccination site in Florida.

Enlarge / Boxes of Johnson & Johnson’s Janssen COVID-19 vaccine at a vaccination site in Florida. (credit: Getty | Paul Hennessy)

The US Food and Drug Administration limited the use of the Johnson & Johnson (Janssen) COVID-19 vaccine late Thursday, citing the risk of a very rare but severe clotting disorder called thrombosis with thrombocytopenia syndrome (TTS).

From now on, the J&J vaccine is only to be used in people ages 18 and up who are unable or unwilling to receive an alternative COVID-19 vaccine. That includes people who have had a life-threatening allergic reaction (anaphylaxis) to an mRNA COVID-19 vaccine, people who have personal concerns about mRNA COVID-19 vaccines and would otherwise not get vaccinated, and people who don’t have access to mRNA COVID-19 vaccines.

The limitation comes as the FDA and the Centers for Disease Control and Prevention have been closely monitoring people who received J&J COVID-19 vaccinations for TTS. To date, the agencies have identified and confirmed 60 cases of TTS linked to the vaccine, including nine deaths. That represents a rate of 3.23 TTS cases per million doses of J&J vaccine administered, and a rate of 0.48 TTS deaths per million doses of vaccine administered, the FDA said Thursday.

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#adenovirus, #blood-clots, #cdc, #covid-19, #fda, #infectious-disease, #jj, #johnson-johnson, #mrna, #public-health, #science, #tts, #vaccine

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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#boosters, #covid, #fda, #infectious-disease, #omicron, #public-health, #science, #vaccines, #variants

Moderna requests FDA authorization for COVID vaccine for kids under 6

Moderna requests FDA authorization for COVID vaccine for kids under 6

Enlarge (credit: Getty | Bloomberg)

In a move highly anticipated by parents the country over, Moderna announced Thursday that it has requested FDA authorization for its two-dose COVID-19 vaccines for children 6 months to 2 years, and 2 years to under 6 years.

If the Food and Drug Administration issues an emergency use authorization (EUA) for the vaccines, they will be the first such vaccines available to the age groups in the now nearly two-and-a-half-year-long pandemic. Parents of young, vaccine-ineligible children have been anxiously awaiting the availability of such vaccines, particularly as much of the country tries to move on from the pandemic even as the number of cases of the extremely contagious omicron subvariants continue to tick upward.

“We are proud to share that we have initiated our EUA submission for authorization for our COVID-19 vaccine for young children,” Moderna CEO Stéphane Bancel said in a statement Thursday morning. “We believe mRNA-1273 [the COVID-19 vaccine] will be able to safely protect these children against SARS-CoV-2, which is so important in our continued fight against COVID-19 and will be especially welcomed by parents and caregivers.”

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#antibodies, #authorization, #children-under-5, #children-under-6, #covid-19, #eua, #fda, #infectious-disease, #moderna, #public-health, #science, #toddlers, #vaccine

Fauci confirms parents’ nightmare: FDA may delay COVID vaccines for kids under 5

Fauci confirms parents’ nightmare: FDA may delay COVID vaccines for kids under 5

Enlarge (credit: Getty | Congressional Quarterly)

The Food and Drug Administration is considering holding off on reviewing Moderna’s COVID-19 vaccine for children under age 5 until it has data from Pfizer and BioNTech on their vaccine for young children. The plan would push back the earliest possible authorization for a vaccine in the age group from May to June—yet another blow to parents who are anxious to protect their young children as the rest of the country ditches pandemic precautions, despite recent upticks in cases.

The FDA’s plan to delay the review was first reported by Politico Thursday morning, with sources telling the outlet that FDA officials worry about green-lighting Moderna’s vaccine, only to find out just a few weeks later that Pfizer’s offers superior protection.

In an interview with CNN’s Kasie Hunt later in the day Thursday, top infectious disease expert Anthony Fauci confirmed that the regulator is considering waiting until summer, likely June, to authorize vaccines for kids under 5. Fauci said the delay was intended to avoid confusion about the vaccines, but he emphasized that he was not involved in the regulators’ decisions and couldn’t explain their thinking further.

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#biontech, #children-under-5, #children-under-6, #covid-19, #fda, #moderna, #omicron, #pfizer, #public-health, #sars-cov-2, #science, #vaccine, #young-children

Thousands report vomiting, diarrhea after eating Lucky Charms cereal

A bowl of General Mills Lucky Charms cereal.

Enlarge / A bowl of General Mills Lucky Charms cereal. (credit: Getty | Justin Sullivan)

The end of the rainbow may not have a pot of gold—but a pot of something entirely different.

Thousands of people have reported stomach pains, nausea, vomiting, and diarrhea after eating Lucky Charms, the “magically delicious” sugar-coated cereal fronted by a cartoon leprechaun that feebly tries to prevent hungry children from getting his colorful charm-shaped marshmallows. The illnesses have left many wondering if the latest lineup of charms includes hearts, stars, horseshoes, clovers, and tasty infectious bacteria.

The website iwaspoisoned.com, which collects consumer reports of food-borne illnesses, has received more than 3,000 complaints about the cereal from all over the US, most of which are from the past few weeks. Lucky Charms has now received more illness reports than any other individual product in the site’s 10-year history, according to Patrick Quade, founder of the site, who spoke with The Wall Street Journal.

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#cereal, #contamination, #fda, #foodborne-illnesses, #general-mills, #lucky-charms, #salmonella, #science

Meet the InspectIR COVID-19 Breathalyzer test just authorized by the FDA

Man providing a sample into the InspectIR COVID-19 Breathalyzer.

Enlarge / Man providing a sample into the InspectIR COVID-19 Breathalyzer. (credit: InspectIR)

The Food and Drug Administration on Thursday announced the authorization of the first breath-based test for COVID-19.

The InspectIR COVID-19 Breathalyzer offers highly accurate test results in about three minutes, without the need for uncomfortable swabbing or collection of hazardous samples. But, before you get your hopes up for a handheld device you can huff into as you head out the door, it’s not quite that convenient. The test requires a high-tech device about the size of a carry-on suitcase—demo versions are literally housed in hard-shelled roll-aboard cases—and it requires a trained technician to operate. To take the test, a person has to sit next to the traveling instrument and blow into it through a straw for about 10 seconds.

The instrument inside the luggage is actually performing gas chromatography-mass spectrometry (GC-MS), which is a gold-standard analytical technique to finely separate out the components of a mixture. Generally, GC-MS samples are vaporized and mixed with an inert carrier gas before going through a capillary column, which separates out components by their boiling point and polarity. Then those components are ionized and fragmented and further separated out by their mass-to-charge ratios. The end readout is various peaks on a gas chromatogram, with each peak having a unique mass spectrum, allowing for the unambiguous identification of specific compounds.

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#breathalyzer, #covid-19, #fda, #gc-ms, #sars-cov-2, #science, #test

Fitbit gains FDA approval for new atrial fibrillation-detection feature

The Fitbit app showing information on irregular rhythm notifications.

Enlarge / The Fitbit app showing information on irregular rhythm notifications. (credit: Google)

Google-owned wearable brand Fitbit announced Monday that it will soon introduce a new atrial fibrillation-detection feature to its devices.

According to a blog post from Google, Fitbit received clearance from the US Food and Drug Administration (FDA), clearing the way for the feature to be deployed to Fitbit wearables in the near future.

Google cites data from a global disease study to state that atrial fibrillation affects around 33.5 million people around the world. Citing another study, it claims that those who suffer from atrial fibrillation have five times as much stroke risk as others.

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#afib, #atrial-fibrillation, #fda, #fitbit, #google, #health, #irregular-heart-rhythm, #smartwatch, #tech, #wearables

Largest trial to date finds ivermectin is worthless against COVID

A box of Ivermectina medicine manufactured by Vitamedic in Brazil.

Enlarge / A box of Ivermectina medicine manufactured by Vitamedic in Brazil. (credit: Getty | SOPA Images)

The largest clinical trial to date on the use of the antiparasitic drug ivermectin against COVID-19 concluded that the drug is completely ineffective at treating the pandemic disease, according to results published in The New England Journal of Medicine late Wednesday.

The double-blind, randomized, placebo-controlled clinical trial was primarily designed to test if ivermectin could reduce the need for hospitalization among 1,358 COVID-19 patients who were at high risk of severe disease. Ivermectin did not, according to the international team of researchers behind the trial, dubbed TOGETHER. “We did not find a significantly or clinically meaningful lower risk of medical admission to a hospital or prolonged emergency department observation with ivermectin,” the researchers reported.

The folks with TOGETHER also found that the drug failed to reduce all other secondary outcomes of COVID-19, including the time to recovery, time to viral clearance on PCR test, time spent in the hospital, the need for mechanical ventilation, the duration of mechanical ventilation, death, or the time to death. “We found no important effects of treatment with ivermectin on the secondary outcomes,” the researchers wrote.

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#anti-parasitic, #clinical-trial, #covid-19, #fda, #infectious-disease, #ivermectin, #misinformation, #pandemic, #sars-cov-2, #science

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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#authorization, #biontech, #booster, #coronavirus, #covid-19, #fda, #infectious-disease, #moderna, #omicron, #pfizer, #public-health, #science, #vaccines

Please stop putting COVID-19 test solution in your eyes and nose, FDA says

A woman takes a swab as part of a COVID-19 antigen rapid test.

Enlarge / A woman takes a swab as part of a COVID-19 antigen rapid test. (credit: Getty | NurPhoto)

The Food and Drug Administration is alerting Americans to the potential dangers of at-home COVID-19 tests after receiving reports of people egregiously misusing them, resulting in injuries.

In a safety communication released Friday, the FDA said it had received reports of injuries after people used the kits’ liquid test solution as eye drops or stuck the solution up their noses. “The liquid test solution is not supposed to touch your body,” the FDA wrote sternly. The agency also reported that some children had been injured after putting test components in their mouths and swallowing the solution.

“The liquid solutions may include chemical ingredients, such as sodium azide, that help the test work properly or act as preservatives,” the FDA wrote. “The test chemicals can be irritating or toxic if they get on your skin, nose, or eyes or if they are swallowed.”

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#covid-19, #covid-19-tests, #fda, #rapid-tests, #safety, #science, #test-solution

Murky case for fourth doses now with FDA as protection wanes, BA.2 looms

The US Food and Drug Administration in Silver Spring, Maryland.

Enlarge / The US Food and Drug Administration in Silver Spring, Maryland. (credit: Getty | Xinhua News Agency)

Vaccine-makers Moderna and Pfizer have now both submitted requests for the US Food and Drug Administration to authorize fourth doses—second boosters—of their COVID-19 vaccines.

Pfizer, along with vaccine partner BioNTech, announced Tuesday that they had asked the FDA to authorize fourth doses for adults age 65 and above. The move followed days of Pfizer CEO Albert Bourla saying in press interviews that a fourth shot is “necessary” for everyone.

Late Thursday, Moderna announced that it, too, had asked the FDA to authorize fourth doses—for all adults. Moderna addressed the broader request in its announcement, saying it’s intended to “provide flexibility” for the FDA and the Centers for Disease Control and Prevention to decide for themselves who should get a fourth dose—whether it’s specific age groups and/or groups with higher risks of 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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#ba-2, #bourla, #cdc, #covid-19, #covid-19-vaccines, #fda, #fourth-dose, #fourth-shot, #omicron, #pfizer, #science, #vaccines

DOJ, FTC, FDA sue man who claims $60 herbal tea cures COVID

DOJ, FTC, FDA sue man who claims $60 herbal tea cures COVID

Enlarge (credit: B4B earth tea llc)

The Department of Justice, the Food and Drug Administration, and the Federal Trade Commission together filed a civil lawsuit against a New York man for falsely and repeatedly claiming that a $60 16-ounce bottle of herbal tea can prevent and cure COVID-19.

The agencies accused Andrew Martin Sinclair, who solely owns and operates B4B Earth Tea LLC, of selling snake oil and preying on vulnerable patients during a pandemic that has, to date, claimed the lives of more than 6 million people worldwide.

According to the lawsuit filed Thursday in the Eastern District Court of New York, Sinclair was warned multiple times by the federal agencies that his health claims for “Earth Tea” were illegal. Yet the Brooklyn resident, who goes by “Busta Sinclair,” continued to claim online and on social media that his herbal tea—said to be made of unnamed vegetables, aloe vera, honey, and bottled spring water—”works within minutes” to cure COVID-19 and can get someone “out of quarantine within 24 hours.”

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#covid-19, #doj, #fda, #ftc, #lawsuit, #science, #snake-oil, #tea

At-home COVID testing just got a lot smarter thanks to Cue Health

Cue Health's at-home molecular diagnostic test amplifies and detects viral RNA from the virus that causes COVID-19.

Enlarge / Cue Health’s at-home molecular diagnostic test amplifies and detects viral RNA from the virus that causes COVID-19.

Plenty of things have changed in the two years since the start of the COVID-19 pandemic. For example, think about how many people now know the difference between a rapid antigen test and a nucleic acid amplification test. Whether it’s for work, travel, or just peace of mind, a lot of us are a lot more familiar with having our nasal cavities poked than we used to be.

In fact, COVID diagnostics even invaded yesterday’s Super Bowl with an advertisement for a small LED-equipped white box from a company called Cue Health. The company has developed a fast and accurate at-home diagnostic test, and thanks to a proctored mode, in which your test is supervised by a doctor, its results will be accepted for things like international travel.

For those who don’t know their PCRs from their LFTs, here’s a quick primer. A rapid antigen test (also sometimes called a lateral flow test) looks for certain proteins from the surface of the virus. These tests are relatively cheap to produce and easy to use. They’re the kind that state and federal governments have made available to people for free.

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#covid-19, #cue-health, #diagnostic-test, #fda, #science

FDA, Pfizer abandon 2-shot COVID vaccine in kids under 5, citing new data

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, Pfizer, and BioNTech announced on Friday that they are abandoning plans to pursue the authorization of a two-dose regimen of COVID-19 vaccines for children ages six months to four years. Instead, they will again put the possibility of an authorization on hold as they await data on the efficacy of a third dose for the youngest children. That data is now expected in early April.

In a press release this afternoon, Pfizer and its partner BioNTech reported that COVID-19 cases among children enrolled in the initial two-dose trial “continue to accumulate according to the study protocol, and more data are being generated because rates of infection and illness remain high in children of this age, especially due to the recent omicron surge.”

“Given that the study is advancing at a rapid pace, the companies will wait for the three-dose data as Pfizer and BioNTech continue to believe it may provide a higher level of protection in this age group,” the press release continued.

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#biontech, #children, #covid-19, #fda, #pfizer, #science, #six-months-to-four-years, #under-5, #vaccine

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

FDA head: Omicron is a “natural disaster… most people are gonna get COVID”

A masked woman with a gray bob.

Enlarge / Dr. Janet Woodcock, acting commissioner of the Food and Drug Administration, testifies during a Senate Health, Education, Labor, and Pensions Committee hearing on Capitol Hill on January 11, 2022 in Washington, D.C. (credit: Getty | Shawn Thew)

US officials are comparing the ultra-transmissible omicron coronavirus variant to a natural disaster as the country continues to shatter records, logging over 1.4 million new COVID-19 cases Monday and seeing hospitalizations at all-time highs of over 140,000.

Officials are now bracing for the weeks ahead, which are expected to bring yet higher numbers of cases that will hamstring health care systems and other essential services nationwide.

“I think that we’re talking about a natural disaster,” Janet Woodcock, acting commissioner of the Food Drug Administration, said in a Senate Health Committee hearing Tuesday. “I think right now, we need to focus on continuity of operations for hospitals and other essential services as this variant sweeps through the population.”

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#cases, #coronavirus, #covid-19, #fda, #hospitalizations, #infectious-disease, #omicron, #public-health, #science, #woodcock

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

FDA gives emergency authorization to Pfizer’s COVID-19 pill

FDA gives emergency authorization to Pfizer’s COVID-19 pill

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COVID-19 patients as young as 12 can now be treated with Paxlovid, an antiviral pill developed by Pfizer, after the Food and Drug Administration issued an emergency use authorization on Wednesday. 

“Today’s authorization introduces the first treatment for COVID-19 that is in the form of a pill that is taken orally—a major step forward in the fight against this global pandemic,” said Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research. “This authorization provides a new tool to combat COVID-19 at a crucial time in the pandemic as new variants emerge and promises to make antiviral treatment more accessible to patients who are at high risk for progression to severe COVID-19.” 

In early November, Pfizer published trial results for the new oral medication, saying that it reduced hospitalizations and deaths due to COVID-19 by 89 percent. Although the results had not undergone peer-review, Paxlovid’s strong effectiveness moved an independent data-monitoring committee to recommend ending the trial early.

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#covid-19, #fda, #merck, #paxlovid, #pfizer, #sars-cov-2, #science

Details released on the Trump administration’s pandemic chaos

Image of a man speaking from behind a podium.

Enlarge / Scott Atlas, a White House adviser, used his position to advocate for allowing the SARS-CoV-2 virus to spread and tried to block testing for it, which would further that goal. (credit: MANDEL NGAN / Getty Images)

Over the past few months, the House Select Subcommittee on the Coronavirus Crisis has been investigating the previous administration’s haphazard and sometimes counterproductive response to the pandemic. As testimony was taken and documents were examined, some of the details of the conflicts between politicians and public health would sporadically come out via press releases from subcommittee members. But on Friday the group issued a major report that puts these details all in one place.

The report confirms suspicions about the Trump administration’s attempt to manipulate the public narrative about its response, even as its members tried to undercut public health officials. So, while reading may trigger a sense of “I thought we knew this,” having it all in one place with the evidence to back it up still provides a valuable function.

Sidelining the CDC

In late February of 2020, just as the pandemic was beginning to pick up in the US, the CDC held a press conference in which Nancy Messonnier issued stark warnings about the potential for COVID-19 to interfere with life in the US. The subcommittee heard testimony that her somber warning angered then-President Trump and, as a result, the CDC was blocked from holding any further press conferences for over three months, during which time the US experienced its first deadly surge of infections.

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FDA authorizes boosters for ages 16 and 17 ahead of holidays, omicron

FDA authorizes boosters for ages 16 and 17 ahead of holidays, omicron

Enlarge (credit: Getty | Noam Galai)

The Food and Drug Administration on Thursday authorized the Pfizer-BioNTech COVID-19 vaccine for use as a single booster dose in teens ages 16 and 17.

The authorization stands to expand access to boosters amid a crushing wave of delta transmission, fears over the looming omicron variant, and the approach of end-of-year holiday gatherings. Currently, boosters are open and recommended for all adults ages 18 and up.

Earlier this week, a crop of preliminary data suggested that boosters will likely be necessary to protect against the omicron variant, which appears to dodge protective immune defenses from both vaccination and prior infection. Previously, data indicated that vaccine effectiveness wanes against delta and previous variants after six months.

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#boosters, #cdc, #covid-19, #fda, #science, #teens, #vaccine

Womp, womp: Efficacy of Merck’s Thor-inspired COVID pill crumbles, vexing experts

A Merck sign stands in front of the company's building on October 2, 2013, in Summit, New Jersey.

Enlarge / A Merck sign stands in front of the company’s building on October 2, 2013, in Summit, New Jersey. (credit: Getty | Kena Betancur)

In a 13-to-10 vote, advisors for the Food and Drug Administration narrowly supported authorizing Merck’s Thor-inspired antiviral pill molnupiravir for use against severe COVID-19.

The FDA’s panel of advisors—the Antimicrobial Drugs Advisory Committee (AMDAC)—struggled in an all-day meeting Tuesday to weigh the drug’s risks, its modest benefits, and the limited available data. The latest analysis suggests that the pill is only 30 percent effective at preventing hospitalization and death from COVID-19 in people at high risk of severe disease. Meanwhile, the drug has the worrisome potential to cause mutations, leading advisors to agonize over whether it should be offered to pregnant people.

Molnupiravir’s final data and today’s vote is a significant disappointment from the early fanfare around the drug, which initially promised to be an easy-to-use oral drug to effectively prevent severe COVID-19. “Our prediction from our in vitro studies and now with this data is that molnupiravir is named after the right [thing]… this is a hammer against SARS-CoV-2 regardless of the variant,” Merck’s head of research and development, Dean Li, said last month.

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FDA authorizes Pfizer and Moderna COVID boosters for all adults

19 November 2021, Hamburg: A tray of prepared syringes for booster vaccinations with Moderna's vaccine.

Enlarge / 19 November 2021, Hamburg: A tray of prepared syringes for booster vaccinations with Moderna’s vaccine. (credit: Getty | Picture alliance)

The Food and Drug Administration has authorized booster doses of both the Pfizer-BioNTech and Moderna COVID-19 vaccines for all people ages 18 and up, the companies announced separately this morning.

The boosters are to be given at least six months after a person’s second dose and, according to Moderna, can be used for mix-and-match boosting. That is, people who received two Pfizer-BioNTech vaccine doses earlier this year could get a Moderna booster and vice versa.

Preliminary data released last month from a mix-and-match booster trial run by the National Institutes of Health found that Moderna boosters appeared to generate the highest antibody levels overall, including in people who had previously received two doses of the Pfizer-BioNTech vaccine. However, the trial used a full dose of the Moderna vaccine (100 micrograms) for a booster, whereas the FDA has authorized a half-dose shot (50 micrograms) for boosters. It’s unclear if the half dose offers the same edge over boosting with a third Pfizer-BioNTech shot, which is given at the same dosage as the first two shots (30 micrograms).

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At least 25 poisoned, 1 dead from “Real Alkalized Water,” CDC report reveals

Blue-tinted jug of Real Water-branded water.

Real Water sold in jugs. (credit: FDA)

At least 25 people in two states were likely poisoned by toxic batches of the “Re2al Alkalized Water,” including five children who suffered acute liver failure and one person who died.

That’s according to a report published by the Centers for Disease Control and Prevention Thursday, which lays out the findings of a multistate investigation into the toxic water. Health investigators suspect additional poisonings went undetected. They noted in their report that hospital records indicated an unusual spike in unexplained “toxic liver diseases” around the time of the poisonings.

The toxic water made headlines earlier this year when health investigators initially linked alkalized water sold by Nevada-based water company Real Water to severe illnesses in five children in Clark County, Nevada. But the new report from the CDC offers the most complete look at the identified cases and illnesses.

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Boosters for all is critical, not a luxury, Fauci says as FDA decision nears

A white-haired man in a face mask.

Enlarge (credit: Getty | Chip Somodevilla)

The Food and Drug Administration is expected to authorize booster doses of the Pfizer-BioNTech COVID-19 vaccine for all adults as early as Thursday, agency insiders told The New York Times Tuesday.

The reported timeline is remarkably fast-paced for the regulatory agency and comes as members of the Biden administration continue to suggest widespread boosting is necessary to bring the COVID-19 pandemic under control.

“I believe… that when we look back on this, we will see that boosters are likely a very critical part of the immunization regimen and not a bonus or a luxury,” top infectious disease expert Anthony Fauci told Reuters on Tuesday.

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Dubious $56,000 Alzheimer’s drug spurs largest Medicare price hike ever

Multistory glass building on a tree-lined campus.

Enlarge / Biogen Inc. headquarters in Cambridge, Massachusetts. Biogen Inc. shares soared after its controversial Alzheimer’s disease therapy was approved by US regulators. (credit: Getty | Bloomberg)

Seniors throughout the US will see a hefty increase to their health care premiums next year thanks in large part to Biogen’s Alzheimer’s drug, Aduhelm, which is priced at $56,000 per year and is not proven to be clearly effective at treating Alzheimer’s.

The Centers for Medicare & Medicaid Services (CMS) announced Friday that the standard monthly premium for Medicare Part B will rise from $148.50 in 2021 to $170.10 in 2022, an increase of $21.60 or roughly 14.5 percent. It is the largest increase ever in terms of dollars and among the largest percentage increases in recent years.

CMS officials said Friday that Aduhelm was responsible for about half of the rise in Part B premiums, according to the Associated Press. Though the CMS is still determining how it will cover Aduhelm under Part B, the agency said the prospect of paying for Aduhelm at all required “additional contingency reserves.”

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FDA authorizes Pfizer COVID-19 vaccine for children 5-11

FDA authorizes Pfizer COVID-19 vaccine for children 5-11

Enlarge (credit: Getty | Congressional Quarterly)

The Food and Drug Administration has issued an emergency authorization for the use of the Pfizer-BioNTech COVID-19 vaccine in children ages 5 to 11.

The FDA’s authorization follows the recommendation of its independent advisory committee, which earlier this week voted nearly unanimously in favor of authorizing the vaccine. The committee of 18 voting members voted 18 to 0 in favor, with one abstention.

In a day-long meeting Tuesday, advisors pored over data and analyses of the vaccine in the younger children, who will receive two shots of a 10-microgram dose—a third of the dosage used in people ages 12 years and up—three weeks apart. Data from clinical trials suggest that the smaller dose in children produces equally strong immune responses as those seen in older age groups while minimizing the risks of side effects.

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Children poisoned by birthday cake decorations loaded with lead, copper

Baby first birthday cake with lit candle.

Enlarge / Baby first birthday cake with lit candle. (credit: Getty )

A recent baking trend of using “luster dusts” to give cake frostings and decorations a shimmery look has poisoned young children with heavy metals in at least two states, health researchers warn in a new report published Friday.

A toxic birthday cake for a 1-year-old left six children (ages 1 to 11) severely ill with vomiting and diarrhea after an October 2018 birthday party in Rhode Island. One child needed to be taken to the emergency room.

Investigators from the Rhode Island Department of Health traced the illnesses to the cake’s thick layer of frosting laced with a rose gold “luster dust.” The cake was produced in a commercial bakery, and the health investigators identified three possible sources of the bakery’s luster dust. One was an importer who identified the dust as “fine copper powder” that was initially sold as “metallic pigment for consumer goods such as floor coverings.” Though the dust was labeled “nontoxic,” it was also labeled “nonedible.”

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#cake, #cdc, #children, #copper, #fda, #food-labeling, #heavy-metals, #lead, #nih, #poisoning, #science, #toxic

Kid COVID-19 vaccines get green light from FDA advisors

A nurse gives a boy a dose of the Pfizer vaccine at a COVID-19 vaccine clinic in Florida on the day before classes begin for the 2021-22 school year.

Enlarge / A nurse gives a boy a dose of the Pfizer vaccine at a COVID-19 vaccine clinic in Florida on the day before classes begin for the 2021-22 school year. (credit: Getty | Paul Hennessy)

A panel of independent medical experts advising the Food and Drug Administration voted 17 to 0 (with one abstention) this afternoon in favor of authorizing the Pfizer-BioNTech COVID-19 vaccine for use in children ages 5 to 11 years old.

The vote is a key step toward the first pediatric COVID-19 vaccine in the US. Next, the FDA will need to sign off on the recommendation from the advisory panel—the Vaccines and Related Biological Products Advisory Committee (VRBPAC)—and issue an emergency use authorization for the 5-to-11 age group. That FDA’s authorization is expected within days. Once that occurs, the federal government will begin shipping pediatric doses of the vaccine to states for distribution at clinics, pharmacies, and pediatricians’ offices.

But before doses can go into any little arms, a panel of independent experts for the Centers for Disease Control and Prevention will also need to weigh in. That panel—the Advisory Committee on Immunization Practices (ACIP)—is scheduled to meet November 2 and 3. If ACIP votes in favor of recommending use of the vaccine in children ages 5 to 11, CDC Director Rochelle Walensky will need to sign off on the committee’s recommendation. That would likely happen quickly, and after that, vaccinations can begin.

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#5-to-11, #authorization, #cdc, #children, #covid-19-vaccines, #fda, #myocarditis, #pfizer, #pfizer-biontech, #science, #vaccines

CDC advisory panel unanimously approves expanded COVID vaccine boosters

Image of vaccine vials and syringes.

Enlarge (credit: iStock / Getty Images)

On Thursday, the Centers for Disease Control’s expert advisory committee on vaccines met to vote on new guidelines for the use of boosters to sustain the immunity provided by the COVID-19 vaccines in use in the US. The day prior, the Food and Drug Administration issued an emergency use authorization (EUA) that greatly expanded the number of vaccinated people who could receive a booster shot. That set the stage for the CDC to determine whether the FDA approval should be adopted as formal health policy.

A key step in the CDC’s policymaking process is approval by its Advisory Committee on Immunization Practices (ACIP). While the CDC director isn’t bound to follow ACIP’s advice (and notably didn’t in an earlier booster decision), overruling ACIP is unusual. Given that ACIP has now voted unanimously to expand booster use to Moderna and Johnson & Johnson vaccine recipients, the CDC director will likely follow its guidance.

FDA sets the stage

On Wednesday, the FDA announced that it was expanding its EUA for COVID-19 vaccine booster shots. Earlier this month, the FDA approved Pfizer/BioNTech boosters for people who are six months out from receiving their initial doses and are at risk of exposure (like health care workers) or severe COVID cases (the elderly and those with health conditions). The CDC approved this guidance despite a split vote against it from its advisory committee.

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COVID vaccines for kids 5-11 up for preorder Wednesday ahead of FDA review

A thirteen-year-old celebrates getting the Pfizer-BioNTech COVID-19 vaccine in Hartford, Connecticut, on May 13, 2021.

Enlarge / A thirteen-year-old celebrates getting the Pfizer-BioNTech COVID-19 vaccine in Hartford, Connecticut, on May 13, 2021. (credit: Getty | JOSEPH PREZIOSO )

Starting tomorrow, October 20, states and other jurisdictions will be able to preorder doses of the Pfizer-BioNTech COVID-19 vaccine formulated for children ages 5 to 11, according to a federal planning document. The orders are in anticipation of a rollout that could begin as early as November 3.

The vaccine is not yet authorized by the Food and Drug Administration, and the Centers for Disease Control and Prevention has not yet given the green light for its administration. But US officials are wasting no time in preparing to vaccinate as many children as possible as quickly as possible. There are an estimated 28 million children in the US between the ages of 5 to 11, and the US government says it has enough vaccine doses for all of them. Vaccine doses are planned to roll out at pediatricians’ offices, pharmacies, health centers, and rural clinics when the time comes.

The Pfizer-BioNTech vaccine is currently available for people ages 12 and up. In late September, Pfizer and BioNTech submitted data to the FDA indicating that small doses of their vaccine—a third of the dose used for adults—could safely and robustly protect children ages 5 to 11 from COVID-19. On October 7, the companies formally requested that the FDA grant an Emergency Use Authorization (EUA) for the use of their vaccine in those youngsters.

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J&J boosters get nod from FDA advisors as agency eyes mix-and-match

Boxes of Johnson & Johnson's Janssen COVID-19 vaccine at a vaccination site in Florida.

Enlarge / Boxes of Johnson & Johnson’s Janssen COVID-19 vaccine at a vaccination site in Florida. (credit: Getty | Paul Hennessy)

A committee of independent advisors for the Food and Drug Administration on Friday voted unanimously in favor of authorizing a second dose of the Johnson & Johnson COVID-19 vaccine to everyone 18 years of age and older, two or more months after a person has received the first dose.

It is the third time the FDA’s advisory committee has recommended additional COVID-19 doses in recent weeks to bolster protection. But the reviewed data, discussion, and vote today were significantly different from the booster-authorization meetings for Pfizer/BioNTech and Moderna COVID-19 vaccines.

Dose two

The J&J vaccine has consistently lagged behind the two mRNA vaccines in efficacy against COVID-19. Some estimates have put the J&J vaccine’s effectiveness against COVID-19 hospitalization as low as 68 percent, while the two mRNA vaccines have seen estimates of effectiveness against hospitalization in the high 80s to low 90s. Recent data suggests that the mRNA vaccines’ protection against infection may start waning six or more months after primary doses—particularly in older and more vulnerable people. This data prompted the push for boosters. But such waning does not appear to be happening with the J&J vaccine.

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#booster, #covid-19, #fda, #johnson-johnson, #science, #vaccine, #vaccine-efficacy, #vaccine-safety

FDA advisors unanimously green-light Moderna boosters for people 65+, high-risk

Words and symbols adorn a large outdoor sign.

Enlarge / The Food and Drug Administration headquarters in White Oak, Maryland. (credit: Getty | Congressional Quarterly)

As expected, a committee of independent advisors for the Food and Drug Administration voted unanimously (19-to-0) Thursday afternoon in favor of authorizing a booster dose of Moderna’s COVID-19 vaccine for certain groups.

The groups flagged for boosting are individuals aged 65 and older, people ages 18 to 64 who are at risk of severe COVID-19 due to health concerns, and those 18 to 64 who are at risk of COVID-19 due to frequent institutional or occupational exposures, such as health care and essential workers. These are the same groups that were previously authorized to get a Pfizer/BioNTech booster.

As with the Pfizer/BioNTech boosters, the Moderna boosters are to be given six months or longer after the first two doses of Moderna’s mRNA vaccine.

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Mix-and-match COVID boosters are as good—if not better than—all the same shots

Extreme close-up photo of a gloved hand holding a tiny jar.

Enlarge / A vial of the current Moderna COVID-19 vaccine. (credit: Getty | Ivan Romano)

Mixing and matching COVID-19 vaccines for booster doses appears safe and as effective—if not more effective—than sticking with the same vaccine for a booster dose. That’s according to preliminary data posted online Wednesday from a clinical trial run by the National Institutes of Health.

The trial bolsters what some have long hoped: that mixing and matching vaccines could provide stronger, broader protection against the pandemic virus and all its variants.

The trial was not large enough to definitively indicate which combination of vaccines offers the best protection. And the early results, available on a preprint server, have not yet been peer-reviewed. But the preliminary trial findings do hint that Moderna’s mRNA vaccine may offer the strongest protection all around—backing up similar findings from earlier vaccine-effectiveness studies. The data also suggests that people who received the one-shot Johnson & Johnson vaccine may want to get a boost with one of the two mRNA vaccines, either Moderna’s or Pfizer/BioNTech’s.

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#antibodies, #covid-19, #covid-19-vaccines, #fda, #johnson-johnson, #moderna, #pfizer, #pfizer-biontech, #science, #vaccines

Biden administration expects J&J boosters in the next few weeks

Boxes of Johnson & Johnson's Janssen COVID-19 vaccine at a vaccination site in Florida.

Enlarge / Boxes of Johnson & Johnson’s Janssen COVID-19 vaccine at a vaccination site in Florida. (credit: Getty | Paul Hennessy)

Johnson & Johnson plans to seek authorization for a booster dose for its one-shot COVID-19 vaccine early this week, according to a report by The New York Times.

J&J is the last to apply for booster authorization among the makers of the three COVID-19 vaccines used in the US. Yet, it is the booster that many health officials are most eager to see. The vaccine, which uses a viral vector strategy rather than an mRNA-based design, is the only available COVID-19 vaccine given as just one shot. Its efficacy has lagged behind the other vaccines throughout the pandemic.

Still, Moderna and Pfizer-BioNTech, both mRNA-based vaccine, have already submitted booster applications to US regulators. On September 22, the Food and Drug Administration granted authorization for a booster dose of the Pfizer-BioNTech vaccine for certain groups of people. The decision was tense, with experts torn over whether a booster for the highly effective vaccine was widely needed.

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COVID-19 vaccines will be added to immunization list required for CA students

California Gov. Gavin Newsom talks with 7th grade students at James Denman Middle School on October 01, 2021 in San Francisco, California.

Enlarge / California Gov. Gavin Newsom talks with 7th grade students at James Denman Middle School on October 01, 2021 in San Francisco, California. (credit: Getty | Justin Sullivan)

California Governor Gavin Newsom on Friday announced that the state will add COVID-19 vaccines to the list of immunizations students are required to get to attend in-person public and private schools.

California is the first state to announce such plans. COVID-19 vaccines will join the ranks of vaccine for measles, mumps, polio, hepatitis B, pertussis, tetanus, and chicken pox, which are already required for school attendance.

The mandate isn’t immediate. The requirement will not kick in until the vaccine is fully approved by the Food and Drug Administration for school aged children. As such, the requirement will be phased in by grade groups—grades 7 through 12 and K-6—and begin at the start of the school term following full FDA approval.

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CDC director overrules experts, allows Pfizer boosters for health workers

CDC Director Rochelle Walensky testifies during a Senate committee hearing in July 2021.

Enlarge / CDC Director Rochelle Walensky testifies during a Senate committee hearing in July 2021. (credit: Stefani Reynolds-Pool/Getty Images)

Just past midnight last night, the director of the Centers for Disease Control and Prevention overruled a committee of independent advisers, allowing for use of a Pfizer/BioNTech vaccine booster dose in people with increased risk of occupational and institutional exposure to the pandemic coronavirus. That includes health care workers, front-line workers, teachers, day care providers, grocery store workers, and people who work or live in prisons and homeless shelters, among others.

Hours earlier, the CDC’s Advisory Committee on Immunization Practices (ACIP) concluded a two-day meeting on booster recommendations—and voted 9-6 against recommending boosters for this group.

“As CDC Director, it is my job to recognize where our actions can have the greatest impact,” Director Rochelle Walensky said in a statement. “At CDC, we are tasked with analyzing complex, often imperfect data to make concrete recommendations that optimize health. In a pandemic, even with uncertainty, we must take actions that we anticipate will do the greatest good.”

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