Since 2016, the US Food and Drug Administration has sought to crack down on fruity, sweet-flavoured e-cigarettes that hook teenagers on nicotine. But at least 20 brands continue to sell China-made disposable devices with kid-friendly flavours such as “peach blueberry candy” and “pineapple strawnana” at liquor stores, smoke shops and convenience stores in the United States, Reuters has found.

Since 2016, the US Food and Drug Administration has sought to crack down on fruity, sweet-flavoured e-cigarettes that hook teenagers on nicotine. But at least 20 brands continue to sell China-made disposable devices with kid-friendly flavours such as “peach blueberry candy” and “pineapple strawnana” at liquor stores, smoke shops and convenience stores in the United States, Reuters has found. Flavoured disposable vaping devices account for one-third of US e-cigarette sales, up from less than two per cent three years ago, according to a Reuters review of retail sales data. Their surge raises questions about the public health agency’s failure to rein in the booming flavoured e-cigarette market and its ability to enforce its own rules, some critics say. Disposable devices and their growing popularity Findings by Reuters are drawn from a dataset produced by IRI, a Chicago market research firm that uses scanner data and other information to track retail purchases. The IRI dataset, which measures purchases from Jan. 12, 2014, to June 12, 2022, provides a rare look at the rise of disposable flavoured-nicotine devices following the FDA’s crackdown on Juul Labs Inc, 35 per cent owned by Marlboro maker Altria Group Inc. The data shows for the first time that consumers spent more than $2 billion on the new generation of disposable e-cigarettes over the past year, surpassing Juul’s once-leading market share by about three percentage points since March. Read more: European Union proposed to ban use of flavoured heated tobacco products The data was shared with Reuters by an individual outside IRI, who declined to be identified. An IRI spokesperson said the company is “unable to confirm any information you’ve received from an outside source” and that the figures should not be attributed to IRI. According to a 2019 IRI press release, IRI measures purchases at retailers including more than 30,000 convenience stores. The FDA said in written responses to questions that it is “deeply committed to addressing the ongoing public health concerns around youth e-cigarette use” and “is constantly monitoring the changing marketplace.” The ban on Juul The FDA in January 2020 banned all flavours except tobacco and menthol in Juul and other cartridge-based e-cigarettes. In June, it sought to ban the sale of all Juul e-cigarettes. The agency has since put its order on hold, saying “there are scientific issues unique to the Juul application that warrant additional review.” Juul referred Reuters to previous statements saying it wants no underage consumers to use its products and that it looks forward to “re-engaging with the FDA” while the ban is on hold. Sweet-flavoured, disposable e-cigarettes began flooding the market in 2020, trying to capitalize on the former popularity of Juul’s cartridge-based device. Both varieties vaporize a liquid that contains nicotine, the addictive chemical that gives smokers a rush. Both contain roughly equal concentrations of nicotine. Disposable devices, which are pre-filled and priced at $15 to $25, can have five to 20 times the amount of liquid as a Juul cartridge, based on visits Reuters made to nine retailers selling both. Some products advertise that a user can take thousands of puffs of a single device. In contrast, a Juul, priced at roughly $10, requires users to add separate cartridges, or pods, of nicotine-laced liquid, priced at $20 to $25 per four-pack. Millions spend weekly on top sellers Three brands - Kangvape Onee Stick, Esco Bars and Breeze Smoke Breeze Pro - rang up weekly sales of more than $3 million apiece as of June 12, according to the data. Representatives of Esco Bars and Breeze Smoke said their products contain synthetic nicotine, a version of the addictive drug that is not derived from tobacco plants and was not under the FDA’s jurisdiction until Congress acted earlier this year. Both companies told Reuters they applied for FDA authorization in 2022. The FDA declined to disclose the names of synthetic nicotine products that applied. Darrell Suriff, CEO at Pastel Cartel, the Texas company that makes Esco Bars, said it spent nearly $3 million preparing applications to the FDA. Firms like his that try to follow the rules should not be penalized, he said: “There’s a lot of bad players in the industry ... We’re not one of them.” Jon Glauser, chief strategy officer for Hyde, in Buffalo, New York, another disposable brand with synthetic nicotine and sales of nearly $3 million per week, said he understands critics’ concerns that sweet-flavoured e-cigarettes appeal to teens, potentially addicting them. But adults “really do like flavours,” he said. Representatives at privately held Shenzhen Kangvape Technology Co did not respond to requests for comment. Filling a 'sweet' void Juul popularized e-cigarettes among teenagers starting in 2017. Juul’s cachet with teens faded after 2019 when it pulled mango, mint and fruit flavours under regulatory pressure, leaving room for dozens of other brands to step in. As sales of flavoured disposable devices have soared, Juul’s US market share fell to about 30 per cent, from more than 70 per cent in 2018 and 2019, according to the data. At Luxury Tobacco & Vape in Raleigh, North Carolina, a display for disposable Elf Bar recently offered more than a dozen flavours such as sour apple and rainbow candy. Juul occupied just a fraction of the shelf. Juul declined to comment on the display. Elf Bar did not respond to requests for comment. According to FDA rules, e-cigarettes cannot be sold in the United States unless their makers submitted scientific applications by September 2020 demonstrating why their products benefit public health. E-cigarettes containing synthetic nicotine had until May 14, 2022, to apply. Reuters provided the FDA with a list of more than two-dozen flavoured devices that the news agency found in stores and online, even though they were not on an FDA list of products that filed applications by 2020. The FDA declined to answer questions about whether the products Reuters identified had applied for the required authorizations. An FDA spokesperson pointed to the agency’s website, which stated: “Our compliance and enforcement work is a multi-step process that cannot happen overnight.” Mitch Zeller, who retired in April as the director of FDA’s tobacco unit, told Reuters there could be gaps on its list because the FDA needed cooperation from applicants in order to publicly list them. “Is FDA going to catch every single violation of the statute? No,” Zeller said, though he said targeting manufacturers that have not applied is FDA’s “number one priority.” The agency said on its website on Aug. 3 that “it is illegal” to sell any e-cigarettes using synthetic nicotine without its authorization. As of Aug. 15, the FDA had not granted authorization to any of them. Seizures Alex Morrin, 19, used Juul starting in 2017 when he was a high school freshman in the Tampa, Florida, area, drawn to its “fruit,” “creme” and “mint” flavours. After Juul eliminated those flavours, Morrin began buying fruity, sweet-flavoured disposable e-cigarettes, such as Cali Plus and HQD Cuvie Plus, made by Cali Pods and HQD Tech USA, both based in Florida. “They just tasted better, and there were more flavours,” he said. “They’re still all out there, and easy to get.” Cali Pods and HQD did not respond to requests for comment. After he began using e-cigarettes, he suffered headaches and nausea, then seizures that sent him to the hospital six times between January 2020 and last November. Morrin and his mother, Winna Morrin, said he had never experienced seizures before his e-cigarette addiction. Winna Morrin provided hospital records corroborating the seizures. Researchers have established no definitive link between vaping and seizures. The FDA told Reuters it is seeking to understand whether the devices’ “nicotine content or formulation may contribute to seizures.” Most reports of seizures from e-cigarettes come from youth, or young adult, users, the FDA said. WATCH WION LIVE HERE:

After Juul e-cigarettes, Americans rally behind 'candy' flavoured disposable e-cigs

Making basic healthcare facilities available to all, the US Food and Drug Administration on Tuesday announced it had signed the historic legislation that allows millions of Americans to buy hearing aids without any prescription, from over-the-counter.

Making basic healthcare facilities available to all, the US Food and Drug Administration on Tuesday announced it had signed the historic legislation that allows millions of Americans to buy hearing aids without any prescription, from over-the-counter. Up until now, the devices were not accessible if an individual did not have a medical subscription. Moreover, only a handful of retail stores sold the device, making accessibility a major issue. Reportedly, FDA changing the rules is expected to benefit nearly 30 million American adults. According to FDA, the finalised rules will reduce the red tapism in the industry. Moreover, it will allow a new class of hearing aids in the market which would not require any standard medical exam or a prescription from a doctor. “Today’s action by the FDA represents a significant milestone in making hearing aids more cost-effective and accessible,” Xavier Becerra, Health and Human Services Secretary was quoted as saying by AP. According to FDA estimates, of the 30 million Americans that need hearing devices, only 600,000 or one-fifth use the device, with the rest not willing to take the tedious doctor's prescription route. Not to forget, the devices are not cheap. A single pair of hearing aid and their fitting cost as much as $5,000 which puts a heavy dent in the patient's wallet and in most cases, is not covered under health insurance. Read More: After Juul e-cigarettes, Americans rally behind 'candy' flavoured disposable e-cigs FDA believes that the decentralisation of the process ought to bring the cost down as traditional manufacturers are expected to scale their operations. Experts predict that the hearing market, after the implementation of the new legislation, in a few years will resemble the eye care market where consumers are spoiled for choices and don't have to necessarily rely on prescriptions and medical exams. However, few caveats have been applied to make sure that patients do not come in harm's way. The new over-the-counter status won't apply to devices that are expected to be used by patients with severe hearing loss. Only a prescription will work in such cases. (With inputs from agencies) WATCH WION LIVE HERE:

Americans can buy hearing aids over-the-counter; FDA clears the way

For individuals with weak eyes, spectacles and eyeglasses are unquestionably a blessing. They allow you to walk without tripping over objects, read, and essentially just see what's in front of you. But they can also be a curse. It is very easy to forget them at home or in the car, they break easily, and Covid, masks have taught us that they fog up real easy, effectively blinding you. But what if you didn't have to wear those pesky glasses all the time? If you're living in the United States this is a possibility. The FDA (Food and Drug Administration) has recently approved an eye drop that can replace glasses.

Watch |&nbsp;WION Fineprint | US approves eye drops that could replace reading glasses

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This drug is called Vuity and it claims to improve age-related near-vision. As per an Express.co.uk report, the eye drops need to be applied once every six hours and starts working within 15 minutes of application.

According to the report, the medication is a formulated form of the well-known compound known as&nbsp;pilocarpine, and the researchers have developed&nbsp;it to&nbsp;quickly adapt to the pH of the tear film.

Also read |&nbsp;<a href="https://www.wionews.com/world/how-much-alcohol-to-drink-at-what-age-the-lancet-study-reveals-497554" hreflang="en">How much alcohol to drink at what age? The Lancet study reveals</a>

Utilising the eye's natural ability to constrict the pupil, the drop enhances near vision while preserving far vision.

The drop is most helpful for people between the ages of 40 and 55, according to the researchers' analysis of two randomised control trials involving 750 participants.

Moreover, they did not suffer any severe adverse effects; however, a few patients did report minor headaches and eye redness.

(With inputs from agencies)

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For individuals with weak eyes, spectacles and eyeglasses are unquestionably a blessing. They allow you to walk without tripping over objects, read, and essentially just see what's in front of you.

For individuals with weak eyes, spectacles and eyeglasses are unquestionably a blessing. They allow you to walk without tripping over objects, read, and essentially just see what's in front of you. But they can also be a curse. It is very easy to forget them at home or in the car, they break easily, and Covid, masks have taught us that they fog up real easy, effectively blinding you. But what if you didn't have to wear those pesky glasses all the time? If you're living in the United States this is a possibility. The FDA (Food and Drug Administration) has recently approved an eye drop that can replace glasses. Watch | WION Fineprint | US approves eye drops that could replace reading glasses This drug is called Vuity and it claims to improve age-related near-vision. As per an Express.co.uk report, the eye drops need to be applied once every six hours and starts working within 15 minutes of application. According to the report, the medication is a formulated form of the well-known compound known as pilocarpine, and the researchers have developed it to quickly adapt to the pH of the tear film. Also read | How much alcohol to drink at what age? The Lancet study reveals Utilising the eye's natural ability to constrict the pupil, the drop enhances near vision while preserving far vision. The drop is most helpful for people between the ages of 40 and 55, according to the researchers' analysis of two randomised control trials involving 750 participants. Moreover, they did not suffer any severe adverse effects; however, a few patients did report minor headaches and eye redness. (With inputs from agencies) Watch WION LIVE HERE: You can now write for wionews.com and be a part of the community. Share your stories and opinions with us here.

US FDA approves new eye drops that can replace spectacles and fix near-vision

The baby formula scarcity the US state of Michigan may ease up with the resumption of operations at a crucial baby formula plant that was shut down by torrential rains last month. The largest manufacturer of baby formula in the US, Abbott Laboratories, stopped its production at its main facility in Sturgis, Michigan, on June 16 due to storms that caused severe flooding. This happened just two weeks after it started its production after being shut down in February as a result of an examination that discovered contamination at the facility, reported by the Guardian.

John Koval, Abbott spokesperson, said that production has resumed for EleCare, a specialised formula for infants with digestive or food allergies, on July 1. He further added that the production of "Similac," a leading product, will be resumed soon.

Also read |&nbsp;<a href="https://www.wionews.com/world/fda-looks-into-death-of-baby-after-drinking-abbotts-formula-491111">FDA looks into death of baby 'after drinking Abbott's formula'</a>

There was a scarcity in the country as a result of the stoppage and subsequent recall of many brands of infant formula. The factory was halted for manufacturing Similac and other products after an FDA investigation discovered contamination as a result of four bacterial infections discovered in baby formula from the facility plant.Two of the babies died. Later, the president addressed the shortage by importing thousands of pounds of formula from Europe.

Watch |&nbsp;Amid ongoing gun violence, US is battling lack of tampons, baby formula shortage

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As per the officials, it was believed that the firm would return in June to help with the supply chain. However, the expectations were dashed by the disastrous rains a few weeks later. It is still unclear when the baby formula will return to the US store shelves.

Also read |&nbsp;<a href="https://www.wionews.com/world/37-million-bottles-of-baby-formula-headed-to-united-states-as-part-of-operation-fly-formula-484255">3.7 million bottles of baby formula headed to United States as part of Operation Fly Formula</a>

Abbott, one of the four businesses that make nearly 90 per cent of the baby formula consumed in the United States, supplies the formula to about half a million of the infants who receive Wic benefits.

(With inputs from agencies)

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The baby formula scarcity the US state of Michigan may ease up with the resumption of operations at a crucial baby formula plant that was shut down by torrential rains last month.

The baby formula scarcity the US state of Michigan may ease up with the resumption of operations at a crucial baby formula plant that was shut down by torrential rains last month. The largest manufacturer of baby formula in the US, Abbott Laboratories, stopped its production at its main facility in Sturgis, Michigan, on June 16 due to storms that caused severe flooding. This happened just two weeks after it started its production after being shut down in February as a result of an examination that discovered contamination at the facility, reported by the Guardian. John Koval, Abbott spokesperson, said that production has resumed for EleCare, a specialised formula for infants with digestive or food allergies, on July 1. He further added that the production of "Similac," a leading product, will be resumed soon. Also read | FDA looks into death of baby 'after drinking Abbott's formula' There was a scarcity in the country as a result of the stoppage and subsequent recall of many brands of infant formula. The factory was halted for manufacturing Similac and other products after an FDA investigation discovered contamination as a result of four bacterial infections discovered in baby formula from the facility plant.Two of the babies died. Later, the president addressed the shortage by importing thousands of pounds of formula from Europe. Watch | Amid ongoing gun violence, US is battling lack of tampons, baby formula shortage As per the officials, it was believed that the firm would return in June to help with the supply chain. However, the expectations were dashed by the disastrous rains a few weeks later. It is still unclear when the baby formula will return to the US store shelves. Also read | 3.7 million bottles of baby formula headed to United States as part of Operation Fly Formula Abbott, one of the four businesses that make nearly 90 per cent of the baby formula consumed in the United States, supplies the formula to about half a million of the infants who receive Wic benefits. (With inputs from agencies) WATCH WION LIVE HERE You can now write for wionews.com and be a part of the community. Share your stories and opinions with us here.

US baby formula shortage: Abbott’s Michigan plant to resume production after halt due to flooding

In a bid to prepare itself for potential surge in COVID-19 cases during the fall, the Food and Drug administration (FDA) of the United States of America has decided to upgrade the Omicron specific booster shots. The new jabs are expected to be bivalent in nature that will target the original COVID strain as well as the virus's most recent strain.

FDA approves upgrading Omicron-specific booster shots

US Food and Drug Administration said on Wednesday (June 22) that it was looking into a new report of death of another baby after it consumed baby formula manufactured by Abbott Laboratories.&nbsp;

As per a report in Wall Street Journal, FDA said that ther reported death took place in the month of January and it came to know about it through a consumer complaint it received on June 10. FDA did not specify which formula the baby had consumed. It said that the investigation was in the preliminary stages and that it would make more news public once it gets more info.

In February, Abbott has started a recall after reports of bacterial infections in children who had consumed the formula made at its Michigan plant. The plant was temporarily closed. This had led to acute shortage of baby formula in the US.

The plant was reopened in first week of June. At that time, the company had said that it would begin production of EleCare and other specialty and metabolic formulas. Initial EleCare product release to consumers beginning on or about June 20.

The plant shutdown and a recall of infant formula had deepened a supply shortage in a nation where, according to federal data from 2020, less than half of babies were exclusively breast-fed through their first three months.

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US Food and Drug Administration said on Wednesday (June 22) that it was looking into a new report of death of another baby after it consumed baby formula manufactured by Abbott Laboratories.

US Food and Drug Administration said on Wednesday (June 22) that it was looking into a new report of death of another baby after it consumed baby formula manufactured by Abbott Laboratories. As per a report in Wall Street Journal, FDA said that ther reported death took place in the month of January and it came to know about it through a consumer complaint it received on June 10. FDA did not specify which formula the baby had consumed. It said that the investigation was in the preliminary stages and that it would make more news public once it gets more info. In February, Abbott has started a recall after reports of bacterial infections in children who had consumed the formula made at its Michigan plant. The plant was temporarily closed. This had led to acute shortage of baby formula in the US. The plant was reopened in first week of June. At that time, the company had said that it would begin production of EleCare and other specialty and metabolic formulas. Initial EleCare product release to consumers beginning on or about June 20. The plant shutdown and a recall of infant formula had deepened a supply shortage in a nation where, according to federal data from 2020, less than half of babies were exclusively breast-fed through their first three months. You can now write for wionews.com and be a part of the community. Share your stories and opinions with us here. WATCH WION LIVE HERE ×

FDA looks into death of baby 'after drinking Abbott's formula'

Staff reviewers of US Food and Drug Administration (FDA) said on Sunday that Pfizer-BioNTech's COVID vaccines were safe and effective for children from ages 6 months to 4 years. &nbsp;

The FDA reviewers said in briefing documents published on Sunday evening that their evaluation did not reveal any new safety concerns related to the use of the vaccine in young children.

The FDA analysis of data from Pfizer's trial was published ahead of a June 15 meeting of its outside advisers. Recommendations from these external advisers will determine the FDA's decision on the vaccines.

"Available data support the effectiveness of the Pfizer-BioNTech COVID-19 Vaccine 3-dose primary series in preventing COVID-19 in the age group of 6 months through 4 years," FDA staff said in the review.

An early analysis of data from Pfizer-BioNTech's vaccine based on 10 symptomatic COVID-19 cases identified when the Omicron coronavirus variant was dominant suggested a vaccine efficacy of 80.3% in the under-5 age group.

COVID vaccines for children under the age of 6 are not yet approved in most countries. Due to low demand for vaccines in for kids aged 5 to 11, it is also not known how many parents would get their young ones vaccinated.

(With inputs from agencies)

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Staff reviewers of US Food and Drug Administration (FDA) said on Sunday that Pfizer-BioNTech's COVID vaccines were safe and effective for children from ages 6 months to 4 years.

Staff reviewers of US Food and Drug Administration (FDA) said on Sunday that Pfizer-BioNTech's COVID vaccines were safe and effective for children from ages 6 months to 4 years. The FDA reviewers said in briefing documents published on Sunday evening that their evaluation did not reveal any new safety concerns related to the use of the vaccine in young children. The FDA analysis of data from Pfizer's trial was published ahead of a June 15 meeting of its outside advisers. Recommendations from these external advisers will determine the FDA's decision on the vaccines. "Available data support the effectiveness of the Pfizer-BioNTech COVID-19 Vaccine 3-dose primary series in preventing COVID-19 in the age group of 6 months through 4 years," FDA staff said in the review. An early analysis of data from Pfizer-BioNTech's vaccine based on 10 symptomatic COVID-19 cases identified when the Omicron coronavirus variant was dominant suggested a vaccine efficacy of 80.3% in the under-5 age group. COVID vaccines for children under the age of 6 are not yet approved in most countries. Due to low demand for vaccines in for kids aged 5 to 11, it is also not known how many parents would get their young ones vaccinated. (With inputs from agencies) You can now write for wionews.com and be a part of the community. Share your stories and opinions with us here. WATCH WION LIVE HERE ×

Pfizer COVID vaccines are safe for small children, says FDA staff

US scientists with the Food and Drug Administration said in a new analysis of data released on Friday that Moderna's coronavirus vaccine is safe and effective for young children and infants. At a meeting next week, the FDA's outside advisors will review this information and decide whether to approve the company's vaccine for babies and children under the age of five.&nbsp;

Children under the age of five are still the only people in the United States who are not eligible for a coronavirus vaccine.

In April, Moderna submitted an emergency use permission request to the FDA for the vaccination of children aged 6 months to under 6 years.

Pfizer and BioNTech are also requesting emergency use permission for their coronavirus vaccine for children. Next Monday, the FDA's outside advisers will review Pfizer and BioNTech's vaccine.

On June 17 and 18, the CDC's advisory committee will meet to approve the vaccinations developed by the firms.

The Biden administration announced this week that it has made 10 million COVID-19 vaccine doses available for young children and newborns, anticipating acceptance of the authorization. The first dosages are expected to be available by June 21.

Watch | Sweden suspends Moderna COVID-19 vaccine for young adults

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The Food and Drug Administration (FDA), which examined data from Moderna's clinical studies independently, found that vaccine effectiveness against symptomatic Covid-19 cases was 51% in babies aged six months to less than two years old and 37% in children aged two to five years.

According to the FDA, the statistics are lower than those found in adult clinical trials because the trials for very young children were conducted during a wave connected to the Omicron variation.

"Although the VE (vaccine efficacy) ... in children six months to five years is lower than that observed in the pivotal adult or older paediatric studies, it is highly consistent with real-world vaccine effectiveness observed against Omicron in adults," the FDA said in a statement.

Despite the fact that Moderna's vaccine is less effective against the Omicron variety, the FDA noted that it is still quite effective against severe cases of the disease.

As a result, the FDA determined that the Moderna data "supports the administration" of the vaccine in two doses of 100 micrograms each in teenagers aged 12 to 17, 50 micrograms in children aged six to eleven, and 25 micrograms in toddlers aged six months to five years.

Moderna's vaccination is currently only available to those aged 18 and up in the United States. 
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US scientists with the Food and Drug Administration said in a new analysis of data released on Friday that Moderna's coronavirus vaccine is safe and effective for young children and infants.

US scientists with the Food and Drug Administration said in a new analysis of data released on Friday that Moderna's coronavirus vaccine is safe and effective for young children and infants. At a meeting next week, the FDA's outside advisors will review this information and decide whether to approve the company's vaccine for babies and children under the age of five. Children under the age of five are still the only people in the United States who are not eligible for a coronavirus vaccine. In April, Moderna submitted an emergency use permission request to the FDA for the vaccination of children aged 6 months to under 6 years. Pfizer and BioNTech are also requesting emergency use permission for their coronavirus vaccine for children. Next Monday, the FDA's outside advisers will review Pfizer and BioNTech's vaccine. On June 17 and 18, the CDC's advisory committee will meet to approve the vaccinations developed by the firms. The Biden administration announced this week that it has made 10 million COVID-19 vaccine doses available for young children and newborns, anticipating acceptance of the authorization. The first dosages are expected to be available by June 21. Watch | Sweden suspends Moderna COVID-19 vaccine for young adults The Food and Drug Administration (FDA), which examined data from Moderna's clinical studies independently, found that vaccine effectiveness against symptomatic Covid-19 cases was 51% in babies aged six months to less than two years old and 37% in children aged two to five years. According to the FDA, the statistics are lower than those found in adult clinical trials because the trials for very young children were conducted during a wave connected to the Omicron variation. "Although the VE (vaccine efficacy) ... in children six months to five years is lower than that observed in the pivotal adult or older paediatric studies, it is highly consistent with real-world vaccine effectiveness observed against Omicron in adults," the FDA said in a statement. Despite the fact that Moderna's vaccine is less effective against the Omicron variety, the FDA noted that it is still quite effective against severe cases of the disease. As a result, the FDA determined that the Moderna data "supports the administration" of the vaccine in two doses of 100 micrograms each in teenagers aged 12 to 17, 50 micrograms in children aged six to eleven, and 25 micrograms in toddlers aged six months to five years. Moderna's vaccination is currently only available to those aged 18 and up in the United States. WATCH WION LIVE HERE You can now write for wionews.com and be a part of the community. Share your stories and opinions with us here.

Covid-19: Moderna vaccine effective and safe for kids under the age of 5, says FDA

United States FDA is going to discuss COVID vaccines for babies next week. Meanwhile, FDA is also investigating rare side-effects of Moderna jabs in teens.

Moderna jabs to approved for infants? FDA to discuss vaccines for babies next week

American multinational pharmaceutical Pzifer completed its emergency use application to the United States Food and Drug Administration (FDA) to administer its COVID-19 vaccine to children under the age of 5 on Wednesday.

Pfizer said that its vaccine called ‘Pfizer-BioNTech COVID-19 vaccine’ is 80% effective against symptomatic COVID-19 for younger children.

"Pfizer and BioNTech completed a rolling application to the U.S. Food and Drug Administration (FDA) for emergency use authorization (EUA) of the 3-µg [microgram] dose of the Pfizer-BioNTech COVID-19 Vaccine for children 6 months through 4 years of age (also referred to as 6 months to under 5 years of age) on June 1, 2022," the company said in a statement.

Children under 5 are the last to get vaccines, but it also requires safety measures in place as it is a very sensitive target age group.

"We recognize parents are anxious to have their young children vaccinated against COVID-19 and while the FDA cannot predict how long its evaluation of the data and information will take, we will review any EUA request we receive as quickly as possible using a science-based approach," the FDA said.

According to a Kaiser Family Foundation poll, a lot of parents are hesitant to vaccinate children as young as 5, with 27 per cent saying they will "definitely not" get their children in this age group vaccinated. Only 18 per cent plan to vaccinate their kids right away, while 38 per cent say that they would like to wait and see before they decide.

[ With inputs from agencies] 
&nbsp;

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American multinational pharmaceutical Pzifer completed its emergency use application to the United States Food and Drug Administration (FDA) to administer its COVID-19 vaccine to children under the age of 5 on Wednesday.

American multinational pharmaceutical Pzifer completed its emergency use application to the United States Food and Drug Administration (FDA) to administer its COVID-19 vaccine to children under the age of 5 on Wednesday. Pfizer said that its vaccine called ‘Pfizer-BioNTech COVID-19 vaccine’ is 80% effective against symptomatic COVID-19 for younger children. "Pfizer and BioNTech completed a rolling application to the U.S. Food and Drug Administration (FDA) for emergency use authorization (EUA) of the 3-µg [microgram] dose of the Pfizer-BioNTech COVID-19 Vaccine for children 6 months through 4 years of age (also referred to as 6 months to under 5 years of age) on June 1, 2022," the company said in a statement. Children under 5 are the last to get vaccines, but it also requires safety measures in place as it is a very sensitive target age group. "We recognize parents are anxious to have their young children vaccinated against COVID-19 and while the FDA cannot predict how long its evaluation of the data and information will take, we will review any EUA request we receive as quickly as possible using a science-based approach," the FDA said. According to a Kaiser Family Foundation poll, a lot of parents are hesitant to vaccinate children as young as 5, with 27 per cent saying they will "definitely not" get their children in this age group vaccinated. Only 18 per cent plan to vaccinate their kids right away, while 38 per cent say that they would like to wait and see before they decide. [ With inputs from agencies] WATCH WION LIVE HERE You can now write for wionews.com and be a part of the community. Share your stories and opinions with us here.

Pfizer applies to FDA for covid vaccine approval for children under five

The US Food and Drug Administration and the Centers for Disease Control and Prevention are investigating a hepatitis A epidemic that may be related to two brands of organic strawberries sold at various merchants in the United States and Canada.

According to the FDA, strawberries purchased between March 5 and April 25 under the FreshKampo and HEB brands should not be consumed.

Also read |&nbsp;<a href="https://www.wionews.com/world/medical-experts-suggest-coronavirus-link-to-mystery-hepatitis-in-children-480039">Medical experts suggest coronavirus link to mystery hepatitis in children</a>

The tainted strawberries were sold at stores across the country, including Aldi, HEB, Kroger, Safeway, Sprouts Farmers Market, Trader Joe's, Walmart, Weis Market, and WinCo Foods.

Consumers in California, Minnesota, and Canada have all reported cases of hepatitis A after purchasing strawberries before becoming ill. According to the FDA, at least 17 illnesses and 12 hospitalizations have been reported thus far across the country.

Watch |&nbsp;Hepatitis of unknown origin grips world, 8 cases suspected in Argentina

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According to the FDA, hepatitis A is an infectious virus that can lead to liver damage. Fatigue, nausea, vomiting, abdominal pain, jaundice, dark urine, and pale faeces are some of the symptoms. Infections usually clear up in one to two weeks, though they can become chronic in rare circumstances.

Also read |&nbsp;<a href="https://www.wionews.com/world/argentina-detects-eight-cases-of-severe-hepatitis-of-unknown-origin-in-children-477309">Argentina detects eight cases of severe hepatitis of unknown origin in children</a>

Strawberries should be thrown away if you don't know what brand you bought or when or where you bought them, according to the FDA. Strawberries that have been frozen should also be discarded.

Anyone who develops hepatitis A symptoms after eating strawberries should seek medical attention immediately.

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The US Food and Drug Administration and the Centers for Disease Control and Prevention are investigating a hepatitis A epidemic that may be related to two brands of organic strawberries sold at various merchants in the United States and Canada.

The US Food and Drug Administration and the Centers for Disease Control and Prevention are investigating a hepatitis A epidemic that may be related to two brands of organic strawberries sold at various merchants in the United States and Canada. According to the FDA, strawberries purchased between March 5 and April 25 under the FreshKampo and HEB brands should not be consumed. Also read | Medical experts suggest coronavirus link to mystery hepatitis in children The tainted strawberries were sold at stores across the country, including Aldi, HEB, Kroger, Safeway, Sprouts Farmers Market, Trader Joe's, Walmart, Weis Market, and WinCo Foods. Consumers in California, Minnesota, and Canada have all reported cases of hepatitis A after purchasing strawberries before becoming ill. According to the FDA, at least 17 illnesses and 12 hospitalizations have been reported thus far across the country. Watch | Hepatitis of unknown origin grips world, 8 cases suspected in Argentina According to the FDA, hepatitis A is an infectious virus that can lead to liver damage. Fatigue, nausea, vomiting, abdominal pain, jaundice, dark urine, and pale faeces are some of the symptoms. Infections usually clear up in one to two weeks, though they can become chronic in rare circumstances. Also read | Argentina detects eight cases of severe hepatitis of unknown origin in children Strawberries should be thrown away if you don't know what brand you bought or when or where you bought them, according to the FDA. Strawberries that have been frozen should also be discarded. Anyone who develops hepatitis A symptoms after eating strawberries should seek medical attention immediately. WATCH WION LIVE HERE You can now write for wionews.com and be a part of the community. Share your stories and opinions with us here.

Hepatitis A linked to strawberries? US FDA and CDC investigating cause

Parents gathered in front of the US FDA headquarters with posters and signs urging to prioritize young children and review data without delay.

US: Parents rally for vaccine for young children

In yet another setback for the Johnson & Johnson COVID vaccine jab, the FDA limits its use. According to FTA, 15% cases of TTS have been fatal.

Another setback for Johnson & Johnson COVID vaccine jab as FDA limits its use

The US government is planning to ban menthol cigarettes and flavored cigars which have taken a disproportionate toll on smokers and other minorities. The FDA says that the proposal would reduce disease and death by helping smokers quit and stopping young people from starting

US plans to ban Methanol cigarettes to reduce disease and death

The Food and Drug Administration (FDA) of the United States have decided to ban sales of menthol-flavoured cigarettes in an attempt to reduce smoking in the general population.

The menthol cigarettes are considered to be one of the most hazardous smoking products in the market and with the increasing cases of lung cancer and other respiratory diseases, this move was imminent.

Also read |&nbsp;<a href="https://www.wionews.com/world/elon-musk-reveals-intentions-to-monetize-tweets-and-cut-salaries-as-part-of-his-pitch-to-bank-lenders-474812">Musk unveils plans to monetise tweets, cut salaries in his pitch to lenders</a>

Menthol cigarettes are extremely popular among smokers because of the cooling effect of menthol and as it is not harsh like normal tobacco products, the addiction rate is also quite high. As a result, they make up one third of the US cigarette market which is valued currently at roughly $80 billion.

Banning them “would help prevent children from becoming the next generation of smokers and help adult smokers quit,” Xavier Becerra, the health and human services secretary told New York Times.

Also read |&nbsp;<a href="https://www.wionews.com/world/as-explosions-rock-kyiv-again-russian-spy-chief-makes-glaring-accusations-474749" hreflang="en">As explosions rock Kyiv again, Russian spy chief makes glaring accusations</a>

The entire process is expected to take around a year to be completed and the initial plan will be published on May 4 as a proposed regulation. However, it can get delayed due to impending legal battles with tobacco companies who have already expressed their displeasure with the decision.

“The scientific evidence shows no difference in the health risks associated with menthol cigarettes compared to non-menthol cigarettes, nor does it support that menthol cigarettes adversely affect initiation, dependence or cessation. As a result, we do not believe the published science supports regulating menthol cigarettes differently from non-menthol cigarettes,” Kingsley Wheaton, the chief marketing officer of British American Tobacco, the leading seller of menthol cigarettes, said.

WATCH |&nbsp;US Capitol riot probe: House committee to hold open hearings

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The Food and Drug Administration (FDA) of the United States have decided to ban sales of menthol-flavoured cigarettes in an attempt to reduce smoking in the general population.

The Food and Drug Administration (FDA) of the United States have decided to ban sales of menthol-flavoured cigarettes in an attempt to reduce smoking in the general population. The menthol cigarettes are considered to be one of the most hazardous smoking products in the market and with the increasing cases of lung cancer and other respiratory diseases, this move was imminent. Also read | Musk unveils plans to monetise tweets, cut salaries in his pitch to lenders Menthol cigarettes are extremely popular among smokers because of the cooling effect of menthol and as it is not harsh like normal tobacco products, the addiction rate is also quite high. As a result, they make up one third of the US cigarette market which is valued currently at roughly $80 billion. Banning them “would help prevent children from becoming the next generation of smokers and help adult smokers quit,” Xavier Becerra, the health and human services secretary told New York Times. Also read | As explosions rock Kyiv again, Russian spy chief makes glaring accusations The entire process is expected to take around a year to be completed and the initial plan will be published on May 4 as a proposed regulation. However, it can get delayed due to impending legal battles with tobacco companies who have already expressed their displeasure with the decision. “The scientific evidence shows no difference in the health risks associated with menthol cigarettes compared to non-menthol cigarettes, nor does it support that menthol cigarettes adversely affect initiation, dependence or cessation. As a result, we do not believe the published science supports regulating menthol cigarettes differently from non-menthol cigarettes,” Kingsley Wheaton, the chief marketing officer of British American Tobacco, the leading seller of menthol cigarettes, said. WATCH | US Capitol riot probe: House committee to hold open hearings

US FDA pushes ahead with move to ban menthol cigarettes to prevent youth initiation

Moderna has formally submitted a request to the Food and Drug Administration for approval of two doses of its COVID-19 vaccine in children fewer than six years old, beginning a long-awaited government review process that might soon see the first vaccines for these youngest Americans approved.

Moderna's request is based on data released in March that showed two 25-microgram doses of their vaccine were effective in this age range. These are lower amounts than the two 100-microgram doses given to adults.

In a statement, Stéphane Bancel, Moderna's CEO, said the 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.&nbsp;

According to the business, they found a "strong neutralising antibody response" and a "favourable safety profile" in two groups of children: 6 months to 23 months old and 2 years old to under 6 years old. 
 
Watch | If you are unvaccinated for COVID, you are a threat to those who're jabbed

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Moderna claims that its vaccination efficacy against infection was 51 percent in infants under the age of two and 37 percent in children aged two to five years old, according to a preliminary study of lab tests collected during the Omicron wave.

According to the Centers for Disease Control and Prevention and several independent infectious disease specialists, more parents should vaccinate and boost their children's immune systems.&nbsp;

Even while the omicron surge has subsided and children are less likely to become really ill, the virus can still be dangerous.

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Moderna has formally submitted a request to the Food and Drug Administration for approval of two doses of its COVID-19 vaccine in children fewer than six years old, beginning a long-awaited government review process that might soon see the first vaccines for these youngest Americans approved.

Moderna has formally submitted a request to the Food and Drug Administration for approval of two doses of its COVID-19 vaccine in children fewer than six years old, beginning a long-awaited government review process that might soon see the first vaccines for these youngest Americans approved. Moderna's request is based on data released in March that showed two 25-microgram doses of their vaccine were effective in this age range. These are lower amounts than the two 100-microgram doses given to adults. In a statement, Stéphane Bancel, Moderna's CEO, said the 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. According to the business, they found a "strong neutralising antibody response" and a "favourable safety profile" in two groups of children: 6 months to 23 months old and 2 years old to under 6 years old. Watch | If you are unvaccinated for COVID, you are a threat to those who're jabbed Moderna claims that its vaccination efficacy against infection was 51 percent in infants under the age of two and 37 percent in children aged two to five years old, according to a preliminary study of lab tests collected during the Omicron wave. According to the Centers for Disease Control and Prevention and several independent infectious disease specialists, more parents should vaccinate and boost their children's immune systems. Even while the omicron surge has subsided and children are less likely to become really ill, the virus can still be dangerous. WATCH WION LIVE HERE

Moderna asks FDA to authorise its COVID vaccine for children younger than 6

There are fears of the Russia-Ukraine war escalating into a nuclear conflict. There is already a scramble for anti-radiation pills. Potassium iodide products are among such pills. Approved by FDA, these are available without a prescription

Ukraine-Russia war: What are anti-radiation medicines? Side effects & availability

US Food and Drug Administration (FDA) has given emergency use authorisation to a Covid diagnostic test that uses breath samples to provide a positive or a negative result.

Called the ‘InspectIR’, this breath analyser Covid test detects chemical compounds associated with coronavirus in breath samples.

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Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health said, “today’s authorisation is yet another example of the rapid innovation occurring with diagnostic tests for COVID-19.”&nbsp;

“The FDA continues to support the development of novel COVID-19 tests with the goal of advancing technologies that can help address the current pandemic and better position the US for the next public health emergency,” he added.

The test, which is the size of carry-on luggage, can show the result in less than three minutes.

Watch |&nbsp;Gravitas: Shanghai Covid Outbreak: Indian consulate "inaccessible"

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The FDA explained how the test is to be used. It must be carried out under the supervision of a licensed health care provider and can be performed in settings where the patient samples are both collected and analysed, such as doctor's offices, hospitals, and mobile testing locations.

InspectIR COVID-19 Breathalyser's performance was tested and validated in a comprehensive study of 2,409 people. The study included both symptomatic and asymptomatic individuals. As per the FDA website, the test had 91.2 per cent sensitivity (the percentage of positive samples correctly identified) and 99.3 per cent&nbsp;specificity (the percentage of negative samples correctly identified) in the trial.

Also read |&nbsp;<a href="https://www.wionews.com/health-and-wellness/what-is-myocarditis-a-rare-complication-of-covid-19-and-non-covid-vaccination-470438" hreflang="en">What is myocarditis? A rare complication of COVID-19 and non-Covid vaccinations</a>

“InspectIR expects to be able to produce approximately 100 instruments per week, which can each be used to evaluate approximately 160 samples per day,” said the agency.

“At this level of production, testing capacity using the InspectIR COVID-19 Breathalyzer is expected to increase by approximately 64,000 samples per month.”

(With inputs from agencies)

US Food and Drug Administration (FDA) has given emergency use authorisation to a Covid diagnostic test that uses breath samples to provide a positive or a negative result.

US Food and Drug Administration (FDA) has given emergency use authorisation to a Covid diagnostic test that uses breath samples to provide a positive or a negative result. Called the ‘InspectIR’, this breath analyser Covid test detects chemical compounds associated with coronavirus in breath samples. Also read | Cases of syphilis, other STDs rose in US during Covid pandemic: CDC report Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health said, “today’s authorisation is yet another example of the rapid innovation occurring with diagnostic tests for COVID-19.” “The FDA continues to support the development of novel COVID-19 tests with the goal of advancing technologies that can help address the current pandemic and better position the US for the next public health emergency,” he added. The test, which is the size of carry-on luggage, can show the result in less than three minutes. Watch | Gravitas: Shanghai Covid Outbreak: Indian consulate "inaccessible" The FDA explained how the test is to be used. It must be carried out under the supervision of a licensed health care provider and can be performed in settings where the patient samples are both collected and analysed, such as doctor's offices, hospitals, and mobile testing locations. InspectIR COVID-19 Breathalyser's performance was tested and validated in a comprehensive study of 2,409 people. The study included both symptomatic and asymptomatic individuals. As per the FDA website, the test had 91.2 per cent sensitivity (the percentage of positive samples correctly identified) and 99.3 per cent specificity (the percentage of negative samples correctly identified) in the trial. Also read | What is myocarditis? A rare complication of COVID-19 and non-Covid vaccinations “InspectIR expects to be able to produce approximately 100 instruments per week, which can each be used to evaluate approximately 160 samples per day,” said the agency. “At this level of production, testing capacity using the InspectIR COVID-19 Breathalyzer is expected to increase by approximately 64,000 samples per month.” (With inputs from agencies)

US FDA approves emergency use of first Covid test that uses breath samples

Moderna&nbsp;Inc on late Thursday (March 17) sought emergency use authorisation with US health regulators for a second COVID-19 booster shot, as a surge in cases in some parts of the world fuels fears of another wave of the pandemic.

The US biotechnology company said its request covered all adults over the age of 18 so that the appropriate use of an additional booster dose of its vaccine, including for those at higher risk of COVID-19 due to age or comorbidities, could be determined by the US Centers for Disease Control and Prevention (CDC) and health care providers.

Moderna's request is significantly broader than Pfizer Inc and its German partner BioNTech SE's application that was filed earlier this week with US regulators for a second booster shot for people aged 65 and older.

Also read |&nbsp;<a href="https://www.wionews.com/world/britain-approves-astrazenecas-preventative-covid-therapy-463272">Britain approves AstraZeneca's preventative COVID therapy</a>

Moderna, without specifically commenting on the effectiveness of a fourth shot, said its submission was partly based on data recently published in the United States and Israel following the emergence of the Omicron variant.

FDA did not immediately respond to a Reuters request for comment.

US health officials, including top infectious disease expert Dr. Anthony Fauci, have raised the prospect of a fourth shot, especially for older people and to prepare for the possibility of another surge in cases.

Also read |&nbsp;<a href="https://www.wionews.com/world/once-pledged-to-keep-covid-vaccine-patent-free-moderna-signals-to-enforce-patent-460237">Moderna once pledged to keep Covid vaccine patent-free. Now it's changing course</a>

CDC data has shown that vaccine efficacy wanes over time and a third shot helps restore it. It, however, has not released comprehensive data based on age or health status to back the case.

The news was first reported by the New York Times.

While COVID cases are falling in the United States and much of the world, infections are rising in China. In the UK and Europe, there has been a reversal in the downward trend of COVID cases as economies have opened up and a second variant of Omicron circulates.

Watch |&nbsp;Gravitas: Global covid cases are rising again

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Moderna Inc on late Thursday (March 17) sought emergency use authorisation with US health regulators for a second COVID-19 booster shot, as a surge in cases in some parts of the world fuels fears of another wave of the pandemic.

Moderna Inc on late Thursday (March 17) sought emergency use authorisation with US health regulators for a second COVID-19 booster shot, as a surge in cases in some parts of the world fuels fears of another wave of the pandemic. The US biotechnology company said its request covered all adults over the age of 18 so that the appropriate use of an additional booster dose of its vaccine, including for those at higher risk of COVID-19 due to age or comorbidities, could be determined by the US Centers for Disease Control and Prevention (CDC) and health care providers. Moderna's request is significantly broader than Pfizer Inc and its German partner BioNTech SE's application that was filed earlier this week with US regulators for a second booster shot for people aged 65 and older. Also read | Britain approves AstraZeneca's preventative COVID therapy Moderna, without specifically commenting on the effectiveness of a fourth shot, said its submission was partly based on data recently published in the United States and Israel following the emergence of the Omicron variant. FDA did not immediately respond to a Reuters request for comment. US health officials, including top infectious disease expert Dr. Anthony Fauci, have raised the prospect of a fourth shot, especially for older people and to prepare for the possibility of another surge in cases. Also read | Moderna once pledged to keep Covid vaccine patent-free. Now it's changing course CDC data has shown that vaccine efficacy wanes over time and a third shot helps restore it. It, however, has not released comprehensive data based on age or health status to back the case. The news was first reported by the New York Times. While COVID cases are falling in the United States and much of the world, infections are rising in China. In the UK and Europe, there has been a reversal in the downward trend of COVID cases as economies have opened up and a second variant of Omicron circulates. Watch | Gravitas: Global covid cases are rising again

Moderna seeks FDA authorisation for second COVID-19 booster for all adults

Moderna's COVID-19 "Spikevax" vaccine received full approval from the US Food and Drug Administration (FDA) on Monday. It had previously been authorized for emergency use in the US.

Janet Woodcock, the acting FDA commissioner, said in a statement that "the public can be assured that Spikevax meets the FDA's high standards for safety, effectiveness and manufacturing quality required of any vaccine approved for use in the United States."

"The FDA's approval of Spikevax is a significant step in the fight against the COVID-19 pandemic, marking the second vaccine approved to prevent COVID-19," Woodcock said.

Also read |&nbsp;<a href="https://www.wionews.com/world/5-billion-ppe-items-worth-ps27-billion-will-go-waste-reveals-uk-government-449112" hreflang="en">5 billion PPE items worth £2.7 billion will go waste, reveals UK government</a>

Age 18 or older is the minimum requirement for obtaining the Moderna vaccine.

A Pfizer's vaccine for individuals aged 16 or older was approved by the FDA at the end of August.

Woodcock expressed the hope that FDA approval of the Moderna vaccine will help more people feel at ease and "may instill additional confidence in making the decision to get vaccinated."

The FDA move was deemed a "momentous milestone" for the company by CEO Stephane Bancel.

"Our COVID-19 vaccine has been administered to hundreds of millions of people around the world, protecting people from COVID-19 infection, hospitalization and death," Bancel said in a statement.

Also read |&nbsp;<a href="https://www.wionews.com/science/us-scientists-come-up-with-cheap-covid-test-relying-on-low-tech-kit-smartphone-find-out-how-does-it-work-448699" hreflang="en">US scientists come up with cheap Covid test relying on low-tech kit, smartphone. Find out how does it work</a>

The Moderna vaccine was approved for emergency use in December 2020.

Moderna has full FDA approval for only the first two doses, emergency use authorisation&nbsp;remains in effect for the booster dose.

A clinical trial that evaluated the effectiveness of Spikevax involved 14,287 vaccination recipients and 14,164 placebo recipients, according to the FDA.

In clinical trials, participants reported pain at the injection site, fatigue, headaches, muscle or joint pain, chills, nausea and vomiting, and swollen lymph nodes as the most common side effects.

Watch |&nbsp;Gravitas: Wuhan scientists flag deadlier coronavirus

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According to the FDA, men aged 18 to 24 were said to be more likely to develop myocarditis or inflammation of the heart muscle, and pericarditis, or inflammation of the surrounding tissue, following vaccination with the second dose.

Despite this, the FDA said it had determined that the "benefits of the vaccine outweigh the risk of myocarditis and pericarditis in individuals 18 years of age and older."

(With inputs from agencies)

Moderna's COVID-19 "Spikevax" vaccine received full approval from the US Food and Drug Administration (FDA) on Monday. It had previously been authorized for emergency use in the US.

Moderna's COVID-19 "Spikevax" vaccine received full approval from the US Food and Drug Administration (FDA) on Monday. It had previously been authorized for emergency use in the US. Janet Woodcock, the acting FDA commissioner, said in a statement that "the public can be assured that Spikevax meets the FDA's high standards for safety, effectiveness and manufacturing quality required of any vaccine approved for use in the United States." "The FDA's approval of Spikevax is a significant step in the fight against the COVID-19 pandemic, marking the second vaccine approved to prevent COVID-19," Woodcock said. Also read | 5 billion PPE items worth £2.7 billion will go waste, reveals UK government Age 18 or older is the minimum requirement for obtaining the Moderna vaccine. A Pfizer's vaccine for individuals aged 16 or older was approved by the FDA at the end of August. Woodcock expressed the hope that FDA approval of the Moderna vaccine will help more people feel at ease and "may instill additional confidence in making the decision to get vaccinated." The FDA move was deemed a "momentous milestone" for the company by CEO Stephane Bancel. "Our COVID-19 vaccine has been administered to hundreds of millions of people around the world, protecting people from COVID-19 infection, hospitalization and death," Bancel said in a statement. Also read | US scientists come up with cheap Covid test relying on low-tech kit, smartphone. Find out how does it work The Moderna vaccine was approved for emergency use in December 2020. Moderna has full FDA approval for only the first two doses, emergency use authorisation remains in effect for the booster dose. A clinical trial that evaluated the effectiveness of Spikevax involved 14,287 vaccination recipients and 14,164 placebo recipients, according to the FDA. In clinical trials, participants reported pain at the injection site, fatigue, headaches, muscle or joint pain, chills, nausea and vomiting, and swollen lymph nodes as the most common side effects. Watch | Gravitas: Wuhan scientists flag deadlier coronavirus According to the FDA, men aged 18 to 24 were said to be more likely to develop myocarditis or inflammation of the heart muscle, and pericarditis, or inflammation of the surrounding tissue, following vaccination with the second dose. Despite this, the FDA said it had determined that the "benefits of the vaccine outweigh the risk of myocarditis and pericarditis in individuals 18 years of age and older." (With inputs from agencies)

Moderna's 'Spikevax' coronavirus vaccine gets full FDA approval in US

US doesn't allow gay men to donate blood. Exceptions are made for those who abstain from sexual activities for 3 months. Senators want this restriction lifted. Palki Sharma tells you which other countries have similar restrictions.

Gravitas: US senators want FDA to allow gay people to donate blood

We have some great news for senior cats who wish to get a new lease on life, senior felines hoping to get a spring back in their step.

For the first&nbsp;time ever, the US Food and Drug Administration (FDA) has approved a monoclonal antibody drug for controlling pain associated with osteoarthritis in cats. It is also the first monoclonal antibody drug approved by the FDA for any animal species.

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During the pandemic, these lab-grown proteins had garnered headlines for preventing severe illness in high-risk people with Covid.

Wear and tear of the cartilage that cushions the ends of the bones leads to osteoarthritis. When the bones in a joint rub against each other, they cause pain and lessen movement, and occasionally cause bone spurs.

60 per cent of cats aged six and older and 90 per cent of cats older than 12 years are thought to suffer from this condition.

"Advancements in modern veterinary medicine have been instrumental in extending the lives of many animals, including cats," said Steven Solomon, director of the FDA's Center for Veterinary Medicine, in a statement.

"But with longer lives come chronic diseases, such as osteoarthritis," he added.

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New injectable drug 'Solensia' attaches itself to a protein called nerve growth factor (NGF) that is involved in the regulation of pain.&nbsp;

The medicine's active ingredient 'frunevetmab' binds itself to NGF, which prevents pain signals from reaching the brain.

Due to the fact that cats cannot directly express their symptoms, researchers asked their owners about their animals' ability to jump onto furniture, use their litter box, or groom themselves, and compared their abilities with before they developed osteoarthritis.&nbsp;

The owners were then asked to assess their cats' responses after receiving treatment.&nbsp;

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<div class="videoWrapper trancodeVideo"><iframe allowfullscreen="" autoplay="1" class="includeVideo" frameborder="0" height="350" src="https://www.wionews.com/videos/gravitas-hamas-claims-killer-zionist-dolphin-killed-their-commando-444252/embed" style="width:100%;max-width:560px;" width="560"></iframe></div>

During randomized clinical trials, cats in the treatment group performed better on assessments than those receiving placebos.

This medicine is injected subcutaneously by a veterinarian once a month and its side effects include vomiting, diarrhoea, injection site pain, scabbing on the head and neck, dermatitis and pruritus (itching).&nbsp;

However, the side effects were mild and did not require discontinuing the treatment.&nbsp;

(With inputs from agencies)

We have some great news for senior cats who wish to get a new lease on life, senior felines hoping to get a spring back in their step. For the first time ever, the US Food and Drug Administration (FDA) has approved a monoclonal antibody drug for controlling pain associated with osteoarthritis in cats.

We have some great news for senior cats who wish to get a new lease on life, senior felines hoping to get a spring back in their step. For the first time ever, the US Food and Drug Administration (FDA) has approved a monoclonal antibody drug for controlling pain associated with osteoarthritis in cats. It is also the first monoclonal antibody drug approved by the FDA for any animal species. Also read | Believe it or not: Rare ‘see-through’ fish colony found in Antarctica During the pandemic, these lab-grown proteins had garnered headlines for preventing severe illness in high-risk people with Covid. Wear and tear of the cartilage that cushions the ends of the bones leads to osteoarthritis. When the bones in a joint rub against each other, they cause pain and lessen movement, and occasionally cause bone spurs. 60 per cent of cats aged six and older and 90 per cent of cats older than 12 years are thought to suffer from this condition. "Advancements in modern veterinary medicine have been instrumental in extending the lives of many animals, including cats," said Steven Solomon, director of the FDA's Center for Veterinary Medicine, in a statement. "But with longer lives come chronic diseases, such as osteoarthritis," he added. Also Read: No kidding: Goldfish actually drove a vehicle on land New injectable drug 'Solensia' attaches itself to a protein called nerve growth factor (NGF) that is involved in the regulation of pain. The medicine's active ingredient 'frunevetmab' binds itself to NGF, which prevents pain signals from reaching the brain. Due to the fact that cats cannot directly express their symptoms, researchers asked their owners about their animals' ability to jump onto furniture, use their litter box, or groom themselves, and compared their abilities with before they developed osteoarthritis. The owners were then asked to assess their cats' responses after receiving treatment. Watch | Gravitas: Hamas claims 'Killer Zionist Dolphin' killed their commando During randomized clinical trials, cats in the treatment group performed better on assessments than those receiving placebos. This medicine is injected subcutaneously by a veterinarian once a month and its side effects include vomiting, diarrhoea, injection site pain, scabbing on the head and neck, dermatitis and pruritus (itching). However, the side effects were mild and did not require discontinuing the treatment. (With inputs from agencies)

Good news for senior cats: US FDA approves drug for arthritis in aged felines

The US Food and Drug Administration has authorised the use of a third dose of the Pfizer-BioNTech's COVID-19 vaccine for children ages 12 to 15, and reduced the wait time between initial vaccination and an extra dose from six months to five months for all ages.

US FDA authorises Pfizer COVID-19 vaccine booster for children ages 12 to 15

The US Food and Drug Administration has amended the use of Pfizer booster doses for teenagers from 12 through 15 years of age.

It has also reduced the time between the completion of primary vaccination of the Pfizer-BioNTech COVID-19 vaccine and a booster dose to at least five months.

The federal agency has also allowed the third dose for immunocompromised children 5 through 11 years of age.

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According to Acting FDA Commissioner Janet Woodcock, “Throughout the pandemic, as the virus that causes COVID-19 has continuously evolved, the need for the FDA to quickly adapt has meant using the best available science to make informed decisions with the health and safety of the American public in mind.”&nbsp;

“With the current wave of the omicron variant, it’s critical that we continue to take effect, life-saving preventative measures such as primary vaccination and boosters, mask-wearing and social distancing to in order to effectively fight COVID-19,” she added.

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The FDA said it reviewed published data and real-world evidence on the safety of booster doses provided by the Israeli Ministry of Health including data from over 6,300 individuals 12-to-15 years of age who received a Pfizer shot.

The vaccine made by Pfizer and its partner BioNTech is the only US&nbsp;option for children of any age. About 13.5 million 12- to 17-year-olds,&nbsp;just over half that age group,&nbsp;have received two Pfizer shots, according to the CDC.

Global COVID-19 cases are surging due to the Omicron variant and health authorities have warned that its extremely high transmissibility could overwhelm many health systems.

Laboratory tests have shown that two doses of the Pfizer-BioNTech and Moderna vaccines generate low immune responses against Omicron, while boosters appear to be protective against the highly-mutated variant.

(With inputs from agencies)

The US Food and Drug Administration has amended the use of Pfizer booster doses for teenagers from 12 through 15 years of age. It has also reduced the time between the completion of primary vaccination of the Pfizer-BioNTech COVID-19 vaccine and a booster dose to at least five months.

The US Food and Drug Administration has amended the use of Pfizer booster doses for teenagers from 12 through 15 years of age. It has also reduced the time between the completion of primary vaccination of the Pfizer-BioNTech COVID-19 vaccine and a booster dose to at least five months. The federal agency has also allowed the third dose for immunocompromised children 5 through 11 years of age. Also read | Record levels of coronavirus revealed in wastewater samples across US According to Acting FDA Commissioner Janet Woodcock, “Throughout the pandemic, as the virus that causes COVID-19 has continuously evolved, the need for the FDA to quickly adapt has meant using the best available science to make informed decisions with the health and safety of the American public in mind.” “With the current wave of the omicron variant, it’s critical that we continue to take effect, life-saving preventative measures such as primary vaccination and boosters, mask-wearing and social distancing to in order to effectively fight COVID-19,” she added. Also read | Over 2,700 flights cancelled in United States due to Omicron-related disruptions The FDA said it reviewed published data and real-world evidence on the safety of booster doses provided by the Israeli Ministry of Health including data from over 6,300 individuals 12-to-15 years of age who received a Pfizer shot. The vaccine made by Pfizer and its partner BioNTech is the only US option for children of any age. About 13.5 million 12- to 17-year-olds, just over half that age group, have received two Pfizer shots, according to the CDC. Global COVID-19 cases are surging due to the Omicron variant and health authorities have warned that its extremely high transmissibility could overwhelm many health systems. Laboratory tests have shown that two doses of the Pfizer-BioNTech and Moderna vaccines generate low immune responses against Omicron, while boosters appear to be protective against the highly-mutated variant. (With inputs from agencies)

Omicron update: FDA amends emergency use of Pfizer booster dose for more teens

The fight against the HIV has been raging around the world for quite some time. As a huge respite, an injectable medication has been approved for prevention against HIV by the Food and Drug Administration in the United States.&nbsp;

It is the first long-acting drug for use as pre-exposure prevention or PrEP, the agency announced on Monday. &nbsp;&nbsp;

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The name of the new drug is Apretude. It can be injected after every two months. The medicine is an alternative to prevention pills for HIV, such as Truvada and Descovy. These pills reduce the risk of HIV by 99% if taken daily. &nbsp;

Analysing the safety and efficacy of the drug, two trials by FDA found that Apretude fared better in reducing chances of contracting HIV than the oral medications, which are taken daily. &nbsp;

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In a statement, Dr Debra Birnkrant, director, antivirals division, FDA’s Center for Drug Evaluation and Research, said, “Today’s approval adds an important tool in the effort to end the HIV epidemic by providing the first option to prevent HIV that does not involve taking a daily pill.” &nbsp;&nbsp;

This medication has been made by ViiV Healthcare, which is majority owned by GlaxoSmithKline.&nbsp;“This injection, given every two months, will be critical to addressing the HIV epidemic in the US, including helping high-risk individuals and certain groups where adherence to daily medication has been a major challenge or not a realistic option,” added Birnkrant. &nbsp;

(With inputs from agencies)&nbsp;

The fight against the HIV has been raging around the world for quite some time. As a huge respite, an injectable medication has been approved for prevention against HIV by the Food and Drug Administration in the United States.

The fight against the HIV has been raging around the world for quite some time. As a huge respite, an injectable medication has been approved for prevention against HIV by the Food and Drug Administration in the United States. It is the first long-acting drug for use as pre-exposure prevention or PrEP, the agency announced on Monday. Also Read: 'An event cancelled is better than a life cancelled': WHO chief The name of the new drug is Apretude. It can be injected after every two months. The medicine is an alternative to prevention pills for HIV, such as Truvada and Descovy. These pills reduce the risk of HIV by 99% if taken daily. Analysing the safety and efficacy of the drug, two trials by FDA found that Apretude fared better in reducing chances of contracting HIV than the oral medications, which are taken daily. Also Read: Biden was in close contact with official who tested positive for Covid In a statement, Dr Debra Birnkrant, director, antivirals division, FDA’s Center for Drug Evaluation and Research, said, “Today’s approval adds an important tool in the effort to end the HIV epidemic by providing the first option to prevent HIV that does not involve taking a daily pill.” This medication has been made by ViiV Healthcare, which is majority owned by GlaxoSmithKline. “This injection, given every two months, will be critical to addressing the HIV epidemic in the US, including helping high-risk individuals and certain groups where adherence to daily medication has been a major challenge or not a realistic option,” added Birnkrant. (With inputs from agencies)

In a first, injectable medication for prevention from HIV gets FDA nod in US

The United States Food and Drug Administration (USFDA) is a 115-year-old federal organisation in America. It is the world's most powerful regulatory body, with an annual budget of $6.1 billion.

USFDA: Pharma regulator is among world's most powerful bodies

The US Food and Drug Administration has now issued an emergency use authorisation for AstraZeneca's Evusheld to prevent people from the deadly coronavirus. Evusheld comprises two types of synthetic antibodies - tixagevimab and cilgavimab. It is given as two intramuscular injections.

"The product is only authorised for those individuals who are not currently infected with the SARS-CoV-2 virus and who have not recently been exposed to an individual infected with SARS-CoV-2," read the statement issued by FDA.&nbsp;

It can only be used if the person has required prerequisites, including moderate to severely compromised immune systems because of a particular medical condition. Also, when there is a history of severe adverse reactions to a Covid vaccine.&nbsp;

The authorisation came after a clinical trial under which 3,500 people were given the drug while 1,700 received a placebo. It was then concluded that the treatment cut the risk of developing Covid by 77 per cent.&nbsp;

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Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research, in a press release by FDA, said, “Vaccines have proven to be the best ddefence available against COVID-19. However, there are certain immune-compromised individuals who may not mount an adequate immune response to COVID-19 vaccination, or those who have a history of severe adverse reactions to a COVID-19 vaccine and therefore cannot receive one and need an alternative prevention option."

This is the first time that the FDA has given emergency authorisation for purely preventative treatment.&nbsp;

Side effects of Evusheld range from hypersensitivity reactions, bleeding at the injection site, headache, fatigue and cough.

Few trial participants also suffered from serious cardiac adverse events after receiving Evusheld. All of these participants had risk factors for cardiac disease or a history of cardiovascular disease before participating in the clinical trial.&nbsp;However, it is not yet clear if Evusheld caused these.&nbsp;

(With inputs from agencies)

The US Food and Drug Administration has now issued an emergency use authorisation for AstraZeneca's Evusheld to prevent people from the deadly coronavirus. Evusheld comprises two types of synthetic antibodies - tixagevimab and cilgavimab.

The US Food and Drug Administration has now issued an emergency use authorisation for AstraZeneca's Evusheld to prevent people from the deadly coronavirus. Evusheld comprises two types of synthetic antibodies - tixagevimab and cilgavimab. It is given as two intramuscular injections. "The product is only authorised for those individuals who are not currently infected with the SARS-CoV-2 virus and who have not recently been exposed to an individual infected with SARS-CoV-2," read the statement issued by FDA. It can only be used if the person has required prerequisites, including moderate to severely compromised immune systems because of a particular medical condition. Also, when there is a history of severe adverse reactions to a Covid vaccine. The authorisation came after a clinical trial under which 3,500 people were given the drug while 1,700 received a placebo. It was then concluded that the treatment cut the risk of developing Covid by 77 per cent. Also read | Biden threatens Russia with 'severe sanctions' if Ukraine is attacked; US troops not to be involved Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research, in a press release by FDA, said, “Vaccines have proven to be the best ddefence available against COVID-19. However, there are certain immune-compromised individuals who may not mount an adequate immune response to COVID-19 vaccination, or those who have a history of severe adverse reactions to a COVID-19 vaccine and therefore cannot receive one and need an alternative prevention option." This is the first time that the FDA has given emergency authorisation for purely preventative treatment. Side effects of Evusheld range from hypersensitivity reactions, bleeding at the injection site, headache, fatigue and cough. Few trial participants also suffered from serious cardiac adverse events after receiving Evusheld. All of these participants had risk factors for cardiac disease or a history of cardiovascular disease before participating in the clinical trial. However, it is not yet clear if Evusheld caused these. (With inputs from agencies)

Covid: In a first, FDA authorises AstraZeneca's Evusheld as a purely preventative treatment

Pfizer's kid-size COVID-19 injection received final approval from US health regulators on Tuesday, paving the way for a substantial extension of the country's vaccination campaign to include children as young as 5.

The Food and Drug Administration has previously approved the injections for children aged 5 to 11.&nbsp;

The dosages given to teenagers and adults are just a third of what is given to teens and adults.

The Centers for Disease Control and Prevention, on the other hand, makes explicit recommendations on who should receive FDA-approved vaccines. 
 
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Dr Rochelle Walensky, director of the CDC, made the news just hours after an advisory council unanimously recommended that Pfizer's vaccines should be made available to the 28 million children in that age bracket.&nbsp;

During a day of live-streamed deliberations, the CDC assembled a panel of independent experts to analyse the existing data on the state of the outbreak in children, the efficiency of Pfizer's vaccine, and its likely adverse effects.&nbsp;

Since the FDA approval, "there hasn't been a moment that teams have not been picking, packing and shipping vaccines," Jeff Zients, the White House pandemic coordinator, said Monday. 
 
Watch | Rise in COVID-19 cases among children in Israel trigger noticeable jump

<div class="videoWrapper trancodeVideo"><iframe allowfullscreen="" autoplay="1" class="includeVideo" frameborder="0" height="350" src="https://www.wionews.com/videos/rise-in-covid-19-cases-among-children-in-israel-trigger-noticeable-jump-419987/embed" style="width:100%;max-width:560px;" width="560"></iframe></div>

"We are planning on some vaccinations towards the end of this week," he said, adding that the programme will be "really hitting full strength the week of November 8."

Last week, FDA officials debated whether every young kid required vaccination.

COVID-19-infected children are more likely to develop high-risk diseases, including obesity or diabetes.

However, otherwise healthy youngsters can get critically ill, and the CDC's advisors eventually advised the injections for all of them, including those who had already recovered from a COVID-19 infection.&nbsp;

(With inputs from agencies)

Pfizer's kid-size COVID-19 injection received final approval from US health regulators on Tuesday, paving the way for a substantial extension of the country's vaccination campaign to include children as young as 5.

Pfizer's kid-size COVID-19 injection received final approval from US health regulators on Tuesday, paving the way for a substantial extension of the country's vaccination campaign to include children as young as 5. The Food and Drug Administration has previously approved the injections for children aged 5 to 11. The dosages given to teenagers and adults are just a third of what is given to teens and adults. The Centers for Disease Control and Prevention, on the other hand, makes explicit recommendations on who should receive FDA-approved vaccines. Also Read: As vaccine mandate deadline looms, New York City braces for workers’ shortage Dr Rochelle Walensky, director of the CDC, made the news just hours after an advisory council unanimously recommended that Pfizer's vaccines should be made available to the 28 million children in that age bracket. During a day of live-streamed deliberations, the CDC assembled a panel of independent experts to analyse the existing data on the state of the outbreak in children, the efficiency of Pfizer's vaccine, and its likely adverse effects. Since the FDA approval, "there hasn't been a moment that teams have not been picking, packing and shipping vaccines," Jeff Zients, the White House pandemic coordinator, said Monday. Watch | Rise in COVID-19 cases among children in Israel trigger noticeable jump "We are planning on some vaccinations towards the end of this week," he said, adding that the programme will be "really hitting full strength the week of November 8." Last week, FDA officials debated whether every young kid required vaccination. COVID-19-infected children are more likely to develop high-risk diseases, including obesity or diabetes. However, otherwise healthy youngsters can get critically ill, and the CDC's advisors eventually advised the injections for all of them, including those who had already recovered from a COVID-19 infection. (With inputs from agencies)

COVID-19 vaccine for children: US gives final nod to Pfizer jabs for 5-11 age group

In what is the first COVID-19 shot for young children in the United States, the health regulator of the country authorised the Pfizer Inc and BioNTech SE coronavirus vaccine for children aged 5 to 11 years on Friday. &nbsp;

The move looks to make the vaccine available to 28 million children in the US. Several of them are back in school for in-person learning. &nbsp;

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The decision comes as a panel of advisers to the Food and Drug Administration (FDA) voted overwhelmingly to recommend the authorisation on Tuesday. &nbsp;

To consider recommendations on how the vaccine should be used in the age group, an advisory panel to the US Centers for Disease Control and Prevention (CDC) is scheduled to meet next week. The CDC director will have the final say. &nbsp;

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Till now, only a handful other countries, including China, Cuba and the United Arab Emirates, have cleared Covid vaccines for children in this age group. &nbsp;

A 10-microgram dose of Pfizer's vaccine in young children, which is lower than the 30 micrograms in the usual vaccine for children above the age of 12 and older, has been authorised by the FDA. &nbsp;

The vaccine showed 90.7% efficacy against coronavirus in a clinical trial of children aged 5 to 11, said Pfizer and BioNTech. &nbsp;&nbsp;

(With inputs from agencies)&nbsp;

In what is the first COVID-19 shot for young children in the United States, the health regulator of the country authorised the Pfizer Inc and BioNTech SE coronavirus vaccine for children aged 5 to 11 years on Friday.

In what is the first COVID-19 shot for young children in the United States, the health regulator of the country authorised the Pfizer Inc and BioNTech SE coronavirus vaccine for children aged 5 to 11 years on Friday. The move looks to make the vaccine available to 28 million children in the US. Several of them are back in school for in-person learning. Also Read: As vaccine mandate deadline looms, New York City braces for workers’ shortage The decision comes as a panel of advisers to the Food and Drug Administration (FDA) voted overwhelmingly to recommend the authorisation on Tuesday. To consider recommendations on how the vaccine should be used in the age group, an advisory panel to the US Centers for Disease Control and Prevention (CDC) is scheduled to meet next week. The CDC director will have the final say. Also Read: Closed under Covid lockdown, Auckland tops Lonely Planet’s list of cities to visit in 2022 Till now, only a handful other countries, including China, Cuba and the United Arab Emirates, have cleared Covid vaccines for children in this age group. A 10-microgram dose of Pfizer's vaccine in young children, which is lower than the 30 micrograms in the usual vaccine for children above the age of 12 and older, has been authorised by the FDA. The vaccine showed 90.7% efficacy against coronavirus in a clinical trial of children aged 5 to 11, said Pfizer and BioNTech. (With inputs from agencies)

First Covid shot authorised by FDA in US for kids aged 5 to 11 years

A key federal advisory committee was discussing Tuesday whether to recommend that a pediatric dose of the Pfizer-BioNTech coronavirus vaccine be offered to 5- to 11-year-olds, setting in motion a string of decisions that could lead to children getting shots as early as the end of next week.

Federal officials hope that the pediatric dose can help close a major gap in the US&nbsp;vaccine campaign that has worried parents, educators and public health leaders. If the Food and Drug Administration grants authorization, about 28 million children will become eligible. Only the youngest, those under 5, would remain uncovered.

Dr. Peter Marks, who heads the FDA division that oversees vaccines, said at the meeting that 1.9 million children aged 5 to 11 have been infected with the virus and more than 8,300 of them have been hospitalized, a third of whom needed intensive care. Nearly 100 have died, making COVID-19 one of the top 10 causes of death during the pandemic in this age group.

Children in this age range are “far from being spared from the harm of COVID-19,” he said.

Dr. Fiona Havers, a specialist in viral diseases at the Centers for Disease Control and Prevention, said that children in this age group make up 10.6% of all cases but only 8.7% of the population. Children have higher levels than adults of the neutralizing antibodies that are essential for preventing infection, she said, but are at least as likely as adults to be infected, she said.

Antibody tests of children also suggested there are many more virus cases than are publicly recorded, Havers said.

Hospitalization rates in the 5-11 age group are three times as high for Black, Hispanic or Native American children as for white children, she said. And more than 2,000 schools with a total of over 1 million students were forced to close between early August and October because of outbreaks, she said.

The committee’s recommendations on whether to authorize vaccines are not binding, but the FDA typically follows them in the days after the vote.

It is unclear how many parents would quickly vaccinate their elementary schoolers if given the chance. Polling has showed that roughly a third of these parents are eager to do so right away, while a third prefer to wait. Since federal regulators cleared Pfizer shots for children ages 12-15 in May, 46% of that age group has been fully vaccinated, compared with about 69% of those 18 and older.

An organized email campaign against giving the vaccine to younger children got underway over the weekend, with panel members deluged by messages urging to vote against recommending authorization, according to Dr. Paul Offit, a panelist who heads the Vaccine Education Center at Children’s Hospital of Philadelphia.

As of early Tuesday, nearly 140,000 public comments had been formally submitted to the agency on the issue. By contrast, only 66 comments were submitted before the panel recommended booster for adult recipients of the Moderna and Johnson &amp; Johnson vaccines.

As the meeting began, Marks said: “I want to acknowledge the fact that there are strong feelings that have clearly been expressed by members of the public both for and against” authorization. He stressed that the only question before the experts was whether shots should be allowed, not whether to mandate them.

The dose for younger children would be one-third of the strength given to people 12 and older, with two shots given three weeks apart. Pfizer and BioNTech are asking the FDA to authorize distribution on an emergency basis.

The process may go more smoothly than when the vaccine manufacturers sought authorization of booster shots for adults — an issue that preoccupied and divided the agency’s regulators and its outside experts for much of the past two months.

Pfizer has provided the FDA with safety data on two study cohorts of children ages 5-11, both of roughly equal size. The first group was followed for about 2 months, the second for about 2 1/2 weeks. Pfizer cited efficacy data only for the first group of about 2,200 children, saying its vaccine had an efficacy rate of 91% against symptomatic COVID-19.

On Friday, FDA regulators said in an analysis of Pfizer’s pediatric trial data that the benefits of staving off COVID-19 with the vaccine generally outweighed the risks of the most worrisome side effects for young children.

Hong Yang, an FDA scientist, said in a presentation Tuesday that even in a scenario where infections nationwide are lower, the benefits of vaccination may outweigh the risks of possible side effects, since people hospitalized with COVID-19 tend to be sicker, and for longer, than those with certain heart conditions tied to the vaccine.

Regulators modelled scenarios that involved varying levels of spread of the virus, and assumed the rate of two rare vaccine-associated heart conditions would be the same in the younger children vaccinated with a one-third dose as in adolescents aged 12-15 who received a full dose.

Federal health officials have said that cases of those heart conditions — myocarditis, or inflammation of the heart muscle, and pericarditis, inflammation of the lining around the heart — after the second dose of a vaccine tend to be mild and resolve quickly.

Pfizer in its presentation to the committee Tuesday said it had worked to make the pediatric vaccines easily recognizable to health providers who would administer the shot. It changed the colour of the vial caps from purple to orange and also made the packaging of the children’s shot orange so that administrators could easily distinguish between those and adult versions.

A key federal advisory committee was discussing Tuesday whether to recommend that a pediatric dose of the Pfizer-BioNTech coronavirus vaccine be offered to 5- to 11-year-olds, setting in motion a string of decisions that could lead to children getting shots as early as the end of next week.

A key federal advisory committee was discussing Tuesday whether to recommend that a pediatric dose of the Pfizer-BioNTech coronavirus vaccine be offered to 5- to 11-year-olds, setting in motion a string of decisions that could lead to children getting shots as early as the end of next week. Federal officials hope that the pediatric dose can help close a major gap in the US vaccine campaign that has worried parents, educators and public health leaders. If the Food and Drug Administration grants authorization, about 28 million children will become eligible. Only the youngest, those under 5, would remain uncovered. Dr. Peter Marks, who heads the FDA division that oversees vaccines, said at the meeting that 1.9 million children aged 5 to 11 have been infected with the virus and more than 8,300 of them have been hospitalized, a third of whom needed intensive care. Nearly 100 have died, making COVID-19 one of the top 10 causes of death during the pandemic in this age group. Children in this age range are “far from being spared from the harm of COVID-19,” he said. Dr. Fiona Havers, a specialist in viral diseases at the Centers for Disease Control and Prevention, said that children in this age group make up 10.6% of all cases but only 8.7% of the population. Children have higher levels than adults of the neutralizing antibodies that are essential for preventing infection, she said, but are at least as likely as adults to be infected, she said. Antibody tests of children also suggested there are many more virus cases than are publicly recorded, Havers said. Hospitalization rates in the 5-11 age group are three times as high for Black, Hispanic or Native American children as for white children, she said. And more than 2,000 schools with a total of over 1 million students were forced to close between early August and October because of outbreaks, she said. The committee’s recommendations on whether to authorize vaccines are not binding, but the FDA typically follows them in the days after the vote. It is unclear how many parents would quickly vaccinate their elementary schoolers if given the chance. Polling has showed that roughly a third of these parents are eager to do so right away, while a third prefer to wait. Since federal regulators cleared Pfizer shots for children ages 12-15 in May, 46% of that age group has been fully vaccinated, compared with about 69% of those 18 and older. An organized email campaign against giving the vaccine to younger children got underway over the weekend, with panel members deluged by messages urging to vote against recommending authorization, according to Dr. Paul Offit, a panelist who heads the Vaccine Education Center at Children’s Hospital of Philadelphia. As of early Tuesday, nearly 140,000 public comments had been formally submitted to the agency on the issue. By contrast, only 66 comments were submitted before the panel recommended booster for adult recipients of the Moderna and Johnson & Johnson vaccines. As the meeting began, Marks said: “I want to acknowledge the fact that there are strong feelings that have clearly been expressed by members of the public both for and against” authorization. He stressed that the only question before the experts was whether shots should be allowed, not whether to mandate them. The dose for younger children would be one-third of the strength given to people 12 and older, with two shots given three weeks apart. Pfizer and BioNTech are asking the FDA to authorize distribution on an emergency basis. The process may go more smoothly than when the vaccine manufacturers sought authorization of booster shots for adults — an issue that preoccupied and divided the agency’s regulators and its outside experts for much of the past two months. Pfizer has provided the FDA with safety data on two study cohorts of children ages 5-11, both of roughly equal size. The first group was followed for about 2 months, the second for about 2 1/2 weeks. Pfizer cited efficacy data only for the first group of about 2,200 children, saying its vaccine had an efficacy rate of 91% against symptomatic COVID-19. On Friday, FDA regulators said in an analysis of Pfizer’s pediatric trial data that the benefits of staving off COVID-19 with the vaccine generally outweighed the risks of the most worrisome side effects for young children. Hong Yang, an FDA scientist, said in a presentation Tuesday that even in a scenario where infections nationwide are lower, the benefits of vaccination may outweigh the risks of possible side effects, since people hospitalized with COVID-19 tend to be sicker, and for longer, than those with certain heart conditions tied to the vaccine. Regulators modelled scenarios that involved varying levels of spread of the virus, and assumed the rate of two rare vaccine-associated heart conditions would be the same in the younger children vaccinated with a one-third dose as in adolescents aged 12-15 who received a full dose. Federal health officials have said that cases of those heart conditions — myocarditis, or inflammation of the heart muscle, and pericarditis, inflammation of the lining around the heart — after the second dose of a vaccine tend to be mild and resolve quickly. Pfizer in its presentation to the committee Tuesday said it had worked to make the pediatric vaccines easily recognizable to health providers who would administer the shot. It changed the colour of the vial caps from purple to orange and also made the packaging of the children’s shot orange so that administrators could easily distinguish between those and adult versions.

FDA panel considers whether Pfizer vaccine should be authorised for young children

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