FDA – www.israelhayom.com https://www.israelhayom.com israelhayom english website Wed, 20 Aug 2025 04:49:17 +0000 en-US hourly 1 https://wordpress.org/?v=6.4.2 https://www.israelhayom.com/wp-content/uploads/2021/11/cropped-G_rTskDu_400x400-32x32.jpg FDA – www.israelhayom.com https://www.israelhayom.com 32 32 Radioactive? FDA sounds the alarm on Walmart-bound shrimp https://www.israelhayom.com/2025/08/20/radioactive-fda-sounds-the-alarm-on-walmart-bound-shrimp/ https://www.israelhayom.com/2025/08/20/radioactive-fda-sounds-the-alarm-on-walmart-bound-shrimp/#respond Tue, 19 Aug 2025 22:29:29 +0000 https://www.israelhayom.com/?p=1081867 The Food and Drug Administration has issued a public advisory against consuming, selling, or serving certain Great Value frozen raw shrimp from Walmart, citing risks of Cesium-137 contamination, a radioactive isotope. ABC News reported that US Customs and Border Protection flagged potential Cesium-137 in shipping containers at four US ports, as detailed in the FDA's […]

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The Food and Drug Administration has issued a public advisory against consuming, selling, or serving certain Great Value frozen raw shrimp from Walmart, citing risks of Cesium-137 contamination, a radioactive isotope. ABC News reported that US Customs and Border Protection flagged potential Cesium-137 in shipping containers at four US ports, as detailed in the FDA's Tuesday press release. Tests on shrimp from BMS Foods, an Indonesian supplier, also showed positive results for the isotope, according to the FDA.

Shoppers browse a Walmart Supercenter (REUTERS/Siddharth Cavale/File Photo)

No shrimp confirmed to contain Cesium-137 has reached the US food supply, ABC News stated, citing the FDA. Nevertheless, the FDA is calling for a recall of all BMS Foods products shipped after the positive container tests, even if those specific items have not been found contaminated.

Consumers should avoid the following Great Value frozen raw shrimp products:

  • Lot code: 8005540-1, Best by Date: 3/15/2027
  • Lot code: 8005538-1, Best by Date: 3/15/2027
  • Lot code: 8005539-1, Best by Date: 3/15/2027

"If you have recently purchased raw frozen shrimp from Walmart that matches this description, throw it away," the FDA said in its press release. The FDA is coordinating with distributors and retailers to facilitate recalls, as ABC News reported, referencing the agency's call "to recommend that firms conduct a recall."

The FDA has ruled that BMS Foods' shrimp violates the Federal Food, Drug, & Cosmetic Act, noting it "in that it appears to have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with Cs-137 and may pose a safety concern." Imports from BMS Foods are banned until the company addresses the issue, as the FDA stated, "until the firm has resolved the conditions that gave rise to the appearance of the violation."

Per the US Environmental Protection Agency, Cesium-137 is a soft, silvery metal that melts near room temperature and forms crystalline powder with chlorides. ABC News cited the EPA, noting that high exposure to Cesium-137 can cause severe burns, radiation sickness, or death.

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Hope for Alzheimer's? FDA approves Eli Lilly's groundbreaking treatment https://www.israelhayom.com/2024/07/03/hope-for-alzheimers-fda-approves-eli-lillys-groundbreaking-treatment/ https://www.israelhayom.com/2024/07/03/hope-for-alzheimers-fda-approves-eli-lillys-groundbreaking-treatment/#respond Wed, 03 Jul 2024 01:30:09 +0000 https://www.israelhayom.com/?p=970921   The US Food and Drug Administration (FDA) has granted approval to Eli Lilly's Alzheimer's drug Donanemab, marketed as Kisunla, marking a significant advancement in the treatment of early symptomatic Alzheimer's disease. This decision, announced on Tuesday, adds a promising option to the limited arsenal of treatments available for this devastating condition. Hope for Alzheimer's? […]

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The US Food and Drug Administration (FDA) has granted approval to Eli Lilly's Alzheimer's drug Donanemab, marketed as Kisunla, marking a significant advancement in the treatment of early symptomatic Alzheimer's disease. This decision, announced on Tuesday, adds a promising option to the limited arsenal of treatments available for this devastating condition.

Alzheimer's disease, the fifth-leading cause of death for adults over 65, affects nearly 7 million Americans, with projections indicating a rise to almost 13 million by 2050. The approval of Kisunla represents a beacon of hope for patients and their families grappling with this challenging illness.

Joanne Pike, president and CEO of the Alzheimer's Association, expressed enthusiasm about the FDA's decision. "This is real progress. Today's approval allows people more options and greater opportunity to have more time," Pike stated. "Having multiple treatment options is the kind of advancement we've all been waiting for — all of us who have been touched, even blindsided, by this difficult and devastating disease."

Lilly's new Alzheimer's drug Kisunla. Credit: Eli Lilly and Company via AP Eli Lilly and Co./AP

Kisunla faced several challenges on its way to FDA approval. The FDA initially rejected the drug last year due to insufficient data and unexpectedly delayed it again in March. However, in June, an advisory panel to the agency recommended the treatment for full approval, concluding that its benefits outweigh the risks.

Kisunla will compete directly with Leqembi, a treatment developed by Biogen and its Japanese partner Eisai, which received approval last summer. Both drugs represent significant milestones in Alzheimer's treatment after three decades of unsuccessful attempts to develop effective medicines against the disease.

These treatments are monoclonal antibodies targeting toxic amyloid plaques in the brain, a hallmark of Alzheimer's. They aim to slow the progression of the disease in its early stages. In a late-stage trial, Kisunla demonstrated a 35% reduction in Alzheimer's progression over 18 months compared to a placebo.

Administered through monthly infusions, Kisunla's pricing structure varies based on treatment duration. A six-month course is estimated at $12,522, while 12 and 18-month treatments are priced at $32,000 and $48,696, respectively. Eli Lilly has confirmed that Medicare coverage and reimbursement will be available for eligible patients.

It's crucial to note that while these treatments offer hope, they are not cures. Drugs targeting amyloid plaques can have significant safety risks, including potentially severe brain swelling and bleeding, known as amyloid-related imaging abnormalities (ARIA). In Kisunla's late-stage trial, three patients tragically died from severe forms of these side effects.

The approval of Kisunla marks the third drug of its kind to reach the market, following Leqembi and Aduhelm, another treatment from Biogen and Eisai. However, Aduhelm was recently discontinued following controversy surrounding its expedited FDA approval in 2021 despite a negative recommendation from an advisory panel.

As the landscape of Alzheimer's treatment continues to evolve, the approval of Kisunla offers renewed hope for millions affected by this debilitating disease. While challenges remain, this development signifies progress in the ongoing battle against Alzheimer's and paves the way for future advancements in treatment options.

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Israel's COVID death toll nears 9,000 as concerns rise over Omicron subvariant https://www.israelhayom.com/2022/02/02/israels-covid-death-toll-nears-9000-as-concerns-rise-over-omicron-subvariant/ https://www.israelhayom.com/2022/02/02/israels-covid-death-toll-nears-9000-as-concerns-rise-over-omicron-subvariant/#respond Wed, 02 Feb 2022 10:50:14 +0000 https://www.israelhayom.com/?p=757893   The coronavirus infection rate decreased slightly in the past 24 hours and currently stands at 26.15%, according to Health Ministry data published on Wednesday morning. Altogether, 230,715 Israelis were screened for the virus on Tuesday, of whom 60,329 tested positive. Follow Israel Hayom on Facebook, Twitter, and Instagram The reproduction rate, which refers to […]

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The coronavirus infection rate decreased slightly in the past 24 hours and currently stands at 26.15%, according to Health Ministry data published on Wednesday morning. Altogether, 230,715 Israelis were screened for the virus on Tuesday, of whom 60,329 tested positive.

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The reproduction rate, which refers to the number of people each confirmed carrier infects, also decreased slightly and now stands at 0.91. Any value below 1 means that the infection is subsiding.

There are 435,189 active cases in the country with 2,763 patients hospitalized. Of those, 1,085 are in serious condition – 316 are critically ill, 260 are on ventilators and 17 are connected to ECMO machines. Currently, 91,239 Israelis are in quarantine, of whom 6,644 are healthcare personnel, including 914 doctors and 2,199 nurses.

Thus far, 647,831 Israelis have been vaccinated with four doses, 4,443,628 with three, 6,096,034 with two, and 6,691,819 have received one shot.

Israel has reported 2,987,977 COVID cases, including 8,926 deaths, since the outbreak of the pandemic in March 2020.

Ministry data also showed that several Israelis who recovered after contracting the Omicron variant went on to get infected with its subvariant BA.2. As such, experts fear that the antibodies created after the Omicron infection do not protect one against its mutation. Similar data was also reported in countries worldwide.

Although it is not yet clear whether BA.2 is more dangerous than the original Omicron strain, it is thought to be about 1.5 times more infectious. Countries that detected the subvariant have since reported an increase or renewal in morbidity. A Danish study that analyzed coronavirus infections in more than 8,500 Danish households between December and January said that not only is BA.2 more infections, it is also more resistant to vaccines.

Nevertheless, the World Health Organization said on Tuesday that the subvariant does not seem to be any more severe than the original BA.1 form.

Dr. Boris Pavlin of the WHO's coronavirus response team told an online briefing that the subvariant is already becoming dominant in the Philippines, Nepal, Qatar, India, and Denmark.

He added, "Vaccination is profoundly protective against severe disease, including for Omicron. BA.2 is rapidly replacing BA.1. Its impact is unlikely to be substantial, although more data are needed."

WHO Director-General Tedros Adhanom Ghebreyeus also said on Tuesday that 90 million cases of COVID have been reported since Omicron was first identified 10 weeks ago – amounting to more than in all of 2020, the first year of the COVID-19 pandemic.

With many countries easing their restrictive measures amid public fatigue about them, Ghebreyeus cautioned that Omicron should not be underestimated even though it has been shown to bring less severe illness than earlier variants – and cited "a very worrying increase in deaths in most regions of the world."

"We are concerned that a narrative has taken hold in some countries that because of vaccines – and because of Omicron's high transmissibility and lower severity – preventing transmission is no longer possible and no longer necessary," he told a regular WHO briefing on the pandemic.

"Nothing could be further from the truth," Tedros added. "It's premature for any country either to surrender or to declare victory. This virus is dangerous and it continues to evolve before our very eyes."

WHO said four of its six regions worldwide are seeing increasing trends in deaths. And yet, many European countries have begun easing lockdown measures, including Britain, France, Ireland, and the Netherlands. Finland will end its COVID-19 restrictions this month. Denmark's government scrapped most restrictions aimed at fighting the pandemic this week, saying it no longer considers COVID-19 "a socially critical disease." The nation of 5.8 million has in recent weeks seen more than 50,000 new cases a day, but the number of patients in intensive care units has declined.

Also on Tuesday, Pfizer drug manufacturer asked the Food and Drug Administration to authorize extra-low doses of its COVID-19 vaccine for children under five, potentially opening the way for them to start receiving shots as early as March.

Pfizer aims to give children as young as 6 months shots that contain one-tenth of the dose given to adults. The company said it had started submitting its data to the FDA and expects to complete the process in a few days.

The FDA said it will convene a panel of independent researchers and physicians in mid-February to help review the Pfizer data. The agency isn't required to follow their advice, but the input is a key step in publicly vetting vaccine safety and effectiveness.

Meanwhile, the Knesset ruled on Monday that the so-called "green pass" vaccine certificates will only be checked at the entrance to public events where there is a high risk of contagion, such as weddings held indoors. The ruling will go into effect next Sunday.

The government also decided that Israelis who have gotten vaccinated with the booster shots will be eligible for the pass indefinitely. For those who received only two doses, the pass will be valid for four months.

Lawmakers also ruled that COVID tests will no longer be mandatory for unvaccinated Israelis traveling abroad, though they may still be necessary in the destination country.
Prime Minister Naftali Bennett said at the meeting that the vaccines were "working well against severe illness and infections" as the reproduction rate is on the decrease.

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In related news, medics and nurses staffing Israel's coronavirus wards have recently lamented the shortage of manpower in parallel to the influx of patients.  

"The staff is exhausted," Yoram Weiss, acting director-general of Hadassah Medical Center in Jerusalem, said. "It's not like at the beginning of the pandemic when everybody was full of energy."

COVID wards have been filling up fast while numbers of staff due to Omicron, which has also sent many healthcare workers into quarantine, affecting the quality of care.

"We have on average 10-15% fewer doctors and nurses, while we need 20-30% more because of the flood of patients," Dror Mevorach, who heads Hadassah's coronavirus ward, told Reuters.

The shortage has also forced hospitals to divert resources to COVID wards, cutting back on other procedures, and in mid-January, several scientists urged the government to intervene to reduce infection rates.

They warned that the sudden influx of severely ill patients – most aged over 60 and many with serious pre-existing health conditions – would overwhelm a chronically under-resourced health system. 

But the government, backed by other experts and with almost 65% of Israel's 9.4 million population vaccinated with a recent booster jab or second dose, has stuck to the softer-touch "living alongside COVID " approach to managing the virus that it adopted last summer.

It has rolled back restrictions while urging the public to self-test and stay at home if they are sick – mirroring moves in several Western nations such as Britain and France.

In January, it cut isolation times and cut quarantine for schoolchildren exposed to a carrier.

For Dvir Aran, a biomedical data scientist at Technion – Institute of Technology in Haifa, the government's moves have been "like watching a train wreck in slow motion".

But other professionals welcome what they see as a call for citizens to take personal responsibility while arguing that any restrictions are likely to have only a limited impact on the highly contagious Omicron.

"The government shouldn't be running a kindergarten, ensuring you stay home when you're sick," Yael Haviv-Yadid, head of the critical care ward at Sheba Medical Center said. 

"Be responsible. Wear a mask and get vaccinated," she said.

i24NEWS contributed to this report.

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TA begins elementary school vaccinations as COVID cases hit 4-month peak https://www.israelhayom.com/2021/12/24/tel-aviv-kicks-off-elementary-school-vaccinations-as-infection-rate-reaches-4-month-peak/ https://www.israelhayom.com/2021/12/24/tel-aviv-kicks-off-elementary-school-vaccinations-as-infection-rate-reaches-4-month-peak/#respond Fri, 24 Dec 2021 10:49:36 +0000 https://www.israelhayom.com/?p=740453   The coronavirus infection rate jumped in Israel by an alarming 73% in just one week, data released by the Health Ministry on Friday revealed. Follow Israel Hayom on Facebook and Twitter The ministry also reported that of the 106,647 Israelis it screened for the virus on Thursday, 1,482 (1.4%) tested positive. Of those, 387 […]

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The coronavirus infection rate jumped in Israel by an alarming 73% in just one week, data released by the Health Ministry on Friday revealed.

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The ministry also reported that of the 106,647 Israelis it screened for the virus on Thursday, 1,482 (1.4%) tested positive. Of those, 387 are returnees from abroad.

The reproduction rate continued to inch up and currently stands at 1.36, the highest it has been since August.

The number of active cases crossed the 10,000 threshold on Thursday and now stands at 10,526. Currently, 129 Israelis are hospitalized, of whom 88 are in serious condition. According to data, 80.5% of the seriously ill have not been vaccinated at all.

Israel has reported 1,361,886 cases, including 8,241 deaths, since the outbreak of the pandemic last year. Thirty-nine of the deaths occurred in December.

Thus far, 4,184,491 Israelis have been inoculated with three vaccine shots, 5,868,003 received two jabs and 6,493,317 got one dose. On Thursday, 11,354 Israelis got vaccinated, mostly children ages 5-11.

The Tel Aviv Municipality launched a vaccination campaign for elementary school students on Thursday.

Officials warned that a fifth coronavirus wave was imminent as the Omicron variant continued to circulate throughout the country, prompting cities to consider expanding immunization campaigns.

"We are on the verge of a fifth wave of the pandemic, which may be more intense than the previous ones," Tel Aviv Mayor Ron Huldai cautioned.

"It is important that we show mutual and personal responsibility, so, this week we will start vaccinating children over the age of 6, in schools and during school hours – just like all other children's vaccines given in schools. Do not say - it will not happen to us. The children need to be vaccinated!" he said.

Thus far, around 150 eligible elementary school students have been immunized, according to a press release on the program.

Starting Sunday, the rollout will be expanded to administer doses during school hours, with vaccine sites set up at some schools during the afternoon.

Also on Thursday, the United States Food and Drug Administration authorized a second pill against the coronavirus, providing another easy-to-use medication to battle the rising tide of Omicron infections.

The announcement on Merck drug manufacturer's molnupiravir comes a day after the agency cleared a competing drug from Pfizer.

Pfizer's pill, Paxlovid, is likely to become the first-choice treatment against the virus, because of its superior benefits and milder side effects.

As a result, Merck's pill is expected to have a lesser role against the pandemic than predicted just a few weeks ago. Its ability to head off severe COVID-19 is much smaller than initially announced and the drug label will warn of serious safety issues, including the potential for birth defects.

Both treatments will be free to patients in the US after being purchased by the federal government.

The FDA authorized Merck's drug for adults with a positive COVID-19 test, early symptoms, and who face the highest risks of hospitalization, including older people and those with conditions like obesity and heart disease.

The agency said molnupiravir should be considered for patients "for whom alternative COVID-19 treatment options authorized by the FDA are not accessible or clinically appropriate." It did not include that restriction for Paxlovid, which was authorized for patients 12 and older.

Molnupiravir, made by Merck and Ridgeback Biotherapeutics, will also carry a warning against use during pregnancy. Women of childbearing age should use birth control during treatment and for a few days after while men should use birth control for at least three months after their final dose, the FDA said. The federal agency also said molnupiravir should not be used in patients under age 18 because it may affect bone growth.

Dr. Nick Kartsonis, Merck's senior vice president of clinical research, said company scientists are still studying the drug and they hope to eventually get it approved for use in children.
Additionally, Pfizer's drug was roughly three times more effective in testing, reducing hospitalization and death by nearly 90% among high-risk patients, compared with 30% for Merck's.

Some experts question whether there will be much of a role for the Merck drug in the US.

"To the extent that there's an ample supply of Pfizer's pill, I think it won't be used," Dr. Gregory Poland of the Mayo Clinic said. "There would be no reason, given it has less efficacy and a higher risk of side effects."

For now, the FDA decision provides another potential option against the virus that has killed more than 800,000 Americans – and over five million people worldwide – even as health officials brace for record-setting cases, hospitalizations, and deaths driven by Omicron.

The seven-day rolling average for US COVID-19 cases climbed past 160,000 on Wednesday, according to data collected by Johns Hopkins University. That's more than double the average in late November.

Antiviral pills like Merck's and Pfizer's are expected to be effective against Omicron because they don't target the spike protein where most of the variant's worrisome mutations reside.

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Researchers have warned that older COVID-19 treatments that are administered by IV are unlikely to work against the new strain.

The FDA based its Merck decision on results showing nearly 7% of patients taking the drug ended up in the hospital and one died at the end of 30 days. That compared with 10% of patients hospitalized who were taking the placebo and nine deaths.

Merck says several hundred thousand treatment courses will be available in the US in the next several days and a million will be available over the next few weeks. The supply of Pfizer's drug is more limited before ramping up in 2022.

The US will pay about $700 for each course of Merck's drug, which requires patients to take four pills twice a day for five days. A review by Harvard University and King's College London estimated it costs about $18 to make each 40-pill course of treatment.

Merck's drug inserts tiny errors into the coronavirus' genetic code to slow its reproduction. That genetic effect has raised concerns that the drug could cause mutations in human fetuses and even spur more virulent strains of the virus. But FDA scientists said the variant risk is largely theoretical because people take the drug for such a short period of time.

i24NEWS contributed to this report.

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'Avoiding 4th COVID shot could take a heavy toll,' expert warns https://www.israelhayom.com/2021/12/23/avoiding-4th-covid-shot-could-take-a-heavy-toll-expert-warns/ https://www.israelhayom.com/2021/12/23/avoiding-4th-covid-shot-could-take-a-heavy-toll-expert-warns/#respond Thu, 23 Dec 2021 11:04:02 +0000 https://www.israelhayom.com/?p=739801   The Health Ministry reported on Thursday morning that of the 98,586 Israelis it screened for the coronavirus in the past 24 hours, 1,400 (1.44%) tested positive. The reproduction rate, which relates to the number of people each confirmed carrier infects, increased and currently stands at 1.34. Follow Israel Hayom on Facebook and Twitter There […]

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The Health Ministry reported on Thursday morning that of the 98,586 Israelis it screened for the coronavirus in the past 24 hours, 1,400 (1.44%) tested positive. The reproduction rate, which relates to the number of people each confirmed carrier infects, increased and currently stands at 1.34.

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There are currently 9,591 active cases in the country with 124 patients hospitalized. Of those, 83 are in serious condition.

Israel has reported 1,360,098 cases, including 8,239 deaths, since the outbreak of the pandemic last year.

Thus far, 4,176,653 Israelis have been fully vaccinated, 5,857,658 received two jabs and 6,481,676 got the first dose.

On Wednesday, health regulators in the United States authorized the first pill against COVID-19, a Pfizer drug that those infected with the virus will be able to take at home to head off the worst effects of the disease.

The long-awaited milestone comes as US cases, hospitalizations and deaths are all rising and health officials warn of a tsunami of new infections from the Omicron variant that could overwhelm hospitals.

The drug, Paxlovid, is a faster way to treat early COVID-19 infections, though initial supplies will be extremely limited. All of the previously authorized drugs against the disease require an IV or an injection.

An antiviral pill from Merck drug manufacturer also is expected to soon win authorization. But Pfizer's drug is all but certain to be the preferred option because of its mild side effects and superior effectiveness, including a nearly 90% reduction in hospitalizations and deaths among patients most likely to get severe disease.

"The efficacy is high, the side effects are low and it's oral. It checks all the boxes," Dr. Gregory Poland of the Mayo Clinic said. "You're looking at a 90% decreased risk of hospitalization and death in a high-risk group – that's stunning."

The Food and Drug Administration authorized Pfizer's drug for adults and children ages 12 and older with a positive COVID-19 test and early symptoms who face the highest risks of hospitalization.

The pills from both Pfizer and Merck are expected to be effective against Omicron because they don't target the spike protein where most of the variant's worrisome mutations reside.

Pfizer currently has 180,000 treatment courses available worldwide, with roughly 60,000 to 70,000 allocated to the US. The company said it expects to have 250,000 available in the US by the end of January.

The US government has agreed to purchase enough Paxlovid to treat 10 million people, and it will be provided free to patients. Pfizer says it's on track to produce 80 million courses globally next year, under contracts with Britain, Australia, and other nations.

Israel's Health Ministry is in negotiations with the pharmaceutical giant to reserve an order for the new drug, but an agreement has not been signed yet.

Meanwhile, Health Minister Nitzan Horowitz said on Wednesday evening that Israelis over the age of 60 will most likely be able to get vaccinated with the fourth dose starting next week with no prior registration required.

"I pray that the Omicron will be less violent, but people who are more vulnerable should be as prepared as possible," he told the media.

On Tuesday, a Health Ministry task force recommended the fourth jab for people over the age of 60, as well as healthcare workers, at-risk patients, and people who work with the elderly, however, the decision is yet to be approved by Health Ministry Director-General Nachman Ash.

Boaz Lev, head of the Health Ministry's panel of experts on virus policy, spoke out in support of the dose during a press conference on Thursday.

"Omicron's reproduction rate is high, he said. "In Germany, it stands at 3.1, in the US almost at 3. Such a high reproduction rate we haven't seen before. In previous waves, it stood at 1.2 and we thought that was awful. The [Omicron] variant has become dominant.

"There's this thing called the cost of a mistake. If a wave comes and we have not vaccinated, what will be the price? Severe morbidity? Mortality? Quarantines? That is the price of the mistake of not vaccinating. Over the next few days, we will use more data from countries where the wave is rising."

In related news, two British studies released on Wednesday provide some early hints that the Omicron variant might be milder than the Delta strain.

Scientists stress that even if the findings of these early studies hold up, any reductions in severity need to be weighed against the fact Omicron spreads much faster than Delta and is more able to evade vaccines. Sheer numbers of infections could still overwhelm hospitals.

An analysis from the Imperial College London COVID-19 response team estimated hospitalization risks for Omicron cases in England, finding people infected with the variant are around 20% less likely to go to the hospital at all than those infected with the Delta variant, and 40% less likely to be hospitalized for a night or more.

That analysis included all cases of COVID-19 confirmed by PCR tests in England in the first half of December in which the variant could be identified: 56,000 cases of Omicron and 269,000 cases of Delta.

A separate study out of Scotland – by scientists at the University of Edinburgh and other experts – suggested the risk of hospitalization was two-thirds less with Omicron than Delta. But that study pointed out that the nearly 24,000 Omicron cases in Scotland were predominantly among younger adults ages 20-39. Younger people are much less likely to develop severe cases of COVID-19.

"This national investigation is one of the first to show that Omicron is less likely to result in COVID-19 hospitalization than Delta," researchers wrote. While the findings are early observations, "they are encouraging," the authors wrote.

The findings have not yet been reviewed by other experts, the gold standard in scientific research.

Data out of South Africa, where the variant was first detected, have also suggested Omicron might be milder there. Salim Abdool Karim, a clinical infectious disease epidemiologist in South Africa, said earlier this week that the rate of admissions to hospitals was far lower for Omicron than it was for Delta.

"Our overall admission rate is in the region of around 2% to 4% compared to previously, where it was closer to 20%," he said. "So even though we're seeing a lot of cases, very few are being admitted."

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CDC formally approves Pfizer COVID vaccine for children https://www.israelhayom.com/2021/11/03/cdc-formally-approves-pfizer-covid-vaccine-for-children/ https://www.israelhayom.com/2021/11/03/cdc-formally-approves-pfizer-covid-vaccine-for-children/#respond Wed, 03 Nov 2021 10:39:34 +0000 https://www.israelhayom.com/?p=712275     Israel's coronavirus infection rate stands at 0.86%, according to Health Ministry data. Of the 82,454 people who tested for the virus Tuesday, 663 were found to have contracted the disease. Follow Israel Hayom on Facebook and Twitter There are 7,447 active cases of the virus. There are 201 people in serious condition, 120 […]

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Israel's coronavirus infection rate stands at 0.86%, according to Health Ministry data. Of the 82,454 people who tested for the virus Tuesday, 663 were found to have contracted the disease.

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There are 7,447 active cases of the virus. There are 201 people in serious condition, 120 of whom are on ventilators.

Although 1,316,201 Israelis have recovered from the virus since the outbreak of the pandemic, 8,106 have died.

On the vaccination front, 6,241,399 Israelis have received at least one dose of the coronavirus vaccine, while 5,736,255 have received two doses. Nearly 4 million Israelis – 3,967,603 – have received all three available doses of the vaccine.

A coronavirus outbreak among foreign workers has been identified in the Jordan Valley after one confirmed carrier was admitted to Baruch Podeh Medical Center in Tiberias over the weekend. So far, 170 cases have been confirmed.

Meanwhile, US health officials on Tuesday gave the final signoff to emergency use of Pfizer's kid-size COVID-19 shot, a milestone that opens a major expansion of the nation's vaccination campaign to children as young as five.

The Food and Drug Administration already authorized the shots for children ages 5 to 11 – doses just a third of the amount given to teens and adults, but the Centers for Disease Control and Prevention formally recommends who should receive FDA-cleared vaccines.

The announcement by CDC director Dr. Rochelle Walensky came just hours after an advisory panel unanimously decided Pfizer's shots should be made available to the 28 million youngsters in that age group.

The decision marks the first opportunity for Americans under 12 to get the powerful protection of any COVID-19 vaccine.

"As a mom, I encourage parents with questions to talk to their pediatrician, school nurse, or local pharmacist to learn more about the vaccine and the importance of getting their children vaccinated," Walensky said Tuesday night, in a statement.

In remarks earlier in the day, she said while the risk of severe disease and death is lower in young children than adults, it is real – and that COVID-19 has had a profound social, mental health, and educational impact on youngsters, including widening disparities in learning.

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Report: 2,500 children hospitalized after contracting COVID-19 https://www.israelhayom.com/2021/10/31/report-2500-children-hospitalized-after-contracting-covid-19/ https://www.israelhayom.com/2021/10/31/report-2500-children-hospitalized-after-contracting-covid-19/#respond Sun, 31 Oct 2021 11:21:44 +0000 https://www.israelhayom.com/?p=710141   Israel's coronavirus infection rate stands at 0.63%, according to Health Ministry data. Of the 37,936 people tested for the virus Saturday, 224 were found to have contracted COVID-19. Follow Israel Hayom on Facebook and Twitter There are 8,526 active cases of the virus in the country. There are 223 in serious condition, 133 of […]

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Israel's coronavirus infection rate stands at 0.63%, according to Health Ministry data. Of the 37,936 people tested for the virus Saturday, 224 were found to have contracted COVID-19.

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There are 8,526 active cases of the virus in the country. There are 223 in serious condition, 133 of whom are on ventilators.

Although 1,310,531 Israelis have recovered from COVID-19 since the outbreak of the pandemic, 8,085 have died.

On the vaccination front, 6,230,706 Israelis have received at least one dose of a coronavirus vaccine, while 5,726,544 have received two jabs. Nearly 4 million Israelis – 3,943,118 – have received all three available doses of the vaccine.

According to a new report from the military task force on the coronavirus released Sunday, 2,500 children have been hospitalized after contracting COVID-19. According to Health Ministry data, one out of every 900 children who contracts the virus will be hospitalized in moderate, serious, or critical condition as a result of the disease or complications from it.

As for the prevalence of PIMS, a multisystem inflammatory condition that can appear in children who contract the virus, around 150 cases have been reported in Israel, meaning one in every 3,500 children who contract the disease. A majority of children who require hospitalization for the condition require treatment in an intensive care unit. Between 1% to 2% of those cases resulted in death.

The report's authors wrote that "an analysis of morbidity in Israel and around the world finds that contrary to popular opinion, the coronavirus disease can certainly be dangerous for children. Although children do generally experience mild forms of the disease," there is a significant percentage of children who contract the virus and "could suffer from significant and even dangerous morbidity."

Following the US Food and Drug Administration's authorization of Pfizer's coronavirus vaccine in children aged 5 to 12, coronavirus chief Salman Zarka told Army Radio Israel was in the process of acquiring doses from the drugmaker. "We are waiting for the experts' decision next Thursday." He said that depending on how the process moved forward, "I believe we can begin vaccinating kids in the second half of November."

Health Ministry Director-General Nachman Ash told the Kan public broadcaster: "We want to examine our morbidity and for the Israeli public to feel we aren't making a decision casually, even if it comes after the FDA authorization. I believe most parents will vaccinate, but it will take time."

Meanwhile, US officials on Friday said barring an unforeseen breakthrough, intelligence agencies won't be able to conclude whether COVID-19 spread by animal-to-human transmission or leaked from a lab.

The paper issued by the Director of National Intelligence elaborates on findings released in August of a 90-day review ordered by US President Joe Biden. That review said that US intelligence agencies were divided on the origins of the virus but that analysts do not believe the virus was developed as a bioweapon and that most agencies believe the virus was not genetically engineered.

China has resisted global pressure to cooperate fully with investigations into the pandemic or provide access to genetic sequences of coronaviruses kept at the Wuhan Institute of Virology, which remains a subject of speculation for its research and reported safety problems. Biden launched the review amid growing momentum for the theory – initially broadly dismissed by experts – that the virus leaked from the Wuhan lab.

China remains an exceedingly difficult place for intelligence operations and has fought back against allegations that it mishandled the emergence of the pandemic, which has killed 5 million people worldwide. Senior officials involved in the full report's drafting said they hoped it would better inform the public about the challenges of determining the virus's origins.

"We don't think we're one or two reports away from being able to understand it," said one official, who spoke on condition of anonymity to discuss intelligence matters.

The full report notes that the Wuhan Institute of Virology "previously created chimeras, or combinations, of SARS-like coronaviruses, but this information does not provide insight into whether SARS Cov-2 was genetically engineered by the WIV."

Information that lab researchers sought medical treatment for a respiratory illness in November 2019 "is not diagnostic of the pandemic's origins," the report said.

Allegations that China launched the virus as a bioweapon were dismissed because their proponents "do not have direct access to the Wuhan Institute of Virology," are making scientifically invalid claims, or are accused of spreading disinformation, the report said.

Four agencies within the intelligence community said with low confidence that the virus was initially transmitted from an animal to a human. A fifth intelligence agency believed with moderate confidence that the first human infection was linked to a lab.

Prior to writing the report, analysts conducted what the report describes as a "Team A/Team B" debate to try to strengthen or weaken each hypothesis.

The report identifies types of data that investigators still want China to provide access to, including records and tissue samples from several markets in Wuhan, including the Huanan Seafood Wholesale Market, Qiyimen Live Animal Market, Dijiao Outdoor Pet Market, and others. Scientists originally believed the virus emerged from animals sold at the Huanan market, which has since been ruled out by some as the origin site.

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Experts sound alarm as vaccine-resistant COVID strain emerges https://www.israelhayom.com/2021/10/29/experts-sound-alarm-as-vaccine-resistant-covid-variant-emerges/ https://www.israelhayom.com/2021/10/29/experts-sound-alarm-as-vaccine-resistant-covid-variant-emerges/#respond Fri, 29 Oct 2021 09:59:22 +0000 https://www.israelhayom.com/?p=709727   The Delta wave continued to subside in Israel on Thursday, according to a report by the Health Ministry. Of the 71,612 Israelis tested for the virus on the day, 651 (0.92%) tested positive. Follow Israel Hayom on Facebook and Twitter There are currently 9,354 active cases in the country with 325 Israelis hospitalized. Of […]

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The Delta wave continued to subside in Israel on Thursday, according to a report by the Health Ministry. Of the 71,612 Israelis tested for the virus on the day, 651 (0.92%) tested positive.

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There are currently 9,354 active cases in the country with 325 Israelis hospitalized. Of those, 227 were in serious condition.

Israel has reported 1,326,538 cases, including 8,081 deaths, since the outbreak of the pandemic.

Thus far, 3,933,391 Israelis have been fully vaccinated, 5,723,252 received two doses and 6,227,581 got inoculated with one jab.

However, while the Delta variant seems to be waning in Israel, as well as the rest of the world, the medical community is already alarmed about another mutation emerging from Tanzania.

The A.30 strain was first detected in the East African country in February but has until now remained relatively isolated within the region. However, in recent weeks several carriers were found to be infected with the mutation in Angola. One case was also detected in Sweden.

According to researchers, A.30 did not mutate from other COVID-19 variants, but rather from the original strain that was found in Wuhan, China, at the outbreak of the pandemic.

Seeing as A.30 has only recently started spreading globally, little research has been done on it. Scientists at Germany's University of Gottingen published the results of a study this week which they conducted to see how A.30 spreads in the human body.

They found that not only did it have higher infection capabilities, but it was also more resistant to antibodies provided by the Pfizer and AstraZeneca vaccines. The scientists concluded that A.30 could potentially cause a global infection wave, and should therefore be closely monitored.

Despite the warning, the World Health Organization has not named A.30 as a potentially dangerous variant, probably due to a relatively low number of reported cases. However, experts have pointed out that the infection rate might be underreported due to the Angolan and Tanzanian healthcare systems' inability to efficiently track and document the virus.

Meanwhile, health officials in Israel are scheduled to convene on Nov. 4 to discuss children's vaccinations after earlier in the week a panel for the US Food and Drug Administration approved kid-size doses of Pfizer's vaccine shots for 5-11-year-olds.

In an effort to be more transparent about its decision-making process, the ministry will broadcast the meeting online. Viewers who registed in advance will be able to pose questions to the experts.

Education Minister Yifat Shasha-Biton praised the move.

"I commend the Health Ministry on its decision to hold a discussion on the children's vaccines in a manner that is transparent to the public. This is the correct and right way. This is how public trust can be built."

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Health Ministry eyes vaccinating children under 12 against COVID within weeks https://www.israelhayom.com/2021/10/27/health-ministry-eyes-vaccinating-children-under-12-within-weeks/ https://www.israelhayom.com/2021/10/27/health-ministry-eyes-vaccinating-children-under-12-within-weeks/#respond Wed, 27 Oct 2021 09:48:33 +0000 https://www.israelhayom.com/?p=708347   The highly contagious Delta variant continued to subside in Israel on Tuesday, according to a report by the Health Ministry. Of the 91,496 Israelis it screened for the virus on the day, 727 (0.85%) tested positive. The reproduction rate is 0.73.  Follow Israel Hayom on Facebook and Twitter There are currently 10,914 active cases […]

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The highly contagious Delta variant continued to subside in Israel on Tuesday, according to a report by the Health Ministry. Of the 91,496 Israelis it screened for the virus on the day, 727 (0.85%) tested positive. The reproduction rate is 0.73. 

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There are currently 10,914 active cases in the country with 342 Israelis hospitalized. The number of seriously ill patients decreased and now stands at 237. Of those, 79% are unvaccinated. 

Israel has reported 1,325,267 cases, including 8,063 deaths since the outbreak of the pandemic. Thus far, 3,924,163 Israelis have been vaccinated three times, 5,720,398 have received two jabs and 6,224,851 have gotten one dose. 

Nevertheless, the ministry said that despite the general decrease in morbidity in the country, one city experienced a worrisome outbreak. According to data, there was a spike in morbidity in 40 educational institutions in Rehovot, central Israel, where students and educational staff were found to be infected.  

The city is designated as "red" under the government's "stoplight" ranking. The ministry has increased vaccination efforts in Rehovot in order to curb the infection. If successful, it will use it as a "model for tackling future outbreaks between waves," the ministry said. 

Also on Tuesday, the US Food and Drug Administration endorsed kid-size doses of Pfizer's vaccine shots for 5-11-year-olds.

An FDA panel voted unanimously, with one abstention, that the vaccine's benefits in preventing COVID in that age group outweigh any potential risks. That includes questions about a heart-related side effect that's been very rare in teens and young adults despite their use of a much higher vaccine dose.

While children are far less likely than older people to get severe COVID, ultimately many panelists decided it's important to give parents the choice to protect their youngsters – especially those at high risk of illness or who live in places where other precautions, like masks in schools, aren't being used.

"This is an age group that deserves and should have the same opportunity to be vaccinated as every other age," said panel member Dr. Amanda Cohn of the Centers for Disease Control and Prevention.

The FDA isn't bound by the panel's recommendation and is expected to make its own decision within days. If the FDA concurs, there's still another step: Next week, the CDC will have to decide whether to recommend the shots and which youngsters should get them.

Full-strength shots made by Pfizer and its partner BioNTech are already recommended for everyone 12 and older but pediatricians and many parents are clamoring for protection for younger children.

Pfizer studied 2,268 elementary schoolchildren given two shots three weeks apart of either a placebo or the kid dose. Vaccinated youngsters developed levels of virus-fighting antibodies just as strong as teens and young adults who got the full-strength shots. More importantly, the vaccine proved nearly 91% effective at preventing symptomatic infection – based on 16 cases of COVID-19 among kids given dummy shots compared to just three who got vaccinated.

The kid dosage also proved safe, with similar or fewer temporary side effects – such as sore arms, fever, or achiness – that teens experience. At FDA's request, Pfizer more recently enrolled another 2,300 youngsters into the study, and preliminary safety data has shown no red flags.

But that study isn't large enough to detect any extremely rare side effects, such as the heart inflammation that occasionally occurs after the second full-strength dose, mostly in young men and teen boys. The panel spent hours discussing if younger children, given a smaller dose, might face that side effect, too.

Statistical models developed by FDA scientists showed that in most scenarios of the continuing pandemic, the vaccine would prevent far more COVID-19 hospitalizations in this age group than would potentially be caused by that rare heart problem.

FDA's models suggested the vaccine could prevent 200-250 hospitalizations for every one million youngsters vaccinated – assuming that virus spread remained high, something that is hard to predict. FDA scientists also said younger kids likely won't have as much risk of heart inflammation as teens but if they did, it might cause about 58 hospitalizations per million vaccinations.

Moderna vaccine manufacturer also is studying its vaccine in young children, and Pfizer has additional studies underway in those younger than 5.

In Israel, Health Ministry Director-General Nachman Ash told Army Radio after the FDA ruling, he estimated the country will begin vaccinating children "in a few weeks." 

He said Israel does not have the doses required for the campaign yet but assured that the ministry would do its utmost "to make the vaccines accessible to all children so that there will be no delay in the immunization. We need to be prepared for another wave – the more people get vaccinated, the less severe the morbidity will be. Getting infected with the coronavirus can lead to more severe side effects than getting vaccinated."

Prime Minister Naftali Bennett is scheduled to meet with senior health officials on Wednesday afternoon to discuss the FDA ruling. The final decision, however, will be made on Nov. 4 during a meeting with the ministry's Advisory Committee on Infectious Diseases and Immunizations. 

In any case, pediatricians in Israel have already welcomed the announcement. 

"I am happy about the decision of the FDA advisory committee, this is a step that will open the door to vaccinating children, and we will discuss this in Israel as well," President of the Israeli Pediatric Association Professor Zachi Grossman said.

"We listened to what was said in the FDA yesterday [Tuesday] and we will have the data and all this will be discussed this coming Thursday. I will recommend proceeding with the [children's] vaccinations and I am sure that most of the members will do the same."

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Nearly 50% of Israeli parents plan to vaccinate their kids for COVID-19 https://www.israelhayom.com/2021/10/26/nearly-50-of-israeli-parents-plan-to-vaccinate-their-kids-for-covid-19/ https://www.israelhayom.com/2021/10/26/nearly-50-of-israeli-parents-plan-to-vaccinate-their-kids-for-covid-19/#respond Tue, 26 Oct 2021 09:37:03 +0000 https://www.israelhayom.com/?p=707665   Israel's coronavirus infection rate stands at 0.88% according to Health Ministry data. Of the 104,838 people who tested for the virus Monday, 866 were found to have the disease. Follow Israel Hayom on Facebook and Twitter There are 11,439 active cases in the country. There are 249 people in serious condition, 139 of whom […]

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Israel's coronavirus infection rate stands at 0.88% according to Health Ministry data. Of the 104,838 people who tested for the virus Monday, 866 were found to have the disease.

Follow Israel Hayom on Facebook and Twitter

There are 11,439 active cases in the country. There are 249 people in serious condition, 139 of whom are on ventilators.

Although 1,304,791 Israelis have recovered from the virus since the outbreak of the pandemic, 8,062 have died.

On the vaccination front, 3,915,254 Israelis have received all three available doses of the coronavirus vaccine. While 5,718,253 have received two doses, 6,222,551 have received at least one jab.

With the US Food & Drug Administration set to deliberate approval of Pfizer's vaccine for children aged 5 to 11 Tuesday, a new survey of 680 parents to children aged 5 to 11 by Israel's Meuhedet healthcare provider has found around half plan to vaccinate their children.

Among those parents polled, 48% said they planned to vaccinate their children. Twenty-three percent said they would refuse to vaccinate their kids, while 29% said they were either considering or leaning against vaccination.

Sixty percent of parents surveyed said studies on the safety and side effects of the vaccines were helpful in helping them reach a decision.

Among those who said they would not vaccinate their children, 37% said they were concerned by possible damage to their children's health down the line, while 18% said there was insufficient information on the efficacy and safety of the vaccine. Eleven percent said they did not want their children to be among the first to get the jab, while 7% said they preferred their children to contract the virus naturally.

Just 2% of those surveyed who said they would not vaccinate their children described themselves as against the vaccine in principle.

The survey found that 60% of vaccinated parents planned to vaccinate their children. Unsurprisingly, 100% of unvaccinated parents said they would not vaccinate.

Mali Kusha, chief nursing officer at Meuhedet and the woman who led the research effort, said: "It is precisely now when morbidity is not high that it is important to move to vaccinate children to prevent or diminish as much as possible the next wave. That is why we wanted to understand what the barriers were to parents who were still debating or had decided not to vaccinate and try to reach them and explain the importance of the vaccine."

She said, "Thirty-six percent of parents said they would consult with their pediatrician, and 23% said they were waiting to see and read articles on the vaccination of children. Therefore, we have no doubt a widespread campaign through the media and pediatricians who have direct and ongoing ties with the families [is necessary]."

Meanwhile, Health Ministry Director-General Nachman Ash told Army Radio he believed the ministry would be more transparent in its decision-making process when it came to authorizing the vaccine for children.

"I believe the process will be more transparent this time. At least some of the deliberations will be broadcast on the internet. We don't want there to be irrelevant influences on the discussion as it is public," he explained.

In an earlier interview with Tel Aviv-based 103FM Radio, the head of Public Health Services at the Health Ministry Dr. Sharon Elroy Preiss said: "I don't think we'll start vaccinating children in Israel in a week and a half. I think serious discussions will be held. We want to present all of the information to the scientific community in Israel, share it with the public, and explain the vaccine in the near future – during the month of November."

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