pfizer – www.israelhayom.com https://www.israelhayom.com israelhayom english website Fri, 29 Apr 2022 04:47:55 +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 pfizer – www.israelhayom.com https://www.israelhayom.com 32 32 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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Pfizer begins study of Omicron-specific COVID shots https://www.israelhayom.com/2022/01/25/pfizer-begins-study-of-omicron-specific-covid-shots/ https://www.israelhayom.com/2022/01/25/pfizer-begins-study-of-omicron-specific-covid-shots/#respond Tue, 25 Jan 2022 16:49:23 +0000 https://www.israelhayom.com/?p=754215   Pfizer has begun a study comparing its original COVID-19 vaccine with doses specially tweaked to match the highly contagious Omicron variant. Pfizer and its partner BioNTech announced the study on Tuesday. Follow Israel Hayom on Facebook, Twitter, and Instagram COVID-19 vaccine makers have been updating their shots to better match Omicron in case global […]

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Pfizer has begun a study comparing its original COVID-19 vaccine with doses specially tweaked to match the highly contagious Omicron variant.
Pfizer and its partner BioNTech announced the study on Tuesday.

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COVID-19 vaccine makers have been updating their shots to better match Omicron in case global health authorities decide the change is needed.
While Omicron is more likely than previous variants to cause infection even in people who have been vaccinated, it is not yet clear that a change to the vaccine recipe is needed.

The original vaccines still offer good protection against severe illness and death. Studies in the US and elsewhere have made clear that adding a booster dose strengthens that protection and improves the chances of avoiding a milder infection.

"We recognize the need to be prepared in the event this protection wanes over time and to potentially help address Omicron and new variants in the future," Kathrin Jansen, Pfizer's vaccine research chief, said in a statement.

The new US study is enrolling up to 1,420 healthy adults, ages 18 to 55, to test the updated Omicron-based shots for use as a booster or for primary vaccinations. Researchers will examine the tweaked vaccine's safety and how it revs up the immune system in comparison to the original shots.

In one study group, about 600 volunteers who received two doses of the current Pfizer vaccine three to six months ago will receive either one or two Omicron-based shots as boosters. Another 600 who have already gotten three regular doses of the Pfizer vaccine will be given a fourth dose of either the regular vaccine or the Omicron-matched version.

The study also will enroll some unvaccinated volunteers who will receive three doses of the Omicron-based vaccine.

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'Millions of people are alive, healthy thanks to Dr. Bourla and his team at Pfizer' https://www.israelhayom.com/2022/01/19/millions-of-people-are-alive-healthy-thanks-to-dr-bourla-and-his-team-at-pfizer/ https://www.israelhayom.com/2022/01/19/millions-of-people-are-alive-healthy-thanks-to-dr-bourla-and-his-team-at-pfizer/#respond Wed, 19 Jan 2022 07:06:57 +0000 https://www.israelhayom.com/?p=751579   Pfizer Inc. chairman and CEO Albert Bourla has been awarded Israel's prestigious Genesis Prize for his efforts in leading the development of a COVID-19 vaccine. Follow Israel Hayom on Facebook, Twitter, and Instagram The $1 million award is granted each year to a person for their professional achievements, contributions to humanity and commitment to […]

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Pfizer Inc. chairman and CEO Albert Bourla has been awarded Israel's prestigious Genesis Prize for his efforts in leading the development of a COVID-19 vaccine.

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The $1 million award is granted each year to a person for their professional achievements, contributions to humanity and commitment to Jewish values. The Genesis Prize Foundation said Bourla had received the largest number of votes in an online campaign in which some 200,000 people in 71 countries participated.

It commended him for his "leadership, determination, and especially for his willingness to assume great risks." It cited Pfizer's decision to turn down US government funding early in the pandemic, a decision that helped the company reduce bureaucracy and expedite development of the vaccine.

Its partner, BioNTech, received funding from the German government, and Pfizer later signed a large supply contract with the United States. The strategy put Pfizer at the forefront of global efforts to fight the coronavirus, with its vaccine the first to be authorized for use in the US and Europe.

The Greek-born Bourla, the son of Holocaust survivors, plans to donate his prize to projects aimed at preserving the memory of Holocaust victims, especially in Greece, the foundation said. Bourla's parents were among the few survivors of Thessaloniki's Jewish community, which was all but wiped out by the Nazis during World War II.

In a statement issued by the foundation, Bourla said he was accepting the prize "humbly and on behalf of all my Pfizer colleagues who answered the urgent call of history."

"I was brought up in a Jewish family who believed that each of us is only as strong as the bonds of our community; and that we are all called upon by God to repair the world," he said.

Pfizer's vaccine was the first to win US approval for emergency use in December 2020, and Israel quickly became one of the first countries to inoculate its population with the vaccine. It later struck a deal with the drug maker to exchange vast troves of data with the company in exchange for continued supplies of what was then a hard-to-get vaccine.

The deal helped turn Israel into an early global leader in the fight against COVID-19 and has provided valuable data for researchers – though it also was criticized by some on privacy grounds and for shining a light on disparities in access to vaccines between rich and poor countries.

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Bourla joins a list of business leaders, artists and entertainers to win the prize. Last year's winner was Hollywood mogul Steven Spielberg.

The prize was inaugurated in 2014 and is run in a partnership between the private Genesis Prize Foundation and the chairman's office of the Jewish Agency, a nonprofit group that has close ties to the Israeli government. It is funded by a $100 million endowment established by the foundation.

The prize is usually awarded in Jerusalem each June at a dinner attended by Israel's prime minister. But the ceremony has been called off the past two years due to the pandemic.

Bourla said he hopes to travel to Jerusalem this summer for the event.

Stan Polovets, founder and chairman of the Genesis Prize, said he was "proud to welcome Dr. Albert Bourla to the honored family of Genesis Prize laureates. Dr. Bourla is a role model for two of the most important Jewish values: commitment to the sanctity of life, and making the world a better place.

"While the COVID pandemic is far from over, millions of people are living and healthy thanks to the achievements of Dr. Bourla and his team at Pfizer. This is a very proud moment, not only for Dr. Bourla, but also for the entire Jewish community," Polovets said.

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COVID deaths, number of seriously ill patients double https://www.israelhayom.com/2022/01/07/covid-deaths-number-of-seriously-ill-patients-double-in-week/ https://www.israelhayom.com/2022/01/07/covid-deaths-number-of-seriously-ill-patients-double-in-week/#respond Fri, 07 Jan 2022 10:45:07 +0000 https://www.israelhayom.com/?p=746667   Coronavirus deaths and the number of seriously ill patients doubled in Israel in a week, according to Health Ministry data published on Friday morning. Follow Israel Hayom on Facebook, Twitter, and Instagram The reproduction rate, which relates to the number of people each confirmed carrier infects, stands at 1.96. Any value above 1 shows […]

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Coronavirus deaths and the number of seriously ill patients doubled in Israel in a week, according to Health Ministry data published on Friday morning.

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The reproduction rate, which relates to the number of people each confirmed carrier infects, stands at 1.96. Any value above 1 shows that the transmission rate is growing.

Of the 206,704 Israelis who were screened for the virus in the past 24 hours, 16,830 (8.22%) tested positive. There are 86,071 active cases in the country with 338 patients hospitalized. Of those, 143 are in serious condition.

Thus far, 4,309,141 Israelis have been vaccinated with the third dose, 5,955,873 got two shots and 6,613,437 received one jab. Over 195,999 Israelis were immunized with the fourth dose since the launch of the campaign five days ago.

Meanwhile, Health Ministry Director-General Nachman Ash said on Thursday that Pfizer's oral coronavirus pills were not a "game-changer."

"We estimate that it will prevent several hundred serious illnesses," he said, speaking to medical students at the Bar-Ilan University in Ramat Gan.

"Many cannot take them because of pregnancy, kidney failure, and other [restrictions]. Another challenge is to identify patients at risk. There is also a logistical complexity to bring the poll to the patient's home on time and monitor the response," he explained.

The first shipment of the Pfizer pills landed in Israel on Dec. 30, one of the first countries in the world to receive the new drug. The Health Ministry granted emergency approval to the medication after the US Federal Drug Administration did the same.

In related news, Coronavirus Commissioner Professor Zarka said in an interview on Friday the ministry predicted 2,500 critically ill patients to be hospitalized with COVID during the Omicron wave.

"Omicron is not yet thought to cause serious illness, but it is too early to celebrate," he said. "Some scenarios predict 4,000 patients in critical condition. But the most likely scenario is 2,500."

Zarka assured the healthcare system would be able to handle such a caseload, but "it needs more oxygen."

In the meantime, the health and education ministries announced on Thursday a new educational outline to take effect next week, pending approval by the government and the Knesset's Education Committee.

The new outline essentially cancels the previous "traffic light" system that determined whether students studied online or in class based on the coronavirus infection rate in the city. It will also scrape the previously necessary 70% of vaccinated students for the class to study face-to-face.
When coming into contact with a confirmed coronavirus carrier, students and teachers will be subject to the same testing and quarantine rules as the rest of the country.

If a teacher or student tests positive for COVID, others who are vaccinated or recovered from the virus (as per Health Ministry definitions) will have to take an at-home antigen test. If the results come back positive, the person will be required to self-isolate for 10 days, to be exited with a doctor's approval.

Non-vaccinated students will have to take a supervised antigen test. If negative, they will be required to quarantine for seven days and take another supervised antigen test at the end of the week. If positive, they will be required to self-isolate for 10 days, to be exited with a doctor's approval.

Teachers will continue to be required to present "green pass" vaccination certificates. Indoor mask mandates will also remain intact.

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Utah tech entrepreneur quits after calling COVID vaccine 'Jewish plot' https://www.israelhayom.com/2022/01/05/utah-tech-entrepreneur-quits-after-calling-covid-vaccine-jewish-plot/ https://www.israelhayom.com/2022/01/05/utah-tech-entrepreneur-quits-after-calling-covid-vaccine-jewish-plot/#respond Wed, 05 Jan 2022 12:57:16 +0000 https://www.israelhayom.com/?p=745515   A Utah tech company founder and onetime prominent figure in state Republican politics resigned on Tuesday from the board of the company he started after sending an email outlining an antisemitic vaccination conspiracy theory. Follow Israel Hayom on Facebook, Twitter, and Instagram David Bateman, founder and board chair of the company Entrata, claimed the […]

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A Utah tech company founder and onetime prominent figure in state Republican politics resigned on Tuesday from the board of the company he started after sending an email outlining an antisemitic vaccination conspiracy theory.

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David Bateman, founder and board chair of the company Entrata, claimed the COVID-19 vaccine is part of a plot by "the Jews" to exterminate people, Fox13 reported.

Dave Bateman, CEO of Entrata, speaks during StartFEST at the Covey Center for the Arts in Provo on Sept. 2, 2015 Stacie Scott/The Deseret News via AP

The email attacks the efficacy of the COVID-19 vaccine and urges people not to get it. It claims the pandemic and "systematic extermination of billions of people" will lead to an effort to "consolidate all the countries in the world under a single flag with totalitarian rule."

The recipients included the owner of NBA's Utah Jazz, Ryan Smith, GOP Gov. Spencer Cox and Utah Senate Minority Whip Luz Escamilla, a Democrat.

"These irresponsible comments are hurtfully antisemitic, blatantly false, and we completely reject them," Cox tweeted.

Bateman confirmed he sent the email in a text message to the news station. He said he had "nothing but love for the Jewish people" but he echoed the assertions in the email. The email contained his personal opinion and was intended for a few friends, he said.

He has retired as CEO of Entrata, a property management software company, but had remained chair of the company's board. Bateman had also been a prominent figure in Utah Republican politics, financially bailing out the party a few years ago when its legal debt mounted during a court fight over paths for candidates to get on the ballot.

The Entrata board of directors asked Bateman to step down Tuesday, and he agreed.

"The opinions expressed by Dave were his alone and do not reflect the views or values of Entrata ... To be absolutely clear, we at Entrata firmly condemn antisemitism in any and all forms," CEO Adam Edmunds said in a statement.

His email was also met with shock and dismay from people like Blake McClary, another prominent Utah tech executive who runs the Salt Lake City chapter of Silicon Slopes, a nonprofit representing the state's tech industry. He tweeted a call for Bateman to step down from Entrata and "not embarrass us."

Rabbi Avremi Zippel of Chabad Utah called the email "blatant antisemitism" and a "flaming pile of garbage" that could lead to real-world violence.

"We know how quickly things go from ridiculous conspiracy theories online and in emails, how that jumps to violence rather quickly," he said.

The COVID-19 vaccines authorized for use in the US were tested in tens of thousands of people and proven to be both safe and effective at dramatically reducing the risk of serious disease and death. The vaccines now have been given to millions of Americans, and that real-world use plus extra government safety tracking have made clear that serious side effects are extremely rare – and that any risk is far lower than the risks posed by COVID-19.

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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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Expert warns Omicron variant could trigger vaccine inequality https://www.israelhayom.com/2021/12/15/omicron-could-trigger-vaccine-inequity/ https://www.israelhayom.com/2021/12/15/omicron-could-trigger-vaccine-inequity/#respond Wed, 15 Dec 2021 10:48:55 +0000 https://www.israelhayom.com/?p=735555   Despite concerns over the fast-spreading Omicron coronavirus variant, the morbidity situation in Israel seems to be under control. The Health Ministry reported on Wednesday morning that of the 106,585 Israelis it screened for the virus in the past 24 hours, 673 (0.70%) tested positive. The reproduction rate, which inched up to as much as […]

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Despite concerns over the fast-spreading Omicron coronavirus variant, the morbidity situation in Israel seems to be under control. The Health Ministry reported on Wednesday morning that of the 106,585 Israelis it screened for the virus in the past 24 hours, 673 (0.70%) tested positive. The reproduction rate, which inched up to as much as 1.09 in recent weeks has decreased to 1.01.

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There are 6,429 active cases in the country with 122 patients hospitalized. Of those, 84 are in serious condition. 

Israel has reported 1,352,067 cases, including 8,224 deaths, since the outbreak of the pandemic last year. On Wednesday, no COVID deaths were reported. 

Thus far, 4,135,124 Israelis have been fully vaccinated, 5,798,867 received two shots and 6,422,632 got one jab. 

Meanwhile, the head of vaccine alliance Gavi, which is leading a United Nations-backed push to get COVID-19 vaccines to developing countries, said that he's seen early signs that rich countries are beginning to withhold donations out of fears about Omicron– warning any new hoarding could lead to "Inequity 2.0."

Gavi chief executive Dr. Seth Berkley took stock of the nearly two-year fight against the pandemic as the alliance released the latest update to its supply forecast for COVID-19 vaccines that it has repeatedly downscaled, largely because of export bans and vaccine hoarding by some producer countries that critics say it should have foreseen.

"With the Omicron variant, what we've seen is panic in many countries that has led acceleration of boosters both to the numbers of people getting them, but also the timeline for getting them," Berkley told The Associated Press in an interview late Tuesday at his home outside Geneva.

He was referring to extra doses given in rich countries to a broad swath of people – not just those at highest risk of contracting severe COVID-19.

The Geneva-based public-private partnership has been the lead manager of the UN-backed COVAX program that initially sought to get coronavirus vaccines to all countries but was pivoted after wealthier countries, and even some poorer ones, started striking their own deals to get jabs.

That locked down much of tight supplies and prompted vast inequality in access to jabs. Of the roughly 10 billion doses that have been delivered worldwide, the vast majority have gone to rich countries. COVAX has delivered just over 700 million.

Gavi chief executive Dr. Seth Berkley (Salvatore Di Nolfi, Keystone via AP) AP

"We also are beginning to see donors not wanting to donate their doses as fast as they might have because of the uncertainty now of where we are," Berkley said, declining to specify. "Of course, our long-term concern is, if it turns out that new variant vaccines are required, that there may be an 'Inequity 2.0' where we see wealthy countries hoard those vaccines once again, like we saw at the beginning of the pandemic."

While Omicron's transmissibility, severity and resistance to vaccines aren't yet fully clear, the new variant could require revisions to existing vaccines or even production of new ones. Berkley says a COVID-19 vaccine from Novavax, which relies on a common technology in flu vaccines and has shown efficacy against variants, could be set to win emergency-use approval within "days" from the World Health Organization.

In recent weeks, global production of COVID-19 vaccines has taken off and supply is less of a problem than it once was. Now, a challenge is making sure countries can take in vaccines that sometimes require storage in very cold temperatures or are delivered in batches that need to be used at the same time once opened.

Wastage is a risk. Berkley said some is inevitable and insisted less than 1% of COVAX vaccines have gone to waste.

While he said it's understandable, if potentially short-sighted, that politicians would want to serve their own people first with vaccines, one leading critic of Gavi's handling of COVAX says a lot of the trouble can be pinned on wealthy-country governments who didn't ensure steady sharing of vaccines. Now, an influx of vaccines in some developing countries could present problems.

"Since high-income country governments hoarded vaccine and didn't allow ... distribution ... to be paced, now we're at this end-of-year dump, basically, and lo and behold, surprise, surprise, fragile health systems -- some of them are having real difficultly accommodating it," said Kate Elder, senior vaccines policy adviser at Médecins Sans Frontières, or Doctors Without Borders, which provides medical care around the world.

Gavi manages COVAX along with the Center for Epidemic Preparedness Innovations and UN health agency WHO, while UNICEF handles distribution of shots into arms.

Berkley said Gavi expects to have delivered between 800 million and 1 billion doses by the end of this year to the poorest developing countries, which he says was in line with targets. Where the alliance faced slippage in deliveries was with wealthier "self-financing countries" that were originally expected to get jabs through COVAX but didn't use it as foreseen – many opting for direct deals with manufacturers.

Gavi expects to have 1.4 billion doses available by the end of his year. It had originally set a goal to deliver 2 billion doses by the end of 2021.

Berkley said Gavi expects another 800 million doses in the first quarter of next year, but not all of those are confirmed. Questions remain about supplies from manufacturers, regulatory approvals, and dose donations that are "somewhat more unpredictable." Places like the United States and the European Union have been key donors.

As it has been forced to adapt and revise its strategies, donations from countries like "Team Europe" have grown increasingly important to COVAX – which was never planned to be a donation mechanism.

"In fact, we didn't even have donations in the original framework and way of working," Berkley said. "That only occurred because of the vaccine hoarding that was occurring in wealthy countries and because of the fact that we had export bans."

Critics say Gavi misjudged national self-interest and wrongly bet on trying to supply the whole world through a vast new program whose long-term impact is questionable. They say focus should have been on strengthening existing vaccine distribution systems, like one through WHO's Americas regional body PAHO (Pan American Health Organization).

"Hindsight is 20/20 but there have been a tremendous number of shortcomings in the COVAX facility, probably many of them which could have been anticipated (by) understanding the environment and how countries with means were going to respond to this pandemic," said MSF's Elder.

In related news, Pfizer pharmaceutical giant said on Tuesday that its antiviral COVID-19 pill showed near 90% efficacy in preventing hospitalizations and deaths in high-risk patients, and recent lab data suggests the drug retains its effectiveness against Omicron. 

The drugmaker said last month that the oral medicine was around 89% effective in preventing hospitalizations or deaths when compared to placebo, based on interim results in around 1,200 people. Data from its final analysis of the trial disclosed on Tuesday includes an additional 1,000 people.

Nobody in the trial who received the Pfizer treatment died, compared with 12 deaths among placebo recipients.

The Pfizer pills are taken with the older antiviral ritonavir every 12 hours for five days beginning shortly after the onset of symptoms. If authorized, the treatment will be sold as Paxlovid.

"It's a stunning outcome," Pfizer Chief Scientific Officer Mikael Dolsten said in an interview. "We're talking about a staggering number of lives saved and hospitalizations prevented. And of course, if you deploy this quickly after infection, we are likely to reduce transmission dramatically."

Pfizer also released early data from a second study suggesting that the treatment reduced hospitalizations by around 70% in a smaller trial of standard-risk adults, including some higher-risk vaccinated people.

It said those results showed a positive trend but were not statistically significant. They are following the results and plan to release data from the final 20% of participants in the 1,100-patient trial. The trial did not show that the drug alleviated symptoms of COVID-19 in that population.

Dolsten said he expects authorization for use in high-risk individuals from the Food and Drug Administration and other regulatory agencies soon. He does not believe an FDA advisory panel meeting will be needed.

"We're in very advanced regulatory dialogues with both Europe and the UK, and we have dialogues with most of the major regulatory agencies globally," he said.

Pfizer submitted data to the FDA last month, asking for emergency use authorization of the drug.

"These are very exciting results," said Dr. Paul Sax, a professor at Harvard Medical School, adding that the FDA should try to accelerate the authorization process as much as possible, noting there are very limited treatment options for high-risk people outside of the hospital.

There are currently no oral antiviral treatments for COVID-9 authorized in the United States.

Analysts on average forecast 2022 revenue of more than $24 billion from the pill, which would more than make up for any decline in vaccine sales after 2021.

Rival Merck & Co has asked for authorization for its antiviral pill molnupiravir. But that drug only reduced hospitalizations and deaths in its clinical trial of high-risk patients by around 30%.

Some scientists have also raised safety concerns about the potential for birth defects from the Merck drug, as well as worries that it could cause the virus to mutate.

Pfizer's treatment works differently. It is part of a class of drugs called protease inhibitors currently used to treat HIV, hepatitis C, and other viruses.

Recent laboratory testing showed that activity against the protease of the Omicron variant is as "good as basically any SARS-COV-2 variant of concern," Dolsten said.

The company has said it can have 180,000 treatment courses ready to ship this year and plans to produce at least 80 million more in 2022.

Dolsten said Pfizer is looking to expand that output further as new variants could push the need for antivirals substantially higher. Current vaccines appear to be less effective at preventing infection with Omicron.

Pfizer, which makes one of the leading COVID-19 vaccines with German partner BioNTech, has agreed to allow generic manufacturers to supply versions of the drug to 95 low- and middle-income countries through a licensing agreement with international public health group Medicines Patent Pool. However, Dolsten said that for next year he expects the drug will be mainly produced by Pfizer.

The MPP told Reuters in a statement, that it will be "well into next year" before pills produced by generic manufacturers under its licenses will be ready for use."

The US government has already secured 10 million courses of the Pfizer treatment for $5.29 billion.

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Meantime, the Sheba Medical Center in Ramat Gan will conduct the world's first study on a fourth vaccine dose against COVID-19, Kan pubcaster reported on Tuesday night.

About 200 volunteers will participate in the study. Their level of antibodies against the virus will be checked before and after receiving the fourth dose.

The study will be supervised by Professor Gili Regev-Yochay, director of Sheba's Infectious Disease Epidemiology Unit, with the backing of the Health Ministry.

The study is going forward "so that data can be based on [the participants] when we come to decide on a fourth dose. At the moment, no one knows and there is no data on this from the world," a senior ministry official was quoted as saying in the report.

The ministry's vaccination committee decided against recommending a fourth COVID vaccine to the general public on Sunday night, including those who are immunocompromised.

Concerns are on the rise in Israel and around the world as Omicron threatens to become the dominant strain globally, although a study from South Africa – where the variant was first detected – indicates that the heavily mutated strain is milder in symptoms than the Delta variant.

However, the study also found that the Omicron is more resistant to the two-dose Pfizer vaccine at 33% efficacy. 

Researchers said that the vaccine offers 70% efficacy against severe Omicron illness, which they called "very good protection."

i24NEWS contributed to this report. 

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COVID hospitalizations soar by 330% in region where Omicron first detected https://www.israelhayom.com/2021/11/30/pfizer-begins-tweaking-covid-vaccine-to-better-combat-omicron/ https://www.israelhayom.com/2021/11/30/pfizer-begins-tweaking-covid-vaccine-to-better-combat-omicron/#respond Tue, 30 Nov 2021 10:50:59 +0000 https://www.israelhayom.com/?p=727101   Despite the arrival of the troubling Omicron coronavirus variant in Israel, the reproduction rate decreased from 1.07 to 1.03 on Tuesday, according to Health Ministry data.  Follow Israel Hayom on Facebook and Twitter Of the 108,300 screened for the virus in the past 24 hours, 636 (0.63%) tested positive. The infection rate stands at […]

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Despite the arrival of the troubling Omicron coronavirus variant in Israel, the reproduction rate decreased from 1.07 to 1.03 on Tuesday, according to Health Ministry data. 

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Of the 108,300 screened for the virus in the past 24 hours, 636 (0.63%) tested positive. The infection rate stands at 0.63%. There are currently 5,570 active cases in the country, with 158 patients hospitalized. Of those, 117 are in serious condition. 

Israel has reported 1,343,218 cases since the outbreak of the pandemic last year, including 8,195 deaths. 

Thus far, 4,078,395 Israelis over the age of 16 have been fully vaccinated, 5,775,598 received two doses, and 6,326,037 got their first jabs. 

According to the ministry's director of Public Health Services, Dr. Sharon Elroi Preiss, the new strain is cause for alarm. 

Speaking at a Knesset committee meeting on Tuesday, she said, "There's no chance the vaccine will be as effective against Omicron as it is against Delta. We must buy time to understand the new variant, whether it is deadly and if it harms children.

"What worries us the most is the rapid spread of the mutation in South Africa. The number of cases went from 200 to 2,000 in just two days. They described how one person infected many others, both vaccinated and unvaccinated. From what we hear, vaccinated individuals do not exhibit significant symptoms, but this is just preliminary data … It will take a few weeks" to know more. 

According to latest data, coronavirus hospitalizations have increased by 330% in the South Africa's Gauteng region, where the variant was first detected.

According to scientists, Omicron has 50 mutations, at least 30 of which are in the spike protein, which the virus uses to infect human cells and which current vaccines focus on to boost the body's immune system to combat COVID-19. As such, Omicron has a heightened ability to transmit and evade antibodies.

Elroi Preiss also said she would soon receive data from South African health officials on the effectiveness of the vaccine against the new strain. 

Also on Tuesday, CEO of Moderna vaccine manufacturer Stephane Bancel told British paper Financial Times that existing vaccines will most likely be much less effective at tackling Omicron, and warned it would take months before vaccine manufacturers would adapt their doses.

Meanwhile, CEO of Pfizer pharmaceutical giant Albert Bourla told media on Monday the company had begun tweaking its vaccine to better protect against Omicron, a process that will take around 100 days. 

He stressed there might not be a need for the inoculation because Pfizer was able to create vaccines for the Beta and Delta COVID-19 mutations, but they were never used because the original shots remained effective. 

Nevertheless, the impact of Omicron on Pfizer's two-dose vaccine remains to be seen.

"I don't think that the result will be the vaccines don't protect. I think the result could be, which we don't know yet, the vaccines protect less," Bourla told CNBC news. 

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Haredi sage Rabbi Chaim Kanievsky endorses COVID vaccination for kids https://www.israelhayom.com/2021/11/26/haredi-sage-rabbi-chaim-kanievsky-endorses-covid-vaccination-for-kids/ https://www.israelhayom.com/2021/11/26/haredi-sage-rabbi-chaim-kanievsky-endorses-covid-vaccination-for-kids/#respond Fri, 26 Nov 2021 05:56:31 +0000 https://www.israelhayom.com/?p=724939   Following the launch of Israel's campaign to vaccinate children against coronavirus, one of the most influential rabbis in Haredi circles called on parents Thursday to vaccinate their children. Follow Israel Hayom on Facebook and Twitter Senior health officials arrived at Rabbi Chaim Kanievsky's residence in Bnei Brak to discuss vaccine safety and ways to encourage […]

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Following the launch of Israel's campaign to vaccinate children against coronavirus, one of the most influential rabbis in Haredi circles called on parents Thursday to vaccinate their children.

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Senior health officials arrived at Rabbi Chaim Kanievsky's residence in Bnei Brak to discuss vaccine safety and ways to encourage vaccination among ultra-Orthodox children.

Among those who attended the meeting were Coronavirus Commissioner Salman Zarka, expert epidemiologist Professor Ran Balicer, and Kanievsky's personal physician, Dr. Meshulam Hart.

Zarka presented Kanievsky with the Food and Drug Administration approval for the children's vaccine, as well as data on efficacy and safety. He also stressed that the Health Ministry had recently reported a rise in coronavirus morbidity, with unvaccinated children comprising most of the new cases.

Balicer, who is director of Health Policy Planning at Clalit Health Fund, demonstrated post-vaccination data on millions of children in the United States and recent studies conducted in Israel and worldwide on the safety of children's vaccines, that showed that the risks of getting infected with the virus outweighed the potential side effects of inoculation.

Hart also spoke out in support of the shots.

Having carefully studied the data, Kanievsky ruled that children ages of five-11 should be vaccinated, and wished experts success in the national campaign.

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