Health Ministry Director-General Nachman Ash approved on Friday a fourth coronavirus vaccination shot to residents of assisted living facilities citing their vulnerability to infections. Doses will also be available for nursing home staff who also wish to get innoculated.

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Already on Thursday, Ash gave the green light to a fourth jab to begin administering the fourth jab to the immunocompromised, such as cancer patients and organ transplant recipients.

With time, "the effectiveness of the booster decreases. We have seen that there is a difference [in antibodies] in a vaccine that was administered recently or fourth months ago. Therefore, I have approved the fourth jab for the immunocompromised due to concerns that they are more vulnerable to the Omicron outbreak," Ash said.

Last week, an advisory panel recommended the fourth jab for Israelis over the age of 60, those with preexisting conditions, and healthcare and nursing home workers. And although Ash accepted the experts' recommendation only partially he said if the Health Ministry sees "signs showing severe illness is expected to rise among the older populations," then the rollout will be expanded."

Nevertheless, in the meantime, "given the gaps of knowledge that exist around the world regarding the efficiency of a fourth dose in the current circumstances, we are acting cautiously and responsibly," Ash said.

The health chief spoke at a special press conference on Thursday that was also attended by Health Minister Nitzan Horowitz, Director of Public Health Services at the Health Ministry Dr. Sharon Elroi Preiss, and Coronavirus Commissioner Salman Zarka.

The press conference took place against the backdrop of a steady increase in the COVID infection rate in recent days, with the senior health experts announcing new restrictions on public life.

According to Ash, the number of participants in outdoor gatherings will not be limited, for now, however, a recommendation has been made to limit outdoor gatherings of over 100 people only to vaccinated Israelis, pending approval. Mask will also be mandated outdoors in outdoor gatherings of over 50 people.

According to Ash, "the healthcare system needs to prepare for the wave of [Omicron] morbidity. We are strengthening the hospitals, as we did in previous waves. Back then, the system dealt with a high number of hospitalized and patients on ventilators, and as such, it must be prepared this time."

Preliminary data on Omicron infections are milder than those caused by other variants, however, the surges have already started stretching Israel's healthcare system, with hospitals filled up with patients suffering from complications of the seasonal flu.

Over four million Israelis have received the third vaccine shot since the beginning of the booster campaign in August.

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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.

"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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The coronavirus reproduction rate continued to rise in the past 24 hours and currently stands at 1.09, according to Health Ministry data published Wednesday. Of the 88,514 Israelis that were screened for the virus on Tuesday, 603 (0.74%) tested positive.

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There are currently 6,505 active cases in the country with 174 patients hospitalized. Of those, 124 are in serious condition.

Thus far, 4,056,586 Israelis have been fully vaccinated, 5,768,276 received two doses and 6,276,292 got their first jabs.

Israel has reported 1,340,320 coronavirus cases, including 8,178 deaths, since the outbreak of the pandemic last year.

Prime Minister Naftali Bennett accompanied his son David as he received the first dose of the coronavirus vaccine today.

"I call on all Israeli parents to come and have their children vaccinated. It is safe and it safeguards our children."https://t.co/aiFv5ylXhr pic.twitter.com/NRAQ1NcFSh

— Prime Minister of Israel (@IsraeliPM) November 23, 2021

Also on Tuesday, Prime Minister Naftali Bennett accompanied his nine-year-old son David to the Clalit Health Services clinic in Herzliya to receive his first vaccination dose, as Israel launched a national vaccination campaign in the morning for children between the ages of 5 and 11.

We have begun a nationwide campaign to vaccinate children in order to protect them. This safeguards both parents and children, and all of Israel. I call on all parents to have their children inoculated, Bennett said.

Speaking at a Coronavirus Cabinet meeting on Tuesday, the ministry's Director of Public Health Services Dr. Sharon Elroi Preiss also encouraged parents to vaccinate their children.

"More than 3 million children [aged 12-15] have already been vaccinated and there were no reports of side effects. The risk of getting infected is much higher than getting vaccinated," she said.

Elroi Preiss also pointed out that "a small percentage of children" also develop the pediatric inflammatory multisystem syndrome (PIMS).

"It is a severe syndrome that appears a few weeks after the child recovers from the virus. Loss of taste is evidence of an effect on the brain, and there is evidence that the coronavirus enters the brain and affects it."

Despite the rising morbidity rate, the committee decided not to reimpose restrictions on public life. Nevertheless, it extended the "green pass" vaccine certificate mandate for indoor gatherings for another two weeks.

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The post In troubling trend, number of COVID cases inches up appeared first on www.israelhayom.com.

United States regulators authorized Friday a third dose of the Pfizer and Moderna coronavirus vaccines to be administered to people with compromised immune systems who are likely to have weaker protection from the two-dose regimens.

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The US Food and Drug Administration amended its emergency use authorization for both vaccines on Thursday, paving the way for people who have had an organ transplant, or those with a similar level of weakened immune system, to get an extra dose of the same shot they initially received.

Video: Reuters

An advisory panel to the US Centers for Disease Control and Prevention voted to recommend the additional shots, and the agency's director signed off on that recommendation on Friday. Immunocompromised individuals can begin receiving the shots immediately, according to an agency spokesperson.

Mixing of mRNA vaccines is permitted for the third shot if their original vaccine is not available.

There is growing concern about breakthrough infections in vulnerable populations in the United States as the country has seen a huge spike in new infections from the highly contagious Delta variant.

The vulnerable group makes up less than 3% of US adults, Rochelle Walensky, director of the CDC, had said before the authorization.

"After a thorough review of the available data, the FDA determined that this small, vulnerable group may benefit from a third dose of the Pfizer-BioNTech or Moderna vaccines," Janet Woodcock, the FDA's acting commissioner, wrote in a tweet on Thursday.

Woodcock said that others who are fully vaccinated do not need an additional vaccine dose right now.

The FDA's decision does not apply to people who received the one-dose Johnson & Johnson vaccine, the CDC said, because there is not enough data to support additional doses yet.

"We think that at least this is a solution for the very large majority of immunocompromised individuals, and we believe that we'll probably have a solution for the remainder in the not-too-distant future," FDA official Peter Marks told the CDC panel.

The FDA and the CDC are working to ensure that immunocompromised recipients of the J&J vaccine have optimal protection, the CDC said.

Meanwhile, scientists are still divided over the broad use of COVID-19 vaccine boosters among those without underlying problems as benefits of the boosters remain undetermined.

Pfizer has previously said the efficacy of the vaccine it developed with partner BioNTech drops over time. Moderna has also said it sees the eventual need for booster doses, especially since the Delta variant has caused breakthrough infections in fully vaccinated people.

Reports of infections among vaccinated people and concerns about diminishing protection have galvanized wealthy nations to distribute booster shots, even as many countries struggle to access first vaccine doses.

The World Health Organization last week called for a moratorium on COVID-19 vaccine booster shots until at least the end of September.

Still, Americans have already started getting additional shots, even before the FDA has authorized them. According to the CDC, more than 1.2 million people have already received one or more additional doses of a COVID-19 vaccine.

CDC officials also presented a set of guidelines to its advisory panel on Friday that it plans to use to help make its decision about whether Americans need further COVID-19 doses more broadly.

The CDC plans to hold another meeting of its Advisory Committee on Immunization Practices in the next several weeks where booster shots will again be discussed.

The New York Times reported on Friday that the Biden administration was already considering expanding the inoculation campaign to Americans who are not immunocompromised. 

According to the report, the administration has already allocated 100 million vaccine doses to this end as officials were ready to go ahead with the move without prior approval from health experts. 

If the administration gives the green light, the vaccination will most likely cover health care workers first, after which older Americans and the at-risk population will be inoculated. 

In doing so, the US administration will adopt the Israeli model. Sources familiar with the matter said that there was no reason to wait for official approval from health experts, especially due to the recent morbidity spike attributed to the spread of the Delta strain in the country. 

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