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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US health officials are hoping data on Israeli military personnel can help clarify the risk of heart muscle inflammation in younger people who have received Pfizer/BioNTech COVID-19 booster shots – a potential factor for US regulators as they consider granting full approval of these boosters.

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A condition called myocarditis has in rare cases been linked to the two-dose mRNA vaccines made by Pfizer/BioNTech and Moderna, mostly in younger males, but US health officials are trying to better understand the risk.

"The real question that we have not yet answered is the safety data of an mRNA in young people vis-a-vis myocarditis," Dr. Anthony Fauci, President Joe Biden's chief medical adviser and top US infectious disease expert, said in a telephone interview.

"The Israelis will relatively soon have that data because they're vaccinating everybody in the country I think from 12 years old up, including their military recruits," Fauci added.

The US Food and Drug Administration in August granted full approval for the Pfizer/BioNTech vaccine for people age 16 and older but the agency has not yet given full approval for its use as a booster shot. Instead, the FDA approved Pfizer's booster under an emergency use authorization with approval on the full biologics license application still pending.

In their review of Pfizer's application regarding booster shots, FDA advisers, in particular, called out the lack of data on myocarditis in younger individuals.

Fauci said the Israel military data should help address the gap in safety information on mRNA vaccines, "which is one of the things that the advisory committee was interested in." Fauci said he expects data from Israeli military recruits specifically to shed light on the safety of the vaccines in younger people in the context of myocarditis.
Biden's administration had sought a broad campaign of boosters for all Americans in light of evidence of waning vaccine effectiveness over time.

The FDA and US Centers for Disease Control and Prevention in September narrowed the recommendation for the Pfizer/BioNTech booster to Americans 65 and older, adults with underlying medical conditions and adults in high-risk working and institutional settings.

Fauci has said he believes the proper regimen for the mRNA vaccines will end up being an initial two doses a few weeks apart, followed by a booster shot a few months later.

In June, the FDA added warnings to labels on the Pfizer/BioNTech and Moderna vaccines about rare cases of myocarditis in adolescents and young adults.

The FDA has granted emergency use authorization but not full approval to the Moderna vaccine as well as a one-dose Johnson & Johnson shot. The FDA on Friday said it will consider Moderna's application for booster shots at an advisory panel meeting on Oct. 14, and J&J's booster application on Oct. 15.

Israel's national digitized database includes data from the country's four healthcare providers, which administer the vaccines, as well as other institutions including the military.

Fauci said US officials plan to follow up with the Israeli Health Ministry about vaccination data involving military recruits. The ministry, which regularly analyzes the data, has shared its findings on vaccine effectiveness and safety with bodies such as the FDA.

A Health Ministry spokeswoman said she was unaware of any specific study of boosters among military personnel.

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The latest limit imposed by the US Food and Drug Administration on the coronavirus booster shot took many by surprise, including Dr. Tal Zaks, an Israeli researcher living in the United States, who was in charge of Moderna's vaccine development. 

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"Yes, I was surprised," he told Israel Hayom. "I think the refusal stemmed from the way the question was posed. But the fact is, the ruling to administer the shot to people over 65 and those at high risk passed unanimously, and in my opinion, it is only a matter of time until the recommendation is expanded." 

Q: In your opinion, is the booster shot effective?

"Yes, data from Israel is clear and it shows that immunity [provided by the third shot] is significantly high."

Q: Do you think the FDA ruling should affect the booster campaign in Israel? 

"I don't think so." 

A few months ago, after serving as a chief medical officer at Moderna – which began as a humble startup and turned into a global vaccine manufacturer – Zaks decided to leave the company and look for a new challenge. Most recently, he was offered a job at Teva Pharmaceuticals, Israel's largest drug producer. 

"My role at Moderna began to change in early 2020 when I enlisted in the battle against the coronavirus," Zaks said from his home in Newton, Massachusetts. "Toward the end, it was clear to me and to the CEO [Stephane Bancel] that I had achieved what I wanted, and that the position of the medical officer has essentially become like that of a minister or ambassador, ensuring the safety of the platform and traveling the world explaining what it does.  

"I learned the importance of communicating with the public and the press, but what motivates me is the scientific endeavor, so for me moving on felt like the natural next step. At the end of the day, the feeling is that the great war [on COVID] is coming to an end. Here and there, additional battles continue, but [for me] it is time to return home, back to civilian life."

Q: What are your plans now? 

"I would like to get into places where I could develop innovative medical technologies and make them accessible, similar to the mRNA platform [that Moderna developed, which is transforming the world of medicine and vaccines. I would like to spend a year or two looking into discoveries I believe are interesting, the ones that could potentially help patients and entire populations.

"Another thing I wanted to do is contribute more to the Israeli biotechnology ecosystem, and so I was delighted when I was offered a place in Teva's directorate. It gives me a channel to be involved, I hope constructively. I will continue to live in the States, but will travel to Israel more often." 

Q: Do you have aspirations to become the coronavirus commissioner in Israel?

"No. It is a position that requires expertise in public health, whereas I have experience in developing drugs and vaccines, not distributing them to the public." 

Q: The break you are taking in between jobs, I assume, is also possible due to your success at Moderna. 

"Sure. What enabled me to take some time off is that for the first time in my life paychecks are less crucial when it comes to supporting my family. Although, the financial aspect was never the one that motivated me. My family and I arrived in the US with nothing, and it went on like that for many years. 

"When you have complete financial freedom, it changes your perspective and makes you think about what it is you would like to do. On paper, my life has changed, but practically speaking, I do not know what to do with this. Part of the luxury is to take a break in order to brainstorm what to do next. Never in my life have I taken more than 3 or 4 weeks off, and the last time I did it was in 2008. 

"My lifestyle has not changed. When we came on a visit to Israel in the spring, I had to convince my wife to fly back in economy plus, as opposed to just economy, with five more inches of legroom."

Zaks, 55, started working at Moderna in 2015. 

Q: Do you miss the old days when Moderna was a small company? 

"Yes, that is what I meant that the size [of the company] defines the position, and I used to love the position I had. But it no longer exists, not in the same format. 

"At the beginning of my career at Moderna, nobody received mRNA Moderna vaccines, not in clinical trials and surely not in actual patients. During my time, we started clinical trials with the new technology, and we conducted more such trials than ever before in the history of biotechnology. If you look at the number of clinical trials [conducted] while I was there – considering the age of the company – we broke several records.

"Before I joined, I remember I spoke with the CEO and told him, 'Why are you hiring me? I am an oncologist, and you need someone with experience in developing vaccines.' And he said, 'We want to cover all fronts with this technology. We will try to develop vaccines against cancer and vascular diseases and rare illnesses.' 

"He was looking for someone with a broad vision who could do a variety of things. No one among developers has experience in all areas, so for me, the challenge was to oversee something that is beyond my experience, and it was a lot of fun." 

mRNA molecules are a segment of DNA that includes instructions for the production of a particular protein. In the case of COVID-19, that protein is called Spike. The laboratory creates the mRNA with a code to make copies of an antigen (the molecule in the virus that triggers an immune response in the body and creates antibodies). When this code is injected into the body, the cell produces only the antigen, without the virus or anything else that could cause disease. Thus, if the immune system encounters the antigen in the future, it will know to recognize and fight it.

Q: Was the race to develop a COVID-19 vaccine like a madhouse?

"Not a madhouse, but incredibly challenging. I served in the IDF, started in combat engineering, and then became a paramedic and medic instructor. My whole life I've avoided using military analogies, but last year I caught myself using for the first time phrases like "enlist in the mission." For there is no other way to describe it. How we worked day and night, had a headquarters and a command, and in essence, this was a war, but without an actual army or engaging in physical battle."

Q: Did you feel the heavy responsibility of developing a vaccine for all of humankind? 

"Yes. Throughout my career, I mainly developed drugs, and as an oncologist, this was mostly medicine for cancer patients. In those cases, I imagined in my mind the patient who would be affected, and here and there, I would hear stories about actual patients who benefitted from the drugs. 

"With COVID, it became personal in a way that no drug developer has ever experienced [before]. And I mean, my mom, who is 80 years old, and lives in Israel. My daughter-in-law, a doctor in New York who now had to wear protective gear, and all the wards in the heart of Manhattan became intensive care units. 

"You just know that you are developing something that will protect your family, we go out to battle and know exactly what we are protecting. For each and every one of us, it was personal and close to heart. That is why the coronavirus was different from how we usually operate." 

Q: When did you feel like you succeeded in overcoming the virus?

"The fact that the front changed was clear already in May 2020, when we saw the results of the first phase of trials. The absolute victory, or the decisive battle, was after the third phase when the final results came in. Pfizer's first, then a week later ours. It was clear that we had won the war, and from then, it was just a matter of time." 

Q: Did you feel like you were in a race with Pfizer to be the first to develop the inoculation?

"No. I said to myself, 'I only have two rivals – the virus and the ticking clock, and to everyone else I wish victory.' Of course, some in the company did take into account the financial aspect and the future, and how we will perform compared to global giants, and they added a competitive element. As long as the pandemic continues and the world needs the products of two companies, and even more, I care less about the competition." 

Q: For Pfizer, as the world's biggest vaccine manufacturer, the race was important.

"No doubt. Many people forget, but Pfizer did not come up with the coronavirus or the mRNA vaccines. It purchased the German BioNTech company and together with it, raced to develop. Moderna, on the other hand, created the vaccine from scratch. 

"BioNTech and Pfizer would not have the coronavirus vaccines today had Moderna not started the race for vaccines against other diseases. After all, the collaboration between them began about three years ago, when they made an agreement to tackle the flu.

"A collaboration that came about because they saw Moderna develop vaccine after vaccine after vaccine. BioNTech was [originally] established to fight cancer, it did not deal with infectious diseases at all." 

Q: So Moderna deserves some of the credit too? 

"I see how much disease and mortality have been prevented in the world, and that is credit enough."

The coronavirus truly put Moderna on the map. If in May 2020 the company's value was estimated at $30 billion, then by the summer of 2021, it increased six-fold, to $185 billion. 

Q: Is a pandemic a good thing for a drug company?

"Paradoxically, yes, because it allows the company to find its place in the world. Moderna before the pandemic and after are two different companies. COVID allowed the company to prove what it can do for humankind."

Q: And earn billions. 

"The company makes a profit because we operate according to a capitalist model. And thank God that it is like that because if you have the choice to develop vaccines for profit or under a communist regime, which one would you choose? 

"Maybe I've lived too many years in the world, but for me, it's not a paradox. On the contrary, I think all of the beauty lies in this. As a doctor in the industry, it may have been my life's biggest personal challenge, to combine financial interest with the greater good, and benefitting the public gives me a tremendous sense of fulfillment. We help people and at the same time, prove to our investors that their investments can yield returns. Win-win." 

Q: What was the most important part for you in the race to develop the vaccine? The knowledge that you contributed? 

"I think both for me and the company, it was the ability to move fast and make decisions, look at data and respond, which was more important than the knowledge. Because no one else before had to deal with what he had to. There was one week, at the end of May in 2020 when we had to make a decision [about vaccine dosage].

"After all, we had informed the world that the first phase of the vaccine trials was successful, and had to finalize the protocol for the third phase, so that we could start the proceedings in July with the relevant government institutions. We had to decide on the right vaccine dosage to be given in the third stage of the trial – 50 or 100 micrograms. 

"Expertise-wise, it was one of the hardest decisions I ever had to make. If 50 micrograms were enough, perhaps we could have provided twice the amount of vaccine doses. But based on the first phase results, the number of antibodies obtained with 100 micrograms was much better than 25, and we had no data about 50. For me, it was important to make a decision based only on the data we had.

"In hindsight, if you look back at Moderna's first and second vaccine trials, both of which had 100 microgram doses, the results speak for themselves. Our dose has 100 micrograms for the first and second doses. Pfizer's has 30 micrograms, and in the third shot – 50."

Q: Is Moderna's vaccine more effective? 

"When it comes to vaccinating a healthy population, 30 micrograms seems to be enough, but as time goes on and you get to populations that are harder to inoculate - cancer patients, those with autoimmune diseases - you see that our vaccine is a little more effective."

Q: Does this mean that those vaccinated with Moderna might not need a booster? For they received 200 micrograms altogether. 

"What's more important is how frequently the immune system was exposed to the virus, not how large of a dose he or she received."

Q: Why do you think Pfizer's vaccine is more common, at least in Israel? 

"Pfizer's success in Israel – and I have tremendous respect for CEO Albert Burla – is that they have worked with the country exceptionally well, compared to other countries. Pfizer gave priority to Israel because it was the first one to say it was purchasing, and also because it provides data that is passed on to the rest of the world, to know what the right thing to do is, which proved successful. 

"Israel deserves credit, and first and foremost the team of Dr. Osnat Luxenburg [director of the Health Ministry's Medical Technology and Infrastructure Administration]. I called them in April last year and said, 'Israel should test our technology and sign up for pre-purchase.

"Her team did a fantastic job and concluded that Israel should not hold back, but go all out for the technology that looks most promising. It's after this that the country began to work with Moderna and Pfizer. 

"You can see the difference between what happened in Israel and what occurred, for instance, in the European Union, which chose the [British-Swedish vaccine manufacturer] AstraZeneca, whose vaccines work with different technology. By the time they woke up and decided to buy mRNA vaccines, Pfizer and Moderna had already sold their doses. 

"As an Israeli, I am proud that data from Israel confirmed the effectiveness of the first and second vaccine doses, and now confirm the effectiveness of the third shot. Israel is leading the way in how to use vaccines correctly." 

Q: Were you not disappointed that Israel signed a contract with Moderna first, but ended up choosing Pfizer? 

"The truth is, no. What's truly important is that people should get their vaccines and be protected. My mom told me at the time, 'I can't wait for the Moderna vaccine, and they are giving Pfizer doses now.' I told her, "Take what is available, the most important thing is that you should get inoculated.'

"The world needs more vaccines that both companies are capable of producing today, and at the end of the day, Moderna has sold all of its vaccines to date. 

"The data that tells us about the effectiveness of our vaccine comes from the hundreds of millions of people in the United States and Europe who received it. That's why we were not harmed when Pfizer was the first [to develop]."

Q: A Pfizer executive once called Israel a sort of a laboratory that has guaranteed them exclusivity.

"Pfizer received exclusivity for one simple reason: it could supply the goods, while Moderna's vaccines arrived in Europe and Israel a little later. The first quantities that came off the US production lines were destined for the American market. Geopolitically, Pfizer had an advantage here, and they used it. I'm glad it worked out in Israel's favor."

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Q: What about the "laboratory" part? 

"I don't think that Israel is a laboratory in the usual sense. As I understand it, he meant that there was an agreement to receive data in exchange for the supply of the vaccines. After all, when Israel received the vaccine it was no longer experimental, it could rely on the results of the third phase, and there was a global approval by then, including by the FDA.

"Israel is a laboratory because it has organized data, that comes from health funds, and vaccines have been administered to the population in an organized manner that could be monitored. Millions in the US received the same vaccines, at the same time, but because the American healthcare system is decentralized, it is impossible to receive information from the field as effectively as in Israel. 

"The way vaccines were administered in Israel became a model for the whole world. A German journalist once asked me, 'The Israeli government is doing such a good job, what advice would you give to Germany's government?" I told him, "A country that has been in an existential danger since its inception knows how to deal with existential threats much better than any Western country that has never known such threats."

Q: Did the change of the Israeli government affect your work at Moderna?

"I didn't feel a difference, because my work always entailed communicating with Health Ministry experts, and those have not changed." 

Q: And what about the change of US administration? 

"This is probably not an answer that would fuel the media drama, but the truth is, no. The Trump administration was very supportive of vaccines, and so has the Biden administration. I spoke several times with David Kessler [President Joe Biden's COVID response chief] towards the end of the Trump presidency, to make sure he knew what we were doing. In this respect, the change of government has not had a significant impact on how we operate."

Q: What is your opinion on Britain's decision to fully open the country? 

"I trust each local health ministry. Opening everything is not a scientific response, but one that finds the balance between public health, economic interests, and the good of the individual. In each country, it depends on the infection rate, the vaccination rate, and economic aspects." 

Q: In Israel, there was a lot of debate about whether schools should reopen as usual. 

"It's a difficult decision. I see it with my nephews – some study from home, some go to school. Of course, we would all like them to be able to go back to the classrooms, but it must be done carefully, because as long as the Delta variant is here, and as long as there are people who refuse to get vaccinated, the danger remains, especially with children. We don't know yet what the most optimal way to vaccinate children is, especially the youngest." 

Q: Perhaps the time has come to learn to live alongside COVID and stop counting the deaths? 

"That time will come, but it is not here yet, as long as the morbidity is high and the Delta strain is here, which for us was a surprise, by the way. We hoped the vaccines would be more effective, and we did find that they are effective against serious illnesses and death. But they are not effective enough to prevent infection, at least not two doses.

"Those who are [double-]vaccinated will have a runny nose [if they get infected with the coronavirus], but if you get three vaccines, you will be able to lead a normal life. Once the third vaccine is common among most of the population, we will see relief. The cases will not completely disappear, but it will be a new world in which we will learn to live alongside the virus and serious morbidity will be minimal."

Q: What about herd immunity? 

"It's a good question. Once we take into account how contagious Delta is, [to achieve] herd immunity the level would need to be very high – theoretically speaking, more than 90% [of the population] would need to be vaccinated or recovered. 

"It is a possibility, although I do not know how soon we will reach that. I believe by then, most of the pandemic will be behind us. There will be pockets of people here and there who are more prone [to getting infected] because they either did not get vaccinated or have weak immune systems, like cancer patients. These people we would need to continue supervising. But generally speaking, the population will learn to live alongside the virus."

Q: You said earlier that the Delta variant surprised you. Why so? 

"Our biggest fear was a variant that would undermine the entire immune system, a variant that would change so much that the previous vaccine would not be effective. What we got was a variant that does not undermine the immune system critically, but has become much stronger. The ability of this virus [Delta] to replicate has increased exponentially. 

"The Delta is a little bit different [than previous strains,] and antibodies are less effective in neutralizing it. That is what makes it so dangerous. If the virus were to leave the immune system, then it doesn't matter how many times you vaccinate, it would not be damaging. The third shot proves that Delta doesn't leave the immune system, but is a new step in its capability to replicate and infect. This we did not expect." 

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The latest limit imposed by the US Food and Drug Administration on the coronavirus booster shot took many by surprise, including Dr. Tal Zaks, the Israeli researcher who was in charge of Moderna's vaccine development.

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"I was very surprised," he told Israel Hayom. "But the ruling to administer the booster shot to people over the age of 65 and those at high risk was passed unanimously, and in my opinion, it is only a matter of time until the recommendation is expanded."

Q: In your opinion, is the booster shot effective?

"Yes, data from Israel is clear and it shows that immunity [provided by the booster] is high."

According to Zaks, Israel's entire innoculation campaign is an inspiration to the world. 

"The way Israel vaccinated its population has become a model for the whole world. How it enlisted for the mission and understood the dangers."

A few months ago, after serving as Chief Medical Officer at Moderna, Zaks decided to leave the company and look for a new challenge. Most recently, he was offered a job at Teva Pharmaceuticals, Israel's largest drug manufacturer. 

"My role in Moderna began to change in early 2020, when I enlisted in the battle against the coronavirus," Zaks said from his home in Newton, Massachusetts. "I learned the importance of communicating with the public and the press, but what motivates me is the scientific endeavor, so for me moving on felt like the natural next step. At the end of the day, the feeling is that the great [COVID] war is coming to an end." 

Q: What are your plans now? 

"One of the things I was looking for is to try and contribute more to the Israeli biotechnology ecosystem, and so I was delighted when I was offered a place at Teva." 

Q: Was the race to develop a COVID vaccine like a madhouse?

"Not a madhouse, but incredibly challenging. I served in the IDF, started out in combat engineering, and then became a paramedic and medic instructor. My whole life I've avoided military jargon, but last year I caught myself using for the first time phrases like "enlist" and "mission." How we worked day and night, had a headquarters and a command. A war without an army or engaging in actual physical battle."

Q: When did you feel like you succeeded in overcoming the virus?

"In May 2020, when we saw the results of the first phase of trials. The absolute victory was after the third phase, when the final results came in. Pfizer's first, then a week later ours."

Q: Did you feel like you were in a race with Pfizer to be the first to develop the vaccine?

 "No. I said to myself, 'I only have two rivals – the virus and the ticking clock, and to everyone else I wish victory.'"

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The highly contagious Delta wave continues to subside in Israel. The Health Ministry reported on Thursday that of the 112,764 Israelis it screened for the coronavirus in the past 24 hours, 5,921 (5.64%) tested positive. The reproduction rate continued to decrease and now stands at 0.81. 

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There are 69,076 active cases in the country, with 1,061 Israelis hospitalized. Of those, 253 are in critical condition and 197 are on ventilators. Based on data, 70% of critically ill patients are unvaccinated Israelis, even though they only make up 7% of the population.  

Israel has reported 1,250,200 cases, including 7,592 deaths, since the outbreak of the pandemic last year. 

Meanwhile, according to the CEO of Moderna vaccine manufacturer Stephane Bancel, the coronavirus pandemic will come to an end within a year. 

In an interview with Swiss daily Neue Zürcher Zeitung, he said, "Based on the vaccine production rate in the last six months, in about half a year there should be enough vaccines for all inhabitants of the earth, including booster shots." According to Bancel, vaccines for toddlers will be available soon as well. 

Bancel said "those who have not gotten vaccinated [against COVID] will be immunized naturally because the Delta variant is so contagious. In such a way, we will come to a situation similar to the flu. There will be two possibilities – to get vaccinated and enjoy a good winter or risk getting infected and even hospitalized."

Bancel also stressed that Moderna's booster shot will not change this year, but mostly likely will in the future. 

"We are running clinical trials at the moment to research how many doses are needed for the Delta variant," he said. "They will form the foundation of our booster next year. We are also testing the Delta Plus Beta variant, the strain scientists expect to be the next highly contagious one. In any case, vaccine prices will not change." 

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Israel's coronavirus infection rate stands at 4.7% as 4,800 of the 108,797 people who tested for the virus Tuesday were found to have COVID-19, according to Health Ministry data released Wednesday. The reproduction rate is 0.83.

There are 74,898 active cases of the virus. There are 723 people in serious condition, 172 of whom are on ventilators.

Although 1,161,949 Israelis have recovered from the virus since the outbreak of the pandemic, 7,582 have died.

Pharmaceutical giant Pfizer announced Monday its COVID-19 vaccine works for children ages 5 to 11 and that it will seek US authorization for this age group soon – a key step toward beginning vaccinations for youngsters.

The vaccine made by Pfizer and its German partner BioNTech is already available for anyone 12 and older.

For elementary school-aged kids, Pfizer tested a much lower dose – a third of the amount that's in each shot given now. Yet after their second dose, children ages 5 to 11 developed coronavirus-fighting antibody levels just as strong as teenagers and young adults getting the regular-strength shots, Dr. Bill Gruber, a Pfizer senior vice president said.

Gruber said the companies aim to apply to the Food and Drug Administration by the end of the month for emergency use in this age group, followed shortly afterward with applications to European and British regulators.

Israeli Pediatric Association President Professor Zachi Grossman welcomed the announcement, saying, "Proving the efficacy and safety of the vaccine in this age group is critical for the protection of children and the end of the pandemic."

He said Israel would wait for FDA approval that is set to come in a few weeks, and following a discussion by the Epidemic Management Team's Vaccination Monitoring Committee, we will start vaccinating.

"I am optimistic and believe that through the right, targeted public outreach among both medical staff and parents, we will reach high levels of vaccination," he said.

Earlier this month, FDA chief Dr. Peter Marks told the AP that once Pfizer turns over its study results, his agency would evaluate the data "hopefully in a matter of weeks" to decide if the shots are safe and effective enough for younger kids.

Pfizer said it studied the lower dose in 2,268 kindergartners and elementary school-aged kids. The FDA required what is called an immune "bridging" study: evidence that the younger children developed antibody levels already proven to be protective in teens and adults. That's what Pfizer reported Monday in a press release, not a scientific publication. The study still is ongoing, and there haven't yet been enough COVID-19 cases to compare rates between the vaccinated and those given a placebo – something that might offer additional evidence.

The study isn't large enough to detect any extremely rare side effects, such as the heart inflammation that sometimes occurs after the second dose, mostly in young men. The FDA's Marks said the pediatric studies should be large enough to rule out any higher risk to young children. Pfizer's Gruber said once the vaccine is authorized for younger children, they'll be carefully monitored for rare risks just like everyone else.

A second US vaccine maker, Moderna, is also studying its vaccine in elementary school-aged children. Pfizer and Moderna are studying even younger tots as young as six months old. Results are expected later in the year.

The announcement comes as the Associated Press reported COVID-19 has now killed about as many Americans as the 1918-19 Spanish flu pandemic did – approximately 675,000.

The US population a century ago was just one-third of what it is today, meaning the flu cut a much bigger, more lethal swath through the country.

Like the Spanish flu, the coronavirus may never entirely disappear from our midst. Instead, scientists hope it becomes a mild seasonal bug as human immunity strengthens through vaccination and repeated infection. That could take time.

While the delta-fueled surge in infections may have peaked, US deaths are running at over 1,900 a day on average, the highest level since early March, and the country's overall toll topped 675,000 Monday, according to the count kept by Johns Hopkins University, though the real number is believed to be higher.

The 1918-19 influenza pandemic killed 50 million victims globally at a time when the world had one-quarter the population it does now. Global deaths from COVID-19 now stand at more than 4.6 million.

The Spanish flu's US death toll is a rough guess, given the incomplete records of the era and the poor scientific understanding of what caused the illness. The 675,000 figure comes from the US Centers for Disease Control and Prevention.

In many ways, the 1918-19 flu, which was wrongly named Spanish flu because it first received widespread news coverage in Spain, was worse.

Spread by the mobility of World War I, it killed young, healthy adults in vast numbers. No vaccine existed to slow it, and there were no antibiotics to treat secondary bacterial infections. And, of course, the world was much smaller.

Yet jet travel and mass migrations threaten to increase the toll of the current pandemic. Much of the world is unvaccinated. And the coronavirus has been full of surprises.

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Hours after a team of experts advising the government on the coronavirus crisis voted to approve a third dose of the COVID vaccine for adults, Health Ministry Director-General Professor Nachman Ash announced on Thursday that Israelis aged 60 and up would get the booster shot.

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Ash instructed healthcare providers to start administering the shots to double-vaccinated Israelis who meet the age criteria starting on Sunday. Israelis had been receiving only two jabs, but in the wake of reports that theeffect of the vaccine appeared to have waned over time officials have recently started administering a third dose to immunocompromised patients, and now with the latest decision, virtually all seniors will be eligible.

As for other age groups, a decision could be based on what regulators in the US would determine.

Another issue that remains in the air is whether or not the government should actively encourage the public to seek a booster shot, or simply allow a third dose of the vaccine for anyone who wants it.

Data collected from at-risk groups in Israel and other countries who have received a third dose indicates that a booster shot does not cause unusual side effects, while having been found to increase the amount of antibodies in recipients' bodies to five to 10 times as many as the recipients had prior to the booster shot.

A few studies have indicated that a combination of different forms of the vaccine provides the best results, so the Health Ministry is considering using Moderna for Israelis seeking a third vaccine dose. Israel used Pfizer vaccines exclusively in its nationwide vaccination campaign.

As the government debates when and how to administer a third vaccine dose, a number of medical centers nationwide re-opened their COVID units on Wednesday in light of a spike in the number of serious COVID-19 cases.

Most COVID units were shuttered following the vaccination campaign, which initially led to a drop in serious cases. But the spread of the delta variant has since been a game-changer, and the number of severe cases in Israel has more than doubled in the past week.

On Tuesday, the Hebrew University of Jerusalem published a study indicating that the Pfizer vaccine was no more than 80% effective in preventing serious illness.

The study, which was presented to the government, also predicted that the number of critically ill patients could reach 400 in less than three weeks if no action was taken to curb the spread of the virus.

Meanwhile, the Health Ministry reported 2,165 new confirmed cases on Thursday morning, which comprise a 2.35% positive rate of the 102,524 tests processed in a 24-hour period. The virus reproduction rate stood at 1.33.

As of Thursday morning, the number of hospitalized COVID-19 patients stood at 275, with 159 listed in serious condition, 33 listed in critical condition, and 26 were on ventilators.

In total, there were 15,292 active or symptomatic patients nationwide.

Since the pandemic reached Israel in early 2020, 6,463 Israelis have died of the virus.

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i24NEWS contributed to this report

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Israel's current coronavirus infection rate stood at 0.8% Sunday, as 423 of the 59,108 people who tested for the virus Thursday were found to be infected with COVID-19.

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There are 4,097 active cases of the virus. Forty-seven Israelis are in serious condition, 13 of whom are on ventilators. While 835,688 have recovered from the virus, 6,438 have died of the disease.

According to the government's traffic-light program for ranking local authorities according to infection rates, there are currently four Israeli communities designated "red," seven "orange," and 16 "yellow."

Health Minister Nitzan Horowitz has declared immunocompromised individuals would be eligible to receive a third dose of Pfizer's coronavirus vaccine. The minister further recommended allowing children aged 12 and under with serious pre-existing conditions to be vaccinated against the virus.

Currently, only Israelis aged 12 and over are eligible for the vaccine.

In interviews with Israeli media outlets, Monday, Health Ministry Director-General Nachman Ash said, "    I cannot say the event is under control." To date, Israel has vaccinated citizens with Pfizer's vaccine, but with morbidity on the rise, Ash said: "We also need to think about using Moderna's vaccines as well.

"There is an increase in morbidity. We're looking at it with concern. I hope we succeed in taking all the steps so that we don't get to a point where there are additional restrictions. Nevertheless, if the trend of increased morbidity continues, in another two months, limitations will be imposed on weddings and other events with a high-risk of [mass] infection."

Ash also commented on Horowitz's plans for a third booster shot as well as pharmaceutical giant Pfizer's announcement over the weekend it intends to apply for US Food and Drug Administration emergency authorization for a third booster shot for the vaccine.

"The third vaccine for the immunocompromised will probably be given today, but it should only be done after consulting with your physician. In the coming days, a decision will be made whether to vaccinate adults aged 65 and over with a third dose of the vaccine," he said.

To date in Israel, a third booster shot is administrated to organ and bone marrow recipients, cancer patients, patients taking medication that suppresses their immune system, as well as other cases set out by the Health Ministry.

Another issue of concern is this most recent spike in infections among children and the opening of the new school year in September.

Ash said: "We have our team and the Education Ministry's team to think about Sept.1. We aren't thinking of imposing any restrictions at this point. Regarding the holidays, there are no plans for that either."

Given the increase in morbidity, a panel advising the government on how to tackle the coronavirus pandemic on Sunday recommended allowing children aged 12 and under to be vaccinated against the coronavirus. Among the panel's members, 79% were in favor of the move. Sixty percent of panel members believed that with this particular age group, the second of two doses required for inoculation could be pushed back later than recommended. A majority of panel members also recommended samples be taken from vaccinated and recovered individuals who were exposed to a verified patient.

The recommendations follow reports 120,000 children in this age group in the United States had been vaccinated against the virus, apparently at their recommendation of their pediatrician.

To date, over 5,730,000 Israelis have received at least one dose of Pfizer's coronavirus vaccine. Over 5,193,500 have received both doses.

As for the tourism sector, with Israel set to see the return of incoming tourism in another two weeks, Tourism Minister Yoel Razvozov told Army Radio, Monday: "There are no plans to postpone the date right now." He said the ministry would base its decision on morbidity levels.

"We will need to find the framework for bringing in vaccinated tourists from recognized countries," he said.

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Prime Minister Naftali Bennett announced Sunday that Israel has signed a deal with pharmaceutical giant Pfizer to move forward the next delivery of coronavirus vaccines from September to Aug. 1.

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The government hopes the earlier delivery will enable more Israeli teenagers to become immunized before the start of the school year in September. In addition, the rapid spread of the Delta variant has led to an increase in morbidity over the past month from single digits to an average of 450 a day.

There are currently 4,130 active cases in the country, with 75 hospitalized patients. The Health Ministry reported an alarming spike in the number of patients in critical conditions, which now stands on 14, and on ventilators (12). Of the 50,325 Israelis screened for the virus over the past 24 hours, 261 (0.6%) tested positive, setting the current infection rate at 1.35.

The IDF reported 61 new cases among its soldiers, with 232 people in self-isolation.

The Health Ministry has labeled four Israeli cities as "red" over COVID morbidity. Seven localities are "orange" and 16 have been ranked "yellow" on the ministry's "stoplight" system. Each designation carries different restrictions on public life, particularly public gatherings in closed spaces.

Israel has reported 835,329 cases, including 6,436 deaths, since the outbreak of the pandemic in March 2020. So far, 5,190,709 Israelis have been fully immunized, and 5,728,526 have received their first jab.

About half of the patients presently hospitalized in serious condition have been vaccinated, according to ministry data. Israel's Coronavirus Commissioner Professor Nachman Ash said on Wednesday the overwhelming majority of them are from at-risk groups, individuals over the age of 60 and with prior health issues.

To that end, the ministry said on Sunday it would begin offering a third Pfizer booster shot to adults with weak immune systems, but stressed it was still weighing whether the third round of shots should be given to the general public.

"We are examining this issue and we still do not have a final answer," Health Minister Nitzan Horowitz told Israel Radio. "In any case, we are currently administering the third shot to people suffering from immunodeficiency … These are for instance people who have undergone organ transplants or suffer from a medical condition which causes a drop in immunity."

Sunday marked the last day for Israelis to receive their first dose, and anyone wishing to get vaccinated will need to wait until the Pfizer shipment arrives. However, Horowitz said that in the meantime, the ministry would plug the inoculation supply gap for ongoing two-dose inoculations of the general adult population by using Moderna vaccines already in stock. Under ministry guidelines, only Israelis over the age of 18 can be immunized using a Moderna dose.

In the meantime, Pfizer asked the American Food and Drug Administration last week for approval to administer the third dose. It plans to conduct an emergency clinical trial with 10,000 participants, including a control group, hoping that by the time the approval is granted, the trial will have proven the booster shot to be effective.

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Israel is planning a second round of COVID-19 vaccination in six months, by which point it expects children to be approved by health regulators to receive jabs, Prime Minister Benjamin Netanyahu said on Tuesday.

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Around 81% of Israeli citizens or residents over 16 – the age group eligible for the Pfizer vaccine in Israel – have received both doses in one of the world's fastest rollouts.

Israel has said it plans to administer vaccines to 12- to 15-year-olds upon approval by the US Food and Drug Administration. Pfizer and its partner BioNTech requested emergency FDA authorization earlier this month for use in that age group.

In televised remarks on Tuesday, Netanyahu said Israel had agreed with Pfizer and Moderna to buy 16 million more doses for the country's 9.3 million population, adding: "We are preparing for another vaccination campaign in six months time."

"Get your shoulders ready and your muscles, if you want, and also the kids, because we estimate there will be approved vaccines by then, for children," he added.

Inoculating children and young people is considered a critical step toward reaching herd immunity and taming the pandemic, according to many experts. Pfizer says its vaccine is safe, effective and produces robust antibody responses in 12- to 15-year-olds.

Pfizer Chief Executive Albert Bourla has said that people will "likely" need a third booster shot of the drug maker's two-dose vaccine within 12 months and could need annual shots.

Israel, meanwhile, has registered eight cases of a coronavirus variant first identified in India and believes that the Pfizer/BioNTech vaccine is at least partially effective against it, a Health Ministry official said on Tuesday.

An initial seven cases of the Indian variant were detected in Israel last week among people arriving from abroad and who have since undergone preliminary testing, the Health Ministry said.

"The impression is that the Pfizer vaccine has efficacy against it, albeit a reduced efficacy," the ministry's director-general, Hezi Levy, told Kan public radio, saying the number of cases of the variant in Israel now stood at eight.

The novel variant, designated B.1.617, was reported by India's health ministry in late March. It contains an E484K mutation, which has been associated with immune escape by other variants, and another mutation known as L425R, which may increase its transmissibility.

Britain and Ireland have also said they are investigating the variant after detecting it within their borders.

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