Experts said that in people who had been vaccinated five months earlier, the booster increased vaccine efficacy tenfold compared with vaccinated patients who didn’t receive it.

By ILAN BEN ZIONyesterday

JERUSALEM (AP) — Israel is pressing ahead with its aggressive campaign of offering coronavirus boosters to almost anyone over 12 and says its approach was further vindicated by a U.S. decision to give the shots to older patients or those at higher risk.

Israeli officials credit the booster shot, which has already been delivered to about a third of the population, with helping suppress the country’s latest wave of COVID-19 infections. They say the differing approaches are based on the same realization that the booster is the right way to go, and expect the U.S. and other countries to expand their campaigns in the coming months.

“The decision reinforced our results that the third dose is safe,” said Dr. Nadav Davidovitch, head of the school of public health at Israel’s Ben-Gurion University and chairman of the country’s association of public health physicians. “The main question now is of prioritization.”

The World Health Organization has called for a moratorium on boosters until at least the end of the year so that more people in poor countries can get their first two doses, but Israeli officials say the booster shot is just as important in preventing infections.

“We know for sure that the current system of vaccine nationalism is hurting all of us, and it’s creating variants,” said Davidovitch, who is also a member of an Israeli government panel of experts. But he added that the problem is “much broader than Israel.”

Israel raced out of the gate early this year to vaccinate most of its adult population after striking a deal with Pfizer to trade medical data in exchange for a steady supply of doses. It has also purchased large quantities of the Moderna and AstraZeneca vaccines.

Most adults had received two doses of the Pfizer vaccine by March, causing infection levels to plummet and allowing the government to lift nearly all coronavirus restrictions.

But in June, the highly infectious delta variant began to spread. After studying the matter, experts concluded that the vaccine remained effective against the virus, but that its efficacy waned roughly five months after the second shot.

In late July, Israel began distributing booster shoots to at-risk citizens, including those over 60. Within weeks, it expanded the campaign to the general population.

More than 3 million of Israel’s 9 million citizens have gotten a third dose of the Pfizer vaccine, according to the Health Ministry.

In a study published last week in the New England Journal of Medicine, Israeli experts said that in people who had been vaccinated five months earlier, the booster increased vaccine efficacy tenfold compared with vaccinated patients who didn’t receive it.

That study tracked about 1 million people 60 and older and found that the booster was “very effective at reducing the rate of both confirmed infection and severe illness,” the Health Ministry said.

A senior Israeli health official, Dr. Sharon Alroy Preiss, was among the experts testifying before the U.S. Food and Drug Administration panel last week in favor of the booster shot. But the regulator decided against boosters for the general population, opting only to authorize it for people aged 65 or older and those in high-risk groups.

Experts cited a lack of safety data on extra doses and also raised doubts about the value of mass boosters, rather than ones targeted to specific groups. The U.S. Centers for Disease Control and Prevention made a similar endorsement Thursday.

The Israeli Health Ministry said the FDA decision “gave validity to the third vaccine operation” underway in Israel, which “decided to act responsibly and quickly in order to treat growing infections.” It said statistics show the booster dose has “restored protection.”

Recent weeks have seen “a declining rate of new infections among the elderly,” the vast majority of whom have received booster shots, and “a continuous increase in the proportion of unvaccinated individuals within the new severe cases,” Dr. Ran Balicer, head of the government’s expert advisory panel on COVID-19, told The Associated Press.

In recent weeks, as the booster campaign has been rolled out, the percentage of unvaccinated among serious COVID-19 cases has climbed, and the overall new cases among people with at least two shots has dropped.

As of Friday, around 70% of Israel’s 703 serious cases of COVID-19 were among the unvaccinated, and about 20% had not received a booster. A month earlier, after Israel vaccinated 1.5 million people with a third dose, those two groups were equally represented among the serious cases.

Over 60% of Israelis — the overwhelming majority of the adult population — have received at least two doses of the coronavirus vaccine.

Some experts noted that the U.S. and Europe were several months behind Israel’s vaccination campaign and predicted those countries would follow suit in the months ahead.

“We are experiencing first a phenomenon that will become apparent likely in many other countries in the coming months and create a similar challenge there,” Balicer said. “Few, if any at all, other countries are walking in our shoes right now.”

The U.K. already is rolling out a booster campaign, with third doses to be offered to anyone over 50 and other vulnerable groups.

The WHO has called on rich countries to refrain from exhausting vaccine stockpiles on boosters while much of the world has yet to receive any. A third shot may be necessary for people with certain health conditions, but “boosters for the general public are not appropriate at this stage of the pandemic,” it said.

“The longer vaccine inequity persists, the more the virus will circulate and change, the longer social and economic disruptions will continue, and the higher the chances that more variants will emerge that render vaccines less effective,” it said in a statement Friday.

Balicer said that Israel, as a small country, has little effect on global supplies and that its role as the world’s laboratory provides “a very important source of knowledge” for other countries.

Israeli Prime Minister Naftali Bennett has exhorted the public to get vaccine boosters as part of his aggressive public relations campaign since taking office in June.

“Israel is the only country in the world that is giving its citizens this gift of the possibility — both legally and in terms of supply — of a booster,” he said last week.

Balicer said other states should ready national plans for the rollout of booster shots.

“Countries that vaccinated more recently should be prepared for the impact of waning vaccine immunity manifesting in midwinter, further intensifying the challenge,” he said.

___

Pfizer Board Member Warns Policymakers: “Natural Immunity” Needs to Be Included In COVID Mandate Plans

Authored by: Jack Phillips via The Epoch Times, MONDAY, AUG 30, 2021 – 10:20 PM

Former Food and Drug Administration Commissioner Scott Gottlieb, who is a Pfizer board member, noted that “natural immunity” gained from a prior COVID-19 infection needs to be included in discussions about policies and mandates.

“The balance of the evidence demonstrates that natural immunity confers a durable protection,” Gottlieb said during a Monday morning TV interview, referring to a landmark new preprint Israeli study that found prior COVID-19 infection confers much more protection against the virus than any vaccine.

“It’s fair to conclude that,” he said.

Although Gottlieb said he would “be careful” about concluding whether natural immunity provides better protection against transmitting the virus, officials “should start assimilating that into our policy discussions.”

“Natural infection confers robust and durable immunity,” he said, citing the Israeli study and others.

However, whether natural immunity or vaccines are better than one another “isn’t that material” when it comes to policy discussions, Gottlieb added.

Last week, researchers from Maccabi Healthcare and Tel Aviv University said that individuals who recovered from COVID-19 had superior protection against the Delta variant of the CCP (Chinese Communist Party) virus than those who received the Pfizer mRNA vaccine, the most commonly used shot in Israel.

“This analysis demonstrated that natural immunity affords longer-lasting and stronger protection against infection, symptomatic disease, and hospitalization due to the Delta variant,” the study concluded, noting their findings came from the “largest real-world observational study” in the world. Their study, which hasn’t yet been peer-reviewed, noted outcomes for a period between June 1 and Aug. 14 of this year.

When researchers compared cases of prior infection that occurred between March 2020 and February 2021 with vaccinations between January and February 2021, they found that the vaccinated cohort was 5.96 times more likely to contract the Delta variant and 7.13 times more at risk for symptomatic disease compared to those previously infected.

The results suggest that natural immunity gained from having survived a previous infection of COVID-19 may wane over time against the Delta variant, the authors wrote.

Those vaccinated were at a greater risk of COVID-19-related hospitalizations compared to those who were previously infected, the authors noted. They said that being 60 years of age or older increased the risk of infection and hospitalization.

The authors of the research paper said they only observed protection against the Delta variant and not other strains. Meanwhile, they only observed the Pfizer vaccine and didn’t look at other vaccines or the effects of a booster shot.

COVID-19 live updates: Vaccine protection against hospitalization is dropping slightly, CDC says

The CDC initially said 97% of people hospitalized with COVID-19 are unvaccinated

Authors: By Julia Jacobo and Ivan Pereira Last Updated: August 30, 2021, 5:18 PM ET

The COVID-19 vaccines’ ability to keep people out of the hospital appears to be dropping slightly, particularly for those 75 and older, the Centers for Disease Control and Prevention announced Monday during an advisory panel.

The CDC has previously estimated that 97% of people in the hospital being treated for COVID-19 are unvaccinated, but that data was collected before the spread of delta, a hyper-transmissible variant that many doctors have warned appears to be making people sicker.

The latest CDC analysis estimates that the ability of the COVID vaccines to keep a person out of the hospital is now between 75% to 95%.

For people older than 75 in particular, vaccine effectiveness against hospitalization experienced the steepest decline, from more than 90% to 80% between June and July.

Health experts are also concerned that a person’s immunity could be waning over time, particularly among older people whose bodies are less likely than younger people to develop a strong immune response to the vaccines.

However, the vaccine still remain highly effective at preventing serious illness, according to the briefing.

Scientists push back on call to endorse booster shots for all

Authors: By Ariel Hart,  Helena Oliviero– The Atlanta Journal-Constitution

Responding to the resurging pandemic and breakthrough infections, President Biden and some top health officials are pushing for the U.S. to begin vaccine booster shots by Sept. 20. But the committee of scientists who officially recommend whether to take such steps met Monday and pushed back.

The scientists said they still had fundamental questions to answer, such as whether the increase in COVID-19 infections after vaccination, so-called breakthrough cases, was related at all to waning effectiveness of the vaccines.

When the Sept. 20 date was announced “it led everyone—it led physicians, it led the public—to believe that they had access to information about these vaccines and the need for boosters that had not yet been publicly released,” said Dr. Sandra Fryhofer of Atlanta, a nonvoting member of the committee. “And to me, that kind of opened the door to a lot of confusion.”

The group, the Advisory Committee on Immunization Practices, advises the Centers for Disease Control and Prevention on whether scientific data merit approval or warnings on vaccines. From the moment its chairwoman opened Monday’s meeting, members made blunt statements that they would follow scientific data and processes on booster shots, regardless.

Other scientists were glad to hear it.

“There is a process that is being undermined by ‘science by leak,’” said Dr. Felipe Lobelo of Emory University, an epidemiologist and associate professor told the AJC. “We don’t really have strong data on when the waning starts; on whether the increased rates of infection and so called breakthrough infections…are occurring because of this waning effect— or is it because delta is more transmissible? Or is it because people are changing behaviors?”

Dr. Carlos del Rio, professor of medicine at Emory University, agreed. “The problem is by focusing on boosters we’re distracting from the biggest problem, which is all the unvaccinated people,” he said.

Without calling them “booster shots,” the FDA has authorized an extra shot for certain people with compromised immune systems, like organ transplant recipients, after they have completed their original coronavirus vaccine regimen. But no decisions have been made for other vulnerable groups, much less the general public.

That leaves Georgians who are now eager for a booster shot not knowing what comes next.

In Avondale Estates, Carolyn Chandler, 80, has marked her calendar for Oct. 16, the day she should get a booster if they’re recommended eight months from initial vaccination, as federal officials have touted.

Ever since Chandler started to see reports showing waning immunity from the vaccines, there was no question for her that she would get a booster.

“I just would like to stick around for a while,” Chandler said.

Israeli experts analyze mRNA COVID vaccines long-term effects

Experts believe there will be no long-term side effects to the mRNA vaccines.

Authors: By MAAYAN JAFFE-HOFFMAN   AUGUST 30, 2021 22:34

As thousands of Israelis rush back to their health funds in search of a third COVID-19 vaccine shot and a Green Pass from isolation after traveling abroad, others are asking if another injection of messenger RNA is safe.The American Food and Drug Administration provided full approval of the Pfizer coronavirus vaccine last week, but noted in its press release that “information is not yet available about potential long-term health outcomes.”However, Tal Brosh, head of the Infectious Disease Unit at Samson Assuta Ashdod University Hospital, told The Jerusalem Post that while he cannot claim to know what is going to happen in 10 years, “there is no true reason to think there are any significant long-term effects” of the vaccine.He explained that there is no other vaccine that was evaluated for a decade before approval and that there is not an example of another vaccine – although no other vaccine is an mRNA vaccine – that has been linked to any significant long-term effects.“There is no evidence of something happening unless it happened in the first two hours, two weeks or two months,” said Michal Linial, a professor of biological chemistry at the Hebrew University of Jerusalem. “We do not know of any other examples in which the immune system decided to suddenly react to a vaccine that was given 15 years prior.”THERE ARE also few examples of people being nervous about taking a booster shot of an already approved vaccine.If a person were to get cut by rusted metal and go to a doctor, the health professional would probably tell that individual to get a tetanus booster shot. It is unlikely this person would ask the doctor if the booster was safe or if it could prevent her from getting pregnant or him from making babies.“This is the same thing,” Linial said. “I can understand in the beginning that this was a breakthrough and people were shocked, like it is some kind of satellite to the Moon and they don’t want to be the first on the satellite. But now we know: This is nothing like that.”Rather, more than two billion people worldwide have been inoculated against COVID-19 with more than five billion doses. Around 210 million Pfizer mRNA doses have been distributed in America, for example. In Israel, more than 8.5 million doses have been administered. While traditional vaccines generally put a weakened or inactivated germ into our bodies, according to the Centers for Disease Control and Prevention, mRNA vaccines “teach our cells how to make a protein – or even just a piece of a protein – that triggers an immune response inside our bodies. That immune response, which produces antibodies, is what protects us from getting infected if the real virus enters our bodies.”Brosh said that this does not mean that the vaccine changes people’s genetic code. Rather, he said the mRNA is more like a USB device that is inserted into a computer: It does not impact the hard drive of the computer but runs a certain program.“ Messenger RNA is a very fragile molecule, meaning it can be destroyed very easily,” Linial explained. “If you put mRNA on the table, for example, in a minute there will not be any mRNA left. This is as opposed to DNA, which is as stable as you get. ”She said that this fragility is true of the mRNA of any living thing, whether it belongs to a plant, bacteria,

WHILE THE Moderna and Pfizer vaccines are based on new technologies, they are asking our bodies to do something they do every day: cells synthesizing protein. Moderna and Pfizer are simply delivering a specific mRNA sequence to our cells. Once the mRNA is in the cell, human biology takes over. Ribosomes read the code and build the protein, and the cells express the protein in the body. This is one of the main reasons to believe there will be no long-term consequences to the vaccine, said Prof. Eyal Leshem, director of Sheba Medical Center’s Center for Travel Medicine and Tropical Diseases. While the Pfizer and Moderna vaccines are the first mRNA ones to ever be brought to market for human patients, Linial said she believes the reason that no mRNA vaccine has been developed until now is because there was just no need to move this fast on a vaccine until COVID-19 came along. In fact, scientists have been experimenting with mRNA for the better part of the last three decades. Leshem said mRNA vaccines for other diseases, including cancer, have been tested in humans for around 10 years and “no long-term effects were registered” in those trials – though he admitted that these trials generally included small numbers of participants. Individuals began receiving mRNA vaccines against COVID-19 as early as July of last year, and adverse effects have been closely tracked worldwide since then. In Israel, the first vaccines were administered on December 20, 2020.“There is more data on the adverse events of these vaccines than we have ever had on any other vaccine,” Brosh said, adding that no vaccine has ever been given to so many people so quickly. Most adverse events were simple “reactogenicity” – reactions that occur soon after vaccination and that are a physical manifestation of the inflammatory response. These can include fever, muscle pain, swelling at the site of injection or swelling of the lymph nodes, for example – all symptoms that can generally be treated with paracetamol or the like. THE VACCINE was linked to one “immune-mediated phenomenon,” said Brosh, and that is myocarditis – inflammation of the heart muscle – which was the predominant serious side effect in young male adults between the ages of 16 and 25. But even then, myocarditis was rare, generally mild, and those people who developed it fully recovered, he said. Moreover, unvaccinated people who contracted COVID-19 were four times more likely to develop myocarditis than vaccinated people were, according to a new study by Clalit Health Services together with Harvard University that was published last week in the New England Journal of Medicine. The study found that there were around 2.7 cases of myocarditis per 100,000 vaccinated people infected with the virus, compared with 11 cases per 100,000 unvaccinated people who were infected. In general, the study showed that individuals who take the Pfizer coronavirus vaccine may suffer from four out of up to 25 clinically relevant side effects: myocarditis, swelling of the lymph nodes, appendicitis and herpes zoster.In contrast, high rates of multiple serious adverse events were associated with coronavirus infection among unvaccinated patients, including a greatly increased risk of developing myocarditis, pericarditis, arrhythmias, heart attacks, strokes, pulmonary embolism, deep-vein thrombosis or acute kidney damage.“So, all together we know the vaccines are safe and effective. This holds true for the initial doses and probably also for the booster doses,” Leshem said. Linial said she believes that most future vaccines will be made of mRNA because “it is an easy, great technology – no question.” She also said that vaccination is the only way to beat this pandemic. “If people want to go back to their lives,” Linial said, “the population must be vaccinated.” 

Durability of mRNA-1273 vaccine–induced antibodies against SARS-CoV-2 variants

  1. Authors: ViewAmarendra Pegu1,†, Sarah O’Connell1,† View ORCID ProfileStephen D. Schmidt1,, Sijy O’Dell1,View ORCID ProfileChloe A. Talana1, Lilin Lai2, Jim Albert Science  12 Aug 2021: eabj4176m OI: 10.1126/science.abj4176

Abstract

SARS-CoV-2 mutations may diminish vaccine-induced protective immune responses, particularly as antibody titers wane over time. Here, we assess the impact of SARS-CoV-2 variants B.1.1.7 (Alpha), B.1.351 (Beta), P.1 (Gamma), B.1.429 (Epsilon), B.1.526 (Iota), and B.1.617.2 (Delta) on binding, neutralizing, and ACE2-competing antibodies elicited by the vaccine mRNA-1273 over seven months. Cross-reactive neutralizing responses were rare after a single dose. At the peak of response to the second vaccine dose, all individuals had responses to all variants. Binding and functional antibodies against variants persisted in most subjects, albeit at low levels, for 6-months after the primary series of the mRNA-1273 vaccine. Across all assays, B.1.351 had the lowest antibody recognition. These data complement ongoing studies to inform the potential need for additional boost vaccinations.

SARS-CoV-2, the virus that causes COVID-19, has infected millions of people worldwide fueling the ongoing global pandemic (1). The combination of RNA virus mutation rates, replication and recombination, in a very large number of individuals is conducive to the emergence of viral variants with improved replication capacity and transmissibility, as well as immunological escape. Of particular interest are the Variants of Concern B.1.1.7 (20I/501Y.V1 or Alpha), B.1.351 (20H/501Y.V2 or Beta), P.1 (Gamma; first identified in Brazil), B.1.429 (Cal20 or Epsilon; first identified in California), and B.1.617.2 (Delta; first identified in India); and Variant of Interest B.1.526 (Iota; first identified in New York). In multiple studies, B.1.351 is the most resistant to neutralization by convalescent or vaccinee sera, with 6-15 fold less neutralization activity for sera from individuals immunized with vaccines based on the virus strain first described in January 2020 (Wuhan-Hu-1, spike also called WA1) (29). Most of these prior studies evaluated sera from vaccinated individuals at timepoints soon after the first or second dose, and had limited data on the durability of such responses. Likewise, clinical studies have reported somewhat reduced efficacy and effectiveness against the B.1.1.7, B.1.351, and B.1.617.2 variants (1012). Although such data provide critical insights into the performance of the vaccines against viral variants, they have not fully addressed the durability of cross-reactive binding and functional antibodies.

Here we investigate the impact of SARS-CoV-2 variants on recognition by sera from individuals who received two 100 mcg doses of the SARS-CoV-2 vaccine mRNA-1273. mRNA-1273 encodes the full-length stabilized spike protein of the WA1 and was administered as a two-dose series 28-days apart. We previously described the binding and neutralization activity against the WA1 SARS-CoV-2 spike longitudinally over 7 months from the first vaccination in volunteers from the Phase 1 trial of the mRNA-1273 vaccine (1316). In the current study, we demonstrate the utility of employing multiple methodologies to assess SARS-CoV-2 vaccine-elicited humoral immunity to variant viruses over time. We tested sera from a random sample of 8 volunteers in each of three age groups: 18-55, 55-70, and 71+ years of age, all of whom had samples available from four timepoints: 4 weeks after the first dose, and two weeks, 3 months, and 6 months after the second dose (Days 29, 43, 119, and 209 after the first dose, respectively).

Three functional assays and two binding assays were used to assess the humoral immune response to the SARS-CoV-2 spike protein. SARS-CoV-2 neutralization was measured using both a lentivirus-based pseudovirus assay, and a live-virus focus reduction neutralization test (FRNT) (17). The third functional assay was a MSD-ECLIA (Meso Scale Discovery-Electrochemiluminescence immunoassay)-based ACE2 competition assay. This method measured the ability of mRNA-1273 vaccine-elicited antibodies to compete with labeled soluble ACE2 for binding to the specific RBD (WA1 or variant) spotted onto the MSD plate. Antibody binding to cell-surface expressed full-length spike was analyzed by flow cytometry. Binding to soluble protein was measured by interferometry in the MSD-ECLIA platform. All samples were assessed against WA1 and the B.1.1.7 and B.1.351 variants in each of these orthogonal serology assays. In addition, all samples were tested against WA1 containing the D614G mutation in both neutralization assays, as well as binding in the cell-surface assay. Further variants were tested in binding assays as follows: S-2P and RBD binding, P.1 against all samples; cell-surface spike binding, P.1, B.1.429, B.1.526, and B.1.617.2 against all samples. A subset of samples – Day 43 to capture the peak response, and Day 209 to look at durability – were evaluated by pseudovirus neutralization against P.1, B.1.429, B.1.526, and B.1.617.2. The specific sequences used in each assay are defined in table S1.

We first assessed the patterns of antibody activity over time. Consistently across assays, low-level recognition of all variants was observed after a single dose (Day 29) (Fig. 1). Activity against all variants peaked two weeks after the second dose (Day 43) with moderate declines over time through Day 209 (Fig. 1). Notably, the values obtained for each assay on a per-sample basis correlated with each other (fig. S1). We next evaluated the relative impact of each variant, considering all timepoints together. Employing the pseudovirus assay, the neutralizing activity was highest against D614G and lowest against B.1.351, with values for all other variants tested falling in between those two variants (Fig. 1A and Fig. 2A). Similar to previous reports from our group (15) and others (18), pseudovirus neutralization ID50s to D614G were 3-fold higher than to WA1 (Fig. 2G). In contrast, using the live-virus FRNT neutralization assay (Fig. 1B and Fig. 2B), titers to WA1 were higher than to D614G, consistent with previous reports for that assay (19). For all other variants, the impact in the live-virus and pseudovirus neutralization assays were concordant: titers against B.1.1.7 were similar to D614G and lower against B.1.351. ACE2 competition was highest for WA1 RBD, intermediate for B.1.1.7, and lowest for B.1.351 (Fig. 1C and Fig. 2C). Spike-binding antibodies were measured using two different methodologies. In the cell-surface spike binding assay, serum antibodies were bound to full-length, membrane-embedded spike on the surface of transfected cells and measured by flow cytometry (20). In this assay (Fig. 1D and Fig. 2D), WA1 and D614G were nearly indistinguishable, with ~1.5-fold reduced binding to B.1.1.7, B.1.526, B.1.617.2, and 2.4 to 3.0-fold reduced binding to P.1, and B.1.429, and B.1.351. We also used the MSD-ECLIA multiplex binding assay to simultaneously measure IgG binding against both the stabilized soluble spike protein S-2P (21) and RBD proteins derived from WA1 and the B.1.1.7, B.1.351, and P.1 variants. The ECLIA assay showed slightly reduced binding to the variant S-2P (Fig. 1E and Fig. 2E) and RBD (Fig. 1F and Fig. 2F) proteins, with the rank order of highest to lowest binding as follows: WA1, B.1.1.7, P.1, and B.1.351. The overall effect of each variant in each assay is tabulated in Fig. 2G, which shows the geometric mean of the ratios between values for WA1 and variant or D614G and variant. In all assays, B.1.351 was the variant that caused the greatest reduction in titers compared to WA1 or D614G.

For More Information: https://science.sciencemag.org/content/early/2021/08/11/science.abj4176.full

‘This Ends The Debate’ – Israeli Study Shows Natural Immunity 13x More Effective Than Vaccines At Stopping Delta

Authors: by Joseph Adinolfi Jr.  FRIDAY, AUG 27, 2021 – 07:39 AM

Dr. Anthony Fauci and the rest of President Biden’s COVID advisors have been proven wrong about “the science” of COVID vaccines yet again. After telling Americans that vaccines offer better protection than natural infection, a new study out of Israel suggests the opposite is true: natural infection offers a much better shield against the delta variant than vaccines.

The study was described by Bloomberg as “the largest real-world analysis comparing natural immunity – gained from an earlier infection – to the protection provided by one of the most potent vaccines currently in use.” A few days ago, we noted how remarkable it was that the mainstream press was finally giving voice to scientists to criticize President Biden’s push to start doling out booster jabs. Well, this study further questions the credibility of relying on vaccines, given that the study showed that the vaccinated were ultimately 13x as likely to be infected as those who were infected previously, and 27x more likely to be symptomatic.

Alex Berenson, a science journalist who has repeatedly questioned the efficacy of vaccines and masks at preventing COVID, touted the study as enough to “end any debate over vaccines v natural immunity.”

Here’s an excerpt from a report by Science Magazine:

The new analysis relies on the database of Maccabi Healthcare Services, which enrolls about 2.5 million Israelis. The study, led by Tal Patalon and Sivan Gazit at KSM, the system’s research and innovation arm, found in two analyses that people who were vaccinated in January and February were, in June, July, and the first half of August, six to 13 times more likely to get infected than unvaccinated people who were previously infected with the coronavirus. In one analysis, comparing more than 32,000 people in the health system, the risk of developing symptomatic COVID-19 was 27 times higher among the vaccinated, and the risk of hospitalization eight times higher.

This time, the data leave little doubt that natural infection truly is the better option for protection against the delta variant, despite the fact that the US won’t  acknowledge the already infected as having antibodies protecting them from the virus.

As the first country to achieve widepsread coverage by the vaccine, Israel is now in an unthinkable situation: daily case numbers have reached new record levels as the delta variant penetrates the vaccines’ protection like a hot knife slicing through butter.

Source: Bloomberg

At the very least, the results of the study are good news for patients who have already successfully battled COVID but show the challenge of relying exclusively on immunizations to move past the pandemic.

“This analysis demonstrated that natural immunity affords longer lasting and stronger protection against infection, symptomatic disease and hospitalization due to the delta variant,” the researchers said.

Unfortunately, the study also showed that any protection is time-limited. Protection offered by natural infection wanes over time, just like the protection afforded by vaccines: The risk of a vaccine-breakthrough delta case was 13x higher than the risk of developing a second infection when the original illness occurred during January or February 2021. That’s significantly more than the risk for people who were ill earlier in the outbreak.

What’s more, giving a single shot of the vaccine to those who had been previously infected also appeared to boost their protection. Still, the data don’t tell us anything about the long-term benefits of booster doses.

This latest data showing the vaccines don’t offer anywhere near the 90%+ protection that was originally advertised by the FDA after the emergency authorization. Other studies are finding harmful side effects caused by the mRNA jabs are also more prevalent than previously believed.

Read the study pre-print below:

2021.08.24.21262415v1.full 

Ultra-Vaxxed Israel’s Crisis Is a Dire Warning to America

“I don’t want to frighten you,” Israel’s COVID czar Dr. Salman Zarka told parliament this week. “But… unfortunately, the numbers don’t lie.”

Authors: Noga TarnopolskyUpdated Aug. 24, 2021 7:51AM ET / Published Aug. 24, 2021 3:38AM ET 

JERUSALEM—The massive surge of COVID-19 infections in Israel, one of the most vaccinated countries on earth, is pointing to a complicated path ahead for America.

In June, there were several days with zero new COVID infections in Israel. The country launched its national vaccination campaign in December last year and has one of the highest vaccination rates in the world, with 80 percent of citizens above the age of 12 fully inoculated. COVID, most Israelis thought, had been defeated. All restrictions were lifted and Israelis went back to crowded partying and praying in mask-free venues.

Fast forward two months later: Israel reported 9,831 new diagnosed cases on Tuesday, a hairbreadth away from the worst daily figure ever recorded in the country—10,000—at the peak of the third wave. More than 350 people have died of the disease in the first three weeks of August. In a Sunday press conference, the directors of seven public hospitals announced that they could no longer admit any coronavirus patients. With 670 COVID-19 patients requiring critical care, their wards are overflowing and staff are at breaking point.

“I don’t want to frighten you,” coronavirus czar Dr. Salman Zarka told the Israeli parliament this week. “But this is the data. Unfortunately, the numbers don’t lie.”

What happened?

The complex and sobering truth is that no single policy or event brought Israel to this crisis, Hagai Levine, a Hebrew University of Jerusalem professor of epidemiology, told The Daily Beast. A deadly set of circumstances came together to put Israel on the precipice, most of which can be summed up as: “We are still in the midst of a pandemic, and there is no silver bullet.”

“All the vectors have influenced the rise in morbidity,” he said.

But the principal causes of Israel’s current predicament are the dominance of the extremely infectious Delta variant, which was carried into the country by Israelis returning from foreign vacations during the weeks in which Israel dropped all restrictive measures—along with the worrisome decrease in vaccine efficacy after about six months.

Israel vaccinated its population almost exclusively with the Pfizer/BioNTech vaccine, which received full FDA approval on Monday and remains the gold standard for the prevention of severe illness due to the coronavirus.

It is not an Israeli problem. It is everywhere.

But in early July, with citizens over the age of 60 almost completely vaccinated, Israeli scientists began observing a worrisome rise in infections—if not in severe illness and death—among the double-vaccinated.

Fully vaccinated people with weakened immune systems appeared particularly vulnerable to the aggressive Delta variant.

By mid-July, Sheba Hospital Professor Galia Rahav began to experiment with booster shots for oncology patients, transplant patients, and the hospital’s own staff. A group of 70 elderly vaccinated Israelis with transplanted kidneys were the first to receive a third dose.

The success of Rahav’s trials in boosting immunity at about the sixth-month mark contributed to the Centers for Disease Control decision, announced last week, to begin offering booster shots to Americans in September.

In order to keep severe illness and the number of COVID deaths down, and avoiding a fourth national lockdown, Israel has embarked on an aggressive effort to provide all adults with boosters in a matter of weeks.

As of this week, all Israelis over 30 will be eligible to receive booster shots. By the end of the month, they are expected to be universally available to anyone over the age of 12 who received their second vaccine five months or more ago.

Israel will then reconfigure its Green Passports, granting them only to the triple-vaccinated, and limiting their validity to six months. In anticipation of this change, the number of unvaccinated Israelis getting their first shots has tripled since the beginning of August.

The World Health Organization has asked wealthy countries to halt all third vaccines for a period of two months, hoping that a moratorium will allow poorer countries, where few citizens have received even a first inoculation, to catch up. The United States rejected the call and Israel has ignored it.

Asked what has brought Israel to peak transmission even as the country has already provided third doses of vaccines to 1.5 million citizens, Rahav, who has become one of the best known faces of Israel’s public health messaging, sighed, saying, “I think we’re dealing with a very nasty virus. This is the main problem—and we’re learning it the hard way.”

“It is a combination of waning immunity, so that inoculated people get reinfected, and at the same time the very transmissible Delta variant,” Rahav said, adding that Israelis lacked the discipline to revert to mask usage as the numbers began rising. “But it is not an Israeli problem,” she added. “It is everywhere.”

For More Information: https://www.thedailybeast.com/ultra-vaccinated-israels-debacle-is-a-dire-warning-to-america

Scientists blast U.S. push for Covid vaccine booster shots as premature, say data isn’t compelling

PUBLISHED THU, AUG 19 20211:44 PM EDTUPDATED THU, AUG 19 20216:27 PM EDT

Authors: Berkeley Lovelace Jr.@BERKELEYJR

KEY POINTS

  • Scientists sharply criticized the Biden administration’s push to widely distribute Covid booster shots, saying the data provided by U.S. officials wasn’t compelling.
  • While data suggests there is a reduction in protection against mild and moderate disease, the shots still held up well against severe disease, scientists said.
  • “The data are showing that yes, we are seeing breakthrough infections but, the infections are mild or moderate colds,” said Johns Hopkins University’s Dr. Anna Durbin.

Scientists sharply criticized the Biden administration’s push to widely distribute Covid-19 vaccine booster shots in the U.S. next month, saying the data provided by federal health officials this week wasn’t compelling enough to recommend third shots to most of the American population right now.

U.S. health leaders say they are preparing to offer booster shots to all eligible Americans beginning the week of Sept. 20. The plan, outlined Wednesday by CDC Director Dr. Rochelle Walensky, acting FDA Commissioner Dr. Janet Woodcock, White House chief medical advisor Dr. Anthony Fauci and other health officials, calls for a third dose eight months after people get their second shot of either the Pfizer or Moderna vaccines.

They cited three new studies, released by the Centers for Disease Control and Prevention, that showed their protection against Covid diminished over several months. One study in New York from May 3 through July 25 showed that vaccine protection against infection dropped from around 92% to 80%. Another study by the Mayo Clinic showed that Pfizer’s vaccine efficacy fell from around 76% to 42% while Moderna’s declined from 86% to 76%.

“Taken together, you can see that while the exact percentage of vaccine effectiveness over time differs depending on the cohort and settings study, the data consistently demonstrate a reduction of vaccine effectiveness against infection over time,” Walensky told reporters during a White House Covid press briefing.

But scientists and other health experts said the data they cited wasn’t compelling, characterizing the administration’s push for boosters as premature. While the data did suggest there was a reduction in protection against mild and moderate disease, the two-dose vaccines still held up well against severe disease and hospitalizations, scientists said.

For example, the New York study released by the CDC showed there were 9,675 infections among fully vaccinated adults, compared with 38,505 infections among unvaccinated adults during the period examined. Among the fully vaccinated people who were infected, 1,271 were hospitalized, accounting for roughly 15% of all Covid hospitalizations.

“People are still highly protected against severe disease, hospitalization, and death. This is what vaccines are supposed to do,” said Dr. Anna Durbin, a vaccine researcher at Johns Hopkins University. “If we start seeing significant upticks of more severe disease and hospitalizations in vaccinated people, that would be a signal to consider boosters.”

The body’s immune system is complex, Durbin said. While the presence of antibodies induced by the vaccine may decline, resulting in a rise in breakthrough infections, the body has other mechanisms, like T cells, that may protect someone from getting seriously sick, she said.

“The data are showing that yes, we are seeing breakthrough infections but, the infections are mild or moderate colds,” she said.

To be sure, federal health officials said the vaccines are still holding up against severe disease over time, even as their ability to prevent infections declines. They said, based on their latest assessment, “the current protection against severe disease, hospitalization, and death could diminish in the months ahead, especially among those who are at higher risk or were vaccinated during the earlier phases of the vaccination rollout.”

There are some groups in the U.S. who would benefit from a third dose right now, according to Dr. Archana Chatterjee, a member of the Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee.

Data does support the need for booster doses primarily among those who are moderate to severely immunocompromised, Chatterjee said. Federal health officials on Friday approved giving booster shots to such people – which include cancer and HIV patients and people who have had organ transplants – after data suggested they don’t produce an adequate immune response after getting two doses.

As of now, “breakthrough infections in the general public tend to be asymptomatic or mild,” she said.

People who are 65 or older or living in a long-term care facility may also benefit from a booster shot, said Dr. Isaac Bogoch, an infectious disease specialist at the University of Toronto,

Israel, a country U.S. officials have also cited in their push for boosters, has begun giving out third doses to the elderly after new data showed a reduction in the effectiveness of Pfizer’s Covid vaccine against severe illness among people 65 and older who were fully vaccinated in January or February.

“Do we all need a third dose of a vaccine right now? No, we don’t. Do some people need a third dose of a vaccine right now? Yes. Will we need a third dose of a vaccine in the near future? Maybe,” Bogoch said in a phone interview.

Dr. Priya Sampathkumar, an epidemiologist at the Mayo Clinic, agreed, saying a booster could be needed for the general public in the future, but not right now. “There isn’t enough data to support the third booster for all at this point,” she said.

Lawrence Gostin, director of the World Health Organization’s Collaborating Center on National and Global Health Law, said federal health officials should put their focus elsewhere: the unvaccinated, both in the U.S. and around the world.

Earlier this month, the WHO asked wealthy nations to stop distributing booster shots until at least the end of September to give poorer countries the chance to vaccinate their populations with the first rounds of shots. 

Shortly after the U.S. announced its booster plan, the international agency condemned wealthy nations that support boosters for the general public.

“Boosting the entire U.S. population while poor people are dying in poor countries is tone-deaf and is widely viewed as uncaring,” Gostin said. “It’s also a slap in the face to WHO after it called for a booster moratorium.”

U.S. Surgeon General Dr. Vivek Murthy defended the administration’s booster plan on CNBC on Wednesday, saying health officials decided to give boosters to the general public at the eight-month mark as a way “to stay ahead of this virus.”

“We are making plans now, because No. 1, you’ve got to plan ahead, but two, we wanted the public to know what we were seeing in the data, in our effort to be transparent and open with the public,” Murthy told “The News with Shepard Smith.”

During a White House briefing Tuesday, press secretary Jen Psaki said the administration believes it can boost the American population while ensuring the rest of the world gets vaccinated.

“We believe that is a false choice. We can do both,” Psaki said, adding that the U.S. is contributing more vaccine doses than any other nation to fight Covid across the globe. “We will continue to be the arsenal for vaccines around the world. We also have enough supply and had long planned enough supply should a booster be needed for the eligible population.”

Covid Vaccines Are Less Effective Against Delta, Large Study Finds Naomi Kresge Bookmark August 19 2021, 4:31 AM

Authors: Naomi Kresge
Copyright © BloombergQuintCopyright ©

Covid-19 vaccines are less effective against the delta variant, according to results in the U.K. from one of the largest real-world studies into the efficacy of the shots. Pfizer Inc. and BioNTech SE’s messenger RNA vaccine lost effectiveness in the first 90 days after full vaccination, though that shot and the one made by AstraZeneca Plc still staved off a majority of Covid infections. When vaccinated people did get infected with delta, they were shown to have similar levels of virus in their bodies as those who hadn’t had shots. This suggests that vaccinating large portions of a population might not protect those who don’t get inoculated, casting doubt on the idea of achieving herd immunity.   There isn’t yet data to show how much the vaccines continue to protect against hospitalization and severe cases of Covid over time.   These latest results are likely to fuel calls to give booster shots to the fully vaccinated even as countries around the world still lack enough supply for first immunizations. The U.S. plans to start offering booster shots on Sept. 20 to all vaccinated U.S. adults. U.K. authorities are still deciding how broadly boosters should be given. In Israel, which started giving third doses of Pfizer-BioNTech this month, initial results show they have been 86% effective for people over the age of 60. 

The U.K. survey, run by the University of Oxford and the Office for National Statistics and published Thursday in a preprint, analyzed more than 3 million PCR tests from a random sample of people for a detailed picture of infection patterns as delta became the dominant variant this year. “We’re seeing here the real-world data of how two vaccines are performing, rather than clinical trial data, and the data sets all show how the delta variant has blunted the effectiveness of both the Pfizer and AstraZeneca jabs,” said Simon Clarke, an associate professor in cellular microbiology at the University of Reading. 

By roughly four and a half months after the second dose, Pfizer’s shot will probably be about on par with Astra’s at preventing infections with a high viral burden, said Koen Pouwels, an Oxford senior researcher who helped lead the study. There wasn’t a statistically significant difference in the Astra shot’s effectiveness over time.  The study results may bring further unease as infections start

For More Information: https://www.bloombergquint.com/onweb/covid-vaccines-are-less-effective-against-delta-in-u-k-study