Sheba Medical Center & Israel Ministry of Health Worker Study: Fourth Pfizer mRNA COVID-19 Vaccine Falters Against Omicron

Posted originally on TrialSite News by Staff on January 18, 2022

The preliminary results of a recent Sheba Medical Center healthcare worker study reveal that a fourth booster lacks the necessary protection against the Omicron variant of the COVID-19 vaccine. While the jab may afford select high-risk populations some benefit, most of the population receives little to no value from the boost. This raises serious questions about the direction of the global pandemic response centered on one dose of a vaccine after another. The implications of these preliminary results are profound if they hold up during final data, peer-review come publishing time. This implies that in just over a year, four vaccination doses were required and that didn’t even cover the entire population widely enough. With a virus such as influenza, an annual vaccine to reduce the risk of infection serves as a rational target benchmark for what these COVID-focused vaccines should be, governments and public health agencies should start stepping back and considering the most rational, economical, and importantly safe approach moving forward. While Pfizer projects another $33 billion-plus revenue year, government authorities need to start thinking about value-based payments associated with such mass vaccination schemes.

The Study

With over 150 medical staff participating in a study commencing in December 2021, the academic medical center, in partnership with the Ministry of Health, launched what is the only currently known investigation into the effects of a fourth Pfizer-BioNtech (BNT162b2 or Comirnaty) booster dose. A first-of-its-kind study conducted in alliance with the Health Ministry, the program proceeded despite the World Health Organization’s attempts to thwart such booster programs in favor of global vaccine equity.

Israel: Vaccination Nation Failing to Stop Omicron

Over the past half-year, TrialSite has been informed by multiple hospital executives in Israel that the American National Institutes of Health (NIH) looks to the Ministry of Health and various hospitals frequently as Israel has become a sort of canary in the mine for the COVID-19 vaccines worldwide. Well, that canary starts to stress, as the indicators of the global vaccination program don’t look great. Yes, the Ministry of Health reports the vaccines have reduced the levels of infectious disease and death, yet the price tag for the COVID-19 vaccination program mounts above and beyond what could have been expected by any rational point of view.

One of the most boosted nations, if not the most boosted nation on the planet, a month ago over 58% of the eligible population received a booster reported the Health Ministry of Israel.Subscribe to the Trialsitenews “COVID-19” ChannelNo spam – we promise

As can be reviewed by Our World in Data, Israel’s vaccination rates are sky high for high-risk elderly populations but increasingly, younger people became hesitant in the country. Perhaps, as more is learned about the virus and the risk-benefit analyses necessary for different cohorts, the inoculation of the entire population based on current unfolding results becomes even more of a shakier target.

Cases Skyrocket

In the meantime, COVID-19 again surges in Israel despite a heavily boosted population. To put things in perspective, yesterday, the nation’s health authorities reported 33,505 new daily infections based on a 7-day average in this nation of 9.2 million people.

The previous record was 22,291 set on September 8th, part of the Delta variant surge from July through October of last year. Cases all but flatlined from late October through mid-December then rapidly ascended, breaking records daily now.

The good news continues to be that death rates are far lower than previous surges, with the deadliest surge occurring from December 2020 to March 2021. But the population becomes weary and increasingly suspect of endless vaccinations as the answer. In fact, much like the U.S. Centers for Disease Control and Prevention (CDC), the health authorities in this eastern Mediterranean nation cut the COVID-19 isolation time from ten to five days in recognition that the Omicron variant isn’t as severe as previous variants, reports multiple media including Haaretz.

Not Good Enough

The media in Israel, such as the Times of Israel, was abuzz with the story that the recent study failed to achieve the desired results. TrialSite links to Reuters and Thomson Reuters Foundation as one of the first sources to cover the hospital’s admission. Led by Professor Gili Regev-Yochay, the study team learned that the current mRNA-based vaccines fail to deliver the necessary value when measured against the goals of a population-wide, effective, and safe means of significantly reducing infection, serious illness, and death. The study investigators do indicate the vaccine still may provide some protection for high-risk cohorts.

But, when considered against the initial target of leading to herd immunity, the vaccines have, frankly, failed to achieve such an outcome. Rather, they are a useful medical regimen for high-risk populations. Based on an accurate risk-benefit analysis, for example, some populations such as the elderly, face higher risks for severe disease or death and consequently, may benefit from the vaccine. Also under consideration are the risks for long COVID. However, an objective, unbiased, and scientific point of view should now intervene and direct courses of action moving forward.

In the Times of Israel, Professor Regev-Yochay went on the record, “The vaccines, which were very effective against the previous strains, are less effective against the Omicron strain.”

Unfortunately, Regev-Yochay continued to the Times of Israel, “We see an increase in antibodies, higher than after the third dose. He continued, “However, we see many infected with Omicron who received the fourth dose. Granted, a bit less than in the control group, but still a lot of infections.”

The lead investigator concluded, “The bottom line is that the vaccine is excellent against the Alpha and Delta [variants], for Omicron it’s not good enough.”

Reports are preliminary, meaning the academic medical center-based study team has more work to do to finalize the study results. But the group had to share this information given the public interest and need for insight. 

Conflict over Messaging?

While the study team representing Sheba Medical Center shared the preliminary findings, this apparently angered the Health Ministry which didn’t want this information floating around the media at this point. With a growing vaccine hesitancy in Israel, the government continues to navigate the media toward a positive projection of vaccine results.

Consequently, Sheba Medical Center issued a statement hours after releasing the results calling for “continuing the vaccination drive for risk groups at this time, even though the vaccine doesn’t provide optimal protection against getting infected with the variant.”

About Sheba Medical Center

Ranked as one of the top 10 hospitals in the world by NewsweekSheba Medical Center was established back in 1948. Based in the Tel Aviv District of Ramat Gan, the 200-acre campus includes 159 medical departments and clinics, nearly 2,000 beds, and 75 laboratories. A major academic medical and research center, Sheba Medical Center research represents an elite research institution.

The center represents one of the top destinations to conduct research, including clinical trials not only in Israel but worldwide.

Lead Research/Investigator

Gili Regev-Yochay, MD, MSc, MPH, Head of the Section of Infectious Dis. Epidemiology at Gertner Institute of Epidemiology Research

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