TrialSite recently reported Israel was gearing up to commence administering the fourth booster vaccine to address the ongoing COVID-19 pandemic in that heavily vaccinated nation. It was also shared in this media channel, however, that rising vaccine hesitancy may result from the ongoing waning effectiveness of the mRNA-based vaccines now in use in this eastern Mediterranean nation. While healthcare centers such as Sheba Medical Center were gearing up for a study involving 100 volunteers, after all the Health Ministry gave the thumbs up, interestingly, they have yet to receive authorization from the so-called Helsinki Committee, an ethics minded committee that must sign off on all clinical trials in Israel. Thus far the panel has yet to authorize the study according to media across Israel, including the Times of Israel. Apparently, after attempts by the media to obtain a reason for the delay, the panel shared this could not be disclosed at this point as deliberations on the topic continue. So, as Israel was to become the first nation to authorize a fourth dose booster in response to COVID-19, this decision is now on hold, at least, till the middle of next week. The man who must make the call is Director-General Nachman Ash. While Prime Minister Bennett wants to move, it is Ash who makes the final call—a powerful man when it comes to healthcare-related decisions.
What is Israel’s Helsinki Committee?
The Helsinki Committee is the body that has the authority in this nation to authorize medical research and clinical trials involving humans. First and foremost, the organization is chartered as a “servant of the public, and its main role is to ensure the wellbeing and rights of trial participants, and ensure that the research/experiment is conducted in accordance with the approved medical ethics guidelines, which are in accordance with the guidelines outlined in the Declaration of Helsinki.”
Did Israel’s Health Ministry sign off on 4th booster?
Yes. Last Tuesday as TrialSite reported, the Health Ministry’s expert advisory panel, in fact, approved the distribution and administration of a fourth COVID-19 vaccine dose to individuals aged 60 years or above as well as for others at risk (e.g., immunocompromised, etc.).
What stopped the process?
Israeli media, including Channel 13, reports that the Health Ministry then paused this decision based on the discussion in a meeting involving a review of initial data implying that given the rapid rise of the Omicron variant and the seeming fact that people infected with the variant of concern are about 50% to 70% less likely to end up in the hospital as compared to those people infected with the Delta variant of concern. Subscribe to the Trialsitenews “COVID-19” ChannelNo spam – we promise
TrialSite has been reporting that while Omicron is more transmissible, the only data thus far reliable suggests it’s less infectious. Of course, this could change with the cold season and widespread viral infections so no one should assume anything at this point.
Why did the UK possibly contribute to this hold?
Recently, the United Kingdom Health Security Agency uncovered that Omicron’s impact is milder than previous variants of concern, however, it is highly infectious and evades vaccines.
According to other European media reports, government data verifies the Omicron variant of concern, at least up till now, leads to less severe results than say from the Delta variant. They do of course warn of high transmissibility.
What’s Israel’s Health Ministry Director-General Point of View?
Director-General Nachman Ash apparently is delving into the UK data for more clarity. Reports initially from Channel 13 are that if the data continues to evidence a more mild, less infectious strain, then the Director-General may put a halt on booster shots, rather than sending the matter back for further research and discussion.
When will Director-General Ash Make a move?
According to another media outlet, the Kan public broadcaster, Channel 11, reports are that Ash may make the move to decide which direction to take by mid-next week.
Why might Nash hold off?
Well, if it is determined that Omicron is, in fact, less dangerous and fully evades existing vaccines then it could make sense to delay the decision and await a vaccine updated and tailored to the super-mutant.
Why are some pro-vax persons so gung-ho about proceeding?
They are concerned about yet another contagion, with widespread infections, even if it is less infectious. Because Omicron is so transmissible, many in the government here expect a tough time in the forthcoming weeks, with hundreds of thousands of new or breakthrough infections.
Are cases on the rise?
Absolutely. Even though this is one of the most heavily vaccinated nations worldwide and a massive booster program occurred during the late summer and into the fall, the cases of SARS-CoV-2 are on the rise again. In fact, by Thursday, 1,420 new COVID-19 cases were reported from the previous day. This represented the highest total since October. On Friday 1,351 cases were reported, continuing a negative trend.
Also, the Times of Israel reports the SARS-CoV-2 positivity rate appears on the rise, slightly from 0.9% a week ago to 1.45% a couple of days ago. Moreover, the important measure known as the R number appears on a gradual rise, from 1.02 in the early part of December to 1.34 on Thursday.
What about serious cases, hospitalization, and death?
These, fortunately, are held low with 123 reported hospitalizations on Thursday. The vaccines do lower the probability of hospitalization and death, at least thus far.