The Israeli Public Emergency Council for the Covid19 Crisis
To:

Prime Minister, Mr. Naftali Bennett
Health Minister, Mr. Nitzan Horowitz
Health Ministry Director-General, Professor Nachman Ash

Lack of Evidence and Research Justifying Administration of a Third Vaccine Dose

Honorable representatives,

It is with great sorrow that we read the proposals of various parties, internal and external to the Ministry, to go ahead with the administration of a third vaccine dose to the immunocompromised and to the public in general.

Modern medicine is based on evidence: studies and data that guide us in making clinical decisions. At this time, only a fewstudies have been conducted on a few patients, without controlled conditions and which have produced modest results (responses in less than half of the subjects). Therefore, there is no solid factually-researched basis showing the efficacy or safety of administering a third vaccine dose to immunocompromised or other people.

It should be noted that the world health organizations (CDC, FDA, WHO) are refusing at this stage to administer a third booster-dose of the vaccine.

We know that the percentage of side-effects among vaccinated people increases significantly with the second dose, and it is possible that the very immunocompromised patients who react to the vaccine will suffer significant side- effects. A studycurrently being conducted is examining a series of corneal implants that failed because of the Covid vaccination. The scenario whereby future implant patients may suffer this because of a third dose of the vaccine is truly terrible.

Lack of knowledge at this stage – this is precisely the point of failure and crisis: the vaccine itself has not passed all regulatoryprocedures and is defined as “under examination”. The State of Israel is now preparing to perform an act that is even outside the scope defined by the manufacturing company, and even this without sufficient research evidence. The recommendation to perform serological tests, the clinical value of which is unknown, further testifies that this is in fact an experiment that is not based on accepted clinical procedures.

The Ministry of Health’s directive to provide treatment without a proper scientific basis is unprecedented and places medicalstaff in a difficult ethical and professional dilemma. This is a guideline that places medical staff on a slippery slope which is a blatant deviation from the way medicine is practiced.

Accordingly, the Ministry of Health should treat the administration of a third vaccine to immunocompromisedindividuals (or other populations) as an experiment for all intents and purposes. The Helsinki Committee should be consulted, those vaccinated should first sign informed consent agreements, and most importantly, the process should be stringently monitored, as is characteristic of clinical trials.

From a scientific, medical, regulatory, and ethical standpoint – it would be correct to go down this path under a research protocol setting.

Administering the vaccine outside of a research-setting will result in data not being collected optimally and will therefore make it difficult to draw any conclusions.

Carrying out the procedure as part of a research study protocol could also contribute to public confidence in the Ministry’sdecisions and help alleviate concerns of the public that the Ministry’s COVID19 policy is based on whim or stockpileconsiderations.

Signed,

Members of the Public Emergency Council for the Covid19 Crisis