The Israeli Public Emergency Council for the Covid19 Crisis

Information Page: The Coronavirus Vaccine Approval

What is the difference between “Approval” and “Emergency Authorization Use,” and why does it matter?

The Public Emergency Council for the Covid-19 Crisis recently turned to the Ministry of Health with a demand   to change the various Ministry advertisements in which the claim is made that the vaccine was  approved  by the American Federal Drug Administration (FDA) and that the vaccine passed all stages of testing, similar to all other medications and vaccines.

Council members did not take this step due to their opposition to vaccinations – almost all of the members have been vaccinated. The demand stemmed from council members’ stance that, at this time of crisis, the need for professional and ethical conduct, transparency and reliability is especially vital. Accordingly, council members surmised that citizens must receive information regarding the vaccine that is precise and conveyed clearly.

After legal action, the Ministry of Health changed the wording and removed the subtitles from informational videos that claimed that the vaccine was approved by the FDA so that they would correspond more accurately to the necessary definition of “Emergency Authorization Use.” This is in light of the fact that the vaccine is still not approved by the FDA, as it has notcompleted all of the accepted steps for vaccine approval as required by the FDA. What actually is the debate about? What difference does it make if the vaccine is approved by the FDA, and what is the meaning of emergency approval?

The American FDA is responsible for the regulation and approval of medications, vaccines, medical equipment and medical treatments. Above and beyond its status as a federal agency of the United States, the FDA serves as a guiding body on a world-wide level. Many countries, Israel among them, depend almost totally on the FDA’s approval process for their own national levels of approval. For example, Israel has never approved a vaccine that has not been previously approved by theFDA, except in one instance (the Sci-B-Vac), use of which was halted and results of which are still being debated in court.

There is no FDA approved vaccine for covid-19 virus. The vaccinations were developed in record time and it was not possible to complete the research needed to receive approval. The permission granted to Pfizer and other companies is solely Emergency Use Authorization, and the vaccine is defined as Investigational.

The permission granted protects the pharmaceutical companies in that damaging side effects caused by the vaccine will be legally defined under the lenient heading, “Investigational Vaccine” and not “Approved Vaccine.” This legal defense is the reason why Pfizer’s CEO emphasizes that the vaccine has yet to receive FDA approval. In instances of Emergency Authorization, the FDA directs that those being vaccinated must be informed regarding:

  1. The investigational nature of the medication (and that it is not approved via the regular required process).
  2. The possible benefits and possible risks
  3. Possible alternatives to treatment

D.T he patient’s full right to refuse treatment.

Moreover, every person must receive a detailed information page that includes various data about the vaccine. This informationleaflet is translated into 29 languages on the FDA website, including Somali and Yiddish, though unfortunately (for no clear reason), it was not translated into Hebrew.

In conclusion, the difference between full Approval and Emergency Use Authorization is: medications under Emergency Use Authorization, including all currently available corona vaccines, have not yet completed FDA-defined research requirements. In other words, all of the information necessary for full approval has yet to be received, according to the FDA’s own website.

For those interested in looking deeper into the matter, the corona vaccines “skipped” a stage in the development process:corona vaccination experiments were meant to be completed in 2023, after two years of long-term follow- up on peoplereceiving the vaccination, in order to determine, among other reasons, if there are medium- or long- term side effects. Due to worldwide pandemic data, the FDA gave emergency permission without this stage. Unfortunately, when primary research results became known, the FDA decided to allow Pfizer to vaccinate the research control group as well, significantly damaging the ability to identify future long-term side effects.

 

It is important to note the difference between experimental treatment of an illness and a vaccine whose stages of research have yet to be completed. An individual suffering from an illness who chooses to take an experimental medication is a person in pain and suffering who expresses a willingness to take a certain risk considering that there is the possibility of recovery. A person receiving a vaccine that has yet to be approved is a totally healthy individual, therefore the vaccine should require a higher level of safety in order to avoid the worsening of the patient’s condition, in accordance with the first rule of medicine –first, do not cause damage (Primum, non nocere). This is especially important as the Pfizer vaccination’s promising technology, the mRNA vaccine, is an innovative technology that has yet to be incorporated in a vaccine. These are the first vaccines of their kind in the world permitted for use on human beings, and they comprise a new category of vaccination treatment. Accordingly,many questions still do not have answers – from effectiveness to safety. Moreover, in the past, a number of corona vaccines were rejected due to concern of severe side effects.

It is important to note that the Ministry of Health is an independent body, not subject to the FDA. Thus, for example, the Ministry of Health decided to encourage vaccinations for pregnant women in all stages of pregnancy, despite that many agencies throughout the world are holding back due to a lack of evaluated information from studies on this topic and fear of possible damage to the fetus. Likewise, the Ministry of Health recommended “booster” shots for those recovered from Corona, despitethe fact that this has not been recognized as accepted protocol elsewhere in the world.

We would like to emphasize that despite all of the above – it does not mean that a vaccine given Emergency Authorization Useis not safe. The significance of the above is that, by definition, all of the required safety tests have yet to be completed, and therefore it is not possible to testify to the safety of the vaccine according the accepted and necessary standards required by the FDA for granting approval.