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Pandemic Journal

Dr Robert Hess: FDA grants full approval to the Pfizer

Dr Robert HEss

Dr Robert Hess – 08/25/2021

Dr Robert Hess: FDA grants full approval to the Pfizer/BioNTech COVID-19 vaccine – What exactly does full FDA approval of a vaccine mean?

The Pfizer/BioNTech COVID-19 vaccine first received Emergency Use Authorization (EUA) from the U.S. authorities in mid-December 2020 for administration to persons aged 16 and older. On Monday, the FDA announced that it has now granted full approval. The vaccine has thus become the first to receive FDA approval for use against coronavirus. More are expected to follow in the coming weeks and months. Emergency Use Authorization continues to apply for use on adolescents aged 12 to 15 years and for administration as a third booster dose to immunocompromised individuals. Further monitoring of the vaccine’s safety and efficacy remains mandatory, even after approval, and will be carried out assiduously.

 

How does full authorization differ from the previous EUA (Emergency Use Authorization)?

For both emergency and full approval of COVID-19 vaccines, the FDA first requires data from Phase 1 trials to determine their safety, as well as possible side-effects and the most effective dosing regimen. Once this is successfully completed, the vaccine is tested for efficacy in a more extensive Phase 2 clinical trial conducted in a controlled setting. It should be mentioned that the number of volunteers in the first COVID-19 safety trials was similar to the number participating in trials for other commonly used vaccines, such as tetanus, diphtheria, whooping cough and meningitis. The difference in the approval procedures lies primarily in the length of time the volunteers remain under surveillance. For emergency approval to be granted, the FDA requires that at least half of the participants in the original trials be followed for at least two months after vaccination, whereas for full FDA approval, participants in the original trials must be followed for at least six months. The vaccine manufacturer is also required to submit more detailed production plans and procedures and to commit to a higher level of monitoring and inspections.

 

How do vaccine approval procedures in the USA differ from those that apply in Europe?

Unlike the FDA, the European Medicines Agency (EMA) has approved the current crop of coronavirus vaccines within the framework of a conditional EU marketing authorization. This has the advantage over emergency marketing authorization that pharmacovigilance (i.e. drug safety), manufacturer controls and other post-authorization obligations are legally binding and subject to ongoing assessment by the EMA’s scientific committees. At the same time, it allows vaccine developers to submit additional data, even after the marketing authorization has been granted (in contrast to a normal marketing authorization, where all data are submitted before the marketing authorization is granted). In addition, the marketing authorization holder is responsible for the product and its safe use. This is in contrast to the emergency marketing authorization under EU law, whereby the marketing authorization holder is exempt from administrative and civil liability. The vaccine developers Pfizer/BioNTech are therefore fully liable.

 

How does full FDA vaccine approval differ from other earlier vaccine approvals?

To speed up the process of full vaccine approval, the FDA has adopted a number of different approaches. These include the Priority Review and Fast Track processes, both of which were used in the case of the approval granted to the Pfizer/BioNTech COVID-19 vaccine. The Priority Review designation signifies that the FDA aims to make a decision on an application within six months, compared to the ten-month period that applies with the Standard Review. However, the scientific/medical standards for approval and for the quality of the evidence required remain unchanged. The Fast Track process is intended to speed up the development and testing of medicines and/or vaccines and to make them available to patients sooner. Fast Track status allows companies to submit parts of their authorization application to the FDA for review as soon as these are completed. There is a further expectation that communication between vaccine manufacturers and the FDA will be intensified and a continuous exchange of information will take place.

 

According to the FDA, the differences between the approval of a COVID-19 vaccine and earlier vaccines lie in the speed of the process and the number of staff deployed. It cannot be ruled out, however, that this acceleration of the process will leave the quality uncompromised, especially with regard to the shortened observation period and the consequent lack of data. We will therefore continue to closely observe the current procedure and any further developments and to keep our Premium clients informed.

Pandemic Journal

Dr Robert Hess: Any decision on whether to receive a booster jab

Dr Robert HEss

Dr Robert Hess – 08/17/2021

Dr Robert Hess: Any decision on whether to receive a booster jab (and which one to choose) or to wait for a next-generation vaccine should be based on the following criteria.

1 – Which is preferable – a booster jab or a next-generation vaccine? This depends on a number of factors, primarily which next-generation vaccine becomes available and when. It should be noted that the latest vaccine under development at BioNTech has been formulated exclusively to counter the threat of the Delta variant. We therefore need to carefully monitor how the virus continues to mutate, because the successor to Delta is already on the way. It may even turn out that, by the time the next-generation vaccine is ready for rollout, the current Delta variant is no longer relevant. At this point in time, BioNTech is the only manufacturer to have not only developed a next-generation vaccine but also to have produced an initial batch. However, it has not yet received official approval. Whether and when this is granted by the FDA will not be based on medical criteria, but on political considerations, namely how to persuade the public to receive the 700 million or so doses of the current vaccine if it became common knowledge that the BioNTech next-generation vaccine had already been approved.

2 – When is the moment to act? Before any action is taken, the individual status of each client has to be considered carefully. The three decisive criteria here are the most recent antibody count, the level of T-cell immunity and the general immune response. These reference values are then run through an algorithm by our AI system to determine the optimal timing of any further vaccination. The decisive factor is, of course, the general immune response and whether it is strong enough and operates with pinpoint accuracy in the event of an infection. This is precisely the purpose of our ongoing monitoring. And it is a good reason to keep taking the recommended supplements very regularly, even into the autumn.

3 – What would a sensible vaccination strategy look like? All three of the above criteria should be considered. For example, if T-cell immunity is weak and the first vaccination was with an mRNA-based vaccine, it would make sense to adopt a mix-and-match approach and switch to one of the vector-based vaccines, because these are better at improving T-cell immunity. The problem for our clients in the USA is that the only vector-based vaccine currently approved there is the Johnson & Johnson, and unfortunately, we are not convinced by the version currently available.

4– What else needs to be considered in deciding on further vaccination? A further criterion in taking the next step is the natural limit on the number of doses the human body can cope with in a given period. The underlying problem is that every vaccine, especially those developed to combat SARS-CoV-2, overstimulates the immune response, thereby triggering autoimmune reactions. We are of the opinion that no-one should receive more than 2-3 doses per year of the vaccines so far developed. Assuming that the pandemic will continue for a very long time, it is important to consider exactly when to vaccinate and which vaccine to choose in order to derive the greatest possible benefit. This way, the risk can be avoided of vaccinating too many times in a limited period of time, thereby putting a strain on autoimmune capacity and prompting autoimmune diseases in the future. After a finite number of vaccinations in a set period of time, of course, the autoimmune capacity has increased to such an extent that, at some point, the benefit has to be weighed against the cost. In other words, the harm done is greater than the risk of damage from Long Covid. That is why we have to be cautious about the number of vaccinations we subject ourselves to within a certain period of time.

5 – What are the potential advantages of a booster jab? If your next vaccination is to be a booster jab rather than a next-generation vaccine, then it must be taken into account that the current vaccines from Moderna and BioNTech are both approximately 30‑35% effective in preventing infection by the Delta variant, i.e. a relatively low rate of efficacy. On the other hand, our internal research and our contacts with BioNTech suggest that a third dose of their vaccine boosts antibody levels by a factor of four. In these circumstances, even a 30% success rate is a strong argument in favor.

Over the next few weeks, we will be checking these criteria as they apply to each of our Premium clients, using all available data. At the same time, we will set our A.I. system to calculate the optimum choice and timing on an individual basis. We will then contact you directly. If you have any questions in the meantime, please contact your consultant.

Pandemic Journal

CureVac were our great hope

Dr Robert HEss

Dr Robert Hess – 06/23/2021

CureVac was the great hope of Dr Robert Hess. They reached for the stars – and came back down with a bump.

Though the news was not entirely unexpected, we regret to report that the breakthrough vaccine promised by CureVac will now not be forthcoming. There are a number of reasons for this, but the main factor was the high demands that CureVac itself placed on the product. The aim was to develop a vaccine that was as natural as possible – ideally the most natural vaccine to date. In the end, it was the much-debated issue of vaccine-induced side-effects and long-term effects that thwarted their endeavor.

CureVac planned to optimize the “cell packaging” required for transport; this was to avoid having to make chemical changes to the product, as has been the case with vaccines from other manufacturers, in order to increase its tolerability. To fulfill this requirement, CureVac developed a highly natural mRNA-based vaccine. It was a risky strategy and one that ultimately failed, because the chemical-free packaging resulted in greater side-effects. This meant they had to limit the injection dose to 12 micrograms, which reduced the efficacy to just below 50%. By comparison, BioNTech sets its injection dose at 30 micrograms, while the Moderna is more than three times higher at 100.

CureVac also had the ambition to not only produce the most natural vaccine, but also to create one that would be effective against the mutations currently in circulation. With this objective in mind, the clinical phase 3 was delayed in order to include mutation events in the development stage of the product. In comparison to the three market leaders – Moderna, BioNTech and AstraZeneca – who tested only the original Wuhan wild type in their phase 3 trials, CureVac included all subsequent known mutations.

Unfortunately, this set the bar too high. CureVac even attempted to incorporate A.I. (artificial intelligence) into the prediction and detection of future mutations early on and to adapt their product to its findings. Essentially, the project failed because of the as yet insurmountable challenge of developing a natural vaccine that also covers current and even future mutations.

All in all, this is very disappointing news in the context of the pandemic, as governments and health bodies are counting on these next-generation vaccines to deal with future mutations by means of A.I. modeling. In this way, scientists would be able to get ahead of the game and anticipate viral mutations before they manifest themselves. As we have stated in previous Keynotes, we see technology as our only hope of bringing the pandemic under control.

There are other projects going down the same route as CureVac, for example the one at the University of Austin in Texas, but this announcement is still bad news for pandemic management.