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Pandemic Journal

Dr Robert Hess: Long Covid After Vaccination

Dr Robert HEss

Dr Robert Hess – 03/23/2022

Dr Robert Hess: Long Covid After Vaccination

In rare cases, coronavirus vaccines may cause Long Covid–like symptoms.

As mentioned the symptomatology of this condition can be very similar to the side-effects and possible long-term consequences of vaccination. While preliminary data suggests that getting yourself vaccinated significantly reduces your risk of succumbing to Long Covid, there have also been cases where vaccination has caused Long Covid-like symptoms – and for a lengthy period of time.

 

We always take a balanced view, so that our clients are optimally informed and can weigh up the available information accordingly. There are no official figures, nor have there been any large-scale studies on this phenomenon as yet, but the symptoms, the link to vaccination and the accounts given by those affected are currently being investigated by the National Institute of Health (NIH) and other researchers around the world.

Previous studies have been too limited in scope and have not allowed 100% conclusions to be drawn about whether any of the vaccines have caused some rare form of long-term health problem and, if so, by what mechanism.

Long Covid-like symptoms such as fatigue, brain fog, insomnia, headaches, blood pressure fluctuations and various others are currently being investigated for a possible link to the administration of a COVID-19 vaccine. A number of scientists and research institutes are looking into this matter, among them neuroimmunologist Avindra Nath, clinical director of the Neurological Diseases Institute of the U.S. National Institutes of Health (NIH). In the specialist journal Science, he posited “temporal associations” between vaccination and Long Covid symptoms, but he would not be drawn on whether there was an “etiological association” (i.e. a causative link). Studies conducted by Nath on around 30 case reports have so far remained unpublished, but publication is expected soon.

Much remains unclear about Long Covid, especially the cause of its non-specific symptoms. It is broadly assumed that there is an underlying persistent immune dysregulation, in other words a defective immune response. Some candidates for further research are beta-interferons, immunoglobulins, mini blood clots and autoantibodies.

The Science article also explores the role of autoantibodies – their importance is recognized not only in acute CoV infection, but also in Long Covid. According to recent studies, autoantibodies can be detected up to six months after infection, and as Harald Prüss, a neurologist at the German Center for Neurodegenerative Diseases (DZNE) and at the Charité Hospital in Berlin, writes in an as yet unpublished paper, they are capable of damaging brain tissue.

Experiments on animals have suggested that antibodies targeting the SARS-CoV-2 spike protein – the same protein that many vaccines use to trigger a protective immune response – could cause collateral damage. While searching for antibody therapies for COVID-19 in 2020, Harald Prüss and his colleagues discovered that, of the 18 antibodies they identified with strong efficacy against SARS-CoV-2, four also attacked healthy tissue in mice – an indication that they could trigger autoimmune problems.

Initial clinical data point in a similar direction. Last year, researchers testing people infected with SARS-CoV-2 found unusually high levels of autoantibodies, which can attack the body’s own cells and tissues. In the May 2021 issue of Nature magazine, immunologists Aaron Ring and Akiko Iwasaki and their colleagues at the Yale School of Medicine reported finding autoantibodies in acute COVID-19 patients that were targeting the immune system and brain. They are now investigating how long the autoantibodies persist and the extent to which they can damage tissues. In January of this year, Cedars-Sinai Medical Center cardiologist Susan Cheng and protein chemist Justyna Fert-Bober reported in the Journal of Translational Medicine that autoantibodies can still be present up to six months after infection, although the researchers did not link their persistence to long-term symptoms.

To find out whether such autoantibodies harm humans, scientists at the German Center for Neurodegenerative Diseases (DZNE) are testing cerebrospinal fluid from Long Covid patients for antibodies that react to brain tissue obtained from mice: if there is indeed a reaction, these antibodies could also attack human neural tissue. Prüss and his team have published a paper in which they describe finding autoantibodies in at least one third of these patients, which are capable of attacking mouse neurons and other brain cells.

In August 2021, a group at Northwestern University reported in an advance publication that, in patients with neurological complications after COVID-19, a subset of T cells is persistently activated, similar to how it would be in persistent SARS-CoV-2 infection, suggesting an aberrant immune response or a lingering virus.

Scientists investigating possible side-effects are faced with a dilemma: their work risks stoking opposition to vaccines that currently seem to be “safe and effective” (this statement cannot be made with 100% certainty. After all, we have only been vaccinating for about 2 years and we are therefore rather cautious with these statements). “You have to be very careful about associating COVID-19 vaccines with complications,” Nath cautions. “People can draw the wrong conclusions. The implications are enormous.” Complex and persistent symptoms like those experienced by most sufferers are even more difficult to study, because patients often don’t have a clear diagnosis.

At the same time, understanding these problems could help those who currently suffer from them and, if a link is found, help in the development of the next generation of vaccines, perhaps identifying the ones that pose a high risk of serious adverse events. “We shouldn’t be averse to adverse events,” is how William Murphy, an immunologist at the University of California, sums it up. In November 2021, he suggested in The New England Journal of Medicine that an autoimmune mechanism triggered by the SARS-CoV-2 spike protein could explain not only the Long Covid symptoms but also some rare vaccine side-effects, and he called for more basic research to investigate possible links. He also maintains that it is more important to reassure the public that everything is being done in research to understand vaccines than to just say everything is safe, an assertion that we also endorse.

In the meantime, many affected people feel they have been let down by the health care system. The issue is sadly neglected, poorly defined and also politically sensitive, so family doctors and hospitals have not yet taken any initiatives. Many would like to see a network of specialist outpatient clinics for people with Long Covid and Long Covid-like symptoms, sharing their knowledge and experience.

Long Covid symptomatology after vaccination seems to be rare so far. Nevertheless, this is a topic that needs to remain in focus and be subjected to greater in-depth investigation. Overall, there are still too many unknowns and therefore there are currently no approved and effective therapies on the market. Nevertheless, we are able to take preventive action. We have already adapted our prophylactic measures in this regard, and we will also revise our supplements. We are one step ahead in this regard and we have put together effective options exclusively for our clients.

If you have any questions about Long Covid or specific symptoms, please do not hesitate to contact your consultant. We will continue to monitor this issue closely and to update our knowledge.

 

Pandemic Journal

Dr Robert Hess: FDA approves booster

Dr Robert HEss

Dr Robert Hess – 09/29/2021

Dr Robert Hess: FDA approves booster dose of Pfizer-BioNTech vaccine for the over-65s and for vulnerable categories but not yet for the wider population.

The issue of booster vaccination has risen high on the agenda, and every country is taking a different approach to it. Israel, Austria and Russia are already offering booster jabs to the general population, whereas Belgium, the United Kingdom, Denmark, Finland, France, Ireland, Italy, Spain and Sweden are restricting them to the immunocompromised or elderly. Germany will reach its own national decision in early October, and in the United States, the FDA announced last week that it had approved boosters, albeit on a more restrictive basis than had been expected.

On 22nd September 2021, the FDA issued Emergency Use Authorization (EUA) for the booster dose of Pfizer-BioNTech’s COVID-19 vaccine, but only for certain population groups. The FDA’s decision not to extend the scheme (at least for the moment) to the general population or to all persons aged 16 and older came as a direct rebuff to the announcement from the Biden administration in August that boosters would become available to all eligible Americans starting in late September. It remains to be seen whether this extension of coverage will now happen. At the beginning of last week, the Key Vaccine Advisory Committee voted by a majority of 16-2 against a third vaccination for younger groups of people because of uncertainty as to whether it could be justified in the absence of firm data.

The approval granted by the FDA to the booster vaccination is limited to the following groups of people:

– persons aged 65 years and older;
– persons aged 18 to 64 years for whom who a severe course of the COVID-19 disease poses a significant risk; and
– persons aged 18 to 64 years who are at high risk of severe COVID-19 complications due to occupational exposure to SARS-CoV-2, such as health care workers, teachers etc.

The CDC made known its own booster vaccination recommendation on 23rd September, which is broadly consistent with the terms of approval granted by the FDA. The CDC further recommends that people aged 50-64 years with an underlying health condition should also receive a booster shot of the Pfizer-BioNTech vaccine.

They also advise that, depending on the balance of individual benefit and risk, people aged 18- 49 with an underlying health condition should also receive a booster shot of the Pfizer-BioNTech vaccine. The roll-out of Pfizer-BioNTech booster vaccinations will now begin quite soon in the United States. The single booster jab is to be administered no earlier than six months after completion of the Pfizer-BioNTech primary series (i.e. the first two doses of COVID-19 vaccine). Moreover, the approval of the booster vaccination only applies to the Pfizer-BioNTech vaccine and does not cover the Moderna or J&J alternatives.

The FDA and CDC have thus laid down a guideline, which we will also follow as far as possible. While booster vaccination undoubtedly makes sense for individuals who have passed a certain age threshold or whose physical constitution warrants and/or allows it, different criteria apply to younger age groups. This is the precise reason why we operate on the individuality principle, answering this question on an individual basis for anyone who does not specifically find themselves in one of the above-mentioned groups. If you have any questions or comments, please do not hesitate to contact one of our SARS-CoV-2 Task Force consultants.

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.