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Corona in an endless cycle? New vaccination recommendations for accelerated approval vaccines

Eleanor Pearce by Eleanor Pearce
September 7, 2023
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Corona in an endless cycle?  New vaccination recommendations for accelerated approval vaccines
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Autumn is coming and corona mania seems to be back in vogue. While there are already calls to roll back the mask requirement, the ÖBB has put out a tender to operate new Covid testing lines by the end of 2025 (Report 24). But that’s not all, because Austrians are now also getting a new vaccination recommendation and a vaccine adapted to the currently prevalent corona variant, which was passed through the accelerated approval process. Heart, what else do you want…

A guest article by Justin Tiffnig

The National Immunization Board (NIG) will make changes to the corona vaccination recommendation from autumn, as seen in a release from the Federal Ministry of Social Affairs, Health, Care and Consumer Protection (BMSGPK). Till now, depending on the vaccine, basic vaccination required up to three doses of vaccination. From autumn onwards, one corona vaccination should be sufficient for basic vaccination. This means that previously unvaccinated people will be considered adequately protected in the future with just one vaccination using an adapted variant vaccine.

It is based on assessments by the EU health authority ECDC. This assumes that practically everyone has had contact with corona in the last three years – either through vaccination or through infection. It seems as if the human immune system has been rediscovered in the mainstream.

NIG’s current vaccination recommendations are as follows: People aged 12 years and older are recommended to receive the new type of vaccine in the autumn. This recommendation applies specifically to people 60 years of age and older, who are at increased risk of developing severe disease, and medical health workers. Vaccination is necessary from the age of 6 months.on individual request” possible.

Vaccine approved under expedited process

BioNTech/Pfizer’s Corminati vaccine, compatible with the Omicron line.2023, has been approved. In Austria, the adapted vaccine from BioNTech is expected to arrive this week and should be available in all federal states next week.

The adapted vaccine was approved in the accelerated approval processAs can be seen from the EU Commission press release:

,The approval has been granted after a rigorous assessment by the European Medicines Agency under the Accelerated Assessment Mechanism. The Commission granted authorization for this adapted vaccine using an accelerated procedure to allow Member States to prepare in good time for their autumn/winter vaccination campaigns.,

Produce for the trash?

Family doctors are currently complaining that BioNTech’s adapted vaccine is not given in single doses, but in six-dose bottles. These have to be applied immediately so that the vaccine does not lose its effectiveness. ,If every time BioNTech vaccination is necessary we will again be caught in organizational redundancy, we will either quickly conduct five more vaccinations, postpone vaccination or Five doses of the vaccine will have to be thrown away”, says Nicola Bühlinger-Gopfarth, Deputy Federal President of the Association of German General Practitioners. BioNTech announced that preparations are underway to make available personalized doses of the optimized vaccine.

Not only has BioNTech tried an adapted vaccine, but Moderna has already submitted an application for approval of a vaccine adapted to version XBB.1.5. However, EU approval is still pending.

The question arises what will happen to the old vaccine dose. If this was not already the case due to the expiry date, with the market launch of the adapted vaccine they have now probably become a matter of dustbin.

In addition, the effectiveness and safety have not been questioned

The establishment’s enthusiasm for vaccines that haven’t been adequately researched remains intact:

,The following still applies: Vaccination is the best protection. Before serious illnesses and long Covid!For example, Health Minister Johannes Rauch continues to be enthusiastic about vaccination.

For the EU Commission, the adapted vaccine is “Another important milestone in the fight against the disease,

Regarding the approval of the adapted vaccine, an EMA release dated August 30, 2023 stated:

,Since the first authorization from the Cominnati, officials have gained a great deal of knowledge about the safety of the vaccine. Side effects are generally mild and short-lived. These include headache, diarrhea, joint and muscle pain, fatigue, chills, fever, and pain or swelling at the injection site. More serious side effects may occur rarely.,
Translated: “Since Comirnaty was first approved, officials have received extensive information about the vaccine’s safety. Side effects are usually mild and short-lived. These include headache, diarrhea, joint and muscle pain, fatigue, chills, fever, and pain or swelling at the injection site. In rare cases, more serious side effects may occur.,

A look at the number of reports of suspected side effects of COVID-19 injections recorded in the Eudravigilance database run by the EMA shows that the EMA has an understanding of the term “rare” that is probably different from the average person. Different: A total of 1,251,007 cases of side effects with the BioNTech vaccine have been reported since records began. Of these, 1,020,264 were related to side effects generally considered “serious”., These are divided as follows:

  • Deaths: 14,141
  • Fatalities: 20,104
  • Hospitalization: 95,482
  • BehindRand: 41.980
  • Birth Defect: 324
  • Critical cases: 361,853
  • Serious side effects: 486,380

Given the high levels of under-reporting of side effects typical of such reporting systems and the questionable effectiveness of marketed preparations, the question arises how the often claimed “positive benefit-risk ratio” can be quantified.

“Then Corona will start again”

Regarding the adapted vaccine, it should be noted that the vaccine in question was adapted to the Omicron subvariant XBB.1.5, to which the currently dominant corona variant “Eris” also belongs. BioNTech says: “The evaluation is based on preclinical data showing that the Omicron XBB.1.5 optimized monovalent COVID-19 vaccine generates an enhanced immune response against various XBB-related sublineages, including XBB.1.5, XBB.1.16, 5.1 (Eris), is still the dominant variant worldwide.,

At the same time, there is news that a new variant “BA.2.86” has emerged, which is said to be quite different from the Omicron variant. According to Frankfurt virologist Martin Stuermer, there is currently no evidence that the BA.2.86 variant can become dominant. But should this happen at some point – for example as soon as sufficient doses of the adapted vaccine become available? – It can logically be concluded that the adapted vaccine and the adapted vaccination recommendation, which refer to the same vaccine, no longer apply.

Virologist Stryker commented on this to Handelsblatt: “B.A. 2.86 Omicron is as different from Omicron as Omicron is from Delta – and thus can weaken existing immunity. Then Corona will start again.,

Tags: acceleratedapprovalCoronacycleendlessrecommendationsvaccinationvaccines
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