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A proposal to expand the “no-fault damage” model operating in Lithuania it was debated by the Seimas Health Affairs Committee last week. This time Rūta Pumputienė, a lawyer representing COVID-19 vaccine manufacturers, said the changes would increase confidence in the COVID-19 vaccine.
He emphasized that the proposal has nothing to do with the quality and safety of COVID-19 vaccines.
Photo from personal archive / Rūta Pumputienė
“This model does not in any way imply a waiver of any requirement for the manufacturer of the vaccine or the quality or safety of the vaccine. For vaccine manufacturers, all the safety of production, quality and other applicable requirements and the obligations and responsibilities arising from them remain <...>.
The point here is not about the role of producers, much less about reducing or waiving their responsibility, but about facilitating the right of patients to compensation, “said the lawyer.
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Will consider changing the legislation
SAM welcomed the proposal to pay compensation to those who experience rare or serious side effects from COVID-19.
The no-fault model idea is a good one and we support it. This would facilitate the process of compensating for the damage caused by the coronavirus vaccine ”, 15 minutes said Algimantė Ambrulaitytė, a specialist with the Ministry’s press service.
„Reuters“ / „Scanpix“ nuotr./Vakcina nuo COVID-19
It is true that it is not yet clear whether SAM will change the legislation to implement this model.
“Before making such a decision and considering how it might be implemented, we must first carefully assess the legal and financial implications, as well as the impact on patient safety. After the aforementioned evaluations, the decision will be made to prepare a draft of the legal acts on the extension of the “harm-no-fault” model for coronavirus vaccines, ”said A. Ambrulaitytė.
When asked what side effects could occur for those who would be vaccinated with COVID-19, the SAM representative did not elaborate: “Contraindications, adverse reactions will be reported after registration of the vaccine.”
BioNTech and Pfizer vaccine is relatively safe and effective
Audrius Ščeponavičius, director of the SAM Department of Public Health, previously indicated that the first COVID-19 vaccines will arrive in Lithuania in early January and will be BioNTech and Pfizer vaccines.
The decision to purchase this vaccine was made by the outgoing government in mid-November, and its SAM submission listed its advantages and disadvantages.
Advantage:
- Pfizer was the first among other vaccine manufacturers to publish interim data on the effectiveness of the vaccine in a phase 3 clinical trial involving 43,538 participants (44,000 planned). The vaccine is reported to be 90% effective;
- The vaccine is likely to be relatively safe because the components of the vaccine (mRNA and lipids) break down (break down) within a few days. The manufacturer claims that there is no risk of insertions, mutagenesis;
- In a preclinical study, studies were conducted in 6 monkeys that showed that virus replication stopped after 3 days and no virus was detected in the lungs.
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Disadvantages:
- little data on antibody response. The level of neutralizing antibodies is relatively low compared to the blood plasma of relapsed individuals;
- The possible long-term effects of mRNA on autoimmune inflammatory processes are unknown;
- the efficacy of the vaccine may be reduced due to mutations in the S protein of the SARS-CoV-2 virus;
- kol kas (until November 16 – 15min) no data are available on the efficacy of the vaccine in risk groups, that is, those over 65 years of age. and people with strange diseases;
- a new type of vaccine platform that is not yet used in medicine or veterinary medicine;
- Unstable mRNA molecule: requires deep freezing (-75 ° C (+/- 15 ° C)), difficult to transport the vaccine on dry ice.
Side effects range from headaches to allergies.
On December 11, BioNTech and Pfizer’s COVID-19 vaccine was approved by the US Food and Drug Administration (FDA) and introduced to US citizens. For the vaccine to be effective, the population will be vaccinated twice with a three-week break.
It is not yet clear how long the immune response will develop after vaccination. posted on the FDA website.
Mild side effects can occur after vaccination with BioNTech and Pfizer:
- pain at the injection site;
- fatigue;
- headache;
- Muscle pain;
- joint pain;
- cold;
- fever;
- swelling or redness at the injection site;
- nausea;
- Feel bad;
- swollen lymph nodes.
Dispel the myth that COVID-19 will not be injected
It is unlikely, but BioNTech and Pfizer could cause a serious allergic reaction, according to the FDA. Such allergies can occur within an hour after vaccination. If this happens, it is recommended that you consult a doctor.
Signs of allergy:
- difficult to breathe;
- swollen face and throat;
- faster heart beat;
- shakes the whole body;
- dizzy, weak.
“These may not be all the possible side effects of the BioNTech and Pfizer vaccine,” the FDA warns, adding that the vaccine is still being tested.
The FDA emphasizes that the coronavirus is not an integral part of the BioNTech and Pfizer vaccine, that is, the vaccines cannot cause COVID-19 infection.
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