Display MoreNorway System of Patient Injury Compensation Authorizes First COVID-19 Vaccine Damages Claims
https://trialsitenews.com/norw…9-vaccine-damages-claims/
The Scandinavian nation of Norway has a special compensation program associated with the nationwide COVID-19 mass vaccination program. Known as the Norwegian System of Patient Injury Compensation (NPE) this organization has identified three cases approved for compensation due to serious adverse events or death. Involving two female health care workers and a male—all in their 30s—two of the individuals have long lasting adverse events while one of the women died. A total of 77 people in Norway have made claims that are now under consideration by the NPE for compensation. A majority of the incidents are associated with the AstraZeneca vaccine, originally developed at University of Oxford and known as ChAdOx1 nCoV-19. Much hope was associated with this vaccine as it’s properties and price point has made it easier to distribute around the world, especially to low-and-middle-income countries (LMICs). The investigational vaccine candidate ran into delays during clinical trials due to adverse events and in fact the studies in the United States never led to emergency use authorization (EUA). The use of this vaccine in several Northern European countries, including those in Scandinavia were put on hold due to some reported safety incidents. Other incidents here involved the mRNA-based vaccines from Pfizer-BioNTech (BNT162b2) and Moderna (mRNA-1273).
TrialSite provides a brief breakdown of this situation for the global community. The NPE reminded the reader that that nation had halted the national vaccination program’s use of the AstraZeneca vaccine due to a number of serious adverse events.
The Most Common COVID-19 Vaccine Side Effects
The NPE reports that the most common side effects associated with the COVID-19 vaccines include dizziness, fatigue, headache, and pain. But others reported bleeding stomach ulcers, cramps, rashes, spasms, paralysis, anaphylactic reaction, blood clots and decreased platelet count.
NPE reminds us that all vaccines carry some risk, some more than others. In the overwhelming number of cases most side effects associated with COVID-19 vaccines are mild and dissipate shortly. These majority cases are precluded from the NPE compensation program.
Norwegian Assessment
Importantly assessments of COVID-19 vaccine safety such as this effort out of Norway isn’t covered by mainstream press, considered an off subject matter as it’s perceived any negative news can impact vaccination programs. The COVID-19 vaccines are still experimental as they are making their way through the regulatory approval process in various countries. They are for the most part safe and effective but there have been incidents given the total volumes associated with mass vaccination.
Transparency and full disclosure are vital for not only adhering to ethics and legal principles, but also as a matter of empowerment for healthcare consumers to fully understand the risks and benefits associated with specific COVID-19-related products.
Norway’s NPE went on the record on Friday August 6 that the AstraZeneca vaccine triggered a series of “Serious side effects” at least in some recipients. An advanced economy with sophisticated health system, Norway investigated the matters thoroughly, involving one of the nation’s top academic medical centers called Oslo University Hospital Rikshospitalet (Rikshospitalet). Specifically Rikshospitalet conducted sophisticated analyses into the special immune reactions observed in association with the AstraZeneca vaccinations. Due to these findings NPE’s director Rolf Gunnar Jørstad, went on the record that the organization would “uphold the applicants” moving on now to calculating the damages for compensation. That is the reimbursement for the financial loss and damage associated with the events. For deaths the NPE compensates as well for funerals and loss of income.
The First Claimants’ Experience
A couple of female health workers were hospitalized back in March immediately after vaccination with severe blood clots and reduced platelet counts. One of these women died a few weeks after the incident while a man still battles with major side effects associated with the vaccine. The male declared “I was admitted with great pains. It was frightening to follow the news about others who had just died from the same vaccine I had received.”
The surviving women declared “I had a severe cerebral hemorrhage and a blood clot. At the hospital, I received many calls from friends and family wondering if I was still alive.”
All three of the claimants were in their 30s. The two surviving claimants still cannot work. Thus the first three claimants, two survivors and the relatives of the deceased woman will receive compensation for vaccine injuries.
77 Claimants
The NPE reported that the government organization has received 77 applications for compensation for COVID-19 vaccine-related adverse effects. 53 of the 77 received the AstraZeneca vaccine, eleven received the Pfizer-BioNTech vaccine known as BNT162b2 and six received Moderna’s mRNA-1273. NPE declares there are still seven cases where it’s unclear which vaccine was used.
Eight of these Norwegian individuals died from the jabs. The deaths can be broken down to four deceased from the AstraZeneca vaccine, one from mRNA-1273 and two from BNT162b2 with two unresolved deaths—that is, it’s not known for certain which vaccine is associated with the event.
According to NPE’s director Jørstad the organization has confirmed absolute causality with one of the eight deaths and now are probing for causation with the other seven deaths.
Norway COVID-19 & Vaccination Updates
Norway experienced a few waves during the COVID-19 pandemic, now entering what is its fourth wave. The Nordic nation of about 5.5 million inhabitants has recorded approximately 140,466 total SARS-CoV-2 cases with 804 deaths. Most recently the Delta variant triggered this present wave, starting in late July and into August the average number of daily cases, based on the seven-day mean, has gone up to 406 new cases per day. Few deaths have occurred since the spring but they do occur from time to time.
About 35.5% of Norway’s population is fully vaccinated while nearly 70% of the population has received at least one jab.
Since earlier this summer breakthrough cases, that is fully vaccinated people getting infected with SARS-CoV-2 has become more common. One prominent early breakthrough cluster of cases was reported on in early July when 450 fully vaccinated people were infected with the coronavirus. According to local public health research here, such as Norwegian Institute of Public Health chief physician Sara Viksmoen Watle, such incidents still represent low probability events. While others there emphasize that at least one in ten of the vaccinated will fall to infection. The good news: few infections progress to serious levels. But disease progression does happen in the vaccinated. Out of the 450 breakthrough cases reported, 21 of the infected were hospitalized. In those cases it most often involves the elderly, that is those over 75.
I love the way TSN misdirects its readership through omission and damning with faint praise. I actually find the TSN editorial slant here DDD (despicable, deceitful and dangerous). So even though 50% of the content in that article I like, overall it is not a helpful contribution.
In this case what it omits is that the Norwegian system, like many, is a no-fault compensation system. In other wards, if something bad happens to you that might possibly be due to some medical treatment, you do not seek to establish whether this is really true, but pay up anyway. out of insurance money provided by govt or industry.
I think these are great schemes:
- avoids feeding lawyers
- compensates people for tragic no fault of their own losses
- keeps legal battles out of medicine
Anyway there is extra reason to want such schemes for COVID vaccination:
No-fault compensation schemes for severe adverse events can help build confidence in vaccine safety after marketing.1
25 of the 194 WHO member states have implemented such no-fault vaccine injury compensation programmes.2
Although the USA is covering COVID-19 vaccine-associated adverse events with the US Countermeasures Injury Compensation Program (CICP) for the duration of the public health emergency declaration, the country is having challenging issues as CICP does not have the ease of access to, and levels of compensation provided by the US National Vaccine Injury Compensation Program available at normal times, exacerbating long-standing inequities based on income, race, and ethnicity.3
Japan has a long-established no-fault compensation scheme for people who have adverse drug reactions from vaccines or drugs. The vaccine health damage relief system (a no-fault compensation scheme authorised by the Immunisation Act of 1976 is managed by the Japanese Ministry of Health, Labour and Welfare (MHLW) and prefectural governments.4
Between February, 1977, and December, 2019, 3419 people were certified by the MHLW.5
In fiscal year 2019, the MHLW received 134 health damage relief claims of which 88 were certified; the annual MHLW budget for these claims in 2019 was US$10·8 million.5
Japan is unique in that it has a no-fault compensation scheme for drugs financed mainly by contribution from pharmaceutical companies. France, Germany, New Zealand, Taiwan, Denmark, Norway, Sweden, and Finland have similar systems.6
In Japan, the scheme for drugs was introduced in 1979 and is authorised by the Pharmaceuticals and Medical Devices Agency (PMDA).7
In fiscal year 2019, the PMDA received 1590 relief claims, 1285 of which were certified, and US$22·6 million was paid within the same fiscal year.8
The COVID-19 pandemic presents an opportunity not only for vaccines, but also for covering drugs under no-fault compensation schemes.