AstraZeneca has contested accusations that the Covid-19 vaccine was “defective”, after a vaccine patient sued for damages, claiming to have suffered a severe side-effect.
The Anglo-Swedish pharmaceutical company, which developed the vaccination with the University of Oxford has filed its defense in a lawsuit brought by Jamie Scott. Scott claimed that he had suffered from a severe and rare type of blood clot after taking the vaccine.
This lawsuit will be closely monitored in case more vaccine recipients file suits. Any damages that are found to be liable would be covered under a UK government scheme for vaccine damage payments.
AstraZeneca has said that the case of the defendant, claiming the vaccine is defective, was “confused”, and “wrong under law”.
The drugmaker stated in the defence that the benefit/risk ratio of the vaccine was positive and remains so. It also noted that the UK medicines regulator has approved the shot and continues to do so.
As the vaccine was being rolled out, in early 2021, concerns about the rare and serious side effect of blood clotting emerged. AstraZeneca revised the label on April 7th and April 15th to warn patients of this concern.
AstraZeneca stated in the filing that there was “reasonable probability” that the vaccine could trigger the side effects, but the exact mechanism was unknown.
Scott was vaccinated on the 23rd of April after warnings. Ten days after the vaccination, Scott began to experience headaches, nausea, and a loss of speech.
In the original filing of his lawyers, they stated that he was left with “very serious injuries, including speech difficulties, diminished cognition, memory, and processing”. It said that he had undergone multiple surgeries and was on extensive medication.
The company stated that Scott, who was 44 years old at the time he received the vaccine, was still in the age group where the vaccine was recommended by the UK even after the updated guidance told people under 30 and those between 30 and39 not at high-risk of Covid-19 to consider other vaccines.
Scott’s attorneys also questioned the effectiveness of AstraZeneca’s vaccine in preventing Covid-19. They cited a reduction in absolute risk of 1,2%. The absolute risk of getting a coronavirus varies depending on how much virus is circulating.
AstraZeneca reported relative risk in accordance with clinical trial norms. This compares the number people who received Covid-19 and the number who were in the placebo group. This resulted in a reported efficacy of 70 percent.
AstraZeneca stated in its filing that the absolute risk reduction wasn’t included in the press releases because it differed depending on the time of the trial and the risk level of the individual. It said that absolute risk reduction data were difficult to interpret and confusing. They also weren’t a good indication of efficacy when taken in isolation.