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Corona research currently: December 10th Oxford-AstraZeneca vaccine - less is more
Update December 14th: In this article, the side effects were added that were not classified as serious counter-reactions by the vaccine manufacturer.
Assistant chance is often the godfather of the greatest scientific knowledge - this experience could possibly also apply to the corona vaccine candidate AZD1222. The team from the University of Oxford and the pharmaceutical company Astra Zeneca has now fully published data from the phase 3 study in the specialist journal The Lancet, which corroborates a surprising result that was announced a few weeks ago in a press release: test participants who received fewer vaccines were apparently better protected against the virus.
One experimental group accidentally received only half the amount of vaccine
A total of 11,636 people participated in the Phase 3 clinical trials. Half of them received a placebo or half the vaccine. There were two study arms, one in Great Britain and one in Brazil. Among the participants in England there was a group of 1,367 vaccinated who, by mistake, received only half of the prescribed dose at the first vaccination. The analysis showed that they were 92 percent protected from Corona, while the effectiveness of the participants from Brazil was only 62 percent. From this, the researchers calculated an overall effectiveness of 70 percent.
This difference poses some puzzles to researchers. Was the higher effectiveness in the participants with half the first dose possibly due to their younger age structure? According to the data, all test subjects were younger than 55 years. The statistical control showed, however, that this is not sufficient to explain the observed effect.
No severe courses of Covid-19 among vaccinated persons
The lead researcher Merryn Voysey from the University of Oxford restricted the study, which has now been published, that it is merely an interim analysis. Only later studies could differences between the various subgroups, such as older and younger participants or belonging to different ethnic groups, explain.
In total, there were 131 Covid 19 diseases among all participants during the experiments. Of these, 30 were vaccinated and 101 were in the placebo group. There were no severe courses in the vaccinated group, but ten in the placebo group had to be treated in hospital and one died as a result of the infection.
A possible serious side effect
When assessing the safety, the researchers can fall back on the data from a total of 23,745 test persons. In addition to those participants in the phase 3 study, there are those from the previous phase 1 and 2 tests. Here there was a serious health problem among those who received the vaccine, which could be related to the vaccination. One participant developed an inflammation of the spinal cord (transverse myelitis). The incident had caused the experiments to stop briefly. There was also another person who had a fever over 40 degrees. However, it is not yet clear whether she belongs to the vaccinated or to the placebo group. However, all have recovered and are still part of the attempts.
Clinical phase 3: 11,636 participants
Clinical phase 1 + 2 + 3: 23,745 participants in England, Brazil and South Africa
Age structure phase 1 to 3
19,588 participants (82 percent): 18 to 55 years.
4,157 people (18 percent): age 55 and over
In phase 3 there were 1,418 people (12 percent) over the age of 55.
Serious health complications
172 of them had no connection with Covid-19 or vaccines
Possible connection with vaccinations 3, of which:
1 in the placebo group,
1 in vaccinated group,
1 not yet clear which group
Update: Moderate counter-reactions (side effects) were already recorded in clinical phases 1 and 2 and in a published in July study shown. Some of these symptoms could be alleviated somewhat with the addition of paracetamol. All reactions occurred within seven days of vaccination.
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