Infections continue to peak, but a corona vaccine still has to be waited for. After the pause of the Oxford vaccine trials last month, this is now the case with the vaccine developed in Leiden. Johnson & Johnson. In the United Kingdom, researchers are looking at the possibilities of Challenge Studies, a way to test vaccines even faster.
Human Challenge Studies in the United Kingdom
Imperial College London works together with the Department for Business, Energy and Industrial Strategy (BEIS) and the Royal Free London NHS Foundation Trust to the project: Human Challenge Studies.
Researchers of the project will deliberately infect people with the virus that causes corona to be able to test vaccines more quickly. The so-called Human Challenge Studies would be carried out with volunteers between the ages of 18 and 30 without health problems.
The project is currently in the first phase. In this phase it is investigated which amount of the virus is minimally needed to make someone sick. According to the researchers, it is not certain whether someone is exposed to the virus in standard clinical tests. These studies would quickly reveal whether people who have been vaccinated actually become less infected with the virus.
Imperial College London expects to start the trials in January 2021. The first results would then be in in May.
There is a lot of controversy surrounding this method of testing. When the vaccines that are tested are not effective (enough), subjects are infected. This can be dangerous even for young people in optimal health.
Tuberculosis vaccine
A national study with 22 hospitals in the Netherlands investigates the effect of the vaccine against tuberculosis on the corona virus. The BCG vaccine is given to people traveling to a country where these infectious diseases are common.
Study participants will be followed for six months after vaccination. It is examined in how many participants corona infection and how often respiratory infections, including corona, should be treated. The first results are expected at the end of this year.
Chinese Sinopharm vaccin
The vaccine from the Chinese state pharmaceutical company Sinopharm will hit the market in a few weeks, according to the company. The vaccine is in the final testing phase. At the end of this year, more than 600 million doses of the vaccine will be available. However, the European Union has not concluded any deals with this pharmaceutical.
The chance that vaccines developed in China will be used in the Netherlands is very small. Vaccines must meet the requirements of the European Medicines Agency (EMA). Chinese pharmaceutical companies have not yet submitted an application for approval to the EMA.
Janssen and Johnson & Johnson (J&J) vaccine
On October 4, J&J published interim data from the Phase 1-2 study involving 796 test persons. The interim results show that one dose stimulated antibody making in almost all participants.
A large proportion of the volunteers suffered from side effects such as: muscle pain, fatigue and fever. This concerns 61 percent of the subjects between 18 and 65 years. Participants over the age of 65 were less likely to suffer from side effects, only 31 percent of them experienced these complaints.
Of concern are the two cases in which participants experienced severe side effects from the vaccine. They developed a high fever and high blood pressure.
On October 12, J&J paused clinical studies worldwide. One of the participants in the study developed an unexplained illness. Despite the pause in the trials, the production of the vaccines continues, also in Leiden.
Oxford vaccine from AstraZeneca
At the end of September, the European Union came out AstraZeneca, the drug manufacturer behind the Oxford vaccine, will protect against potential lawsuits. These are lawsuits that are brought because the vaccine still causes side effects. This protection is of great importance to the company. In the phase 3 testing, the company will not notice a very rare side effect. These are side effects that, for example, only occur in 1 in 100,000 people.
A threshold has been agreed to where AstraZeneca pays legal costs itself. The EU grants this protection because the vaccine is so cheap. With other vaccines such as the J&J vaccine, the EU offers no legal protection.
The vaccine will cost only $ 4 per dose, according to US data, which is about $ 3.40. For example, the J&J vaccine costs $ 10, more than twice as much as the AstraZeneca vaccine.
Modern
On September 29 Modern published the results of the phase 1 study. This was a study with 40 participants with volunteers over 56 years old. The vaccine had elicited a good immune response. The side effects were comparable to a high dose of the flu vaccine. These are side effects such as headache and increase.
Moderna has run into the problem of not being able to find enough ethnic minority subjects. This concerns, for example, Native American groups. If the tests cannot be performed on this group, Moderna cannot guarantee safety for these ethnicities. The focus of the search for test persons is currently with these minorities.
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