Drama about the effect of the well-known corona vaccine – VG



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STUDY: A volunteer receives the corona vaccine candidate from AstraZeneca and the University of Oxford. Photo: John Cairns / University of Oxford

By mistake, many of the study participants received half a dose in the first vaccine. The question now is whether the vaccine has been adequately tested in the elderly.

It was recently revealed that parts of the AstraZeneca candidate vaccine trial were conducted by giving participants half doses in the first part of vaccination. This part was also not performed in the elderly, who are more vulnerable to the coronavirus.

So questions are now being asked about whether the vaccine is up to 90 percent effective, as the company announced earlier this fall, writes the New York Times.

The average degree of protection is 70 percent, but AstraZeneca has stated that it has been shown to be 90 percent effective in cases where people were vaccinated first with a half dose and then with a full dose. In cases where subjects received two full doses, the degree of protection was 62 percent.

– A useful bug

The candidate vaccine is a collaboration between the Swedish company AstraZeneca and the University of Oxford. More than 20,000 volunteers participated in the study; half in the UK, half in Brazil.

Here’s how the candidate vaccine works:

Vice President Mene Pangalos admits that it was not the intention for the participants to partially receive half a dose, but that the results are still promising.

– Actually, this can end as a useful mistake, he says.

The US health authorities have stated that this part of the trial was only administered to participants under 55 years of age.

Probably a new global study

Now the company will likely conduct a new global test round that includes the half-dose method. The new round of testing was announced Thursday.

– It is clear that it generates some uncertainty about the degree of protection and therefore it seems sensible to extend the trial to obtain more reliable data. With regard to all the candidates we are considering using in Norway, we want there to be reliable and robust results from clinical trials, Medical Director Steinar Madsen of the Norwegian Medicines Agency tells VG.

– Does it weaken your confidence in the efficacy of the vaccine?

– No, I can’t say that now. There will be a dialogue between AstraZeneca and the European Medicines Agency as soon as possible. Obviously there will be a discussion here and the situation needs to be clarified. This vaccine is already being considered in Europe, so all relevant data will be sent to the Medicines Agency.

Area Director Geir Bukholm at the National Institute of Public Health still believes that evaluations of the study data will be possible.

– Are you afraid you don’t have a good enough decision base about Astrazeneca? What is not a good enough basis to really evaluate the effect?

– No, I don’t mean that. I think when Astrazeneca presents its results and protocols, there will be good data there. There is no reason to believe otherwise.

– What are the protocols?

– The protocols are how the vaccinated are monitored. They have a very complete description of how they do it, for each individual person like ours the real vaccine or the placebo. There are detailed protocols that will provide information on the efficacy and side effects of vaccines.

Competitors

Previously, both Moderna and the group Pfizer and BioNtech have confirmed that their vaccines are about 95 percent effective against the virus.

However, the Oxford vaccine is much cheaper, easier to store and therefore also easier to distribute around the world. It should probably be stored cold, but not in freezing temperatures like the RNA vaccines from, among others, Pfizer and CureVac.

The approval process for the vaccine in the EU is underway. The European Medicines Agency (EMA) accepts applications for vaccines on behalf of all EU / EEA countries.

Before the EMA approves a vaccine, neither Norway nor the other EU countries receive doses.

The EU alliance, of which Norway is a member, has reserved 300 million doses, with the possibility of expanding by 100 million. The COVAX global alliance is also focused on this vaccine. The United States has ordered at least 300 million doses.

This is also one of the vaccines the UK is targeting.

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