Corona news: Biontech reports vaccine success

The pharmaceutical companies Biontech and Pfizer have presented the results of the phase III study of their corona vaccine. The manufacturers hope for 90 percent protection against the virus.

Finally there is good news in the corona pandemic: The pharmaceutical companies Biontech and Pfizer could apply for approval from the US FDA for their newly developed corona vaccine as soon as next week. To this end, the manufacturers presented the results of the so-called phase III study of their vaccine. According to the preliminary interim results, the vaccination could offer more than 90 percent protection against Covid-19. For this purpose, vaccination should take place in two steps at an interval of three weeks each.

Promising results

The vaccine had been developed under the project name "Lightspeed" (speed of light) since mid-January. In order for a vaccine to be approved, it must be clinically tested in a total of three phases. In the crucial third phase on humans, the vaccine is used on volunteers from representative groups. In total, the vaccine was tested on approximately 43,500 people in the third phase. Half of them were given an ineffective placebo, the other half were given the vaccine. Of all the volunteers, a total of 94 people were infected with corona – most of those affected were in the placebo group. In purely mathematical terms, 86 people in the placebo group would have to have been infected; there should be a maximum of eight cases among the vaccinated people – this would give the estimated effectiveness of 90 percent. The vaccine manufacturers did not communicate the exact number of cases.

WHO recommends an effectiveness rate of 50 percent or more

In a communication, Biontech writes: "The distribution of the COVID-19 cases that occurred between the vaccine group and the placebo group indicated an effectiveness rate of over 90 percent seven days after the second dose." According to the study protocol, the rate achieved is much better than it would have been necessary for the vaccine to be recognized as effective: The World Health Organization (WHO) recommended a maximum of 25 corona infections as a minimum target among the subjects who had been vaccinated. That would correspond to an effectiveness rate of around 50 percent.

Are we now getting the pandemic under control?

In principle, scientists rate the study results as positive. Herd immunity cannot be achieved with the estimated effectiveness rate, but the spread of the pandemic can be slowed down significantly, tweeted virus expert Florian Krammer from the Icahn School of Medicine at Mount Sinai Hospital in the USA. But there are still many unanswered questions. For example, these are only interim results published ahead of time that have not yet been assessed by independent experts. It is also unclear whether the vaccine is just as effective in various population groups, such as high-risk patients, as in the study.

When is a case a case?

Even when the study protocol was published on a voluntary basis by Biontech, there was criticism from some quarters. Because In the study, all people infected with Covid-19 were counted as cases, even if those affected only showed mild symptoms. It is more difficult to make statements about how effectively the vaccine can prevent corona infections with severe disease courses. It is also unclear whether the vaccination prevents a symptom-free infection.

Nevertheless, the outlook is generally positive: In order to question the effectiveness of the vaccine, 70 test persons would have to contract Covid-19 by the end of the study period – and the majority of these persons would have to come from the group of those who were vaccinated. This would mean that the vaccine's effectiveness would fall below the 50 percent recommended by the WHO.

Vaccine soon in Europe too?

If the FDA approves the vaccine, the approval in the USA applies. For approval in Europe, a further approval would first have to be given by the European Medicines Agency (EMA). Experts expect an application for an urgent release, so that the vaccine could perhaps even be approved in Europe this year or at least early 2021.