But one sentence in particular in the 700-page newspaper warms people’s minds. Biontech writes: “We may not be able to demonstrate sufficient efficacy or safety of our Covid-19 vaccine and / or variant-specific compounds to warrant permanent regulatory approval in the United States, United Kingdom, in the European Union or other countries where the vaccine has been received conditional or emergency marketing authorization. “
Some conclude that even the manufacturer admits that he placed an ineffective and unsafe remedy on the market.
The stock market supervisory authority issues precise rules
But it’s not true. The statement is contained in a “Cautionary Statement Regarding Forward-Looking Statements”. This legal information is prescribed in detail by the stock exchange supervisory authority in order to avoid possible claims by investors.
In the Biontech report, this regulation means that all possible influences on corporate profits and business development must be described. This should allow investors to get an idea of all possible risks.
Potential uncertainties listed include, but are not limited to, competition from other vaccines and their efficacy, cost, shipping and storage options, safety, side effects, and duration of immune response. Company results could also be affected, for example, “by the extent to which a vaccine against Covid-19 will continue to be needed in the future”.
The Biontech Comirnaty vaccine is currently subject to conditional market approval in the European Union. This was first granted in December 2020 and extended for another year to November 2021.
As did Comirnaty in the studies
The European Medicines Agency (EMA) places the same safety requirements on Covid-19 vaccines as on any other vaccine approved in the EU. With conditional approval, data is evaluated as it becomes available, rather than when all surveys are completed.
After a first emergency approval in the United States, the FDA had already granted full approval for the drug in August 2021.
According to the current state of science, Comirnaty is approximately 90% effective against severe Covid 19 disease if infected with the Delta variant. According to the Robert Koch Institute, initial data show that the protection of the omicron mutant is less good.
In a Pfizer-funded study, three doses were 85% effective against omicron hospitalizations within the first three months of vaccination. But it dropped to 55 percent after three months or more. At no time during the pandemic did known researchers claim that a corona vaccination protects 100 percent from Covid-19.