Verification of the facts of the annual report
Biontech does not doubt the effectiveness of the vaccine
Biontech’s annual report for the US Securities and Exchange Commission says the Mainz-based company doubts the safety and security of its crown agent. But is it really so?
Biontech’s vaccine has been used around the world against the corona virus for nearly a year and a half. It offers protection to millions of people against serious Covid diseases. Although many international studies have already shown this, opponents of vaccination continue to lash out against the drug. With reference to a Biontech document from the US, the manufacturer was recently accused of not being convinced of its vaccine at all.
Claim: “Biontech doesn’t even believe in vaccination itself,” says the AfD, for example.
Facts: The core of the indictment against the pharmaceutical company in Mainz is its report to the United States Securities and Exchange Commission (SEC) of March 30, 2022 for the financial year 2021. According to the United States Commercial Code, such report must be presented annually by foreign joint stock companies.
In principle, Biontech refers in this report to the “high level of protection” of vaccination. The agent offers “a high level of protection against critical variants, including alpha, beta and delta”. According to the company, the latest laboratory studies also showed that three doses of the vaccine were also effective against the Omicron variant.
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. 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.
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 protection is less good for the omicron mutant. In a Pfizer-funded study, the efficacy of three doses against omicron hospitalizations was 85% within the first three months after 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.