Annual Report Fact Check: Biontech Has No Doubt About Vaccine Efficacy

Annual Report Fact Check
Biontech does not doubt the efficacy of the vaccine

Biontech’s annual report for the US Securities and Exchange Commission is said to indicate that the Mainz-based company doubts the protection and safety of its own corona agent. But is it really like that?

Biontech’s vaccine has been used worldwide against the corona virus for almost a year and a half. It offers millions of people protection against serious Covid illnesses. Although numerous international studies have already proven this, vaccine opponents continue to rage against the drug. Referring to a Biontech document from the USA, the manufacturer was recently accused of not being at all convinced of its vaccine.

Claim: “Biontech does not even believe in vaccination itself”, says the AfD, for example.

Rating: False.

Facts: The focus of the prosecution against the Mainz pharmaceutical company is its report to the U.S. Securities and Exchange Commission (SEC) dated March 30, 2022 for fiscal year 2021. According to the U.S. Commercial Code, such report must be submitted annually by foreign joint-stock companies.

In principle, Biontech refers in this report to the “high level of protection” of vaccination. The agent provides “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 equally effective against the Omicron variant.

But one sentence in particular in the 700-page diary warms the spirits. 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 continued regulatory approval in the US, UK, in the European Union or other countries where the vaccine has received emergency or conditional marketing authorisation.”

Management Warning

Some conclude that even the manufacturer admits to having put on the market an ineffective and dangerous remedy. But this is not true. The statement is contained in a “Caution Regarding Forward-Looking Statements”. This legal information is prescribed in detail by the stock exchange supervisory authority in order to avoid possible claims for damages by investors. In Biontech’s report, this regulation means that every conceivable influence on corporate profits and business development must be described. This should allow investors to get an idea of ​​all the 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 durability of immune response. Business results could also be affected, for example by “the extent to which a Covid-19 vaccine will continue to be needed in the future”. The Biontech Comirnaty vaccine is currently subject to conditional marketing authorization in the European Union. This was first granted in December 2020 and extended for one year in November 2021.

The European Medicines Agency (EMA) imposes the same requirements on the safety of Covid-19 vaccines as on any other vaccine approved in the EU. With conditional approval, data is assessed as soon as it is available – rather than when all investigations are complete. After an initial 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 when infected with the Delta variant. According to the Robert Koch Institute, the first data show that the protection of the omicron mutant is less good. In a Pfizer-funded study, the efficacy of three doses of omicron against hospitalizations was 85% during the first three months after vaccination. But it dropped to 55% after three months or more. At no time during the pandemic have well-known researchers asserted that a corona vaccination protects 100% against Covid-19.

Leave a Comment