The accusation by opponents of vaccination keeps coming up: Biontech has doubts about the effectiveness of its corona vaccine. Here we explain why this is wrong.
Berlin/Mainz – The Corona vaccine from Biontech/Pfizer has been approved in Germany since the end of December 2020. Millions of people worldwide have been given the Biontech/Pfizer vaccine called Comirnaty. The vaccine protects people from serious Covid diseases. Although many international studies have already proven this, vaccination opponents and vaccination skeptics continue to storm against the drug.
With reference to a Biontech document from the USA, the manufacturer was recently accused of not being at all convinced of his vaccine. AfD politicians also took up these allegations. “Biontech doesn’t even believe in the vaccination itself,” says the AfD, for example. What is it about this claim by opponents and critics of vaccination?
First things first: This assertion is wrong. The focus of the allegation against the pharmaceutical company from Mainz is its report to the US Securities and Exchange Commission (SEC) of March 30, 2022 for the 2021 financial year. According to the US Commercial Code, such a report must be submitted annually by foreign stock corporations.
Sentence from the Biontech/Pfizer annual report is taken out of context
In principle, Biontech refers in this report to the “high level of protection” of the 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 have also shown that three doses of vaccine were also effective against the Omicron variant. But one sentence in particular in the 700-page paper heats people’s 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 permanent regulatory approval in the US, UK, European Union or in other countries where the vaccine has received emergency or conditional marketing authorization.”
From this, some conclude that even the manufacturer admits to having put an ineffective and unsafe drug on the market. But that’s not true. The statement comes in a warning notice with predictions from management. This legal information is prescribed in detail by the stock exchange supervisory authority in order to avoid possible claims for damages by investors. In the Biontech report, this regulation means that all conceivable influences on company profits and business development must be described. This should enable investors to get an idea of all possible risks.
Biontech needs to educate investors about 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 the immune response. Business results could also be impacted by, for example, “the extent to which a Covid-19 vaccine will continue to be needed in the future.”
vaccine | Comirnaty |
Manufacturer | Biontech/Pfizer |
mode of action | mRNA vaccine |
effectiveness | in 95 percent of cases, the disease does not become severe |
The Biontech vaccine Comirnaty is currently subject to conditional market approval in the European Union. This was first granted in December 2020 and extended by another year in November 2021. So the Comirnaty vaccine is still subject to conditional approval. This can only change after two years. For the final approval, two-year long-term studies including long-term observations are required. The European Medicines Agency (EMA) places the same requirements on the safety of Covid-19 vaccines as on any other vaccine approved in the EU. With conditional approval, data is evaluated as soon as it becomes available, rather than when all investigations are complete. After an initial emergency approval in the USA, the FDA had already granted full approval for the drug in August 2021.
Biontech/Pfizer: Corona vaccine protects less well against Omicron than against Delta
After infection with the Delta variant, Biontech/Pfizer showed around 90 percent effectiveness against severe Covid 19 disease. This is the current state of science. According to the Robert Koch Institute, the first data for the Omicron variant show that the protection is less good. In a Pfizer-funded study, three-dose efficacy against omicron hospitalizations was 85 percent within the first three months after vaccination. But it dropped to 55 percent after three months or more. At no time during the pandemic have well-known researchers claimed that a corona vaccination protects 100 percent against Covid-19. (dpa/ml)
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