The EU approved COVID-19 vaccines with “ZERO safety checks”! – True or false?

Since about two days, social media are awash with statements claiming that the EU approved COVID-19 vaccines with zero or insufficient or incomplete safety checks. If true, this would be most concerning.

But is it?

The European Medicines Agency (EMA), which is responsible for evaluating and authorizing medicines in the EU, has stated that all approved COVID-19 vaccines underwent a rigorous scientific assessment of their safety, efficacy, and quality.

• Clinical Trials: Before approval, COVID-19 vaccines were tested in large-scale clinical trials involving tens of thousands of participants. These trials were designed to assess the vaccine’s safety, efficacy, and ability to generate an immune response.
• Rolling Reviews: To accelerate the process during the pandemic, the EMA used a “rolling review” procedure. This allowed them to evaluate data from ongoing clinical trials as it became available, rather than waiting for a complete data package. While this sped up the timeline, it did not compromise the standards for a thorough review.
• Continued Monitoring: After a vaccine was granted a conditional marketing authorization, the EMA and EU member states continued to closely monitor its safety. This “pharmacovigilance” system involves collecting and analyzing data on suspected side effects from various sources, including reports from patients, healthcare professionals, and ongoing studies.
• Benefit-Risk Assessment: The EMA’s approval process is always based on a benefit-risk assessment. This means that a vaccine is only approved if its overall benefits in preventing disease outweigh any potential risks of side effects. The vast majority of known side effects for COVID-19 vaccines are mild and short-lived, while the serious side effects are very rare.
• Transparency: The EMA has publicly shared information about its evaluations, the basis for its decisions, and regular safety updates to maintain transparency and build public trust.

So, are the statements that the EU approved COVID-19 vaccines with zero or insufficient or incomplete safety checks just lies?

Let’s say they are misunderstandings.

It all seems to go back to a European Parliament hearing on October 10, 2022, when a Pfizer official, Janine Small was asked by Dutch Member of European Parliament (MEP) Rob Roos a direct question: “Was the Pfizer Covid vaccine tested on stopping the transmission of the virus before it entered the market? If not, please say it clearly. If yes, are you willing to share the data with this committee? And I really want a straight answer, yes or no…” Janine Small’s response was, “Regarding the question around, um, did we know about stopping the immunization before it entered the market? No.” She then added that the company had to “move at the speed of science to really understand what is taking place in the market,” and that the company had to “do everything at risk” to provide a vaccine during the pandemic.

It seems clear that Janine Small  meant “transmission” when she said “immunization”. The context of the question and her subsequent explanation makes this evident. The primary goal of the initial clinical trials was to determine, if the vaccine was safe and effective at preventing severe disease, hospitalization, and death from COVID-19. Measuring transmission is a much more complex metric that is often studied in post-market surveillance and real-world data, not in initial clinical trials.

The fact that the initial trials did not measure transmission was already public knowledge and was stated in the clinical trial protocols and regulatory filings. The EMA public assessment report, for instance, noted that the question of the vaccine’s efficacy in relation to viral transmission was “yet to be addressed.”