The European Commission admits for the first time that COVID vaccines were authorised for use in humans without “complete” safety data
The European Commission has admitted that COVID vaccines were administered to the population without sufficient safety data, as there was no complete scientific dossier at the time of their approval. Brussels has explained that the first authorisations were conditional, an extraordinary mechanism designed for health emergencies such as the pandemic, which allows medicines to be distributed while more clinical information is gathered.
The acknowledgement appears in the official response sent at the end of August to Austrian MEP Gerald Hauser of the FPÖ, who had complained that European citizens were never informed that the efficacy and possible long-term effects of mRNA vaccines had not yet been proven. The Advance Purchase Agreement signed by the Commission on 20 November 2020 with BioNTech and Pfizer already expressly warned that Member States accepted ‘the unknown long-term effects and efficacy of the vaccine, as well as the possibility of side effects not yet detected’.
According to the EU executive, the approval of this type of product requires subsequent ‘strict control measures’ and can only be granted if the agencies conclude that the immediate benefits outweigh the potential risks. However, Hauser criticised this practice for turning millions of Europeans ‘into unwitting guinea pigs’.
The debate is not limited to the Old Continent. In the United States, Health and Human Services Secretary Robert F. Kennedy Jr. has shaken up the healthcare system by reshaping the decision-making bodies involved in immunisation. In June, he dismissed the 17 voting members of the Advisory Committee on Immunisation Practices (ACIP), citing conflicts of interest and the need to restore confidence in vaccination policies. The committee was reconstituted with specialists who are more critical of mRNA technologies.
From now on, this revamped scientific panel will evaluate the safety data for COVID-19 vaccines and issue new recommendations alongside the Food and Drug Administration (FDA). Among his first measures, Kennedy withdrew the recommendation to vaccinate healthy children and pregnant women, as well as tightening the criteria for the approval of future vaccines against the virus.
The controversy grew last week when it emerged that the FDA will present evidence linking at least 25 infant deaths to the administration of coronavirus vaccines. These findings will be discussed at a meeting of the CDC’s ACIP, which could reignite the controversy over vaccine safety and open a broader debate about the responsibility of the authorities who promoted their widespread use in the midst of the pandemic.
