European Medicines Agency insists regulatory process was not rushed, amid reports it was under pressure
The European Medicines Agency, which is evaluating the safety and efficacy of vaccines against Covid-19 in its role as the EU’s healthcare regulator, has said that hacked internal emails relating to its vaccine evaluation that have been published online have been altered in a way that could harm public trust.
“Some of the correspondence has been manipulated by the perpetrators prior to publication in a way which could undermine trust in vaccines,” the EMA said on 15 January. It did not provide any information on the nature of what was manipulated or how.
The EMA insisted that, although there is “an urgent public health need” to make vaccines available as soon as possible, “there has always been consensus across the EU not to compromise the high-quality standards and to base any [EMA] recommendation on the strength of the scientific evidence on a vaccine’s safety, quality and efficacy, and nothing else”.
Under pressure
On 16 January, the newspaper Le Monde reported that documents hacked from the EMA had been published on the ‘dark web’—the part of the internet that is not visible to normal search engines and can only be accessed with specific software.
It said that, in one email from 19 November, a senior EMA official allegedly said a conference call with the European Commission took place in an atmosphere that was “rather tense, sometimes even a little unpleasant”, and that this was an indication of what the EMA might face in future “if expectations are not met”. Research Professional News has asked the EMA for comment.
The EMA recommended the approval of the Pfizer-BioNTech Covid-19 vaccine on 21 December and the Moderna vaccine on 6 January—several weeks after similar approvals in the UK and the US. The slower pace of the EU evaluation drew criticism from some wishing to see a faster regulatory process.
The agency said it will continue to “fully support” an ongoing criminal investigation into the hack.