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The conditional authorization of the Pfizer / BionTech vaccine is scheduled for the 29th of this month at the latest, while in relation to Moderna it should be announced on January 12, 2021.
The agency is also reviewing vaccine developments at the University of Oxford, AstraZeneca and Johnson & Johnson.
“The EMA was the target of a cyberattack. The Agency has already promptly launched an investigation, in close collaboration with the authorities and other relevant entities,” the published note reads.
This communication occurs at a stage in which the EMA is validating the different vaccines for inoculation against covid-19.
Later, Pfizer revealed more information about the attack, which consisted of the theft of documents related to the vaccine.
“It is important to note that neither the BioNTech nor Pfizer systems were breached in this incident and we are not aware of any personal data that has been hacked,” a statement read.
“We are awaiting further information on the AEM investigation and will react accordingly, in accordance with European legislation. Given critical public health considerations and the importance of transparency, we continue to provide clear evidence on all aspects of vaccine development and the regulatory process, ”the document reads.
In the statement, AEM did not say when the attack occurred.
Last week, the EMA received formal requests for “conditional authorization” from the pharmaceutical companies Pfizer / BioNTech and Moderna for the use of vaccines in the European Union, after the United Kingdom already started vaccinating the population without waiting, under Brexit, studies. European Medicines Agency.
Emer Cooke, the chief executive, expects the European Union agency team to finish reviewing orders before Dec. 29 for Pfizer and Jan. 12 for Moderna.
On the 2nd of this month, in Lyon, Interpol issued a global alert to its 194 member countries, including Portugal, alerting them to prepare for attacks by organized crime networks that will soon act on covid-19 vaccines.
The “orange warning” from Interpol (International Criminal Police Organization) describes possible criminal activities such as counterfeiting, theft and illegal advertising of future vaccines against covid-19 and influenza, criminal behaviors that were already detected during the period pandemic with other products.
The warning also covers criminal examples in which the perpetrators advertise, sell and administer bogus vaccines.
With a series of covid-19 vaccines to be approved shortly and with global distribution, it is critical that countries ensure the security of the supply chain and identify illicit ‘websites’ selling counterfeit products, as they have already done. happened with the masks. and alcohol gel.
Good coordination between criminal police forces and the various health regulatory bodies, according to Interpol, will play a vital role in ensuring the safety of individuals and the well-being of communities in this pandemic period.
In addition to the dangers of ordering potentially fatal products, an analysis by Interpol’s CyberCrime Unit revealed that there are around 3,000 websites associated with online pharmacies suspected of selling illicit drugs and medical devices and that 1,700 contained cyber threats. like computer viruses.
From the modern pharmaceutical company, EMA received less clinical data and the technical information exchange process will take place in the coming weeks.
The EMA has a joint system (peer review) to ensure that the result is as valid and reliable as possible.
The most advanced vaccines were developed in record time, and the EMA launched a “real-time” review process in early October of all the data provided by pharmacists to streamline the analysis process pending clinical trials.
[Notícia atualizada às 20:48]
