The European Medicines Agency (EMA) has faced pressure to certify several COVID-19 vaccines, Le Monde writes via RIA Novosti.
The French publication studied documents that got into the Network, which indicate that, for example, the quality of the Pfizer-BioNTech drug was questioned, but this did not prevent a number of high-ranking EU officials from insisting on an early approval of the vaccine.
In particular, one of the agency’s employees, according to the publication, was surprised by the statement of the head of the European Commission, Ursula von der Leyen, who, in an ultimatum, indicated the need to approve the Pfizer-BioNTech and Moderna vaccines by the end of the year.
“There are still problems with both drugs,” an EMA employee quotes the publication.
It also notes that the approval of the Pfizer vaccine in mid-December 2020 was regarded by the European Commission as “an unacceptable delay.”
“Whatever we do, speeding up the negotiation process or carrying it out within the required time frame to obtain accurate guarantees <…>, the EMA will have to face questions and criticism from various parties (European Commission, EU Member States, European Parliament, media and the general public )”, the agency official said in a statement.
According to the material, the researchers’ greatest question was caused by the Pfizer vaccine, since the main objection arose after the revealed fact of the discrepancy between the compositions of commercial lots and those used in clinical trials. Concerns were also raised by the lack of approval for some manufacturing sites and the lack of data on commercial shipments of the vaccine, the authors said.
One way or another, as noted by Le Monde, the agency, in addition to pressure, had to face a hacker attack, which resulted in the leak of the studied documents to the Internet. In an interview with the publication, however, representatives of the organization admitted that “the publicized emails reflect the problems and discussions that took place.”
Earlier, Russia has already paid attention to manipulations with the certification of the Pfizer vaccine. Permanent Representative of Russia to the EU Vladimir Chizhov noted that the European Medicines Agency had “twisted its arms” so that the drug was approved on December 21.