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WorldPosted at: Jan 18 2021 12:52AM


Leaked emails show EU regulator faced pressure in green-lighting Pfizer vaccine

Brussels, Jan 17 (Sputnik) The European Medicines Agency’s (EMA) confidential emails leaked on the dark web on Sunday testifies that the regulator faced pressure to speed up the authorization process for the Pfizer vaccine, Le Monde reported, citing the correspondence.
On December 9, EMA said that it had been subject to a cyberattack. On Friday, it confirmed that some of the unlawfully accessed documents related to COVID-19 medicines and vaccines had been leaked on the internet, noting that "some of the correspondence has been manipulated by the perpetrators prior to publication in a way which could undermine trust in vaccines."
Despite this, EMA still admitted to the French daily, which studied some of the correspondence dating from November, that the leaked emails do reflect issues and discussions that were in place at the time.
In a November 12 correspondence, an EMA employee says that European Health Commissioner Stella Kyriakides, while insisting that all EU nations should receive a coronavirus vaccine simultaneously, stressed that member states should not enforce national procedures before an EU-wide authorization.
In a letter dated November 19, a high-ranking EMA official mentions a conference call with the European Commission that was allegedly held in a quite tense atmosphere and made it clear what EMA may face should it fail to meet expectations, regardless of whether they are realistic or not.
The next day, the same official wrote to the Danish regulator said that they were surprised by European Commission President Ursula von der Leyen naming two vaccines that would receive an authorization by the end of the year, namely Pfizer/BioNTech and Moderna. The EMA official maintained that there were still problems with both vaccines.
Other documents provide insight into three key concerns that the EU regulator voiced in relation to the Pfizer/BioNTech vaccine in November.
The concerns are the absence of approval with respect to certain production sites, lack of data on commercial batches of the vaccine, and, most importantly, qualitative differences between commercial vaccine batches and those used in clinical trials.
While noting that it is unclear who is behind the cyberattack, the newspaper claims that since the emails were leaked at Rutor, it might mean that "the hacker comes from Russia or is a Russophile."
In Friday’s press release, EMA insisted that the marketing authorizations for Pfizer/BioNTech and Moderna vaccines were granted in late December and early January, respectively, "following an independent scientific assessment." The regulator stressed that "despite this urgency, there has always been consensus across the EU not to compromise the high-quality standards and to base any recommendation on the strength of the scientific evidence on a vaccine’s safety, quality and efficacy, and nothing else."
SPUTNIK ACL0052
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