Covid-19 vaccine-related documents accessed and copied from the EMA last month suggest that the agency appeared to have been pressured into approving the Pfizer-BioNTech vaccine as quickly as possible despite a range of concerns, Le Monde reports, after investigating files found on the dark web.
The files reportedly include 19 letters sent between 10 and 25 November by agency employees, including among them emails sent to multiple recipients (whose potential for manipulation is therefore deemed more difficult).
These include a letter dated 12 November between EMA staff and EU health commissioner Stella Kyriakides, who reportedly told the regulator that European countries should “receive the vaccine at the same time,” and advised against “forcing” countries to apply national regulatory procedures to avoid further delays in drugs' approval.
A second letter, dated, 19 November, features a senior EMA official describing a “rather tense,” “sometimes even unpleasant” conference call with European Commission officials which gave “an idea of what the EMA may face if expectations, realistic or not, are not met” on the timeframe for approval.
In correspondence dated 20 November, the same official was said to have told members of the Danish Medicines Agency that they were “surprised” by European Commission President Ursula von der Leyen’s move to say publicly that the Pfizer-BioNTech and Moderna vaccines would receive approval before the end of 2020, despite lingering concerns by EMA regulators “with both drugs.”
For the Pfizer-BioNTech preparation, the documents said these “problems” included a lack of inspections at manufacturing facilities, lack of data on commercial lots, “and most importantly, the fact that there are differences in quality between commercial batches and those used in clinical trials,” and in particular – a decrease in the integrity of its main active ingredient – RNA.
The latter issue, Le Monde says, was said to have “caused the greatest concern among researchers tasked with evaluating the vaccine’s quality,” with fears reportedly related not only to effectiveness, but to safety.
US, Canadian, UK Regulators Reportedly More Lax
The Documents also found that the issues brought up by the Europeans were not considered serious by the US Food and Drug Administration, as well as by Canadian and British regulators, as the emergency approval for a vaccine’s temporary use in the three countries are less restrictive than those of the European Union. For this reason, health authorities were urged to “align the general requirements” more closely with the FDA and the Canadian agency “to avoid” a hypothetical situation in which one region “receives all the sub-optimal material.”
Pfizer and BioNTech reportedly responded to the EMA’s concerns in a report dated 26 November, with the review saying that inspections at production sites had begun, and proposing the creation of a 60-percent RNA minimum integrity rate, with one manufacturer saying differences in the amount of RNA “should not affect” the preparation’s effectiveness or safety.
However, a document dated 30 November showing correspondence between the EMA and manufacturers suggested that the EMA was not entirely satisfied, saying “critical issues” needed to be addressed through a “stricter control strategy,” particularly “given the innovative nature of this type of product and limited experience” in handling it.
The Pfizer-BioNTech vaccine was approved by European regulators on 21 December, 2020, having already been permitted for use in the US and the UK earlier that month.
The Pfizer-BioNTech vaccine, sold to the EU for 15.50 euros per dose for 300 million doses, faced flak this week after Norway linked 13 deaths to side effects, and Dutch media reporting that about 100 people in the Netherlands had developed side effects of various severity after taking the preparation. Similar problems were reported in Belgium, Finland and Israel, with the latter country reporting partial facial paralysis among 13 Israelis jabbed by the shot.
