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Parliamentary questions
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25 September 2020
P-005248/2020
Priority question for written answer P-005248/2020
to the Commission
Rule 138
Michèle Rivasi (Verts/ALE)
 Subject: Position of EMA and Commission regarding the non-compliant placebo in AstraZeneca’s COVID-19 vaccine clinical trials

The Commission has pledged to purchase 300 million doses of the ChAdOx1 vaccine produced by AstraZeneca (AZN). However, it appears that the clinical trials conducted by AZN to ascertain the side-effects of the vaccine do not comply with the standard protocol followed by pharmaceutical companies to verify the efficacy and safety of medicinal products. Instead of using a control group of test subjects injected with a saline solution as a placebo, the AZN clinical trials use injections of the meningitis vaccine Nimenrix (Pfizer).(1)

1. Any vaccine may have undesirable side-effects. On what grounds does AZN operate differently from other laboratories and why does it use a meningitis vaccine for its control group? How could the Commission pay AZN while the latter’s clinical trial protocol does not comply with established standards?

2. Given that the EMA has the responsibility to compare the clinical trials, how can it justify this bias in the clinical trials of AZN and does it have real-time access to the raw data from the ChAdOx1 clinical trials?

3. Why did the UK health agency — unlike the FDA — authorise the resumption of the ChAdOx1 clinical trials despite the two identified cases of transverse myelitis(2)? What does the EMA have to say on the matter?

 

(1)Safety and immunogenicity of the ChAdOx1 nCoV-19 vaccine against SARS-CoV2: a preliminary report of a phase 1/2, single-blind, randomised controlled trial, The Lancet, 15 Aout 2020 (https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31604-4/fulltext)
(2)AstraZeneca, Under Fire for Vaccine Safety, Releases Trial Blueprints, New York Times, 19 sept 2020 (https://www.nytimes.com/2020/09/19/health/astrazeneca-vaccine-safety-blueprints.html)
Original language of question: FR
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