BETA

2 Amendments of Emmanouil FRAGKOS related to 2023/2156(DEC)

Amendment 9 #
Draft opinion
Paragraph 6 a (new)
6 a. Notes the role that the EMA plays in implementing measures to enable flexible regulatory processes and stresses the fact that EMA did not ensure the safety and efficacy of the authorised vaccines; Notes that the conditional market authorisation to COVID-19 vaccines was granted under the condition that the benefits of the vaccines far outweighed their potential risks; Notes that this condition was not met since in the COVI committee hearing the Pfizer representative Janine Small has specifically stated that, when the vaccines have entered the market, they "did not know if the vaccines are stopping the spread of the virus", as well as commissioner Didier Reynders has stated in the European Parliament Plenary in Strasbourg on 28 April 2021 that, "while putting in place the Digital Green Certificate, we have to live with the fact that there are still scientific uncertainties regarding COVID-19. We do not yet have full scientific evidence about the effects of vaccination or recovery from the virus"; 1a _________________ 1a https://multimedia.europarl.europa.eu/en/ webstreaming/covi-committee- meeting_20221010-1430-COMMITTEE- COVI; https://www.europarl.europa.eu/doceo/doc ument/CRE-9-2021-04-28-ITM- 004_EN.html
2023/12/04
Committee: ENVI
Amendment 10 #
Draft opinion
Paragraph 6 b (new)
6 b. Notes with deep concern that the "COVID-19 vaccines safety update" report released periodically by the European Medicines Agency shows many side effects including 12,000 spontaneous reports of fatal outcomes in the EU; 2a _________________ 2a https://www.ema.europa.eu/en/human- regulatory/overview/public-health- threats/coronavirus-disease-covid- 19/covid-19-medicines/safety-covid-19- vaccines
2023/12/04
Committee: ENVI