THE STATE OF THE EUROPEAN UNION REPORT. Europe in a period of transition

EUROPEAN HEALTH UNION 99 Meeting these objectives will require providing re- sources and guarantees to companies to make it possible to produce vaccines in the EU that can guarantee suffi- cient supplies for all Member States; to do this, the Emer- gency Support Instrument 15 was used and APA contracts ( Advanced Purchase Agreements ). It was also necessary to make environmental legislation and the EU’s regula- tory framework more flexible to accelerate development, authorisation and availability of vaccines, without com- promising its quality, safety and effectiveness standards, measures approved by the Council on 14 July 2020. 16 From the second quarter of 2020, the Commission entered into negotiations with all the main pharmaceu- tical companies working on projects to develop covid-19 vaccines, Sanofi-GSK, Johnson & Johnson, BioNTech-Pfiz- er, Astra-Zeneca and Moderna. The Commission negoti- ated and signed APA contracts with these companies, on behalf of all Member States, on the condition that the vaccine was approved and demonstrated to be safe and effective, purchasing the doses required for the entire population of the EU. These contracts were criticised 17 due to their opacity and secrecy, so the Commission decided to publish them all, albeit censored and expur- gated. 18 The first APA contract for a covid-19 vaccine was signed by the Commission in August 2020 with As- 15  European Commission. Emergency Support Instrument. https:// ec.europa.eu/info/live-work-travel-eu/coronavirus-response-old/emer- gency-support-instrument_es 16  European Council. Press release. 14/07/2020.Vacuna contra la COV- ID-19: el Consejo adopta medidas para facilitar un desarrollo rápido. (COVID-19 Vaccine: the Council adopts measures to facilitate fast development.). https://www.consilium.europa.eu/es/press/press-re- leases/2020/07/14/vaccine-against-covid-19-council-adopts-meas- ures-to-facilitate-swift-development/ 17  Samper E. Los contratos de los Estados europeos para la adquisición de vacunas contra el coronavirus están rodeados de secretismo (The European Member States’ contracts to purchase coronavirus vaccines are cloaked in secrecy). elDiario.es-27/92020. https://www.eldiario.es/ sociedad/contratos-estados-europeos-adquisicion-vacunas-coronavi- rus-rodeados-secretismo_1_6241372.html 18  European Commission.Advanced Purchase Agreements (expurgated information). https://ec.europa.eu/info/live-work-travel-eu/coronavi- rus-response/public-health/eu-vaccines-strategy_es#documents tra-Zeneca 19 for a total of 400 million doses; subse- quently, further similar contracts were signed with BioNTech-Pfizer, Moderna and Janssen, all companies whose vaccines were authorised by the EU after approv- al by the EMA. 20 Contracts were also signed with Sa- nofi-GSK and CureVac, pharmaceutical companies whose vaccines were still in the development stage in late June 2021. Furthermore, negotiations are on-going with No- vavax, a company with a new innovative vaccine, based on the spicule protein, that demonstrated almost 90% efficacy in a recent phase-3 test; 21 also with Valneva, that is developing a deactivated virus vaccine. The vaccine contracts signed by the Commission guarantee almost 4,400 million doses to EU Member States and in turn, these doses can be donated to other countries. 22 It is important to highlight that the promising vac- cination rollout has been possible thanks to internal agreements on highly important topics for harmonious, cooperative and coordinated implementation of covid-19 vaccination throughout the EU. The four most relevant aspects of these agreements have been: 23 (1) rules to distribute vaccines fairly among Member States, (2) com- mon criteria on priority groups to access the vaccine (most vulnerable people, older people, etc.), (3) forecasts for distribution logistics and possible bottle necks and (4) a strategy against fake news on the vaccines. This policy, 19  European Commission. La Comisión alcanza un primer acuerdo so- bre una posible vacuna. (The Commission reaches an initial agreement on a possible vaccine.) Press release. 14/08/2020. https://ec.europa.eu/ commission/presscorner/detail/es/ip_20_1438 20  On 12 December, the EU authorised the sale of the first vaccine against covid-19, from BioNTech-Pfizer, after the EMA assessment. Subsequently, in 2021, vaccines were also authorised from Moderna (21 January 2021), AstraZeneca (29 January 2021) and Janssen (11 March 2021). 21  Heath, P. T. et al. (2021). Safety and Efficacy of NVX-CoV2373 Cov- id-19 Vaccine. N Engl Journal of Medicine https://doi.org/10.1056/ NEJMoa2107659 22  European Parliament. Parliamentary Questions. 11 June 2021. https://www.europarl.europa.eu/doceo/document/E-9-2021-001917- ASW_EN.html 23  EU Council. Press release 30/10/2020. https://www.consilium. europa.eu/es/press/press-releases/2020/10/30/remarks-by-president- charles-michel-after-the-video-conference-of-the-members-of-the-eu- ropean-council-on-29-october-2020/