- Corriere della Sera <https://www.corriere.it/> <https://www.corriere.it/dataroom-milena-gabanelli/>
Covid vaccine, all the mistakes of Italy and Europe: contracts, powers and the operational plan that is not there by Milena Gabanelli and Simona Ravizza <https://www.corriere.it/dataroom-milena-gabanelli/vaccini-covid-contratti-poteri-piano-operativo-errori-italia-ue-ema-inghilterra-usa-contratto-astrazeneca-moderna-pfizer-miliardi-dosi/30c15e80-7f77-11eb-b700-62d4180eb118-va.shtml#commentFormAnchor> <?body=www.corriere.it/dataroom-milena-gabanelli/vaccini-covid-contratti-poteri-piano-operativo-errori-italia-ue-ema-inghilterra-usa-contratto-astrazeneca-moderna-pfizer-miliardi-dosi/30c15e80-7f77-11eb-b700-62d4180eb118-va.shtml&subject=(none)> The United States and Great Britain are traveling <https://www.bloomberg.com/graphics/covid-vaccine-tracker-global-distribution/>fast, they are at 27% and 35% of the vaccinated population respectively compared to 9% in Europe. <https://www.bloomberg.com/graphics/covid-vaccine-tracker-global-distribution/> In our slowness there is more than one reason, always kept silent in official statements, and that originates well before the arrival of vials. The powers of drug agencies: why Ema arrives 20 days later The European vaccination campaign, as we have now understood, started late compared to the US and the UNITED Kingdom because the authorisation of regulatory agencies, that is, the green light for the use of vaccines, came twenty days later. Pfizer/BioNTech obtains authorization on December 2 fromthe British Mhra,december 11 fromthe American FDA, and only on December 21 fromthe European EMA. The same for Moderna: FDA December 18, Ema January 6, Mhra January 8. AstraZeneca: Mhra December 30, EmaJanuary 29, FDA has not yet disbanded the reserves. But what's really behind what's being dismissed as a simple Ema delay? The lack of a tool that allows, in emergency contexts, and lack of alternatives, to approve the use of medicines with a faster procedure. TheFDA, on the other hand, has this power and has exercised it, as has The United Kingdom. In Europe,emergency use authorisation is the responsibility of the drug agencies of the individual States, but it has never been included in European legislation by the willingness of the Member States to limit the role of EMA,which has thus had to go through a longer process. After the Ebola epidemic 2014-2016, the need for the value of this instrument at European level was discussed, but without success. Now that we have touched on it, the matter is back on the table. The background to the negotiations: who was at the table to negotiate The lack of a strong mandate also discounts it in negotiations with pharmaceutical companies. The United States and Great Britain signed agreements to purchase the doses with Pfizer and AstraZeneca between May and July, europe coming in three to four months later. With Moderna, the US closes on 11 August, the EU on 25 November. The difference is that they come to the negotiations with the partner industries, we Europeans from customers The Americans, after the H1N1 pig epidemic, began investing in vaccine research and created a special authority, the Barda. To finance and coordinate research the National Institute of Health(NIH); while to accompany the development of clinical trials, also imposing the protocols to be followed, there is theFDA.These public agencies create, on April 17, 2020, the Activconsortium, a public-private partnership where the main pharmaceutical industries sit, initially funded with 10 billion dollars, with the aim of coordinating research and quickly developing a vaccine. Britain, leaving the EU, and with a manufacturer at home (AstraZeneca) actually treats itself. In Europe, on the other hand, not only has little targeted investment been made in research into vaccine development, but under pressure from a part of the public that is wary, what was already there has been dismantled. Therefore the production capacity, so invoked today in the name of autonomy from other countries, has been reduced: Baxter and Novartis have closed with vaccines, GSK has found it more convenient to expand in America. Important but small realities, such as BioNTech, Oxford and CureVac, are not enough for Europe to face the immense challenge. So after realizing that few countries have the strength to deal alone, the European Commission is delegated to negotiate for everyone. But it does not have an expert apparatus or even a specific authority: a power that the Member States have never wanted to grant. The only tool he has owned since 2014 is the legal basis for the joint purchase of pandemic vaccines built by the then Director General of Health, Paola Testori Coggi, after the pig fever of 2009, when each country, going on its own, had spent billions. The conditions under which Europe buys: the secret clauses of contracts Itis a very complex activity and requires specific expertise, but there areno skills within the Commission. Ursula von der Leyen makes the best possible choice: she moves from Dg Commerce to Dg Health Sandra Gallina, skilled in her sector, but without the experience she needs in this case. The Director-General starts work with a negotiating team of seven Member States, selected by the Steering Committee on which all countries are represented. For Italy the best choice would have been to delegate the director of the office that prepares the negotiating dossiersof the Italian Medicines Agency, which knows all the tricks of the trade, but it was preferred to send Giuseppe Ruocco, secretary general of the Ministry of Health. In these circumstances, the EU sits at the negotiating table, while on the other hand there are legions of lawyers and pharmaceutical companies who have done nothing else in life In the end, they dictate the conditions:the EU participates in the business risk in the expansion of the production chain with a contribution of 2.8 billion euros, to be scaled from the price of each vial on the first supply. Fortunately the vaccine is located and works. The agreement provides <https://ec.europa.eu/commission/presscorner/detail/en/IP_21_302> that any side effects are entirely borne by the individual States(here the document). <https://www.corriere.it/dataroom-milena-gabanelli/21_marzo_07/contratto-stipulato-ue-astrazeneca-05735ef6-7f52-11eb-b700-62d4180eb118.shtml> It has never happened before, but it is reasonable, given the tight deadlines by which marketing is required; equally reasonable would have been pretending to do half and half The delivery constraints: the wording used is that the pharmaceutical company will 'do everything possible', but no penalty is established otherwise (here the document). <https://www.corriere.it/dataroom-milena-gabanelli/21_marzo_07/contratto-stipulato-ue-astrazeneca-d7f4bede-7f56-11eb-b700-62d4180eb118.shtml> There is the ok of all member countries. Agreed the price, 2.6 billion doses are designed, to be distributed to each country in proportion to the population. In December the vaccination campaign starts and the result is this: the EU starts with 48 thousand doses, Britain with 86 thousand, the US with 556 thousand. <https://ourworldindata.org/grapher/cumulative-covid-vaccinations?tab=table&stackMode=absolute&region=World>Despite the substantial contribution, we are the last in line. It was not until 29 January that the Commission armored the doses produced in Europe, tying their export to prior authorisation. <https://eur-lex.europa.eu/legal-content/IT/TXT/HTML/?uri=CELEX:32021R0111&from=EN> It is the measure that allows Italy to block at the end of February the sending of 240 thousand AstraZeneca vials to Australia. La situazione italiana: i vaccini consegnati e quelli in arrivo Il nostro piano vaccinale del 12 dicembre prevedeva la consegna, fra gennaio e marzo e da più fornitori, 28,2 milioni di dosi (qui il documento <https://www.corriere.it/dataroom-milena-gabanelli/21_marzo_07/piano-strategico-ministero-salute-fe15696a-7f56-11eb-b700-62d4180eb118.shtml> ). Non sarebbero mai potute arrivare, perché in quella data AstraZeneca e Moderna non erano ancora state autorizzate nemmeno da Stati Uniti e Gran Bretagna L’unica pronta a consegnare era Pfizer-BioNTech, e tutti hanno chiesto a Pfizer, che ha dovuto spartire le dosi, con un occhio di riguardo alla Germania, che aveva finanziato con la loro ricerca con 325 milioni. Sta di fatto che nei documenti del 12 febbraio le forniture vengono ridotte a 15,7 milioni (qui il documento <https://www.corriere.it/dataroom-milena-gabanelli/21_marzo_07/1-documento-piano-vaccinale-aggiornato-1c7245ac-7f63-11eb-b700-62d4180eb118.shtml> ). I tagli più pesanti sono operati da AstraZeneca. Le ragioni «sospette» è che in parte abbiano preso altre destinazioni, ma ci sono anche quelle tecniche (non ci sono scorte, e basta un malfunzionamento per ritardare la produzione). Pertanto le consegne, per settimane avvengono a singhiozzo. A ieri Pfizer/BioNTech ha consegnato 4,5 milioni di dosi su 9 (50%), Moderna 493 mila su 1,3 milioni (38%) e AstraZeneca 1,5 milioni su 5,4 (28%). <https://www.governo.it/it/cscovid19/report-vaccini/> <https://www.governo.it/it/cscovid19/report-vaccini/> Tra gennaio e febbraio complessivamente abbiamo ricevuto 6,3 milioni di vaccini, ciò vuol dire che nel mese di marzo complessivamente ne avremo 9,4 milioni (9,1 milioni ancora da consegnare). E da aprile sono in programma consegne per altri 24 milioni da Pfizer/BioNTech, 4,6 da Moderna, 10 da AstraZeneca e 7,3 del nuovo vaccino monodose Johnson & Johnson (qui il documento <https://www.corriere.it/dataroom-milena-gabanelli/21_marzo_07/1-documento-piano-vaccinale-aggiornato-20d9545c-7f57-11eb-b700-62d4180eb118.shtml> ). Significa che occorre essere pronti con la macchina organizzativa, e che tagli e ritardi non potranno più essere un alibi per giustificare le inefficienze del sistema che ci sono state finora. Vediamo quali. What works and what doesn't: more doses than the ability to do them To speed up the administration, staff are needed:in Finanziaria 508 million euros are allocated, put in the hands of the emergency commissioner (until last week Domenico Arcuri) to hire 3 thousand doctors and 12 thousand nurses. <http://www.salute.gov.it/portale/home.html> The task of finding them is entrusted to the interim agencies. So far, not even half of the expected staff have arrived. In the vaccination plan of 2 January, which by decree must be implemented by the Commissioner, there are general indications on the <https://www.trovanorme.salute.gov.it/norme/renderNormsanPdf?anno=2021&codLeg=78657&parte=1%20&serie=null> categories that have priority (social and health personnel, guests of nursing homes, over 80s, chronically ill, then by age). The vaccines are distributed by the Commissioner with a double track: for Pfizer and Moderna on numbers indicated by the Regions (which have calculated each with different criteria), while for AstraZeneca it goes as a percentage of the ISTAT population. From then on, responsibility and choices are the responsibility of the regions. According to Commissioner Arcuri's circular of 12 January on 100 vaccines arriving, 30 must be set aside as an escort for the recall(here the document). <https://www.corriere.it/dataroom-milena-gabanelli/21_marzo_07/aggiornamento-consegne-vaccini-12-febbraio-430dcd82-7f57-11eb-b700-62d4180eb118.shtml> If we look at the general data, the difference between vaccines delivered and administered, even with regional variations, is in line with the stocks to be kept(from March 3rd the Ministry formalizes that for AstraZeneca a single dose is enough for those who have already had Covid). <http://www.quotidianosanita.it/governo-e-parlamento/articolo.php?articolo_id=93114> But it is enough to break down the data to understand that things are not going so well. As long as hospitals have to vaccinate doctors, social and healthworkers and nursing home guests, the organization works: from the end of December to February 7, about nine of the ten doses received are administered. Problems start when hospitals switch to over-80s The speed of the vaccination campaign begins to slow down in the week 8-14February: out of 100 doses delivered only 36 were administered, the one after 46, the next 67. As of yesterday Lazio vaccinated 146,861 (37%) over 80, Emilia-Romagna 110,682 (30%), Lombardy 115,480 (16%), Sicily 57,983 (18%). With AstraZeneca (recall after 12 weeks) we start with teachers and law enforcement. Teachers and school staff generally vaccinated in Tuscany around 43 thousand, in Campania 64 thousand, in Lombardy 2,651. As of March 5 (Gimbe survey for Dataroom)out of 1.5 million AstraZeneca doses delivered, only 516,489 were used. The others are all in the refrigerators. The mass campaign: enough with the regions in scattered order >From April the mass campaign will begin, which means at least 500 thousand people a day. Will it be possible? Perhaps so, but a national strategic operational plan that has never been done so far must be implemented quickly. At the moment there is completely no coordination of the various regional implementations of the vaccination campaign, thus producing the misalignments that are before everyone's eyes In summary: no one has yet said 'you region mustrespect this objective, tell me which staff you use, what your organisational model is, and I am monitoring you'. In addition to indicating the appointment system. Britain's model leads to better on-call mode rather than by reservation. For a week now we have had a new commissioner, Francesco Paolo Figliuolo, an expert in logistics. The role of Civil Protection has also been enhanced. Let's hope so. [email protected] https://www.corriere.it/dataroom-milena-gabanelli/vaccini-covid-contratti-poteri-piano-operativo-errori-italia-ue-ema-inghilterra-usa-contratto-astrazeneca-moderna-pfizer-miliardi-dosi/30c15e80-7f77-11eb-b700-62d4180eb118-va.shtml -- http:www.antic.org --- You received this message because you are subscribed to the Google Groups "SERBIAN NEWS NETWORK" group. To unsubscribe from this group and stop receiving emails from it, send an email to [email protected]. To view this discussion on the web visit https://groups.google.com/d/msgid/senet/CAHTRw0ZajFW%3DRy3Cp2w9oNqfmTY4okfZZyqUS9CjJViDB205jA%40mail.gmail.com.
