ACCOUNTS WITHOUT THE OSTE? DEMANSION THE OSTE (even if everyone's health goes away) (As a Skeptical Chemist)

In the beginning it was the Italian vaccine, which was not exactly Italian, namely the Oxford-IRBM vaccine. "In the beginning" was in April. "Vaccine in September", said Di Lorenzo (IRBM), but there was no money. It was not clear whether the animal model had been made or, if so, who had made it. Instead, it became clear that there was a problem with funds: clinical trials had to be started and there wasn't a cent, instead ten million were needed, at least. Di Maio and Speranza had poured out many words but in the end, quietly, they had sent Di Lorenzo to Cassa Depositi e Prestiti, where time passed and a spider did not rise from the hole. While in Italy the perfidious Johnson puts the 20 million. The center of gravity of the project is definitively moved to the UK when Astra Zeneca buys the project. And here the game gets serious.

Italy France Holland and Germany form a buying group on the fly and option the Oxford-AZ vaccine, 400 million doses ( https://www.cnbc.com/2020/06/15/italy-france-the-netherlands- germany-to-pay-843-million-vaccine.html ). This happens on June 13th. In close proximity to the purchasing group are Spain, Poland and Sweden ( https://www.lamoncloa.gob.es/lang/en/gobierno/news/Paginas/2020/20200619covid19-vaccines.aspx ).

And suddenly everything becomes confused, because at the same time the Commission on June 17 officially communicates the “EU Strategy for COVID-19 vaccines” ( https://eur-lex.europa.eu/legal-content/EN/TXT/? qid = 1597339415327 & uri = CELEX: 52020DC0245 ). On May 20, the Commission had also launched Emergency Support Instrument, with 2.7 billion of endowment: on June 17 it declares that

“The Commission will finance part of the costs faced by vaccine manufacturers in the form of Advance Purchase Agreements. The allocated funds must be considered as an advance on the payment of the vaccines that will actually be purchased by the states "

It becomes quite clear that the Commission puts the money forward, and if it puts it forward, the states do not put it forward, as a rule – clearly the Commission funds are European budget funds, so they were put in by the member states, but this is a another matter.

In the first two weeks of July we no longer hear of an Italian-French-German-Dutch-etc buying group. But on 14 July La Stampa brings out the famous headline “COVID, the vaccine works – the goal is to distribute it without experimentation” ( https://ilchimicoscettico.blogspot.com/2020/07/follie.html ). And on Sole24Ore the issue of the legal shield for producers comes out. There are ongoing negotiations but it is not clear who is dealing with whom (yet – and I say this also with reference to the writer – it was all black and white, online on the Commission's website, hidden in plain sight).

Now (with hindsight) it is clear that the whole affair has passed under the Emergency Support Instrument, but ESI is none other than the Commission, which starting from July begins to deal with vaccine developers, individually, and with their associates. / Vaccine Alliance lobby ( https://ilchimicoscettico.blogspot.com/2020/08/vaccini-anticovid-lobby-e-europa.html ). On 14 August, the commission signs the first agreement with Astra Zeneca ( https://ec.europa.eu/commission/presscorner/detail/en/ip_20_1438 ). "Today, after weeks of negotiations, we have the first EU advance purchase agreement for a vaccine candidate. I would like to thank AstraZeneca for its constructive commitment to this agreement of such great importance to our citizens," said Stella Kyriakides, Commissioner for Health.

In a plastic representation of the functioning of European democracy, the issue will reach the responsible committee of the European Parliament only this week ( https://www.europarl.europa.eu/committees/it/debate-on-eu-vaccine-strategy-and -advanc / product-details / 20200902CAN56921 ), when the games have already been done:

Sanofi-GSK: 300 million doses

Johnson and Johnson: initial purchase of 200 million doses and possible purchase of an additional 200 million

CureVac: Purchase of 225 million doses

Moderna: initial purchase of 80 million dose with the option to purchase another 80 million.

( https://ec.europa.eu/info/live-work-travel-eu/health/coronavirus-response/emergency-support-instrument_en )

Clearly ESI is completely unbalanced against Moderna on the vaccine side and, in general, against drugs, or rather the only new drug: it provides 150,000 doses of remdesivir, for 30,000 patients (a fortune that the second wave of us still does not see).

Please note: of everything we have talked about, remdesivir is the only one for which there has been a regulatory pronouncement (and on both sides of the Atlantic).

As for these different vaccines, rebus sic stantibus, EMA is completely excluded from the process (and still does not have a practice for a single vaccine).

Overseas, the Trump administration has been lobbying the FDA for months, which should give an idea of the role of the FDA. Here EMA, quite simply, was not taken into consideration. Nobody thought that it should be included in the process, an eloquent example of the weight that is given in Europe to pharmaceutical regulation today.

Repubblica relaunches: vaccine in November (and talks about the Oxford-AZ one https://rep.repubblica.it/pwa/generale/2020/09/06/news/vaccino_fabbriche_gia_in_moto_a_novembre_10_milioni_di_dosi-266427987/ ): probably someone thinks that delivering in a month and half the practice at EMA everything must be resolved in a formality, the stamp of a bureaucrat, and then off we go.

But the whole thing is further curious why the clinical researchers engaged in the trials of the Oxford-AZ vaccine are falling from the clouds.

Vogon Today

ACCOUNTS WITHOUT THE OSTE? DEMANSION THE OSTE (even if everyone’s health goes away) (As a Skeptical Chemist)