Despite the delays, the penalties against Pfizer do not take effect automatically. All the details
The anti-Covid-19 vaccination campaign has only started a month ago, but the government has already had to put the vaccination plan back on its feet. Immunization of the over 80s has been postponed by at least a month, while the vaccination of health personnel also slows down to give priority to boosters.
All the fault of Pfizer's delays, says the emergency commissioner Domenico Arcuri, fierce against the Big Pharmaceutical, which, however, against any legal moves by Italy, is in an iron barrel, thanks to the contract signed with the EU, as revealed today by Corriere della Sera.
All the details.
THE DELAYS OF PFIZER
Let's start with the numbers. In total, Italy is entitled to 40 million doses of Pfizer's vaccine, of which 8.7 million will have to be delivered by the first quarter of 2021. This is 13.46% of those ordered from Brussels, which will arrive in Italy with weekly deliveries agreed with the pharmaceutical company.
And it was Pfizer himself who announced from mid-January that weekly deliveries would be delayed. In the last week there has been a 29% cut in supplies, and this week by 20%.
CLAUSES, PENALTIES AND NOT ONLY: PFIZER IN AN IRON BARREL
Delays, however, which cannot be contested. In the contract signed between Brussels and Pfizer, as discovered by Corriere della Sera , the penalties "are exclusively on quarterly supplies and not on weekly ones".
The contract, explains the newspaper, establishes "a penalty of 20% of the value of the doses not delivered" which increases according to the days of delay. “The application of penalties is not automatic”, reads the contract according to Corsera . At the end of the first quarter, the way to a "remedy" for the default must be explored. Pfizer could reimburse the countries, decide whether to terminate the contract or, only alternatively, the application of the penalty will be considered.
STATE LAWYER INVESTED INNELESS?
And therefore, the battle that the Italian government would like to wage with Pfizer, involving the state advocacy already seems to be lost from the start.
PFIZER: AGREEMENT ON DOSES, NO VIALS
Lost not only because of the clause, but also because according to Pfizer there are no delays. "From next week, Pfizer's supply of the vaccine will return to full capacity," said Pfizer contacted by Sky Tg24 . The pharmaceutical company then added that “from 8 to 18 January the ampoules required by the ordering plan were sent, then there was a reduction due to the readjustment of the Belgian production site in Puurs. With the government's decision to administer 6 doses instead of 5, Pfizer has reduced the number of vials, but not the expected doses, which remains the same. What is happening is the result of a misunderstanding in the count of the doses which is not the count of the vials ".
THE GRANT OF THE EMA
And this is where we need to take a step back. After the vaccine was approved on January 8, 2021, the EMA, in line with the FDA, established that a sixth dose of vaccine could be extracted from each vial, instead of the 5 announced.
THE NEW CALCULATIONS OF THE BIG PHARMA
And that sixth dose is certainly not free. This is why Pfizer claims: “After dilution, one vial contains 6 doses of 0.3 mL. Vial labels and cartons may state that after dilution, a vial contains 5 doses of 0.3 mL. The information in this Fact Sheet regarding the number of doses per vial after dilution supersedes the number of doses stated on vial labels and cartons ", ie:" After dilution, one vial contains 6 doses of 0.3 mL. Vial labels and packages may indicate that, after dilution, one vial contains 5 doses of 0.3 mL. The information contained in this information sheet regarding the number of doses per vial after dilution supersedes the number of doses indicated on the bottle labels and cartons ”.
THE WORDS OF ARCURI
These calculations, however, do not seem to affect Arcuri. The extraordinary commissioner for the emergency, at Live #noneladurso, attacks Pfizer and Astrazeneca (who announced delays even before approval): “They are treating 27 European countries like poor people. Let's get it out of our minds that Italy is more penalized than others. These companies do not produce soft drinks and snacks. They have pledged to give a certain amount of vaccines which are far more important than drinks and snacks. If we had the vaccines that were announced by pharmaceutical companies by the autumn we could vaccinate up to 45 million Italians, but I don't believe these companies. I want to see the vaccines. There may be asymmetries, according to which the few things that are produced do not necessarily go to the places where they have to go ”.
THE CONTRACT WITH GERMANY
It must be said that, as Corriere della Sera points out , that not all EU states are treated in the same way. In the documents available to the State Attorney for the warning that could already start today, it is confirmed that BioNTech, the German company that together with Pfizer produced the vaccine, "has signed a parallel contract with Germany in addition to the one agreed from Brussels. And that risks undermining the equitable distribution of doses among the states of the Union established as a percentage of the inhabitants of each country, since it guarantees Berlin an additional supply of 30 million doses ”, writes the Corriere.
SILERI: THE DIFFIDENCE MAKES SENSE
Pierpaolo Sileri, Deputy Minister of Health, also agrees with the legal action against Pfizer, despite the initial hesitation. “Pfizer's delays are related to the ability to produce in relation to the plant and location currently in operation. Moreover, the contract is in relation to the doses and not to the vials. The legal action, the warning first of Italy but also of Europe, has a rationale, that is to receive the agreed doses and then makes sense with respect to the delays that may not be recovered ", said Sileri, speaking on Radio24 .
"However, Pfizer has already declared that from 1 February the delays and the doses will be made up: if the delay extends for more than two weeks, the problem becomes large, not only for Italy but for the whole of Europe".
This is a machine translation from Italian language of a post published on Start Magazine at the URL https://www.startmag.it/sanita/ecco-come-pfizer-si-e-vaccinata-contro-le-penali-per-i-ritardi/ on Mon, 25 Jan 2021 11:51:27 +0000.