Keys to the EU’s confidential and flawless contracts with Pfizer and Moderna


Up to 18 euros per dose and limits on liability on the part of the pharmaceutical companies. These are some of the main keys to the advance purchase contracts signed by the European Commission with Pfizer Y Modern to supply vaccines against COVID-19 and that this weekend they were unveiled by the RAI. Pfizer’s is dated November 20, 2020 and Moderna’s is dated December 4, 2020.

The contract between the EU and AstraZeneca includes a cost of 870 million and the pact to deliver vaccines manufactured in the United Kingdom

The contract between the EU and AstraZeneca includes a cost of 870 million and the pact to deliver vaccines manufactured in the United Kingdom

Know more

The EU has kept them hidden for months, first refusing to publish them and then blacking out sensitive data.

These are the agreements with which the EU paid an advance of 700 million euros to Pfizer and 318 million to Moderna, to ensure 200 million and 80 million doses respectively.

Vaccine prices

The figure of 15.50 euros per dose of the Pfizer-Biontech vaccine that has often been talked about is not exactly correct: it is the average between two different prices agreed with the pharmaceutical company.

In fact, the company sold its serum for 17.50 euros for the first 100 million doses and for 13.50 euros between 100 and 200 million doses.

But then the price goes up: for all additional orders placed within 3 months after the authorization granted by EMA (therefore until March 21), it amounts to 15.50 euros per dose. Then again at 17.50 euros. And it seems that the price will rise again in the future.

At the moment, however, Moderna is the most expensive vaccine on the market: 18.80 euros ($ 22.50) per dose.

Limits to liability

The contracts also confirm that, in the event of side-effect damage, compensation will fall almost exclusively to the States. The concessions made to pharmaceutical companies in the area of ​​civil liability have been debated across Europe for months. But the text reiterates that the use “occurs in a period of epidemic conditions and the administration of the products will be carried out under the exclusive responsibility of the Member States.”

Pharmaceutical companies are liable only in the event of willful misconduct or a proven violation of good manufacturing practices that all companies must adhere to in accordance with the EMA.

Patents, on the other hand, remain in private hands, despite public funding.

Delays without big penalties

As has been seen in the case of Astrazeneca, which is going to deliver a third of what is expected in the first half of 2020, the contracts tend to protect large pharmaceuticals against possible delays in deliveries.

Specifically, a clause is included in the Pfizer contract whereby, if the EMA authorization arrives before August 15, 2021 (as it happened) but the company’s production is insufficient to fulfill the expected orders, it is simply undertakes to review the delivery schedule on the basis of unspecified “fair and equitable principles”.

For Moderna, however, the conditions seem a bit stricter: if delivery is delayed for more than 90 days, the States can cancel the order.

Production costs

Among the annexes to Moderna’s contract is a detail of the costs incurred to start production: from $ 85 million in raw materials to $ 173 million in investments in structures, mainly at the Lonza group plant. However, the same is not the case in the agreement with Pfizer.

This week, the European Commission has asserted the option to buy an extra 100 million, up to 600 million for this year, as reported by the European Health Commissioner, Stella Kyriakides. In the past week, Brussels also announced that Pfizer would advance 50 million from the fourth quarter to the second, to alleviate the setbacks of AstraZeneca and Janssen due to side effects with cases of thrombi.

The Community Executive also announced a third contract with Pfizer for 1.8 billion doses between 2021 and 2023 in view of the variants and the need to vaccinate minors.

Brussels has signed contracts with AstraZeneca (400 million doses, although no more than 100 are expected for the first half of the year), Sanofi-GSK (300 million doses), Johnson & Johnson (400 million doses), BioNTech- Pfizer (600 million doses), CureVac (405 million doses) and Moderna (460 million doses).

The European Commission has also held exploratory talks with the pharmaceutical company Novavax with a view to acquiring up to 200 million doses and with Valneva with a view to acquiring up to 60 million doses.

.



Source link