Representatives of the pharmaceutical industry involved in the development, production and delivery of the Covid-19 vaccines ordered by the EU came to profess their good faith on Thursday 25 February before MEPs on the industry and public health committees.
Representatives from AstraZeneca, Moderna, CureVac, Novavax, Johnson&Johnson, Pfizer and Sanofi all repeated over and over how their teams are mobilised “24 hours a day, 7 days a week” to produce as many vaccines as possible and how complicated it is to do this in such a short period of time.
AstraZeneca especially in the sights
AstraZeneca was the subject of many questions from MEPs. The company is indeed under fire for having delivered only half of the doses promised in the first quarter, i.e. 40 million, and for having announced this week that it would not produce in the EU half of the doses that will be delivered in Europe in the second quarter, contrary to what was planned (these doses are expected to be produced in the United States).
In response, AstraZeneca CEO Pascal Soriot said he was very saddened by the current delivery delays, reiterating that they are due to manufacturing problems. “The reason for the lower than expected supply is lower than expected productivity, unfortunately”, he explained. According to him, the quantity of doses that can be extracted from a litre produced in a bioreactor varies from one production site to another, with a ratio of one to two.
Asked to explain a possible exclusivity of delivery between the company and the United Kingdom, as he mentioned in an interview at the end of January, Pascal Soriot replied: “The overwhelming majority of what is manufactured in the EU (including the Netherlands) is going to EU supply”, adding that the Dutch manufacturer’s production was originally reserved for the UK. “This is definitely what I call sharing!”
A slightly more precise schedule
The hearing also gave a clearer idea of the timetable for vaccines that have not yet been authorised.
As a reminder, at this stage, only vaccines from Pfizer/BioNTech, Moderna and AstraZeneca are authorised in the EU. The Commission has also concluded contracts with Sanofi-GSK, Johnson&Johnson and CureVac, and is in talks with Novavax and Valneva. In her introduction, however, Health Commissioner Stella Kyriakides said: “We stand ready to update or conclude new advance purchase agreements and to tackle any bottlenecks”.
At the hearing, CureVac’s CEO Franz-Werner Haas said he expects “conditional market approval in late May/early June”. Sanofi expects to enter a phase 3 clinical trial in the second quarter of 2021 and to receive approval in the fourth quarter. Novavax CEO Stan Erck refused to comment, but pointed out that the European Medicines Agency was already analysing the data on an ongoing basis. Eventually, “we will be able to produce 2 billion doses per year and 150 million per month”, he said.
A message to EU leaders
The hearing was held on the sidelines of a videoconference of European heads of state and government on the Covid-19 pandemic, which aimed in particular to identify ways of speeding up the production and delivery of vaccines.
Johnson&Johnson CEO Paul Stoffels answered this question with one word: “Collaboration!”, adding that his company is working tirelessly to build three production plants in the EU, the US, and Asia, and is in contact with seven different fill and finish companies. He concluded: “We believe that J&J will meet its commitment of 200 million doses for the EU in 2021”. CureVac also boasts a pan-European collaboration with more than 15 partners across Europe. The company, said Franz-Werner Haas, is aiming for 300 million doses in 2021 and 1 billion in 2022. As for Moderna, the company pointed out that the substance is manufactured in Switzerland, finishing is carried out in Spain and soon in France, while distribution is carried out from Belgium.
For all CEOs, echoing a position paper published the previous day by the Federation of Pharmaceutical Industries and Associations (EFPIA), however, the removal of intellectual property rights (compulsory licensing) is not an appropriate response. “The problem with intellectual property and patent sharing is not about sharing patents, but about moving to large manufacturing capacity”, said Pascal Soriot of AstraZeneca.
Export mechanism and transparency
Finally, the hearing addressed issues of transparency. “This is the dualstrategy of the European Parliament: support for the European negotiating framework (nothing would have been worse than 27 competing frameworks) and the demand for transparency at all levels”, warned the chair of the Public Health Committee, Pascal Canfin, in his introduction.
At this stage, however, only four contracts have been published, in redacted form. The CEO of CureVac was pleased that his company has shown the way. “We think that’s the way it should be!” said Franz-Werner Haas. For her part, Angela Hwang said that Pfizer is working with the European Commission to also make public a redacted version of its contract with the EU.
Finally, several CEOs have condemned the EU’s export transparency mechanism. Angela Hwang (Pfizer) clearly expressed her opposition, stressing that it is very important to be able to import and export worldwide. For his part, Franz-Werner Haas (CureVac) indicated that his company had been penalised by this mechanism. “Export controls affected us in some ways, because we couldn’t get clinical trial materials in Latin America”, before indicating that this had caused a delay of a week. For its part, AstraZeneca played the good pupil, indicating that it “fully agrees to use this mechanism”. Urged to put rumours to rest, Pascal Soriot said the mechanism had been used “to export samples to Mexico to show them that the vaccine manufactured in Los Angeles is the same as the one in Europe”. (Original version in French by Sophie Petitjean)