The European Parliament’s Special Committee on Covid-19 heard from representatives of companies that have developed vaccines against Covid-19 authorised in the European Union.
Dr Rudolf Ertl, Senior Vice President of Commercial Operations at Gilead, outlined the steps the company took when SARS-CoV-2 emerged. Mr Ertl described Covid-19 as a complex disease. He assessed the European approach favourably: “This is the approach that allows us to deal with this type of challenge”, he said, adding that it was “a good learning exercise to see what could be done under pressure”.
Asked by several MEPs about Remdesivir, including Jutta Paulus (Greens/EFA, German) and Véronique Trillet-Lenoir (Renew Europe, French), among others, why the company had shared the results of the Solidarity trial - deemed inconclusive - with the European Commission only the day after the contract was signed, Mr Ertl said that the drug had shown a reduction in hospital stays after other placebo trials. Mr Ertl said Solidarity was not a controlled trial and that the effect of the drug was more apparent in some patients and with early treatment with oxygen. In his view, the WHO had not made this distinction.
Thomas Triomphe, Executive Vice-President of Vaccines at Sanofi, believes that the Covid-19 vaccine developed with GSK is ready to be used as a fourth booster dose. He hopes for a rapid market authorisation. He added that, in line with the advance purchase agreements, the company had tried to see what could be done at the European sites to enable the delivery of doses to those EU countries that had already placed some orders as soon as authorisation was granted.
Mr Triomphe said that at present, Covid-19 vaccine production capacity is significantly higher than what can be administered (12.1 billion versus 1.2 billion). For him, the challenge is no longer the provision of vaccines, but the implementation of vaccination campaigns.
He identified five important elements for the EU: - maintaining regulatory flexibility until the end of the pandemic for future generations of vaccine. He believes that the system set up by the European Medicines Agency has been fundamental in speeding up the availability of vaccines; - public-private collaboration to foster investment in research and clinical development in the EU. Mr Triomphe hopes that the European Health Emergency Preparedness and Response Authority (HERA) will be ambitious on this point. However, he believes that HERA does not yet have the necessary budget and tools; - the establishment of sustainable networks to implement a wide variety of technologies in times of crisis; - the removal of supply and trade barriers that affect the production process and increasing the efficiency of public procurement. Mr Triomphe said he had appreciated dealing with the European Commission as a single point of contact, but would like to see generic conditions for public procurement; - better developing international collaboration to accelerate business development plans.
Iskra Reić, Executive Vice-President of Astra-Zeneca in Europe and Canada, called for higher investment in research by governments in collaboration with industry. She believes that HERA can play this role of accelerator. She also calls for an improvement in terms of regulation to strengthen the EU’s contribution.
Ms Reić welcomed the EMA’s accelerated process. She called for improved digital infrastructure for clinical trials and increased spending by Member States on prevention. She also said she wanted “a change of mindset so that health is seen as a strategic asset to invest in and not as a cost”.
As for non-compliance with the contract signed with the European Commission, Ms Reić cites “a pre-existing contract” with the British government which the firm had to honour. She also spoke of “confusion” and “lack of clarity” over this breach of contract which led to legal action. “Astra-Zeneca regrets the Commission’s decision to launch the proceedings”, she said.
Stéphane Bancel, CEO of Moderna, recounted the company’s trajectory. He does not see the recent lifting of patents by the World Trade Organization as helpful and said that this could have dangerous long-term implications for the company: in his view, if a lifting of intellectual property rights had taken place earlier, Moderna or BioNTech would not have been able, without profit, to raise capital, grow to the size they are today and be ready for the pandemic.
He echoed Mr Triomphe’s statements, reiterating that the current problem was no longer one of vaccine supply. On this issue, regarding the patent infringement lawsuit against Pfizer-BioNtech, Mr Bancel said that Moderna was not going to seek royalties from low-income countries or withdraw Pfizer-BioNtech-produced vaccine doses from the market, but that Moderna had initiated the lawsuit because it felt it was the right time to do so, now that supply issues were no longer an issue. (Original version in French by Émilie Vanderhulst)