This article is part of our special report Transparency in the race for a COVID vaccine.
EU lawmakers from across the political spectrum stressed the need for transparency in the COVID-19 vaccine process in a hearing with pharmaceutical industry representatives, emphasising that this is necessary to combat a growing vaccine hesitancy in the EU.
The hearing was co-hosted by the health (ENVI) and industry (ITRE) committees at the European Parliament on Tuesday (22 September).
It was called to explore the ways to secure access to COVID-19 vaccines for EU citizens after MEPs requested more information about the advanced payment agreements (APA) signed between the European Commission and a growing number of pharmaceutical companies.
These agreements cover part of the upfront costs faced by vaccine producers, allowing investments to be made that might not otherwise have occurred, while also acting as a down-payment on the vaccines that will actually be purchased by member states.
Most recently, pharmaceutical companies Sanofi and GlaxoSmithKline (GSK) finalised an APA with the Commission for the supply of up to 300 million doses of a COVID-19 vaccine once it is approved.
However, while MEPs welcomed the collaborative efforts made so far to accelerate the development and subsequent rollout of a COVID-19 vaccine, questions were raised as to the transparency of these agreements, with a number of lawmakers pointing out that these have not been made publicly available as of yet.
Members lamented that they have had “very little information from the Commission with regards to the content of these contracts,” with MEP Pascal Canfin calling this a “fundamental part of democratic accountability”.
This concern over transparency comes on the back of a recently published joint statement from leading health NGOs calling for more transparency on the governance of the APAs.
“At this crucial stage in the development of one of the main elements of the EU’s response to COVID-19, trust and accountability need to be upheld in order to safeguard and promote public health, the quality of healthcare systems, patient and consumer safety,” the statement said.
In response to MEPs’ concerns, two of the companies leading the charge in the race to find a COVID-19 vaccine, Sanofi and CureVac, agreed to participate in the hearing alongside representatives from academia and specialised medical groups.
Transparency vital for trust
Green MEP Petra de Sutter stressed that this lack of transparency “undermines public trust” in pharmaceutical companies as a responsible partner, while the socialist MEP Tiemo Wölken raised concerns over its contribution to a growing vaccine hesitancy in the EU, saying this is something the EU “cannot afford”.
In response, Thomas Triomphe, executive vice president of Sanofi, stressed that although the exact content of the contact is currently still under confidentiality, the contract was agreed in full accordance with the normal EU process for a call for tender for the development and manufacturing of a vaccine.
Industry representatives stressed their commitments to transparency, with Triomphe outlining Sanofi’s commitment to providing auditable reports to the EU for each step.
Likewise, Jean Stéphenne, chairman of the supervisory board of CureVac, emphasised the “joint responsibility for transparency,” offering a commitment that all data will be made publicly available.
‘Fragile’ vaccine confidence
Sue Middleton, president of Vaccines Europe, a specialised vaccines group within the European Federation of Pharmaceutical Industries and Associations (EFPIA), also emphasised the commitment of the industry to produce a vaccine in line with proper procedural processes, stressing that this is vital to counter vaccine hesitancy.
She highlighted the recent pledge made by nine CEOs of companies developing COVID-19 vaccine candidates to uphold the integrity of the scientific and regulatory process, including a commitment to apply for vaccine approval only once clinical trials which met regulatory requirements of expert authorities were successfully concluded.
She said the pledge was made for companies to play their role in building confidence in these vaccines, warning that this confidence is “fragile” in many EU countries.
Middleton added that EU authorities must also lay down preparations in the event of adverse effects, either directly or indirectly, as a consequence of the COVID-19 vaccine, which she warned may be likely given the unprecedented scale of this vaccine campaign.
“How we collectively handle this will be key to building or reducing confidence in the COVID vaccine,” she warned, adding that there may well be knock-on effects for vaccine confidence in future.
“One practical approach to building confidence would be to allow any EU citizen who believes they may have been harmed by the vaccine to seek compensation quickly via a no-fault compensation system,” she said.
She added that although this was already in place in 11 member states, not all of these schemes automatically translate to the COVID-19 vaccine.
[Edited by Zoran Radosavljevic]