Addressing Parliament’s ENVI and ITRE committees on “How to secure access to COVID-19 vaccines for EU citizens,” Sweeney told MEPs that while the development of a safe vaccine was the priority, controlling the virus will require other public health measures being taken at the same time.
He said the European Medicines Agency (EMA) was currently in contact with 150 “candidates” who are developing potential vaccines. Human trials began in April and efforts had been made to “significantly shorten” the time needed to approve any vaccine.
He stressed that approval must be based on scientific evidence and that safety was of paramount importance “as a vaccine will be given to millions of people.”
Authorisation will be granted only “when it can be shown that the benefits are greater than any risks.”
He said, “Vaccines have risks and benefits and, even once the EU grants marketing authorisation, no one vaccine will be 100 percent safe. Significant resources at the EMA are being allocated to this task and we will do whatever we can to tackle it.”
Members of both committees heard from key players representing the pharmaceutical industry, academia and civil society, addressing the challenges the EU faces about deployment of a future vaccine.
“Vaccines have risks and benefits and, even once the EU grants marketing authorisation, no one vaccine will be 100 percent safe” Fergus Sweeney, EMA
The debate focused on adequate clinical trials, speedy manufacturing and commercialisation as well as equitable distribution of a safe vaccine across the EU.
Another keynote speaker, Professor Robin Shattock of the faculty of Medicine at the Department of Infectious Disease, Imperial College London, said it had been developing a potential vaccine with human clinical trials involving 400 volunteers since June.
The aim, he said, is for much larger trials involving up to 20,000 people, by the end of the year.
He said, “So far, the patients have responded well but any vaccine will only be rolled out if we can be sure that it is safe and effective.”
International clinical trials are due to start later this year with potential approval by mid-2021, he told the committees.
“If successful this could change the way we tackle future pandemics.”
“We are all in a race against the virus and not against each other. The more vaccines that pass the finishing line the better it will be that there is global access to a vaccine” Professor Robin Shattock, Imperial College London
He pointed out that their work had received £40m from the UK government and £5m from philanthropic groups to support this work.
“If we can find a vaccine it will be distributed by a not-for-profit social enterprise that we have established and that will waive all royalties. The aim should be to make a vaccine available in less wealthier parts of the world.”
He noted that Imperial College, in the past, had received €23m from the EU’s Horizon programme for an HIV vaccine.
Shattock told MEPs, “We are all in a race against the virus and not against each other. The more vaccines that pass the finishing line the better it will be that there is global access to a vaccine.”
He warned, “We should bear in mind that this is not the first global pandemic and almost certainly it will not be the last so we need international cooperation to fund vaccine technology. This is crucial.”
Thomas Triomphe, Executive Vice-President at Sanofi, said his company has made “significant” investment and was “mobilising our resources and expertise.”
“We want to ensure access to any vaccine for all EU citizens and that is why we have recently signed a purchase agreement with the Commission which will provide up to 300 million doses for people in Europe” Thomas Triomphe, Sanofi Executive Vice-President
There has been an “unprecedented” partnership with GSK - “a traditional competitor for us” - with clinical studies for a vaccine underway.
He said, “We want to ensure access to any vaccine for all EU citizens and that is why we have recently signed a purchase agreement with the commission which will provide up to 300 million doses for people in Europe.”
“This task is both critical and urgent because this pandemic has killed nearly one million people worldwide. It has also destroyed livelihoods and wrecked economies. But there is some reason for hope and optimism because there has been significant progress in our understanding of the disease.”
“The more of us who engage in these kinds of partnerships the higher the chance will be of success. But we must not compromise on safety.”
He said that the sector faces “unprecedented challenges” and the scale of the crisis, “means that sufficient numbers of vaccines must be produced.”
Triomphe also emphasised the “urgency” of the challenge, saying “we are trying to do in one or two years what it usually takes a decade to accomplish. This accelerated scale-up will only be possible if the EU and Member States are willing to share on investment.”
He said the agreement with the Commission was a “social contract,” adding, “we are committed to developing a vaccine and making it widely available. This is our obligation to society.”
He concluded, “We must also look beyond this crisis, learn the lessons and prepare for the next pandemic. This fight against the virus is very personal for our own employees whose lives have been transformed. Some colleagues have lost their personal battle against Coronavirus so our determination on this is very strong.”
Jean Stéphenne, chairman of the Supervisory Board at CureVac, a biotech company, spoke of the need to work closely with the authorities to ensure the safety and efficacy of any vaccine.
He suggests that as many as 30,000 to 50,000 people need to be involved in any trials in order to demonstrate this.
“Because of the scale of the problem it may be necessary to start production without having all the results of clinical trial. A vaccine is the only way to control this crisis and for us to go back to a normal life.”
He added, “I still believe that a vaccine will be ready in 6 to 12 months.”
ENVI committee chair, French RE member Pascal Canfin, said it was important for MEPs to know “what the Commission has actually signed up to with these pharma companies.”
“We have had little info from the Commission on this so far regarding these contracts. This is a matter of transparency.”
ITRE chair, Romanian EPP member Cristian Silviu Bușoi, said, “Any vaccine should be both affordable and safe and we must have a strong assurance that all Member States will receive their vaccine dosage without delay. Beyond this crisis, it is clear we need more research and innovation to avoid a future crisis and to be better prepared.”
An estimated 2 billion doses of future vaccines have already been ordered by “high income” countries and Médecins Sans Frontières (MSF) says it is “deeply concerned about an inequitable” global distribution of future COVID-19 vaccines possibly “leaving many other countries empty-handed.”
In order to control COVID-19 over the long term, an international, rather than nationalistic, response is needed.
MSF has called on the EU “to take actions to ensure equitable distribution of COVID-19 vaccines based on the World Health Organization’s (WHO) fair allocation mechanism and provide political and financial support to the COVAX facility established to provide vaccines to the 92 poorest countries in the world.”
Meanwhile, members of the Transport and Tourism Committee debated the crisis on Wednesday.
Lola Cardenas, representing the World Tourism Alliance, told members that the sector represents 1 in 10 jobs in the world, “so it is a very relevant sector.”
She said that worldwide, so far, some 50 million tourism jobs had been lost, adding, “we are now heading to a worst-case scenario if cases continue to rise, with a total of 197 million jobs projected to be lost by the end of the year globally.”
“Our alliance is now calling for comprehensive testing and tracing and the removal of travel restrictions. This is needed to restore confidence in travel and we have to realise that the recovery will depend on travel and tourism.”
Juan Marin, a travel expert from Andalusia in Spain, said, “Tourism is very important for jobs in our region which very much depends on this sector.”
Spanish RE deputy José Ramón Bauza Díaz said, “I hope the Commission will note how important tourism is. Business in the sector has been four times less than normal but, so far, the EU has failed in its response to the tourism sector.”
Greek GUE member Elena Kountoura said, “The tourism industry faces a huge crisis and we must protect the workers and SMEs in this sector. If we don’t deal with this now we will have a catastrophe because the virus is rearing its head again in Europe.”
On Wednesday, Parliament’s Tourism Task Force said the sector “is on the verge of collapse.”
A statement said, “More than six months have passed in this emergency situation, yet there are still no common criteria in the EU on how to handle and live with this pandemic: no universal hygiene and health protocols, no common rules for testing or on how to assess the risks, no adhering to the free movement principle.”
“Even when travelling is partially possible, the wide array of rules make it extremely difficult. People are confused and have no guarantees that their planned trips can and will go ahead. The tourism sector, that employs 22 million people in Europe, is on the verge of collapse. This is no small threat: depending on the country, tourism accounts from 4.3 percent to 25 percent of the GDP.”