Under threat of emerging variants, the EU is taking to heart lessons learned so far in the global COVID-19 pandemic to accelerate the review of vaccines, improve data sharing from clinical trials and address the difficulties inherent in the mass production of vaccines that may contain up to 400 components.

With the rapid development of the SARS-CoV-2 vaccines, “science has in a sense overtaken industry,” European Commission (EC) President Ursula von der Leyen told the European Parliament during a Feb. 10 plenary debate on the EU’s vaccination strategy.

To date, more than 17 million people in the EU have been vaccinated, but the region has a long way to go to meet its goal of vaccinating 70% of the adult population by the end of the summer, much less keep its commitments to help provide the vaccines to other parts of the world.

Ursula von der Leyen, president, European Commission

“The fact is that today we are not where we want to be in combating the virus,” von der Leyen said. “We were late in granting authorization. We were too optimistic about mass production. And maybe we also took for granted that the doses ordered would actually arrive on time.”

One of the lessons learned is the complexity of producing millions of vaccine doses in such a short time. “There is simply no way of setting up a production facility overnight,” von der Leyen said, acknowledging that in focusing on the development of COIV-19 vaccines, “overall we have underestimated the difficulties inherent in mass production.”

Having learned that lesson, the EC created a task force to step up industrial production of the vaccines. The task force is charged with identifying production problems and helping to find solutions to them. “Industry has to match the ground-breaking pace of science,” von der Leyen said.

Part of the problem is that the first vaccines authorized are new mRNA-vaccines that never before have been manufactured at scale. Von der Leyen said one of the current manufacturing bottlenecks is linked to two synthetic molecules used in the vaccines. Manufacturers have said that if they had just 250 more grams of those molecules, they could produce 1 million more doses of vaccine.

“We need more coordination on the supply of key ingredients,” von der Leyen said. “We need to improve manufacturing surge capacity, and we need to boost cooperation between the public and private sector,” especially in preparing for new mutations.

Getting prepared

To help with that preparation, the EC is launching the Bio Defence Preparedness program next week as its first action under its new Health Emergency, Preparedness and Response Authority, Commissioner Stella Kyriakides testified before Parliament.

A public-private collaboration, the preparedness program will develop and manufacture vaccines at scale “to respond to the threat of new variants more forcefully,” she said.

The preparedness agenda against emerging variants will necessitate adapting current regulations to meet new challenges, developing rapid sequencing and clinical characterization of new mutations, and systematically sharing samples and data across networks and labs. “To defeat the virus, we need to know as much detail about it as possible,” von der Leyen said.

Other actions include launching a European clinical trial network, as well as a regulatory framework that will enable the EMA to review vaccines as quickly as possible.

Stopping global spread

During her remarks to Parliament, von der Leyen justified the approach the EU member states have followed in jointly ordering and sharing vaccines. “I don't even want to imagine what it would have meant if some large member states had secured the vaccine while the rest went empty-handed,” she said, as she urged the EU to show the same solidarity with its neighbors and partners across the world.

“This is . . . a matter of stopping the spread of the virus to reduce the likelihood of mutations,” she said. “The access to vaccines for low- and middle-income countries is therefore as much about our own interest as it is about solidarity.”

Von der Leyen’s comments coincided with a joint UNICEF and World Health Organization (WHO) statement highlighting the disparities in providing COVID-19 vaccines globally. So far, 128 million vaccine doses have been administered globally, but more than 75% of those doses have been administered in 10 countries accounting for 60% of global GDP, according to the Feb. 10 statement.

Meanwhile, almost 130 countries, accounting for 2.5 billion people, have yet to administer a single dose. “This self-defeating strategy will cost lives and livelihoods, give the virus further opportunity to mutate and evade vaccines, and will undermine a global economic recovery,” the two organizations said.

UNICEF and WHO called on government leaders “to look beyond their borders and employ a vaccine strategy that can actually end the pandemic and limit variants.” They also urged vaccine manufacturers to maximize production, transfer technology to other manufacturers who can help scale the global supply, equitably allocate their limited vaccine supplies, and make it a priority to share safety, efficacy and manufacturing data with WHO for regulatory and policy review.

Despite such pleas, some governments continue to erect barriers. Last week, Pfizer Inc. said it withdrew its application for emergency use authorization in India for its COVID-19 vaccine after the country’s drug regulator required it to conduct a safety and immunogenicity study in India.

Also, the EC adopted a measure last month requiring EU member states to authorize the export of COVID-19 vaccines from companies that have EU advanced purchase agreements for the vaccines. The requirement was intended to “ensure timely access to COVID-19 vaccines for all EU citizens and to tackle the current lack of transparency of vaccine exports outside the EU,” the EC said at the time.

Von der Leyen addressed that measure during the Parliament debate, saying it was not intended to restrict companies that are honoring their EU contracts. The measure also has an automatic exemption for vaccine exports to European Economic Area countries and the rest of the European “neighborhood,” for humanitarian needs, and for the 92 low- and middle-income countries covered by COVAX.

“Europe is always ready to help. But we insist on our fair share,” von der Leyen told Parliament.