Europe’s New Drug Agency Head Warns of Vaccine Safety Challenges

Monitoring the safety of Covid-19 vaccines, especially those relying on novel technologies such as messenger RNA, will be one of the biggest challenges once shots are rolled out widely, according to Europe’s new drug agency chief.

Positive results won’t “remove the need to monitor very carefully these new vaccines, particularly the first couple that seem to be coming through,” Emer Cooke, who becomes executive director of theEuropean Medicines Agency Monday, said in an interview. “We haven’t had mRNA vaccines before, and when it goes into a large population you need to be sure” safety remains under review.

Cooke, the first woman to run the EMA in its 25-year history, takes over at a pivotal time as the agency grapples with both the pandemic and Brexit. Europe’s equivalent to the U.S. Food and Drug Administration is also evaluating new products such as mRNA vaccines, which essentially teach the body’s cells to make their own protection and have never been approved for use in humans.

The regulator has startedtwo accelerated reviews for potential Covid vaccines fromPfizer Inc. andAstraZeneca Plc, with the first approval expected soon. Pfizer and partnerBioNTech SE last week became the first drugmakers in the race torelease advanced trial data, saying their mRNA vaccine was more than 90% effective in preventing the illness.

More data from fellowmRNA vaccine creator Moderna Inc. is expected inthe coming days, while Astra and its partner, the University of Oxford, may also have preliminary results in the next few weeks.

While many questions remain about longevity of protection and how easily vaccines can be deployed globally, Cooke, who follows Guido Rasi in the EMA’s top spot, said she’s encouraged by the data and hopeful that strong results will help with take-up. Vaccine advocates have become concerned that fading trust in governments, political interference and the quest to create a shot in record time could fuel doubts about Covid vaccines, hindering the rollout.

“It’s one of the things I’ve been worried about,” she said. “But with promising results such as the ones we’re seeing at the moment, it should be easier to explain the benefits of the vaccines.”

Another priority is outlining its differing stance from the FDA on an efficacy benchmark for vaccines. Unlike its U.S. counterpart, the EMA has declined to put a target on how effective a vaccine must be to gain approval, opting to wait until more data are available. The U.S. agency has said any shot would need to prevent disease or decrease severity in at least 50% of those vaccinated. A paper outlining the EMA position will be published soon, Cooke said.

An Irish national with six siblings, Cooke learned the art of negotiation at an early age. After getting a pharmacy degree in Ireland, she worked at the national drugs regulator before moving on to roles at the European Federation of Pharmaceutical Industries and Associations, the EMA and the World Health Organization, where she oversaw regulation of medicines.

Cooke “has incredibly genuine Irish grit,” said Murray Lumpkin, an official at the Bill and Melinda Gates Foundation who first met her about 30 years ago when he was working at the FDA. “You get what you see.”

When Cooke, 59, applied for the role in June 2019, the prospect of a pandemic wasn’t on her mind. But experience working at the EMA during the 2009 swine flu pandemic gave her insight into managing such crises.

The same skills may also help her navigate any difficulties when the Brexit transition period ends this year. The EMA is set to lose a key partner in the U.K. regulator — traditionally a big contributor to EU drug approvals and clinical trials — and will need to find ways to plug the gap.

“It’s not a really good time for it all to come together,” said Cooke. “But on the other hand, maybe it’s also an opportunity to show how prepared we are.”

— With assistance by Gina Turner

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