Europe’s new drug agency head warns of ‘vaccine safety’

Bloomberg

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 became executive director of the European Medicines Agency (EMA) on Monday, said. “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 US Food and Drug Administration (FDA) 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 started two accelerated reviews for potential Covid vaccines from Pfizer Inc. and AstraZeneca Plc, with the first approval expected soon. Pfizer and partner BioNTech SE last week became the first drugmakers in the race to release advanced trial data, saying their mRNA vaccine was more than 90% effective in preventing the illness.
More data from fellow mRNA vaccine creator Moderna Inc is expected in the 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 dffering stance from the FDA on an efficacy benchmark for vaccines. Unlike its US 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 US 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.