COVID VACCINE 'UNLIKELY' TO BE READY FOR USE THIS YEAR IN EU

 Bloomberg 8 0ctober 2020 - by Suzi  Ring

© Bloomberg European Medicines Agency Executive Director Guido Rasi Interview.  Guido Rasi.  Photographer Luke MacGregor/Bloomberg

(Bloomberg) -- A Covid-19 vaccine is looking “unlikely” by year-end, according to the head of Europe’s drug regulator, even as the agency conducts sped-up reviews of two front-runners for a successful shot.

“Technically, of course it’s possible. Practically it’s very difficult -- it’s very unlikely,” Guido Rasi, executive director of the European Medicines Agency, said Thursday in an interview. Even if drugmakers “submit the data in a few weeks, we are already approaching middle of October, so if we wait a few weeks and we take a minimum time of evaluation, more or less we are at the end of the year.”

Pressure is mounting globally for a vaccine as infections soar past 36 million and countries face resuming restrictions that have strangled their economies. The EMA has started two so-called rolling reviews -- real-time evaluations of data to speed up potential approvals -- of jabs from AstraZeneca Plc and the University of Oxford, and from Pfizer Inc. and BioNTech SE. In the U.S., getting a shot through by the November election, President Donald Trump’s desired deadline, also looks increasingly unlikely.

The first vaccines will probably be given conditional marketing authorizations, according to Rasi. These are temporary, one-year approvals granted when the benefit of having a product immediately available outweighs the risk of less substantial data. Regulators would need to know the duration of immunization for a vaccine before granting a full marketing clearance, he said.

European Union countries could still use national emergency powers to distribute a vaccine before the EMA approves one. The U.K. set out plans in August to amend legislation and clarify its powers so that an unlicensed Covid-19 shot could be temporarily authorized in Britain. But this could create confusion around safety, and countries would do better focusing on their vaccine distribution plans than trying to have a shot “a few days before,” according to Rasi.

“I really discourage” the thought of EU countries going it alone, he said. If a country tries to go ahead of the EMA, it might be “perceived as though this rush is not giving us all the reassurance about the safety and efficacy, so might just fuel vaccine hesitancy.”

Asked about the U.S. regulator’s decision to continue to pause AstraZeneca’s final-stage trial in America, Rasi said he thought the Food and Drug Administration was very close to releasing its opinion and didn’t see the situation as a major issue. Astra told analysts this week that it expects an update in the next one to two weeks on the trial, which was halted after a U.K. participant fell seriously ill. Tests have already resumed in the U.K., Brazil and South Africa.

Rasi will step down as head of the EMA on Nov. 15, with Emer Cooke, a former colleague at the agency, set to replace him. She has been working as head of medicines regulation at the World Health Organization.

The timing of any vaccine approval will ultimately depend on the strength of the data behind it, Rasi said. If the data appear favorable, approval “will be an easy and fast process,” said Rasi. If not, “the more time you might need to analyze, evaluate.”

More information from the leading vaccine trials could be made public this month, including results from a two-shot regimen by Pfizer and German partner BioNTech. Data from the Astra-Oxford global trials may also be published in the coming weeks.