EMA official says COVID-19 vaccine could be approved in a year

Regulatory NewsRegulatory News | 14 May 2020 |  By 

A vaccine against SARS-CoV-2, the novel coronavirus scourging the globe, could be approved in the European Union in about a year, Marco Cavaleri, the European Medicines Agency’s top official overseeing anti-infectives and vaccines, said Thursday.
Cavaleri cautioned that this is an optimistic view but said the ambition is to have a vaccine approved next Spring and that he is skeptical of claims that a vaccine could be ready by September.
“I have to stress that this is a best-case scenario,” he said during a virtual press conference, noting that not all development efforts will bear fruit, and there is always the potential for unforeseen delays.
Cavaleri also said that EMA expects all vaccines to prevent coronavirus disease (COVID-19) will be studied in large Phase 3 trials before approval and noted that EMA would be open to reviewing data from challenge studies, where volunteers are intentionally infected with the virus, if such studies were found to be ethical.
“As regulators, we are going to be very careful in having a good assessment of the safety and efficacy of these vaccines, and therefore we will not be cutting corners,” he said.
For drugs, approval could come sooner as many products being studied to treat COVID-19 are already approved for other indications or have been studied in humans for other conditions.
“It might be possible that before the summer, some of these therapeutics could be approved,” Cavaleri said, noting that we have already seen topline trial results for some products. Earlier this month, EMA announced it had started a rolling review of Gilead Sciences’ remdesivir after preliminary results from a US study found patients taking the drug recovered faster than those on placebo. (RELATED: EMA kicks off rolling review of Gilead’s remdesivir, Regulatory Focus 1 May 2020).
Cavaleri emphasized that EMA has been working closely with other regulators through the International Coalition of Medicines Regulatory Authorities (ICMRA) to ensure alignment on regulatory expectations for drugs and vaccines for COVID-19.
“This is very important because we all recognize the importance in being aligned in the requirements and what we can do in order to speed up the development of vaccines and therapeutics in the context of COVID-19,” he said.
EMA has been in contact with developers regarding roughly 115 therapeutics and 33 vaccines, according to Marie-Agnes Heine, Head of Communications at the agency.


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