European regulators could approve the first vaccine against Covid-19 this year, after a flurry of trials by drugmakers leading the race showed promising results.
“We are preparing ourselves for that possibility so that we as regulators will be ready,” Marco Cavaleri, head of anti-infectives and vaccines at the European Medicines Agency, said in an interview Tuesday. “It will be a matter of seeing whether this data could be sufficient for allowing any kind of approval by the end of 2020.”
The EMA will start working with drugmakers on a rolling review after the summer, according to Cavaleri. Trial data, manufacturing and clinical decisions will be assessed by the regulator in real time to speed up the approval process. The approach should allow any successful vaccine to be officially approved within a matter of days once submitted, Cavaleri said.
Optimism over prospects for Covid-19 jabs is growing after the University of Oxford and AstraZeneca Plc published promising results from early human tests of a shot on Monday. Vaccine partners Pfizer Inc. and BioNTech SE, as well as China-based CanSino Biologics Inc., also announced early positive data from their vaccine trials. AstraZeneca Chief Executive Officer Pascal Soriot said the company hopes to be able to start delivering a vaccine by year-end.
The first approved shot will probably be for adults only, as child testing takes longer and kids don’t appear to be as seriously affected by the disease, Cavaleri said. More research is needed on the rate of transmission by children, and the regulator will have to consider the risks and benefits of giving any vaccine to them, he said.
Efficacy Target
Unlike the U.S. Food and Drug Administration, the EMA has declined to put a target on the efficacy needed for a vaccine, opting to wait until more data is available. The FDA has said any candidate shot would need to prevent disease or decrease severity in at least half of those vaccinated to earn approval.
“For the time being it’s very difficult to define any threshold,” said Cavaleri. “We have to look at the benefit-risk of the vaccines once data become available and this precludes the possibility of being so definitive on what will be a minimal acceptable level of efficacy.”
The race to get a vaccine approved by the end of the year would also avoid a potential Brexit headache for drugmakers. Starting in January, any shot would need to be approved by both the EMA and the U.K.’s Medicines and Healthcare Products Regulatory Agency. A representative for the MHRA said the agency was “prioritizing work to support the development of vaccines and medicines” to fight the pandemic.
-Bloomberg
