The first vaccine against the coronavirus disease could be approved by the European regulators this year, after a couple of trials by drugmakers leading the race showed encouraging results.
According to Bloomberg, the head of anti-infectives and vaccines at European Medicines Agency, Marco Cavaleri, said, ‘’We are preparing ourselves for that possibility so that we as regulators will be ready. It will be a matter of seeing whether this data could be sufficient for allowing any kind of approval by the end of 2020.”
Cavaleri said that the EMA will start working with drugmakers on a rolling review after the summer. He also said that 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.
The EMA has, however, refused to set a target on the efficacy needed for a vaccine, opting to wait until more data is available, unlike the US Food and Drug Administration (FDA). The FDA has said that any vaccine candidate shot would need to prevent disease or decrease severity in at least half of those vaccinated to earn approval.
Going further, Cavaleri said, ‘’For the time being it’s very difficult to define any threshold. 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.”
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The backstory
Recall that there has been growing optimism over prospects for developing a vaccine for COVID-19 following the publishing of positive results by University of Oxford and AstraZeneca Plc 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 own vaccine trials. AstraZeneca Chief Executive Officer Pascal Soriot said the company hopes to be able to start delivering a vaccine by the end of the year.
What this means
The race to get a vaccine approved by the end of the year would also avoid a potential Brexit headache for drugmakers. With effect from 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.
