EMA considers AstraZeneca vax; Swissmedic okays Moderna's

Regulatory NewsRegulatory News | 12 January 2021 |  By 

The European Medicines Agency (EMA) could issue an opinion on the COVID-19 vaccine co-developed by AstraZeneca and the University of Oxford as early as 29 January, according to a press release the agency issued on Tuesday.
The agency announced that it has received the full application packet for conditional marketing authorization of the chimpanzee adenovirus vector vaccine following a rolling review that began 1 October.
The AstraZeneca vaccine, already authorized for use in the UK, was the first to be accepted into EMA’s rolling review scheme. In December 2020, the agency’s human medicines agency (CHMP) asked for additional “scientific information on issues related ot quality, safety and efficacy of the vaccine,” according to the press release. That additional information is currently under consideration by CHMP.
In interim analysis of four clinical trials, effectiveness for AstraZeneca’s COVID-19 vaccine was lower than that seen for the two messenger RNA (mRNA) vaccines currently authorized in the EU and the US, ranging from 62% to 90% depending on the trials.
One trial inadvertently used a different dosing scheme for the two-dose series: a subset of participants received a lower dose for the prime vaccination and a full dose for the booster. For these patients, the vaccine was 90% effective. The vaccine had a good safety profile, and though its effectiveness thus far falls short of the approximate figure of 95% seen for mRNA COVID-19 vaccines, it is still above the 50% bar set by FDA and other regulators.
Another European regulator, Swissmedic, has temorarily authorized the mRNA vaccine co-developed by Moderna and the US National Institutes of Health. The Moderna vaccine had been under review with the agency, which had previously granted a similar temporary authorization the Pfizer-BioNTech mRNA vaccine, since November 2019.
“This means that a second COVID-19 vaccine has satisfied the strict requirements for safety, efficacy and quality and can be used with immediate effect in Switzerland,” wrote Swissmedic in announcing the second approval.
"The rapid, but at the same time conscientious, review in the rolling procedure has proved very successful. This is another important step forward in enabling a large proportion of the population in Switzerland to be vaccinated quickly against COVID-19," said Swissmedic Executive Director Raimund Bruhin.
Although longer dosing intervals than the recommended 28 days have been okayed during the pandemic by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), Swissmedic explicitly ruled out stretching out the dosing interval and sticking with the one-month gap between prime and boost. “In line with the latest data, Swissmedic recommends keeping to this vaccination interval and not deferring the second dose of the vaccine as mentioned in the product information,” wrote the agency, which also advised sticking with the same vaccine for both doses, rather than adopting a mix-and-match approach.
Because Moderna had no previous drug products authorized in Switzerland, the firm’s Swiss branch first had to obtain an establishment license. “Swissmedic granted the license partly on the basis of a successful inspection of Moderna’s Swiss plant,” according to the press release.


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Tags: coronavirus, EMA, EU

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