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The European Medicines Agency on Friday continued to back the full marketing authorization for Oxford/AstraZeneca’s vaccine in light of an ongoing assessment of rare blood clots after vaccination, but noted its benefits increase with age and infection rates.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) analyzed the vaccine’s benefits and the risk of unusual blood clots with low platelets in different age groups, comparing low monthly infection rates (55 per 100,000 people), medium (401 per 100,000 people) and high (886 per 100,000 people).
“The committee showed that the benefits of vaccination increase with increasing age and infection rates,” EMA said.
The analysis looked at preventing hospitalizations, ICU admissions and deaths due to COVID-19, based on different assumptions of vaccine effectiveness. However, “there were insufficient data available from across the EU to provide further context on benefits and risks with regard to sex,” the EMA said.
The analysis “may guide EU member states when they adjust their vaccination strategies depending on the infection rates and ages of people who still need to be vaccinated,” the agency added.
The committee also recommended that people get their second vaccine dose between four and 12 weeks after giving the first. But it noted data is too limited to suggest changing current recommendations — for example, moving to a longer interval, opting to not give a second dose at all, or giving an mRNA vaccine booster.
The announcement comes after EMA’s safety committee confirmed on April 7 an association between the viral vector vaccine and rare cases of blood-clotting disorders — while emphasizing that the benefits of taking the vaccine far exceeded the risks.
With most of the blood clot cases were reported in people under 60, many EU countries have opted to restrict its use to older adults. Denmark has stopped using the vaccine entirely.
Following the announcement, Health Commissioner Stella Kyriakides said in a statement she has written to all EU health ministers to inform them of the EMA’s interim analysis. She urged the maximum possible coordination of approaches based on science, while taking into account different national situations.
Marketing authorization
At its press briefing Friday, the EMA was repeatedly quizzed on whether it would consider restricting the use of the vaccine. Its spokespeople said it would not but explained how risk varies across age groups and epidemiological conditions.
The risk of the blood clotting condition is 1.9 per 100,000 people after one dose in the 20-29 age group, they noted.
They showed data illustrating that when infection rates are low, the number of prevented hospitalizations due to COVID-19 — at 4 cases per 100,000 people — is therefore more than those of rare clot cases in this age group.
But this is not the case for ICU admissions or deaths in a low infection rate scenario. The number of blood clot cases outweighs the number of prevented ICU admission and deaths for people under 60.
“It’s important to state that hospitalization with COVID-19 is extremely serious,” said Peter Arlett, head of data analytics at EMA.
“There’s a significant benefit in terms of avoiding hospitalization of all age groups,” he added, underlining that the benefits continue to outweigh the risks for all adults over 18.
While there are too few blood-clot events in the younger age group for ICU admissions and deaths to show that benefit, “for hospitalizations the data are very clear,” he added.
Noël Wathion, deputy executive director of the EMA, pointed out that the agency would need to carry out a further benefit-risk evaluation requiring more data before making any changes to the marketing authorization.
Wathion added that AstraZeneca, as part of its conditional marketing authorization, is carrying out further clinical studies, and that the agency is continuing to collate real-world data on the vaccine.
The analysis released Friday is meant to guide EU countries decisions, since “the situation in one country is not the same as in another,” he added.
“It is too early… to consider any particular regulatory change,” he said. “We [would] need to have much more evidence in terms of benefits and risks, which then have to be weighted against each other.”
This story has been updated.
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