EU regulator finds benefits of Oxford/AstraZeneca vaccine increase with age and infection rates – POLITICO

The European Medicines Agency today 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.

This article is part of POLITICO’s premium policy service: Pro Health Care. From drug pricing, EMA, vaccines, pharma and more, our specialized journalists keep you on top of the topics driving the health care policy agenda. Email [email protected] for a complimentary trial.