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In report released by EMA’s human medicines committee (CHMP) it is recommended to continue giving a second dose of Vaxzevria between 4 and 12 weeks after giving the first one in line with the product information.
Vaxzevria (formerly COVID-19 Vaccine AstraZeneca) is authorised in the EU to prevent COVID-19, which can cause severe disease and death. The disease can also have long-term consequences in people of all ages, including in otherwise healthy people.
The benefits of Vaxzevria outweigh its risks in adults of all age groups; however, very rare cases of blood clots with low blood platelets have occurred following vaccination.
To support national authorities making decisions on how to best use the vaccine in their territories, EMA’s human medicines committee has further analysed available data to put the risk of these very rare blood clots in the context of the vaccine’s benefits for different age groups and different rates of infection.
The analysis will inform national decisions on the roll out of the vaccine, taking into account the pandemic situation as it evolves and other factors, such as vaccine availability. The analysis could change as new data become available.
The CHMP considered recommendations to give the second dose of Vaxzevria after a longer interval than the recommended 4-12 weeks, to not give a second dose at all, or to give an mRNA vaccine as a second dose.
However, there has not been enough exposure and follow-up time to determine whether the risk of blood clots with low blood platelets after a second dose will differ from the risk after the first dose. At present there are no or limited data to change current recommendations.
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