AIFA authorizes the AstraZeneca vaccine for the prevention of COVID-19 disease in individuals over the age of 18, as per EMA indication.
"The arrival of a third vaccine represents an important contribution to the ongoing vaccination campaign", comments AIFA DG Nicola Magrini and "AIFA has provided indications for optimizing the use of existing vaccines by making the most of their different characteristics".
The Agency's Technical-Scientific Commission (CTS), which met today, January 30, 2021, confirmed the EMA's assessment of the efficacy (59,5% in reducing symptomatic COVID-19 infections) and on the benefit / risk ratio favorable of the vaccine. We therefore have a valid additional option in combating the pandemic, also in consideration of the greater manageability of use of this vaccine.
It is a tool that strengthens the vaccination campaign in Italy and, although the available data indicate a lower efficacy than that of the other two vaccines available, the comparison between the three vaccines is difficult, given the diversity of the populations studied and the need to complete their studies.
In particular, the data from the registration studies of the AstraZeneca vaccine show a level of uncertainty in the estimation of efficacy in subjects over 55 years, as this population (in which however a good antibody response was observed) was poorly represented.
In an attempt to contextualize the best conditions of use of this vaccine compared to the other available vaccines (BioNTech / Pfizer and Moderna) and underlining that a conclusive evaluation can only take place at the end of the ongoing clinical trials, the CTS suggested:
1. A preferential use of messenger RNA vaccines in older and / or more frail subjects. For the definition of specific risk categories, please refer to the provisions of the strategic plan for the anti SARS-CoV2 / COVID-19 vaccination of the Ministry of Health.
2. A preferential use of the AstraZeneca vaccine, pending the acquisition of further data, in subjects between 18 and 55 years, for which more solid evidence is available.
Finally, the Commission reserved the right to provide precise indications on more specific aspects, such as the interval between the administration of the two doses, following further investigations.
“We have another weapon against the pandemic - observes President Giorgio Palù in conclusion - Others will soon be added. An integrated approach between vaccines and COVID-19 therapies currently in use and in experimentation is desirable ”.