From the Italian Medicines Agency the yes to the third dose of the anti Covid vaccine for immunosuppressed subjects but also the elderly housed in long-term care facilities and health workers most at risk of exposure to the infection. For the possible reference to the totality of the population, it will be necessary for the European medicines organization to express itself first, concluding, probably within a month, the work already started.
For those studying the “booster” dose
Ema is currently studying a booster dose of the Comirnaty vaccine (Pfizer-BioNTech) to be administered six months after the second dose to people aged 16 years or older. Booster doses are given to vaccinated people (i.e. people who have completed the primary vaccination) to restore protection after it has decreased. The assessment is made on the basis of the data presented by the pharmaceutical company and the outcome – as anticipated – is expected “within the next few weeks”, unless additional information is required. Among the information provided by Pfizer-BioNTech to the examination of the Committee for Human Medicines (CHMP) of EMA there are also the results of an ongoing clinical study in which about three hundred adults with healthy immune systems received a booster dose about six months after the second dose.
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The cases distinct from the ECDC
In the debate on the so-called third dose of the anti Covid vaccine, Ema highlighted the importance of distinguishing between boosters for everyone, that is, for people with a normal immune system, and additional doses for the most fragile. In a note released on September 1 by the ECDC, the European Center for Disease Prevention and Control, and signed by Ema, it was clarified that “additional doses of Covid-19 vaccine should already be considered for people with a severely weakened immune system, as part of their primary vaccination, if they do not achieve an adequate level of protection with standard primary vaccination ‘. Instead, on the basis of current evidence, the administration of booster doses to fully vaccinated individuals in the general population was defined as “not urgent.”
It is evaluated whether to adjust times for definitive ok
“In the context of the current pandemic”, the European Medicines Agency is “proactively monitoring the progress of the studies that are part of the specific obligations” envisaged for the companies producing anti Covid vaccines that currently hold authorization for entry into conditional trading (Cma), “to assess whether any adjustments to the timing initially set for the fulfillment of these obligations would be justified on the basis of the evidence accumulated so far”. The EU regulatory body has clarified that the Cma is in any case a real authorization, granted after careful evaluation of the data on the product subject to approval. «We would like to emphasize that conditional marketing authorizations – the Agency specified – are the main EU tool for accelerating the approval of medicines during a public health emergency or to address unmet medical needs. They are provided “subjecting them to” conditions (or specific obligations) that the holder of the authorization must satisfy according to a defined schedule and are subject to annual renewal. Once all obligations have been fulfilled to the satisfaction of the EMA, the Cma can be transformed into a standard marketing authorization.
The modulation of checks
During the annual renewal exercises, or earlier if deemed appropriate, the Committee for Medicinal Products for Human Use (CHMP) verifies that the benefits of the medicinal product in question continue to outweigh the risks and that the fulfillment of specific obligations is in line with the requests. The Cma was granted at the moment by the EMA for the vaccines Comirnaty (Pfizer / BioNTech), SpikeVax (Moderna), Vaxzevria (AstraZeneca) and Covid-19 Janssen (J&J group), and the details on the specific obligations imposed on manufacturers “in context Cma are available – the authority points out – in the product information relating to each vaccine ».