A Health column to answer readers’ doubts about Covid. A way to examine news and information that sometimes turn out to be hoaxes. Here is a question that came to the editorial office. If you have any questions to ask the editorial staff, write to: [email protected]
Request
I often hear that Sars-CoV-2 vaccines were prepared too quickly and are not safe. Is that so?
Reply
No, this is not the case because this time the process to approve them has speeded up, making some bureaucratic steps faster. Before authorizing i vaccines against Covid-19 the competent authorities have verified their quality and safety. Candidates were asked and performed the same tests as other previously approved drugs and vaccines.
The realization of a new vaccine sometimes takes a very long time, the results of the various experimental phases arrive in a single block, at the end, and are included in a formal application for marketing authorization by the company that produces.
Faster process in pandemic
During the pandemic, the‘process has been speeded up, thanks to a particular data review system called Rolling review. Translated: cyclical revision, i.e. continuous. The Ema (European Medicines Agency) defines it as “a regulatory tool to speed up the evaluation of a promising drug during a health emergency”. One of its bodies, the Committee for Medicinal Products for Human Use (CHMP), examines the data as it is provided by the various studies and, once it considers the information available to be sufficient, the vaccine manufacturer can submit the formal application. .
Covid, mRna vaccines do not change our genome
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The pandemic task force
EMA is also supported by its Pandemic Task Force (Covid-Etf), a group of experts from the medicines regulatory network that advises on the development, authorization and safety monitoring of drugs and vaccines for Sars-CoV-2. . The benefit is a faster and better coordinated regulatory process.
Monitoring
Like all vaccines, even the one against Sars-CoV-2 can cause undesirable effects. The belief that security monitoring will only take place once the campaign is over is wrong. For any drug, the experimentation does not end with its commercialization, because phase 4 is entered, called post-marketing surveillance: safety and any secondary effects are evaluated on a constantly increasing population sample. Manufacturing companies typically send a report to the European Medicines Agency every six months. For vaccines against the Sars-Cov-2 virus, however, this dossier is monthly. Furthermore, given the large number of immunized subjects, the EMA will arrange further large-scale controls.
There is another aspect to consider: with regard to vaccines based on a viral vector (for example AstraZeneca and Johnson & Johnson), it was possible to take advantage of a known and already used development technology, which helped to shorten the time.
Source: Ema, Ecdc, Iss
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