The U.S. Food and Drugs Administration (Fda) has definitively approved Pfizer / BioNTech’s Covid vaccine.
The vaccine has so far been used in the US thanks to an emergency authorization from the FDA. The FDA is also considering the full approval of another Covid vaccine produced in the United States, that of the pharmaceutical company Moderna. On the latter, the final decision could come in a few weeks.
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What could change in the United States
Pfizer’s final approval is expected to trigger the vaccination requirement for employees in many public and private organizations that have been waiting for this step to introduce it.
Federal and state health officials also hope that full approval will convince those Americans who have so far not vaccinated precisely out of skepticism of the emergency ok.
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The authorization process in the European Union
The European Commission granted conditional marketing authorization for the vaccine developed by BioNTech and Pfizer on 21 December 2020. The conditional marketing authorization (CMA) certifies that the safety, efficacy and the quality of the vaccine is proven and that the benefits of the vaccine outweigh the risks, while allowing developers to submit additional data on the vaccine even after marketing authorization (as opposed to normal authorizations, for which all data must be submitted prior to release).
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The difference between emergency authorization and conditional authorization
Conditional Marketing Authorization (CMA) provides safeguards that an emergency authorization may not offer. In reality, the emergency use authorization does not authorize a vaccine, but the temporary use of an unauthorized vaccine. On the one hand, the CMA ensures that all pharmacovigilance and manufacturing controls, including batch controls for vaccines and other post-approval obligations, are carried out in a legally binding manner and are regularly evaluated by EMA’s scientific committees. and, on the other hand, the possibility of having recourse to regulatory action if necessary.
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An emergency use authorization, as stated on the European Commission’s website, allows the temporary use of a medicine under certain conditions, as long as emergency circumstances arise. Unlike in the case of a conditional marketing authorization, the medicine remains unauthorized and cannot be placed on the market.
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In Italy
As of December 2020, the European Medicines Agency (EMA) has recommended the provisional granting of conditional marketing authorizations for COVID-19 vaccines. AIFA acknowledged the European decisions, authorizing the use of the vaccine on the national territory.
The hoax of the revocation of the authorization denied by the AIFA
In recent days, AIFA had to deny the totally false news according to which, following the authorization by the Agency for the use of some monoclonal antibodies against COVID-19, the marketing authorization of the vaccines would have failed Covid issued by the EMA.
This news, which is circulating on some internet sites and on social networks, is completely without foundation, explains Aifa in a note: the authorization of some therapeutic indications of monoclonal antibodies by Aifa, has no correlation with the authorizations for COVID-19 vaccines, “which remain perfectly valid”.
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