Pfizer vaccine, EMA or the European drug agency “will discuss whether the available data can support a conversion of the conditional authorization” granted to Pfizer / BioNTech’s Covid vaccine “into a full authorization”. Qualified sources report this to Adnkronos Health.
After the final ok received in the US by Comirnaty * (green light that has passed the emergency authorization allowing the marketing for the prevention of Covid in the over 16), the question that everyone has asked is: when this step will also take place in Europe ? It should be noted that, compared to the emergency use approvals that other regions of the world have used, Covid vaccines have received marketing authorization from the beginning in the EU. To be precise, a conditional authorization (Cma).
The authorizations of this type, granted to the 4 vaccines approved in the EU, “are provided – as the EMA pointed out when asked about it – with specific obligations. We have established a calendar for each vaccine within which we expect the presentation of the latest data. pending: for all these will be the final clinical trial reports of the pivotal study and can only be submitted when the long-term follow-up on safety and efficacy that has been enforced has ended. For Comirnaty the final reports should be presented in December 2023 “. The time horizon is therefore this. “It is the starting point, but we will discuss it again,” explained the source.
In any case, this is how it works in the EU: conditional authorizations for marketing are “accompanied by all the guarantees, controls and corresponding obligations”. They immediately become valid in all EU member states at the same time and provide a “scientific basis for introducing vaccination programs and a continuous framework for vaccine control and supervision”.
These authorizations are “subject to annual renewal, during which the EMA CHMP committee verifies that the benefits of the medicinal product in question continue to outweigh the risks and that the fulfillment of the specific obligation” required by the conditional authorization is on the good side. Once all obligations have been met to the satisfaction of the experts, the committee may recommend that the Cma be transformed into a full marketing authorization (this is typically the result of one of the renewal exercises annual)”.