What is an emergency approval for corona vaccines?

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The term „emergency approval“ that is often used at the moment is misleading and actually also wrong. Because in truth, the corona vaccines, for which approval has been applied for from the European approval authority EMA, are not an emergency, but a conditional approval.

Such a „Conditional Marketing Authorization“ (CMA) has in principle been in existence for a long time and manufacturers then apply for this form of approval if there is an unmet medical need for it, but not all the necessary data for a regular approval are available.

In any case, the data on the basis of which the European Medicines Agency (EMA) grants a conditional marketing authorization must show that the advantages and benefits of the immediate availability of a vaccine (or a drug) outweigh the risks for the patient.

Once a CMA has been granted, companies must provide additional data from ongoing or new studies within predetermined deadlines to confirm that the benefits continue to outweigh the risks. The ultimate goal is to achieve regular approval.

Although a vaccine was recently approved by the British authority “for an emergency”, this is not valid for the EU. The EMA will – hopefully – grant the conditional approval for the European market.

Additional information:

More details on the role of the authority in the development and approval process of a vaccine (AGES – Austrian Agency for Health and Food Safety)

General overview of the types of drug and vaccine approval processes.

Who grants approval for a corona vaccine and what happens next?

If the EMA Committee for Medicinal Products for Human Use (CHMP) decides that the benefits outweigh the risks of the coronavirus vaccine, it sends its recommendation for conditional approval to the EU Commission. The EU Commission will then accelerate its decision-making process in order to grant approval for a corona vaccine within a few days, which is valid in all EU and EEA member states.
How are corona vaccines tested after conditional approval?

As soon as new medicines come onto the market, manufacturers and EU authorities continuously collect and review new information about medicines and take action if necessary. In line with the EU’s COVID-19 vaccine safety surveillance plan, this surveillance will be more frequent and include activities specific to COVID-19 vaccines. For example, in addition to the regular updates required by law, the companies will submit monthly safety reports and conduct studies to monitor the safety and effectiveness of COVID-19 vaccines after they have been approved.

Which vaccine candidates have submitted for approval?

The companies currently have

Moderna (mRNA-1273) on December 1, 2020
Biontech and Pfizer (BNT162b2) on December 1, 2020

Submitted for a Conditional Marketing Authorization to the EMA for their two vaccine candidates.

More information and updates about the progress of the external processes can be found in the COVID-19 focus of the European Medicines Agency.

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