December 5, 2022

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No final approval after 14 months – why?

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In: Yasina Hip

A dose of Bionrech vaccine Comirnaty. © Image Alliance / dpa / Gentsch

In December 2020, the first doses of mRNA vaccine against corona virus were vaccinated from Biotech and Moderna. To date, however, they have not received final approval – and why?

Amsterdam – About 62.5 million people in Germany, or 75 percent of the population, have been vaccinated against the virus. Corona virus Retrieved (February 18, 2022). In addition, about 56 percent of Germans are now vaccinated, so they have been vaccinated for the third time. Politicians and experts are currently debating the need for a fourth vaccine. What might be surprising: Two mRNA vaccine manufacturers, Biontech and Moderna To date there is only conditional approval, with the final version of the European Drugs Agency (EMA) still pending. Why is this condition after 14 months?

Biotech and Moderna: the first extension of conditional approval

Before Biotech’s Comirnaty vaccine can receive conditional marketing approval in December 2020, the company must submit a comprehensive set of efficiencies, safety and quality to the EMA. Based on this, an EMA spokesperson followed As per the conditional approval given. At the same time, Biotech is committed to sending current data to the EMA until July 2021.

Company of Mines Will meet the requirements and already apply for an extension of conditional approval by June 2021. After verifying all the required data, the EMA This is in November 2021. The spokesman says: “As part of this annual extension, it has been verified that the fulfillment of specific obligations continues according to plan and that the benefits of the drug in question continue to outweigh the risks.”

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Biontech and Moderna: This is not for final approval

The Comirnaty vaccine is therefore still subject to conditional approval. This can only be changed after two years. For final approval, two years of long-term studies, including long-term observations, are required. However, the vaccine was only used for 14 months, so there are still ten months until final approval.

Nevertheless, EMA does not expect full approval until 2024. By then all studies will be completed and the safety data of the two-year phase 3 clinical study may be included. If all goes well for the EMA’s Committee on Human-Use Medicinal Products (CHMP), it may recommend “changing the conditional permit to full approval,” a spokesman said.

Biotech and Moderna: The Long Process for Approval

However, according to Dr. Rolf Hömke, Research Spokesman for the Research-Based Pharmaceutical Manufacturers Association, Ordinary. All responsible authorities must constantly exchange information and monitor the process. Theodore Tinkerman, professor of pharmacology at Homeke and Frankfurt University Great confidence and confidence in EMA and work Safety of vaccines.