Coronavirus vaccines Biontech and Moderna: still no final approval after 14 months - why?
Created: 02/23/2022, 11:59 am
By: Yasina Hipp
In December 2020, the first doses of the mRNA vaccines against the coronavirus from Biontech and Moderna were vaccinated.
To date, however, they have not received final approval - why is that?
Amsterdam – Around 62.5 million people in Germany, i.e. 75 percent of the population, have now received two vaccinations against the corona virus (as of February 18, 2022).
In addition, about 56 percent of Germans have now been boosted, so they have been vaccinated for the third time.
Politicians and experts are currently discussing the need for a fourth vaccination.
What may come as a surprise is that the two mRNA vaccines from the manufacturers Biontech and Moderna only have conditional approval to date, and the final version from the European Medicines Agency (EMA) is still pending.
Why is this still the case after 14 months?
Biontech and Moderna: First extension of the conditional approval
Before Biontech's Comirnaty vaccine received conditional marketing authorization in December 2020, the company had to submit a comprehensive set of efficacy, safety and quality data to the EMA.
According to an EMA spokeswoman for
Bild.de
, the conditional approval will then be issued on this basis.
At the same time, Biontech was obliged to continue to transmit current data to the EMA until July 2021.
The Mainz-based company fulfilled the requirements and applied for the extension of the conditional approval in June 2021.
After checking all the necessary data, the EMA granted it in November 2021. The spokeswoman says: "As part of this annual extension, it has been verified that the fulfillment of the specific obligations is on track and that the benefits of the medicinal product in question continue to outweigh the risks".
Biontech and Moderna: This is missing for the final approval
So the Comirnaty vaccine is still subject to conditional approval.
This can only change after two years.
For the final approval, two-year long-term studies including long-term observations are required.
However, the vaccine has only been used for 14 months, so there are still ten months to go before final approval.
Nevertheless, the EMA does not expect full approval until 2024. All studies will be completed by then and safety data from the two-year phase 3 clinical study could also be included.
If everything goes satisfactorily for the EMA's Committee for Medicinal Products for Human Use (CHMP), it can recommend "converting the conditional approval into a full approval," said the spokeswoman.
Biontech and Moderna: Lengthy process to approval
However, according to Dr.
Rolf Hömke, research spokesman for the Association of Research-Based Drug Manufacturers, normal.
All responsible authorities would continuously exchange information and monitor the process.
Hömke and also Prof. Theodor Dingermann, pharmaceutical biologist at the University of Frankfurt, are
extremely
convinced and confident about the work of the EMA and the safety of the vaccines.
