As the number of COVID-19 cases is on the rise, the U.S. intends to start administering booster doses for new variants of the COVID-19 virus starting next month, opting to skip the human trial stage in order to more quickly get the vaccines on the market.
The new vaccines are expected to reach Europe by September, Toivo Maimets, head of the Scientific Council advising the Estonian government, promised Wednesday.
"I was at a meeting of the European Medicines Agency two weeks ago where they said that both Moderna and Pfizer have submitted applications for the marketing authorization of bivalent vaccines, and that the European Medicines Agency will issue it by September," Maimets said. "There are several 'buts' here, however. Bivalent means that these are against the original virus and the omicron-1 variant, but right now we're seeing omicron-5. This means that in the race against the virus, we're behind."
According to the council chair, both companies already have trials underway for vaccines against the omicron-5 variant as well, and that the European Medicines Agency can authorize them for use in November. "We'll never win the race against the virus at this rate," he said. "The good news, however, is that the vaccines against the original virus help prevent severe illness and death as well. These are reasonable to use."
mRNA vaccines have been marketed as vaccines that are easy to adapt to whatever form a virus takes.
According to Maimets, updating the vaccine for new viruses does indeed take just a few weeks, and lab testing can likewise be conducted quickly, but three phases of human trials must be conducted on vaccines and medicinal products for human use, which takes time.
"The Americans opted to skip human trials for this vaccine," he explained. "That's taking a risk — and this is evidence of the FDA and EMA's different styles. The U.S. is more willing to take risks. Sometimes the courage to take risks pay off, but sometimes Americans have shot themselves in the foot this way."
Nonetheless, both the FDA and the EMA share the same main objective: to ensure that medicines work, that they are safe and that they support drug development, Maimets stressed.
"These three things conflict with one another, and it's difficult to strike a balance between them," he acknowledged. "I prefer Europe's more conservative approach, which quickly leads to results but in which we're clearly aware of possible rare side effects."
Editor: Aili Vahtla