Pharmaceutical Moderna has collected enough research data to apply for a license for its corona vaccine from the US FDA and the European Medicines Agency (EMA). The group announced this today.
A few weeks ago Moderna already released preliminary results of its phase 3 study. According to the pharmaceutical company, this showed an effectiveness of 94.5 percent.
However, more data had to be collected before the group could proceed to apply for approval. The participants’ vaccinations had to be at least two months ago to allow enough time to identify any side effects.
In addition, more participants in the study had to contract a corona infection. The effectiveness can be calculated by comparing participants who received the vaccine with participants who received a placebo. Moderna says the vaccine candidate is safe for users.
Ernst Kuipers of the LCPS today called it a blessing that the vaccines are moving so quickly. According to him, an exceptional performance is delivered by the pharmaceutical companies:
According to Moderna, thirty participants contracted a serious corona infection. They all belonged to the group that received a placebo. No serious side effects would have been reported during the study.
NOS op 3 explains in this video how it is possible that vaccines are available so quickly:
Moderna is the second pharmaceutical company after Pfizer to submit an application for its vaccine, but Pfizer has not yet formally done so in Europe. Moderna is already filing the application with the EMA today, the company said in a press statement.
Like Pfizer, the Moderna vaccine uses mRNA technology, which mimics a piece of genetic material from the virus’ spike protein.
The advantage of the Moderna vaccine compared to that of Pfizer is that it needs to be stored at a less low temperature: -20 degrees instead of -70. That makes logistics easier.
6.2 million doses
The Netherlands will have access to a maximum of 6.2 million doses of Moderna. Because everyone has to be vaccinated twice, that amount is good for the vaccination of 3.1 million people.
The European Medicines Agency has been watching the investigation since October. Because of the so-called rolling review this vaccine can be approved much faster than usual. Where different steps of assessing the studies normally take place one after the other, this now happens simultaneously. The requirements for vaccine approval are no less strict.
Last week, the EMA chief said he hoped to be able to approve the first vaccines before Christmas.