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To date, the UK, Bahrain and Canada have approved the Pfizer / Biontech crown vaccine. An approval is expected soon in the US, after a group of experts from the US FDA recommended the vaccine on Thursday.
The EU has also come a long way in its scrutiny. Under the current plan, the European Medicines Agency (EMA) can issue a recommendation on the Pfizer / Biontech vaccine on December 29.
– This is the plan. But if something comes up that needs to be examined further, it can of course be delayed, says Ulla Wändel Liminga, scientific lead at the Agency for Medical Products and Swedish representative on the EMA’s drug safety committee.
Different approval processes
Unlike an emergency permit, which has been granted in the UK, for example, the EU will grant a market permit, which requires more extensive scrutiny.
An emergency approval means that you approve the use of one batch at a time. In Sweden, there is an equivalent called a contingency license, but the Public Health Agency has announced that it will wait for the green light from the EU.
Furthermore, it is unclear whether any country can receive advance deliveries, as agreements with vaccine manufacturers have been concluded at the EU level.
However, an EU authorization is conditional, which means that pharmaceutical companies are imposed certain conditions that must be met after approval. In addition, as with all medicines, they must continue to report new data on an ongoing basis.
– When more data are available, they should be submitted, and the authorities will assess whether they are sufficient for there to be full approval. We will have a very close monitoring in the coming years. A conditional approval means that the balance between benefit and risk is reassessed annually, says Ulla Wändel Liminga.
“Sweden deeply involved”
Sweden also has a special responsibility to examine the Pfizer / Biontech vaccine in detail, together with France.
Within the EMA, two countries are typically designated as responsible for basic research, while the other member states act to ensure quality and provide feedback, according to Wändel Liminga.
– The evaluation of the Pfizer / Biontech vaccine is ongoing within the EMA system, and Sweden is deeply involved in that research, where we address every little pebble. It is then discussed on several different occasions within the EU system, so that all Member States have a chance to comment, before we reach a common EU position. There are many who are involved, she says.
Does it matter which country is responsible for the detailed review?
– No, not because of the end result. It’s about how to distribute the work, where you are a basic researcher or a quality insurer. Everyone should have the opportunity to submit comments. You may think it’s a bit bureaucratic at times, but it works out well when a lot of people are involved and they look at this.
