AstraZeneca vaccine has been formally approved by the EU – VG

On Friday, the European Medicines Agency (EMA) recommended the third corona vaccine for use in the EU:

The AstraZeneca vaccine has now also been approved by the European Commission.

The vaccine is approved for use by anyone over the age of 18. The vaccine received conditional approval on Friday afternoon, but is now formally approved by the EU.

– We have just approved the AstraZeneca vaccine on the EU market after a positive assessment by the Norwegian Medicines Agency EMA, writes the director of the European Commission, Ursula von der Leyen, in a Twitter message on Friday evening .

– I hope the company delivers the 400 million doses that we agreed upon. We will continue to do everything we can to secure vaccines for Europeans, our neighbors and partners around the world, he continues.

With the new delivery of the AstraZeneca vaccine, FHI expects 1.8 million Norwegians to be vaccinated before the summer.

Geir Bukholm, director of infection control at FHI, tells VG that FHI will decide next week whether the newly recommended corona vaccine should be given to the elderly.

– We will make a decision in no time, early next week, says Bukholm.

Recently, there has been great uncertainty about whether this vaccine has an effect in people over 55 years of age.

The EMA notes Friday that there is little data from studies on the effect in this age group, but writes that the vaccine is assumed to also provide protection to those 55 and older.

The British mutation is loose in eastern Norway, but there are other variants that are of more concern to experts:

NIPH: I don’t know if the vaccine has no effect.

Bukholm says that the AstraZeneca vaccine gives a very good immune response after the first dose.

– We do not know about the AstraZeneca vaccine no has an effect on the elderly. We know that the effect in this age group has not been documented, he says.

– We must constantly consider to use vaccines with preferably documented effect for the age groups that obtain the best effect. Moderna and Pfizer vaccines have a documented effect in these age groups.

The Norwegian Medicines Agency informed NTB on Friday that they expect the AstraZeneca vaccine to arrive in Norway in early February.

– Get to Norway as soon as possible. You should already be in Norway by early February, subject director Steinar Madsen tells NTB.

– Probably all vaccines are good

The Pfizer and Moderna vaccines, which are approved for use in the EU and Norway, have a protection rate of around 95 percent. The AstraZeneca vaccine was previously reported to have an effect of around 70 percent.

In the press release, EMA writes that the vaccine has a 59.5 percent effect.

This is the average of two studies that have looked at the degree of protection.

At the same time, it is not uncommon for vaccines to have a 50 to 60 percent effect. According to FHI, the flu vaccine given annually in Norway has a protection rate of 60 percent.

– The new vaccine does not have as good an effect as the other two approved. Will this have any effect on who you give it to?

– Of course we are considering this, at the same time we think that probably all vaccines are good. It is always difficult to compare the effect between various vaccines, says Bukholm.

The EMA has received a flexible recommendation on when to receive the second dose of this vaccine:

They recommend receiving the second dose of the vaccine no less than four weeks later and no more than 12 weeks after the first.

It is up to FHI to decide when the second dose should be administered in Norway.

NIPH: Production expected to start again

To this, Bukholm says:

– Studies indicate that a better response is obtained by lengthening the interval between the first and second doses. We will probably not settle for the shortest interval possible, within this framework. We will probably find an interval in between.

– The downside of using too long is that it takes too long before you get full immunity and vaccination.

There has been a total conflict between AstraZeneca and the EU in recent days, after the company had production problems in one of the subcontractors that will produce vaccines for the EU, and therefore announced a significant reduction in the number of doses that can deliver in February.

AstraZeneca are the ones that will offer the most doses to the EU and Norway with the agreements we have today, and the announced reduction would mean, according to FHI, a delay of two months in the vaccination of Norway.

• NB: Are you not fully up to date on the dispute between AstraZeneca and the EU? read more his, his Y his.

The solution to the conflict between AstraZeneca and the EU is not yet clear.

– We hope they start their production completely again, but we hope it doesn’t take too long, says Bukholm.

– Because it is important that we receive the largest amount of vaccine doses before summer.