Recommends AstraZeneca vaccine be approved – also for the elderly – VG

They write in a press release on Friday.

At the same time, they note that there is little data from studies on the effect in people over 55 years of age, but write that the vaccine is assumed to provide protection to these age groups as well.

For the vaccine to be formally approved for use in the EU – and Norway – the EU Commission must assess the case and make a formal decision. When the Moderna and Pfizer vaccines were approved, this happened on the same day.

Only when there is formal approval can doses be shipped.

Read all about vaccines and approval. in the special of VG vaccines.

AstraZeneca’s first dose delivery will be around 200,000 in February. This is a drastic reduction from 1.12 million doses of AstraZeneca originally planned.

– The documentation was sufficient for a conditional approval of this vaccine. It then has a lower degree of protection than vaccines already in use, and it is up to FHI to decide who will receive the vaccine in Norway and how it will be incorporated into the Norwegian vaccination program, says Steinar Madsen at the Norwegian Agency for Drugs for GBV.

Confusion about the effect in the elderly.

Therefore, the EMA has decided that the vaccine should be approved, also for the elderly. There has been a lot of discussion over the last few days.

They write in the press release that this is based on experiences from other vaccines and that there will be more information on the effect in the elderly in future studies.

In the past few days, there has been a major issue about how well the vaccine actually works for the elderly, especially for the age group 65 and older, about which there is little data in vaccine studies.

Earlier this week, the German newspapers Bild and Handelsblatt also wrote that the vaccine had an effect of between eight and 10 percent in people over 65. It wasn’t long before AstraZeneca came out and told German DW that this is“Completely wrong”.

What has been questioned is the good effect the vaccine will have in the elderly, not whether it has more side effects in the elderly. As a general rule, the elderly have weaker side effects if there is a difference between age groups, because they have a weaker immune response.

The side effects of the AstraZeneca vaccines are quite similar to the common side effects of the Pfizer and Modern vaccines, such as fever, malaise and muscle pain, according to Madsen of the Norwegian Agency for Medicines.

– There is little evidence that there should be other or more serious side effects in the elderly. We have extensive experience in this since vaccinating the elderly with other vaccines, he says.

59.5 percent protection

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.

– This degree of protection is found in the bottom layer of vaccines where we have data from large studies, says Madsen.

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 group that received the best effect of the vaccine from previous studies was a group in which patients received a half dose, followed by a full dose one month later; then the vaccine should have had a 90 percent degree of protection. But this was done by mistake and applied only to a small group.

– One of the paradoxes of the tests that were carried out was that it seemed that the degree of protection was greater in those who had received one and a half doses, but they are not included in these calculations. There were very few patients to build on, Madsen says.

The EMA has also received a flexible recommendation on when to receive dose two: they recommend that you receive 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.

The vaccine was the first to be reviewed by the EMA, but the process has taken time because there have been several different studies related to the vaccine, the EMA said at a news conference on Friday.

In addition, they state that it is currently not known whether the AstraZeneca vaccine protects against new COVID-19 mutations, but they say the company has been told to investigate this further.

Conflict over the number of doses we receive

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.

This is how the EMA worked

Conditional approval of a vaccine is based on sufficient but not completely finished data. The companies that have requested this have had to submit a final large data packet for investigation, something Pfizer did on January 12.

This is the data package that has been reviewed in the EU system and that according to the EMA shows results good enough for the vaccine to be used.

The EMA vaccine study is led by two European countries, but all countries can contribute to the process with advice, opinions and questions. Norway is also actively contributing to this process, Steinar Madsen, medical director of the Norwegian Medicines Agency, previously told VG.

In addition, there is a candidate vaccine that is still being considered, a so-called “continuous review”, in the EU system: the Johnson & Johnson candidate. Therefore, vaccines that are under “continuous review” are considered for approval, but have not gone so far that they have formally requested conditional approval yet.

The candidate vaccines for CureVac, Sanofi, Novavax and Valneva are also relevant for Norway, but they are further behind in the process and have not yet been carried out for “continuous review” in the EU.

Read more about the total of eight vaccines Norway can get through the EU, and where they are in the process, by clicking on them below: