vaccine, Coronavirus | Three vaccines are struggling to be approved first

This weekend came the news that the pharmaceutical company AstraZeneca and Oxford University resumes the clinical trials of its coronary vaccine.

The entire study was paused last week while an independent expert group investigated a potentially serious side effect in a female study participant.

Many feared that this break would lead to one of the most important vaccines having to throw in the towel. The echo from experts, however, was that this was routine. Many believe that the break was good news that showed that the safety mechanisms that will ensure that we get safe vaccines also work in the current extraordinary situation.

The Oxford vaccine is the one that Norway and the EU have hoped to be first out, with the first deliveries already in December.

Also read: Norway gets far too few vaccines – who should not be given priority? (+)

It is unclear whether the break will delay any approval of the vaccine, but because the break was short and thousands have already received the vaccine, it is unlikely that it will create major delays.

Race between three players

But at the same time as AstraZeneca has encountered obstacles, the pharmaceutical giant Pfizer and its partner BioNTech announce that they are pushing for gas.

On Saturday, the message came that they want to increase the number of subjects in their final vaccine study from 30,000 to 44,000 people.

– The proposed expansion will allow for greater variation among participants, including adolescents up to 16 years and people with HIV, hepatitis C and hepatitis B, in addition to providing additional information about the vaccine’s safety and effectiveness, the companies write in a press release.

The companies believe that the vaccine trials may have good enough answers to be approved by the end of October. The Pfizer boss himself believes that everything is in place for the vaccine to be rolled out before Christmas.

Also read: The world’s largest pharmaceutical group: The vaccine probably ready before Christmas

Unlike AstraZeneca’s fairly traditional vaccine, Pfizer is focusing on a vaccine technology that has so far never been approved for use in humans. An approval of a so-called mRNA vaccine will thus be a historic breakthrough.

Two similar, but still different competitors

Pfizer is one of two companies that the US Drug Administration (FDA) hopes can be ready by November 1. The other company is Moderna, which started its Phase 3 studies on the same day as Pfizer. Both are developing a so-called mRNA vaccine.

Also read: Next month, the United States may have two vaccines ready

According to industry website Stat There are indications that Pfizer may complete its study earlier than Moderna.

First, Moderna has said that they also want to expand the number of test persons, although this may have a negative effect on progress.

The actual way in which the studies are carried out can also make Pfizer come first:

– Both vaccines require two doses. Pfizer gives its second dose after three weeks, while Moderna gives its after four weeks. Pfizer also starts collecting data on covid-19 infections earlier than Moderna does, writes Stat.

Requires a lot

If Pfizer were to reach the finish line first, the first vaccine to hit the market would also be the one that would create the greatest challenges when it comes to distribution.

The main reason why no mRNA vaccines have been approved so far is that mRNA breaks down very quickly, which gives the vaccines a short shelf life. The researchers’ biggest challenge has therefore been to find a way to stabilize the content long enough for the vaccines to be distributed efficiently.

– The challenges that are being worked on a lot now are the stabilization of RNA in the form of being able to wrap it in protective material such as lipid nano-particles (LNP) as a kind of mini soap bubbles. It stabilizes the RNA strand at the same time as the delivery to the cells that will make the proteins RNA codes for becomes easier, Bjørn Dystevold Nilsson in the vaccine organization CEPI tells Nettavisen.

– There are also challenges with cold chain for RNA, but there is hope of solving this and that LNP helps to make RNA more thermostable as well, or possibly if you can freeze-dry the vaccine, she says.

What the freezer chain does Pfizer’s vaccine extra challenging: It requires storage in minus 70-80 degrees. Then it does not hold with a regular freezer, instead you probably have to use dry ice which requires far more logistics. Outside such storage, the vaccine lasts only around 24 hours. Experts believe that in practice this means that the vaccine can only be offered at large vaccination centers, not for example in pharmacies and doctors’ offices.

The vaccines from AstraZeneca and Moderna, in turn, require to be stored in minus 20 degrees, and possibly refrigerated for a few days.

Also read: NIPH explains why they do not want threats, punishment and injunctions

The EU has an agreement (in progress) with all the companies

Norway will have access to vaccines through the EU’s procurement program. So far, the EU has formally signed a procurement agreement with AstraZeneca, which will secure Europe 300-400 million doses.

In addition, the EU has letter of intent with Pfizer, Moderna, Sanofi-GSK, Johnson & Johnson, and Curevac.

The agreement with Pfizer says that the EU will initially buy 200 million doses, with the possibility of 100 million extra.

In total, the EU vaccine program plans to purchase approximately 1.5 billion doses.

The entire EEA area, with the exception of the United Kingdom, consists of about 450 million inhabitants.

Also read: Erna Solberg disappointed with USA’s no to international vaccine cooperation

–