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You will probably never get it at the doctor’s office.
News broke this weekend that the pharmaceutical company AstraZeneca and the University of Oxford are resuming clinical trials of their coronary vaccine.
The entire study was stopped last week while a group of independent experts investigated a potentially serious side effect in a study participant.
This is ChAdOx1 nCoV-19, the vaccine for AstraZeneva.
Photo: Sean Elias (Reuters)
Many feared that this breakdown would lead to one of the most important vaccines having to throw in the towel. The echo from the experts, however, was that this was routine. Many believe that the breakdown was good news that showed that the safety mechanisms that will ensure that we get safe vaccines also work in today’s extraordinary situation.
The Oxford vaccine is the one that Norway and the EU hope will be the first to be launched, with the first deliveries already in December.
Also read: Norway receives too many vaccines, who should not be given priority? (+)
It is unclear whether the pause will delay approval of the vaccine, but because the pause was short and thousands of people have already received the vaccine, it is unlikely to lead to major delays.
Race between three players
But at the same time that AstraZeneca has run into 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 extension will allow greater variation among participants, including adolescents up to 16 years of age and people with HIV, hepatitis C and hepatitis B, in addition to providing additional information on the safety and efficacy of the vaccine, the companies write in a Press release.
The companies believe vaccine trials may have good enough responses to be approved by the end of October. The Pfizer boss himself believes that everything is ready for the vaccine to be deployed before Christmas.
Also read: The largest pharmaceutical group in the world: the vaccine will probably be ready before Christmas
Unlike AstraZeneca’s rather traditional vaccine, Pfizer is focusing on a vaccine technology that has never been approved for use in humans until now. The approval of the so-called mRNA vaccine will therefore be a historic breakthrough.
Two similar but still different competitors
Pfizer is one of two companies that the US Drug Administration (FDA) expects to be ready by November 1. The other company is Moderna, which began its phase 3 studies on the same day as Pfizer. They are both developing a so-called mRNA vaccine.
Also read: Next month, the United States may have two vaccines ready
According to the 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 people, although this may have a negative effect on progress.
The actual way studies are conducted can put Pfizer first:
– Both vaccines require two doses. Pfizer administers its second dose after three weeks, while Moderna administers it after four weeks. Pfizer also begins collecting data on COVID-19 infections before Moderna, writes Stat.
Requires a lot
If Pfizer were to reach the finish line first, the first vaccine to hit the market would also create the biggest challenges when it comes to distribution.
The main reason why mRNA vaccines have not been approved so far is that mRNA breaks down very quickly, giving vaccines a short shelf life. Therefore, the researchers’ biggest challenge has been finding a way to stabilize the content long enough for the vaccines to be distributed efficiently.
– The challenges on which a lot of work is being done now are the stabilization of RNA in the form of being able to wrap it in protective material such as lipid nanoparticles (LNP) as mini soap bubbles. It stabilizes the RNA strand while delivering it to cells which will make the proteins that encode RNA become easier, says Bjørn Dystevold Nilsson of the vaccine organization CEPI to Nettavisen.
– There are also cold chain challenges for RNA, but there is hope to solve this and that the LNP also helps make the RNA more heat stable, or possibly if the vaccine can be lyophilized, he says.
The chain of freezing that makes Pfizer’s vaccine more challenging: it requires storage at 70-80 degrees below zero. So it doesn’t hold up with a regular freezer, instead you probably have to use dry ice, which requires a lot more logistics. Outside of such storage, the vaccine only lasts for about 24 hours. Experts believe that in practice this means that the vaccine can only be offered in large vaccination centers, not for example in pharmacies and doctors’ offices.
AstraZeneca and Moderna vaccines, in turn, should be stored at minus 20 degrees and possibly refrigerated for a few days.
Also read: NIPH explains why they do not want threats, punishments and court orders
The EU has an agreement (in progress) with all companies
Norway will have access to vaccines through the EU procurement program. So far, the EU has formally signed an acquisition agreement with AstraZeneca, which will guarantee Europe between 300 and 400 million doses.
In addition, the EU has letters of intent with Pfizer, Moderna, Sanofi-GSK, Johnson & Johnson and Curevac.
The agreement with Pfizer states that the EU will initially buy 200 million doses, with the possibility of an extra 100 million.
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, has about 450 million inhabitants.
Also read: Erna Solberg disappointed with the United States’ no to international cooperation on vaccines
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