[ad_1]
PROMISING: The drug company’s results may bode well for a new corona vaccine. Photo: Gisle Oddstad
The pharmaceutical company Pfizer and the biotech company BioNTech believe their vaccine candidate is more than 90 percent effective against the coronavirus.
The first analyzes from pharmaceutical giant Pfizer were published on Monday.
– This is a very, very rewarding result. One of the big questions has been how effective these vaccines are, and a 90 percent degree of protection is a good result, says Steinar Madsen, a physician and medical director at the Norwegian Medicines Agency.
According to the Washington Post, Pfizer and German biotech company BioNTech say their corona vaccine candidate is more than 90 percent effective in protecting people against the virus, compared to the placebo variant.
– I’d say this is a historic moment, says Pfizer’s director of vaccine research and development.
The statement is based on a preliminary analysis of the collected data.
HAPPY: The doctor and medical director of the Norwegian Medicines Agency, Steinar Madsen, thinks there is a good chance Photo: Kyrre Lien, VG
– It can mean a lot in the fight against covid-19
The director of the Norwegian Medicines Agency explains to VG that the study includes a total of 43,000 subjects, divided into two groups: one group receives a placebo and the other a vaccine. Then look at how many people are infected in each group.
– The first analysis was carried out after 94 cases of infection, and based on these, the protective effect has been estimated at 90 percent. The test will continue until it has received 164 cases of infection, explains Madsen.
– If the numbers are maintained until the end, it is very rewarding and can mean a lot in the fight against covid-19.
The subject director himself believes that a lot is needed for the remaining results to deviate from the results they have received so far. Therefore, Madsen believes this bodes well for a new vaccine.
– These are the first results that have been published where the degree of protection has really been seen, he points out.
In addition, the director explains that they do not yet know how long the degree of protection lasts and that this will be crucial to obtain a response before the vaccine can be used.
Vaccination system ready in December
It is still uncertain when a vaccine will be available in Norway, says Madsen.
However, health personnel and an entire system are ready to start vaccinating as soon as relevant.
– In principle, the Norwegian Medicines Agency has indicated that a conditional approval can be ready at the end of the month between January and February. It is on the basis of the data we have now, but there may be new data that may move on this date, says the director of the Norwegian Medicines Agency.
– But we have a system to be able to start the vaccination as of December 1, although we have not received the vaccine yet.
Norway is part of the EU procurement cooperation. If the vaccine is approved here, through this agreement you will get your share of vaccines.
– The question is how fast the doses can be produced. These are things that go into planning now, says Madsen.
The Pfizer vaccine has been tested in patients who have not been sick in the past. So far, no serious side effects have been identified in the test subjects.
“These are hugely positive and encouraging preliminary results, and attest to the great ingenuity and skill of the research community in finding COVID-19 vaccine candidates,” says Richard Hatchett, director of the CEPI vaccine coalition.
In the EU approval process
If results remain as good over a longer period of time, the vaccine may protect as well as other well-known childhood vaccines, such as the measles vaccine, writes the New York Times.
They hope to be able to produce vaccines that can make 15-20 million people immune by the end of the year, the newspaper writes.
The vaccine in question is one of two vaccines for which the EU has already started the approval process. It is a collaboration between the German BioNTech, the American Pfizer and the Chinese Fosum Pharma. Phase 3 trials began in July 2020. The vaccine will be tested on volunteers in the United States, Argentina, Brazil, and Germany, among other locations.
Difficult to store
The BioNTech / Pfizer vaccine is one of those that can be difficult to store and transport if it is to be distributed throughout Norwegian municipalities. This is because it must be stored in very cold temperatures. Some of these RNA vaccines need to be stored at temperatures as low as 70 degrees below zero. Also, it probably requires two doses per person.
Other candidate vaccines may be easier to store because they can be refrigerated. Johnson & Johnson’s candidate vaccine has another advantage: it only requires one dose.
The EU is negotiating a purchase agreement for up to 300 million doses for all EU countries and Norway, if the vaccine is safe and effective against covid-19. The United States has invested in the project through Operation Warp Speed, to achieve 100 million doses, with the possibility of expanding by 500 million doses. It is also one of the vaccines the UK is focusing on.
Pfizer has estimated that they can apply for approval in the United States in the third week of November. The Norwegian Medicines Agency has planned that a vaccine can receive conditional approval in Norway and Europe in January at the earliest.
