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“I am concerned that there will be great uncertainty in the population that will prevent people from getting vaccinated. We want the vaccine to be adopted by as many people as possible, primarily to protect every person who is vaccinated, says Camilla Stoltenberg of the FHI.
The vaccine has many known side effects. The Norwegian Medicines Agency is now asking the public to help increase this knowledge.
What the research shows
When the Norwegian Medicines Agency evaluates vaccine, it takes into account value in use in comparison with risk factors.
- A vaccine is only approved when the benefits are considered to outweigh the risks. The goal is always for the population to receive the protection they need with the vaccine without risking serious side effects, says Audun Hågå, director of the Norwegian Medicines Agency.
So far, the knowledge about side effects comes from conducted clinical trials. Research is sufficient to detect rare side effects.
What is certain is that the vast majority will experience side effects after receiving the COVID-19 vaccine. "The side effects found are mild to moderate and very much like flu symptoms," says Madsen.
The most common side effects are headache, fever, chills, and pain in the muscles and joints. Symptoms usually disappear after a few days.
"The available data has revealed some serious side effects," says Madsen.
At the same time, there are some side effects and certain ethnic groups that research to date says little about.
. Side effect reporting portal
A comprehensive vaccination program is underway in Norway and a large proportion of the Norwegians at risk are likely to be vaccinated within a month.
The Norwegian Medicines Agency encourages everyone who takes the vaccine to report any side effects from form of the form on the website of the Norwegian Medicines Agency.
"That way, we can monitor the side effects and see if they are vaccine-related or not," says Madsen.
He points out that reporting systems in the US and UK detected around eight cases of allergic shock in people who received the vaccine.
- It's a small number and there is nothing to worry about at the moment. But this is a rare side effect that has not been revealed in research. This shows the potential of the reporting system to map unknown side effects in the future, he says.
"By reporting side effects you help us make the treatment safer," says Madsen.
We don't know that
Although the research done is extensive, there are still a few age groups that we don't know enough about.
Children and people over the age of 75 have little coverage.
- Moreover, we do not know how well pregnant women are protected. So there are groups of people we need to learn more about, says head doctor Sara Viksmoen Watle at FHI.
It is too early to say anything about long-term side effects, except that there may be rare side effects in the future that have not been identified in studies.
Even if the vaccine is approved, and vaccination begins in many countries, research into vaccines will continue.
- Conditional approval implies that the vaccine manufacturer will continue research so that the vaccine is tested for two years. At the same time, other countries will start their own research, and in addition to the reporting systems, they will provide us with a lot of information, says Hågå.
Other questions that will be important in the future are whether the vaccine will prevent infection, how long it will last, and what the effect will be over time.
It encourages vaccinations
The Norwegian Medicines Agency is convinced that the two vaccines that reach Norway first are safe.
“I am optimistic and reassured after looking at the available data on the Pfizer and Moderna vaccines. These are good vaccines with little risk. They're just very well made, says Madsen.
Norwegian Institute of Health The public hopes that the population trusts that the vaccine is safe so as to vaccinate as many people as possible.
