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News came in on Monday that the European Medicines Agency (EMA) is recommending conditional approval of Pfizer’s coronary vaccine, which has been named Comirnaty.
On December 26, just under 10,000 of the first vaccines will be released. On December 28, 35,000 additional doses will be received and a weekly delivery of 40,000 vaccines is expected from the first week of January.
The studies that have been done before the vaccine was approved are extensive.
– A phenomenal scientific effort has been put into the development of vaccines. We know a lot about them and can say with a high degree of probability that we are aware of the vast majority of side effects, says Steinar Madsen, medical director of the Norwegian Medicines Agency.
But the job of mapping side effects is far from clear, and now the Norwegian Medicines Agency is asking for help from the population to increase awareness.
What the studies show
When the Norwegian Medicines Agency evaluates a vaccine, they look at the utility value against risk factors.
– A vaccine is only approved if the benefit is considered to be much greater than the risk. The goal is always for the population to get the vaccine protection they need, without being exposed to serious side effects, says Audun Hågå, director of the Norwegian Medicines Agency.
The knowledge we have about side effects so far comes from clinical studies that have been done. The studies are large enough to detect rare side effects.
– The truth is that the vast majority will experience side effects after receiving the coronary vaccine. The side effects that have been discovered are mild to moderate and are very reminiscent of flu symptoms, Madsen says.
The most common side effects are headache, fever, chills, and muscle and joint pain. Symptoms usually disappear after a few days.
– In the available data, few serious side effects have been revealed, says Madsen.
At the same time, there are some side effects and some ethnic groups that studies so far can say little about.
MEETING: Steinar Madsen, Medical Director of the Norwegian Medicines Agency, Chief Medical Officer Are S. Berg of the Norwegian Institute of Public Health and Audun Hågå, Director of the Norwegian Medicines Agency, gave a press conference on the status of vaccines and coronary vaccines on Tuesday. Photograph: Stian Lysberg Solum / NTB
Side Effects Report Portal
The comprehensive vaccination program is underway in Norway, and within a month a large proportion of Norwegians in risk groups will likely be vaccinated.
The Norwegian Medicines Agency encourages everyone who takes the vaccine to report any side effects on a form on the pages of the Norwegian Medicines Agency.
– In this way, we can monitor side effects and investigate whether they are related to the vaccine or not, says Madsen.
He notes that the reporting systems in the US and the UK have detected around eight cases of allergic shock in people who have received the vaccine.
– This is a low number and so far there is nothing to worry about, but it is a rare side effect that has not been revealed in studies. 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 treatment safer, says Madsen.
Difficult with the elderly
The National Institute of Public Health has developed a priority list of who gets the vaccine first. There are nursing home residents, people who are 85 and older, and people who are over 75 who will be given first priority in the queue.
The Norwegian Medicines Agency says it is challenging to examine the side effects of the vaccine in older people.
– We will vaccinate many older people and some will die shortly after receiving the vaccine. The challenge for us is to look at the causal relationship and connection in time to find out if death may be related to the vaccine or if there are other causes behind it, says Madsen.
In clinical studies, there were no people older than 85 years.
– So we know less about how this group will react to the vaccine and whether they will achieve equally good protection, he says.
We don’t know this
Although the studies that have been carried out are extensive, there are still several age groups that we do not know enough about.
Children and people over the age of 75 are only included to a small extent in the studies.
– Also, we don’t know how well pregnant women are protected, so these are groups we need to learn more about, says Chief Physician Sara Viksmoen Watle at FHI.
It’s too early to say anything about long-term side effects, other than the fact that in the future there may be rare side effects that haven’t been identified in studies.
Even if the vaccine is approved and vaccination begins in multiple countries, vaccine studies will continue.
– A conditional approval assumes that the vaccine manufacturer continues studies, so the vaccine is investigated for two years. At the same time, other countries will start their own studies, plus the reporting systems will give us a lot of information, says Hågå.
Other questions that will be important in the future are whether the vaccine prevents infection, how long the vaccine will last, and how well it works over time.
INVITE: The director of the National Institute of Public Health, Camilla Stoltenberg, hopes that as many people as possible receive the coronary vaccine. Photograph: Stian Lysberg Solum / NTB
Encourage vaccination
The Norwegian Medicines Agency is very confident that the two vaccines that arrive first in Norway are safe.
– I feel optimistic and calm after looking at the data available on the Pfizer and Moderna vaccines. They are good vaccines with little risk. They are just very well made up, says Madsen.
The National Institute of Public Health hopes that the population will trust that the vaccine is safe, so that as many people as possible are vaccinated.
– I am concerned that there is great uncertainty in the population that leads to people not wanting to be vaccinated. We want as many people as possible to get vaccinated, first and foremost to protect all vaccinated people, says FHI’s Camilla Stoltenberg.
Both FHI and the Norwegian Medicines Agency will play open cards about the vaccine, which is voluntary to take in Norway.
– We will always be open about what we know and do not know, he says.
