Norway’s Health Authority Says Further Use of AstraZeneca Riskier Than COVID, Recommends Pulling Vaccine Permanently
"Since there are few people who die from COVID-19 in Norway, the risk of dying after vaccination with the AstraZeneca vaccine would be higher than the risk of dying from the disease"
Since use of the AstraZeneca vaccine was put on hold on 11th March, the Norwegian Institute of Public Health has considered further use of the AstraZeneca vaccine in Norway, together with other experts.
“We now know significantly more about the association between the AstraZeneca vaccine and the rare but severe incidents with low platelet counts, blood clots and haemorrhages, than when Norway decided to pause use of the AstraZeneca-vaccine in March,” says Geir Bukholm, Director of the Division of Infection Control and Environmental Health at the Norwegian Institute of Public Health.
“Based on this knowledge, we come with a recommendation to remove the AstraZeneca vaccine from the Coronavirus Immunisation Programme in Norway,” says Bukholm.
Bukholm points out that this has not been an easy recommendation to make. It has a direct consequence for when the risk groups can receive a coronavirus vaccine, with subsequent protection, while also having an impact on when it will be possible to lift infection control measures.
Higher risk associated with AstraZeneca vaccine than from COVID-19 disease in Norway
Having come a long way in vaccinating the oldest citizens, Norway has reduced the risk of death for many of those most at risk. Since most of the elderly have either been vaccinated, or soon will be, this means that continued use of the vaccine would mainly be among the under-65 years age group if we were to use this vaccine in Norway.
Calculations have been performed based on Norwegian data where the risk of dying from COVID-19 disease among the different age groups is compared with the risk of dying from the severe, but rare, condition with severe blood clots observed after AstraZeneca vaccination.
“Since there are few people who die from COVID-19 in Norway, the risk of dying after vaccination with the AstraZeneca vaccine would be higher than the risk of dying from the disease, particularly for younger people,” says Bukholm.
In addition, there is reason to assume that there is scepticism about using the AstraZeneca vaccine in Norway, and it is uncertain how many people would have accepted an offer of this vaccine now.
For those who have had the first dose
People who have had the first dose of the AstraZeneca vaccine will be offered another coronavirus vaccine for their second dose.
“We will come back with more specific information about when and how people who have had their first dose will get their second dose. One dose gives good protection against COVID-19 for at least 12 weeks,” says Bukholm.
Postponed rollout of Johnson vaccine
The European Medicines Agency (EMA) announced on 9th April that they have begun signal management for the COVID-19 Vaccine Johnson to investigate whether there is an association between the vaccine and several reported cases of severe blood clots among vaccinated people. Johnson has announced a pause in deliveries to Europe after the US Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) recommended a temporary pause in the use of the Johnson vaccine, following reports of several cases of severe blood clots after vaccination in the USA.
“Use of the Johnson vaccine in Norway has been put on hold until more information becomes available from ongoing investigations,” explains Bukholm.
Consequences for vaccination progress
The Norwegian Institute of Public Health estimates that removing the AstraZeneca vaccine from the immunisation programme would incur a delay of approximately two weeks.
Not using the Johnson vaccine would delay the immunisation programme by up to 7 weeks for some age groups.
Currently, there are under 200 000 doses of the AstraZeneca vaccine and 24 000 doses of the Johnson vaccine in storage in Norway. The doses are being stored in accordance to regulations until it is decided how these shall be used.
Norway’s health authority has recommended AstraZeneca be withdrawn from its Covid-19 vaccination program, but the country’s government has delayed a final decision until May.
“The government believes we do not yet have a good enough basis for drawing final conclusions,” Høie said.
“We must assess the consequences for the health of the entire population if we have to live with restrictions for longer than other countries in Europe”, he added.
Use of AstraZeneca has been on hold in Norway since March 11th due to suspected serious side effects including blood clots and low platelet counts.
The government said it was setting up an expert committee to undertake a comprehensive risk assessment on the vaccine. The committee will submit its report ahead of the decision in May .
The risk assessment will look at both AstraZeneca and the Johnson & Johnson vaccine, which has delayed its European rollout due to reported blood clots.
“We set up this committee because we want to know more about the consequences for the population and society before we make a decision,” Høie said.
Johnson & Johnson and AstraZeneca are based on the same vaccine technology. As such, a decision by to withdraw AstraZeneca in May could also be significant for Johnson & Johnson’s single use Janssen vaccine.
“If we now say no to AstraZeneca, it could have consequences for the opportunity to use Johnson & Johnson,” Høie said.
Norway has ordered over a million doses of the Janssen vaccine.
The vaccination program in Norway could face delays of up to seven weeks if both serums are dropped according to head of the NIPH, Camilla Stoltenberg.
Stoltenberg also said the recommendation to recommend withdrawing the vaccine was one of the hardest decisions the authority has made during the pandemic.
So far, five patients under the age of 50 have been admitted to Oslo University Hospital (OUS) with severe blood clots after taking the AstraZeneca vaccine. Three of them have died.
Experts at the hospital have said the blood clots were triggered by a strong immune response linked to the Anglo-Swedish manufacturers serum.
The EMA added that the benefits of the vaccine outweigh the risks.
Source: The Local