Norway has been one of the most successful countries in Europe in the fight against Covid-19, with only Iceland experiencing fewer deaths relative to the size of its population.
So when, after vaccinating 120,000 of its 5.3m people with the Oxford/AstraZeneca jab, Norway found six cases of severe blood clots in recipients that led to the death of four people, the number stood out.
“It is quite remarkable. For the young nurses, young doctors who have been vaccinated, it is not good news for them. The sentiment in Norway because of this is a little special,” Steinar Madsen, medical director at the Norwegian Medicines Agency, told the Financial Times.
Nordic nations hold off on AstraZeneca jab as scientists probe safety concerns
Norway, Denmark and Sweden stand apart from the use of the AstraZeneca jab after at least 16 countries last week temporarily suspended or limited its use over concerns number of recipients. On Thursday, the European Medicines Agency declared the vaccine safe after its own probe found no link, and inoculation resumed in Germany, Italy, Spain and other countries, with France limiting its use to the over-55s.
The three Scandinavian nations say they will decide this week whether to restart their programmes. Late on Sunday evening, Norwegian authorities announced two further deaths — taking the total to four — of people suffering from an unusual set of symptoms: severe blood clots.
We have only had about 650 deaths so far . . . If we had been in a precarious situation like in the UK, the attitude of the Norwegian population would have been different
Steinar Madsen, medical director at the Norwegian Medicines Agency
The cases that sparked the concerns involve an unusual set of symptoms: severe blood clots alongside low levels of blood platelets and bleeding. Madsen said Norwegian experts had “never seen anything quite like this before”.
Norway dissented from the EMA decision because it wants the symptoms listed as a possible side effect. An investigation at Oslo University Hospital — where three of the Norwegians with the symptoms were hospitalised and one died — found it was highly likely there was a connection with the vaccine.
Since the safety concerns were first raised, the EMA and World Health Organization have continued to recommend use of the vaccine, saying the benefits outweighed the risks. On Thursday, the regulator said that out of 20m people who had received the AstraZeneca vaccine in Europe, including the UK, it had received and reviewed 25 reports of clots associated with low levels of blood platelets.
Madsen said Norway agreed with the EMA that for the population as a whole, the AstraZeneca vaccine had a “positive risk-benefit ratio”. However, he said, there were “some very severe cases” and the difficulty lay in balancing the various factors.
“We are in a very lucky position. We have only had about 650 deaths so far. We are in a totally different situation to the UK, Italy, Germany, France, Czechia. If we had been in a precarious situation like in the UK, the attitude of the Norwegian population would have been different,” he said.
Experts on immunity and infection say it is plausible that a heightened inflammatory response to vaccination could in extremely rare cases lead to serious and even fatal blood disorders, such as those observed in Europe. No direct link to the AstraZeneca vaccine has been proved and the mechanism of such a severe reaction is unknown.
Peter Openshaw, professor of experimental medicine at Imperial College London, pointed out that Covid-19 itself causes serious clotting disorders so it was possible that the virus’s spike protein, produced by the body after vaccination, might provoke a similar response in a small number of recipients. Alternatively, another component of the vaccine, such as the adenovirus vector used in the AstraZeneca jab, might induce an excessive immune reaction, he said. However, he stressed that such explanations were speculative.
Sten Vermund, the dean of Yale School of Public Health, also said the spike protein could explain any autoimmune reaction, noting both Norwegian and German scientists were independently postulating the same cause.
Stephan Lewandowsky, chair in cognitive psychology at the University of Bristol in the UK, argued that the small number of events found in smaller countries with a low number of vaccinations could be skewing the picture.
“Randomness is ‘lumpy’ and if you look at many smaller countries then you may find a clustering of cases in one or the other country by chance alone, even though there is no signal in the overall data,” he warned. “That’s why agencies like the EMA that look at all available data have the best information to make a decision about safety.”
But there are examples with vaccines for other diseases where the risk-benefit ratio has led to a pause. In the US, Vermund said, the swine flu vaccine of 1976 was associated with a complex neurological condition called Guillain-Barre syndrome. “It was rare but serious and since the 1976 pandemic influenza did not manifest as feared, vaccination was stopped altogether,” he said. “The cost was not worth the benefit in that case.”
A series of narcolepsy cases in Scandinavia after administration of the Pandemrix flu vaccine may have “sensitised” those countries to adverse vaccine events, said Peter English, a retired Public Health England consultant in communicable disease control.
“The number of cases of this rare condition was so small that it is not possible to be certain that the vaccine was the cause, but the current consensus seems to be that it likely was,” he said.
Madsen said another issue in Norway, a society known for high levels of mutual trust and openness, was that it was important for the authorities to be as transparent as possible. “The worst thing that could happen is that the population could think something is being hidden from them,” he added.
Penelope Ward, a professor of pharmaceutical medicine at King’s College London, said countries were free to make their own decisions and were “answerable to their populations” for them.
But, she warned: “That will include the continued risk of Covid infection and associated deaths, which both remain significantly more common in the Nordic region than the very rare risk of complex thrombotic or bleeding disorders reported following receipt of the vaccin
Aw.knickers.ft the ft with a load of script .
