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Spain halts AstraZeneca vaccine 'pending EMA verdict', but does not believe there is 'cause for alarm'
15/03/2021
SPAIN has halted its roll-out of the AstraZeneca or 'Oxford' vaccine for at least 15 days pending further investigation after the country's first case of blood clots recorded in a person to whom it had been administered.
Health authorities in national government stress they do not believe there is cause for alarm, since only one case of thrombosis out of 939,534 people given the AstraZeneca vaccine has been registered, but has temporarily withdrawn it pending a European Medicines Agency (EMA) inquiry.
Denmark was the first country to stop administering the 'Oxford' vaccine, followed swiftly by Norway and, since then, by the Republic of Ireland, Italy, Iceland, Bulgaria, Germany France, and The Netherlands.
Some countries have opted just to shelve doses of the batch associated with thrombosis cases, including Luxembourg, Romania, Austria, Lithuania, Latvia and Estonia.
The UK, where the vaccine was developed, has not done so.
At first, although Spain had decided not to give the AstraZeneca jab to anyone of 55 years old or over due to 'insufficient data' and 'inconclusive results' about its safety and effectiveness above this age – purely because not enough volunteers in this category were able to participate in clinical trials, not because of any adverse reactions or reduced immunity detected in these – its health authority opted not to halt the roll-out.
Health minister Carolina Darias did not consider the risk to be worth stopping the crucial process of immunising the population as quickly as possible so life could return to normal – only 10 cases of blood clots in 17 million doses administered had been detected.
But when Spain reported case number 11 – albeit literally one in a million – Sra Darias decided to delay further inoculation with the AstraZeneca drug 'temporarily' until the EMA had analysed the situation.
She said this had been a 'very difficult' decision, but that even though the cases reported were 'extremely few and far between', they were 'particularly significant' as they had occurred with a vaccine that, in most countries, including Spain, has only been given to young adults and, in the majority of those affected, with no pre-existing physical health conditions.
As at the weekend, the EMA had recommended not postponing any AstraZeneca jabs as the 'benefits outweighed the possible risks', despite Denmark's and Norway's having already done so altogether and five other countries had chosen to discard the batch involved.
Head of the Spanish Medications and Healthcare Products Agency (AEMPS), María Jesús Lamas, said the country's 'risk assessment' had 'changed' after a person had been diagnosed on Saturday with a blood clot to the brain and a 'major' reduction in blood platelets, which 'implied an abnormal clotting activity'.
Neither Sra Lamas nor Sra Darias have been willing to disclose any details about the person in question, other than to assure that they are 'recovering', that the situation was 'very infrequent', albeit 'very significant'.
Not every one of the 11 cases in 17 million reported up to the weekend in the European Union – which now appear to have risen to 30 in five million across the continent of Europe, including three more in Norway and two more in Germany – have been as fortunate as the recipient in Spain; some have died, including a female doctor in Italy in the last two days and a 49-year-old lady nurse in Austria a week ago.
Sra Darias says warning signs start to appear within three days to a fortnight after the jab and are mainly in the form of a 'debilitating', migraine-like headache which does not respond to any painkillers, is worse when lying down and causes blurred vision.
Some recipients of the 'Oxford' vaccine have described the side-effects as being 'like the worst hangover of their lives', and Spain's health minister says the headaches reported are 'considerably more intense' than a 'normal' reaction to a vaccine should be.
Many of Spain's regions had just started vaccinating teachers in private and State schools and colleges and nursery schools, police and other emergency response workers, and non-front line health and care workers, aged under 55, using the AstraZeneca jab which, unlike the Pfizer and Moderna inoculations, where both doses need to be given between 18 and 21 days apart, the recommended gap between jabs is 12 weeks.
Today (Monday), however, large numbers of teachers getting ready for their vaccine appointments said they had been telephoned by their health authorities telling them not to attend.
Their reactions range from disappointed, believing they would soon be safe from Covid, to relieved, as they had been feeling apprehensive about becoming a 'statistic'.
Spain's government has, however, urged everyone to 'remain calm'.
“What we are hoping for at the moment is that the AstraZeneca vaccine offers at least partial protection against Covid following the first dose,” said Sra Lamas.
“The chances of suffering adverse effects from any medicine always exist, but the situation we are dealing with is one where the chances are highly improbable, as the incidence is extremely low.”
This said, neither the AEMPS boss nor the health minister have any answers as yet as to what will happen if the British-made vaccine is to be recalled at the EMA's instructions or recommendations, given that nearly a million people in Spain have had their first dose and should have been getting their second within three months.
Sra Darias says that as the AstraZeneca is the vaccine with the longest period between doses – in trials, the second injection was found to be more effective after 12 weeks than after eight – this, at least, gives the EMA time to reach some conclusions.
By then, Spain and other countries that had been using the AstraZeneca jab are hoping they will have worked out an alternative strategy if the EMA says none of the original recipients should receive their second dose.
Neither is it clear whether Spain and the rest of the EU will be able to meet their targets of 70% of their populations being vaccinated by summer if the 'Oxford' jab is no longer recommended.
Until the EMA gives its verdict, says Sra Lamas, the AstraZeneca will still be arriving in Spain in the agreed batches, and will be stored at the AEMPS until they are either deemed safe to use, or need to be destroyed under controlled conditions.
At present, Spain is collating data on side-effects suffered by everyone who has had the jab – if any – to attempt to 'identify a pattern or profile'.
The postponement of the AstraZeneca vaccine in Spain came within hours of the health ministry's deciding to 'investigate' the possibility of increasing the maximum age of its administration to 65, in line with 'positive experiences' in results among this community elsewhere in Europe.
Related Topics
SPAIN has halted its roll-out of the AstraZeneca or 'Oxford' vaccine for at least 15 days pending further investigation after the country's first case of blood clots recorded in a person to whom it had been administered.
Health authorities in national government stress they do not believe there is cause for alarm, since only one case of thrombosis out of 939,534 people given the AstraZeneca vaccine has been registered, but has temporarily withdrawn it pending a European Medicines Agency (EMA) inquiry.
Denmark was the first country to stop administering the 'Oxford' vaccine, followed swiftly by Norway and, since then, by the Republic of Ireland, Italy, Iceland, Bulgaria, Germany France, and The Netherlands.
Some countries have opted just to shelve doses of the batch associated with thrombosis cases, including Luxembourg, Romania, Austria, Lithuania, Latvia and Estonia.
The UK, where the vaccine was developed, has not done so.
At first, although Spain had decided not to give the AstraZeneca jab to anyone of 55 years old or over due to 'insufficient data' and 'inconclusive results' about its safety and effectiveness above this age – purely because not enough volunteers in this category were able to participate in clinical trials, not because of any adverse reactions or reduced immunity detected in these – its health authority opted not to halt the roll-out.
Health minister Carolina Darias did not consider the risk to be worth stopping the crucial process of immunising the population as quickly as possible so life could return to normal – only 10 cases of blood clots in 17 million doses administered had been detected.
But when Spain reported case number 11 – albeit literally one in a million – Sra Darias decided to delay further inoculation with the AstraZeneca drug 'temporarily' until the EMA had analysed the situation.
She said this had been a 'very difficult' decision, but that even though the cases reported were 'extremely few and far between', they were 'particularly significant' as they had occurred with a vaccine that, in most countries, including Spain, has only been given to young adults and, in the majority of those affected, with no pre-existing physical health conditions.
As at the weekend, the EMA had recommended not postponing any AstraZeneca jabs as the 'benefits outweighed the possible risks', despite Denmark's and Norway's having already done so altogether and five other countries had chosen to discard the batch involved.
Head of the Spanish Medications and Healthcare Products Agency (AEMPS), María Jesús Lamas, said the country's 'risk assessment' had 'changed' after a person had been diagnosed on Saturday with a blood clot to the brain and a 'major' reduction in blood platelets, which 'implied an abnormal clotting activity'.
Neither Sra Lamas nor Sra Darias have been willing to disclose any details about the person in question, other than to assure that they are 'recovering', that the situation was 'very infrequent', albeit 'very significant'.
Not every one of the 11 cases in 17 million reported up to the weekend in the European Union – which now appear to have risen to 30 in five million across the continent of Europe, including three more in Norway and two more in Germany – have been as fortunate as the recipient in Spain; some have died, including a female doctor in Italy in the last two days and a 49-year-old lady nurse in Austria a week ago.
Sra Darias says warning signs start to appear within three days to a fortnight after the jab and are mainly in the form of a 'debilitating', migraine-like headache which does not respond to any painkillers, is worse when lying down and causes blurred vision.
Some recipients of the 'Oxford' vaccine have described the side-effects as being 'like the worst hangover of their lives', and Spain's health minister says the headaches reported are 'considerably more intense' than a 'normal' reaction to a vaccine should be.
Many of Spain's regions had just started vaccinating teachers in private and State schools and colleges and nursery schools, police and other emergency response workers, and non-front line health and care workers, aged under 55, using the AstraZeneca jab which, unlike the Pfizer and Moderna inoculations, where both doses need to be given between 18 and 21 days apart, the recommended gap between jabs is 12 weeks.
Today (Monday), however, large numbers of teachers getting ready for their vaccine appointments said they had been telephoned by their health authorities telling them not to attend.
Their reactions range from disappointed, believing they would soon be safe from Covid, to relieved, as they had been feeling apprehensive about becoming a 'statistic'.
Spain's government has, however, urged everyone to 'remain calm'.
“What we are hoping for at the moment is that the AstraZeneca vaccine offers at least partial protection against Covid following the first dose,” said Sra Lamas.
“The chances of suffering adverse effects from any medicine always exist, but the situation we are dealing with is one where the chances are highly improbable, as the incidence is extremely low.”
This said, neither the AEMPS boss nor the health minister have any answers as yet as to what will happen if the British-made vaccine is to be recalled at the EMA's instructions or recommendations, given that nearly a million people in Spain have had their first dose and should have been getting their second within three months.
Sra Darias says that as the AstraZeneca is the vaccine with the longest period between doses – in trials, the second injection was found to be more effective after 12 weeks than after eight – this, at least, gives the EMA time to reach some conclusions.
By then, Spain and other countries that had been using the AstraZeneca jab are hoping they will have worked out an alternative strategy if the EMA says none of the original recipients should receive their second dose.
Neither is it clear whether Spain and the rest of the EU will be able to meet their targets of 70% of their populations being vaccinated by summer if the 'Oxford' jab is no longer recommended.
Until the EMA gives its verdict, says Sra Lamas, the AstraZeneca will still be arriving in Spain in the agreed batches, and will be stored at the AEMPS until they are either deemed safe to use, or need to be destroyed under controlled conditions.
At present, Spain is collating data on side-effects suffered by everyone who has had the jab – if any – to attempt to 'identify a pattern or profile'.
The postponement of the AstraZeneca vaccine in Spain came within hours of the health ministry's deciding to 'investigate' the possibility of increasing the maximum age of its administration to 65, in line with 'positive experiences' in results among this community elsewhere in Europe.
Related Topics
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