EMA safety committee, PRAC, is revising the situation caused by the specific batch of AstraZeneca batch, as well as all other cases of thromoembolic episodes and other people suffering conditions related to blood clots discovered after vaccination. According to the EMA, with the information currently available the number of this kind of cases in vaccinated people "is no higher than that observed in the general population". Up until March 9, there have been 22 cases among the 3 million who have received the AstraZeneca vaccine in the European Economic Space (EU + Iceland, Liechtensten and Norway).
Two batches of AstraZeneca vaccine put several EU countries on alert
Denmark and Norway suspend administration and Italy and Austria recall at least two different batches
London / BarcelonaHysteria around the AstraZeneca vaccine. After the Danish Directorate General of Health announced this Thursday the temporary suspension of its administration due to "serious cases of thrombi" in people who had received it, Norway has also made the same announcement of suspension and Italy, also this Thursday, has withdrawn a batch (the ABV2856) of vials of the production of the Anglo-Swedish pharmaceutical company. These almost cascading decisions have taken place in the light of the one taken last Sunday by Austria, which stopped administering the Oxford/AstraZeneca vaccines from the ABV5300 batch, while a death due to coagulation disorders and a pulmonary embolism disease is being investigated.
In Denmark, one of the cases that has alerted health authorities is also linked to a death. However, in a statement, the country's health authorities have stressed that it is not yet possible to conclude that there is a link between the vaccine and the formation of blood clots. In fact, hours before the Danish announcement, on Wednesday evening, the European Medicines Agency (EMA) said in another statement that it had launched an investigation into the matter but that "there are currently no indications that the vaccination has caused these conditions, which are not listed as side effects with this vaccine".
"We are in the middle of the largest and most important vaccination programme in Danish history, and right now we need all the vaccines we can get. Therefore, putting one of the vaccines on hold is not an easy decision. But it is precisely because we vaccinate so many people that we have to respond in a timely manner when we become aware of possible serious side effects. We have to clarify this before we can continue to use AstraZeneca's vaccine," Soren Brostrom, head of the National Board of Health, said this morning. More than 140,000 Danes have received the first injection of AstraZeneca's vaccine. "We still don't know if the blood clots and death are due to the vaccine, but it has to be thoroughly examined for safety," says Tanja Erichsen of the Danish Medicines Agency.
In Austria, concern is focused on a 49-year-old woman who died from multiple thrombosis (formation of blood clots in the blood vessels) and a 35-year-old woman who developed a pulmonary embolism (blockage of the pulmonary arteries). The latter, however, is recovering. The first patient died ten days after vaccination. Since 9 March, two other case reports of thromboembolic events have been received for this batch.
Denmark is investigating specific cases of possible effects. Norway's decision, however, is "precautionary", Geir Bukholm, director of infection prevention and control at the Norwegian Institute of Public Health, told a press conference. In addition, Austria's decision to suspend the administration of the ABV5300 batch prompted Lithuania, Estonia, Luxembourg, Greece and Latvia to also recall vials of the same batch. According to the information provided by the EMA, vials of the same Austrian batch under suspicion have been distributed to 17 EU countries. In total, one million doses have gone to Austria, Bulgaria, Cyprus, Denmark, Estonia, France, Greece, Iceland, Ireland, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Poland, Spain and Sweden.
Italy withdraws another batch
As for Italy's recall of batch ABV2856, the country's regulator (AIFA) has justified it after having detected "some serious adverse events in temporary concomitance with the supply" of doses with the same origin, the aforementioned batch ABV2856. AIFA, however, argues that this is a preventive measure and that, for the moment, "no causal link has been established between the administration of the vaccine and these events". The Italian agency's statement, however, does not specify what they are.
Meanwhile, the Dutch health authorities have reported a case of thrombosis in a person who had received the AstraZeneca vaccine. It is, they say, a minor situation and did not require hospitalisation. The case is being analysed to determine whether there is indeed a link between the health problem and the vaccine. So far, the Netherlands has not made any decision on whether to suspend the campaign that uses the AstraZeneca doses. Nor has it been clarified whether the vaccine in question corresponded to the batch withdrawn in Austria.
Call for calm
In Barcelona, Hospital de Sant Pau's Dr. José María Soria Fernández has called for calm now that the Spanish government is one step away from authorising the use of AstraZeneca for over-55s because, he insisted, the "control mechanisms and safety of the vaccine work very well" and stopping the supply of a drug that is already on the market is within normal parameters and, in fact, for at least a year after it is firs marketed it is strictly monitored to check whether it causes serious conditions. The specialist, head of the Genetic Diseases Genomics Unit, has indicated that with the little information available on the Danish cases it is still too early to say whether there is a cause-effect relationship with the doses administered.
For 10 months Soria has been leading the Precis-covid-19 project, which analyses the risk of thrombi in coronavirus patients. In fact, he explains that with the data in hand it has been proven that thrombosis has a high incidence among patients and, for example, states that 60% of those who come to the ICU suffer from them and pathological clots -which obstruct veins and arteries and cause strokes or pulmonary embolisms- are responsible for a third of deaths.
The specialist reports two fatal cases that the Austrian authorities are also investigating to see if they are related to the AstraZeneca vaccine. Two women aged 30 and 49 suffered thromboses after being immunised. One of them died and the other is hospitalised with a pulmonary embolism. However, Dr. Soria wants to convey calm and avoid generating anxiety while awaiting the results of the investigations.
The Spanish Minister of Health, Carolina Darias, has made the same statement. Talking to La Sexta she has called for "prudence" and "calm" and has recalled that no incident of this nature has been reported in Spain and recalled that the EMA is analysing the facts in order to make a decision.
The Secretary of Public Health, Josep Maria Argimon, also stressed that this type of research is always carried out with any vaccine and that, although "we must be vigilant and very cautious," he has pointed out that the alert issued by the Spanish agency to explain the situation in Denmark "does not recommend the withdrawal" of the vaccine. "In Denmark, as happened in Austria, some effects have been observed that coincide in time with the AstraZeneca vaccine. Countries' pharmacovigilance always initiate an investigation when such events take place to check if it is anything more than a coincidence or a temporal relationship or if the vaccine is the cause of this effect," he explained.