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EMA Prepares To Present Investigation Findings Into J&J Vaccine And Blood Clots Risk

European Medicines Agency experts were on Tuesday preparing to present their findings from the investigation they had conducted into possible links between the coronavirus vaccine of Johnson and Johnson and extremely rare cases of unusual clotting disorders reported in the U.S.

EMA Prepares To Present Investigation Findings Into J&J Vaccine And Blood Clots Risk

The company last week, halted the rollout of its single-dose vaccine in Europe, following the recommendation of the U.S. Food and Drug Administration for pausing its use while cases of the rare blood clot were examined. Six cases of the blood clots had been identified by officials among around 7 million people in the US immunized with J&J vaccine.

EMA Prepares To Present Investigation Findings Into J&J Vaccine And Blood Clots Risk

Johnson & Johnson had called on European governments to store the vaccine until the EU drug regulator came out with its guidance on its use. Europe had not yet rolled out widespread use of the vaccine. 

According to commentators, the delay had dealt a blow to the European Union’s vaccination efforts that had been hit by shortages in supply, unusual blood clots in a few people who had received the AstraZeneca Covid-19 shot, and logistical problems. Meanwhile, experts have voiced concern that the temporary halt on J&J’s vaccine could undermine confidence in vaccination and add to resistance against immunization efforts.

South Africa, last week put the vaccine use on hold following the US move, and countries including the Netherlands, Italy, Romania, Croatia and Denmark put the J& J vaccine shots into storage.

The blood clots seen in cases of individuals that had been administered the J&J shots were occurring in unusual body parts, such as veins draining blood from the brain. Those patients also had abnormally blood platelet levels, a condition associated normally with bleeding, not clotting.

Regarding the AstraZeneca  vaccine, German and  Norwegian scientists  had suggested that in some individuals the immune system was responding in an abnormal way, forming  antibodies that attacked their platelets.

According to commentators, it was not clear yet, if a similar mechanism was not at work with the Johnson & Johnson vaccine. However, both the AstraZeneca and J&J vaccines, as also the Russian COVID-19 vaccine and the Chinese  vaccine, used the same technology. They trained the immune system for recognizing the spike protein that coated the coronavirus. They used a cold virus, called an adenovirus, to do that and carry the spike gene into the body.

According to Eleanor Riley, professor of infectious diseases and immunology at the University of Edinburgh, suspicion was increasing that the rare cases might be triggered by the adenovirus component of the J&J and AstraZeneca vaccines. She added that while more data was needed, the case remained that for most adults in the USA and Europe, the risks associated with contracting Covid-19 by far outweighed any risk from vaccination.

The Director-General of the World Health Organization Tedros Adhanom Ghebreyesus on Monday said, globally over 5 million new coronavirus cases were confirmed last week, which was the highest-recorded single week number. He added that hospitalizations and cases  among younger people were on the rise at an alarming rate.

European drugs regulator, the European Medicines Agency, which regulated drugs use in the member nations of the union, said last month that a “possible link” existed between rare blood clots and the AstraZeneca vaccine, but added that the benefits of vaccination far outweighed the Covid-19 risk. It went on to note that the risk was less than the risk of blood clots faced by women using birth control pills.

With the Johnson & Johnson order for the supply of 200 million doses, the EU officials had been hoping that the single-shot vaccine could help boost Europe’s lagging vaccination rates and protect populations that  were hard  to reach like the homeless  and  migrant workers.

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