Experts at the European Union Drugs Regulatory Agency said on Tuesday that they found a “possible link” between the Johnson & Johnson COVID-19 vaccine and very rare blood clots after a small number of cases were reported in the United States, but confirmed that the vaccine still outweighed the very small risks for recipients who develop the unusual blood clots.
The European Medicines Agency has issued a warning about the rare blood clots in the labels of Johnson & Johnson’s COVID-19 vaccine. The agency said these rare blood problems should be considered as “very rare side effects of the vaccine.”
Last week, Johnson & Johnson halted its European rollout of the vaccine after US officials recommended a break in the vaccine when they discovered six very rare cases of blood clots among nearly 7 million people who had been vaccinated.
European officials said they considered all available evidence from the United States, which consisted of eight reports of severe cases of rare platelets associated with low platelets, including one death.
Last week, J&J halted its European launch of its single-dose vaccine after the US Food and Drug Administration recommended that officials suspend its use while investigating the rare blood clots. Officials identified six cases of very unusual blood clots among nearly 7 million people vaccinated with the shot in the United States
Johnson & Johnson recommended that European governments store their doses until the EU Medicines Agency issues guidance on their use. widespread use of the shot in Europe has not yet started.
The delay was another blow to vaccination efforts in the European Union, which have been plagued by shortages of supply, logistical problems and concerns about unusual blood clots, even in a few people who received the AstraZeneca COVID-19 vaccine. Experts worry that the temporary halt to J & J’s shots could further shake the vaccine’s confidence and complicate COVID-19 immunization work worldwide.
Blood clots in unusual parts of the body
Last week, South Africa suspended its use of the vaccine in the wake of the US break, and countries such as Italy, Romania, the Netherlands, Denmark and Croatia stored their J&J doses.
Blood clots linked to the J&J vaccine occur in unusual parts of the body, such as veins that drain blood from the brain. These patients also have abnormally low levels of platelets, a condition normally associated with bleeding, does not coagulate.
With the AstraZeneca vaccine, researchers in Norway and Germany have suggested that some people experience an abnormal immune system response and form antibodies that attack their own platelets.
It is not yet clear if there may be a similar mechanism with the Johnson & Johnson vaccine. But both the J&J and AstraZeneca vaccines, as well as a Russian COVID-19 vaccine and one from China, are manufactured using the same technology. They train the immune system to recognize the nail protein that covers the coronavirus. To do this, they use a cold virus, called adenovirus, to carry the nail gene into the body.
“There is growing suspicion that these rare cases may be triggered by the adenovirus component of the AstraZeneca and J&J vaccines,” said Eleanor Riley, Professor of Immunology and Infectious Diseases at the University of Edinburgh. She said that although more data was needed, “it is still the case that for the vast majority of adults in Europe and the United States, the risks of developing COVID-19 far outweigh any risks of being vaccinated.”
More than 5 million new cases last week
On Monday, the Director General of the World Health Organization, Tedros Adhanom Ghebreyesus, said that more than 5 million new cases of cororavirus were confirmed worldwide last week, the highest number ever in a single week. He noted that falls and hospital stays among younger people “increased at an alarming rate.”
The European Medicines Agency, which regulates medicines used in EU member states, said last month that there was a “possible link” between the AstraZeneca vaccine and rare blood clots, but said the benefits of vaccination outweigh the risks of COVID-19. It noted that the risk is less than the risk of blood clots that healthy women face from birth control pills.
The European Union ordered 200 million doses of Johnson & Johnson for 2021 and EU officials had hoped the vaccine could be used with one shot both to increase the continent’s lagging vaccination levels and to protect hard-to-reach populations, such as migrant workers and the homeless.
Last month, the African Union announced that it had signed an agreement to purchase up to 400 million doses of the J&J vaccine. Johnson & Johnson also has a deal to deliver up to 500 million doses to the UN-backed COVAX initiative that helps get vaccines to the world’s poor.
Possible problems with the J&J vaccine would be another unwelcome complication for COVAX and for billions of people in developing countries depending on the program. COVAX was recently hit by delivery issues after its largest supplier, the Serum Institute of India, announced that it would delay exports of the AstraZeneca vaccine for several months due to a sharp increase in cases on the subcontinent.