LONDON (AP) – Experts from the European Medicines Agency are preparing to draw conclusions on Tuesday from their investigation into possible links between the Johnson & Johnson coronavirus vaccine and very rare cases of unusual clotting disorders in the US.
Last week, J&J stopped its European implementation of the single-dose vaccine after the US Food and Drug Administration recommended officials to discontinue it while the rare cases of blood clots is being investigated. Officials have identified six cases of the extremely unusual blood clots among nearly 7 million people who were immunized with the shot in the US
Johnson & Johnson advised European governments to store their doses until the EU drug regulator provides guidance on their use; the widespread use of the shot in Europe has not yet begun.
The delay was a further blow to the vaccination efforts in the European Union, which are plagued by supply shortages, logistical problems and concerns about unusual blood clots, even among a small number of people who received the AstraZeneca COVID-19 vaccine. Experts are concerned that the temporary cessation of J & J’s uptake could further frighten vaccine confidence and complicate the global immunization efforts of COVID-19.
Last week, South Africa suspended its use of the vaccine after the US interruption, and countries such as Italy, Romania, the Netherlands, Denmark and Croatia stored their J&J doses.
The blood clots linked to the J&J vaccine are found in unusual parts of the body, such as veins that drain blood from the brain. The patients also have abnormally low platelets, a condition usually associated with bleeding and not clotting.
With the AstraZeneca vaccine, scientists in Norway and Germany have suggested that some people experience an abnormal immune system reaction and form antibodies that attack their own platelets.
It is not yet clear if there could 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 protein that covers the coronavirus. To do this, they use a cold virus, called an adenovirus, to carry the spike gene into the body.
“The suspicion is growing that these rare cases may be caused by the adenovirus component of the AstraZeneca and J&J vaccines,” said Eleanor Riley, a professor of immunology and infectious diseases at the University of Edinburgh. She said that although more information was needed, “it is still the case that the risks associated with contracting COVID-19 for the vast majority of adults in Europe far outweigh any risk of being vaccinated.”
Tedros Adhanom Ghebreyesus, director general of the World Health Organization, said on Monday that more than 5 million new cases of coronavirus were confirmed worldwide last week, the highest number ever in one week. He noted that cases and hospitalizations among younger people were ‘increasing at an alarming rate’.
The European Medicines Agency, which regulates medicines regulated in European Union 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 risks of COVID-19 far exceeded. It has been noted that the risk is less than the blood clot risk that healthy women face due to birth control pills.
The European Union has ordered 200 million doses of Johnson & Johnson for 2021 and EU officials hoped the one-shot vaccine could be used to boost the continent’s vaccination backlog and 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 J&J vaccine. Johnson & Johnson also has an agreement to deliver up to 500 million doses to the UN-backed COVAX initiative that helps get vaccines to the world’s poorest.
Any concern about the J&J vaccine is another unwelcome complication for COVAX and for the billions of people in developing countries, depending on the program. COVAX was recently hit by supply-side issues after its largest supplier, the Serum Institute of India, announced that exports of the AstraZeneca vaccine would be delayed by several months due to an increase in cases on the subcontinent.