EU regulator prepares to issue advice on use of J&J vaccine

LONDON (AP) – Experts from the European Medicines Agency prepare to present on Tuesday the conclusions of their study on possible links between the Johnson & Johnson coronavirus vaccine and very rare cases of unusual coagulation disorders discovered in the US

Last week J&J stopped the European rollout of its single-dose vaccine after the U.S. Food and Drug Administration recommended that officials discontinue its use while the rare cases of blood clots are being investigated. Officials identified six cases of the highly unusual blood clots among nearly 7 million people immunized with the shot in the US

Johnson & Johnson advised European governments to store their doses until the EU drug regulator issued guidelines on their use; the widespread use of the shot in Europe has not yet begun.

The delay was another blow to vaccination efforts in the European Union, plagued by supply shortages, logistical problems and concerns about unusual blood clots, including in a small number of people who received the AstraZeneca COVID-19 vaccine. Experts are concerned that the temporary halt of J & J’s shot could further shake confidence in the vaccine and complicate COVID-19’s global vaccination efforts.

Last week, South Africa stopped using the vaccine in the wake of the US hiatus, and countries like Italy, Romania, the Netherlands, Denmark and Croatia stocked their J&J doses.

The blood clots associated with the J&J vaccine occur in unusual parts of the body, such as veins that drain blood from the brain. Those patients also have abnormally low platelets, a condition normally related to bleeding, not clotting.

With the AstraZeneca vaccine, scientists 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 whether a similar mechanism could exist with the Johnson & Johnson vaccine. But both the J&J and AstraZeneca vaccines, as well as a Russian COVID-19 vaccine and a vaccine from China, are made with the same technology. They train the immune system to recognize the spike protein that envelops the coronavirus. To do that, they use a cold virus called an adenovirus to deliver the spike gene into the body.

“There is a growing suspicion that these rare cases may be caused 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 while more data was needed, “it remains that for the vast majority of adults in Europe and the US, the risks associated with contracting COVID-19 far outweigh the risk of vaccination.”

On Monday, World Health Organization Director General Tedros Adhanom Ghebreyesus said that more than 5 million new cases of cororavirus were confirmed worldwide last week, the highest number ever in one week. He noted that cases and hospitalizations among younger people are “increasing at an alarming rate.”

The European Medicines Agency, which regulates medicines used in member states of the European Union, said last month that there is a “possible link” between the AstraZeneca vaccine and rare blood clots, but said the benefits of vaccination far outweigh the risks. from COVID-19. It noted that the risk is less than the risk of blood clots that healthy women run from birth control pills.

The European Union has ordered 200 million doses of Johnson & Johnson by 2021, and EU officials had hoped the one-off vaccine could be used both to increase the continent’s lagging vaccination coverage and to protect hard-to-reach populations such as migrant workers and the homeless.

Last month, the African Union announced it had signed a deal to purchase up to 400 million doses of the J&J vaccine. Johnson & Johnson also has a deal to supply up to 500 million doses to the UN-backed COVAX initiative that is helping deliver vaccines to the world’s poor.

Any concerns about the J&J vaccine would be another unwanted complication for COVAX and for the billions of people in developing countries, depending on the program. COVAX was recently hit with supply problems after its largest supplier, the Serum Institute of India, announced it would delay exports of the AstraZeneca vaccine for several months due to an increase in the number of cases in the subcontinent.