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Belgium stops administering Janssen COVID-19 vaccine to people under 41 after woman dies from severe thrombosis

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Jiya Saini
Jiya Saini is a Journalist and Writer at Revyuh.com. She has been working with us since January 2018. After studying at Jamia Millia University, she is fascinated by smart lifestyle and smart living. She covers technology, games, sports and smart living, as well as good experience in press relations. She is also a freelance trainer for macOS and iOS, and In the past, she has worked with various online news magazines in India and Singapore. Email: jiya (at) revyuh (dot) com

Belgium has decided to temporarily stop administering Johnson & Johnson’s Janssen COVID-19 vaccine to people under 41 after a woman under the age of 40 died in the country after receiving the single dose of the Janssen COVID-19 vaccine.

The Inter-ministerial conference has decided to temporarily administer Janssen’s vaccine to the general population from the age of 41 years, pending a more detailed benefit-risk analysis by the EMA.

the Belgian health ministers said in a statement

At the time of the announcement, there was no immediate comment from J&J.

The woman – who was under the age of 40 – died on May 21, after being admitted to hospital with severe thrombosis and platelet deficiency, the statement said.

She was vaccinated through her employer and outside of the official Belgian vaccination campaign.

Deliveries of J&J’s vaccine in Belgium have so far been limited to about 40,000 units, with 80 percent of the doses administered so far to people over 45 years old, the statement said.

J&J said on April 20 it would resume rolling out its COVID-19 vaccine in Europe with a warning on its label, after requesting countries, including Belgium, to pause its use amid concerns about possible links to rare blood clots.

J&J has said that no clear causal relationship has been established between the clots and its shot while the EMA has maintained that the benefits of the shot outweigh any risks.

Meanwhile, Belgium has asked for advice from the EMA to evaluate the link between the woman’s death and the J&J vaccine.

It did not confirm when it expected EMA’s final opinion on it.

The combination of blood clots with low blood platelet count has also been identified with the AstraZeneca coronavirus vaccine.

A link between the condition – medically referred to as thrombosis and thrombocytopenia (VITT) – and the J&J vaccine was identified by safety reviews performed by the FDA (in conjunction with the CDC) and the EMA.

They both concluded that these events are very rare and that the benefits of the vaccine outweigh the risks for adults aged 18 and older.

Authors of a study published in the New England Journal of Medicine (NEJM) suggested that this rare serious adverse event could be related to the adenoviral technology used for both AstraZeneca and the J&J vaccines.

However, On 16 April 2021, Janssen (the manufacturer) pushed back against this hypothesis, arguing that the two vaccines use different “adenoviral vectors” containing slightly different parts of the spike protein, therefore the biological effects may be quite different.

On 21 April 2021 the results of the Phase 3 clinical trials were published.

Phase 3 clinical trials demonstrate the safety and effectiveness of a new medicine or vaccine in the typical patient likely to use it.

The study involved 39,321 participants (half receiving the vaccine and half receiving a control injection) and it assessed safety and efficacy against COVID-19 disease.

The study was initially paused on 11 October 2020 following a suspected serious adverse event.

It resumed on 27 October 2020 following a data and safety monitoring board review that found no evidence that this event was related to the vaccine.

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