Johnson & Johnson’s Janssen COVID-19 vaccine
is the latest vaccine to come under scrutiny after Belgium pulled the plug on rolling it out for people under the age of 41 following the death of a woman from severe side-effects. “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. The EMA is the European Union’s European Medicine’s Agency.
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.
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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.
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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 Centre for Disease Control, 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.The UK has already secured 30 million doses of the Johnson & Johnson/Janssen vaccine vaccine.
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.
It must be stressed that there is overwhelming evidence that the vaccines currently deployed in the UK are safe and effective in protecting from COVID-19 disease and transmission.
This post originally appeared on Daily Express :: Health Feed