Tuesday, May 17, 2022

First cases of myocarditis linked to booster

Australia’s drug regulator has confirmed the first cases of rare heart inflammation following booster vaccines.

Australia’s drug regulator has confirmed the first cases of rare heart inflammation following booster vaccines.

As of January 9, there have been six reports of probable myocarditis – four after Pfizer and two after Moderna – and 12 reports of probable pericarditis – 10 after Pfizer and two after Moderna – after a third or booster dose of a COVID-19 vaccine. After, according to the latest security update from the Therapeutic Goods Administration (TGA).

“The TGA is monitoring the safety of booster vaccine doses in adults,” the regulator said.

“It is not expected that the types of side effects will differ for the first and second vaccine doses based on the results of clinical trials, and observations from regulators overseas where more booster doses have been given.”

Myocarditis, or inflammation of the heart muscle, and pericarditis, or inflammation of the lining around the heart, are serious but rare side effects associated with mRNA vaccines.

According to the TGA, myocarditis—which it describes as “very rare”—is reported in one to two out of every 100,000 people receiving Pfizer and two to three out of 100,000 receiving Moderna. Is.

But 12 cases per 100,000 for Pfizer in teenage boys and 17 per 100,000 for Moderna, and 6 per 100,000 for Pfizer in young men under 30 and 12 per 100,000 for Moderna after the second dose. It is more common.

“As of January 9, 2022, we have received approximately 950 reports of suspected adverse events identified after a third or booster dose,” the TGA said.

“This includes very few cases of myocarditis and pericarditis. The most common adverse events reported to TGA after a booster dose are swollen lymph nodes (also known as lymphadenopathy), headache, fatigue, muscle pain, and fever. Swelling. Lymph nodes are a common and known side effect of vaccines and occur when the immune system is stimulated and were seen in clinical trials.

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The TGA says it has also received nearly 3000 reports of adverse reactions following vaccination in children and adolescents.

The most commonly reported reactions in children 12 to 17 years of age are chest pain, headache, dizziness, nausea, and fever.

“Reports of more serious effects following vaccination in children in the US were extremely rare with 100 reports from 8.7 million vaccine doses – the most common being fever, vomiting and, in some cases, seizures,” it said.

“Importantly, myocarditis was also very rare in this age group, with 11 confirmed reports from more than eight million doses – all of which were mild cases. The TGA is closely monitoring reports of adverse events in this age group.” And if any security issue arises she will inform the same.

As of January 9, from 28.4 million doses of Pfizer and 2.1 million doses of Moderna, 467 cases of probable myocarditis — 423 from Pfizer and 44 from Moderna — and a further 1048 cases classified as “suspected” myocarditis — from Pfizer 952 and 96 from Moderna.

Suspicious cases include those reporting both myocarditis and pericarditis. There have been an additional 2183 cases of suspected pericarditis alone – 2015 from Pfizer and 168 from Moderna.

TGA stresses that myocarditis is “often mild, and cases usually resolve after a few days with treatment and rest”, but about half of cases result in hospitalization.

“Five people with confirmed myocarditis were treated in intensive care,” the TGA says.

“This represents about 1 percent of all confirmed myocarditis cases. Most of the hospitalized patients were discharged within four days.”

According to Department of Health data from Sunday, 92.5 percent of people over the age of 16 in Australia are now fully vaccinated, and nearly half a million people over the age of 18 have received more than two doses.

It was stated by Australia’s Chief Medical Officer Paul Kelly that a fourth booster dose was on the cards.

Professor Kelly said the government’s vaccine advisory group, the Australian Technical Advisory Group on Immunization (ATAGI), would “absolutely” consider the possibility.

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,[ATAGI] Weekly meeting continues. They will fully consider a fourth or later dose,” Prof Kelly told reporters in Canberra on Saturday.

Earlier this month, Israel became the first country to introduce a fourth dose of the vaccine.

Denmark and Chile have also started giving second boosters to people at risk for serious illness.

However, there is growing pushback for the booster, including from the World Health Organization (WHO) and the European Medicines Agency (EMA).

Last week, the EMA said there was still no data to support the need for a fourth dose, and warned that repeated boosters could cause “problems with the immune response.”

“While the use of additional boosters may be part of contingency plans, repeated vaccinations within short intervals will not represent a sustainable long-term strategy,” EMA vaccine strategy chief Marco Cavallari said at a media briefing, according to Reuters.

,[Boosters] Might be done once, or maybe twice, but it’s not something we can think of that needs to be repeated constantly.”

It came as the WHO warned a vaccination strategy “based on repeated booster doses of the original vaccine composition is unlikely to be appropriate or sustainable”.

The UK’s chief vaccine adviser, Professor Sir Andrew Pollard, who helped develop the Oxford-AstraZeneca vaccine, also called for an end to ongoing mass vaccination.

“It’s not really affordable, sustainable or maybe everyone on the planet needs to be vaccinated every four to six months,” Prof Pollard told BBC Radio 4 Today Program. “In the future, we need to target vulnerable people.”

Pfizer Chief Executive Albert Boerla said last week that two doses of its current COVID-19 vaccine provide “very limited protection, if any” against the Omron variant, while three doses are “appropriate against hospitalizations and deaths.” provides security”.

Dr Baurla said Pfizer was working on an Omicron-specific version of the vaccine, which should be available by March.


Read related topics:Vaccination


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