US Food and Drug Administration (USFDA), on Friday (June 4), voiced concern over potential myocarditis link to Novavax Covid-19 vaccine. Experts will soon weigh its use in the United States.&nbsp;

The Novavax vaccine is already authorized in other countries, particularly in Europe.&nbsp;

An independent committee is due to meet on Tuesday to evaluation the vaccine and give its recommendation. The committee has been convened at the request of USFDA.

USFDA has published a lengthy document analysing data about the vaccine. It has done the same in past for three other vaccines which are already authorised in the country.

After USFDA's document, Novavax stock dropped 20 per cent on New York Stock Exchange.

Novavax's vaccine was found to be 90 percent effective against symptomatic cases of the disease, in trials conducted before the appearance of the Omicron variant, according to the FDA.&nbsp;

However in the group which was given the vaccine, six cases of myocarditis were found. Mysocarditis is inflammation of heart muscles. In the placebo group, one such case was found.

Five cases occurred within two weeks of vaccination.&nbsp;

"Identification of multiple potential vaccine-associated cases" out of 40,000 clinical trial participants "raises concern that if causally associated, the risk of myocarditis following" the Novavax shot "could be higher than reported" on other vaccines such as Pfizer or Moderna, the FDA said.

(With inputs from agencies)

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US Food and Drug Administration (USFDA), on Friday (June 4), voiced concern over potential myocarditis link to Novavax Covid-19 vaccine. Experts will soon weigh its use in the United States.

US Food and Drug Administration (USFDA), on Friday (June 4), voiced concern over potential myocarditis link to Novavax Covid-19 vaccine. Experts will soon weigh its use in the United States. The Novavax vaccine is already authorized in other countries, particularly in Europe. An independent committee is due to meet on Tuesday to evaluation the vaccine and give its recommendation. The committee has been convened at the request of USFDA. USFDA has published a lengthy document analysing data about the vaccine. It has done the same in past for three other vaccines which are already authorised in the country. After USFDA's document, Novavax stock dropped 20 per cent on New York Stock Exchange. Novavax's vaccine was found to be 90 percent effective against symptomatic cases of the disease, in trials conducted before the appearance of the Omicron variant, according to the FDA. However in the group which was given the vaccine, six cases of myocarditis were found. Mysocarditis is inflammation of heart muscles. In the placebo group, one such case was found. Five cases occurred within two weeks of vaccination. "Identification of multiple potential vaccine-associated cases" out of 40,000 clinical trial participants "raises concern that if causally associated, the risk of myocarditis following" the Novavax shot "could be higher than reported" on other vaccines such as Pfizer or Moderna, the FDA said. (With inputs from agencies) You can now write for wionews.com and be a part of the community. Share your stories and opinions with us here. WATCH WION LIVE HERE ×

USFDA expresses concern over possible Novavax myocarditis link

A large part of the world's population has received the coronavirus (COVID-19) vaccine, either one or two; some even have been inoculated with the booster shots. More than 10 billion doses of COVID-19 vaccines have been administered globally as of March 2022.&nbsp;

Some people have experienced the side effects of the Covid vaccines, usually mild and self-limiting. Fever, fatigue, headache, muscle pain, chills, diarrhoea and pain at the injection site are some of the common symptoms experienced by most people.&nbsp;

However, a recent <a href="https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(22)00059-5/fulltext">report</a> published in The Lancet Respiratory Medicine concluded that some people have experienced severe heart inflammation. It has been described as a rare risk associated with COVID-19 vaccines.&nbsp;

Researchers from National University Hospital, Singapore examined international databases to understand the&nbsp;incidence of myocarditis following COVID-19 vaccination and compare this with non-COVID-19 vaccination as well.&nbsp;

Experts have noted that Myocarditis is an inflammation of the heart muscle (myocardium). The inflammation can reduce the heart's ability to pump and cause rapid or irregular heart rhythms (arrhythmias).&nbsp;

It has also been understood that the term&nbsp;pericarditis&nbsp;refers to inflammation of the pericardium and&nbsp;myocarditis and both can occur together in clinical practice.&nbsp;

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The study mentioned&nbsp;that the "overall risk of myopericarditis after receiving a COVID-19 vaccine is low". However, younger males have an increased incidence of myopericarditis, particularly after receiving mRNA vaccines.&nbsp;

Part of the study read, "Nevertheless, the risks of such rare adverse events should be balanced against the risks of COVID-19 infection (including myopericarditis)."&nbsp;

The study was based on a sample size of more than 400M vaccine doses and the overall incidence of myocarditis from 22 studies was 33·3 cases per million vaccine doses.&nbsp;

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The study noted that it did not differ significantly between people who received COVID-19 vaccines and those who received non-COVID-19 vaccines.&nbsp;

As rates of myocarditiss were higher in smallpox shots as compared to coronavirus jabs. Whereas it is about the same as in influenza, measles, mumps and rubella and polio vaccines.&nbsp;

"Our research suggests that the overall risk of myopericarditis appears to be no different for this newly approved group of vaccines against Covid- 19, compared to vaccines against other diseases,"&nbsp;said Dr. Kollengode Ramanathan, a cardiac intensivist at the Hospital.&nbsp;

"The risk of such rare events should be balanced against the risk of myopericarditis from infection and these findings should bolster public confidence in the safety of Covid-19 vaccinations,"&nbsp;Ramanathan added.&nbsp;

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"The occurrence of myopericarditis following non-Covid-19 vaccination could suggest that myopericarditis is a side effect of the inflammatory processes induced by any vaccination and is not unique to the SARS-CoV-2 spike proteins in Covid-19 vaccines or infection,"&nbsp;said Dr Jyoti Somani, an infectious diseases specialist at the Hospital.&nbsp;

"This also highlights that the risks of such infrequent adverse events should be offset by the benefits of vaccination, which include a lower risk of infection, hospitalisation, severe disease, and death from Covid-19,"&nbsp;she added.&nbsp;

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Another study published in the journal&nbsp;<a href="https://www.ahajournals.org/doi/abs/10.1161/CIR.0000000000001064">Circulation</a>&nbsp;stated that found that 54 out of nearly 57,000 adults were hospitalised due to acute myocarditis after COVID-19.&nbsp;

The study, "SARS-CoV-2 Infection and Associated Cardiovascular Manifestations and Complications in Children and Young Adults: A Scientific Statement From the American Heart Association" focused on people in the US and Europe hospitalised with COVID-19 from February 2020 until April 2021.&nbsp;

A large part of the world's population has received the coronavirus (COVID-19) vaccine, either one or two; some even have been inoculated with the booster shots.

A large part of the world's population has received the coronavirus (COVID-19) vaccine, either one or two; some even have been inoculated with the booster shots. More than 10 billion doses of COVID-19 vaccines have been administered globally as of March 2022. Some people have experienced the side effects of the Covid vaccines, usually mild and self-limiting. Fever, fatigue, headache, muscle pain, chills, diarrhoea and pain at the injection site are some of the common symptoms experienced by most people. However, a recent report published in The Lancet Respiratory Medicine concluded that some people have experienced severe heart inflammation. It has been described as a rare risk associated with COVID-19 vaccines. Researchers from National University Hospital, Singapore examined international databases to understand the incidence of myocarditis following COVID-19 vaccination and compare this with non-COVID-19 vaccination as well. Experts have noted that Myocarditis is an inflammation of the heart muscle (myocardium). The inflammation can reduce the heart's ability to pump and cause rapid or irregular heart rhythms (arrhythmias). It has also been understood that the term pericarditis refers to inflammation of the pericardium and myocarditis and both can occur together in clinical practice. ALSO READ | Reversal of time? Scientists de-age human skin cells by 30 years in trial The study mentioned that the "overall risk of myopericarditis after receiving a COVID-19 vaccine is low". However, younger males have an increased incidence of myopericarditis, particularly after receiving mRNA vaccines. Part of the study read, "Nevertheless, the risks of such rare adverse events should be balanced against the risks of COVID-19 infection (including myopericarditis)." The study was based on a sample size of more than 400M vaccine doses and the overall incidence of myocarditis from 22 studies was 33·3 cases per million vaccine doses. ALSO READ | An AI approach that can accurately predict when will one have a cardiac arrest. Find out more! The study noted that it did not differ significantly between people who received COVID-19 vaccines and those who received non-COVID-19 vaccines. As rates of myocarditiss were higher in smallpox shots as compared to coronavirus jabs. Whereas it is about the same as in influenza, measles, mumps and rubella and polio vaccines. "Our research suggests that the overall risk of myopericarditis appears to be no different for this newly approved group of vaccines against Covid- 19, compared to vaccines against other diseases," said Dr. Kollengode Ramanathan, a cardiac intensivist at the Hospital. "The risk of such rare events should be balanced against the risk of myopericarditis from infection and these findings should bolster public confidence in the safety of Covid-19 vaccinations," Ramanathan added. WATCH | Fight heat wave with these 7 items in your diet × "The occurrence of myopericarditis following non-Covid-19 vaccination could suggest that myopericarditis is a side effect of the inflammatory processes induced by any vaccination and is not unique to the SARS-CoV-2 spike proteins in Covid-19 vaccines or infection," said Dr Jyoti Somani, an infectious diseases specialist at the Hospital. "This also highlights that the risks of such infrequent adverse events should be offset by the benefits of vaccination, which include a lower risk of infection, hospitalisation, severe disease, and death from Covid-19," she added. Another study published in the journal Circulation stated that found that 54 out of nearly 57,000 adults were hospitalised due to acute myocarditis after COVID-19. The study, "SARS-CoV-2 Infection and Associated Cardiovascular Manifestations and Complications in Children and Young Adults: A Scientific Statement From the American Heart Association" focused on people in the US and Europe hospitalised with COVID-19 from February 2020 until April 2021.

What is myocarditis? A rare complication of COVID-19 and non-Covid vaccinations

Israel's Health Ministry said on Tuesday, it found the small number of heart inflammation cases observed mainly in young men, who received Pfizer's COVID-19 vaccine in Israel,&nbsp;were likely linked to their vaccination. 
 
Pfizer has said it has not observed a higher rate of the condition, known as myocarditis, than would normally be expected in the general population. 
 
In Israel, 275 cases of myocarditis were reported between December 2020 and May 2021 among more than five million vaccinated people, the ministry said in disclosing the findings of a study it commissioned to examine the matter. 
 
Most patients, who experienced heart inflammation spent no more than four days in hospital and 95% of the cases were classified as mild, according to the study, which the ministry said was conducted by three teams of experts. 
 
The study found "there is a probable link between receiving the second dose (of Pfizer) vaccine and the appearance of myocarditis among men aged 16 to 30," it said in a statement. 
 
According to the findings, such a link was observed more among men aged 16 to 19 than in other age groups. 
 
Pfizer said in a statement that it is aware of the Israeli observations of myocarditis, noting that no causal link to its vaccine has been established. 
 
Adverse events are thoroughly reviewed and Pfizer meets regularly with the Vaccine Safety Department of the Israeli Ministry of Health to review data, it said. 
 
A US&nbsp;Centers for Disease Control and Prevention advisory group last month recommended further study of the possibility of a link between myocarditis and mRNA vaccines, which include those from Pfizer and Moderna Inc. 
 
CDC monitoring systems had not found more cases than would be expected in the population, but the advisory group said in a statement that members felt healthcare providers should be made aware of reports of a "potential adverse event." 
 
The Israeli ministry released the statement, which contained no recommendations, ahead of a widely expected decision on whether to begin vaccinating youngsters aged 12 to 15 in Israel. 
 
It said a team examining that issue would make its recommendation to the ministry's director-general, but gave no date. 
 
Israeli media reports said a decision on including the 12-15 age group in the country's vaccination programme could come as early as Sunday. 
 
Israel has been a world leader in its vaccination rollout. 
 
With COVID-19 infections down to just a handful a day and total active cases at just 340 across the country, the economy has fully opened, though restrictions remain on incoming tourism. 
 
Some 55% of Israel's population has already been vaccinated. As of Tuesday, restrictions on social distancing and the need for special green vaccination passes to enter certain restaurants and venues were scrapped. 
 
(With inputs from agencies)

Israel's Health Ministry said on Tuesday, it found the small number of heart inflammation cases observed mainly in young men, who received Pfizer's COVID-19 vaccine in Israel, were likely linked to their vaccination.

Israel's Health Ministry said on Tuesday, it found the small number of heart inflammation cases observed mainly in young men, who received Pfizer's COVID-19 vaccine in Israel, were likely linked to their vaccination. Pfizer has said it has not observed a higher rate of the condition, known as myocarditis, than would normally be expected in the general population. In Israel, 275 cases of myocarditis were reported between December 2020 and May 2021 among more than five million vaccinated people, the ministry said in disclosing the findings of a study it commissioned to examine the matter. Most patients, who experienced heart inflammation spent no more than four days in hospital and 95% of the cases were classified as mild, according to the study, which the ministry said was conducted by three teams of experts. The study found "there is a probable link between receiving the second dose (of Pfizer) vaccine and the appearance of myocarditis among men aged 16 to 30," it said in a statement. According to the findings, such a link was observed more among men aged 16 to 19 than in other age groups. Pfizer said in a statement that it is aware of the Israeli observations of myocarditis, noting that no causal link to its vaccine has been established. Adverse events are thoroughly reviewed and Pfizer meets regularly with the Vaccine Safety Department of the Israeli Ministry of Health to review data, it said. A US Centers for Disease Control and Prevention advisory group last month recommended further study of the possibility of a link between myocarditis and mRNA vaccines, which include those from Pfizer and Moderna Inc. CDC monitoring systems had not found more cases than would be expected in the population, but the advisory group said in a statement that members felt healthcare providers should be made aware of reports of a "potential adverse event." The Israeli ministry released the statement, which contained no recommendations, ahead of a widely expected decision on whether to begin vaccinating youngsters aged 12 to 15 in Israel. It said a team examining that issue would make its recommendation to the ministry's director-general, but gave no date. Israeli media reports said a decision on including the 12-15 age group in the country's vaccination programme could come as early as Sunday. Israel has been a world leader in its vaccination rollout. With COVID-19 infections down to just a handful a day and total active cases at just 340 across the country, the economy has fully opened, though restrictions remain on incoming tourism. Some 55% of Israel's population has already been vaccinated. As of Tuesday, restrictions on social distancing and the need for special green vaccination passes to enter certain restaurants and venues were scrapped. (With inputs from agencies)

Israel sees probable link between Pfizer vaccine and myocarditis cases

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