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The FDA has postponed the Moderna Covid-19 vaccine to examine rare side effects of myocarditis in adolescents

Food and Drug Administration is delaying approval decisions

Modana Of a corporation

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Adolescent Covid-19 vaccine To assess whether shots may increase the risk of rare inflammatory heart disease, according to people familiar with the matter.

After the strengthening of the four Scandinavian countries Stance on giving Moderna vaccine to young adults Last week, the FDA reviewed the risk of a condition known as myocarditis among young men vaccinated with Moderna, especially compared to young men vaccinated.

Pfizer Ltd

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When

BioNTech SE,

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People said.

So far, people have said that regulators have not determined whether the risk is high. The delay may take weeks, but the timing is unclear, one said.

Authorities plan to further review the data before deciding whether to extend vaccine eligibility to younger people, people said.

As the FDA approaches the decision to authorize Pfizer’s Covid-19 vaccine for children ages 5-11, public health officials and pediatricians are conducting research with families to ensure parents hesitate about shot safety. I’m sharing.Photo: John Rocher / Associated Press

The risk of myocarditis is the latest complication for vaccine makers, regulators, and public health authorities who have encouraged vaccination to protect against Covid-19. Rare blood coagulation Hurt the development of

AstraZeneca

With PLC

Johnson & Johnson

shot.

The risk of myocarditis is also a problem among many who are vulnerable to vaccination but are concerned about side effects.

parents Aspiring to inoculate their youth The Pfizer-BioNTech vaccine will continue to be available. Delayed authorization can increase the hesitation of some people who have postponed due to safety concerns. However, the FDA’s attention can also ease the minds of hesitant parents.

According to the FDA’s decision, Pfizer’s vaccine Preferred shots for adolescents and children As the United States expands its vaccine deployment, it will further strengthen its leading position in the United States and global markets.

“I think people can rest assured that the risk of myocarditis from the mRNA vaccine is low and it seems to be balanced between the different products,” said Paul Burton, Chief Medical Officer at Moderna, in an interview. ..

The FDA’s own data on vaccinations between the young age group of 18-25 years who are allowed to receive Modana injections show a significant difference in the incidence of myocarditis between people taking the Modana or Pfizer-BioNTech vaccine. Does not show, he added.

Dr. Burton said Modana asked the Nordic countries for data, but hasn’t seen it yet.

In an interview this week, Stephane Bancel, CEO, said the benefits of the company’s vaccine, including strong and long-term protection, outweigh the risks.

“Some countries want to be super-conservative, it’s their privilege, of course, but in the data I’ve seen I’m a young man vaccinated with anyone in my family But it would be comfortable, “he said.

Moderna’s share price fell 3.75% during trading Friday afternoon after the Wall Street Journal reported an FDA delay.

Centers for Disease Control and Prevention published last month Moderna vaccine shows that it is more effective in keeping people away from the hospital From Pfizer and Johnson & Johnson’s.

Moderna shots taken by tens of millions of adults have been found to be safe in a study tested on 3,700 adolescents. According to the company, no cases of myocarditis have been reported in this study.

The company announced Research results In May, and The result has been published At the New England Journal of Medicine in August.

Based on the findings, Moderna asked the FDA in June to expand its use to ages 12-17. Authorities said they were about to emit a green light in recent weeks, but withdrew last week after Denmark, Finland, Norway and Sweden recommended use for people under the age of 30.

The Moderna vaccine is currently approved for use by people over the age of 18 in the United States. FDA Allows Use of Pfizer-BioNTech Vaccine Children up to 12 years old May, about a month later Companies have submitted their request During April.

According to the US Census Bureau, the United States has an estimated 25 million children between the ages of 12 and 17. According to the Centers for Disease Control and Prevention, more than 12 million US adolescents have already been fully vaccinated with the Pfizer-BioNTech vaccine.

Myocarditis is a condition characterized by inflammation of the inner layer around the heart. This is usually caused by a viral infection. In extreme cases, it can lead to abnormal heartbeat, heart failure and death.

This condition has been reported in a small number of people who have obtained the Pfizer-BioNTech and Moderna vaccines that use the same messenger RNA technology.A health expert advises the Centers for Disease Control and Prevention said There seems to be a link..

The labels on both shots warn of an increased risk of myocarditis after vaccination. According to researchers, vaccinated cases are generally mild.

Health officials encourage vaccination, noting that cases of myocarditis are rare and tend to be mild. They say the benefits of vaccination outweigh the risks. Myocarditis is also a side effect of Covid-19, according to health experts, and some studies have shown that it occurs more often after Covid-19 infection than vaccination.

An Israeli study of the health records of about 2 million people over the age of 16, published last month in the New England Journal of Medicine, found that: Covid-19 is much more likely to cause myocarditis Pfizer-From BioNTech Vaccine. Israel uses the Pfizer-BioNTech vaccine almost exclusively.

Preliminary information from several US health claim data sources presented to a panel of vaccine experts advised by FDA authorities on Thursday shows the incidence of another heart-related condition called myocarditis and pericarditis. From 18 years old to 25 years old after the second inoculation of the mRNA vaccine.

FDA analysis showed no significant difference in the incidence of myocarditis between the Moderna and Pfizer-BioNTech vaccines.

Scandinavian countries cite unpublished data in ongoing studies, but show that the relative incidence of myocarditis is higher in people vaccinated with Moderna than in Pfizer-BioNTech. increase.

Scandinavian health officials said they hope that the data underlying the guidance on the Moderna vaccine will be available by the end of the year.

Data show that vaccinated patients have fewer cases of overall myocarditis in Norway, but more common cases of myocarditis after a second dose of the Moderna vaccine compared to Pfizer’s vaccine. Said Sarah Vixmorne Wattle, a pediatrician and senior health care officer, who worked with the Infectious Diseases and Vaccines Department of the Norwegian Institute for Public Health.

She said Norway is still analyzing the data to assess whether the risk of myocarditis justifies a permanent recommendation.

According to the Wall Street Journal analysis of the report up to October 14, the European Medicines Agency’s safety database recorded reports of myocarditis in moderna vaccine recipients three times as many as Pfizer-BioNTech recipients.

The database contains unidentified reports of side effects that are being investigated for direct association with the vaccine.

Both the Moderna vaccine and the Pfizer-BioNTech vaccine have been approved for use by drug regulators in the European Union and the United Kingdom in people over the age of 12. In fact, some European countries have restricted use of Moderna in teens, and the UK offers single doses. Pfizer vaccine for young teenagers.

Write in Felicia Schwartz felicia.schwartz@wsj.com

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The FDA has postponed the Moderna Covid-19 vaccine to examine rare side effects of myocarditis in adolescents

Source link The FDA has postponed the Moderna Covid-19 vaccine to examine rare side effects of myocarditis in adolescents

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