Moderna asks FDA for emergency use of its COVID-19 vaccine booster for all adults

Moderna asks FDA for emergency use of its COVID-19 vaccine booster for all adults

  • Moderna has filed with the FDA for emergency use authorization for its COVID-19 vaccine booster
  • Currently, the booster is only approved for people over 65 and those at high risk due to underlying conditions or their job
  • Data has shown that the booster increased the levels of neutralizing antibodies, including against the parent virus and variants
  • Moderna’s vaccine has been shown to be safe but linked to an increased risk of rare heart inflammation or myocarditis, most commonly in young men


Moderna Inc has applied to the US Food and Drug Administration (FDA) for approval for the Covid booster injection for all adults.

Currently, the booster is approved for people aged 65 and over and those at high risk due to underlying conditions or their job.

The Johnson & Johnson booster is currently approved for all adults, and the FDA is expected to approve the Pfizer booster this week.

If Moderna is approved, all Americans 18 and older will be eligible for an additional dose.

Moderna submitted its application to the FDA for emergency use authorization of its COVID-19 vaccine booster. Pictured: A Walmart chemist holds a bottle of Moderna vaccine, February 2021

Currently, the booster is only approved for those over 65 and those who are at high risk due to underlying conditions or their job.  Pictured: Diana Serlo, a retired registered nurse, administers a COVID-19 vaccine booster at Excela Norwin Square in North Huntingdon, Pennsylvania, September 2021

Currently, the booster is only approved for those over 65 and those who are at high risk due to underlying conditions or their job. Pictured: Diana Serlo, a retired registered nurse, administers a COVID-19 vaccine booster at Excela Norwin Square in North Huntingdon, Pennsylvania, September 2021

In August, boosters were approved for immunocompromised Americans who had received either the Pfizer or Moderna vaccine after data showed they were less likely to develop high antibody levels after two doses.

Shortly afterward, the White House announced that booster shots would become available to all Americans beginning September 20, due to data indicating declining efficacy of the first shots.

At the time, Moderna said the data supports the use of boosters for people 18 years and older six months after receiving the second injection, citing the injections’ diminishing effectiveness in preventing infection and the increased antibody levels produced by third injections. delivered.

But many scientists, including senior FDA officials, disagreed, arguing that the vaccines are still highly effective at preventing serious illness and death.

Unlike Pfizer’s booster, which is only a third dose of the vaccine, Moderna’s booster is a dose of 50 micrograms (µg) – half the dose of the original vaccine.

Previous data has shown that the booster increased the levels of neutralizing antibodies, including against the parent virus and variants, including the beta and gamma variants.

The Moderna vaccine has been shown to be safe but has been linked to an increased risk of rare heart inflammation or myocarditis, most commonly in young men.

At a meeting of the Centers for Disease Control and Prevention (CDC) advisory committee to discuss booster dose approval for the Moderna and Johnson & Johnson injection last month, young men who received the Moderna COVID-19 vaccine were found to have a higher at risk of developing a rarer case of heart inflammation than those who received the Pfizer-BioNTech vaccine,

A CDC official presented data showing that young men under the age of 30 who received the Moderna vaccine experienced a slight increase in myocarditis and pericarditis cases.

The CDC found that 36.8 of every million men ages 18 to 24 who received the Pfizer vaccine, and 10.8 of every million men ages 25 to 29, developed myocarditis.

Moderna recipients had higher rates of the condition, with 38.5 of the million men ages 18 to 24 and 17.2 of every million ages 25 to 29 developing the condition.

After age 29, the rate of heart inflammation as a side effect of the vaccine decreases significantly.

US health officials have long recognized heart inflammation risk as a possible side effect of Pfizer and Moderna vaccine in young me – with the CDC to give a warning in June.

Despite this data, the Moderna vaccine is still considered safe and effective, with less than 0.01 percent of people who receive the injection developing myocarditis.

This is a latest news item and will be updated.

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