Moderna asks FDA for emergency use authorization of its COVID-19 vaccine booster for all adults
- Moderna submitted its application to the FDA for emergency use authorization of its COVID-19 vaccine booster
- Currently, the booster is only approved for those aged 65 and older and for people at high risk due to underlying conditions or their jobs
- Data have shown the booster increased levels of neutralizing antibodies, including against the original virus and variants
- Moderna’s vaccine has been shown to be safe but is linked to an increased risk of rare heart inflammation, or myocarditis, mostly among young men
Moderna Inc has asked the U.S. Food and Drug Administration (FDA) for authorization of its Covid booster shot for all adults.
Currently, the booster is approved for people aged 65 and older and those at high risk due to underlying conditions or their jobs.
The Johnson & Johnson booster is currently authorized for all adults and the FDA is expected to approve the Pfizer booster this week.
If Moderna receives authorization, it means all Americans aged 18 and older will be eligible for an extra dose.
Moderna submitted its application to the FDA for emergency use authorization of its COVID-19 vaccine booster. Pictured: A Walmart pharmacist holds a vial of the Moderna vaccine, February 2021
Currently, the booster is only approved for those aged 65 and older and for people at high risk due to underlying conditions or their jobs. Pictured: Diana Serlo, a retired registered nurse , administers a COVID-19 vaccine booster shot 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 after, the White House announced booster shots would become available for all Americans starting on September 20 due to data suggesting waning efficacy of the initial shots.
At the time, Moderna said the data support the use of boosters for people aged 18 and older six months after receiving the second shot, citing the waning effectiveness of the shots at preventing infection, and the increased antibody levels provided by third shots.
But many scientists, including senior officials at the FDA, disagreed and argued that the vaccines are still highly effective at preventing severe illness and death.
Unlike Pfizer’s booster, which is merely a third dose of its vaccine, Moderna’s booster is a 50 microgram (µg) dose – half the dose of its original vaccine.
Previous data has shown the booster increased levels of neutralizing antibodies, including against the original virus and variants, including the Beta and Gamma variants.
The Moderna vaccine has been shown to be safe but is linked to an increased risk of rare heart inflammation, or myocarditis, mostly among young men.
During a meeting of the Centers for Disease Control and Prevention’s (CDC) advisory committee to discuss approval of booster doses for the Moderna and Johnson & Johnson shot last month, young men who received the Moderna COVID-19 vaccine were found to be at higher risk of developing a rare case of heart inflammation than those who received the Pfizer-BioNTech vaccine,
A CDC official presented data that showed young men under the age of 30 who receive the Moderna vaccine have experienced a slight uptick in myocarditis and pericarditis cases.
The CDC found that 36.8 out of every one million men aged 18 to 24 who received the Pfizer vaccine, and 10.8 of every one million aged 25 to 29, developed myocarditis.
Moderna recipients had higher rates of the condition, with 38.5 out of every one million males aged 18 to 24, and 17.2 of every million aged 25 to 29, developing the condition.
After age 29, the rate of heart inflammation as a vaccine side-effect significantly falls off.
American health officials have long recognized the risk of heart inflammation as a potential side-effect of the Pfizer and Moderna vaccine in young me – with the CDC issuing a warning in June.
The Moderna vaccine is still considered safe and effective despite these data, with less than 0.01 percent of people who get the shot developing myocarditis.
This is a breaking news story and will be updated.