Moderna seeks authorization for COVID-19 vaccine in children as young as 6 months old

While a portion of the public is now eligible to receive a second booster dose of COVID-19 vaccine, the FDA has not yet authorized a vaccine for children aged 6 months to 5 years old.

Moderna (Nasdaq:MRNA) is vying to be the first. The company announced today that it is filing a request for emergency use authorization (EUA) for its mRNA-1273 vaccine in young children. The company anticipates that it will complete the filing next week.

The request breaks young children into two groups, with the first covering the ages of 6 months to under 2 years and the second covering kids between 2 and 5 years old. The authorization request refers to a primary series consisting of two 25-μg doses of mRNA-1273.

Moderna also seeks similar authorizations for young children from other international regulatory bodies.

The company is basing the requests on positive interim data from the Phase 2/3 KidCOVE study, which met its primary endpoint.

The study analyzed…

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Full COVID-19 vaccination could ultimately mean three doses

Dr. Anthony Fauci

While mRNA vaccines from Moderna (NSDQ:MRNA) and Pfizer (NYSE:PFE) had 95% efficacy in Phase 3 clinical trials, their effectiveness in the real world has dropped with the rise of the Delta variant. 

As a result, breakthrough infections have grown more common in people who have received two doses of mRNA vaccines.

Ultimately, full vaccination may require three doses, concluded Chief Medical Advisor to the President Dr. Anthony Fauci in a press briefing. While acknowledging that the FDA would need to make the final decision, “I must say from my own experience as an immunologist, I would not at all be surprised that the adequate full regimen for vaccination will likely be three doses,” Fauci said. 

In the briefing, Fauci pointed to booster data emerging from Israel recently published in a preprint. The Pfizer-BioNTech vaccine led to a 70% to 84% risk reduction 14 days after admin…

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COVID-19 vaccinations continue to decline in the U.S.

[Photo by Daniel Schludi on Unsplash]

The pace of COVID-19 vaccination in the U.S. continues to fall. Today, the U.S. administered about 600,000 COVID-19 vaccine doses, which is far fewer than two months ago.

At the mid-April peak, healthcare workers administered more than 3 million COVID-19 vaccine doses. The pace of vaccination fell steadily from that time to early June before stabilizing at around 1 million doses per day.

Complicating matters is the spread of the Delta variant (B.1.617.2), which ravaged India. The variant is now dominant in the U.K. and Europe, threatening to undermine the return to normalcy there.

According to a preprint study, the Delta variant could become dominant in the U.S. within a matter of weeks. Indeed, the variant already is the cause of almost half of COVID-19 infections in some Midwest and mountain states, said CDC Director Dr. Rochelle Walensky in a briefing on …

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FDA plans to warn of rare myocarditis risk following COVID-19 vaccination

FDA has acknowledged that myocarditis and pericarditis are rare possible complications for patients receiving mRNA COVID-19 vaccines from Moderna and Pfizer/BioNTech. The agency, however, estimated that the condition occurs in 12.6 out of one million recipients of the vaccine aged 12 to 39. 

The conditions appear to be more common in males. 

The FDA warning will state that health officials have observed myocarditis or pericarditis in a limited number of people after receiving the second vaccine dose. The onset of symptoms usually occurred within several days to a week. The warning will recommend that people with post-vaccination myocarditis or pericarditis symptoms seek medical care. 

Federal officials, however, continue to stress that the benefits of the mRNA vaccines clearly outweigh the risks. In an HHS statement, multiple health officials from the public and private sector stress that the heart issue is “an extremely rare side effect, and only an exc…

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