Home Updates FDA Delays Decision on Moderna Vaccine EUA for Adolescents

FDA Delays Decision on Moderna Vaccine EUA for Adolescents

FDA approval of Moderna’s emergency use authorization request for its vaccine for children 12 to 17 years has been delayed until January 2021

FDA Delays Decision on Moderna Vaccine EUA for Adolescents Till Jan

The Food and Drug Administration (FDA) announced to delay its decision on the request of Moderna vaccine emergency use authorization (EUA) for children twelve to seventeen years of age, until at least January 2022, according to the company statement. In a press release, a Cambridge biotechnology company said that the federal agency directed that it will take at least January to complete the review on Moderna application for the COVID-19 vaccine use in kids 12-to-17-year-olds.

Moreover, the drug agency told Moderna Friday evening that it required more time to evaluate growing global statistics on the risk of myocardial inflammation that in rare cases occurs after inoculation. The action of the agency comes after many nations like Nordic countries, and Japan raised concerns that the Moderna coronavirus vaccine increases the risk of myocarditis infection in men eighteen to thirty. In Sweden and Finland, regulatory authorities recommended against the Moderna vaccine use for men younger than thirty.

In June, Moderna asked the Food and Drug Administration to approve its vaccine for twelve to seventeen-year-olds. However, the dose I authorized for eighteen and older. The proposed regimen of the vaccine for adolescents is the same as for adult people – two doses with hundred micrograms, given twenty-eight days apart. On Sunday, the company said it plans to delay asking the agency for approval of its COVID-19 vaccine for kids six to eleven years old. Moreover, that age group will receive two doses of a half shot of fifty micrograms.

The FDA Authorized Pfizer-BioNTech Vaccine for Kids 12 to 15

On one side, the FDA delays its decision on Moderna vaccine authorization, and on the other side, Pfizer and its German partner, BioNTech, received approval for their vaccine into younger age groups. Previously, the FDA approved the Pfizer-BioNTech vaccine in May for adolescents in two doses of ten micrograms. That shot is one-third the adolescent and adult shot. Similarly, the vaccine is expected to be available for younger kids this week, following a review by the CDC advisers and a possible approval from the CDC Director Rochelle Walensky.

Moderna stated that the safety and health assurance of vaccine recipients is of top importance for the company and that it is working in close collaboration with the FDA. In August, the Washington Post reported that the health agency delayed authorization of Moderna COVID-19 vaccine for adolescents. Furthermore, federal health officials analyzed reports that the dose might be associated with a greater risk of myocarditis inflammation in young males than the Pfizer-BioNTech vaccine.

Several Nordic countries such as Denmark, Finland, Sweden, and others said the latest information on the myocardial inflammation rate in the recipients of Moderna was raising concerns and requesting the FDA to take another look at its decision. Both vaccines of Moderna and Pfizer-BioNTech associated with an escalated risk of myocarditis among young males after the second dose. Physicians and federal officials said the vaccine-brought myocarditis tends to be quickly and mildly treated – and that coronavirus can cause more severe myocarditis and other serious issues.

How many Adolescents Received Moderna Vaccine?

The Pfizer-BioNTech and Moderna COVID-19 vaccines both use the same technological platform, such as messenger RNA. Statistics from the U.S. on whether the myocarditis occurrence in Moderna vaccine is more significant than with the Pfizer-BioNTech vaccine have been mixed, with one data set not showing an enlarged risk and the other showing a higher risk. According to the statistics of Moderna, over 1.5 million adolescents received its COVID-19 vaccine globally, and that its worldwide safety database doesn’t suggest a higher risk of myocarditis in that age group.

FDA Delays Decision on Moderna Vaccine EUA for Adolescents
FDA Delays Decision on Moderna Vaccine EUA for Kids 12-to-17
Source: Web

Jen Psaki Tested Positive for Coronavirus

Jen Psaki, the White House Press Secretary, tested positive for the COVID-19 infection Sunday, five days after her last in-person meeting with U.S. President Joe Biden. She expressed that she received the vaccination shots and experienced mid symptoms of COVID-19. Further, she added that the president sat outside over six feet apart from her and wore a facemask during the Tuesday meeting. Instead, the president tested negative for coronavirus on Saturday.

The White House denied revealing the number of breakthrough coronavirus infections that recently occurred among the staff members. Moreover, former U.S. President Donald Trump avoided face masks and played down the seriousness of the COVID-19 in its early stages. However, Trump contracted coronavirus in the waning stages of the 2020 U.S. Presidential campaign, and several of his staff members, including ex-press secretary Kayleigh McEnany, came down with the infection.

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