Moderna’s new COVID-19 vaccine mNexspike approved by FDA, but there’s a limit on who can use it
The U.S. has given the green light to a new COVID-19 vaccine developed by Moderna, known as mNexspike. This vaccine, while not intended to replace their current Spikevax shot, offers a second option for combatting the ongoing pandemic. mNexspike is a cutting-edge vaccine that allows for a lower dosage, approximately a fifth of the dose of the existing Spikevax vaccine, by refining its immune target.
“This approval adds an important new tool to help protect individuals at high risk of severe COVID-19 illness,” stated Stephane Bancel, CEO of Moderna, following the approval by the Food and Drug Administration.
The FDA has approved the use of mNexspike for all adults aged 65 and older, as well as individuals between the ages of 12 and 64 who have underlying health conditions that put them at increased risk from the coronavirus. This approval aligns with the restrictions set for another COVID-19 vaccine from Novavax.
Unlike Moderna’s existing vaccine, mNexspike faces limitations in terms of its target population. Health Secretary Robert F. Kennedy Jr. and other officials have expressed skepticism regarding vaccines, leading to the imposition of these restrictions. Moderna’s original vaccine, Spikevax, has been widely used for individuals aged 6 months and older without such limitations. The company plans to offer both vaccine options in the upcoming fall season.
The FDA’s approval of mNexspike was based on a study involving 11,400 participants aged 12 and above. The study compared the new low-dose vaccine with Moderna’s current vaccine and found it to be safe and equally or even more effective than the original shot, according to the company.
This development comes shortly after the Trump administration withdrew funding for Moderna’s research on a potential pandemic flu vaccine, despite promising early results. Additionally, the CDC has revised its recommendations for children regarding the COVID-19 vaccine under Kennedy’s guidance.
The CDC now advises against universal vaccination for all children, focusing instead on moderately or severely immunocompromised children, as well as most adults. Kennedy’s directive emphasized the need for further review of the vaccine’s safety and benefits, particularly for healthy children and pregnant individuals. This decision has sparked debate within the healthcare community, with some questioning the basis of the directive and its impact on public health.
