COVID19 - GHealth News

May212025 by GHealth NewsNo Comments

FDA Grants Limited Approval to Novavax COVID-19 Vaccine for High-Risk Groups Only

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GHealth News - The U.S. Food and Drug Administration (FDA) has granted full approval to Novavax’s COVID-19 vaccine, but with limited use: it's only approved for adults 65 and older, or for those 12 to 64 with underlying health conditions that raise their risk from COVID-19. Previously, Novavax’s vaccine had emergency use authorization for all individuals 12 and older. Unlike mRNA vaccines from Pfizer and Moderna, which are fully approved for those 12+ and authorized for children as young as 6 months, Novavax uses a more traditional protein-based approach, making it unique among available options in the U.S. The FDA did not explain the reasoning behind the unusual restrictions, though the decision aligns with skepticism from Trump administration officials, including Health Secretary R...

FDA Requests New Trial for Novavax COVID-19 Vaccine Amid Delayed Approval

COVID19

GHealth News - The U.S. Food and Drug Administration (FDA) has asked Novavax to conduct a new clinical trial for its COVID-19 vaccine, delaying the company's bid for full approval, according to a Wall Street Journal report. The request comes after intervention by appointees under Health and Human Services Secretary Robert F. Kennedy Jr., sparking uncertainty around the shot’s future. Novavax, which uses a protein-based vaccine platform as an alternative to mRNA vaccines from Pfizer-BioNTech and Moderna, said its application remains "approvable" and it awaits further FDA feedback. The company is negotiating a smaller, more affordable study and noted its commitment to meeting the agency’s post-marketing requirements. The delay follows missed regulatory deadlines and internal FDA change...

China Rejects CIA Claim of COVID-19 Lab Leak

COVID19

GHealth News - China stated on Monday that a laboratory origin of COVID-19 was "extremely unlikely," following the CIA's assertion that the virus was more likely to have originated from a lab than through natural transmission. "The conclusion that a laboratory leak is extremely unlikely was reached by the China-WHO joint expert team based on field visits to relevant laboratories in Wuhan," said foreign ministry spokeswoman Mao Ning. "This conclusion has been widely recognized by both the international and scientific communities," she added. On Saturday, the CIA reported that the virus was "more likely" to have leaked from a Chinese lab rather than being transmitted through animals.