outsiders Birds: FDA Approves Second COVID-Safe Vaccine
U.S. Food and Drug Administration (FDA) has approved another vaccine maker to create a COVID-19 shot, with caveats. Newsweek reached out to Novavax, a protein-based COVID-19 vaccine, for a statement this week. The vaccine is adjuvanted, which means it’s targeted primarily to people aged 12–65 who have at least one underlying condition that increases their risk for severe COVID-19 outcomes. A letter from the FDA Friday stated that the vaccine is approved for those aged 65 and older or people aged 12–65 with moderate to severe health conditions.
Why It Matters
COVID-19, caused by the SARS-CoV-2 virus, has swept through the world in early 2020, leading to lockdowns, hospitalization spikes, and millions of deaths. Over seven million people have died globally, with U.S. deaths reaching the highest recorded figure, at 1,223,101. Of these deaths, 38 percent were in the U.S., the largest single-source of COVID-19 deaths globally. The vaccine, previously approved for mRNA-based vaccines, relies on an adjuvanted structure, which operates differently from mRNA vaccines. The reason for its production is unclear yet, and it has sparked debates about vaccine safety and affordability.
What To Know
Novavax’s adjuvanted vaccine is approved for use primarily in people aged 65 and older or 12–65 who have at least one condition that raises their risk of severe COVID-19. The FDA says confidence in the vaccine is important, calling it a fresh alternative to mRNA vaccines. The company submitted the product to the FDA on April 1 alongside Phase 3 clinical trial data. However, unlike mRNA vaccines, which inject small amounts ofRNA to trigger an immune response, the adjuvanted vaccine uses a protein spike to help create antibodies and further stimulate an immune response during infections.
What To Know
Developed since 2020, Novavax is part of the European vaccine industry, unlike mRNA vaccines that are widely used globally. The company’s vaccine, while effective, has faced challenges due to FDA decisions regarding the vaccine’s affordability. This aligns with observations from Robert F. Kennedy Sr., who has been vocal against medicinal treatments, particularly vaccines, in his appointment as U.S. Secretary of Health and Human Services. Kennedy describes the FDA’s approach as reducing accessibility andplaceholder for certain conditions, rather than being more affordable or manipulative.
What Happens Next
Novavax’s vaccine has been approved prematurely in some regions, while others haveGNU. Robert Kennedy’s appointment revealed a deeper issue with the vaccine industry as a whole, including potential subsidies and pricing distortions due to the misuse of vaccines as weapons. The FDA has currently not approved review of these vaccine claims, which couldzmically be the beginning of a shift toward more accessible and just pharmaceutical products. The agli จำหน่าย聋, including Care streamed by余额的非政府组织，如荷兰卫生服务 mansion(Dutch Health Service Organization),开始于2022年3月21日在荷兰的The Hague。 Novavax的疫苗接种 Program on March 21, 2022.
date: Novavax is required to provide data on people who receive the vaccine, including rates of myocarditis. Clinical trials are still being conducted, but the objection to reliance on_Novavax as a vaccine is likely to remain because the Swiss health system has long prioritized individual care and targeted medicines over large-scale immunizations like mRNA vaccines. While some predict the future of cleaner, more affordable vaccines, the market is uncertain, as those relying on large-scale immunization methods like mRNA vaccines have strong investment tracks.
