FDA grants emergency use authorization for updated Novavax COVID-19 vaccine even without clinical trial data

By lauraharris // 2024-09-06

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The Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for the updated Novavax COVID-19 vaccine despite the lack of clinical trial data. According to the FDA, the updated and protein-based Novavax COVID-19 vaccine is specifically designed to target the omicron variant JN.1 strain of SARS-CoV-2. The updated vaccine is produced using a similar process to earlier Novavax formulas and individuals receiving it may experience side effects similar to those reported with previous versions. This EUA applies to individuals aged 12 and older, with the updated vaccine featuring a monovalent component that aligns with the omicron JN.1 variant. Those who have never been vaccinated can receive two doses approximately three weeks apart, while previously vaccinated individuals can get a single booster dose. Meanwhile, the previous Novavax COVID-19 vaccine, Adjuvanted (2023-2024 Formula), will no longer be authorized for use. "The COVID-19 vaccines have had a tremendous positive impact on public health, and vaccination continues to be the most effective method for COVID-19 prevention. COVID-19 remains a very real risk for many people, and we encourage individuals to consider getting an updated COVID-19 vaccine when eligible," claimed Peter Marks, the director of the FDA's Center for Biologics Evaluation and Research. "Today's authorization provides an additional COVID-19 vaccine option that meets the FDA's standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization." (Related: FDA warns of CARDIAC INFLAMMATION risk linked to the Novavax COVID-19 vaccine.) In line with this, the updated vaccine will soon be available after the Maryland-based company's product receives regulatory clearance. However, Barbara Loe Fisher, the co-founder and president of the National Vaccine Information Center, argued that the FDA should not claim safety and effectiveness in the absence of clinical trial data. "The assertion rings hollow when the FDA has not required manufacturers of the mRNA biological [products] to provide scientific evidence to the public that safety and effectiveness have been demonstrated," Fisher stated.

FDA: Novavax COVID-19 vaccine linked to cardiac inflammation risk and other side effects

The original version of Novavax COVID-19 vaccine was not safe either. In fact, the FDA linked the vaccine to cardiac inflammation risk. In June, 2022, the agency released documents that revealed four cases of myocarditis, an inflammation of the heart muscle, which occurred during clinical trials of the vaccine among 30,000 participants from December 2020 to September 2021. "These events raise the concern for a causal association with this vaccine, similar to the association documents with mRNA COVID-19 vaccines. Post-marketing data from individuals receiving mRNA vaccines [has] demonstrated increased risks of myocarditis and pericarditis, particularly within seven days following the second primary dose," the FDA noted. "Data from passive surveillance during post-authorization use in other countries also indicate a higher than expected rate of myocarditis and pericarditis … associated with the vaccine. Further evaluation is needed to inform the risk of myocarditis and pericarditis, and their outcomes, as additional data emerge over time." The FDA also cited other side effects associated with the Novavax vaccine, including tenderness at the injection site, headache, fatigue, muscle pain, hypersensitivity and swelling of the lymph nodes. One case of Guillain-Barre syndrome, a rare neurological disorder known to be associated with other COVID-19 vaccines, was also reported during the clinical trials. Head over to Vaccines.news for more stories about the Novavax COVID-19 shot. Watch Dr. Jane Ruby expose that Novavax is the next spike protein bioweapon disguised as the "safer option."

This video is from the Information Warfare channel on Brighteon.com.

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FDA: Novavax COVID-19 vaccine linked to cardiac inflammation risk and other side effects

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