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The FDA has determined that the Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) has met the statutory criteria for issuance of an EUA, and that the known and potential benefits of the...
- Who Can Take This Vaccine?
- Should Pregnant and Breastfeeding Women Be Vaccinated?
- Who Is The Vaccine Not Recommended for?
- Is It Safe?
- How Efficacious Is The Vaccine?
- What Is The Recommended Dosage?
- Can This Vaccine Be ‘Mixed and Matched’ with Other Vaccines?
- Does It Prevent Infection and Transmission?
- Does It Work Against New Variants of Sars-Cov-2 Virus?
- How Does This Vaccine Compare to Other Covid-19 Vaccines Already in use?
The vaccine is safe and effective for all individuals aged 12 and above. In line with the WHO Prioritization Roadmap and the WHO Values Framework, older adults, health workers and immunocompromised persons should be prioritised. Adolescents with moderate to severe immunocompromising conditions belong to the highest priority-use group. The Novavax v...
Emerging post-introduction pharmacovigilance data relating to the use of NVX-CoV2373 in pregnant women have not identified any pregnancy-related safety concerns and based on previous evidence from other protein-based vaccines during pregnancy, efficacy is expected to be comparable to non-pregnant women of a similar age. WHO has identified pregnant ...
The vaccine is not recommended for people younger than 12 years of age. Individuals with a history of anaphylaxis to any component of the vaccine should not take it. Persons with acute PCR-confirmed COVID-19 should not be vaccinated until after they have recovered from acute illness and the criteria for ending isolation have been met. Anyone with a...
SAGE has thoroughly assessed the data on the safety and efficacy of the vaccine and has recommended its use for people aged 12 and above. The WHO EUL process also evaluates the quality of manufacturing along with safety and efficacy. Very rare serious adverse events of myocarditis and pericarditis have been observed though cases typically occurred ...
The efficacy of Novavax (NVX-CoV2373) has been assessed in three Phase 2 and Phase 3 trials. Of the two Phase 3 trials, both found that the efficacy of the vaccine against mild, moderate, and severe disease is 90%. The efficacy of Novavax(NVX-CoV2373) in adolescents 12 to 17 years of age was evaluated in an interim analysis of the paediatric expans...
SAGE recommends the use of the Novavax (NVX-CoV2373) vaccine as 2 doses (0.5 ml) given intramuscularly. An 8-week interval is recommended between primary series doses of NVX-CoV2373. A first booster dose is recommended 4-6 months after the completion of the primary series. In accordance with the WHO Prioritization Roadmap, the highest priority-use ...
SAGE accepts two heterologous doses of WHO EUL COVID-19 vaccines as a complete primary series. However, there is limited evidence available on the use of Novavax (NVX-CoV2373) in a heterologous schedule.
As there is not currently sufficient evidence to date to evaluate the impact of the vaccine on transmission, public health and social measures must continue, including use of face masks, physical distancing, handwashing, appropriate ventilation, and other measures as appropriate in particular settings, depending on the COVID-19 epidemiology and pot...
In a Phase 3 study conducted in the USA and Mexico during a period in which multiple variants (Alpha, Beta and Delta) were in circulation, vaccine efficacy against mild, moderate, or severe COVID-19 was 90%. In view of these findings, WHO recommends the use of Novavax (NVX-CoV2373) vaccine according to the WHO Prioritization Roadmap, even if curren...
It is impossible to compare vaccine head-to-head due to the different approaches taken in designing the respective studies, but overall, all of the vaccines that have achieved WHO Emergency Use Listing are highly effective in preventing severe disease and hospitalization due to COVID-19. This webpage was updated on 28 September 2022 to reflect upda...
Sep 12, 2023 · October 3, 2023. This Emergency Use Authorization and CDC recommendation makes Novavax's vaccine the only protein-based non-mRNA COVID vaccine option in the U.S. Novavax expects doses will be available in thousands of locations across the U.S. in the coming days, including CVS Pharmacy and Rite Aid.
Oct 20, 2022 · The FDA approved a 2023-2024 Novavax vaccine in October 2023 for ages 12 and older to target the SARS-CoV-2 XBB.1.5 strain a few weeks after newly updated Pfizer-BioNTech and Moderna mRNA vaccines were approved. Novavax’s version replaces its original vaccine, which was found to be 90% effective in its initial clinical trials.
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Jun 6, 2023 · Novavax COVID-19 Vaccine, Adjuvanted is available under emergency use authorization (EUA) to prevent COVID-19 in individuals 12 years of age and older. The vaccine is authorized for emergency use...
Jun 14, 2021 · Results from a Phase 3 clinical trial enrolling 29,960 adult volunteers in the United States and Mexico show that the investigational vaccine known as NVX-CoV2373 demonstrated 90.4% efficacy in preventing symptomatic COVID-19 disease. The candidate showed 100% protection against moderate and severe disease.
