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Novavax’s COVID-19 vaccine candidate approved for emergency use by FDA as a booster

Novavax’s COVID-19 vaccine, Adjuvanted (NVX-CoV2373) has been granted emergency use authorisation (EUA) by the US Food and Drug Administration (FDA) as a booster in adults 18 years and older, the company announced.

Following the FDA’s decision, the US Centers for Disease Control and Prevention (CDC) recommended use of the vaccine as a booster.

The authorisation is specifically for individuals unable to receive an FDA-authorised mRNA bivalent booster, or those who would choose not to receive any other booster dose.

Unlike the latest mRNA boosters from Pfizer/BioNTech and Moderna, which target both the original strain of SARS-CoV-2 and the Omicron subvariants, the Novavax booster only targets the original strain.

Stanley Erck, president and chief executive officer, Novavax, said: “The US now has access to the Novavax COVID-19 Vaccine, Adjuvanted, the first protein-based option, as a booster.

“According to CDC data, almost 50% of adults who received their primary series have yet to receive their first booster dose. Offering another vaccine choice may help increase COVID-19 booster vaccination rates for these adults.”

The authorisation was based on positive results from the company’s phase 3 Prevent-19 clinical trial, as well as from the UK sponsored COV-BOOST trial.

As part of the Prevent-19 trial, healthy adult participants were given the booster eight or 11 months after their primary series. Following the booster dose, antibody levels increased significantly relative to pre-boost levels, the company reported, exceeding levels associated with protection in phase 3 clinical trials. Neutralising antibodies also increased by 34- to 27-fold compared to pre-boost levels.

In the COV-BOOST trial, the booster induced a ‘robust antibody response’ when used as a heterologous third booster dose.

In terms of safety, local and systemic reactions following the booster had a median duration of approximately two days and the incidence of grade 3 or higher events remained relatively low, the company reported.

The FDA granted EUA for a two-dose primary series of Novavax’s vaccine candidate in adults 18 years and older in July and for adolescents aged 12 to 17 years in August.

The vaccine is also available for use as a booster in adults 18 years and older in the EU, Japan, Australia, New Zealand, Switzerland and Israel. A number of countries also have policy recommendations allowing use of the vaccine as a heterologous or homologous booster dose.



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