Lauren Dempsey, MS in Biomedicine and Law, RN, FISM News
The FDA announced this week that the agency has granted an emergency use authorization (EUA) for the Novavax COVID-19 vaccine. The approval makes Novavax the fourth vaccine available for “emergency use authorization” and uses different technology than those previously available.
The Novavax COVID-19 vaccine is a subunit vaccine, which means that it uses conventional technology and contains parts of the pathogen in order to elicit an immune response.
FDA Commissioner Dr. Robert Califf said, “Authorizing an additional COVID-19 vaccine expands the available vaccine options for the prevention of COVID-19, including the most severe outcomes that can occur such as hospitalization and death.”
Researchers created the vaccine by inserting genes that create SARS-CoV-2 spike proteins into an insect virus, which then infected and replicated inside of moth cells. Researchers then extracted and purified the spike proteins to be used in vaccines.
They also used soapbark tree extract as an adjuvant, which increases the body’s immune response to a vaccine.
According to the National Institutes of Health, the safety data and results from Phase 3 of the clinical trials – which included more than 29,000 participants – showed it to be 90.4% effective in preventing symptomatic COVID-19 disease and 100% effective in protecting against moderate and severe disease.
In those considered high risk, Novavax was 91% effective at preventing symptomatic COVID-19 infection. The most common side effects reported were pain, tenderness, redness, and swelling at the injection site, fatigue, muscle pain, headache, joint pain, nausea, vomiting, and fever.
Data does not conclude if the vaccine prevents transmission of the virus, despite about 21,000 of the participants being monitored for 2 months after completing the vaccination series.
The vaccine is available in a two-dose series, with shots administered 21 days apart.
The FDA continues to reiterate its claims of high standards for the emergency vaccine approval process.
“Today’s authorization offers adults in the United States who have not yet received a COVID-19 vaccine another option that meets the FDA’s rigorous standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization. COVID-19 vaccines remain the best preventive measure against severe disease caused by COVID-19, and I encourage anyone who is eligible for, but has not yet received, a COVID-19 vaccine to consider doing so,” Dr. Califf said.
Dr. Califf’s statements come after Dr. Anthony Fauci, recently admitted that vaccines “don’t protect overly well” from infection.
One of the things that’s clear from the data is that even though vaccines – because of the high degree of transmissibility of this virus – don’t protect overly well, as it were, against infection.
It has been well reported that vaccine durability is very poor, with efficacy falling to about 20% just months after vaccination. Vaccinated individuals can contract and transmit the virus in much the same way that unvaccinated individuals do.
Fauci, however, continued to recommend that individuals get vaccinated, saying they provide more protection against severe illness, which can lead to hospitalization or death.