The US Food and Drug Administration (FDA) has given emergency use authorization (EUA) to Novavax’s COVID-19 vaccine, making it the fourth authorized vaccine in the US against COVID-19.
The two-dose protein-based, adjuvanted vaccine has been authorized for use in adults 18 years of age and older for the prevention of COVID-19 caused by SARS-CoV-2.
Analysis of clinical trial data for Novavax’s COVID-19 vaccine showed that the shot was over 90 percent effective in preventing all forms/severities of COVID-19, from mild to severe. Among individuals 65 years of age and older, the efficacy was around 79 percent. In a press release outlining the authorization, the FDA noted that the clinical trial for Novavax’s vaccine was conducted before the appearance of the omicron and delta variants.
The vaccine is branded as Nuvaxovid outside the US with approvals/authorizations in Canada, the EU, UK, Australia and South Korea.
The vaccine authorization was held up for several weeks due to changes Novavax had made to the vaccine’s manufacturing processes.
Novavax’s vaccine was part of the US government’s Operation Warp Speed program to rapidly develop COVID-19 vaccines, through which it received $1.8 billion in taxpayer funding.
“Novavax COVID-19 Vaccine, Adjuvanted provides another alternative for adults and adds another vaccine to the COVID-19 vaccine supply for the United States. The American public can trust that this vaccine, like all vaccines that are used in the United States, has undergone the FDA’s rigorous and comprehensive scientific and regulatory review,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, in the FDA news release.
Last month, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) backed Novavax’s vaccine after reviewing data from the Phase III randomized, placebo-controlled PREVENT-19 (the PRE-fusion protein subunit Vaccine Efficacy Novavax Trial | COVID-19) trial that is evaluating the efficacy, safety and immunogenicity of NVX-CoV2373 with a Matrix-M adjuvant.
Novavax’s vaccine was assessed in an ongoing randomized, blinded, placebo-controlled study conducted in the US and Mexico. The effectiveness of the vaccine was assessed in clinical trial participants 18 years of age and older who did not have evidence of SARS-CoV-2 infection through six days after receiving the second vaccine dose.
Of the participants, around 17,200 received the vaccine while 8,300 received saline placebo. The vaccine was found to be 90.4 percent effective in preventing mild, moderate or severe COVID-19, with 17 cases of COVID-19 occurring in the vaccine group and 79 cases in the placebo group. There were no moderate or severe COVID-19 cases reported among individuals in the study who received the vaccine compared with nine cases of moderate and four cases of severe COVID-19 reported in participants that were administered placebo.
The vaccine was 78.6 percent effective in a subset of participants 65 years of age and older.
Safety data came from about 26,000 clinical trial participants who were administered the vaccine and 25,000 who received placebo. The most commonly reported side effects among those that received the Novavax shot included pain/tenderness, redness and swelling at injection site, fatigue, muscle pain, headache, joint pain, nausea/vomiting and fever. At least two months of safety data following the second dose was collected from 21,000 individuals who received the vaccine.
Could the Novavax Shot Offer a Solution to Those Weary of mRNA Technology?
Novavax’s COVID-19 shot has been highly anticipated because it uses more ‘traditional’ protein technology (like the hepatitis B and HPV vaccines) that people may be more accepting of compared to genetic vaccines like mRNA vaccines. The hope was that it may win over the vaccine hesitant, particularly those skeptical of the perceived newness of mRNA vaccine technology and rare side effects such as myocarditis and pericarditis.
Although it may appear that the protein vaccine may have arrived too late given that the Pfizer-BioNTech and Moderna vaccines have been out for well over a year now, over 30 percent of Americans are still not fully vaccinated against COVID-19.
But some experts don’t think the vaccine will do much to sway the opinion of those that remain unvaccinated.
Dr. Paul Offit, the director of the Vaccine Education Center at the Children’s Hospital of Philadelphia and member of an independent advisory group to the FDA, told CNBC’s Make It that, “I don’t think a shot like Novavax with well-worn technology is suddenly going to convince unvaccinated people to say, ‘Now, I want to get a vaccine, now I believe a vaccine will keep me out of the hospital and ICU.’”
However, encouragingly, CNBC cited a recent Morning Consult poll which revealed that of the unvaccinated people surveyed, 28 percent thought protein-based shots were safe while only 17 percent said the same about mRNA vaccines.
Nevertheless, 77 percent of those polled said that even if a protein-based COVID shot were authorized in the US, they still would not get it.
Dr. Offit says vaccine denialism has become a cultural issue in the US, making it difficult to sway opinions.
Despite this, experts say having a fourth COVID-19 vaccine option is good news overall, particularly from a supply perspective in the case of a company facing manufacturing issues.
It is also a welcome addition if COVID-19 vaccination becomes an annual occurrence.
The FDA Will Continue to Monitor Safety and Expects a Filing for Approval
The FDA said that as part of the authorization, it is mandatory for Novavax and vaccination providers to report serious adverse events, cases of multisystem inflammatory syndrome (MIS) and cases of COVID-19 that result in hospitalization or death to the Vaccine Adverse Event Reporting System (VAERS), along with any vaccine administration errors in monthly safety reports submitted to the FDA.
The FDA also said “it has evaluated the pharmacovigilance plan submitted by the company to monitor the safety of Novavax COVID-19 Vaccine, Adjuvanted as it will be used under EUA to ensure that any safety concerns are identified and evaluated in a timely manner. As a condition of authorization, the company will conduct studies to further assess its safety, including studies to further assess the risks of myocarditis and pericarditis.”
The federal agency expects Novavax to continue collecting safety and effectiveness trial data in order to pursue approval (licensure).
Novavax said it plans to file a full FDA biologics license application (BLA) by the end of the year.