Novavax on Wednesday it said its vaccine targeting both Covid-19 and the flu triggered an immune response similar to its separate injections against each virus, in an early indication that a combined vaccine targeting both viruses could prove effective, though more are needed. studies.
Chief Medical Officer Filip Dubovsky, during a call with reporters, said the company’s early-stage clinical trial found that up to 25 micrograms of the Covid formulation combined with up to 35 micrograms of the flu formulation triggered a promising level of antibodies. protectors.
“What we showed in this study is that we were able to get really comparable immune responses to the individual vaccines before the combination,” Dubovsky said.
Participants in the phase one trial had an average age of 59 and all had previously received COVID vaccines. Novavax will present the data at the World Vaccine Congress in Washington, DC, on Wednesday.
Novavax plans to move forward with a phase two trial this year to confirm appropriate dosage levels and launch a phase three efficacy trial during the 2023 flu season at the earliest, Dubovsky said.
Public health experts expect COVID-19 becoming a seasonal respiratory virus similar to influenza that will likely require annual vaccination because immunity from injections declines over time. Vaccine makers are racing to develop combination shots targeting both viruses to make it easier for people to protect themselves when covid and flu circulate simultaneously.
“Combination vaccines are an attractive public health intervention,” Dubovsky said. “You are attacking two life-threatening diseases in one medical contact, giving a single vaccine.”
Novavax, an early entrant in the US government’s 2020 race to develop covid vaccines, does not currently have a licensed vaccine in the US. The company applied to the Food and Drug Administration (FDA) to authorize his covid vaccine in January. Dubovsky told reporters Wednesday that the FDA is still reviewing Novavax’s application.
The Novavax Covid vaccine uses a different technology than the Pfizer‘sand modern‘s, which rely on messenger RNA to turn human cells into factories that produce copies of the virus’ spike protein, inducing an immune response that fights Covid. The spike is the part of the virus that attaches to and invades human cells.
Novavax injections, on the other hand, completely synthesize the virus spike outside the human body. The spike’s genetic code is placed into a baculovirus that infects insect cells, which then produce copies of the spike that are purified and extracted. The spike copy, which cannot replicate or cause covid, is injected into people to induce an immune response against the virus.
The vaccine also uses an adjuvant containing a purified extract from the bark of a South American tree, to induce a broader immune response. The adjuvant has been used in licensed malaria and herpes zoster vaccines. Novavax Standalone Covid Injections consist of 5 micrograms of the peak copy and 50 micrograms of the adjuvant.
Novavax uses the same technology for its stand-alone flu vaccine candidate, which targets four strains of the virus.
While the formulation of up to 25 micrograms of covid in the combination vaccine is higher than the stand-alone injection, Dubovsky said it is within the range of the other FDA-licensed covid vaccines, which have dosage levels between 50 and 100. micrograms.
The 25 microgram formulation tested in the combination vaccine trial was well tolerated and safe, Dubovsky said. The most common side effects were pain at the injection site, fatigue and headaches, he said.