A well being employee prepares a dose of the Novavax vaccine because the Dutch Well being Service Group begins with the Novavax vaccination program on March 21, 2022 in The Hague, Netherlands.
Patrick Van Katwijk | Getty Photographs
Novavax on Wednesday mentioned its vaccine concentrating on each Covid-19 and the flu triggered an immune response much like its stand-alone photographs in opposition to every virus, in an early indication {that a} mixture vaccine concentrating on each viruses might show efficient although additional research is critical.
Chief Medical Officer Filip Dubovsky, throughout a name with reporters, mentioned the corporate’s early section medical trial discovered that as much as 25 micrograms of the Covid formulation mixed with as much as 35 micrograms of the flu formulation triggered a promising degree of protecting antibodies.
“What we demonstrated on this research is we have been in a position to get the immune responses actually similar to what the person vaccines did previous to mixture,” Dubovsky mentioned.
Members within the section one trial had a median age of 59 and all of them had beforehand obtained Covid vaccines. Novavax is presenting the info on the World Vaccine Congress in Washington, D.C., on Wednesday.
Novavax plans to maneuver ahead with a section two trial this yr to verify the suitable dosing ranges, and launch a section three trial on efficacy through the 2023 flu season on the earliest, Dubovsky mentioned.
Public well being specialists count on Covid to grow to be a seasonal respiratory virus much like the flu that may seemingly require annual vaccination as a result of immunity from the photographs wanes over time. The vaccine makers are racing to develop mixture photographs concentrating on each viruses to make it simpler for individuals to get protected when Covid and the flu are circulating concurrently.
“Mixture vaccines are a horny public well being intervention,” Dubovsky mentioned. “You’re hitting two life-threatening ailments in a single medical contact, giving a single vaccination.”
Novavax, an early participant within the U.S. authorities’s 2020 race to develop Covid photographs, doesn’t presently have a licensed vaccine within the U.S. The corporate requested the Meals and Drug Administration to authorize its Covid vaccine in January. Dubovsky advised reporters on Wednesday that the FDA remains to be reviewing Novavax’s software.
Novavax’s Covid vaccine makes use of completely different expertise than Pfizer‘s and Moderna‘s photographs, which depend on messenger RNA to show human cells into factories that produce copies of the virus spike protein, inducing an immune response that fights Covid. The spike is the a part of the virus that latches onto and invades human cells.
Novavax’s photographs, alternatively, absolutely synthesize the virus spike outdoors the human physique. The genetic code for the spike is put right into a baculovirus that infects insect cells, which then produce copies of the spike which might be purified and extracted. The spike copy, which might’t replicate or trigger Covid, is injected into individuals to induce an immune response in opposition to the virus.
The vaccine additionally makes use of an adjuvant that accommodates an extract purified from the bark of a tree in South America, to induce a broader immune response. The adjuvant has been utilized in licensed vaccines in opposition to malaria and shingles. Novavax’s stand-alone Covid photographs include 5 micrograms of the spike copy and 50 micrograms of the adjuvant.
Novavax makes use of the identical expertise for its stand-alone flu vaccine candidate, which targets 4 strains of the virus.
Whereas the as much as 25 microgram Covid formulation within the mixture vaccine is increased than the stand-alone shot, Dubovsky mentioned it is effectively throughout the vary of the opposite FDA-licensed Covid vaccines, which have dosing ranges between 50 and 100 micrograms.
The 25 microgram formulation examined within the mixture vaccine trial was effectively tolerated and protected, Dubovsky mentioned. The most typical unwanted effects have been injection web site ache, fatigue and complications, he mentioned.
