Novavax says vaccines targeting Covid and influenza show promising results in early data

Novavax said on Wednesday that its vaccine targeting both Covid-19 and influenza triggered an immune response similar to its independent shot against each virus, as an early indication that a combination vaccine targeting both viruses may prove effective, although further investigation is needed. .

Chief Medical Officer Filip Dubovsky said during a call with reporters that the company’s early phase of clinical trials showed that up to 25 micrograms of the Covid formulation combined with up to 35 micrograms of the flu formulation triggered a promising level of protective antibodies.

“What we demonstrated in this study is that we were able to get the immune responses really comparable to what the individual vaccines did before the combination,” Dubovsky said.

Participants in the Phase 1 study had a median 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 the appropriate dosage levels and launch a phase three trial of efficacy during the 2023 flu season at the earliest, Dubovsky said.

Public health experts expect Covid to become a seasonal respiratory virus similar to the flu, which is likely to require annual vaccination because immunity to the shots diminishes over time. Vaccine manufacturers are racing to develop combination shots aimed at both viruses to make it easier for people to be protected when Covid and influenza circulate simultaneously.

“Combination vaccines are an attractive public health intervention,” Dubovsky said. “You hit two life-threatening diseases in one doctor’s contact and give a single vaccination.”

Novavax, an early participant in the U.S. government’s 2020 race to develop Covid shots, does not currently have an authorized vaccine in the United States. The company asked the Food and Drug Administration to approve its Covid vaccine in January. Dubovsky told reporters on Wednesday that the FDA is still reviewing Novavax’s application.

Novavax’s Covid vaccine uses a different technology than Pfizer’s and Moderna’s shots, which rely on messenger RNA to transform human cells into factories that produce copies of the virus tip protein, inducing an immune response that fights Covid. The spike is the part of the virus that attaches itself to and invades human cells.

Novavax’s shot, on the other hand, synthesizes the virus tip outside the human body. The genetic code for the tip is put into a baculovirus that infects insect cells, which then produce copies of the tip, which are purified and extracted. The spike copy, which cannot replicate or cause Covid, is injected into humans to elicit an immune response against the virus.

The vaccine also uses an adjuvant containing an extract purified from the bark of a tree in South America to elicit a broader immune response. The adjuvant has been used in approved vaccines against malaria and shingles. Novavax’s standalone Covid shots consist of 5 micrograms of the tip and 50 micrograms of the adjuvant.

Novavax uses the same technology for its independent influenza vaccine candidate, which targets four virus strains.

While the up to 25 micrograms Covid formulation in the combination vaccine is higher than the stand-alone dose, Dubovsky said it is well 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 injection site pain, fatigue and headaches, he said.

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