Novavax Inc said on Tuesday its experimental COVID-19 vaccine produced antibodies against the novel coronavirus and appears to be safe, according to initial data from a small, early-stage clinical trial.
The Maryland-based biotechnology company said its vaccine candidate, NVX-CoV2373, produced higher levels of the antibodies in healthy volunteers after two doses than those found in recovered COVID-19 patients, raising hopes for its eventual success.
The addition of its Matrix-M adjuvant, a substance designed to boost the body’s immune response, did enhance the effect of the vaccine in the study, the company said.
The Novavax Vaccine
The Novavax vaccine is among the first of a handful of programs singled out for U.S. funding under Operation Warp Speed, the White House program to accelerate access to vaccines and treatments that can fight the virus.
Effective vaccines and treatments are considered essential to halting a pandemic that has claimed more than 695,000 lives worldwide.
Novavax research chief Gregory Glenn told Reuters the company will start much larger late-stage clinical trials soon and could potentially glean enough data to obtain regulatory approvals as early as December.
The U.S. government in July agreed to pay Novavax $1.6 billion to help cover costs related to testing and manufacturing the vaccine, with the aim of procuring 100 million doses by January 2021.
The trial, which started in late May, tested the vaccine in 106 subjects aged 18 to 59 versus a placebo. Phase I of the study looked at the vaccine’s safety and ability to induce immune responses.
It tested 5 microgram and 25 microgram doses of the vaccine, with and without the adjuvant.
Of the 126 people given the vaccine, five developed severe side effects, including muscle pain, nausea, and joint pain, and one had a mild fever. The side effects lasted on average two days or less.Twenty-five volunteers got placebo injections, which are injections that do nothing. Three of those had side effects, Glenn said.
Novavax also released animal data on Tuesday. In the study, 12 monkeys received two doses of the vaccine and were then exposed to the virus that causes Covid-19. Eleven of the 12 monkeys showed no signs of infection in their noses or lungs. One monkey, which received a low dose of the vaccine, briefly showed signs of infection in the lungs, but all signs of infection were gone two days later.
Two other US companies — Moderna and Pfizer — have also released encouraging Phase 1 data. Last week, those two companies started their Phase 3 trials with 30,000 volunteers each.
The Phase II and Other Candidates
The company said the second vaccination induced greater levels of side effects such as swelling and pain at the injection site, which are not considered serious, with only one participant experiencing fever.
The Phase II portion of the study will be conducted in multiple countries, including the United States. It will gauge the vaccine’s ability to prevent infections or reduce severity of COVID-19, in addition to safety and immune response, among a broader range of volunteers.
Novavax, Moderna, Pfizer, Johnson & Johnson, AstraZeneca and GlaxoSmithKline have all received funding from the federal government’s Operation Warp Speed Program to develop Covid-19 vaccines, and two more unnamed companies will also receive funding, according to Moncef Slaoui, the head of the program.Slaoui said he expects a vaccine to be available in December or January with enough doses for high-risk Americans, such as the elderly and those with underlying health problems. He said he expects there to be enough vaccine for every American by the end of 2021.