Novavax Inc announced its experimental vaccine produced a promising immune response against the new coronavirus, according to initial clinical trial data.
The Maryland-based company said participants generated high levels of neutralizing antibodies and T cells, both needed to boost immunity.
Additionally, the levels were higher than those seen in patients who recovered from COVID-19, the illness caused by the virus.
The company said it could launch a large pivotal Phase III trial as early as late September and, on a conference call, added that it could produce between one billion and one billion doses of the vaccine in 2021.
Novavax chief researcher Gregory Glenn told Reuters the advanced stage clinical trial could potentially glean enough data to get regulatory approvals as early as December.
Novavax’s vaccine uses synthesized pieces of the surface protein that the coronavirus uses to invade human cells and stimulate the production of antibodies. Pictured: Three potential coronavirus accines are kept in a tray at Novavax Laboratories in Gaithersburg, Md., March 20
Participants who received two low or medium dose injections with or without adjuvant, which is an agent that stimulates the immune response, had higher levels of antibodies than seen in patients with recovered coronavirus. Pictured: Participants in a clinical trial receive a coronavirus vaccine in Melbourne, Australia on May 26
Novavax, which has never produced a vaccine before, created an injection containing synthesized pieces of the surface protein that the coronavirus uses to invade human cells.
The idea is that the protein will cause human cells to stimulate the production of antibodies to fight infection.
The Phase I trial, which began in late May, tested the vaccine in 106 participants aged 18 to 59, while 25 people received a placebo at two sites in Australia.
The inoculation, named NVX-CoV2373, was administered with or without adjuvant, which is an agent stimulating the immune response.
The volunteers were divided into four groups and given five micrograms or 25 micrograms with or without the additional ingredient.
For those who were immunized, they received the vaccine by intramuscular injection about 21 days apart.
Eight study participants experienced unwanted side effects after receiving a second dose of the vaccine during the trial, although none required medical intervention, the company said.
Headaches, fatigue and muscle aches were among the most common side effects, and the vaccine was overall “well tolerated,” according to a statement.
Novavax said adding the adjuvant improved the effect of the vaccine in the study.
Officials say, for further testing, they probably go ahead with the lower dose.
The phase II part of the study will be conducted in several countries, including the United States.
It will assess the vaccine’s ability to prevent infections or reduce the severity of COVID-19, in addition to safety and immune response, in a wider range of volunteers.
The Novavax vaccine is one of the first of a handful of programs selected for US funding as part of Operation Warp Speed, the White House program aimed at accelerating access to vaccines and treatments capable of combating the virus.
Effective vaccines and treatments are seen as key to ending a pandemic that has claimed more than 695,000 lives worldwide.
In July, the Trump administration agreed to pay Novavax $ 1.6 billion to help cover the costs of testing and manufacturing the vaccine, with the goal of purchasing 100 million doses by January 2021. .
As COVID-19 vaccines are being developed at an unprecedented rate, safety concerns are being watched very closely.
“When you talk about vaccinating the whole world, safety is almost more important than effectiveness,” said Brad Loncar, managing director of Loncar Investments, an investment fund specializing in biotechnology companies.