Another coronavirus vaccine on the horizon? Novavax plans to make TWO BILLION doses of its shot after early studies suggest people who got injected with it have more COVID-19 antibodies than virus survivors
- Novavax’s vaccine uses synthesized pieces of the surface protein that the coronavirus uses to invade human cells and spurs antibody production
- Participants either received two shots of a low- or medium-dose with or without an adjuvant, which is an agent that boosts the immune response
- The inoculation produced high levels of neutralizing antibodies, higher than those seen in recovered patients
- The company hopes to start its phase III trial by September, obtain regulatory approvals by December and produce two billion doses in 2021
Novavax Inc announced its experimental vaccine produced a promising immune response against the novel coronavirus, according to early data from clinical trials.
The Maryland-based company said participants generated high levels of neutralizing antibodies and T-cells, both of which are needed to build up immunity.
What’s more, the levels were higher than those seen among patients who’ve recovered from COVID-19, the disease caused by the virus.
The company said it could start a large pivotal Phase III trial as soon as late September and, on a conference call, added that it could produce between one billion and billion doses of the vaccine in 2021.
Novavax research chief Gregory Glenn told Reuters the late-stage clinical trial could potentially glean enough data to obtain 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 spurs antibody production. Pictured: Three potential coronavirus accines are kept in a tray at Novavax labs in Gaithersburg, Maryland, March 20
Participants who received two shots of a low- or medium-dose with or without an adjuvant, which is an agent that boosts the immune response, had higher levels of antibodies than those seen in recovered coronavirus patients. Pictured: Clinical trial participants are given a coronavirus vaccine in Melbourne, Australia, May 26
Novavax, which has not produced a vaccine before, created a shot that contains 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 spur production of antibodies to fight the infection.
The Phase I trial, which began in late May, tested the vaccine in 106 participants between ages 18 and 59 while 25 people were given a placebo at two sites in Australia.
The inoculation, named NVX-CoV2373, was given with or without an adjuvant, which is an agent that boosts the immune response.
Volunteers were split into four groups and given either five micrograms or 25 micrograms with or without the extra ingredient.
For those who were immunized they were given the jab via intramuscular injection about 21 days apart.
Eight study participants experienced adverse side effects after receiving a second vaccine dose during the trial, although none required medical intervention, the company said.
Headache, fatigue, and muscle pain were among the more common side effects, and the vaccine was ‘well tolerated’ overall, according to a statement.
Novavax said the addition of the adjuvant did enhance the effect of the vaccine in the study.
Officials say, for further trials, they likely move forward with the lower dose.
The Phase II portion of the study will be conducted in multiple countries, including the US.
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.
The Novavax vaccine is among the first of a handful of programs singled out for US 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.
In July, the Trump administration 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.
Because COVID-19 vaccines are being developed at unprecedented speed, safety issues are being watched very closely.
‘When you are talking about vaccinating the entire world, safety is almost more important than efficacy,’ said Brad Loncar, chief executive of Loncar Investments, an investment fund specializing in biotechnology companies.
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