(CNN) — A third American company has published the results of a study showing that its vaccine against coronavirus it is safe and elicits an immune response.
Novavax, Inc. published Phase 1 data on Tuesday from 131 volunteers showing that after two doses of the vaccine, participants developed neutralizing antibodies at levels more than four times higher on average than the antibodies developed by people who had recovered from covid- 19. Neutralizing antibodies fight the virus that causes covid-19.
“That is good. That is really encouraging, “said Novavax President Dr. Gregory Glenn.
The vaccine also induced a response from T cells, a type of immune cell, according to an analysis of 16 randomly selected volunteers, according to the report.
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The report has been submitted to a medical journal, but has not yet been reviewed by scientists outside of Novavax and has not been published.
Study participants received two doses of the vaccine in various doses, with and without an adjuvant, a component to boost the immune system.
Of the 126 people who received the vaccine, five developed serious side effects, including muscle pain, nausea, and joint pain, and one had a mild fever. Side effects lasted an average of two days or less.
Twenty-five volunteers received placebo injections, which are injections that do nothing. Three of them 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 the nose or lungs. One monkey, who received a low dose of the vaccine, briefly showed signs of infection in the lungs, but all signs of infection disappeared two days later.
Two other US companies, Moderna and Pfizer, have also released encouraging Phase 1 data. Last week, those two companies began their Phase 3 trials with 30,000 volunteers each.
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Novavax, Moderna, Pfizer, Johnson & Johnson, AstraZeneca and GlaxoSmithKline have received funding from the federal government’s Operation Warp Speed program to develop covid-19 vaccines, and two other unidentified companies will also receive funding, according to Moncef Slaoui, the director of the Program.
Slaoui said he hopes a vaccine will be available in December or January with sufficient doses for high-risk Americans, such as the elderly and those with underlying health problems. She said she hopes there will be enough vaccines for all Americans by the end of 2021.
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