Novavax Phase 1 data shows coronavirus vaccine is safe and elicits an immune response

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An employee works at the Stabilitech laboratory in Burgess Hill south east England, on May 15, 2020 where scientists are trying to develop an oral vaccine for the COVID-19 illness. – The scientists at Stabilitech are one of the teams attempting to develop a vaccine for COVID-19. Ingested in a capsule into the gut, Stabilitech’s potential oral vaccine aims to prompt an immune response in mucosal cells in the respiratory system and elsewhere in the body. The firm believes that will be more effective in tackling respiratory illnesses like coronavirus. The British government is touting the country as a global leader in the big-money investment race to find a vaccine for COVID-19. (Photo by BEN STANSALL / AFP) / TO GO WITH AFP STORY BY JOE JACKSON (Photo by BEN STANSALL/AFP via Getty Images)

A third US company has released study results showing its coronavirus vaccine is safe and elicits an immune response.

Novavax, Inc. released Phase 1 data 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 off the virus that causes Covid-19.

“That’s good. That’s 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, the report stated.

The report has been submitted to a medical journal, but has not yet been reviewed by scientists outside of Novavax or published.

Study participants received two doses of the vaccine at various dosages, both with and without an adjuvant — a component to boost the immune system.

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.

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.

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