On phase 1, data shows Novavax coronavirus vaccine is safe and elicits an immune response

Researchers look at a sample of a respiratory virus at Novavax labs in Maryland. ANDREW CABALLERO-REYNOLDS/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 on Tuesday, August 4th, 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 one or two doses of the vaccine at various dosages. Some participants also received an adjuvant, which is a component to boost the immune system. Those who received two doses with the adjuvant had the best immune response.

Of the 106 study subjects who received the vaccine, five developed severe side effects, including muscle pain, nausea, and joint pain, and one study subject 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.

Pharmaceuticals 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.

Source: https://edition.cnn.com/