Novavax Announces Promising Phase 1 Results for its COVID-19 Vaccine

A third United States based company has announced that its vaccine candidate is safe and elicits an immune response. The results of the phase 1 of clinical trials have been submitted to a medical journal but have not been peer- reviewed or published yet.

The company, Novavax, based in Maryland has previously received $1.6 billion from the US federal government to fund the development of its vaccine for coronavirus. The positive results from the trial’s phase 1 that were announced yesterday, sent the company’s stock up by 8.5% to $170.50 in after-hours trading.

The biotech giant has previously never manufactured a vaccine in its 33 years of history. Even though previously the company has suffered financially, optimism over its coronavirus and influenza vaccine candidates has led investors to bid its stock up nearly 3,900% as of closing Tuesday.

According to latest reports, the vaccine candidate of the company is different from all other vaccines in the development right now. The vaccine by Novavax, NVX-CoV2373, works by blocking the action of the spike (a protein), on the coronavirus. This spike is used by the virus to gain entry into the human cell. The vaccine ensures that the virus does not enter the human cells and cause an infection.

All of the subjects were in the study were given two doses of the vaccine at various dosages, with and without an adjuvant. Adjuvants in a vaccine help boost the immune system.

The company released its initial data from 131 subjects, which showed that two doses of the vaccine, developed neutralizing antibodies at levels more than four times higher in subjects on average than the antibodies developed by people who had recovered from Covid-19.

Neutralizing antibodies fight off the virus that causes Covid-19. Antibodies are tiny proteins in the body that recognize the virus and usually get attached to it, in order to quash the virus. Among all antibodies only a small amount attaches themselves to the virus and try to stop it from entering and infecting the cell. These antibodies are called neutralizing antibodies.

The Novavax vaccine also elicited a T-cell response from immune cells, which ensures a different kind of immunity in people. This response was seen in an analysis of 16 randomly selected volunteers, the report stated.

Among 126 people who received the vaccine only five had side effects for two or more days, like muscle pain, nausea, and joint pain, and one had a mild fever. Three out of 25 people who received placebos, also reported side effects.

The company also released results from its animal trials on the same day. During the study, 12 monkeys were given two doses of the vaccine and were then exposed to the coronavirus intentionally.

Out of them all, 11 monkeys did not develop any signs of infection in their noses or lungs. Only one subject, who received a low dose of the vaccine showed signs of lung infection. That one monkey also got cleared of that infection within two days.

Novavax is set to have a later-stage clinical trial with up to 30,000 subjects beginning in the fall. The company said that if its vaccine is shown to be effective, it can produce 100 million doses by the beginning of next year, or enough to give to 50 million people if administered in two doses.

The two other companies in US that have developed a promising vaccine candidate in phase 1 trials are Moderna and Pfizer. Both companies have now started their Phase 3 trials with 30,000 volunteers each.

These three companies and Johnson & Johnson, AstraZeneca and GlaxoSmithKline have all received federal funding through government’s Operation Warp Speed Program to develop Covid-19 vaccines.

According to the head of the program, Moncef Slaoui, two other companies will receive funds as well. The government is expecting a vaccine to be available in December or January. It has also been indicated that the people who are at high risk of developing coronavirus infections like who are immunocompromised or have underlying health issues will be given preference.

Slaoui also said that hopefully there to be enough vaccine for every American by the end of 2021 as Novavax’s coronavirus vaccine is only one of the 18 candidates that have entered Phase 1 trials.

Right now, 12 vaccines are in Phase 2 trials and six are in Phase 3 being tested on thousands of people. Another Chinese vaccine developed by company CanSino Biologics, have been approved for limited military use in China for a year, making it the first ever novel coronavirus vaccine to be approved for human use in the world.

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