An Overview of the Novavax COVID-19 Vaccine

Novavax is a Maryland-based biotechnology firm that is taking a traditional approach to developing a vaccine against the coronavirus disease 2019 (COVID-19). The company began a Phase 3 trial of its vaccine candidate, NVX‑CoV2373, in the United Kingdom in September and a second Phase 3 trial in the United States and Mexico in December. These two late-stage trials will enroll a combined total of about 45,000 participants.

While this puts Novavax behind its competitors, initial results of its vaccine trials show promise.

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How It Works

The Novavax vaccine uses a custom-made spike protein that mimics the natural spike protein in the SARS-CoV-2 virus. Novavax has for years worked on developing its recombinant nanoparticle technology, and created the first COVID-19 vaccine using this method in the spring. By summer, early clinical trials showed that the vaccine appeared to be safe, and more advanced trials entered the planning stage in the United States and other countries.

The two-dose vaccine works by introducing a protein that prompts an antibody response, which blocks the ability of future coronavirus to bind to human cells and prevents infection. The protein is combined with Novavax's Matrix-M adjuvant, which is important in enhancing the immune response elicited by the protein antigen.

How Effective Is It?

Early vaccine trial results published by Novavax revealed a strong antibody response to the vaccine in animals. By August 2020, early human trials showed strong antibody responses with no serious adverse events and few side effects.

In late January, Novavax announced that a preliminary analysis of data from its U.K. Phase 3 trial showed that the vaccine was 89.3% effective and included protection from the U.K. variant B.1.1.7. The company also announced that the vaccine was 60% effective in a Phase 2b clinical trial in South Africa and included protection from the South African variant B.1.351.

Results from all late-stage clinical trials are expected in 2021.

In Novavax's trial, participants will not be directly exposed to the virus, but instead researchers will use a natural infection approach. The challenge will then be determining whether the vaccine or other protective measures like masking or social distancing offered the most protection.

When Will It Be Available?

Novavax's vaccine candidate is generating a lot of interest because early animal study data showed that it was highly effective at preventing replication of the coronavirus in nasal passages. It is an important development for COVID vaccines since it may help reduce both infection and transmission rates. Although, this has not yet been established in human studies.

However, Novavax is behind its competitors when it comes to clinical trials so even if continues to do well in trials, the vaccine may not be available until late 2021. The company has not released any estimates on distribution dates yet. The company itself also faces a significant challenge since 2019 was a difficult year for Novavax. Science magazine reported that the company sold some of its manufacturing facilities and has to rely on more contractors to manufacture many of its vaccines. This could result in a delay in production.

No information has been provided yet about the price of the vaccine.

Who Can Get the Novavax Vaccine?

Like other COVID-19 vaccine candidates, the Novavax vaccine has been tested in adults aged 18 and up. The company has not provided updates on trials in children and teens. Information hasn't been provided yet on concerns for specific groups.

Regardless of study group populations, who can get COVID vaccines will largely be a regulatory decision made by the Food and Drug Administration (FDA). Eligibility during distribution will then be determined at the state level and by the Centers for Disease Control and Prevention (CDC).

The CDC is leading vaccination efforts, and all orders of the COVID-19 vaccine, regardless of the manufacturer, will go through the agency. The CDC is overseeing the distribution of vaccines too. CDC’s Advisory Committee on Immunization Practices (ACIP) has made recommendations on how to prioritize vaccine supplies.

Healthcare workers and people living in long-term care facilities were the first to receive the authorized COVID-19 vaccines. According to the CDC, there are more than 18 million healthcare workers in the United States, and about 1.3 million Americans living in long-term care facilities. Each of these people would need to receive two doses of the vaccines authorized so far.

The CDC estimated that it will take several months before the supply of vaccines catches up to the demand. Guidance on who will receive the vaccine and when will be decided as supplies become available. The United States alone has a population of about 330 million—meaning nearly 700 million vaccine doses will be needed to vaccinate all of America if other vaccines follow a two-vaccine dose.

Although little information is available on the specifics of when everyone will receive the vaccines and where they can get it, state and local health departments will be coordinating efforts to distribute doses of the vaccines as they become available. The vaccine should be available both in physician offices and retail locations like pharmacies that administer other vaccines.

Once the vaccine is available, any doses purchased by the U.S. government will be free to its citizens. While the vaccine itself is free, the facility or agency that offers the vaccine may charge a fee for administration. Public health programs and insurance plans are expected to reimburse patients for any costs associated with COVID-19 vaccination, but no information has been made available yet.

Side Effects and Adverse Events

No serious adverse events were reported in early trials of the Novavax vaccine, but more information will be available after the late-stage trial results are published. In Phase 3, adverse events "occurred at low levels and were balanced between vaccine and placebo groups." according to Novavax.

Funding and Development

Novavax has been awarded more than $2 billion globally for its efforts to develop a COVID-19 vaccine, with $1.6 billion from the U.S. government alone. The U.S. funds were given as a part of Operation Warp Speed and from the Biomedical Advanced Research and Development Authority (BARDA). BARDA is a program that falls under the U.S. Department of Health and Human Services. That program and Operation Warp Speed have sought to speed up how quickly vaccines to fight COVID-19 can be developed and approved for use.

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