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 announced in late November that its vaccine candidate, NVX‑CoV2373, had enrolled more than 20,000 patients in its late-stage trials. Phase 3 trials were expected to begin sometime in December. While this puts Novavax behind its competitors, initial results of its vaccine trials show promise.

Novavax

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How It Works

The Novavax vaccine uses a custom-made spike protein that mimics the natural spike protein in the novel coronavirus. 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 is 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 in April revealed a strong antibody response to the vaccine in animals.

By August, early human trials showed strong antibody responses with no serious adverse events and few side effects. Results from late-stage clinical trials in humans 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. This is an important development for COVID vaccines since it can help reduce both infection and transmission rates.

However, Novavax is behind its competitors when it comes to clinical trials so even if it does 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. 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, but this information will hopefully be revealed by late-stage clinical trials.

Regardless of study group populations, who can get COVID vaccines will largely be a regulatory decision made at the state level and by The Centers for Disease Control and Prevention. 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.

Health care workers and people living in long-term care facilities will be the first to receive the vaccines, which will be limited at first. According to the CDC, there are more than 18 million health care 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 top vaccine contenders 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. Other side effects were mild or absent, 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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