What to Know About Novavax and Covid-19

Novavax and COVID-19

Over the last two years, the COVID-19 pandemic has sparked a worldwide epidemiology and vaccine development response. Novavax is one of the top biotech companies involved in COVID-19 vaccine development and research. 

Novavax developed one authorized COVID-19 vaccine, has one Omicron variant booster vaccine in the preclinical stage, and a combination COVID-19 and flu vaccine in trial.

About Novavax  

Novavax is a Maryland-based biotechnology company that investigates and counters serious infectious diseases through vaccine creation and development. Novavax was originally founded in 1987 and, since its inception, has been home to scientists who have developed experimental vaccines for Ebola, Influenza, and other respiratory viruses.

Novavax aims to re-envision how to approach infectious disease research, vaccine development, and treatment through innovative biotechnology. Their experts also provide insights and informational articles on the general clinical trial process for vaccines, the importance of boosters, and demonstrate commitment to accessible vaccines and health care. 

Novavax lists seven disease areas of research: 

• COVID-19
• SARS (severe acute respiratory syndrome)
• Seasonal Influenza
• Malaria
• RSV (respiratory syncytial virus)
• Ebola
• MERS (Middle East respiratory syndrome)

Novavax COVID-19 Vaccination 

Currently, Novavax has one authorized COVID-19 vaccine sold under the brand names Nuvaxovid and Covovax. It is the fourth vaccine developed against covid-19, along with the mRNA vaccines (Pfizer and Moderna) and the Johnson and Johnson single-dose. The booster vaccine and combination vaccine have yet to be approved.

In February 2021, the European Medicines Agency (EMA) started its review of the Nuvaxovid vaccine, which was followed by conditional marketing authorization across the European Union in December of 2021. In the United States, Nuvaxovid received Federal Drug Administration (FDA) approval and recommendation for emergency use authorization for people ages 18 and older on June 6, 2022.  

With the FDA emergency authorization of the Nuvaxovid vaccine, the new option has promised to be available for market use as the fourth approved vaccination very soon. Nevertheless, there are some key differences between the Novavax, Pfizer, Moderna, and Johnson and Johnson options. 

1. Novavax contains the coronavirus spike proteins, unlike the mRNA (Pfizer and Moderna) options that contain a genetic code to create similar, but not identical proteins. It's important to note that using proteins in vaccines is a safe and effective process that has been used in other vaccines such as hepatitis b, diphtheria and tetanus. 
2. Similar phase by phase development process and six-month timeframe as traditional influenza vaccinations. 
3. Can be used for people allergic to mRNA components 

Comparing Novavax and Other Vaccination Options  

Below is a chart comparing the Novavax vaccination to the Pfizer, Moderna, and Johnson and Johnson options that are currently available at your local pharmacy. As of July 13, 2022, the FDA authorized and the CDC recommends the usage of the Novavax vaccine on adults ages 18 and older. Following the approval, President Biden and the Department of Health and Human Safety requested 3.2 million doses of Novavax to be sent to pharmacies around the country as early as the second week of August.  

Comparison of Novavax, Pzfizer, Moderna, Johnson and Johnson  

Source: WebMD 

Emergency Authorization and FDA Approval Timeline   

Although the other COVID-19 vaccinations underwent a similar emergency use authorization process as Novavax, there is still hesitation and confusion regarding what emergency use authorization means and how it impacts the market use of the vaccine.

All COVID-19 vaccines included in Novavax are rigorously tested and evaluated to determine safety and effectiveness. During the COVID-19 response, vaccine development time was shortened by running phases concurrently, but the phases and standards for evaluation have always been determined by the FDA. 

There are a total of the three testing phases that examine the safety and efficacy of the vaccine:

Phase 1: the vaccine is given to a small group of healthy volunteers

Phase 2: If safety and efficacy are found, the vaccine moves to be tested on a larger group of volunteers

Phase 3: then the population size is increased again for the last trial. Phase 3 provides information on immune response and provides more data on the side effect and overall effectiveness

The chart below illustrates the process of new vaccine development and phases, approval, and manufacturing.  

Source: Center for Disease Control and Prevention 

Frequently Asked Questions About the Novavax COVID-19 Vaccine (Nuvaxovid)  

Below are some of the most asked questions about the Novavox vaccination. 

Who can get the Novavax vaccine?  

The vaccine is safe and effective for all individuals ages 18 and older, and similar to the other vaccination options, older adults, healthcare workers, and those with underlying health conditions should be prioritized. 

The Novovax vaccine can be administered to individuals who have tested positive for COVID-19 in the past; however, individuals should wait three months post-infection before receiving the vaccination. 

In regards to pregnant and breastfeeding individuals, there is not yet data specifically for the Novavax vaccine. However, based on the previous studies and evidence from other protein-based vaccinations, efficacy for pregnant individuals is expected to be comparable to efficacy amongst non-pregnant individuals of the same age. For individuals who are breastfeeding, The World Health Organization (WHO) recommends the use of Novavax, as the vaccine does not contain live viruses and will not pose a risk to the breastfeeding child.   

Who should not get the Novavax vaccine?  

The Novavax is not recommended for people under the age of 18, individuals with a history of anaphylaxis, or anyone who presents with a fever of 100F or higher. Those who show a PCR-confirmed COVID-19 should not be vaccinated until 3 months after they are presented with a negative COVID-19 test. 

How effective is Novavax compared to other vaccines?   

Novavax's effectiveness has been examined in a total of 6 trials that should 90% efficacy against mild, moderate, and severe COVID-19 infections. For a marker of comparison, Pfizer's efficacy is 95%, Moderna’s is 95%, and Johnson and Johnson’s is 67%.

What is the dosage of the Novavax vaccine?   

Similar to the Pfizer and Moderna vaccines, the Novavax vaccine should be administered in 2 (0.5 ml) doses in a 3-4 week interval. Individuals who are immunocompromised may require an additional dose since they are at higher risk of severe COVID-19 infection.  

Does the Novavax vaccine protect against new variants of COVID-19? 

Based on current research and data, Novavax provides 90% effective protection against mild, moderate, and severe COVID-19 cases from the Alpha, Beta, and Delta strands. The current data does not show the effectiveness against the Omicron variant.  

Will Novavax Protect Against the New Omicorn Variants?  

Novavax is 90% effective in protecting against severe infection and hospitalization, however, the clinical trials and research on the vaccine were done prior to the presence of the delta and omicron variants, therefore efficacy against those subvariants is currently unknown. 

Bottom Line

Receiving emergency authorization for the Novavax vaccination is the first step to eventually getting both FDA and the Center for Diseases Control (CDC) approval. Hopefully soon we will have four safe and effective vaccine options — a much different prognosis than in the first few months of the pandemic.  

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