When Will Novavax Vaccines Be FDA Authorized As Covid-19 Boosters?

The Barenaked Ladies may have sung, “It’s been one week since you looked at me.” But it’s been eight weeks since Novavax announced that they had submitted a emergency use authorization (EUA) application to the U.S. Food and Drug Administration (FDA). This was an application for their protein-based Covid-19 vaccine Nuvaxovid (NVX-CoV2373) to be used as a booster. And some on social media have been wondering what’s taking so long for the FDA to consider the EUA amendment application to be A-OK. For example, health journalist and science writer Liz Highleyman wondered aloud on Twitter (as opposed to wondered silently on Twitter) why the Novavax vaccine isn’t already available as a booster in the U.S.:

As you can see, Highleyman posted this query after Eric Topol, MD, founder and director of the Scripps Research Translational Institute, had tweeted about a study that showed how the Novavax vaccine was able to induce robust T-cell immunity, which by the way is a good thing.

Sure, the FDA needs time to review all the data and information that Novavax submitted as part of the EUA application to feel confident about the safety and effectiveness of Nuvaxovid being used as a booster. Sure, what’s needed for a booster is not exactly the same as what’s needed for a primary series, meaning the first time a person gets any Covid-19 vaccine. Sure, the FDA shouldn’t be like a vending machine, dishing out EUAs as if they were bags of chips. But business writer James Surowiecki did point out on Twitter that the FDA had recently granted EUA’s to the Moderna and Pfizer-BioNTech bivalent Covid-19 mRNA boosters with a lot shorter turnaround times:

So why has there been a difference in turnaround times? It’s not as if the Nuvaxovid vaccine is completely new, despite it’s name starting with a “new” sound. It’s been available in the U.S. as a two-dose primary series for adults (meaning for adults who haven’t received any Covid-19 vaccines yet) since mid-July after receiving an EUA on July 13 from the FDA. The FDA subsequently added the 12-to-17 year age group to this EUA in August, as I reported then for Forbes. In fact, Nuvaxovid has been available in other countries for even longer, having received authorization for use in the European Union back in December 2021 and in Japan in April 2022.

In some ways, the Nuvaxovid vaccine is even less new than the Comirnaty and Spikevax vaccines, which are the seemingly rarely used formal names for the Pfizer-BioNTech and Moderna Covid-19 mRNA vaccines. The Covid-19 mRNA vaccines consist primarily of messenger RNA (mRNA) that serve as blueprints for your cells to manufacture spike proteins. These are the spike proteins that stud the surface of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), making it look like the end of one those BDSM maces that you hide when your parents visit. By contrast, the Nuvaxovid vaccine includes the spike proteins themselves. The spike proteins are produced by a recombinant technology that’s long been used by other vaccines such as Hepatitis B and pertussis vaccines, as I covered for Forbes back in mid-July. The Nuvaxovid vaccine serves as a great response to those anonymous anti-vaccination social media accounts that are pushing against the Covid-19 mRNA vaccine by claiming incorrectly that they are actually “gene therapy” and somehow alter your DNA.

Plus, other countries have already using Nuvaxovid as a Covid-19 booster for a little while now. For example, in April, the Japan Ministry of Health, Labour and Welfare (MHLW) had granted approval for the Nuvaxovid vaccine to be marketed both for primary immunization and boosters. And on September 12, the European Commission authorized the use of the Nuvaxovid Covid-19 vaccine as both a homologous (i.e., after the same type of vaccine, Nuvaxovid, was used for the primary series) and heterologous (i.e., after a different type of vaccine was used for the primary series) booster for adults 18 years of age and older.

Of course, with the Pfizer-BioNTech and Moderna Covid-19 mRNA vaccines having been the “Alpha-dog” vaccines (and Beta, Delta, etc. vaccines) in the U.S. since late 2020, most people due to get boosted now will have gotten the Covid-19 mRNA vaccines as their previous vaccinations. So, you may be wondering what level of protection a Nuvaxovid Covid-19 booster may offer as a heterologous booster. Again, homologous boosting is when the booster is the same vaccine type as the primary series. Heterologous boosting is when the booster is a different type. Well, a research letter recently published in the Journal of Infection described how Nuvaxovid boosters in nine individuals who had previously received two doses and 41 individuals who had previously received three doses of the Pfizer-BioNTech, the Moderna, or the Astra-Zeneca ones. The study did find that such heterologous boosting with the Nuvaxovid Covid-19 booster did result in enhanced cross-reactive immunity as measured by antibody levels against the Omicron BA.1 and BA.5 subvariants.

Nuvaxovid boosters could give the U.S. vaccination efforts a needed boost. In using an old standby technology, Nuvaxovid vaccines don’t have to be kept as cold as the Covid-19 mRNA vaccines need to be kept, making Nuvaxovid vaccines a whole lot easier to transport and store. This could help vaccination efforts better reach those who may be currently harder-to-reach, such as low income or rural locations that may not have the freezers needed to store the Covid-19 mRNA vaccines.

Having an additional booster to choose from could really help the U.S. population in general. The U.S. faces a lot of Covid-19 uncertainty going into the late Fall. Europe has already been seeing upticks in Covid-19 cases and Covid-19-related hospitalizations. Americans have been ditching Covid-19 precautions such as face mask wearing as if they were furry boots, shutter shades, or neon activewear. Meanwhile, the protection offered by people’s primary vaccinations or previous infections from 2021 may have waned significantly by now. Interest in getting booster has waned as well, with just 48.9% of Americans having received at least one booster. And as of late September, only 4.4 million Americans have gotten the bivalent Covid19 mRNA boosters.

All of this could leave a lot of the U.S. population rather “bare naked” when it comes to protection against Covid-19 this Winter.