Novavax Covid-19 Booster Gets FDA Authorization, Does This Deserve More Attention?

Well, the U.S. finally has a Covid-19 booster that’s not a mRNA vaccine. On October 18, the U.S. Food and Drug Administration (FDA) has just extended the emergency use authorization (EUA) for Novavax’s adjuvanted (NVX-CoV2373) Covid-19 vaccine to now include a first booster dose for those 18 years and older. That same day, the Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky, MD, signed a decision memo “allowing Novavax monovalent Covid-19 boosters for adults.” So, has this development gotten as much attention as the Pfizer-BioNTech and Moderna Covid-19 mRNA boosters got when they first received such EUA extensions last year? Not exactly.

In fact, @HarlotKnight, whose Twitter profile includes the description “journalist in a grunge band,” asserted via a tweet that a local pharmacy wasn’t even aware of the CDC change in guidance for the Novavax Covid-19 vaccine:

Hmm, does that sound like a “Black Hole Sun” in communicating an important change? Wonder how many people are more aware of Olivia Wilde’s special salad dressing than the new Novavax Covid-19 booster? Shouldn’t the availability of the Novavax Covid-19 vaccine as a booster be a bigger deal? After all, the Novavax booster provides an option for those who may feel more comfortable with a technology that’s been employed for years for other vaccines such as the hepatitis and pertussis vaccines. Plus, the Novavax Covid-19 vaccine is easier to store and transport than the Covid-19 mRNA vaccines, as I covered this for Forbes back in July when Nuvaxovid had first received an EUA from the FDA making it AOK to be used as a primary series. Again, while the Pfizer-BioNTech and Moderna vaccines consist of messenger RNA (mRNA) serving as blueprints for your cells to produce the spike proteins that stud the surface of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the Novavax Covid-19 vaccine contains the actual spike proteins themselves.

Having more choice in general tends to be a good thing as a nothing-but-iceberg-lettuce salad bar or a one-flavor ice cream shop probably wouldn’t do so well. You probably wouldn’t frequent a restaurant where the server says, “yeah, don’t bother reading the menu, because you are having the chicken.” In the case of Covid-19 boosters right now added choice may be especially needed. It could give the U.S. booster program a much-needed boost.

The whole Covid-19 booster program in the U.S. hasn’t exactly been a rousing success. Only around 111.3 million people in the U.S. have gotten at least one Covid-19 mRNA booster. Considering that the U.S. has around 329.5 million people, that’s less than 35% of the total population. Only about 26.7 million folks ended up getting the second original Covid-19 mRNA booster. And only 19.4 million (or less than 6% of the total population) have gotten the Covid-19 bivalent mRNA booster, as of October 21 according to the CDC Covid data tracker. Since immune protection from Covid-19 mRNA vaccines seems to wane after four to six months, that means the vast majority of the U.S. may now be in “wane’s world.” They may be significantly less protected against Covid-19. Think about that the next time you move amongst a large maskless crowd to get to the communal nacho dip platter.

Now this amended EUA still does not allow the Novavax Covid-19 vaccine to serve as a booster for all situations. The FDA specifically authorized the Novavax Covid-19 vaccine, adjuvanted, as “a first booster dose (0.5 mL) to the following individuals at least 6 months after completion of primary vaccination with an authorized or approved COVID-19 vaccine:

• Individuals 18 years of age and older for whom an FDA-authorized mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate, and
• Individuals 18 years of age and older who elect to receive the Novavax COVID-19 Vaccine, Adjuvanted because they would otherwise not receive a booster dose of a COVID-19 vaccine.”

That does means that the Novavax Covid-19 vaccine can be used for both heterologous—the booster is of a different type from the vaccine type used for the primary series— and homologous—meaning the vaccine types are the same—boosting. Including both types of boosting is important because of those who have gotten vaccinated already, most have gotten the Pfizer-BioNTech or Moderna Covid-19 mRNA vaccines because those were, you know, the main game in town and the ones that seemingly have gotten the most attention from the Trump and then the Biden Administrations.

However, this does leave a major remaining gap in the Novavax Covid-19 vaccine EUA. The EUA specifies its use as a “first booster dose,” which technically doesn’t include those who have already gotten at least one Covid-19 mRNA booster already. That had some on social media wondering why:

The question is when will the FDA further expand the EUA to include all potential booster situations. As I reported for Forbes on October 13, a number of people on social media were wondering why the FDA was taking over two months to expand the Nuvaxovid EUA to include boosters. So now the wait for the next EUA expansion begins. What exactly does the FDA need to determine that the Novavax Covid-19 vaccine can serve as a second booster or the role that the bivalent Covid-19 mRNA boosters are supposed to serve right now? And will such an EUA expansion occur before the next Covid-19 surge, which many expect to occur in November?

It’s never a great situation to have the U.S. depend solely on products from only one or two pharmaceutical companies as the U.S. has for the Covid-19 boosters. That can leave the Biden Administration way too dependent on Pfizer and Moderna and give such companies way too much negotiating power. Instead, the Biden Administration should continue to encourage development of new Covid-19 vaccine boosters and give all such boosters equal time. First-to-market shouldn’t necessarily mean the only-to-market. Otherwise, everyone would still be communicating via Friendster, checking their schedules on their Palm Pilots, playing Everquest until 4 am, and watching the “Three Amigos” on Betamax rather than see Elon Musk tweet about a different “Three Amigos.”