in , , , ,

Here Are 3 Things Different About It

Here Are 3 Things Different About It

“Nova” means “new” in Latin. And the Novavax Covid-19 vaccine that just got emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) is certainly new. It’s new in that it’s not completely new. And that could make a significant difference.

The FDA announced the EUA on July 13, after the FDA’s independent Vaccines and Related Biological Products Advisory Committee had voted in favor of the authorization the previous week, on June 7. The EUA covers those 18 years of age and older. So if you can get a Costco card or get piercings or tattoos by yourself, you can get the Novavax Covid-19 vaccine. The Novavax vaccine now joins the Pfizer/BioNTech, Moderna, and Johnson & Johnson (J&J)/Janssen ones as Covid-19 vaccines available in the U.S. for adults.

The Novavax Covid-18 vaccine, which goes by the Scrabble-friendly trade name “Nuvaxovid,” has been authorized as a two-dose primary series given three weeks. or roughly only two Scaramuccis apart. Nuvaxovid had already already received authorization for use in the European Union back in December 2021 and in Japan back in April. So this vaccine ain’t completely new to the World, and the U.S. certainly ain’t going to be the first country to use the vaccine.

The FDA based its authorization in big part on results from an ongoing randomized, blinded, placebo-controlled study of around 17,000 adults in the United States and Mexico who received the vaccine and around 8,300 who received a saline placebo instead. There have been 17 Covid-19 cases in the vaccine group versus 79 cases in the placebo group, suggesting that the vaccine was 90.4% effective in preventing mild, moderate or severe Covid-19. Among those 65 years and older, the measured effectiveness was somewhat lower at 78.6%. Of note, these clinical trial results came before the delta and omicron variants of the Covid-19 coronavirus hit the scene. So take these effectiveness numbers with an Ugg boot full of salt.

The trial hasn’t raised any substantial safety concerns about the Novavax vaccine. The most commonly reported side effects were similar to the side effects that have been seen with the other Covid-19 vaccines such as irritation at the injection site (e.g., pain/tenderness, redness and swelling) and general constitutional symptoms (e.g., fatigue, muscle pain, headache, joint pain, nausea/vomiting and fever). Now, similar to the other Covid-19 vaccines, there was some increase in the risk of myocarditis, which is inflammation of the muscles of your heart, and pericarditis, which is inflammation of the membrane that surrounds your heart like Saran Wrap around a chocolate Easter bunny. But the risk of these conditions from the vaccine appear to be much, much lower than the risk of getting myocarditis or pericarditis from being infected with the Covid-19 coronavirus.

While the other Covid-19 vaccines may have received more fanfare in the U.S. when they first rolled out back in late 2020 and early 2021, this new “new” vax is not simply more of the same. Rather, it’s different in several key ways:

Key Difference 1: Instead of mRNA technology, the Novavax Covid-19 vaccine uses more traditional vaccine technology.

As you may have heard by now, the Pfizer-BioNTech and Moderna Covid-19 vaccines consist of mRNA encapsulated in lipoprotein envelopes. These mRNA serve as blueprints for your cells to manufacture the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein. These spike proteins stud the surface of the virus making it look like a spiky massage ball or the end of one of those BDSM maces that your roommate accidentally found in your closet. Similarly, the J&J Covid-19 vaccine uses a modified adenovirus to bring instructions to your cells to make these spike proteins.

Note that these vaccines do not alter your DNA, as some people and anonymous anti-vaccination social media accounts have claimed. They won’t make you grow extra arms, morph into a sheep, or suddenly like Justin Bieber’s song “Baby.” Again, they simply provide blueprints for get your cells to produce the spike protein for a limited amount of time so that your immune system can see these spike proteins and react in spike, so to speak.

While researchers have been working on these technologies for years, it is true that the Pfizer-BioNTech and Moderna Covid-19 vaccines were the first time such mRNA approaches received EUAs (and subsequent approvals) from the FDA. The J&J Covid-19 vaccine approach is similar to the approach recently used for the Ebola vaccine but is still different from what’s been used for more traditional vaccines. So some people may have been hesitant to get any of the three Covid-19 vaccines that have been available since early 2021 considering them still new.

The same can’t be said about the Novavax one. The Novavax Covid-19 vaccine includes a combination of the actual SARS-CoV-2 spike protein and what’s called the Matrix-M adjuvant. Novavax uses insect cells to produce the spike protein for the vaccine. Including the actual protein from a virus is an approach that’s long been used for other vaccines such as the hepatitis B and pertussis vaccines. The Matrix-M is not a movie sequel staring Keanu Reeves and some peanut butter M&M’s. Rather it consists of saponin extracts from the bark of Quillaja saponaria (soapbark) trees along with some cholesterol, and phospholipids. The soapbark tree is native to Chile. The Matrix-M serves as an adjuvant, a compound that can further boost your immune response to the spike protein. Including an adjuvant in a vaccine is not new either. As described by the Centers for Disease Control and Prevention (CDC), various adjuvants such as aluminum and MF59 have been used in vaccines for decades. In fact, the AS01B adjuvant in the Shingrix vaccine (the recombinant herpes zoster vaccine to prevent Shingles) includes QS-21, which is also extracted from the Chilean soapbark tree. So it’s not as if using a compound from the soapbark tree is completely new either, making this a case where the bark is not worse than the potential bite of the Covid-19 coronavirus.

Key Difference 2: The Novavax Covid-19 vaccine can be transported and stored in standard refrigeration

Unlike the more fragile mRNA, the components of the Novavax Covid-19 vaccine are more durable. Therefore, standard refrigeration can suffice rather than the ultracold circumstances needed for the Pfizer/BioNTech and Moderna Covid-19 vaccines. This can make it a lot easier to transport, store, and administer the Novavax Covid-19 vaccine. It can help reach locations that don’t have the resources to maintain special freezers.

Key Difference 3: The Novavax Covid-19 vaccine offers the possibility of more heterologous boosting.

This may be yet another case of different being good. I’ve covered for Forbes in December 2021 the potential advantage of mixing-and-matching different vaccine types for your primary Covid-19 vaccine series and boosters. Heterologous boosting is when the type of booster is different from the type of vaccine used in the primary series. By exposing your immune system to the SARS-CoV-2 in different ways, you could strengthen your immune response just like dating different types of people can help you better recognize a douchebag or a Harley Quinn. That’s assuming that you don’t want a douchebag or a Harley Quinn. While the Pfizer/BioNTech and Moderna mainly differ in the amount of mRNA they contain and the mRNA vaccine differ from the J&J vaccine in the ways they get your cells to produce the spike proteins, the Novavax Covid-19 vaccine is even more different from all three. It would be useful to conduct studies that compare various mix-and-match strategies that include the Novavax Covid-19 vaccine.

So far, the FDA has only authorized the primary series of the Novavax Covid-19 vaccine and not boosters of the vaccine. However, not surprisingly, Novavax has been talking to the FDA about using their vaccine as a booster to other types of Covid-19 vaccines. Authorization of this booster possibility would then offer even more heterologous booster possibilities. So it may not be too long before, the Novavax Covid-19 vaccine can give you a boost.

Ultimately, the arrival of the Novavax is potentially very good news. Not only might this help get more people vaccinated, it could also serve as heterologous boosting option. It’s a reminder that more different Covid-19 vaccines are needed as well. Research and development of new Covid-19 vaccines should not slow or stop just because there are already Covid-19 vaccines on the market. As with most product, variety and competition are good, leading to more innovation and better products. After all, you wouldn’t tell all manufacturers to stop designing new footwear simply because Crocs and Ugg Boots have already been on the market.

What do you think?

A Strange Fossil in South China Reveals an Intriguing Link With The First Americans

A Strange Fossil in South China Reveals an Intriguing Link With The First Americans

Fintech execs convicted in US after $160 million sent to Nigeria

Fintech execs convicted in US after $160 million sent to Nigeria