FDA: Novavax Covid-19 Vaccine Is Now Authorized For Ages 12 To 17

Teenagers will now have another option when it comes to getting vaccinated against Covid-19. And this new option is good because it is in many ways old.

On August 19, the U.S. Food and Drug Administration (FDA) sent a letter to Novavax, Inc. This wasn’t a “hi, how you doing’” letter. Instead, this letter indicated that the FDA had agreed to modify the Emergency Use Authorization (EUA) for the Novavax Covid-19 adjuvanted vaccine to include those 12 through 17 years of age as well. The original EUA, issued on July 13 had been for those 18 years and older, as I covered previously for Forbes. Now, in general, having more options tends to be a better thing, whether it’s gelato flavors, haircuts, or vaccines. But having the Novavax vaccine now as an option for teenagers is especially important as an answer to some of the anti-vaccination claims out there.

As I have described for Forbes, some personalities and anonymous social media accounts have been trying to label the Pfizer/BioNTech and Moderna Covid-19 mRNA vaccines as “gene therapy” and claimed that such vaccines may alter your DNA. This despite the fact that the mRNA in the vaccines is designed to simply serve as blueprints for your cells to make the spike proteins that stud the surface of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) rather than change your genes. Such unsupported “gene therapy” claims may have convinced some folks to shy away from these mRNA vaccines. Also, some people may be worried about the seeming newness of the mRNA technology, even though it’s been under development for years prior to 2020.

Well, anti-vaccination social media accounts can’t quite say the same things about the Novavax Covid-19 vaccine. It uses old standby technology that’s long been used for other vaccines such as the hepatitis B and pertussis vaccines. They use insect cells to produce the actual SARS-CoV-2 spike protein and then combine it with the Matrix-M adjuvant. As I’ve written before for Forbes, the Matrix-M is not a movie sequel staring Keanu Reeves, but instead consists of saponin extracts from the bark of Quillaja saponaria (soapbark) trees, some cholesterol, and phospholipids that serves as an adjuvant. An adjuvant is an ingredient that can be added to a vaccine to help further boost your immune response, in this case, to the spike protein. This is a similar adjuvant approach to what’s used in the Shingrix vaccine that you can get to protect you against shingles.

Of course, unlike many anti-vaccination claims, the FDA has to use actual scientific data to make its EUA decisions. The FDA expanded the EUA for the Novavax vaccine, “Nuvaxovid,” after reviewing safety and effectiveness data from the clinical trial on the 2,232 individuals in the 12 to 17 year age range. Of these, 1,487 had received at least one dose of the vaccine and 745 had received saline placebo. They found that the vaccine elicited antibody responses in the adolescents similar to those in adults. Trial results suggested that at least seven days after the second dose was administered, the vaccine was 78.29% effective in preventing polymerase chain reaction (PCR)-confirmed symptomatic Covid-19. Of course, with the potpourri of variants and subvariants including the Omicron ones that have emerged since the trial results were recorded, these days the effectiveness of the Novavax may not be quite as high. Future studies will be needed to determine exactly how effective the vaccine will be against the BA.5 Omicron subvariant, for example, or whatever jumble of letters and numbers variants emerge in the near future.

At present, the data suggests that that the effectiveness Novavax vaccine will be in the same ballpark as that of the Pfizer/BioNTech and Moderna Covid-19 mRNA vaccines. So if you haven’t yet been vaccinated against Covid-19, you could go with any of these. In fact, clinical trial results have suggested that the Novavax vaccine may have less side effects. Anecdotal reports have seemed to support this such as the following from Down Under, where the Novavax vaccine has already been authorized as a booster:

Chances are the anti-vaccination personalities and social media accounts won’t simply say, “oh, OK, now that there is a Covid-19 vaccine that uses standard technology that’s been used for years, go ahead everyone and get the vaccine.” They’ll probably come up with some more “But…umm’s” and new hand wavy reasons why the vaccine will turn you into a coffee maker or something like that. Regardless, it is better to have more Covid-19 vaccine options out there, and not have one or two companies control the market. Plus, there is certainly for improvement when it comes to the Covid-19 mRNA vaccines. The U.S. and other countries should continue to encourage the development and use of newer Covid-19 vaccines. That includes looking at the old to develop the new.