COVID-19: A NEW VACCINE!
I actually wrote this back in July, but it's been, as my good friend Dr. Zachary Rubin puts it, Disinformation Whac-A-Mole and my posts have mostly been reactive to the repeated waves of false info that keep crashing onto our mental shores. However, there was a new update, and I realized it's still important to put this out there, especially at a time when not enough people even know about the importance of updated boosters. Most of my COVID-centric essays lately have been reminders and justification of the continuation of mitigation measures despite the country desperately seeking to drop them. So it's nice to be able to talk about some new and positive developments.
In July, the FDA authorized a fourth vaccine to help prevent and fight COVID-19. NovaVax has been in research for some time now, and has been authorized in Europe before now, but in the USA it took a backseat to the mRNA vaccines and J&J/Janssen.
Here's what I wrote in February 2021:
Novavax has created a vaccine that is a viral spike protein on a nanoparticle - more of a traditional vaccine, similar to HPV and the influenza vaccines. In a trial of nearly 16,000, It showed a strong 95.6% efficacy against the wild type, and 85.6% against B-1.1.7 (first found in the UK). However, vaccine efficacy was lower against B-1.351 (49.4% overall, 60.1% in those negative for HIV). An important takeaway is that 1/3 of the study patients in South Africa (4,400) had had a previous COVID-19 infection - getting infected with the wild-type COVID doesn't necessarily protect against B-1.351. NovaVax is now considering a bivalent vaccine (containing spike proteins of both wild type and B-135.1) or a reformulation. Shout out to my friend, pharmaceutical scientist Kayla Andrews, for lending me a hand with summarizing these (she did most of the work so I didn't have to)!
What we have learned since then, based on data obtained while Delta was the dominant variant (pre-Omicron): Final efficacy was reported as 90.4% against symptomatic COVID-19 and 100% against severe illness.
So NovaVax, a recombinant nanoparticle vaccine, takes an insect-specific virus (baculovirus) and genetically engineers it to include the SARS-CoV-2 spike protein, and they infect moth cells with that. The baculovirus replicates in the moth cells to make more spike protein, and then they take that protein and put it on lipid nanoparticles to create a look-alike for your immune system to recognize and later fight off SARS-CoV-2.
Why a fourth company making a vaccine? There are two great things about NovaVax:
It is a different technology. The more weapons we have against COVID-19 the better. Now anyone who was allergic to any components of the mRNA vaccines can get a different vaccine. In addition, anyone who was hesitant about mRNA vaccine technology, even though it is safe and effective, now has an alternate vaccine choice as well!
It is stable in regular refrigerator temperatures! This will hopefully help in distribution of the vaccine to areas with less access.
Like with the other vaccines, this will likely need to be a three-dose vaccine. Also like the other vaccines, side effects/adverse reactions were mild-to-moderate and only lasted a few days. Most reports of reactogenic effects were arm pain and fatigue. There were six cases of myocarditis after vaccination out of 41,546, all of which occurred in the first 20 days after vaccination. In other countries, among a combined 744,235 doses, there were 36 reports of myocarditis or pericarditis. This seems slightly more frequent than with the mRNA vaccines, but it is still early on in surveillance - I expect that it will continue to be mild and self-limited when it does happen, and still considerably less frequent than myocarditis due to COVID-19 infection.
Just last week, the FDA authorized that NovaVax could be utilized as a booster dose as well, so if you want to mix and match or had a reaction to the mRNA vaccines, this is now an option! The NovaVax is only formulated against original SARS-CoV-2, though they report it has some effect against BA.5 (though this is not really proven yet). They are still planning a bivalent booster for release in early 2023.
There is ZERO reason to fear the mRNA vaccines, but if you were resistant to the idea, now you have another option! Please do not wait any longer. Go get vaccinated and/or boosted straightaway!
CDC MMWR 7/2022 on the Authorization of NovaVax: https://www.cdc.gov/mmwr/volumes/71/wr/mm7131a2.htm
Novavax authorized as Booster: https://www.cnbc.com/2022/10/19/fda-authorizes-novavaxs-covid-shots-as-mix-and-match-booster-to-pfizer-or-moderna.html