What You Need To Know A fourth covid jab brand has now been approved for EUA by the CDC. The Novavax vaccine was approved for ages 18 and up on July 13, 2022. According to the company, this vaccine was made without using human fetal-derived cell lines or tissue, including HEK293 cells. That would set them apart from their Pfizer, Moderna, and J&J counterparts. This could cause issues for unvaccinated people who were granted a religious exemption to vaccine mandates based on the abortion line. At least one Healthcare Network has already made the move to withdraw previously granted religious exemptions based on the availability of the Novavax jab. The Froedtert Health network in Wisconsin has sent out the ultimatum to get vaccinated or resign. The network's COVID-19 Vaccine Religious Exemption Review Committee wrote, "Your original exemption submission and additional documentation you provided do not meet the criteria of explaining your sincerely held religious belief that conflicts with receiving the COVID-19 vaccine, including the new Novavax vaccine. The religious exemption will not be upheld, despite additional comments provided that "related to opinions or non-factual information." They went on to claim that if the staff members don't get a first dose by September 21, they will be "considered voluntarily resigned." Other Healthcare Networks like Riverside Health Systems in Virginia and Houston Methodist in Texas are rumored to be looking into doing the same despite the fact that in the last month Joe Biden went on "60 Minutes" and declared the Pandemic to be over and even Canada, one of the most restrictive Countries when it comes to medical tyranny, has softened their vaccine and mask mandates. The Armed Forces are also looking into Novavax as a tool to get more unvaccinated soldiers the jab but have not made any changes to policy. There is still a Federal Injunction preventing them from firing members of the military who refuse. According to Dr Fryhofer (AMA's liaison to the CDC's Advisory Committee on Immunization Practices), "A two-dose series of Novavax protein subunit COVID vaccine is now recommended for unvaccinated" individuals who are 12 or older "for primary vaccination against COVID-19...Unlike mRNA vaccines, protein-based vaccines do not contain any genetic material." She claims that this should be reassuring to those who worried about mRNA vaccines and said this technology has been around for 30 years being used in vaccines for flu, hepatitis B and whooping cough.
While some might buy into the safety of this jab the CDC battled the vaccine company over whether or not to include myocarditis as a known adverse reaction and did so despite pleas from Novavax. Myocarditis has been linked to the other covid jabs, especially in young men. So what about the efficacy of the new jab? Based on the studies turned into the CDC which led them to grant an EUA exemption, it was overall about 90% effective at preventing covid. This sharply declined for people 65 and older, dropping to 79%. For some unexplained reason, the study showed that the efficacy was only 77% for Hispanics. Then you have to understand that the study the CDC used was data against the alpha variant. A South African study showed that Novavax was only 51% effective against the Beta variant. There is no data to show how effective it was against later variants, including the omicron variant which has now taken over as the dominant variant. It is impossible to know how effective it actually is but if the other jabs are any indication, the efficacy will lower significantly. Despite this, the company is moving forward to get as much of their product into the vaccine market as possible and make up for lost time. In 2020 when they first started working on Novavax, the company saw their stock shoot up 2,700%, which beat early performance from Pfizer and Moderna. Being late to the party has hurt the stock tremendously, with it seeing an 85% drop just this year. The company hopes that they can make up for lost time as they are currently making pushes to serve as a booster for other brands, vaccinate teens, be the first 2 in 1 Covid/flu combination vaccination (they are already on phase 3 testing while the next closes is on phase 1) on the market, and be the primary jab used to get the unvaccinated "on board". At this point, 40 Countries have granted Novavax EUA approval, they have 51 million doses contracted to Australia, and the US has 3.2 million doses ready to ship.
Additional Information for Those Who Want to Dig Deeper: Novavax arrived in Australia after most of the population already received a primary two-dose course, and the vaccine is not yet recommended as a preferred booster by the Australian Technical Advisory Group on Immunization (Atagi). It was suggested that "more permissive eligibility settings" could increase usage and reduce pressure on Pfizer and Moderna. Federal health minister, Mark Butler asked Atagi to reconsider its recommendations around Novavax's booster shot potential. It sounds like the health minister is trying to find a way to use the 11 million doses ordered as they currently have only used 200,000. The Novavax jab is a protein subunit vaccine. This technology has been used in other known vaccines, such as the hepatitis B vaccine. Their hope is the product could appeal to individuals who preferred a traditional technology to that of mRNA. To date, this hasn't offered Novavax much in the way of sales. Last month, Novavax cut its annual vaccine sales forecast to the range of $2 billion to $2.3 billion from an earlier projection of $4 billion to $5 billion. The company acknowledged its late arrival to market is one of the reasons for this. Novavax is hoping to get authorization to be a booster option for other brands and is the farthest along in the development of a potential combined coronavirus-flu vaccine. It's set to launch a phase 3 trial next year while Moderna is still in phase 1. Dr Sandra Fryhofer is an Atlanta general internist and chair of the AMA Board of Trustees. She also serves as the AMA's liaison to the Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) and is a member of ACIP's COVID-19 Vaccine Work Group. When interviewed about the Novavax vaccine, here are some of the things she had to say. "We now have a third type of vaccine in the fight against COVID. This vaccine contains harmless spike protein subunits with an adjuvant added to boost immune response. And, unlike mRNA vaccines, protein-based vaccines do not contain any genetic material. Our vast experience with protein subunit vaccines should be reassuring to those who worry about the newness of mRNA vaccine technology." When asked about the technology behind it she explained "This protein-based platform is new for COVID vaccines but it's not really new. This technology has been around for more than 30 years and it's already been used in making other vaccines, for example, for flu, hepatitis B and whooping cough." When asked about its usage she said "Novavax can only be used as a primary series because the Food and Drug Administration (FDA) has not authorized it as a booster yet. However, there's a lot of interest in the prospect of using Novavax as a booster, especially since mRNA vaccines don't seem to be that durable." She added that the "FDA representatives said that booster data would be reviewed very quickly, as quickly as possible, once that data is submitted." When asked about its efficacy the Dr exclaimed "The study data submitted to FDA says, overall, it was about 90% effective at preventing COVID, however, it did not seem to work quite as well in those 65 and older. Vaccine efficacy in this older group was 79%. And for some unexplained reason for which it doesn't make any physiological sense, vaccine efficacy in those of Hispanic ethnicity was also a little lower at 77%," she added, noting "here's the catch: The studies submitted to FDA were done before Omicron started circulating." As a result, "we just don't know how it will work against Omicron," Dr. Fryhofer said. "The Omicron surge started in December 2021 and still dominates. Omicron's BA.5 sublineage now makes up" 80% and BA.4 makes up a little more than 5% "of specimens tested, and who knows what variant is next on the menu." She also admitted "The Novavax studies were done during a time when the Alpha variant was predominant, and the South Africa study showed that Novavax was only 51% effective against the Beta variant," adding that "we really can't compare vaccine effectiveness of Novavax to that of mRNA vaccines based on the data that we currently have available." When it came time to talk about the safety of the vaccine, the Dr explained "Unfortunately, as we've seen with the mRNA vaccines, there have been reports of myocarditis and pericarditis after Novavax during the clinical trials and also in early post-authorization data. The Myocarditis risk was addressed by the FDA in its guidance fact sheets, and FDA explains the chance of myocarditis is very low, but it can occur usually within 10 days following vaccination. It also says patients who have chest pain, shortness of breath, a fast heartbeat, heart fluttering, or a pounding heart should seek medical care right away." She was asked about giving the jab with other vaccines and said "Also, there's no problem giving Novavax or any of the other COVID vaccines with other vaccines with one exception: orthopoxvirus vaccines." She added that while "we're in the middle of a monkeypox outbreak ... ACAM2000 and JYNNEOS are the two vaccines available for orthopoxvirus viruses. Unfortunately, ACAM2000 has been linked to myocarditis. We don't know if there's an increased risk of myocarditis with JYNNEOS yet, but if you've received a dose of one of these orthopox vaccines, CDC suggests waiting four weeks to get a COVID vaccine dose," Dr. Fryhofer explained. "However, if you've already received a COVID vaccine and you're now at risk of monkeypox due to exposure, no need to wait. Go ahead and get the monkeypox vaccine dose now." So she says don't mix them if you took the monkeypox jab first but the other way around is just fine. I don't know how that makes any sense but I won't be taking any of them. Government statistics show "About 26–37 million U.S. adults have not yet received a single dose of a COVID-19 vaccine and would benefit from starting a primary series. As many as 26 to 37 million U.S. adults have not yet been vaccinated." They hope this more traditional technology platform will convince some of these vaccine holdouts to roll up their sleeves. I doubt it. "Data suggests that some people who have remained unvaccinated against COVID-19 have been waiting for authorization of a traditional protein-based vaccine before getting vaccinated," Dr. Fryhofer added. She then said "As of July 2022, more than 599 million doses of COVID vaccines have been administered in the U.S., but about 26 to 37 million U.S. adults have not yet received even a single dose of COVID-19 vaccine. I hope that having this more traditional vaccine platform option available will move the needle for at least some of those still not vaccinated. And at least for now, this vaccine is available free of charge." When asked about health systems revising their religious exemption policies and forcing employees to get it or "resign", professor Dorit Reiss explained "I've said publicly before that I think Novavax does change the situation in relation to arguments about cell lines. This is the first I've heard of an employer actually moving on it." Reiss added that of the many claims to back up religious exemptions she's come across, the fetal cell line argument was the most common, partially because it might curry favor from pro-life judges. But other reasons, like the claim that some religions require blood to be free of contamination, have also been used." This could make it harder for people who don't want the jabs to get a religious exemption. If the reports are true, this does eliminate the fetal cell line argument. While there are other things a person can file a claim for, this could give businesses the ability to lessen the amount granted. As with the other vaccines, there are several concerning adverse reactions we know about and not enough testing to even start to know what the long term effects are going to be. Written by Chris Turner Online Content Chair Sources: https://www.theguardian.com/australia-news/2022/sep/28/australias-covid-vaccine-review-recommends-expansion-of-novavax-eligibility-amid-fears-of-moderna-shortfall https://www.fool.com/investing/2022/09/26/is-there-hope-for-this-struggling-vaccine-stock/ https://www.ama-assn.org/delivering-care/public-health/what-doctors-wish-patients-knew-about-novavax-covid-19-vaccine https://www.ama-assn.org/delivering-care/public-health/what-sets-apart-novavax-option-other-covid-19-vaccines https://www.cbsnews.com/news/novavax-fda-authorizes-mrna-alternative-covid-19-vaccines/ https://www.fda.gov/media/158914/download#page=19