Below are the most recent items we think are worth sharing with you:
1) FDA briefing documents say there are no safety signals in the Novavax data, and myocarditis was the same in the placebo and vaccinated groups, debunking the false media claims
The FDA last Friday released the briefing documents to prepare for the upcoming FDA expert committee meeting this Tuesday to decide whether to recommend authorization of the Novavax vaccine. The FDA documents note that: A) During the main part of the phase 3 trial, the number of cases of myocarditis/pericarditis were balanced evenly between vaccine recipients and the placebo group. There was no statistical difference between vaccine and placebo for myocarditis/pericarditis. B) After the phase 3 trial crossed over to having all people vaccinated, statistically there should have been between 1.6 and 4.6 cases of myocarditis/pericarditis based on the number of participants. The mid-point of that is 3.1 cases. In other words, if you simply picked the same number of people from the population and tracked them for the same length of time without receiving a vaccine or placebo, usually 3.1 cases would occur. That's because myocarditis/pericarditis sometimes occurs in some people. That's exactly what took place in the extended time period after the trial cross-over began: 3 cases occurred. Here are a few excerpts from the FDA documents:
PAGE 14: SAFETY CONCLUSIONS: The safety data from the clinical program supports a positive benefit-risk profile which includesa favorable reactogenicity profile. Safety was well-characterized via exposure in > 40,000recipients of the vaccine at the proposed dose level and dosing interval across all clinical studies.
Local and systemic events were generally mild to moderate in intensity and of short duration. Most AEs were mild to moderate severity, and SAE rates in the NVX-CoV2373 group were lowand comparable to placebo. In addition, there were no clinically significant safety signals forAESIs (adverse events of special interest) or other safety events of interest. ....
PAGES 69-70: 7.5.2 Myocarditis/Pericarditis
In the placebo-controlled phases of the clinical program,myocarditis/pericarditis events were balancedin both the NVX-CoV2373 and placebo groups;2 events (0.007%) in NVX-CoV2373 and 1 event (0.005%) in placebo.When evaluated with an exposure-adjusted IR per 100 PY (person years);myocarditis/pericarditis cases in the NVX-CoV2373 group occurred at 0.03 events/100 PY compared with cases in placebo at 0.02 events/100 PY with astatistical risk difference of 0.00(95% CI: -0.06, 0.07).
In the post-crossover phase of Study 301 (US/MX) and Study 302 (UK), three participants reported myocarditis/pericarditis.A background rate of myocarditis/pericarditis was determined utilizing data from ACCESS, a study funded by the EMA to determine background rates for COVID-19 vaccine AESIs. The total exposure to vaccine after the crossover, as of 31 October 2021 was 14,513 PY.The expected number of cases of myocarditis/pericarditis, as calculatedbased on ACCESS background rates ranged from 1.6 – 4.6 cases/14,513 PY. The observed rate of 3 cases/14,513 PY is within the range of expected background cases. ....
Note that the health ministry of Canada has the same data as the FDA and on their website, it says: "A few cases of myocarditis and/or pericarditis have been reported following the administration of the vaccine, but there is not yet enough information to determine if cases of myocarditis and/or pericarditis are related to the vaccine. NACI, PHAC and Health Canada will continue to monitor the emerging evidence on the safety of the vaccine." It also says: "Side effects, for example, fatigue, headache and muscle pain, were typically mild and resolved within 1 or 2 days." Furthermore, every major drug agency other than the FDA has already authorized the Novavax vaccine, they have the same data as the FDA and they haven't given even the slightest indication that the Novavax vaccine is linked to myocarditis. That indicates that media reports conveying there is a causal link between the vaccine and myocarditis are inaccurate misinformation. Those reports caused a 20% one-day drop in the share price. When enough investors realize they were given incorrect information, the share price will likely rebound.
2) Of the 744,235 first doses given, almost no cases of myocarditis / pericarditis occurred in Canada, the EU, New Zealand or South Korea. The only significant amount of "reports" were in Australia, but were found by the FDA to be dubious
The most important thing to be aware of is that these numbers include every possible potential myocarditis/pericarditis "report" regardless of whether any symptoms actually occurred or were made up by anti-vaxxers. This is because people can simply call a phone number and claim to suspect they have myocarditis/pericarditis (or symptoms of them), and it gets reported and added to the totals. In fact, people who post on social media saying they think they have myocarditis/pericarditis (or symptoms) are also turned into reported cases and added to the totals. For these reasons, the Novavax FDA document says:
Spontaneous adverse event reports that are included in the Summary Safety Reports (SSRs) arise from the use of the vaccine in the real-world setting and are captured into surveillance systems similar to the FDA Vaccine Adverse Events Reporting System (VAERs), from a variety of sources, including health care providers, vaccinees, the medical literature and social media posts. However, these passive reporting systems have many limitations, including underreporting, duplicate reporting, variable report quality and accuracy, inadequate data regarding the numbers of doses administered, and lack of direct and unbiased comparison groups. These spontaneous reports may not be medically confirmed and are generally not verified.
At InvestorVillage, the Australia reports were assessed by a user, Redplate, who was the head of research and development for a major vaccine company and recently retired:
However the Australian spontaneous reports are discussed a bit more and most are dismissed by FDA as either ‘too long after vaccination, likely duplicate report, poorly documented (read anti vax hoax) and maybe two attributable to vaccine or can’t be dismissed as not attributable. The FDA gave little credence to most of these spontaneous reports. Thus the conclusion the vaccine was adequately safe and effective. Risk benefit was for approval.
He also posted this rebuttal of someone claiming myocarditis was an issue. VEARs is the type of passive reporting that the excerpt above explains is not reliable:
Yes VEArs is in fact mostly bullshit. Since you can’t seem to follow the actual words FDA put out they picked apart each so called myocarditis report one by one and all but one can be eliminated. The single case the report says may be vaccine associated as it can’t be eliminated is a frequency of 1 out of 740,000 administered in Australia. They removed the others as being long after vaccination likely duplicated responses, and specific confounding medical conditions. Being honest (unlike you) they can’t eliminate causality. But the FDA clearly and precisely picked apart the spontaneous reports as they see them for what they are, mostly anti vax bullshit generated in a climate of heightened hype on vaccine myocarditis.
In the fully adjudicated data there is not a signal of a safety concern and that is the FDA factual conclusion.
Did you actually read the documents? Seems you missed both the summary conclusions that it was safe and effective and the details they used to dismiss the credibility of the ‘spontaneous Australian reports’. I found their write up fair and balanced and reaching an accurate conclusion that it was safe and effective. And of course in the heightened hysteria of anti vax bullshit about mRNA and the massively overblown risks of myocarditis they had to have that full discussion. Had to. You understand that right?
In essence, some media outlets took a couple of snippets of the discussion out of context and falsely claimed or implied there was a causal link between the Novavax vaccine and myocarditis/pericarditis. Here are some details that flesh out what the retired head of R & D said. As page 71 of the document describes, excluding Australia, only 5 reports of myocarditis/pericarditis occurred. That is lower than occurs naturally. So even if those reports were accurate, people who received Novavax had lower rates of myocarditis/pericarditis than normal in most countries. Moreover, these 5 reports were assessed more closely and were probably not actual cases. So basically there were 0 reliable reports of myocarditis/pericarditis in any country other than Australia. Australia is a small country with only 26 million people. Bizarrely, 89.1% of the myocarditis/pericarditis reports (41 out of 46) came from there, but only 17% of the doses were given there. Such a huge discrepancy instantly indicates that something fishy is at play. By the time the vaccine was rolled out in Australia earlier this year, nearly all anti-vaxxers were aware of myocarditis/pericarditis related to the RNA vaccines. Their best chance of hurting the new vaccine, Novavax, would be to call the reports phone number and post on social media claiming to suspect having myocarditis/pericarditis or symptoms. However, of 35 spontaneous reports and the symptoms described, none of them definitively matched the definition of myocarditis or pericarditis. Only 10 met a probably case definition of pericarditis and only 1 met a probable case definition of myocarditis. Pericarditis is far less significant and severe than myocarditis. So only one of the reports fit a probable case definition for myocarditis. Clearly it's preposterous for news outlets to claim that real world data indicates Novavax has any link at all to myocarditis. Here's a clip from one of the newly released FDA documents:
More than 740,000 doses of vaccine have been administered in Indonesia, Australia, EU, New Zealand and South Korea. The report included 35 spontaneous reports of suspected myocarditis or pericarditis, none of which met a definitive case definition. Ten reports met a probable case definition of pericarditis and 1 report met a probable case definition of myocarditis. All of the probable cases originated from Australia. Many of these reports are missing important information including diagnostic workup. Two cases appear to be duplicates reports which, if confirmed, will reduce the total number of probable pericarditis cases to 8. It is worth noting that there are currently a number of anomalies in the preliminary reporting of these cases. Most notably, all of the probable and possible cases that have been reported from Australia, a country that represents ~17% of the doses administered to date.
A second FDA document said that of the potential pericarditis cases, "six reports involved recurrent pericarditis. In five of these cases, the prior episode of pericarditis was reported to have occurred following an mRNA COVID-19 vaccine." That means that six of the people had already experienced pericarditis before, and five of them had recently had it after getting an RNA vaccine. It's possible that if their hearts had not recently been negatively affected by RNA doses, the Novavax vaccine would have had no correlation with pericarditis ... just like it had no correlation in all of the other countries. Here is a link to the document:
3) Novavax issued a statement to debunk media reports, though it wasn't as widely covered as the myocarditis claims
On Friday afternoon Novavax debunked the claims of a causal link to myocarditis. Here is the press release:
Throughout the pandemic, as publicly available vaccines have been administered, there have been numerous investigations into findings related to myocarditis. We have learned that we can expect to see natural background events of myocarditis in any sufficiently large database, and that young males are at higher risk. Myocarditis is most often caused by nonspecific viral infections.
The data from our placebo-controlled studies show that overall, in our clinical development program, the rate of myocarditis was balanced between the vaccine and placebo arms (0.007% and 0.005%). Furthermore, in the post-crossover portions of our studies, the cases we have seen are all within the expected rate.
Based on our interpretation of all the clinical data supporting NVX-CoV2373, including over 50,000 participants in clinical trials, we believe there is insufficient evidence to establish a causal relationship. We will continue to monitor all adverse events, including myocarditis and pericarditis.
The majority of articles were written before Novavax issued the statement. Most of those news outlets did not do follow-up articles about the Novavax rebuttal. So it may take a couple of days or a couple of weeks for the information to become better known. Here is a link to the statement:
4) Analyst from B Riley reiterates $181 price target, says there is "minimal to no risk" of not receiving EUA in the US, expects almost unanimous FDA vote in favor of Novavax.
He said he expects an almost unanimous vote in favor of Novavax authorization. Here are excerpts from his note:
As previously noted (5/24 panel preview note), there remains minimal to no risk to the scientific and clinical data package making a compelling case supporting an almost unanimously positive panel vote by VRBPAC committee members; of note, the EUA voting question is identical as previously used for mRNA vaccines' EUAs, i.e., “Based on the totality of scientific evidence available, do the benefits of the Novavax COVID-19 Vaccine when administered as a 2-dose series outweigh its risks for use in individuals 18 years of age and older?”
• FDA states in its review that the totality of submitted safety and effectiveness Study 301 (PREVENT-19) data package (n=29k+) meets the Agency’s expectations, as stated in FDA’s official Guidance on Development and Licensure of Vaccines to Prevent COVID19 for efficacy....
We also note FDA's favorable review of NVX-CoV2373 local and systemic reactogenicity profile, which we believe has an important role to play in LT real-world adoption, including as a booster and as COVID/flu combination product. .... Similarly, Novavax’s briefing document primarily focuses on clinical modules submitted, primarily aimed at the focus of the VRBPAC panel, suggesting that Chemistry, Manufacturing, and Controls (CMC) data package review is likely beyond the scope for 6/7 panel discussions. The company believes to have provided adequate and comprehensive analytical comparability assessment supporting quality comparability of the vaccine product intended for use under EUA (manufactured at SRII) to the vaccine product evaluated in clinical trial (manufactured at Par Sterile Products, Inc) that provides the key data to support the vaccine’s safety and effectiveness.
• Deeper dive into the myocarditis controversy. In the briefing document, 7 cases of myocarditis/pericarditis are reported from Study 301 (US/MEX, 2:1 randomization) and Study 302 (UK). Note, there were only two cases of myocarditis/pericarditis reported from Study 302, which were discussed in the EMA CHMP assessment report (link). For the five cases of myocarditis/pericarditis reported from Study 301, but not discussed in the EMA CHMP assessment report, one case was reported in the placebo group (72 days post dose 2 of placebo vaccination), 1 case was reported 3 days after booster (dose 3), and one case was reported 28 days after dose 1, in conjunction with COVID diagnosis. For the remaining 2 cases from Study 301, in FDA's opinion, 1 case could be linked to acute rheumatic fever and nonrheumatic streptococcal myocarditis, while the last 1 case lacks a clear alternative etiology, thus supporting a concern for a causal relationship to NVAX’s vaccine.
5) Cowen's analyst reiterates Outperform rating and a $150 price target for Novavax
Here is a clip about the Cowen's analyst who reiterates his buy recommendation:
The analyst comments " Overall, we believe the briefing documents suggest that the vaccine meets all the requirements for approval and we expect a positive vote at next week's meeting. .... Novavax has disclosed that the FDA has recently completed their on-site inspection of Serum's manufacturing facility in India which appeared to be one of the last gating items to approval of the CMC package. ....
As for the near-term impact of the potential EUA approval, recall, as part of the OWS funding, Novavax has already committed to supplying the U.S. government with 100MM+ doses of Nuvaxovid, and, therefore, we do not expect that it will have any meaningful near-term revenue implications. However, we do believe this potential approval will remove a major overhang for the stock as it would finally allow Novavax to establish their presence on the U.S. market. Importantly, Nuvaxovid's third-dose booster data suggest strong protection against both major Omicron variants (BA.1 and BA.2) and the company is running Omicron monovalent and bi-valent studies that could support a strain-switch authorization ahead of the fall (topline results expected in Q3)."
6) Jefferies analyst reiterates $190 price target, and expect the FDA committee's review will be positive
Here is a clip from a news article:
Jefferies analyst Roger Song, who also rates Novavax a buy, said he expects the committee’s review to be positive and nothing in the documents is really a “deal breaker.” ....
Analysts remain mostly bullish with price targets implying the shares could rally more than 230% over the next 12 months. Meanwhile, the company’s jab has been authorized for use in other countries, including the UK and Japan.
7) Future Covid booster shots will likely need fresh formulations as new coronavirus variants of concern will continue to emerge probably every 4 to 7 months
This is written by a post-doctoral fellow who the US NIH funds and helped work on the Moderna and J & J vaccines. He points out that new variants have emerged to become dominant every 4 to 7 months, which will most likely continue to be the case. His phrasing is even stronger: "There's no reason to think" the trend of new dominant variants will change every 4-7 months. Here are the relevant excerpts from an article by him:
I often get asked how frequently, or infrequently, I think people are likely to need COVID-19 booster shots in the future. No one has a crystal ball to see which SARS-CoV-2 variant will come next or how good future variants will be at evading vaccine immunity. But looking to other respiratory viral foes that have troubled humanity for a while can suggest what the future could look like. ....
As SARS-CoV-2 continues to evolve and is likely to become endemic, it is possible people may need periodic booster shots for the foreseeable future. I suspect scientists will eventually need to update the COVID-19 vaccine to take on newer variants, as they do for flu. ....
Over the course of the COVID-19 pandemic, a new SARS-CoV-2 variant of concern has emerged and dominated transmission in a series of contagion waves every four to seven months. Almost like clockwork, the D614G variant emerged in the spring of 2020 and overtook the original SARS-CoV-2 outbreak strain. In late 2020 and early 2021, the alpha variant emerged and dominated transmission. In mid-2021, the delta variant overtook alpha and then dominated transmission until it was displaced by the omicron variant at the end of 2021.
There’s no reason to think this trend won’t continue. In the coming months, the world may see a dominant descendant of the various omicron subvariants. And it’s certainly possible a new variant will emerge from a nondominant pool of SARS-CoV-2, which is how omicron itself came to be.
Current booster shots are simply additional doses of the vaccines based on the outbreak SARS-CoV-2 virus strain that has long been extinct. The coronavirus variants have changed a lot from the original virus, which doesn’t bode well for continued vaccine efficacy. The idea of tailor-made annual shots – like the flu vaccine – sounds appealing. The problem is that scientists haven’t yet been able to predict what the next SARS-CoV-2 variant will be with any degree of confidence. ....
Yes, the dominant SARS-CoV-2 variants in the upcoming fall and winter seasons may look different from the omicron subvariants currently circulating. But an updated booster that more closely resembles today’s omicron subvariants, coupled with the immunity people already have from the first vaccines, will likely offer better protection going forward. It might require less frequent boosting – at least as long as omicron sublineages continue to dominate.
The Food and Drug Administration is set to meet in the coming weeks to decide what the fall boosters should be in time for manufacturers to produce the shots. ....
8) Novavax executive says the FDA has already inspected the SII factory, and expects FDA authorization soon
Here are a few excerpts from an article about an interview with a Novavax executive:
Chief Commercial Officer John Trizzino told Yahoo Finance in an exclusive interview Wednesday that the company is optimistic about the upcoming meeting. ....
Trizzino said the FDA has now completed inspection at the Serum Institute, and the doses for the U.S. market, at least initially, will be coming from India.
"They've built out capacity for us over the last couple of years," Trizzino said of SII.
Doses from that facility have been sent to Europe, where Novavax also has a manufacturing site in the Czech Republic, as well as to Australia and Canada. For 2022, South Korea's SK bioscience and the Czech site will be the manufacturing sources, along with Serum, Trizzino said.
Novavax has said it is eyeing the vaccine hesitant, especially those who are wary of the newer mRNA technology, such as Pfizer (PFE)/BioNTech (BNTX) and Moderna (MRNA), or of the rare side effects associated with adenovirus vaccines like AstraZeneca and Johnson & Johnson (JNJ).
What the FDA and CDC decide about the two-dose recombinant protein vaccine will determine the company's fate for the year.
"I think we're now in a position to have a successful '22," Trizzino said, noting the year will be foundational for the company.
"We believe we are going to have sustainable revenue generation and be an important part of annual revaccination for COVID for the foreseeable future," he added.
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