There is a wildly statistically-significant skew in the death rate from Covid-19 vaccines by lot number.

https://market-ticker.org/akcs-www?post=244109

Swedish Professor Says 5 Shots of COVID Vaccine May be Necessary

https://summit.news/2021/08/06/swedish-professor-says-5-shots-of-covid-vaccine-may-be-necessary/

"This Is Worrying Me Quite A Bit": mRNA Vaccine Inventor Shares Viral Thread Showing COVID Surge In Most-Vaxxed Countries

https://www.zerohedge.com/covid-19/worrying-me-quite-bit-mrna-vaccine-inventor-shares-viral-thread-showing-covid-surge-most

Taking (partial) profits

Today is why we take partial profits, while letting the rest ride.

Sinovac Biotech (SVA) dropped $2 down to the $9's. A friend I helped sold out yesterday at the peak at $11.25--most of us sold out in the $9's Friday. Not bad given we bought in the $4's barely more than a month ago.

It is impossible to buy at the absolute low and sell at the absolute high--no one has a crystal ball (although my friend's fortuitous exit was near the peak). However, we can buy lower and sell higher. Now that we're playing with house money, we can focus on other opportunities without getting emotionally attached with one winner.

Having said that, this swine flu play is hardly over. Those of us who got in back in May are REALLY doing well, waiting for more breakouts to the upside--again, with house money.

On a related note, SVA received a commitment of orders from South Korea today, in addition to receiving approval for their flu vaccine from the Chinese State Food and Drug Administration (SFDA) yesterday.

http://finance.yahoo.com/news/Sinovac-Announces-Supply-prnews-1032672347.html?x=0&.v=24

NVAX shares continue steady advance

Shares of Novavax, a virus-like particle (VLP) vaccine manufacturer, continued its steady climb today amid continuing concerns about the mutation influenza strains. FDA approval is several years away, but NVAX's novel approach to manufacturing recombinant vaccines has given them contracts to work with the National Institute of Health (NIH) and commercial commitments in India (with parrtner Cadila) and Spain (with partner Rovi).

http://www.scienceprogress.org/2009/08/influenza-vaccine/

NVAX's VLP manufacturing platform accelerates vaccine production, reducing ramp up time from 6 - 8 months to 4 weeks. Facilities cost are also reduced by 90%. Yields are increased due to elimination of egg-based manufacturing process used by traditional vaccine makers. Most importantly, the VLP process could potentially enable the production of a "super vaccine", which provides immunogenicity for all mutated strains of influenza.

Disclosure: I am long NVAX shares.

Shares of SVA surge

Sinovac shares soared over 50% this morning, as the Chinese State Food and Drug Administration (SFDA) approved its swine flu vaccine.

http://finance.yahoo.com/news/Chinese-biotech-Sinovac-gets-apf-212124857.html?x=0&.v=1

My investment thesis a few weeks ago was that they would receive an order for several million doses from the city of Beijing alone, with more to come from other provinces. Since then, they have received a commitment for 10 million doses from Mexico, as well as distribution rights for the Philippines.

The Chinese domestic population alone provides a huge market, and since Sinovac has already run human clinical trials demonstrating safety and efficacy for their flu vacccines, more orders should arrive from other countries, especially in neighboring Asia.

Disclosure: I am long SVA shares, and took a profit of over 100% on 25% of my original holdings.

Swine flu portfolio rally

Shares of BCRX, NVAX, SVA, HEB, and APT all increased double-digit percentages today. I keep expecting the overall market to roll over and have protective puts in place--hence, the hedges keep eroding in value. But I am not complaining, given triple digit gains on the aforementioned stocks.

Exit strategies for longs need to be in place. But after polling several experts in the field, the swine flu will be worse than general public expectations. Also, very few understand the five vaccines and the anti-virals available, either approved or under Emergency Use Authorization review. Unless, of course, they've been reading these blogs for a few months (pardon the temporary lapse in modesty).

The most recent update is that egg-based vaccines won't be available until October, due to lower than expected yields. With a 21-day duration between doses, and one more week thereafter before immunogenicity kicks in, most students and young adults won't be immunized until November at the earliest. As noted before, with schools already in session, the swine flu will peak in October, rendering many vaccines useless among the targeted population.

Anti-virals will have to step in, even though Tamiflu has tolerability as well as efficacy issues due to resistance. Inhaled Relenza has limitations, so intravenously administered Peramivir has BCRX longs excited about an imminent EUA stockpiling order.

Good luck to all longs, and good luck to those who will become infected with the novel H1N1 virus.

Disclosure: Long shares in BCRX, NVAX, SVA, HEB, and APT.

NVAX and SVA swine flu vaccines are effective

Shares of NVAX and SVA rose approximately 10% this morning on positive results of their respective swine flu vaccines. NVAX's VLP vaccine immunized ferrets from the flu, while the SVA egg-based vaccine displayed immunogenicity among humans.

http://www.reuters.com/article/marketsNews/idINN1834168720090818?rpc=44

NVAX has multiple partnership agreements with India's Cadila and Spain's Rovi to manufacture the VLP vaccine for Asian, European, and Latin American countries. NVAX is also working with the NIH and FDA in clinical-stage trials in the US.

SVA has an order for a minimum of 10 million doses to cover Beijing, but will likely garner additional orders for domestic Chinese provinces as well as other Asian countries, including a distribution deal for the Philippines.

BCRX and NVAX receive positive news

Leerink Swann, an investment bank specializing in biotech and life science companies, upgraded their price target on BCRX from $5 to $10, on an estimated Emergency Use Authorization order of $394 million for US stockpiling of the anti-viral Peramivir. The report was curious in the exact amount of $394, as the specificity could be a telegraph that an order is imminent. In any case, longs have been anticipating EUA for weeks, so the waiting game continues, as longs and shorts battle for positioning.

NVAX received good news this morning, according to an article in Indian Times. Cadila, a NVAX partner for their vaccine-like particle (VLP) flu vaccine, announced they are the first pharma company to produce a vaccine for the novel H1N1 virus in India. NVAX, in addition to receiving milestone payments, will receive 20% royalties on sales of the vaccine in India, meaning revenue from the Cadila partnership will go directly to NVAX's bottom line, as Cadila picks up all clinical development costs. Approval is expected by the end of this year. See previous blogs for NVAX value proposition and our investment thesis, mainly higher vaccine yields, faster vaccine production, and lower in-border manufacturing costs. All of these benefits are due to not needing eggs to produce the VLP vaccine. Under- and un-developed countries will greatly benefit due to faster ramp and lower cost structure, as well as the ability to control domestic manufacturing capacity. They won't be held hostage to foreign healthcare resources.

In fact, in a bit of irony, with India fast-tracking NVAX's VLP vaccine, the US may be on the outside looking in if vaccine production falls short. That would be a travesty considering NVAX is a US supplier of vaccines. This is another shameful example of the FDA dragging their feet, partly due to insidious pressure from incumbent big pharmaceutical companies to impede progress of promising competitive solutions from innovative upstarts like NVAX.

APT and SVA

I opened up a position in APT a week and a half ago, as they make a particularly effective N-95 protection mask against communicable diseases.

http://finance.yahoo.com/news/Swine-Flu-Masks-Prevention-or-indie-3995316474.html?x=0&.v=1

Based on the SARS scare, shares shot up for two quarters. This pandemic flu, while not having nearly the high death rates as SARS, is spreading much faster than other pandemics, hence triggering my buy order.

SVA is a Chinese vaccine and hepatitis drug manufacturer. It is already profitable, unlike its US counterparts still in the clinical stage. The Chinese domestic market is huge, and SVA should be able to secure a larger order than the projected one for 10 million doses (5 million people). Even at that conservative number, and estimate of $5 per dose, revenue projects to $50 million annually. This places a buy out offer price of $250 million, which yields a price per share of $6, based on 43 million outstanding shares. At a current price of $4.99, shareholders get the rest of the company (hepatitis drugs) for free. Add in the distribution deal for the Philippines, and other potential orders from other Asian countries, and SVA has some serious upside.

Disclosure: I have long positions in APT and SVA.

NVAX

NVAX, a long-term influenza play, surged again today, despite no news. An FDA vaccine committee meeting is occurring today, but I don't expect any orders or EUA to come out of it. Without any major catalysts in the near-term horizon, I decided to take some profits, after effectively doubling my money in two months. I will leave the rest on the table as NVAX VLP technology gains traction in Spain and Indian, and potentially with the rest of the world. The NVAX value proposition is a faster time to vaccine manufacturing, higher yields, and reduced manufacturing cost from disposable systems.

Other swine flu companies are consolidating after a huge run up. I anticipate another leg up as awareness of its virulence gains media attention. It's all house money at this point, so I will let the market run its course into the fall flu season.

Mortality rates from swine flu

The FDA Vaccine Advisory Committee had a meeting yesterday, and according to the latest data, 5 - 9% of confirmed H1N1 cases required hospitalization, with approximately half of them dying. That equates to a 2.5 - 4.5% lethal rate.

In Mexico, 6% of confirmed cases required hospitalization, and 46% died, which yields a 3% lethal rate, in line with US data.

http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/VaccinesandRelatedBiologicalProductsAdvisoryCommittee/UCM172424.pdf

According to the CDC:

Each flu season is unique, but it is estimated that, on average, approximately 5% to 20% of U.S. residents get the flu, and more than 200,000 persons are hospitalized for flu-related complications each year. About 36,000 Americans die on average per year from the complications of flu

.

Extrapolating those numbers, 15 million to 60 million Americans contract the seasonal flu every year. Of those, 1.3% to 0.3% require hospitalization. Of those hospitalized, 18% will die, on average. The lethal rate is 0.24% to 0.06%.

By contrast, with the swine flu, based on a worst-case scenario of 100 million Americans (33%) contracting the swine flu, up to 9 million will require hospitalization, of which 4.5 million will perish. That's a 125-fold increase in deaths from the swine flu this winter season.

We won't know what the actual outcome will be yet, but the consensus among world health officials is that this novel H1N1 virus is spreading faster than any other pandemic influenza in history. While not especially lethal, it is more lethal than most seasonal influenza viruses.

HEB

HEB shares dramatically dropped $0.92 to $2.40, giving up all the gains from the past several days. The conference call update on swine flu initiatives worldwide didn't impress investors, as they focused on the delays in FDA approval for Ampligen as a treatment for Chronic Fatigue Syndrome. Days like today are exactly why one should take partial profits on recent large gains, which we did yesterday. As this is all "house" money, I can afford to wait for further developments on either the CFS or swine flu adjuvant front.

BCRX and NVAX share prices were up modestly today after large gains in previous trading sessions, waiting in anticipation of tomorrow's FDA vaccine advisory committee meeting. Both are waiting for pending positive news on Emergency Use Authorization, which will allow them to manufacture doses for the national stockpile. NVAX's VLP technology cuts down the time to manufacture vaccines, which is becoming increasingly urgent as the pending swine flu season is expected in September when schools re-open.

BCRX's Peramivir is not a vaccine, but an anti-viral treatment that reduces the symptoms of the flu and shortens recovery time. EUA is expected for intravenous use in severe cases requiring hospitalization.

Both NVAX and BCRX are working with health officials worldwide, with especially intense clinical activity being performed in Japan and the US.

Swine flu plays resurface ahead of next FDA vaccine meeting

BioCryst Pharmaceuticals (BCRX) gapped up again 22% from yesterday's close of $6.21 to $7.58 today, up 22%, while Hemispherx Biopharmaceuticals surged almost 33% from $2.49 to $3.31. Both are up triple digits since we bought them in May (see June 4, 2009 "Swine flu revisited" blog).

BCRX's Peramivir is an effective intravenous anti-viral against seasonal flu, avian flu, and the latest swine flu (H1N1), shown to reduce flu symptoms in Phase III trials conducted by Japanese partner Shionogi. BCRX is also waiting for Emergency Use Authorization (EUA) by the FDA for severe cases requiring hospitalization. The EUA is required since Peramivir is not approved by the FDA. Peramivir has shown at least equal efficacy against the flu when compared to Roche's Tamiflu anti-viral in clinical trials.

HEB is having a conference call tomorrow to update the investment and medical communities on their clinical developments for Ampligen, a flu adjuvant. Studies have been performed worldwide for use of Ampligen as a booster alongside existing vaccines. Ampligen is also under FDA review for approval as a treatment for Chronic Fatigue Syndrome.

Novavax (NVAX) ended today's session at $3.19, up from $3.02. They also named John Trizzino Senior VP of International and Government alliances, in a sign that they are intensifying efforts with government agencies worldwide on getting approved for their vaccine-line particle (VLP) platform. With VLP, the time to manufacture a vaccine is cut in half--approximately 10-12 weeks, and yields are higher because they don't require egg-based cultures. Fixed costs are also lower due to disposable manufacturing systems.

This Thursday, July 23, the FDA Vaccine and Related Biological Products Advisory Committee will meet with vendors to discuss vaccines against the H1N1 virus: http://www.fda.gov/AdvisoryCommittees/Calendar/ucm170908.htm

This meeting is a sequel to the National Biodefense Science Board (NBSB) meeting held last month (see July 20, 2009 "BCRX potential" blog). The questions held at the NBSB will hopefully be answered this Thursday during the FDA Vaccine AC meeting. Shares of all 3 aforementioned companies jumped in anticipation of positive results.

As mentioned in previous blogs, the World Health Organization (WHO) raised the pandemic alert in June to Phase 6--the highest level possible, which last occurred 41 years ago. The foregone conclusion is that the H1N1 is spreading faster than previous pandemic flus. By the time it hits the US hard in the fall, it is estimated that 1 out of 3 Americans will contract the virus. So far, the mortality rate is lower than the avian flu, but should it mutate, the result strains could increase the severity as well as the virulence.

HEB

HEB message boards are gettings tons of chatter, most of it garbage, but it's usually emblematic of a pivotal inflection point in the share price, either up or down. Longs are expecting FDA approval of Ampligen for treatment of Chronic Fatigue Syndrome (CFS), a recently diagnosed debilitating medical condition. Patients and doctors swear by Ampligen's efficacy, despite the disease being marginalized in the past by the mainstream medical community. Now that CFS is recognized by the FDA, Ampligen's approval as an orphan drug (there are no other CFS treatments approved simply because CFS wasn't formally recognized as a disease) should be a blockbuster, according to long investors.

Ampligen has also been deemed effective as an adjuvant to flu vaccines in Japan and other countries, so the share price has spiked up in the last month from depressed levels. It has also been effective in clinical trials for boosting the efficacy of cancer vaccines in clinical trials. As Dr. William Carter, CEO of HEB stated in an interview last night, which is causing the uproar: "We have multiple shots on goal." See the June 4 blog on the swine flu.

Doubters (and shorts) will point to HEB's checkered history of FDA non-approvals and share dilution (altho HEB does already have one commercially approved drug for Alferon).

The pumping and bashing will continue unabated over the weekend, and the old adage "volume before price" will inevitably be proven again, as HEB will continue its high price volatility going into Monday.

HEB is a risky and volatile play. Do your due diligence. This is not a recommendation.

Disclosure: I am long HEB.