National Institutes of Health Director Dr. Francis Collins and National Institute of Allergy and Infectious Diseases Director Dr. Anthony Fauci meet with Bill Gates of the Bill and Melinda Gates Foundation in June 2017 at NIH.

COVID-19 Meltdown and Pharma’s Big Money Win

by Barbara Loe Fisher
The Vaccine Reaction

Dr. Anthony Fauci, director of the National Institute for Allergy and Infectious Diseases (NIAID) told Americans on Apr. 1, 2020 that modeling reports suggested COVID-19 infections could eventually “kill 100,000 to 240,000 Americans,”^{1 2 3} which was considerably less than the worst case 1.7 million mortality figure the Centers for Disease Control and Prevention (CDC) talked about on Mar. 13,⁴ and a fraction of the doomsday 2.2 million mortality figure projected by a scientist at Imperial College London.^{5 6}

The next day, Fauci called for an all-state nationwide lockdown⁷ and CDC officials instructed Americans to cover their faces with cloth masks if they have to leave their homes to buy food or seek medical care.⁸

On Apr. 6, University of Washington modeling experts, who influenced the setting of current federal and state “social distancing” policies, lowered U.S. COVID-19 mortality estimates from the worst case 162,000 fatalities they predicted on Mar. 26 to about 82,000 deaths.^{9 10} Two days later, on Apr. 8, they lowered U.S. mortality estimates even further to 60,415 deaths by Aug. 4, but included the caveat “assuming full social distancing through May 2020.”¹¹

With the U.S. economy in meltdown, this week, Dr. Fauci warned that, until a COVID-19 vaccine is available, we have to prepare for a new normal. He said:¹²

If back to normal means acting like there never was a coronavirus problem, I don’t think that is going to happen until we have a situation where you can completely protect the population.

If you want to get to pre-coronavirus, that might never happen in the sense of the fact that the threat is there,” but I believe with the therapies that will be coming online and the fact that I feel confident that over a period of time, we will get a good vaccine, we will never have to get back to where we are right now.

COVID-19 Deaths by the Numbers

By Apr. 12, 2020, there had been nearly 22,000 COVID-19 related deaths reported in the U.S. population of 325 million people and over 110,000 deaths in a global population of 7.8 billion people.¹³ According to the CDC, most cases are asymptomatic or mild, including in children,¹⁴unless an individual has an underlying chronic health problem like asthma, obesity, diabetes, autoimmunity, immune suppression, high blood pressure, chronic obstructive pulmonary disease (COPD) or heart disease.^{15 16 17 18}

There are large mortality variations among different countries and similar wide variations in mortality among populations living in different states in the U.S.¹⁹

At least one study published on Apr. 5 has found that air pollution subjecting individuals to long term exposure to fine matter particulates greatly increases the risk for death from COVID-19, noting that,

The majority of the pre-existing conditions that increase the risk of death for COVID-19 are the same diseases that are affected by long-term exposure to air pollution.²⁰

A small increase in long-term exposure to PM_2.5 [fine particulate matter] leads to a large increase in COVID-19 death rate, with the magnitude of increase 20 times that observed for PM_2.5 and all-cause mortality. The study results underscore the importance of continuing to enforce existing air pollution regulations to protect human health both during and after the COVID-19 crisis.

A Mar. 30 report in The Lancet estimated the overall case fatality ratio in China has been 1.38 percent, but is substantially higher in those over 60 years old.²¹

Recent published data from the CDC also confirms that mortality in the U.S. is much higher among senior citizens over age 65, rising to 10 to 27 percent for those over age 85.²²

The CDC continues to state that individuals at higher risk for serious illness from COVID-19 infection are those over age 65 and “people of all ages with underlying medical conditions, particularly if not well controlled.”²³

U.S. COVID-19 Mortality Statistics: Science or Assumptions?

On Mar. 24, the Director of Division of Vital Statistics, National Center for Health Statistics (NCHS) operated by the CDC issued a COVID-19 memo Alert with Q&A instructions informing doctors and coroners that

“a newly-introduced ICD code [UO7.1 COVID-19] has been implemented to accurately capture mortality data for Coronavirus Disease 2019 (COVID-19) on death certificates.”

When determining the underlying cause of death listed on the death certificate, the memo states that:

The underlying cause [of death] depends upon what and where conditions are reported on the death certificate. However the rules for coding and selection of the underlying cause of death are expected to result in COVID-19 being the underlying cause more often than not.

CDC officials make it clear that on cases where the death certificate indicates uncertainty about the cause of death, there likely be no follow up and the death will be listed as COVID-19:

If a death certificate reports terms such as “probable COVID-19” or “likely COVID-19,” these terms would be assigned the new ICD code [UO7.1 COVID-19]. It is not likely that NCHS will follow up on these cases.

Finally, answering the question, “Should COVID-19” be reported on the death certificate only with a confirmed test?” the CDC’s memo emphasizes that lab confirmation of COVID-19 is unnecessary to list the cause of death as COVID-19 on the death certificate:

“COVID-19 should be reported on the death certificate for all decedents where the disease caused or is assumed to have caused or contributed to death.” [boldfaced text was boldfaced in the CDC’s Alert].

In an Apr. 9 NBC “Today Show” interview, Dr. Fauci was asked whether some deaths are being falsely counted as COVID-19 deaths when they are really due to other causes. He replied:²⁴

There’s absolutely no evidence that that’s the case at all. I think it falls under the category of something that’s been unfortunate―conspiracy theories that we hear about every time we have a crisis of any sort. There’s always this popping up of conspiracy theories. I think the deaths that we’re seeing are coronavirus deaths and the other deaths are not being counted as coronavirus deaths… I think there’s more of a chance of missing some that are really coronavirus deaths not being counted.

Economic and Social Meltdown Continues

More than two months after the World Health Organization (WHO) declared the outbreak of COVID-19 in China as a “Public Health Emergency of International Concern,”²⁵ which was followed the next day by the CDC’s Jan. 31 declaration of a national Public Health Emergency in the U.S.,²⁶ it appears that the government’s pandemic planning efforts spanning four decades failed to prepare federal and state health agencies to respond quickly,^{27 28 29 30 31} despite federal legislation ³² that ensured substantial annual congressional appropriations to the U.S. Department of Health and Human Services (DHHS) since 2006 for pandemic planning.^{33 34}

Right now, COVID-19 testing kits are slowly rolling into the states but in limited quantities,^{35 36} and health care workers are continuing to report critical shortages of personal protective equipment (PPE) and medical supplies.^{37 38 39}

With almost every state government following federal guidelines and either requesting or ordering residents to quarantine themselves at home – whether they are healthy or sick – families are facing unprecedented economic losses.⁴⁰

On Apr. 3, the U.S. Bureau of Labor Statistics (BLS) reported huge declines in employment in the leisure and hospitality industries – mainly in food and beverage – but also in healthcare, social assistance, professional and business services, retail trade, and construction.⁴¹

Unemployment in the U.S. rose by almost a full percentage point to 4.4 percent, the largest over-the-month rate increase since 1975, with the number of unemployed persons rising from 1.4 million to 7.1 million in March. The BLS report said the sharp unemployment increases reflects the “efforts to contain” the coronavirus in the U.S.

Lower income families without savings and dependent upon hourly wages and part-time work in service professions are hit especially hard.⁴² Understaffed social service support systems are struggling to cope with significant increases in depression, spousal and child abuse, and calls to suicide hotlines.^{43 44 45}

However, some scientists,^{46 47} doctors ⁴⁸ and politicians ⁴⁹ want quarantines to stay in effect beyond April 31, even though the managing director of the International Monetary Fund Kristalina Georgieva warned on Apr. 9 that the economic fallout of shutdowns is approaching that of the Great Depression.⁵⁰

We are still faced with extraordinary uncertainty about the depth and duration of this crisis. It is already clear, however, that global growth will turn sharply negative in 2020, as you will see in our World Economic Outlook next week. In fact, we anticipate the worst economic fallout since the Great Depression.

Bill Gates Calls for 10 Week Nationwide Shutdown and Certificates of Immunity Allowing Unrestricted Movement

In an OpEd in the Mar. 31 The Washington Post, Microsoft founder and philanthropist social reformer Bill Gates called for a nationwide federally enforced quarantine for all states that would last “10 weeks or more:”

Because people can travel freely across state lines, so can the virus. The country’s leaders need to be clear: Shutdown anywhere means shutdown everywhere. Until the case numbers start to go down across America—which could take 10 weeks or more—no one can continue business as usual or relax the shutdown.^{51 52}

Several days earlier in a TED interview, Gates talked about how the strict social distancing and quarantine measures in place in the U.S. are designed to prevent a majority of the U.S. population from being infected with and recovering from COVID-19, which confers natural immunity and contributes to herd immunity in human populations.

He also stated there will be a need for people to have “certificates” that prove they have either recovered from the infection or have been vaccinated once a vaccine is produced. He said:⁵³

Now we don’t want to have a lot of recovered people, you know. To be clear, we’re trying through the shutdown in the United States, to not get to one percent of the population infected. We’re well below that today, but with expotentiation you could get past that three million. I believe we will be able to avoid that with having this economic pain.

Eventually, what we’ll have to have is certificates of who is a recovered person, who’s a vaccinated person, because you don’t want people moving around the world where you’ll have some countries that won’t have it under control, sadly. You don’t want to completely block off the ability for people to go there and come back and move around.

Fauci Agrees with Gates: COVID-19 Natural Herd Immunity Not Wanted

At a Apr. 6, White House briefing of the Coronavirus Task Force, Dr. Fauci confirmed that strict social distancing and quarantine measures are at least partially in place to prevent populations from developing natural herd immunity. He said:⁵⁴

One issue that’s going to be important and it has to do with somewhat of a comparison, for example, with influenza. We go through multiple cycles of influenza [and] there’s always a degree of background immunity in a population. That will ultimately happen [with COVID-19] if we get a situation where we get back to normal. Now, I hope we don’t have so many people infected that we actually have that herd immunity, but I think it would have to be different than it is right now.

In an Apr. 9 interview on National Public Radio (NPR), Bill Gates returned to the message that some “social distancing” measures have to stay in place “until we get a vaccine that almost everybody’s had.” He said:

What I’m saying, what Dr. [Anthony] Fauci is saying, what some other experts are saying, there’s a great deal of consistency. We’re not sure yet which activities should be resumed, because until we get a vaccine that almost everybody’s had, the risk of a rebound will be there. …

As we follow the numbers into May and see if we can get them down to a very low level, then in parallel, this debate about which things have benefits to society and can be formatted so the infection risk is very low, which things should we resume? I do think manufacturing, construction, a lot of things we’ll do, but large public gatherings may have to wait until we have that vaccine.

Governments Make Fast Tracked COVID-19 Vaccines Main Priority

Immediately after the Jan. 30 WHO declaration that a novel coronavirus outbreak in China posed a “public health emergency of international concern,” press releases were issued by the Gates Foundation⁵⁵ and World Health Organization (WHO)⁵⁶ informing the world that experimental coronavirus vaccines already in development would be put on a fast track to licensure for global use.

On Mar. 9, WHO released its COVID-19 R&D roadmap that, according to BioWorld, had been endorsed by “400 experts” and included funding from the European Commission (37.5 million euros), German government (10 million euros) and an additional 46 million euros from the UK government, with 20 million euros going directly to the Coalition for Epidemic Preparedness (CEPI) for vaccine development. CEPI committed $100 million to speed up licensure of COVID-19 vaccines but said it was trying to raise $2B more to speed vaccines to market.⁵⁷

The WHO’s R&D plan stated there was an “urgent need” to fill in scientific knowledge gaps about the “basic biology” of COVID-19 infection and clinical evolution of COVID-19 and its epidemiology, as well as the need to develop appropriate animal models for research because some previous SARS and MERS vaccine studies in animals showed enhanced respiratory disease can occur in vaccinated animals after exposure to the live virus. The WHO roadmap stated,

“Evaluating the potential for enhanced disease in humans is critical before [vaccines] can be assessed through larger-scale studies.” ⁵⁸

By mid-March and early April, the WHO, National Institutes of Health,⁵⁹ universities, ⁶⁰ and global pharmaceutical corporations⁶¹ had announced development of more than 50 experimental COVID-19 vaccines.^{62 63} Using vitamin and supplement therapies or currently licensed prescription drugs^{64 65 66 67 68 69} has taken a back seat to an aggressive push to keep restrictive “social distancing” measures in place until fast tracked experimental vaccines are licensed.^{70 71 72}

Maintaining that the only solution to dealing with the new coronavirus is universal use of a new vaccine,^{73 74} this single solution approach guarantees even bigger profits in the exploding global vaccine market that has doubled over the past decade from $20B in 2010 ⁷⁵ to $42B in 2018. ⁷⁶Dominated by the UK’s GlaxoSmithKline, France’s Sanofi and U.S. drug giants Merck and Pfizer, the vaccine market is projected to double again by 2026 to over $93B.⁷⁷

There are already reports from Wall Street predicting big gains in Biotech stocks based on multiple companies developing COVID-19 vaccines and new drugs.⁷⁸ One company, Moderna, which is partnering with the National Institute of Allergy and Infectious Diseases (NIAID) headed by Dr. Fauci, has seen a 78 percent increase in its stock price since it announced in February that its experimental messenger RNA vaccine was ready for clinical trials.⁷⁹ The company’s CEO has become a new billionaire overnight.⁸⁰

Big Pharma Getting More Money to Deliver COVID-19 Vaccines by Late 2020 or Early 2021

Responding to the call by public health officials to lockdown the U.S. with in-home quarantines, Congress passed the CARES Act signed into law on Mar. 27, 2020 that will cost American taxpayers over two trillion dollars.

The federal legislation includes $27B for development of COVID-19 vaccines, drug therapies and purchase of pandemic medical supplies. The legislation did not include a cap placed on how much money drug companies can charge and profits they can make on the COVID-19 vaccines and drug therapies they develop with the use of money from the government.

Already, there are questions being raised about just how far the price gouging will go when those COVID-19 drugs and vaccines are licensed by the FDA and recommended by the CDC.⁸¹

On Mar. 30, the HHS Assistant Secretary of Preparedness and Response announced that the government is taking steps to

“speed the development and manufacturing of vaccines to prevent COVID-19.”⁸²

The same day, Johnson & Johnson issued a press release stating that the Biomedical Advanced Research and Development Authority (BARDA) had awarded J&J’s Janssen Pharmaceutical Companies $1B to establish new U.S. vaccine manufacturing capabilities and additional production capacity outside the U.S and produce a global supply of more than 1 billion doses of the COVID-19 vaccine using AdVac® and PER.C6® technologies.⁸³

J&J plans to initiate human clinical studies in September 2020 and deliver the first batches of vaccine for emergency use authorization in early 2021.⁸⁴

BARDA was created by Congress in 2006 under the Pandemic and All Hazards Preparedness Act,⁸⁵ legislation that has given billions of dollars to DHHS since then to develop “bioterrorism” and pandemic influenza vaccines.⁸⁶

That federal legislation also removed all civil liability from pharmaceutical companies for injuries and deaths caused by vaccines and drugs manufactured in response to declared public health emergencies, such as pandemics.⁸⁷

According to a Mar. 30 Reuters report, Moderna, Inc.

“also signed a deal with the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services. The arrangements are part of the federal government’s effort to encourage drugmakers to be able to produce massive amounts of COVID-19 vaccines even before any are proven to work.”⁸⁸

Earlier in March, the National Institute of Allergy and Infectious Diseases (NIAID) headed by Dr. Fauci issued a press release on Mar. 16 announcing that a Phase1 human clinical trial conducted by Kaiser Permanente Washington Health Research Institute in Seattle has begun to evaluate an experimental mRNA vaccine for COVID-19 (mRNA-1273) co-developed by NIAID scientists and scientists at Moderna, Inc, based in Cambridge, Massachusetts.

The Coalition for Epidemic Preparedness (CEPI) helped fund the manufacturing of the vaccine for the Phase 1 clinical trial.⁸⁹

Moderna and NIAID are conducting human trials of the experimental mRNA-1273 COVID-19 vaccine without first conducting animal trials, which has always been an important part of the vaccine licensing process.⁹⁰

On Mar. 30, Moderna stated that its COVID-19 vaccine might be read for emergency use in some people, including healthcare workers, by the fall of 2020:⁹¹

The Company further reported that while a commercially-available vaccine is not likely to be available for at least 12-18 months, it is possible that under emergency use, a vaccine could be available to some people, possibly including healthcare professionals, in the fall of 2020. Any emergency use would be subject to authorization by the appropriate regulatory agencies, based on the emergence of clinical data for mRNA-1273 that would support use of the vaccine prior to licensure.

An Apr. 3 Philadelphia Inquirer article trumpeting that “Coronavirus has created a new golden age for vaccines and Philly is at the heart of it,”⁹² pointed out at least part of the heavy financial investments the U.S. government has made in vaccine development through BARDA since 2006:

When the original BioShield funding ran out, Congress began a series of annual appropriations totaling about $1.5 billion a year to fund BARDA vaccine development efforts and to build up the emergency medical stockpile. A special $5 billion was appropriated for the multinational Ebola virus fight in 2015.

The [March 2020] CARES Act has multiplied those resources, splitting $27 billion between rebuilding the depleted medical stockpile and BARDA vaccine funding—on top of $6 billion appropriated for those purposes in the first anti-coronavirus bills last winter.

Experimental COVID-19 Vaccines Using Eight Different Platforms

Coronaviruses are a group of diverse, single-stranded, enveloped RNA viruses that cause a wide range of respiratory, gastrointestinal and neurologic illnesses with varying severity in animals and humans.

Most coronaviruses, including those causing the common cold, are not associated with significant mortality, with the exception of Severe Acute Respiratory Syndrome (SARS-CoV), which emerged in China in 2002, and the coronavirus causing Middle East Respiratory Syndrome (MERS-CoV), which was identified in Jordan and Saudi Arabia in 2012.⁹³

COVID-19 is referred to in the medical literature as severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) or COVID-19.⁹⁴

Drug companies and government agencies racing to be the first to license a COVID-19 vaccine, are using different technology platforms to create experimental vaccines: inactivated virus; attenuated virus; protein subunit; virus-like particle, DNA, RNA and non-replicating vector.⁹⁵

Traditional vaccines contain attenuated or inactivated viruses and bacteria or proteins, as well as adjuvants, such as aluminum, to stimulate an immune response that produces artificial immunity.

For example, older viral vaccines for smallpox and measles vaccine contain live attenuated viruses; injectable influenza vaccines contain inactivated viruses; the recombinant hepatitis B virus vaccine is a protein subunit vaccine, while the newer human papillomavirus (HPV) virus vaccine contains virus like particles.

For the past two decades, researchers have been experimenting with new technology platforms, notably ones that introduce foreign DNA and RNA into cells of the body, to develop experimental vaccines for SARS, MERS, HIV and other diseases but, so far, none have been proven effective and safe for humans.⁹⁶

DNA and mRNA Vaccines: Flying Blind into Uncharted Territory

Gene-based vaccines encode a viral protein from a pathogen (like COVID-19) in human DNA or mRNA. DNA vaccines deliver pieces of DNA into human cells to stimulate the immune system to create antibodies specific to pathogenic proteins without causing disease.

DNA vaccines require no culture or fermentation for production and no refrigeration after production because they are made in a lab using synthetic processes, and can be produced in large quantities for less money than traditional vaccines.⁹⁷

Messenger RNA (mRNA) vaccines inject human cells with mRNA, usually within lipid nanoparticles, to stimulate cells in the body to become manufacturers of viral proteins.^{98 99}

In March 2020, a virologist at Imperial College London told Chemistry World that one advantage of using mRNA technology to make vaccines for humans is that, “Rather than generating proteins in a manufacturing plant and purifying them, you are getting the muscle to do the job and make the protein itself.”¹⁰⁰

Like DNA vaccines, mRNA vaccines can be produced in the lab using faster and less expensive process than traditional vaccines. RNA vaccines can be delivered with syringes, nasal spray or needle-free into the skin (patches).

Although neither DNA or mRNA vaccines have been tested in large-scale clinical trials, an Apr. 3 article in Chemical and Engineering News highlights the breakneck speed at which COVID-19 vaccines “are moving new technologies from the computer and into the clinic at an unprecedented rate.”

What should be separate pre-licensure phases for proving safety and effectiveness – preclinical animal models, clinical testing, and manufacturing – are now “happening all at once.”¹⁰¹

• “It’s like building an airplane when you are flying,” said Inovio Pharmaceuticals CEO Joseph Kim.
• “They have been described as the vaccines of the future,” says Dan Barouch, Director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center. “However, they have not yet been pressure-tested… The COVID crisis is a great opportunity for those technologies to be pushed.”
• “It will be the first time that they will be tested in so many people,” says Wim Tiest, a former vaccine developer at GlaxoSmithKline now heading up a COVID-19 program at the Belgian mRNA vaccine company eTheRNA Immunotherapies.

But will spending lots of money to cut corners and speed up licensing of COVID-19 vaccines using experimental DNA and mRNA technology – or other types of new technology–end up putting millions of people at risk for vaccine failures and reactions leading to chronic illness?

There are nagging questions about DNA¹⁰² and mRNA ¹⁰³ vaccine platforms and they are not trivial. According to a 2011 article in Harvard College Global Health Review, DNA vaccine safety concerns include potential side effects as:¹⁰⁴

• “chronic inflammation because the vaccine continually stimulates the immune system to produce antibodies;”
• “possible integration of plasmid DNA into the body’s host genome, resulting in mutations, problems with DNA replication, triggering of autoimmune responses, and activation of cancer-causing genes;”

According to researchers at University of Pennsylvania and Duke University, mRNA vaccines also have potential safety issues:¹⁰⁵

• Local and systemic inflammation;
• Stimulation of auto-reactive antibodies;
• Induction of a potent type 1 inteferon responses, which have been associated with inflammation and potential autoimmunity;
• Presence of extracellular RNA, which may contribute to edema and pathogenic thrombus formation (blood clots).

Top COVID-19 Vaccine Candidates Being Tested

Following is a selection of companies identified by MarketWatch that are among those leading the race to be the first to get a COVID-19 vaccine licensed for global use:^{106 107}

Inovio Pharmaceuticals, Inc. (US). Inovio’s COVID-19 vaccine (INO-4800) is a DNA vaccine that will be tested in 30 clinical trials in the U.S., China and South Korea in April 2020. Headquartered in Pennsylvania, Inovio has partnered with Philadelphia’s Wistar Institute, Ology Bioservices, Inc. and Beijing Advaccine Biotechnology Co. in China ¹⁰⁸ with plans to have 1 million doses of the vaccine ready for further trials or “emergency use” by the end of 2020.

Inovio received a $5M grant from the Gates Foundation to test a delivery device for INO-4800 and a $9M grant from CEPI to accelerate development of the COVID-19 vaccine. In partnership with Florida-based Ology Bioservices, Inc, Inovio secured a $11.9M contract with the Department of Defense for upcoming clinical trials and potential manufacturing of the vaccine for military personnel in the future.¹⁰⁹

Describing Inovio’s DNA vaccine, Precision Vaccinations states:¹¹⁰

This one-of-a-kind platform delivers optimized DNA into cells, where it is translated into proteins that activate an individual’s immune system to generate a robust targeted T cell and antibody response. CELLECTRA uses a brief electrical pulse to open small pores in the cell reversibly to allow the plasmids to enter. Once inside the cell, the plasmids begin replicating, thereby strengthening the body’s own natural response mechanisms.

Johnson & Johnson, Inc. (U.S.) J&J is working with BARDA, which has awarded the company $1B, to develop on an adenovirus vectored COVID-19 vaccine using J&J’s Advac technology and PER.C6¹¹¹ (cell line derived by transformation of embryonic retinal epithelial cells with human adenovirus type 5 E1 region gene) for production.

Phase 1 clinical trials of the J&J vaccine are scheduled for September 2020 and the company is planning to have investigational doses of vaccine available for “emergency use” by early 2021.

Moderna, Inc. (U.S.) In partnership with the National Institute of Allergy and Infectious Diseases (NIAID), Moderna’s mRNA vaccine is being tested on adults in Phase 1 clinical trials in Seattle with funding from NIAID, BARDA and CEPI. Moderna plans to have vaccine doses available for “emergency use” by the end of 2020.

Pfizer, Inc. (U.S.) and BioNTech (Germany) In a joint venture with BioNTech, Pfizer will develop and distribute an mRNA vaccine produced by BioNTech (BNT-162), expected to enter clinical testing by the end of April 2020 in Germany and the U.S. BioNTech is also testing the vaccine in collaboration with Shanghai Fosun Pharmaceutical Group in China.

Dynavax Technologies Corp. (U.S.) and Clover Biopharmaceuticals (China) China’s Clover Biopharmaceuticals has developed a protein-based subunit coronavirus vaccine candidate (COVID-19 S-Trimer) and Dynavax, a California based biotech company, is providing technical expertise and the company’s proprietary toll-like receptor 9 (TLR9) agonist adjuvant, CpG 1018 for use in Clover’s COVID-19 vaccine.

Dynavax’s CpG 1018 is a synthetic oligonucleotide adjuvant that is used in recombinant hepatitis B vaccine Heplisav-B. Dynavax is also collaborating with Australia’s University of Queensland as part of a CEPI initiative to develop a COVID-19 vaccine.

GlaxoSmithKline plc (U.K.) and Clover Biopharmaceuticals, Inc. (China) GSK has an AS03 vaccine adjuvant system platform that it is making available to Australia’s University of Queensland and to Clover Biopharmaceuticals, Inc., a Chinese biotechnology company that will use GSK’s AS03 adjuvant in combination with a COVID-19 S-Trimer vaccine. S-Trimer is a trimeric SARS-CoV-2 spike (S)-protein subunit vaccine candidate.

Sanofi SA (France). Sanofi is working with BARDA to use its recombinant DNA platform to test a preclinical vaccine candidate for SARS to manufacture a COVID-19 vaccine. In 2017, Sanofi acquired Protein Sciences, which had been developing a SARS vaccine.

Novavax, Inc. (U.S.). Novavax’s COVID-19 vaccine candidate (NVX-CoV2373) is a stable, prefusion protein made using Novavax’ proprietary nanoparticle technology and the company’s proprietary Matrix-M™ adjuvant will be incorporated into it to stimulate high levels of neutralizing antibodies.¹¹² According to Novavax, Matrix-M is a sanponin-based adjuvant that contain purified saponin fractions mixed with synthetic cholesterol and a phospholipid to form stable particles that stimulate a strong immune response and “enhancing antigen presentation in the local lymph nodes.”¹¹³

Novavax has received $4M from CEPI to develop a COVID-19 vaccine and Emergent Biosolutions, Inc. has indicated it would support contract development and manufacturing of the vaccine. The company plans to start Phase 1 clinical studies by June.

CureVac AG (Germany). CureVac, a German biotech company, which has received 80 million euros in funding from the European Commission, has developed an mRNA vaccine for COVID-19. It is planning to test the vaccine in human clinical trials (Phase 1 and Phase 2) this summer and wants to skip Phase 3 trials so the vaccine can be on the market by this fall.¹¹⁴

Vaxart, Inc. (U.S.). Vaxart is a California based biotech company that has a partnership with Emergent Biosolutions, InC to develop Vaxart’s oral COVID-19 candidate. Based on Vaxart’s proprietary VAAST platform, the vaccine is a room temperature stable tablet that is swallowed and provides mucosal immunity.

Sweden Refused to Lockdown

Sweden, a country with a population of 10M people refused to lockdown its country because of COVID-19 despite heavy criticism. Although Sweden requested its citizens to stay home if sick and practice social distancing when possible, the government did not close businesses, primary schools, restaurants, shops, gyms and recreational facilities, which has prevented the country from suffering the kind of economic meltdown being experienced by most other countries.¹¹⁵

As of Apr. 10, 2020, Sweden has reported 870 deaths from COVID-19 and the nation’s public health agency reported that the numbers of confirmed infections are dropping.

Read the full article at TheVaccineReaction.org.

Comment on this article at VaccineImpact.com.

References

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