Vaccines Development

By pjain      Published May 18, 2020, 6:52 p.m. in blog Health   

Part of Germ Theory Series

Public Perceptions of Vaccines

Testing, Regulation and Approval of Vaccines

Fears of Vaccines causing ADHD and Worse

Myths of Vaccines

Problem: Vaccine

10+ years to research, develop, safety and efficacy and approve

Vaccines typically take ten to fifteen years of research and testing.

Why does it take so long to develop?

The Covid-19 pandemic is a nightmare, as no one wants to wait four years for a vaccine, while millions die and economies remain paralyzed.

High Failure Rates

And only six percent of the projects that scientists launch reach the finish line.

This is even lower than the public trials which have 10% chance of success. 37% fail Phase 1 69% fail Phase 2 42% fail Phase 3 15% fail FDA New Drug application procedure

Coronavirus common family may help find Covid-19

The outbreaks of SARS and MERS, which are also caused by coronaviruses, spurred lots of research. SARS and SARS-CoV-2, the virus that causes Covid-19, are roughly 80 percent identical, and both use so-called spike proteins to grab onto a specific receptor found on cells in human lungs.

Coronavirus common family in which Covid-19 lies (after MERS/SARS learning) helped scientists developed a test for Covid-19 quickly. - NIH.

Mutation of Base Disease - Flu of the Year!

  • HIV mutates a LOT, and has made a vaccine search 50+ years if it ever emerges.

Covid supposedly has a few stable strains and doesn't appear to mutate significantly and exists within a family of familiar respiratory viruses.

I Academic R&D Life Sciences - 18 months typical

Advanced Genetic Sequencing in Vaccine Development

Mutation of Base Disease - Flu of the Year!

  • HIV mutates a LOT, and has made a vaccine search 50+ years if it ever emerges.

  • While flus do mutate into many strains - all common under Coronavirus category, it is possible to rapidly tweak their vaccines, hence the term - Flu of the Year vaccines for them still have a 60%+ efficacy. This is why insurers pay for hundreds of millions of doses per year throughout the world especially for vulnerable, even if not 100% effective.

Covid supposedly has a few stable strains and doesn't appear to mutate significantly and exists within a family of familiar respiratory viruses.

II Pre-clinical Development - 24 months typical

III Safety

Phase 1 Trials - 6 months typical

Phase 2 Trials - 12 months typical

Phase 3 Trials - 12 months typical

Speedup How and Risks

Accelerated R&D can miss side-effects

ANY form of accelerated testing runs the risk of missing potential side effects.

  • A vaccine for dengue fever, and one for SARS that never reached the market, were abandoned after making some people more susceptible to severe forms of the diseases, not less.

Greed and Rush to Test can be highly unethical

  • The Wuhan institute was involved in a 2018 scandal in which ineffective vaccines for diphtheria, tetanus, whooping cough and other conditions were injected into hundreds of thousands of babies.

Parallel Safety and Efficacy Trials of R&D

are combining trials that used to be carried out one after the other. They are pushing their formulations into production, despite the risk that the trials will fail, leaving them with millions of useless doses.

Testing the Safety

Vaccine should be shown to be safe before testing how well it works.

Challenge trials - Test Vaccine Candidates in Human Volunteers

Challenge trials were used in the early days of vaccine research.

However now are carried out under strict conditions and only for illnesses, like flu and malaria, that have established treatments.

NYU researchers have proposed infecting vaccinated volunteers with the coronavirus — the method known as challenge trials. The procedure might cut months or years off the development but would put test subjects at risk.

For young and healthy, Covid-19 morbidity is very very low, and fatalities are close to zero. Also, these volunteers are likely to be exposed eventually anyway as estimates are 50-70% of the "herd" will eventually be infected anyway, unlike malaria, etc.

  • The <0.1% chance of death of volunteer with "normal" Covid virus is a tradeoff against even a few weeks or years earlier vaccine.
  • The risk of delays is also high, with thousands dying for every week is measured against challenge human risks- PDF

  • However, due to so little being known (less than few months) about Covid-19 reinfection and true recovery, there is a huge ethical risk. Truly informed consent, even by willing volunteers, may not be possible. Even medical experts do not yet know all the effects of the virus. Those who have appeared to recover might still face future problems.

  • In US Congress a bipartisan group of 35 lawmakers to sign a letter asking regulators to approve such trials.

  • A website, 1daysooner.org, say they have signed up more than 9,100 potential volunteers from 52 countries.

Testing the Safety

Pilot to Scaling up Manufacturing R&D, Building Factories - 3-4 years

The challenge - Early but hard to make?

“Let’s say we get one vaccine quickly but we can only get two million doses of it at the end of next year ..And another vaccine, just as effective, comes three months later but we can make a billion doses. Who won that race?” - Bill and Melinda Gates Foundation’s vaccine development program.

Push Manufacturing R&D - Multiple Formulations into scaling up Production to be ready

Manufacturing at Scale with Regulated Safety/Efficacy QA - 2 years

Manufacturing Prowess vs Best Vaccine

Labor intensive Process to Make Vaccines

FDA approval and ongoing regulation - 1 year

Economics of Vaccine Manufacturing

In or out Selling to Doctors and Insurer Formularies - gives Big Pharmas an EDGE!

FDA "regulation" and blocks is one reason preventing India and China from directly branded

Low Profit - Big Pharma in West Import and "Private label" for 90%+ of margins

Fear of Unlimited Torte liability a key risk

  • By private labeling

Big Pharma Business Majors, Monopolies and Government Nexus

USA Government making Noise "for America First"!

Mr. Trump said he was personally in charge of “Operation Warp Speed” to get 300 million doses into American arms by January.

China sees HUGE LEAP and Market share grab

The most promising clinical trial in China is financed by the government.

--- History of Vaccines

1967 Mumps Dr. Hilleman

In March 1963 Dr. Hilleman's daughter got sick with mumps, and her father was a vaccine researcher. He promptly got a frozen swab of her throat and got to work weakening her viruses until they could serve as a mumps vaccine. In 1967, it was approved by the F.D.A.

Dr. Hilleman still holds the record for the quickest delivery of a vaccine from the lab to the clinic.

Varicella - 28 years

FluMist 28 years

HPV 15 years

Rotavirus 15 years

Pediatric Anti-virus 11 years

2030+ HIV 50+ Years - no Vaccine in Sight!

The highly mutating HIV virus has made search for a vaccine, actively tried for since 1980s, really hard.

After nearly 40 years of work, here is what we have to show for our vaccine efforts: a few Phase 3 clinical trials, one of which actually made the disease worse, and another with a success rate of just 30 percent. - NYTimes

Now unlikely before 2030 or later, putting the timeline at around 50 years.

In just a few months of 2020 deaths from Covid-19 in the US at 65,000+ have crossed the total HIV/AIDS deaths per year.

The exponential rise from early 1980s HIV/AIDS deaths per year. throughout for 15+ years the peaking at 42,000/year in 1994, 1995. Basically simple use of condoms and widely available antibody testing took 15 years to take effect.

But then it fell dramatically as these public policy and education measured kicked in just 2 years.

Then researchers developed a litany of antiviral drugs that lowered the death rate and improved health outcomes for people living with AIDS. Today’s drugs can lower the viral load in an H.I.V.-positive person so the virus can’t be transmitted through sex.

By 1998 it just declined exponentially to 5000 deaths/year. So while there were millions of HIV positives, the disease itself was rarely progressing as before. This likely was due to antivirals that prevented progression.


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