May 25 2020
Q: Scientist speaking on “60 minutes Australia” in the “Shot In The Dark” episode says “a coronavirus vaccine in just 12 months is “fake news"”. Separately, prof. Karol Sikora speaking on “This Morning” show by another Down Under station thinks that “we might not need a vaccine for COVID-19 ”. Thoughts?
A: Both may be correct. Here is why. Let’s look at the history of vaccine development. I included only vaccines available in the United States.
The first vaccine as we know it was introduced by British doctor Edward Jenner in 1796 for small pox;
It took almost 100 years before the next vaccine - for cholera was developed in 1884 by a Spaniard Jaume Ferran I Clua, while working in France ;
Two French scientists, Louis Pasteur and Émile Roux, developed the first rabies vaccination in 1885;
The first typhoid vaccines were developed in 1896 by a Brit Almroth Edward Wright, in collaboration with two Germans Richard Pfeiffer and Wilhelm Kolle;
Albert Calmette, a French physician and bacteriologist, and Camille Guérin, a veterinarian produced the first and only tuberculosis vaccine BCG in 1921 (Bacillus Calmette–Guérin vaccine);
The diphtheria vaccine was developed in 1923 by Gaston Ramon, a veterinarian at the Pasteur Institute in France, and, independently from Ramon, by a British physician Alexander Thomas Glenny;
The tetanus vaccine was developed in 1924 by Gaston Ramon;
The first effective pertussis vaccine was developed in 1932 by Americans Pearl Kendrick and Grace Eldering. Another American - Leila Denmark is also credited with independently developing the effective pertussis vaccine in 1933-34;
The Austrian-South African immunologist Max Sterne (1905–1997) developed an attenuated live anthrax animal vaccine in 1935;
A South-African Max Theiler, working with an American Hugh Smith at the Rockefeller Foundation introduced the first successful yellow fever vaccine in 1938;
Japanese Encephalitis vaccine was developed in late 1930s by BIKEN (the Japanese Research Foundation for Microbial Diseases) and KAKETSUKEN (The Chemo‐Sero‐Therapeutic Research Institute);
The first commercial influenza vaccine became available in the USA in 1945;
The first successful demonstration of polio vaccine was by a Polish-American Hilary Koprowski in 1950, with a live attenuated virus which people drank. This vaccine, however, was not approved in the United States. An inactivated polio vaccine, developed a few years later by an American Jonas Salk, came into use in 1955. A different, oral polio vaccine was developed by another Polish-American Albert Sabin and came into commercial use in 1961;
The first measles vaccine became available in 1963;
The first effective mumps vaccine Mumpsvax developed by an American Maurice Hilleman from the mumps virus infecting his five-year-old daughter, Jeryl Lynn Hilleman. was licensed by FDA in 1967. The Mumpsvax vaccine was recommended for routine use in the US in 1977;
Rubella vaccine was developed in 1969 by Americans Harry M. Meyer and Paul J. Parkman and their team;
Adenovirus vaccine was introduced in 1971;
Haemophilus influenzae type B vaccine was developed in 1977;
The first vaccine for pneumonia (Streptococcus pneumoniae) was developed in 1977;
The first vaccine for meningitis (Neisseria meningitidis) became available in 1978;
Hepatitis B vaccine was approved in the United States in 1981;
Varicella (chickenpox) vaccine first became commercially available in 1984;
Hepatitis A vaccine was approved in Europe in 1991, and the United States in 1995;
Rotavirus vaccine first became available in the United States in 2006;
The first HPV vaccine became available in 2006;
Herpes Zoster vaccine was approved by FDA in 2006.
Q: What about Ebola, malaria, Dengue fever and other vaccines?
A: Indeed, there are several vaccines approved outside of the United States:
Hepatitis E vaccine was approved in 2012 in China;
Enterovirus vaccine was approved in 2015 in China;
Malaria vaccine received “positive scientific opinion” from the European Medicine Agency in 2015. FDA did not recommend its use due to questionable efficacy;
Dengue fever vaccine was granted Brazil’s approval in 2015;
Ebola vaccine was granted “conditional approval” by the European Medicine Agency in 2019.
Q: How long it normally takes to develop a vaccine?
A: It took anywhere between 10 and 23 years to develop currently available vaccines. Notably, the 40 years of attempts to develop HIV vaccine yet to produce a viable candidate.
Dr. Why: I cannot resist mentioning that our “geniuses/heroes” Dr. Fauci and Dr. Birx led this project from its inception. Got the point?
Q: Why it takes so long?
A: Vaccine development includes multiple steps:
Antigen identification and production: 2-5 years;
Animal testing: 1-2 years;
Human clinical trials (phase I-III): 4-8 years;
Filing and licensing: 1-2 years;
Post-marketing surveillance: 2-5+ years.
Q: Why do we need post-marketing surveillance?
A: There are several reasons for this. The main are:
Vaccine safety is the main focus of post-marketing surveilance. Clinical trials usually involve between 15,000 to 100,000 subjects, while vaccine is offered to billions of subjects. It is impossible to extrapolate data from 100,000 subjects to approximately 7,500,000,000 subjects currently living (1:75,000);
The length of immunity induced by a vaccine can only be fully evaluated over a human life expectancy. As of 2018 the shortest life expectancy was in Central African Republic - 52.8 years, and the longest in Japan - 84.5 years. Therefore, if a newborn is vaccinated, it will take anywhere between 52 and 84 years to determine the true length of immunity.
Q: How are we able to produce new influenza vaccine every year?
A: Indeed, a new “seasonal” influenza vaccine is produced every year based on the mix of dominant viral strains from a year prior. Therefore, it takes at least 18 months to make it: 1 year of surveillance to determine mix of strains to be included and 6 months for actual vaccine development and start of production. Once produced, the vaccine is used until the next season, e.g. the total time needed to make and administer vaccine is 2.5 years.
The reason a “new” influenza vaccine can be produced in such a short period of time is that it is not really “new” but rather a modification of the prior year(s) vaccine and the whole process of manufacturing and approval is collapsed to make it to a new “season”, which means “lots of corners are cut” to make it happen.
The issue at hand: influenza vaccine uptake rarely exceeds 40% of population, and it is almost never more than 50% effective (protective). Sounds like a coin toss, isn’t it?
Q: Is there a way to shorten the time needed to develop SARS-CoV-2 vaccine?
A: Yes. There are several reasons vaccine can be made available faster than a historical minimum of 10 years:
Virus (antigen) identification was performed by China in January of 2020. The time for production is 6 months. The estimated time savings is 1-4 years;
Candidate vaccines for original SARS and MERS viruses can be recycled. The estimated time savings is 1 year;
Animal testing can be cut to 6 months - 1 year or skipped altogether. The estimated time savings is 1-2 years;
Human clinical trials (phase I-III). The phase I trials on volunteers have been ongoing for 2-3 months already. If each phase is cut by 1/2, the time savings is 2-4 years;
Filing and licensing can be cut to 3-6 months by loosening regulations and time needed to go through bureaucratic hurdles. The estimated time savings is 9 months to 1.5 years
Post-marketing surveillance: 2-5+ years. This cannot be shortened.
The bottom line: the shortest possible time needed to introduce SAFE and EFFECTIVE vaccine BEFORE post- marketing surveillance starts is 4 years unless pharma, researchers and government have been hiding previously developed safe and effective vaccine. The time can be further shortened by abandoning “SAFE and EFFECTIVE” requirement before vaccine is released to public. This is the only way to get vaccine out in 12-18 months.
Q: Can the fact that there are up to 100 reported vaccine candidates shorten the time?
A: No, it may prolong the process by requiring COMPARISON between different candidates to be performed. This is typically done in phase III clinical trials. It will prolong the process by at least 2 years.
Q: How long it takes to produce and distribute vaccine?
A: If we take influenza vaccine as a reference point, approximately 169 million doses were produced and distributed in the USA alone in 2018-2019 flu season. Hence to produce and distribute SARS-CoV-2 vaccine to the entire population of the USA (estimated >330 million people), when available, will require doubling capacity currently available for production and distribution of influenza vaccine.
Q: What about the need for continuing production of influenza and other approved vaccines?
A: Well, it will either have to be abandoned or the entire capacity for making and distributing 330 million doses of the “new coronavirus” vaccine must be build from scratch! What is the time required? Your guess is as good as mine…
Q: What is the estimated cost?
A: Again, if we use influenza vaccine as a reference point, the estimated cost of producing 20 million doses per year is $1 billion. Therefore, approximately $16.5 billion needed to produce 330 million doses per year. This does not include the cost of building new manufacturing capacity, distribution, training, marketing, and, potentially, enforcement. Given the estimate of 2018 world population of 7.594 billion, the cost of producing vaccine for the entire world is x 22 of the USA cost or $363 billion. It is “peanuts” for the USA - we own “the printer”!
Q: Why prof. Sikora thinks that we might not need a vaccine?
A: The reasons are:
“self-limiting” character of ALL epidemics which wain as the pool of susceptible subjects decreases;
disappearance of the “original” SARS virus few years after its discovery.
Q: Why politicians and healthcare administrators tell us that vaccine is “around the corner”?
A: There are several reasons for this “optimism”:
short term political gain;
lobbing by pharma and researchers who have “no lose” proposition because of flood of funding from the government and private investors;
incompetence of decision makers and/or their advisors;
wishful thinking…
Dr. Why: have you heard about vaccine against wishful thinking? It is knowledge. It is hard to believe that professionals (not politicians) who speak from the podium and on news channels proclaiming that the SARS-CoV-2 vaccine is coming soon and feed this information to The POTUS lack elemental knowledge but, they sure hope that public flanked “vaccination by knowledge” making it easy to sell fantasies and business plans.
Please see previous blogs on the subject: