Doses of cholera vaccine are being given to patients as fast as they are
produced and the global stockpile has run completely dry, as deadly
outbreaks of the disease continue to spread.
This does not shock anyone in the field of emergency epidemic response
because the vaccine stockpile has been precariously low for years.
The surprise — the good news, which is in itself surprising since ‘cholera’
and ‘good news’ are rarely used together — is that three new vaccine
makers are setting up production lines and joining the effort to replenish the
stockpile.
And a fourth company, the only one that currently makes the vaccine, which
is given orally, has been working at a pace that experts describe as “heroic”
to expand its production.
Yet even with all this, the total global supply of the vaccine that will become
available this year will be, at best, a quarter of what is needed.
At the end of February, countries had already reported 79,300 cases and
1,100 deaths from cholera this year. Since there is no uniform system for
counting cases, this is most likely a gross underestimate.
In October 2022, the organization that manages the global emergency
cholera vaccine stockpile made an unprecedented recommendation that
people receive only one dose of the vaccine instead of two in an effort to
stretch the supply. A single dose of the cholera vaccine provides between
six months and two years of immunity, while the full regimen of two doses
delivered a month apart gives adults roughly four years of protection.
Last year, countries sent requests for 76 million doses of the vaccine for
single-dose “reactive campaigns” — efforts to vaccinate people in places
with active outbreaks.
There were only 38 million doses in the stockpile, so only half the requests
were filled, and those were with only a single dose. No vaccines were left for
preventive campaigns that would ideally be carried out in places such as
Gaza, where all of the conditions for large outbreaks exist, or in places
where cholera is endemic.
The race to make more cholera vaccine illustrates all of the reasons it’s so
hard to respond to epidemics even with the participation of committed drug
makers who are not scared off by the slim profit margins in an immunization
that’s mostly for poor people.
Cholera can cause death by dehydration in as little as a single day as the
body tries to expel virulent bacteria in streams of vomit and watery diarrhea.
The disease is spread through unclean drinking water. The current
outbreaks are being driven by the spread of conflict and climate disasters
that force people into crowded living situations without adequate sanitation
systems. In recent months, there have been outbreaks in 17 countries,
including Afghanistan, Zambia and Syria.
Yet demand has only grown since then.
The South Korean company EuBiologics is currently the sole company
worldwide that makes the cholera vaccine. The company had been aware for
some time that there would be pressure on the supply of the vaccine
because the only other firm that made it, an Indian subsidiary of the drug
company Sanofi, had announced in 2018 that it would end production of the
vaccine, which it did in 2023.
To cover the gap in vaccine production, Rachel Park, the director of
international business at EuBiologics, said the company decided to try to
simplify its vaccine formula, streamlining steps and ingredients so it could
make more doses faster.
The company was then making more of the bulk drug product than it could
put into tubes quickly, so it contracted a second Korean firm to assist.
EuBiologics also invested in construction of a second manufacturing site
that would double the amount of the vaccine the company could make. The
company has taken the lengthy and expensive steps of having both the
simplified vaccine and its new facility approved by the World Health
Organization in a process called prequalification, which means that
countries will not have to administer their own regulatory assessments.
When the new plant starts producing the company will be able to make up
to 46 million doses a year.
“EuBiologics is really the unsung hero of the story,” said Dr. Julia Lynch, the
director of the cholera vaccine program for the International Vaccine
Institute, a United Nations-backed organization based in Seoul. “They are
doing everything they can to get volumes up as fast as possible.”
Together, these steps should increase production to a total of about 46
million doses this year, and to about 90 million doses in 2025 and onward,
Ms. Park said. But that will still most likely be significantly less than what the
world requires.
“Doses are being allotted before they are even produced,” said Dr. Daniela
Garone, the international medical coordinator for Doctors Without Borders
who sits on the committee that decides which countries will receive doses,
and how many. “We weren’t expecting it to be better this year, but we didn’t
think it would be this much worse.”
There is some more hope on the distant horizon: Three more drug
companies have cholera vaccines in their pipeline. The International Vaccine
Institute has licensed its vaccine to Biological E, an Indian firm, and is
sharing the formula and equipment for making it.. If all goes well, that
vaccine could come to market by the end of 2026 because Biological E is a
large company that already makes many products prequalified by the W.H.O.
In South Africa, a company called Biovac will soon start clinical trials on
what eventually could be the first vaccine ever produced from start to finish
in sub-Saharan Africa. Biovac hopes to conclude the trials by 2027. After
that, it will most likely take at least a year for the vaccine to obtain W.H.O.
prequalification, said Dr. Morena Makhoana, the chief executive of Biovac.
Bharat Biotech, another big Indian company with large production capacity,
is working on its own oral cholera vaccine. It could bring its vaccine to
market by the end of 2025.
To spur companies to invest in producing cholera vaccines, Gavi, the
international organization that supplies immunizations to low- and middle-
income countries, has indicated the possibility of advance market
commitments — the promise of future orders that would encourage
drugmakers to invest in producing the cholera vaccine. Gavi pays
EuBiologics $1.53 per dose for the vaccine.
Bharat and Biological E both plan to produce about 15 million doses per year
initially, Dr. Lynch said — “modest quantities” by the standards of these
huge Indian companies that could make more if the market continues to
grow.
The potential demand is difficult to predict, she said. “That’s really the
question: Is what the world is going through right now a kind of phenomena
of a few years triggered by something?” Dr. Lynch said. “Or is this a new
normal? Is this a new kind of set point?”
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Posted by EQF on April 11, 2024
Hi ao,
I recommend that you go to my Earthquake Forecasting Web site and use the E-mail address at the bottom of each Web page to contact me. Then we could discuss specific matters that I don't like discussing in a public forum that can be visited by young children. Use a free Google E-mail address or whatever, if you want to remain anonymous.
Use any search engine and type in:
earthquake research index.html Data.html
My Earthquake Forecasting Web site should be at or near the top of the returned list.
WORLD GOVERNMENT IRRESPONSIBILITY
In my opinion, world governments are largely responsible for many of the problems we see around the world including the fact that many drugs are not available when and where they are needed.
Health problems involve complicated matters. But, I believe that many of them largely stem from government officials having little or no sense of direction or concern for the value of human life.
I can easily prove the above. World government have on quite a few occasions dealt with various types of problems based on recommendations that I personally sent them. One recommendation that I am planning to send them is discussed towards the end of this posting.
They and their scientists and health officials should have been able to determine that this or that problem could and SHOULD be solved. They should not have had to rely on MY advice.
Sadly, that situation continues even today. It is constantly amazing to me how little government officials seem to know about or care about important matters.
"PRE-VACCINATIONS" BEFORE THE "TRUE" VACCINATION
People posting notes here who are medical experts, professional or amateur, might want to comment on the following. I am planning to recommend this advice to World Governments.
World Governments are doing an especially miserable job with regard to the subject of vaccinations. It is likely that most people in the general public have NO idea at all regarding how a vaccine actually works.
For a virus or bacterium etc. to spread, usually, most of the virus or bacterium needs to be present in the blood or lungs etc. If only a small part of the virus or bacterium is present it cannot reproduce. And a healthy immune system will eventually get rid of it.
Often, vaccines just contain a small part of a virus etc. The human immune system then recognizes that small part of the virus as being a threat and it launches an attack on anything that looks like that small part of the virus. The immune system is in effect "tricked" into attacking the entire virus.
One of the problems with vaccines is the fact that they don't contain only a small chunk of the original virus or bacterium. They also contain various materials such as egg proteins etc. that have been used during the creation of the vaccine.
Some small number of people are highly allergic to the egg proteins etc. So, those extra materials can harm the patient more than the actual vaccine will help them.
What the medical community could be doing, something that I plan to recommend to World Governments, is to create "incomplete" vaccines that contain those extra materials such as the egg proteins, but not the part of the virus that activates the immune system.
Then before people started getting a specific vaccine such as ones related to Covid-19 and ESPECIALLY ones related to the vaccines we usually get when we are children, the medical people would expose the person or child to a very small amount of that "Pre-Vaccine" and see if he or she, especially a child, had a strong reaction to those extra materials.
This could be done with a shot in an arm etc. that contained only a very small amount of material. Or it might involve a patch placed on a child's arm or leg.
If the child or adult etc. had a strong reaction to the shot or the patch then medical people would not give the child or the adult the full vaccine as that might then seriously affect his or her health.
Quite a few lives could probably be saved if this precautionary step were taken. Plus, many people around the world would then not be so afraid of getting any vaccinations at all. They would already know what to expect from them.
Medical personnel should also be constantly telling people how vaccinations actually work. Many people, even highly intelligent ones, truly believe that you can contract Covid-19, for example, from simply getting the vaccination shot.
I myself have actually had to draw pictures of a virus and then the part of the virus that is used with the Covid-19 vaccine and show it to those people to explain to them why they could not possibly catch the virus from the vaccination.
Even that won't work for some people.
These are personal opinions.
Regards to all,
EQF
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