From large multinational pharmaceutical companies to small professional vaccine companies, they are investing in huge capital to develop new crown vaccines. If it can make progress, how to produce large -scale production will be a challenge.
After the 9.11 terrorist attack, then US President George W Bush promised that the United States would allocate $ 5.6 billion for vaccine production and other countermeasures to fight biological terrorism.
This promotion of new ceiling and anthrax to prevent the development of drug development will be quickly used to fight against new coronary virus pneumonia (COVID-19).At present, institutions, including World Bank and Bill and Merhnda Bull; Organizations, Bill Melinda Gates Foundation, are competing for huge costs for vaccine research and development.
However, there are more than 80 new crown pneumonia candidate vaccines in the world are under development. Preparing production facilities for several candidate vaccines will cost billions of dollars, including some vaccines that will never be successfully listed.
The senior person who had played for the government of Bush and Obama, the Richard Hatches of the Popular Psychological Epidemic Innovation Alliance (CEPI) of the current leadership, said: Even before the results of the first phase of the clinical trials were the first phase of the clinical trial results,We have already made some considerable investment.
The person in charge of the Popular Diseases and Epidemic Innovation Alliance added that the investment decision was made in such an early stage, which was full of financial risks.At present, the alliance is coordinating funds for several international new crown pneumonia research projects.
The Global Vaccine Immunization Alliance (GAVI) estimates through public and private donors to raise funds for the global vaccine (GAVI) estimation that the cost of producing hundreds of millions of vaccines in the production of hundreds of millions of vaccines will beThe company's 50 million US dollars ranging from about $ 700 million from zero.If the vaccine needs a new technical platform, then this number may be higher, and in addition, the clinical development cost of each candidate vaccine is estimated to be at least $ 500 million.
The two ways to get new coronal virus immunity
With several different vaccine technologies that have entered the stage of human test, how to allocate limited funds has begun to become complicated, especially when policy makers are aimed at the timetable of 12 to 18 months.
Large multinational companies such as Johnson Johnson said they have the ability to expand their existing large -scale vaccine production processes.This requires a large number of improved viruses in human cells in biological reactors.
Johnson & Johnson's new crown pneumonia candidate vaccine is based on a cold virus. The virus has lost its activity and cannot be copied in the human body. However, it can still carry the virus DNA into the human body to produce a antigenCreate this antigen to the virus.In this case, the antigen is like a spike on the surface of the new coronary virus. Johnson & Johnson hopes that this will cause the human body to produce an immune response, providing them with protection when the patient encounters the new coronary virus itself.
This American company has promised to invest $ 500 million to help the production of vaccines, and it has also received a $ 500 million investment provided by the government.Johnson & Johnson produces this non -active virus in a cell line. The company has spent 10 years developing this cell line to make it have high production efficiency, and its biological reactor can now produce 300 million vaccines each year.
Johnson & Johnson Paul Bull; Paul Stoffels said the company is improving its production capacity, and the final output may reach 1 billion doses of new crown pneumonia vaccines per year.
However, Johnson & Johnson's candidate vaccine entered the clinical trial stage in September this year, and the smaller enterprise specializing in the production of so -called credit RNA (MRNA) vaccines has tested their prototype vaccines in volunteers in the United States and Germany.
The method of updating is to transcribe a certain element of the virus genetic password to a transmission system to transmit it to human cells.These cells responded by making viruses. Just like the previous method, the immune system was ready to deal with the actual new coronal virus.However, this technology does not depend on the cell line and is expected to greatly shorten the production time, although there is no MRNA vaccine to enter the market.
MRNA vaccine manufacturer Moderna CEO Stana Bull; Steacute (Phan Bancel) said: If you have a large reactor and have very large devices to purify the product, then you will eventually have a very large and huge,Factions with very expensive costs, and build these factories for a long time.
This Boston biotechnology company headquartered in Boston is the first American company to invest vaccines into clinical trials. From the announcement of the virus genome to the production of the first vaccine for only 42 days, it breaks through the historical record.
The company has recently signed an agreement worth as high as 483 million US dollars with the US government. It plans to expand its production to several million doses per month by the end of this year, and increase to tens of millions of doses every month next year.
Other companies are also ambitious.Biontech, a German company specializing in MRNA and clinical trials this week, said it can use existing equipment to produce hundreds of millions of vaccines.
Even so, technical challenges still exist.Bond Sel said that in this vaccine, MRNA uses lipid nanoparticles mdash; mdash; that is, a lipid bubble mdash; mdash; is passed by the carrier, which is a complicated process to combine the two together.
Delivery problem
The Popular Disease Epidemic Innovation Alliance stated that the last stage of the development of vaccine, that is, the preparation of drugs and poured into the so -called Filling and Finishing stage of a small bottle or syringe, is the most likely place to occur.
For the clinical trial stage that requires at most thousands of vaccines, this work is done by small professional companies.
Polymun is a family company with 90 employees. It is headquartered near Vienna, Austria. It is preparing fat nanoparticles for several new clinical study of crown pneumonia.Biontech and Imperial College London are both customers.
If any of these candidate vaccines enter the next stage through early tests, larger manufacturers must be found to produce such new vaccines.Orelia Bull, the head of the Global Vaccine Immunization Alliance; Aurelia Nguyen said that the problem is that we have no ready -made tactical manuals for candidate vaccines such as MRNA and DNA.
Another consideration about candidate vaccines is that they must store conditions before use.
Inovio Pharmaceuticals, headquarters in Pennsylvania, is undergoing early clinical trials of its DNA vaccine. The company said that its products can save MDash at room temperature for one year; this makes it easierTransport in the country.
Inovio CEO Joseph Bull; Joseph Kim said: Compared with traditional vaccines and even RNA vaccines, this is a huge advantage.
However, this vaccine can only be injected through one smart device. This device looks like an electric toothbrush, which can emit electrical pulses, punching on the cells, and allowing DNA to enter.
It is necessary to find sufficient technical personnel for unprecedented scale vaccine production, but also use a series of new technologies. These are also possibleMake the production process complicated.
In Germany, it is not difficult for people to receive correct education and training at university. The Rolf Houml (MKE) of the German Research Pharmaceutical Enterprise Association (VFA) saidPerson in charge of production.
Dr. Harchetter, an epidemic of the Epidemic Disease Prevention Innovation Alliance, said that the constraints of time mean that most new crown vaccines must be produced in existing factories.He added that an important concern is that the efforts to curb this major epidemic should not be at the expense of other important projects.
What we don't want to do, he warned that he found that he had to consider stopping the production of measles vaccines for the production of new crown vaccines.
Translator/He Li
