COVID-19 Vaccines: Why so difficult to increase production? 

COVID-19 Vaccines: Why so difficult to increase production?   The supply of COVID-19 pneumonia vaccines in European and American countries is in short supply.  Why is it so difficult  for vaccine companies to increase production?

The COVID-19 pneumonia epidemic in European and American countries is getting worse, and the supply of vaccines exceeds demand. The public and government departments are constantly urging, why can’t vaccine production be faster?

Maria Elena Bottazzi, a vaccine expert at Baylor College of Medicine, wrote on Fox News that the process of producing a COVID-19 vaccine is very complicated. Vaccine companies do not have the experience of producing hundreds of millions of doses of vaccine in a short period of time, and any small problem in the entire process may seriously affect the overall efficiency.

Different vaccines have different formulations and production requirements, and the production process is complicated

The immune principle of the vaccine is roughly the same, that is, the immune memory is formed by training the human immune system to recognize the characteristic protein structure of the virus. However, the production technology, raw materials, and expertise of different companies are not universal.

Pfizer and Moderna’s COVID-19 vaccines use mRNA technology, which uses a gene to synthesize virus spike proteins in the human body to activate the immune system. It is easy for scientists to make a small number of test-use gene fragments in the laboratory, but no one has ever produced 1 million doses of genetic vaccine, let alone 100 million or even 1 billion doses. Expanding the scale of production not only requires increasing production materials, but also involves the chemical reaction between genetic components and enzymes. These enzymes are not efficient when the concentration of raw materials increases significantly.

The principle of AstraZeneca’s COVID-19 vaccine is to implant the virus spike protein gene into a special adenovirus to induce an immune response in the body. This adenovirus needs to be cultured using living cells in a giant bioreactor, and then extracted and purified to make a vaccine preparation. If the cultured cells are aging, fatigued, and mutated, it will affect the production, and there are many variable factors.

There is also an inactivated vaccine. The raw material is the killed new coronavirus. Therefore, there are more production steps and stricter requirements for biosafety.

In addition, in order to ensure the quality of each batch of vaccines, all vaccine companies require frequent testing of each process, and special inspection steps also take up a lot of time.

It is impossible for pharmaceutical companies to convert existing production lines to COVID-19 vaccine lines. For example, Sanofi, a well-known vaccine company, said that it will provide factories to assist Pfizer in producing the COVID-19 vaccine, but it will not provide the first dose until July and August. The difficulty can be imagined.

Pressure on the vaccine supply chain

Vaccine production requires sufficient raw materials. Compared with other industries, vaccine production mainly relies on biological manufacturing, which brings the risk of errors and is almost impossible to avoid. Both Pfizer and Moderna stated that their suppliers are reliable, but they still need to prepare for shortages of raw materials, and the challenge is very difficult. With vaccine production running around the clock, once any kind of raw material is cut off, the loss of the entire production capacity will be difficult to compensate.

At present, Pfizer’s production in Europe has slowed down, saying that it is upgrading its vaccine factory in Belgium; AstraZeneca also said that due to lower-than-expected output of some suppliers, it will reduce delivery of vaccine products to the EU.

Other factors are also restricting vaccine production. For example, while fighting the epidemic, pharmaceutical companies must continue to produce vaccines against polio, measles, meningitis and other diseases. The production of these vaccines may conflict with the production of COVID-19 vaccines in terms of raw materials and production resources. .

What methods can increase production?

The first way to increase production is to expand production scale. Pfizer CEO Albert Bourla said that Pfizer’s plant in Belgium is undergoing technological upgrades. After completion, the total annual vaccine production will increase from 1.3 billion doses to 2 billion doses. Moderna also said that with the expansion of production capacity, the annual output may increase from 500 million doses to 1 billion doses.

Cooperative production is also one of the ways to expand production. Moderna is working with Lonza in Switzerland to produce the vaccine and complete the final bottling steps. AstraZeneca will produce 1 billion doses of vaccine in cooperation with the Serum Institute of India and is expected to become a major supplier in developing countries.

At the same time, Johnson & Johnson is about to announce the vaccine’s clinical Phase III trial data, Novavax has entered the final testing stage, and the latest report claims that the effective rate is close to 90%. If their vaccine is approved, they will be added to the vaccine distribution list.

In addition, Pfizer has also increased production through a small change. Each dose of Pfizer vaccine was originally required to be distributed to 5 people, but the actual dose can be used by 6-7 people. Pfizer will equip each batch of vaccine product boxes with corresponding new syringe kits. This syringe can reduce the loss of medicine. Each bottle can be filled with 6 needles, which is equivalent to an increase of 20% in production capacity.

In any case, it is the first time for every vaccine company to produce such a large dose of vaccine in a short period of time. It has continuously gained more experience in production, and its monthly production volume has increased compared with the previous month. Experts call on us to maintain sufficient confidence in the supply of vaccines.

(source:internet, reference only)

Disclaimer of medicaltrend.org