Look at the paradox of this epidemic moment: big corporations are political villains, embedded on the left and right. Still, the main and perhaps only, because the Covid-19 curse is simple, are the vaccines developed by Big Pharma.
Few people are more aware of this contradiction than J. Paranson and Alex Gorsky, Johnson’s CEO.,
Best known for products such as Healthcare Device, Pharmaceutical and Consumer-Goods Company, Band-Aids and Tylenol. Politicians have tried to persuade her industry to use prescription-drug prices and talc in her baby powder, which was discontinued in 2020 in North America. But now J&J is a household name for developing a single-shot covid vaccine, which was approved for emergency use by the Food and Drug Administration last month. The vaccine is at a critical juncture in increasing the supply of U.S. vaccines and will enable one billion people worldwide to be vaccinated this year.
Jammu and Jenny’s Way to the Vaccine – From the failure of life-saving success, to the writing of investments to success, there is little known story about science, occupational risk and innovation. There are also lessons for those who think that capitalism is just about vague profits.
“We wouldn’t be where we are today if we hadn’t invested billions of dollars for decades,” Mr. Gorsky, 60, said in an interview Monday morning after the FDA authorized his covid vaccine. U.S. Army veterans sat from 30:00 a.m., getting into an early morning workout before meetings. The J&K Covid-19 vaccine development has been a sprint over the past year, but the process it has led has been a decades-long marathon.
Vaccines such as polio, MMR (measles, mumps and rubella) and seasonal flu are made from weak or inactivated viruses. But patients often produce a weakened immune response to an inactivated virus, and shots using a weakened virus can make immunocompromised people sick. The manufacturing process is also cumbersome.
Over the past few decades, scientists have been studying a potentially more efficient and effective method known as the “vector vaccine”: genetically engineered viruses are used for the immune system by transmitting the immune system to human cells. Our cell machinery then makes doppleganers. Harmful appearance stimulates the same immune response, marshaling antibodies and white blood cells. When a real pathogen invades, the immune system is ready.
“There are many levels of reaction in your body in this situation. There is an immediate response, and a long-term response, “says Mr. Gorsky.” Your body recognizes the virus and begins to produce antibodies, as well as T-cell and B-cell responses. “
B-cells produce antibodies that act like sentinels and prevent infection. Provides T-cell backup if a virus enters the frontline defense of antibodies and helps put white blood cells into action. The antibodies may fade after a few months, but the T-cell sticks longer and has some power of photographic memory. In 2002-04, some people infected with SARS were found to have T-cells that remembered the virus a decade later.
U.S. In trials, the J&K vaccine has been found to be 72% effective in preventing moderate to severe covid symptoms (i.e., two or more symptoms that do not require hospitalization). It is less than 95% of the Moderna and Pfizer-Bioentech vaccines, which have received emergency-use authorization, and which are followed by booster a few weeks after the initial shot. But the trial is not directly comparable. For one thing, the J&K trial was later, in the fall and early winter, when more virus types were circulating. Some types of mutations in their spike proteins, which help the virus to infiltrate human cells, partially respond to the antibody. Removes.
T-cells are not so easily deceived. One reason scientists are excited about the J&K vaccine is that a single shot of it induces a strong T-cell response. This means that the immune system is more likely to last longer – how long it remains to be seen – and less likely to be defeated by new variants.
Mr. Gorsky credits Advoca for the strong multilayered immune response to his innovative adenovirus-vector platform from the J&K vaccine, which he has developed over a decade.
Adenoviruses can cause such common colds – hence the name because they differed in the first human en denoids – are easier to manipulate because they have a larger genome. They do not even integrate their genes into ours. This makes them an ideal tool for vector-vaccines. The problem is that many people have pre-existing antibodies to the adenovirus from previous infections, so their immune system may try to kill the vaccine like a cold.
In 2007, the promising Merck HIV vaccine, which used adenovirus-5 or Ad5, failed to prevent infection at a later stage of the clinical trial. Worst of all, the data indicated that people tested positive for AD5 antibodies More This phenomenon is known as vaccine-induced growth, rather than in people susceptible to HIV infection who received placebo. A 2008 article in the Journal of Experimental Medicine was titled, “Failed HIV Merk Vaccine Study: A Step Back or a Starting Point for Future Vaccine Development?”
That was the latter. Merck’s HIV-vaccine failure led to further studies of other adenoviruses such as AD26 – the vector for the J&K Covid-19 vaccine. The Dutch biotech company Crucel was experimenting with Ed 26 in vaccines to prevent malaria and other infectious diseases. Unlike Ed 5, antibodies to Ed 26 do not appear to disrupt the vaccine. In 2009, J&J partnered with Crucel to develop a vaccine that they hoped would one day prevent the spread of all influenza strains. Two years later, J&J bought Crucel for 2. 2.4 billion.
Mr Gorsky says, “We had little experience with the vaccine at the time. But capitalism puts it at risk: many cruise vaccine studies failed, and” we wrote off a very significant portion of our initial investments. ” Still, Crucel was brought up with “the seeds of two really important technologies that we are doing today.”
There was an advocacy platform. The second was PER.C6 manufacturing technology, capable of preparing large quantities of vaccines quickly and cheaply. Despite previous failures, J&J continued to work on vaccines for Ebola, HIV, Zika and the respiratory syncytial virus, all of which are prevalent in developing countries.
The company has registered more than 150,000 patients in vaccine trials for these diseases, and last summer the European Medicines Agency approved its Ebola vaccine. Mr Gorsky says the company is confident that its vaccine platform is safe from tests for other diseases, even among people who are immune to its Ed 26 vector.
Conducting tests in the developing world also gave the company’s scientists the confidence and knowledge to conduct global tests for its covid vaccine. Most of the participants in the J-Jenny covid vaccine trial were U.S. citizens in South Africa. – 12.7%, 17.3% in Brazil and 23.3% in five other Latin American countries. Tests in South Africa and Brazil have shown that the J&K vaccine can prevent death even against serious illness and new types of death.
“While we were discussing clinical trial sites, and we asked if they could do this logically, some of our scientists visited them and said, ‘They can do this job perfectly, and I’m sure. I can give that they can, ‘says Mr. Gorsky. “Ultimately it’s the only thing that puts us in a position to try such a high quality at the same moment, even in the face of such challenges.”
J&J was a few months behind some other vaccine manufacturers, in part because its scientists had to create a trade-make to create a single shot vaccine, which could be included in developing countries, mass-produced and quickly distributed. A single dose is required to produce a strong immune response, but the response is not strong enough to cause side effects.
“We developed more than a dozen different permutations, and then we gave them some preliminary tests and selected one of our candidates that we thought we would get the best balance,” says Mr Gorsky. The J&K vaccine works to transport DNA using its advocacy platform that spike proteins into human cells on the surface of the coronavirus.
J&J then worked together on the FDA and the Biomedical Advanced Research and Development Authority, another federal agency, clinical trials and distribution. Mr Gorsky says in his 300 years working in the pharmaceutical industry, he has never seen so much collaboration between drug makers and the government, with whom “we were sharing information in real time.” Drug manufacturers have also joined: “We all knew that, when we participated in the markets, the real competition here was the coronavirus.”
Merck recently agreed to produce the J&J vaccine in its factories. Merck stopped the development of two of its Covid-19 vaccine candidates in January after showing weak immune responses after initial clinical trials. Among the Merck vaccines are J&S. A different virus vector was used than, but one showed success against Ebola.
The J&K vaccine is the third to receive FDA approval, but preliminary results from trials on AstraZeneca and Novavax suggest it is also very effective. All of these Covid-19 vaccines use innovative technologies that have been developed and tested over decades on other diseases. The AstraZeneca vaccine is similar to J&J, but uses the chimpanzee adenovirus as a vector. Pfizer-Bioentech and Moderna vaccines inject the genetic code of the virus through mRNA, instructing human cells to produce pseudo-spike proteins, which in turn trigger an immune response. The Novavax vaccine again uses engineered spike-protein clones.
About 85% of vaccine candidates fail the trial, and those who succeed take 10 to 15 years to develop historically. It seems like an incredible stroke of luck and science that we have so many Covid-19 vaccines so soon. But it is more than that. Credit year of research and investment by drug manufacturers, as well as government cooperation during the epidemic, which Mr. Gorsky hopes will be eradicated.
“I think this is a golden moment, not only for Johnson & Johnson, but also for the biopharmaceutical industry,” he says. “We fundamentally believe that having a market-based, innovation-based, biopharmaceutical as well as medical-technology environment is crucial for bringing the best healthcare outcomes.”
Mrs. Finley is a member of the journal’s editorial board.
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