A cure for the pandemic
When will the coronavirus treatment and vaccine be available
Vitalina Dzutseva, Forbes, 03/18/2020
For links, see the original article.
Bill Gates, speaking in Massachusetts in 2018, said that the world needs to prepare for a pandemic just as it is preparing for war. "We cannot predict when a new pandemic will appear, but given the constant emergence of new pathogens, the growing risk of bioterrorism and the ever–increasing migration in the modern world, there is a significant likelihood that a major and deadly pandemic could happen in our time," Gates said.
In his article of February 28, 2020, published in The New England Journal of Medicine, he already speaks about the current pandemic that has engulfed the world: "In any crisis there are two tasks: to solve an urgent problem and to prevent its recurrence. Now we need to save lives, as well as improve the methods of response and coordination of actions. The first is relevant, the second has decisive long-term consequences." The Bill and Melinda Gates Foundation was founded in 2000, on February 5, 2020, the foundation invested $100 million in the study of the virus and new developments.
The modern pharmaceutical industry is focused on many dangerous diseases, but in recent years the fight against infectious pathology has not been its main priority. This is explained by the fact that this market segment is estimated as insignificant (there are not so many patients, sometimes therapy is required once in a lifetime, infections occur quickly, unlike chronic diseases). In addition, the final cost of drugs is low, and the interest of modern medical science is aimed at early diagnosis, not treatment of the consequences. An important reason is that humanity is accustomed to believe that it controls the situation with the help of the existing pharmaceutical arsenal.
The emergence of a new virus that has chosen a survival strategy in the form of a long asymptomatic carrier (according to recent data, asymptomatic carrier of the virus is possible for up to 37 days) and high contagiousness has critically changed the picture of the modern world.
According to the Singapore National University on March 13, the virus mutated once again at the end of February, when a fragment of 382 "letters" (nucleotides) disappeared from its genome. It is assumed that this was the reason for the lengthening of the duration of asymptomatic carrier compared to the original strain (all the data given are correct only at the time of writing the article). Perhaps this is the strategy of the virus to ensure greater spread and survival in the human population.
WHO and global health agencies have focused their attention at the moment on drugs that have already been approved for other indications, because this accelerates their entry into the market. Companies that took part in the race, but did not become the first in it, will not receive much profit, but there are equally important benefits: companies will confidently increase their capitalization, declaring themselves to the international community and showing that they are among the few who can make breakthrough developments in record time.
In the US, the government has allocated a total of $8.3 billion, of which $3 billion directly for the development of drugs from COVID-19. Vaccine and drug development companies received funding mainly from two organizations: the Office of Biomedical Research and Development (BARDA) and the National Institute of Allergy and Infectious Diseases (NIAID), a division of the National Institutes of Health.
What pharmaceutical developments are encouraging at the moment?
Currently, the WHO "Platform for Registration of Clinical Trials" (WHO) has 263 clinical trials of drugs from COVID-19. WHO Assistant Director General Bruce Aylward said that so far the most promising drug is Remdesivir from Gilead Sciences. The capitalization of this biotech company is $87 billion. Gilead is well known for developing the drug Sovaldi for hepatitis C and the drug Truvada for HIV. The company began clinical trials in China after peer-reviewed journals showed that its antiviral candidate Remdesivir gave positive results in a case involving an American patient and Chinese in vitro tests. The drug was invented at one time to fight the Ebola disease. The early phases of clinical trials have already been completed. Several phase III trials are currently underway, one of them – a double-blind placebo-controlled on 394 patients – should be completed in April 2020. Two other open-label, on 400 and 600 patients, will be completed in May 2020. If the treatment proves to be effective, then this drug will become a control group in new comparative studies. The results will be published in peer–reviewed journals and on the WHO website in late April - early May.
It should be noted that according to the interim information, the effectiveness of the drug is confirmed, but there are questions about its safety, since it causes an increase in liver transaminases. It is too early to draw conclusions, since the information is based on only three patients in an extremely serious condition and an increase in transaminases may be associated with the course of the underlying disease.
The main hopes are pinned on the development of a vaccine against COVID-19. The main investor of such developments at the moment is CEPI (the Coalition for Innovations in the Field of Epidemic Preparedness – a global organization based in Oslo). 10-12 candidates joined the race to find vaccines immediately after the publication of the coronavirus genome. CEPI is funding six of them. The head of CEPI, Melanie Saviy, says that it is necessary to spend about $2 billion to maintain developments that show the best results (at least three candidates) to the level when they can be submitted for approval to regulatory authorities. $100 million has already been invested in the program in the first quarter of 2020. In the next quarter, according to CEPI, it is necessary to raise about $350 million. The UK government has provided a total of £50 million to CEPI, Germany – €145 million.
One of the undisputed leaders of this race is the Boston biotech company Moderna. On January 23, the vaccine development was funded by CEPI and NIAID. The company's main product is RNA vaccines. Already on February 24, the company announced that it had sent the first vials of its mRNA-1273 to NIAID for a phase one clinical trial. This happened just a month after the start of development and 42 days after the publication of the decoded genome of the virus, which is much faster than the researchers' response to previous outbreaks – such as SARS.
The phase I clinical trial has already begun, the first patient was included in the study on March 16, 2020. The study is scheduled to be completed on June 1, 2021. In the wake of this success, the shares of Moderna have increased by 10.88% since January 1, 2020.
However, the market was changed by the news that another leading company, Inovio Pharmaceuticals, announced the acceleration of the development of its INO-4800 DNA vaccine against COVID-19. The company began developing the vaccine on January 10, three hours after the publication of the genetic code of the virus. The CEPI grant is also a source of funding for the company's developments. Preclinical studies were conducted from January 23 to February 29, 2020. The company plans to start clinical trials in the United States in April with 30 participants. Clinical trials of this vaccine will also begin in China and South Korea in April. 3,000 doses of the vaccine have been prepared for research in three countries. By the end of the year, Inovio Pharmaceuticals plans to deliver 1 million vaccines to the market. After the publication of this information, the shares of Inovio Pharmaceuticals immediately rose by 70%. The company's capitalization now stands at $893 million.
The third leader, Novavax Inc, is still at the preclinical stage of research. The company's development is a recombinant vaccine made of nanoparticles. The source of funding is a CEPI grant. The initial investment was $4 million.
Investors' interest is clear: the first company to develop a safe and effective COVID-19 vaccine will occupy the market, since the whole world will need it. The potential market is estimated at at least a record $35 billion.
But there is also a large share of risk for all potential leaders of this race. Clinical studies may reveal unexpected critical side effects.
What else can affect the stock price of companies developing vaccines? Vaccination may be impossible or very difficult because of the damaging effect of antibodies, that is, for the same reason that attempts to create a vaccine against SARS pneumonia failed. This hypothesis is put forward by a study published on March 13, which examines the possible mechanism of lung damage. The hypothesis is discussed that the own immune system turns against the host, and then the "virus-activated" immune response can attack its own lungs. For this reason, the use of IL-6 receptor inhibitors (anti-inflammatory cytokine) is considered promising for the treatment of COVID-19.
This hypothesis is confirmed by Chinese scientists from USTC (University of Science and Technology of China). They announced at a government teleconference promising results in 14 extremely severe patients on the drug Actemra (monoclonal antibody against IL-6) from the Swiss Roche. A study of this drug is already underway in 188 patients. A few weeks ago, the Chinese authorities introduced into their guidelines a criterion (an increase in the level of IL-6) as an indicator of the deterioration of the course of COVID-19 pneumonia.
Roche donated its $2 million drug to China. In 2019, Actemra increased sales by 8% in constant currencies, reaching $2.42 billion and ranking sixth among Roche's best-selling medicines.
At the same time, Regeneron Pharmaceuticals Inc and Sanofi SA, which produce the FDA-approved drug Kevzara (IL-6 inhibitor), are also preparing to start research on their drug against the severe form of COVID-19.
Hundreds of clinical studies and the participation of the best scientific and clinical schools in the world allow us to hope that we will find a cure, and with it – a way out of the pandemic. However, you need to understand that the results will be in months or even a year. Such developments are technically complex, expensive and require the consolidation of efforts and scientific potential of the best specialists from all countries of the world.
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