Moderna is one of several companies, in addition to Pfizer / BioNTech, AstraZeneca, Novavax, Johnson & Johnson, that managed to create and bring to global markets a vaccine against SARS-CoV-2 coronavirus. Moreover, Moderna, like Novavax, is not a pharmaceutical giant, but still a startup, albeit a very large one. The coronavirus vaccine is its first product on the market, and the first for which the company has conducted phase 3 trials, the large-scale studies needed to bring a product to market. By the beginning of the pandemic, the rest of the company's development portfolio was completely "immature", although extensive – five products in the initial stages of clinical research.
What led to the creation of vaccines against coronavirus
The development of coronavirus vaccines during the pandemic has become an unprecedented event in the history of biopharmaceuticals. At the beginning of the pandemic, there was not a single expert who expected a vaccine to be on the market in less than three years. But a year later, vaccines were available! What is it – cutting corners, unprecedented luck or a demonstration of the possibilities of modern science? A little of everything, but more than the last.
Regulatory agencies (primarily the US Food and Drug Administration FDA) responded very quickly, entering into a dialogue with developers and allowing them to move on to the next stages of development as data accumulates. The huge monetary and human resources devoted to the fight against the virus made it possible to carry out many processes in parallel, and not sequentially, as usual: for example, large-scale production began to be deployed before the results of a phase 3 clinical trial were received (this is usually not done, because the study may fail ). Luck also played a role: in a sense, the virus was lucky that it did not mutate as quickly as the same flu, and that the antibodies that are produced during vaccination were able to stop it (unlike, for example, HIV).
Luck also played a role – in a sense, we were lucky with the virus
But the main thing is still a scientific backlog that has been created over decades. Experiments with mRNA vaccines and adenoviral vectors began as early as the 1980s, and all this time there were attempts to create something that worked, which, however, for the most part, failed. The first sufficiently safe and effective RNA drugs entered the market in 2018 (for the treatment of rare liver diseases). That is, by 2020, a critical mass of technologies and competencies has accumulated, which made it possible to create vaccines against coronavirus.
Finally, another of the factors that made it possible to create a covid vaccine so quickly is that people at the peak of the pandemic fell ill in the hundreds of thousands a month. This means that it was not a big problem to quickly recruit groups of 20-40 thousand people to test the effectiveness of vaccination and quickly enough to get the difference in the number of cases in the vaccinated and control groups (which proves the effectiveness of vaccination).
What prevents vaccination against other diseases
Can Moderna or other companies replicate this success with other communicable and noncommunicable diseases? Short answer: it's possible, but likely not as fast as Paul Burton claims.
One problem is that, unlike the coronavirus, for other diseases it is not possible to quickly form large groups of people to test the effectiveness of vaccination. Under normal conditions, for infections and diseases outside of a pandemic, recruiting even a thousand people is a matter of several months.
In addition, no one, except for pharmaceutical companies, spends (and is not able to spend) huge amounts of money on risky developments. Therefore, although the pandemic allowed two technologies – mRNA vaccines and vaccines based on adenoviral vectors – to succeed (and also work out their large-scale production), this does not mean at all that success in other diseases will be as fast and guaranteed.
No one but pharmaceutical companies spends huge sums on risky developments.
According to statistics, only 10% of new drugs with which clinical trials are conducted reach the market. In oncology, this share is even less – 5-6%. Moderna enters on a broad front, and this increases the likelihood of success in at least some indications. Currently, the company's development portfolio includes 48 projects, 25 are at the clinical stage, five of them are at a late stage (phase 3). The company recently presented the results of phase 3 clinical trials of a respiratory syncytial virus (RSV) and influenza vaccine.
The RSV vaccine turned out to be effective, at the level of other competitors who have recently published their results. But so far there has been a small embarrassment with the flu vaccine: it turned out to be no worse than usual only against some strains (type A), and against type B strains it could not prove sufficient effectiveness. However, the company's platform is very flexible and allows you to create, test and mass-produce a new version of the vaccine in just a few months, which was demonstrated when creating boosters against SARS-CoV-2 of the Omicron variant.
What about vaccines for cancer and cardiovascular disease?
RNA preparations – not all and not at once
In the case of cancer, RNA drugs under development can be called vaccines, because they cause the production of antibodies and a cellular response against tumor antigens (“wrong” tumor molecules that differ from normal, to which an immune response can be developed), that is, they act approximately like vaccines against infectious diseases. agents. True, these are not preventive vaccines that we are used to, but therapeutic ones – they are administered when a person is already sick. The long-term protection of a therapeutic vaccine is still in question, but experience with other immuno-oncological drugs (vaccines also belong to this class) shows that if a relapse has not occurred within a year, then with a very high probability this particular cancer will not return again – the immune system is at a standstill. guard. True, a person is not immune from other types of cancer.
It would be very tempting to create preventive cancer vaccines, but this will definitely not happen before 2030: even if research on such a vaccine were started now (and there is still no trace of it), years of observation are needed to prove that it really helps.
It would be very tempting to create a cancer vaccine, but it certainly won't happen before 2030.
But in the case of cardiovascular, respiratory or rare hereditary diseases, it is wrong to talk about vaccination. We are talking about therapy, in which mRNA enters the cell and the necessary protein begins to be produced there, which improves the course of the disease or even cures it.
Developments in oncology and cardiology
At the end of 2022, Moderna published preliminary results of a melanoma vaccine. The results are good, but not enough to claim that this is a real breakthrough: there are still too few patients, and the follow-up period was one year. It is possible that the drug will prove its effectiveness in the upcoming phase 3, however, this is only one type of cancer out of hundreds, and is not a cure for 100% of patients, but only an improvement in existing therapy. This type of therapy will definitely not help all patients: it is based on the identification of specific mutations in a given person, and there is always the risk of errors, lack of information, diversity of tumor cells and their evolution (and this is only part of the reasons why personalized cancer vaccines have not yet worked ).
Moderna has published preliminary results of a melanoma vaccine. But it's not a breakthrough
Moderna has several other anti-cancer products, but they are all early and therefore very risky.
Moderna's development of cardiovascular disease therapies is also quite early and uses an approach that has been shown to fail repeatedly in clinical trials. Perhaps Moderna will succeed this time, but again, this is a rather niche development, and it will definitely not be possible to create a “vaccine” for everyone.
What to expect in the future
However, the world of biopharmaceutical developments is not limited to Moderna and RNA drugs alone. Every year new developments appear, based both on traditional approaches (low molecular weight substances, antibodies) and on the most modern ones, for example, gene and cell therapy drugs or Zolgensma. These medicines are indeed capable of curing previously incurable diseases, but so far this is a piece and very expensive (worth several million dollars) product for the treatment of rare diseases. Thousands of developments are underway in more common diseases such as autoimmune (type 1 diabetes, rheumatoid arthritis), cardiovascular diseases, etc., and by 2030 a number of these developments are likely to be successful. But it can be said for sure that over the remaining seven years, the problems of cancer, autoimmune, and infectious diseases in general will not be resolved.
New drugs can cure previously incurable diseases, but this is a piece and very expensive product.
Unfortunately, new developments themselves are very expensive (we are talking about tens and hundreds of thousands of dollars, and sometimes millions) and are not available in developing countries. So far they are not really needed there: the main problems there are hunger, lack of clean water and infectious diseases. One can only hope that when these problems are solved, new developments will become orders of magnitude cheaper and will become available to everyone (remember that antibiotics were also very expensive at first).
Why is the director of Moderna giving such an interview? This is likely part of a public relations campaign aimed at increasing the interest of the public and investors amid falling sales of covid vaccines. The public will still quickly forget what Burton promised there, but an instant resonance is provided. Recently, the CEO of the company Stefan Bancel spoke in the US Congress, defending the pricing policy of the company and pharmaceutical manufacturers in general. This is an important mission in principle, because the public and congressmen quickly forget who saved millions of lives during the pandemic and thanks to whom all new drugs appear, and continue to set the dogs on pharmaceutical companies as a convenient election target. But so far, Paul Burton's statements do not look professional enough.