The vaccine works: a billion doses a year since December – Younipa

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It’s called mRNA-1273. And it creates antibodies that neutralize the covid. The tests are ok and will be approved in the fall. Then mass production will start.

The point on the Vaccine. The weekly L ’Expressed publishes exclusively the results of the research by the American biothec company Moderna and the exclusive interview with Andrea Carfi, the Italian scientist in charge of the infectious diseases team of Modern

Here the whole interview

Two months that are worth two years, or maybe more. Sixty days have passed since the start of the clinical trial of the vaccine against the SARS-CoV-2 virus of the American biothec company Moderna and the first results, made public on May 18, have been defined by all very promising experts.

First of all, the vaccine has proven to be safe, has no side effects and is well tolerated. But above all, the data show that vaccinated people developed levels of antibodies equal to or higher than those measured in subjects infected with the virus and subsequently recovered. So encouraging news that Anthony Fauci, director of the NIAID (National Institute of Allergy and Infectious Diseases) and head of the White House task force for the coronavirus emergency, is also unbalanced.

Fauci said he was “cautiously optimistic” with respect to the efficacy of the Moderna vaccine “precisely because” he told CNN, “the first results showed the ability to neutralize the virus by administering reasonable doses of the vaccine, and it is reasonable to foresee that if the same levels of antibodies are confirmed on a larger number of people, the vaccine will protect against infection “. Andrea Carfí, an Italian scientist, who has been in the US for ten years and two at the head of the team on infectious diseases of Moderna, also participates in the frantic race for the vaccine to defeat the scourge of 2020. Interviewed by the Espresso site last March, he had appeared optimistic since the first days of the first phase of human experimentation and, apparently, the facts today prove him right. “Caution was and continues to be a must, but yes, I confirm that optimism was well answered,” Carfi told Espresso today. «In fact, on all 45 volunteers who underwent the first phase of the trial, the vaccine was safe, confirming the data obtained in clinical studies of our other vaccines. We also observed the production of antibodies in all vaccinated subjects and in eight of them we demonstrated the presence of neutralizing antibodies, that is, capable of not only recognizing the virus but also of blocking it, thus avoiding infection.

Andrea Carfí, an Italian scientist, who has been in the US for ten years and two at the head of the team on infectious diseases of Moderna, also participates in the frantic race for the vaccine to defeat the scourge of 2020. Interviewed by the Espresso site last March, he had appeared optimistic since the first days of the first phase of human experimentation and, apparently, the facts today prove him right.

“Caution was and continues to be a must, but yes, I confirm that optimism was well answered,” Carfi told Espresso today. «In fact, on all 45 volunteers who underwent the first phase of the trial, the vaccine was safe, confirming the data obtained in clinical studies of our other vaccines. We also observed the production of antibodies in all vaccinated subjects and in eight of them we demonstrated the presence of neutralizing antibodies, that is, capable of not only recognizing the virus but also of blocking it, thus avoiding infection. After vaccine administration, the titers of these antibodies appear comparable to those of people infected and then cured of SARS-CoV-2 infection. In a few weeks we will have the final results of all 45 volunteers who received the mRNA vaccine. In the meantime, we continue testing on animal models. We already know that mice vaccinated with mRNA-1273 (the name of the Moderna vaccine, ed.) Have antibodies that neutralize the virus and, more importantly, are protected when exposed to the virus.

Was there a precise moment when you understood that the road was the right one?
“Phase 1 is conducted by the NIH (National Institute of Health) and the data was presented in one of these now normal online meetings with dozens of co-workers, late at night. For the first time we could analyze the data closely, there was a certain tension, many details, many questions. But it was clear that the data was positive. I remember saying at one point that the results were exceptional and suddenly we all agreed and a great liberating applause broke out. Emotions add to expectations. It was a good moment. ”

Results that encourage us to march quickly to the next stages. What is the path?
“We will soon have data on the vaccine administered to older people, then Phase 2 will begin which will involve 600 volunteers and we will have more information on the tolerability, safety and ability of the vaccine to induce immune responses. They will serve to confirm the dose of vaccine to be administered in subsequent clinical studies. People vaccinated in Phase 1 will also be constantly monitored and the antibody titers measured over time. In some previous studies it has been found that, in subjects infected with other coronaviruses and then cured, the antibody titers decrease rapidly. With the vaccine it is hoped that the antibody responses will be longer lasting and will allow more extended protection over time ».

Andrea Carfi

And by July Phase 3 will start to test the effectiveness of the vaccine on large numbers …
“In the next two months we should start the decisive phase which will include thousands of people, in the United States and perhaps also in Europe, the comparison between who will receive the vaccine and those who receive a placebo and therefore the evaluation of effectiveness. At this point, if everything proceeds as we hope and when the vaccine is authorized by the health authorities, it can be used on a large scale. There is the possibility that the vaccine can be administered even before the conclusion of the trial, but it is a decision that falls to the FDA (Food and Drug Administration), based on the trend of the infections and the numbers of deaths “.

Does this mean that an analysis will have to be made between costs, in terms of human lives, and certain benefits?
“It means that once confirmed the first essential fact, that the vaccine is safe for humans and that it has the potential to carry, it could theoretically be considered to be administered to groups at high risk of contagion, such as doctors and healthcare personnel, even not knowing its effectiveness one hundred percent. Because in any case the benefit, even if not definitively ascertained, still represents a better prospect of the risk of contracting the virus and the disease without any vaccine protection or effective treatment. But these are assessments that, I repeat, are up to the health authorities ».

In the past few months, everything has happened. The world has stopped, the unfinished long wave of deaths has arrived, the peak of the infections and then the gradual effects of the lockdown. Now a timid return to life, with so many uncertainties that remain. How do you live in Moderna in these months?
«We are experiencing a moment of rapid growth, many investments, many hires, especially in the clinical and production sectors. We know that everyone’s contribution is fundamental and we feel we are part of a team that is playing a decisive game. In April, Moderna obtained $ 483 million in funding from the government agency Barda (Biomedical Advanced Research and Development Authority) to accelerate vaccine development. And we have made significant collaborations with the most important government institutions in the health sector. A network of fundamental alliances to deal with an emergency like the one that is still ongoing “.

At the same time, you are planning to start large-scale vaccine production. Where are you at?
“Moderna announced an agreement with the Swiss drug manufacturer Lonza a few weeks ago for a ten-year collaboration. Two industrial sites are already planned, one in the United States and the other in Switzerland. Our manufacturing facility, which has produced vaccines for other clinical trials, will be upgraded. It will be necessary to consider whether to open others in different areas of the planet to produce 1 billion doses of vaccine per year “.

Lonza’s managing director, Albert Baehny, confirms that the first commercial batch, produced in the USA, could be available by December and, in February 2021, those of the Visp plant in Switzerland will follow. Yet the vaccine, however large the production, will still not be accessible to everyone.
«These are considerations that go beyond our role. The goal is to vaccinate as many people as possible. Obviously there will be assessments on groups most at risk, on areas where outbreaks are found, but let’s not forget that vaccinations are really effective only if a broad vaccination coverage is reached to reach the so-called flock immunity. In this case we are also talking about 60-80 percent of the population. ”

In the field there are massive investments, many public funds. There are dozens of research groups and companies that target the vaccine. Could it be that there are more than one vaccines and it will be possible to reach a wider vaccination coverage in the world more quickly?

“It’s likely to imagine that more than one vaccine will be approved in the coming months. The team from the University of Oxford has recently announced the start of tests on more than ten thousand people in the UK hoping to have data by September. There is also a vaccine from the Chinese company CanSino, whose clinical data have recently been published in Lancet, which appears safe and well tolerated. Given the circumstances, the turmoil in the sector is evident. Then, which vaccine will have the highest level of protection will be seen over time. But at present several vaccines will be useful and necessary to face the global pandemic ».

All united in the search for the vaccine?

“Let’s say there is an intense exchange of information in international forums, there are alliances that have been created and many collaborations between industries and academic institutions. But we don’t all do the same things. In a sense, it is better to have different approaches because there will be more chances of success. Obviously, the objective remains for each of us to arrive as early as possible to obtain approval and use of the vaccine. ”

Modern in this race has also received negative comments: the technology is new, not yet proven concrete …
“True. The criticisms or doubts of some arise from the fact that vaccines based on mRNA technology do not yet exist on the market. Hence prudence, sometimes the opposition of skeptics. I, on the other hand, am convinced of the opposite. We are testing a real technological revolution, as I argued in front of the scientific committee of Moderna, where a Nobel laureate, professors from Harvard, MIT from Boston and other large American universities sit. If, but I prefer to say when, the mRNA vaccine will be approved, it will be a turning point. Clearly the vaccine for Covid-19 represents today a hope for the whole world and a top priority, but many other vaccines will come out of this technology in the coming years, some of which already in advanced clinical studies, such as the very important one against cytomegalovirus (CMV ) which entails malformations in the fetus, infantile deafness, microcephaly, a virus that affects thousands of children every year only in the USA and for which there is neither vaccine nor therapeutic solutions. We are experiencing an important, historic moment for technological innovation in medicine. ” (Source L’Espresso)





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