The news known in recent weeks is increasingly cooling the long-awaited possibility that some of the vaccines being developed against the coronavirus distribution begins before the end of this year. A month ago, the Minister of Health, Salvador Illa, insisted that the first doses would arrive in Spain in December or January. This Friday, however, he recognized that the antidote will take, “if all goes well, five or six months”, which places the horizon, at the earliest, in March, a forecast in which the European Medicines Agency (EMA) agrees.
“It is very difficult, almost impossible, have the vaccine by 2020. If all goes well, in the first months of 2021 there could be three approved by the EMA”, the executive director of the community body, the Italian Guido Rasi, also said this Friday. In an interview on the Skytg24 television channel, Rasi has pointed towards spring, when he hopes they will be available “the first important doses for populations at risk”.
“Availability will increase very quickly after approval. I think that if we are lucky, many of those who want to get vaccinated could do so by the summer of 2021”, has added. This Wednesday the World Health Organization (WHO) assured however that the youngest will have to wait until 2022 to get vaccinated.
Leading trials in the EU
The first vaccines that the EMA could approve are those of AstraZeneca, Moderna and Pfizer. All three have obtained confirmation from the agency to request a marketing authorization from the European Union. This means that the evaluation of your projects has started through a procedure called rolling review.
This is a exceptional mechanism for research that is considered promising activated by the EMA due to the health emergency, with the aim of accelerating deadlines but “without prejudice to the guarantees of quality, safety and efficacy established in European legislation”. The process will continue until sufficient evidence is available to support a formal application for marketing authorization. It will be at that time when the body concludes if the vaccines exceed the usual standards of quality, safety and efficacy.
The three investigations are in phase III, in which the vaccine is tested in thousands of people to see if it is safe and effective, but the North American pharmaceutical companies Moderna and Pfizer seem to be leading this race, since until now neither of the two has reported incidents that have caused the testing to be halted. In Moderna’s case, the 22,194 participants in his study have already received their second dose and the Canadian Ministry of Health will also begin evaluating their vaccine. In the case of Pfizer, it has just obtained the green light from the US Food and Drug Administration (FDA) to include children between the ages of 12 and 16 in its clinical trials, in addition to the 44,000 volunteers it already has.
The one that AstraZeneca carries out, together with the University of Oxford, seems to have been somewhat behind. Despite having come to say that it could be ready in November, the professor of Pharmacoepidemiology at the university center, Daniel Prieto-Alhambra, pointed out a few days ago that “the best situation would be for it to be approved towards the end of the year and vaccination could begin by the first quarter of 2021“. The two specific interruptions they had to make after both volunteers fell ill have slowed down the process. In both cases it was ruled out that these events had something to do with the antidote, but until that point was confirmed, the workers were paralyzed.
That is what has also happened to the Belgian Janssen, owned by the multinational Johnson & Johnson, which has stopped phase III of its work for a “unexplained illness” on a participant. The company recalled that, in the event of any incident, “pausing recruitment or dosing is a standard component of a clinical trial protocol”.
The vacuna rusa Sputnik V It has, for its part, begun to be tested in people over 60 years of age, but they do not expect to have vaccinated 80% of the country’s population for 9 to 12 months. Y the French group Sanofi You are working on a project for which you have scheduled an accelerated production start to be available in the middle of next year.
Status of treatments
Along with the antiviral Remdesivir, which has been talked about so much and according to a recent trial accelerates the recovery of patients, on the use of different drugs to treat the disease, the director of the EMA has explained that “there are at least two or three medications or approaches that are surely effective”. “Using cortisone at the right time, not too early or too late, or using blood thinners. And now the possibility of starting to use monoclonal antibodies is very close, the ones that seem to have been used in the White House”Rasi added.
The treatment received by US President Donald Trump, who has already recovered from the infection, is a new drug, known as RAIN-COV2 and developed by the pharmaceutical company Regeneron. It is a combination of two monoclonal antibodies (which are all the same), directed against the Spike protein of SARS-CoV-2. It is currently in phase 2 and 3 of clinical trials for the treatment of Covid and in phase 3 to prevent infection in homes where infected people live.
This therapy is similar to the one that the pharmaceutical company was developing Eli Lilly, who has had rehearsals suspended due to concerns about her safety. This decision was made after Trump praised the treatment and the company requested emergency approval for its use.
Here in Spain, hope is in the cyclosporine, a drug that is used to prevent rejection in organ donation operations and whose use has reduced the probability of dying from coronavirus by 81% in a first study carried out by researchers from the Quirónsalud Madrid University Hospital and the European University.
Likewise, the Higher Center for Scientific Research (CSIC) works on what is called lethal mutagenesis, or what is the same, mutating the pathogen until it is harmless. In this line, two drugs have been effective. They are Favipiravir and Rivadivine, which have been used previously against influenza and childhood respiratory diseases and which could have the ability to accelerate the mutation of the coronavirus until it is unable to continue infecting.
The Spanish biotechnology company PharmaMar has also announced that its analyzes with Aplidin, an antitumor drug, for the treatment of adult patients with coronavirus who require hospital admission have achieved “positive results”, both in safety and in efficacy. As the company has detailed, the most recent results have shown “a marked reduction in viral load” in patients between four and seven days after the start of this therapy.