At least three new vaccines will be available in the European Union in the coming months. Two of them are being tested in hospitals and manufactured in Spanish laboratories. Each uses a different technology and the first to arrive only needs one injection. Together, they will contribute up to 100 million extra doses to Spain. A third wave of new injectables is expected after the summer. It is the great offensive against the coronavirus .
"Around 8 if all goes well," said Health Minister Carolina Darias on Wednesday, referring to the authorization of a new vaccine in early March. It is the one created by the Belgian company Janssen (whose parent is the giant Johnson & Johnson). Trials of this drug are in their final phase. On February 26, he already has an appointment with the United States Food and Drug Administration (FDA) to analyze his request for emergency use. If it happens as with the three previous approved vaccines, a few days later the European Medicines Agency (EMA) will do it.
Janssen's vaccine, Ad26.COV2-S as they have called it, has several advantages . The main one is that in the most advanced trial, called ENSEMBLE, they are studying it under a single dose regimen. The authorization requested from the EU is for it, so the 400 million units committed (200 + another 200 optional) will allow vaccinating as many people. For its population, Spain would correspond to just over 40 million.
The Janssen vaccine will be administered in a single dose although they also test with two injections
Among its strengths is that, with a technology similar to that of AstraZeneca and Oxford , it lasts three months at temperatures of a conventional refrigerator, without the need to freeze it, and two years below zero. Another of its strengths is that, adding its other double-dose experiment, it is being tested with some 100,000 volunteers from various countries, including Spain. In addition, a third of the almost 50,000 participants in ENSEMBLE are over 65 years of age, thus avoiding the problems that AstraZeneca is having , for example, which is being reserved for minors of that age. Its efficacy, the most recent results of the single dose trial show a percentage of 66%, which rises to 85% at the time of avoiding an aggravated course of the disease. The first figure is lowered because the test includes several thousand South Africans. Everything indicates that the dominant variant of the coronavirus in South Africa is more resistant to the vaccine.
"You cannot compare efficacy percentages between different vaccines," recalls Dr. Alberto Borobia, coordinator of the clinical trials unit at La Paz hospital, from Madrid. Factors such as the design of the experiment, the sample size and characteristics of the volunteers or the time at which the tests are carried out are involved. Janssen's ENSEMBLE, for example, is designed to measure protection against moderate to severe cases of covid, while trials of other vaccines include mild or asymptomatic cases.
La Paz is one of eight Spanish hospitals participating in ENSEMBLE 2, a trial also with Janssen's vaccine, but testing the efficacy of the double dose. They don't have data yet, as they started recruiting the 30,000 volunteers in January. "It includes 30% who are over 65 years old," Borobia highlights. They will follow them weekly and, as in the previous trial, will be based only on the symptomatic ones. The researcher hopes to be able to analyze the impact of the new coronavirus variants, although that will depend on the degree of actual incidence of these mutations among the population.
One last advantage of Ad26.COV2-S, at least for Spaniards, is that A good part of the vaccines will be made at the Catalan pharmaceutical company Reig Jofre. Specifically, their laboratories will receive the antigen and will be in charge of the formulation, filling and packaging of the vaccine. The company says they will be able to produce 250 million doses a year. So the problem of shortages could be a thing of the past.
Also in Spain, the next vaccine will be produced, that of Novavax. The agreement between this biotech company from the US and the European Union has not yet been closed, but the Reuters agency picked up on Thursday a statement from an EU official stating: “the talks with Novavax have intensified and our objective is to have the contract this week or the next one ”. In principle, they would supply 100 million doses plus another optional. The EMA is already reviewing its results in real time for its authorization, which could take place in April.
According to data from an ongoing trial in the United Kingdom, with a double dose, this vaccine would have an efficacy of 89% in a sample where and half of those infected were infected with the British variant of the virus. However, in another parallel experiment in South Africa, the percentage of efficacy dropped to 60%, confirming the danger of the mutation that appeared in that country.
“Novavax's is a protein-based vaccine that contains a novel adjuvant that is also its property. ”Says Andrés Fernández, executive director of the Zendal group, the Galician company that has been manufacturing the antigen for this vaccine for a few weeks, which uses a different technology from the rest already approved. “The antigen – which is the part that generates the immune reaction in the human body – is produced in insect cells. To do this, a virus that is only capable of infecting insects is transformed so that it carries the appropriate protein in its message ”, explains Fernández.
Novavax's vaccine uses an inactivated, human-safe insect virus to sneak into cells and activate the immune response
What they do is inoculate
into moth cells and, when they have been infected, they inactivate them and extract the protein that will generate protection. "This is the part that is done in Biofabri, of the Zendal group," concludes its executive director. They are obtaining 1,000 liters of antigen a week at their O Porriño plant, in Pontevedra.
A new vaccine should arrive after the summer. It is the one created by CureVac, another biotechnology company, this German. The agreement with the EU stipulates the delivery of at least 405 million doses, of which 10% will be for Spaniards. And it has already been testing in Spain for a few days.
The research institutes of the Basque hospitals of Cruces and Donostia and the San Carlos Clinic in Madrid have begun the trial with 3,000 Spanish volunteers, who are part of a more global experiment, too double dose. Antonio Portolés, the principal investigator of the Madrid Clinic, then told the EFE agency that "it seeks to verify the immunogenicity of the vaccine, that is, the generation of neutralizing antibodies" against covid, to know "if it is possible to completely neutralize the virus and that those vaccinated do not transmit the disease when they are already immunized. ”
"Perhaps you have to vaccinate against the coronavirus every year, as with the flu" Felipe García, coordinator of the COVID-19 vaccine project at the Hospital Clínic-IDIBAPS in Barcelona.
The CureVac vaccine uses messenger RNA technology that Moderna and Pfizer / BioNTech have already made famous. Of the 242 vaccines controlled by the World Health Organization, 63 of them already tested in humans, 11% use this genetic mechanism to activate immunity. But, with Curevac, 50% of the vaccines in use are mRNA.
"They are easier to create and produce," says the coordinator of the COVID-19 vaccine project at Hospital Clínic-IDIBAPS in Barcelona Felipe García . “From when they have the sequence of the virus until they create the vaccine, a few weeks are enough. There is no other technology that allows this ”, adds García, who uses this same approach for which they are investigating, still in the preclinical phase. The scientist closely follows the evolution of the CureVac vaccine. "The particle that protects the RNA is different from Moderna or Pfizer," he says. If you can keep the messenger RNA until it gets into cells, you will give this formulation an advantage. "The technology and production are much cheaper," he assures.
For García, although the rest of the vaccines, like the Spanish ones, arrive later, "it is key to have a technology like this in Spain." For him, its elasticity is such that it would allow raising new defenses against a future viral threat not in a year, a real achievement now, but "in months and even weeks." Also, remember, there are more and more signs that "you have to vaccinate against the coronavirus every year, as with the flu."
Even the creators of the Russian vaccine Sputnik V have shown interest in undergoing the review of the European Medicines Agency
The offensive against the coronavirus in Europe does not stop here. The EMA has advised on legal and regulatory aspects to several oriental vaccines, most of them Chinese. But they have not shown, to date, interest in entering Europe. The case of Russian Sputnik V, already massively distributed in other regions of the planet. The European health authorities acknowledged that the Russians had shown their interest in submitting their trials to community review.
More realistic will be the arrival, on an undetermined date, of the vaccine from the French company Valneva. His is based on a more traditional technology, the use of the inactivated virus itself. "Our vaccine is currently the only inactivated candidate in clinical trials against covid in Europe," says Valneva medical director Juan Carlos Jaramillo. In January they announced that their talks with the EU to supply another 60 million doses are well advanced. So more arsenal.
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