The European Medicines Agency (EMA) has received the authorization request for the vaccine developed by Janssen-Cilag International, a Belgian subsidiary of the multinational Johnson & Johnson.
This is the first step that officially sets in motion the machinery of the European regulator to assess and pronounce on the safety and efficacy of the vaccine for use in European territory.
The EMA's Committee for Medicinal Products for Human Use (CHMP) could issue an opinion on the punctures in mid-March, according to the agency's statement issued on Tuesday.
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Little by little, and despite criticism and setbacks since the start of the vaccination campaign, Brussels is reaping the fruits of diversification in its vaccine strategy.
If the so-called conditional authorization is granted to the Johnson & Johnson drug, which is a single dose, it would be the fourth prototype approved for use in the European Union, after Pfizer-BioNTech, Moderna and AstraZeneca .
Brussels signed with Janssen last October a contract to acquire, if its vaccine was approved, 200 million doses (with the possibility of another 200 million more).
“Positive news”, Health Commissioner Stella Kyriakides has expressed through a tweet after the EMA announcement.
"It is a welcome step in our efforts to achieve more safe and effective vaccines."
The EU currently has a diversified portfolio of six potential vaccines totaling 2.3 billion doses.
Positive # COVID19 vaccine news, with @JNJNews application to @EMA_News for conditional marketing authorization.
This is a welcome step in our efforts to secure more safe & effective vaccines.
#SafeVaccines https://t.co/17TcZVfWta
- Stella Kyriakides (@SKyriakidesEU) February 16, 2021
In case of receiving the positive report from the EMA (and the subsequent green light of the Community Executive, which usually takes a few hours after the regulator's decision) it would be the first single-dose vaccine in the EU, so the 400 million Potential punctures negotiated by the Commission would serve to vaccinate an equal number of people.
Spain, depending on its population, would correspond to just over 40 million doses of Janssen.
This vaccine also has an appointment with the United States Food and Drug Administration (FDA) for this February 26 to analyze its request for emergency use in this country.
The appeal of the puncture also lies in its easy logistics and handling.
The vaccine technology is similar to AstraZeneca's and can be stored and transported for months at conventional refrigerator temperatures, without going through the complex deep-freezing processes required by Pfizer's vaccine, for example.
Recent trials carried out with a single dose show an efficacy of 66%, rising to 85% in preventing an aggravated picture of the disease (although the reduction of the first first figure could be due to the fact that the trials have included thousands citizens of South Africa, where a more drug-resistant variant of the coronavirus is dominant).
The prototype has been developed from an adenovirus modified to contain the gene that makes the SARS-CoV-2 spike protein, which the virus needs to enter the cells of the body.
After inoculation, the person's immune system thus recognizes the protein as foreign and produces antibodies activating T lymphocytes (white blood cells) to attack it.
If, later on, the person comes into contact with the SARS-CoV-2 virus, their immune system will recognize the spike proteins of the virus and will be ready to defend the body against it.