At a special meeting of the European Medicines Agency on March 11, it was suggested that Janssen’s vaccine (Ad26.COV2.S) would arrive in Spain, Conditional authorization Commercialization in all countries/regions in the European Union (EU).
This vaccine will soon be distributed in my country and is the first single-dose vaccine approved. This is one of its main advantages, in addition, it can also fight against new major variants.
Its storage and distribution conditions must also be considered, because it only requires refrigerator temperature (between 2ºC and 8ºC) and can even be stored for up to 12 hours at room temperature (up to 25ºC).
Janssen’s vaccine is the first vaccine to be licensed for single-dose administration
These characteristics will be beneficial to the distribution and management of Janssen vaccine in my country, greatly speed up the immunity of the entire population, and improve the long-awaited herd immunity.
The importance of this vaccine
The vaccine is based on the technology already used in previous vaccines developed by the company against other diseases such as Ebola virus, Zika virus, malaria, respiratory syncytial virus or HIV. They used a modified human adenovirus Ad26 to make it impossible to replicate. This technology has been tested in more than 100,000 people for more than five years.
In the specific case of a vaccine against covid-19, the adenovirus has been genetically modified so that it expresses a fragment of the new coronavirus (the S protein of SARS-CoV-2) in its membrane. Therefore, instead of administering a coronavirus, a human virus that is incapable of producing the disease but capable of inducing the production of antibodies against this protein is administered. Such antibodies are called spikes or spikes.
Phase 2 clinical trial
The authorization of this new vaccine is based on information obtained in phase 1 and 2 clinical trials and clinical trials. Inclusive research, Including phase 3 clinical trials to test the safety and effectiveness of a single dose of Jansen’s vaccine.
Our country is one of the three European countries that have conducted Phase 2 clinical trials, including 550 healthy volunteers between the ages of 18 and 55, and a group of people over 65
my country is one of the three European countries that have conducted Phase 2 clinical trials, including 550 healthy volunteers between the ages of 18 and 55, and a group of people over 65. Its purpose is to evaluate the safety and activity of different doses and treatment regimens (1 or 2 doses and different dose levels). In addition, in March this year, a new group of 12 to 17-year-old teenagers was added to expand the information for this age group.
Subsequently, the Phase 3 clinical trial of the ENSEMBLE study was started to evaluate the efficacy of a single dose as a strategy to use useful vaccines in pandemic emergencies. This randomized, double-blind clinical trial has been conducted in 43783 volunteers over the age of 18 on three different continents (North America, South America and Africa). Your results are the basis for the current approval of the vaccine.
Their results showed the efficacy of using 85% of Janssen vaccines to prevent serious diseases (hospitalizations and deaths related to COVID-19) in all regions and age groups studied and countries with different variants. These include variants that have attracted high attention, such as B.1.351, which was first discovered in South Africa. The onset of the protective effect was observed 14 days after the dose was administered, and 85% of the protective effect was reached at 28 days.
The prevention of serious diseases, including hospitalization and death due to covid-19, has been observed starting 14 days from the first dose.
In addition, the data shows that the vaccine is well tolerated, with less than 0.5% of serious adverse reactions at the puncture site, and less than 1.5% of serious adverse reactions related to the vaccine, such as headache, muscle pain, fatigue and high fever.
Next step: Phase 3
At the same time, in December 2021, Spain started the Phase 3 clinical trial of the ENSEMBLE-2 study under the coordination of the University Hospital of La Paz to evaluate the efficacy after two doses.
This is a randomized, double-blind clinical trial, which includes more than 30,000 people of legal age, including healthy people, patients with comorbidities, and more than 30% of people over 60. Half of the volunteers received two doses of the vaccine, while the other half received a placebo.
This research has been conducted in 121 centers on five continents, of which Spain has participated in more than 3,000 volunteers, representing a representative sample of the world’s population, especially the population of our country.
Alberto M. Borobia is the main investigator of the Phase 2 clinical trial of the Janssen vaccine Ad26.COV2.S at the University Hospital of La Paz and the co-investigator of the ENSEMBLE-2 clinical trial, coordinated by the Central Department of Clinical Research and Clinical Trials (UCICEC). Dr. Borobia does not have any other types of conflicts of interest with the Janssen laboratory.