It is a vaccine for preventing coronavirus disease (COVID-19) in people over 18 years of age. The vaccine does not contain SARS-CoV-2 and cannot cause COVID-19.
The vaccine contains a molecule called mRNA (messenger RNA) that includes the instructions for producing the S (spike) protein of the virus (the one the virus needs to be able to enter human cells).
When a person receives the vaccine, some of their cells read the mRNA instructions and temporarily produce the S-protein. Their immune system recognises this protein as being foreign, so it produces antibodies, and activates T-cells (lymphocytes) to attack it. If that person then comes into contact with the SARS-CoV-2 virus, their immune system quickly recognises it and initiates a defence response against the virus.
The vaccine requires two doses at least 28 days apart.
The mRNA in the vaccine does not stay in our bodies. It is destroyed just a few hours after the vaccination. It never comes into contact with the cell nucleus (the whole process takes place in the cytoplasm) and there is therefore no risk of any genetic modification.
A clinical trial has been conducted on over 30,000 participants. Half of them received the vaccine (vaccinated group) and half were given a placebo (control group).
The vaccine's effectiveness was determined in more than 28,000 participants aged over 18 who showed no signs of previous infection. The study showed a 94% reduction in the number of symptomatic cases of COVID-19 in the vaccinated group (11 cases out of 14,134 vaccinated) when compared to the control group (185 cases out of 14,073 unvaccinated). The vaccine was also 91% effective among participants with risk factors for severe disease caused by COVID-19 (asthma, COPD, diabetes, arterial hypertension, and obesity).
In the clinical trial, 343 individuals who had already had COVID-19 were vaccinated. These people were excluded from the effectiveness analysis, however, no particular or special side effects were recorded among these participants.
There is not enough data to conclude how the vaccine works in people who have already had COVID-19. The current guidelines recommend waiting at least three months from the disease recovery date before vaccinating these people.
We still do not know. All the trial participants will continue to be monitored (for up to 2 years) to provide further information on how long the protection lasts. Experimental data indicates that immunity to COVID-19 is likely to last for months or years, but not for life.
The Moderna vaccine is not recommended for children under 18 years of age because there is currently no information about the effects on this age group. The EMA has reached an agreement with Moderna to conduct a trial on this population group at a later stage.
The data is still limited. It is possible that immunosuppressed people will not respond as well to the vaccine, but from a safety perspective there are no additional problems. Immunosuppressed people can be vaccinated, as their risk of developing severe forms of COVID-19 is high.
Based on the information available to date and accumulated experience, the vaccination of pregnant women is safe. It is also recommended, as SARS-CoV-2 infection during pregnancy increases the risk of complications and the development of severe COVID. It can be administered at any time during pregnancy, and women planning a pregnancy can receive any of the COVID vaccines without having to wait between vaccination and conception.
Breastfeeding women can receive the vaccine without having to stop breastfeeding. Moreover, an added benefit of vaccinating pregnant and breastfeeding mothers is that the antibodies generated are transferred to the foetus through the breast milk.
According to the Spanish Ministry of Health, the Pfizer/BioNTech and Moderna vaccines are recommended during pregnancy and breastfeeding, but other vaccines may be used in other countries.
Most people who are vaccinated will not experience significant side effects. These may appear during the first week after vaccination. They are not usual after the first two days. The frequent mild or moderate effects observed in clinical trials were (source EMA):
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Substantiated information by:
Antoni TrillaSenior Consultant Head of the Department of Preventive Medicine and Epidemiology
Eduard Vieta PascualPsychiatristPsychiatry and Psychology Head of Department
Gema Maria Lledó IbáñezMédico internistaServicio de enfermedades autoinmunes
Jacobo Sellarés TorresPneumologistPneumology and Respiratory Allergy Service
Josep M. Miró Meda
Josep Maria PeriClinical psychologist
Maica RubinatSpecialist in Sports MedicineGeneral Secretary for Sport and Physical Activity of the Generalitat de Catalunya
Mariona ViolanSpecialist in Sports MedicineGeneral Secretary for Sport and Physical Activity of the Generalitat de Catalunya
Published: 12 March 2020
Updated: 12 March 2020
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