Human medicines European public assessment report (EPAR): Spikevax (previously COVID-19 Vaccine Moderna), elasomeran,imelasomeran and elasomeran,davesomeran and elasomeran,COVID-19 mRNA vaccine (nucleoside-modified), COVID-19 virus infection, Date of…
Primary vaccination
A very large clinical trial showed that Spikevax, given as a two-dose regimen, was effective at preventing COVID 19 in people from 18 years of age. The trial involved around 30,000 people in total. Half received the vaccine and half were given dummy injections. People did not know whether they received the vaccine or the dummy injections.
Efficacy was calculated in around 28,000 people from 18 to 94 years of age who had no sign of previous infection.
The trial showed a 94.1% reduction in the number of symptomatic COVID-19 cases in the people who received the vaccine (11 out of 14,134 vaccinated people got COVID-19 with symptoms) compared with people who received dummy injections (185 out of 14,073 people who received dummy injections got COVID-19 with symptoms). This means that the vaccine demonstrated a 94.1% efficacy in the trial. The trial also showed 90.9% efficacy in participants at risk of severe COVID-19, including those with chronic lung disease, heart disease, obesity, liver disease, diabetes or HIV infection.
Another study showed that an additional dose of Spikevax increased the ability to produce antibodies against SARS-CoV-2 in organ transplant patients with severely weakened immune systems.
The effects of Spikevax were also investigated in a study involving over 3,000 children aged 12 to 17 years. The study showed that Spikevax produced a comparable immune response in 12- to 17-year-olds to that seen in young adults (aged 18 to 25 years), as measured by the level of antibodies against SARS-CoV-2. In addition, none of the 2,163 children who received the vaccine developed COVID-19, compared with four of 1,073 children given a dummy injection. These results allowed to conclude that the efficacy of Spikevax in children 12 to 17 years old is similar to that in adults.
An additional study involving three groups of children aged 6 months to under 2 years, 2 to 5 years and 6 to 11 years showed that Spikevax produced a comparable immune response in these age groups to that seen in young adults (aged 18 to 25 years), as measured by the level of antibodies against SARS-CoV-2. These results indicate that the efficacy of Spikevax in children 6 months to 11 years old is similar to that in adults.
Booster vaccination
Spikevax
Data showed a rise in antibody levels when a booster dose of Spikevax was given in adults with a normal immune system after the second dose of Spikevax or after primary vaccination with another mRNA vaccine or an adenoviral vector vaccine. The company also presented supporting evidence from studies, including data regarding the use of a booster dose of Spikevax in young adults aged between 18 and 25 years, together with post-authorisation data and real-world evidence from the use of a booster dose in young people.
Further data showed that a booster dose of Spikevax in children aged 6 to 11 years and in adolescents aged 12 to 17 produced a comparable immune response to that seen in young adults (aged 18 to 25 years).
Spikevax bivalent Original/Omicron BA.1
A study involving more than 800 adults aged 18 years and above found that a booster dose of Spikevax bivalent Original/Omicron BA.1 induced a stronger immune response against the SARS-CoV-2 strain and the Omicron subvariant BA.1, compared with a booster dose of Spikevax. The study compared the level of antibodies in people who were given a second booster dose of either Spikevax or Spikevax bivalent Original/Omicron BA.1, after previous vaccination with a primary series and booster dose of Spikevax. It was also concluded that Spikevax bivalent Original/Omicron BA.1 could be used as a first booster after primary vaccination and that the immune response induced by a booster dose of Spikevax bivalent Original/Omicron BA.1 in children aged 6 to 11 and adolescents aged 12-17 years would be at least equal to that in adults, given that previous data with Spikevax have shown a comparable effect.
Spikevax bivalent Original/Omicron BA.4-5
The composition of Spikevax bivalent Original/Omicron BA.4-5 is identical to that of Spikevax bivalent Original/Omicron BA.1, with the exception of an mRNA molecule encoding for different, but closely related, Omicron subvariants. Therefore, based on the data for Spikevax bivalent Original/Omicron BA.1 as well as data for Spikevax given as a booster, Spikevax bivalent Original/Omicron BA.4-5 is expected to generate an immune response against both the original SARS-CoV-2 strain and the BA.4 and BA.5 subvariants. Spikevax bivalent Original/Omicron BA.4-5 is expected to be more effective at triggering an immune response against the BA.4 and BA.5 subvariants than Spikevax. This is further supported by non-clinical laboratory data, which showed that the adapted vaccine is able to trigger an adequate immune response.
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