The European Medicines Agency (EMA) has recommended granting a conditional marketing authorisation to the Moderna Covid-19 vaccine, but it is still being considered by UK regulators.
The phase three results suggest vaccine efficacy against the disease was 94.1%, and vaccine efficacy against severe Covid-19 was 100%.
Here’s what we know about the Moderna vaccine.
– How was the trial run and what are the results?
More than 30,000 people in the US took part, from a wide range of age groups and ethnic backgrounds.
Two doses were given 28 days apart so researchers could evaluate safety and any reaction to the vaccine.
The analysis was based on 196 cases, of which 185 cases of Covid-19 were observed in the placebo group versus 11 cases observed in the active vaccine group.
Moderna also released data relating to severe cases.
All 30 severe cases occurred in the placebo group and none in the group which had received the vaccine, known currently as mRNA-1273.
– What happens now?
The EMA has recommended that the Moderna jab be granted conditional marketing authorisation by the EMA.
The European Commission will now fast-track the decision-making process to grant a decision on the conditional marketing authorisation for Covid-19 Vaccine Moderna, allowing vaccination programmes to be rolled out across the European Union.
A conditional marketing authorisation is a formal authorisation of the vaccine, covering all batches produced for the EU and providing a robust assessment to underpin vaccination campaigns.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is conducting a rolling review of the vaccine from the American firm.
– When will people in the UK get the vaccine?
The UK Government has secured seven million doses of the jab – enough to vaccinate about 3.5 million people.
After approval from the MHRA, doses could start being delivered in the spring if it meets the standards.
– How does the vaccine work?
The Moderna jab is a messenger RNA (mRNA) vaccine.
Conventional vaccines are produced using weakened forms of the virus, but mRNAs use only the virus’s genetic code.
An mRNA vaccine is injected into the body, where it enters cells and tells them to create antigens.
These antigens are recognised by the immune system and prepare it to fight coronavirus.
No actual virus is needed to create an mRNA vaccine. This means the rate at which the vaccine can be produced is accelerated.
– But is the vaccine safe?
Moderna said the vaccine was generally well tolerated, with no serious safety concerns identified to date.
Severe events after the first dose included injection-site pain, and after the second dose included fatigue, myalgia (muscle pain), arthralgia (joint pain), headache, other pain and redness at the injection site.
But these were generally shortlived.
– Is the Moderna vaccine better than those from Pfizer/BioNTech or Oxford and AstraZeneca?
The UK is already rolling out the vaccines developed by Pfizer/BioNTech, and the University of Oxford with AstraZeneca.
Data published in The Lancet medical journal in early December showed the Oxford vaccine was 62% effective in preventing Covid-19 among a group of 4,440 people given two standard doses of the vaccine, when compared with 4,455 people given a placebo drug.
Of 1,367 people given a half first dose of the vaccine followed by a full second dose, there was 90% protection against Covid-19 when compared with a control group of 1,374 people.
Data from Pfizer and BioNTech indicates the vaccine is 95% effective.
In December, this jab was granted approval for use in the EU.
However, it is difficult to say whether one option is better than the other, as each trial has had different protocols and they cannot be directly compared.