Final results of trials of Moderna’s vaccine against Covid-19 confirm that it has 94% effectiveness and that no one who has been vaccinated with it has developed serious illness, said the company, which initiated the process of approval with regulators around the world.
The American company submits the data to regulators in the United States, Europe and the United Kingdom for an emergency license. He expects the U.S. Food and Drug Administration to review it at its Dec. 17 meeting, Moderna said.
The UK has bought 7 million doses of the vaccine – 5 million the day Moderna announced its interim result of 94.5% effectiveness and an additional 2 million last week. But deliveries of the vaccine to the UK are not expected until March. Massachusetts-based Moderna received $ 2.48 billion in U.S. federal funds and played a key role in the Trump administration’s Operation Warp Speed.
Although they have made deals around the world, the United States will have access first. Moderna said he expected to have 20 million doses of his vaccine ready for use in the United States by the end of this year. In August, the United States bought 100 million doses with an option on another 400 million. Moderna says it is on track to manufacture 500 million to 1 billion doses worldwide by 2021.
Like Pfizer / BioNTech, Moderna used new mRNA (messenger RNA) technology to develop its vaccine, involving the genetic code of the virus rather than any killed or weakened part of it. The two companies announced remarkable and very similar results. Pfizer’s final data analysis gave its vaccine 95% effectiveness.
Moderna becomes the third company to transmit its data to regulators for approval, after Pfizer and then Oxford University / AstraZeneca. The British vaccine has an overall efficacy of 70%, although among a subset of volunteers who received a lower dose, the efficacy increased surprisingly to 90%. This finding will now be tested in the United States, amid concerns that it may be linked to the young age of the volunteers, who were all under the age of 55 in this part of the trial.
However, 70% efficiency is enough to be very useful in a pandemic, especially in countries without ultra-cold freezers, minus 70 to minus 80 C, needed for the Pfizer vaccine. Moderna’s vaccine is said to be stable for a month at normal refrigerator temperatures when taken out of the freezer, but the cost will be prohibitive in many parts of the world. In August, the company said it was charging between $ 32 and $ 37 a dose and defended its right to make commercial returns. The Oxford vaccine will cost less than £ 3 a dose. The UK has purchased 100 million doses of the Oxford vaccine, which will be a central part of its mass vaccination plans.
Moderna’s phase 3 analysis looked at 30,000 people who received the vaccine in the United States, 196 of whom became ill. Thirty people became seriously ill and one died, but none of them received Moderna’s vaccine. The trials included a significant number of people in the highest-risk groups, with 7,000 people over 65 and over 5,000 younger people with chronic conditions, such as diabetes, severe obesity and heart disease.
The study included 11,000 people from black, Asian and minority ethnic communities, the company said, or 37%, the same proportion as the US population. There were 33 older adults and 42 people from BAME backgrounds in the final analysis. The company said there were no serious side effects. The most common were sore arms, headaches, and fatigue.
Full data from the trial has not been published, but will be published in a peer-reviewed journal in due course, Moderna said.
“This positive primary analysis confirms the ability of our vaccine to prevent Covid-19 disease with an efficiency of 94.1% and, above all, the ability to prevent serious Covid-19 disease. We believe that our vaccine will provide a powerful new tool that could change the course of this pandemic and help prevent serious illnesses, hospitalizations and deaths, ”said Stéphane Bancel, CEO of Moderna.
Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene & Tropical Medicine, said it was important not to pay too much attention to the exact percentage value for efficacy.
“While the best estimate is 94.1% against all Covid-19 diseases, the statistical uncertainty is such that the data is consistent with an actual efficiency of around 87%,” he said. “It is of course always very good efficiency. Likewise, 100% efficacy against more severe diseases is compatible with 90% efficacy again, this is very good and it is proof that both serious and mild diseases are avoided.
There was no evidence the vaccine was worse in the elderly, he said, which was encouraging.
Azra Ghani, professor of infectious disease epidemiology at Imperial College London, said it was good news that no one who received the vaccine developed serious illness. “While this does not exclude some risk of serious disease after vaccination given the relatively low number of severe cases, these results suggest very high efficacy (> 85%) against this endpoint,” she said. .
She looks forward to the full results, which will include data on whether the vaccine prevents asymptomatic infections. “Effectiveness against this would be very welcome as it would give the first indication of the wider indirect impact that a generalized vaccination could have on reducing the spread,” she said.