Inclusion of elderly and high-risk people in the Moderna trial suggested the vaccine would protect those most vulnerable to the disease, said Peter Openshaw, professor of experimental medicine at Imperial College London, who described the results. as “extremely exciting”.
Although more expensive, Moderna’s vaccine could potentially offer a major advantage over that of Pfizer, which requires ultra-cold freezing between -70 ° C (-94 ° F) and -80 ° C. production facility to the patient.
Moderna said they have improved shelf life and stability, meaning their vaccine can be stored for six months at -20 ° C for shipping and long-term storage, and at standard refrigeration temperatures of 2 ° C to 8 ° C for 30 days.
Moderna said it could potentially manufacture 1 billion doses by the end of 2021, adding an additional 1.3 billion from Pfizer / BioNTech within the same time frame. Both vaccines require two doses and are to be evaluated by regulators in the coming weeks.
Speaking at a press briefing, Fauci, the director of the U.S. National Institute of Allergy and Infectious Diseases, which co-developed the vaccine, praised the Moderna jab and others still in the works. testing.
He urged people to continue to follow the guidelines to fight the disease. “We must not let the realization of an effective vaccine make us feel that we can let our guard down… In fact, that should be an incentive to double down, because then we will ultimately have the synergy between a vaccine and a public health measure. which will get us out of the very difficult situation.
Stéphane Bancel, Managing Director of Moderna, said: “It has been incredible teamwork. I think none of us probably thought we could get to this place in the last 10 months.
Moderna’s interim analysis, based on the first 95 patients with confirmed Covid infections, found the candidate vaccine to be 94.5% effective. The company said it plans to apply to the US regulator, the Food and Drug Administration (FDA), for emergency use authorization in the coming weeks. In the analysis, 90 of the patients had received the placebo and the other five had received the vaccine.
Although provisional, the results are particularly interesting because the trial included a large proportion of people at high risk for severe Covid-19 and these appear to have been well protected.
The Moderna vaccine, which is being tested in more than 30,000 volunteers, is not expected to be available outside the United States until next year. The biotech company said it will have 20 million doses ready to ship to the United States by the end of 2020 and hopes to manufacture between 500 and 1 billion doses globally next year.
Guardian graphic
Moderna has agreed to supply the United States with 100 million doses, with an option to purchase an additional 400 million. Japan, Canada, Switzerland, Qatar and Israel have also signed agreements and the European Commission has a “potential purchase agreement” for doses of 80 to 160 m.
The vaccine, which is based on mRNA technology similar to that of BioNTech, is expected to be evaluated by the FDA on a final analysis of 151 Covid cases among trial participants who will be followed on average for more than two months .
Doses
At £ 38 to £ 45 for a course of two injections, Moderna’s vaccine is more expensive than other favorites. AstraZeneca and the University of Oxford aim to sell their vaccine for around £ 3 a dose, while vaccine trials with Johnson & Johnson and a collaboration between Sanofi and GSK are expected to cost around £ 8 a dose. Pfizer charges the US around £ 30 for a two-shot course.
Moderna’s two-dose vaccine injects genetic material called mRNA into the body, which cells then use to produce the spike protein that the virus uses to invade cells. The spike protein covers the surface of the virus and is one of the primary targets of the body’s immune response to clear infection.
There is some statistical uncertainty about the 94.5% figure, but Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene & Tropical Medicine, said based on the published figures the efficacy was probably even better. than 85%.
A question mark remains as to whether the Pfizer vaccine prevents serious illness. Moderna’s results, published by an independent data security oversight committee, are encouraging on this point.
Out of 11 participants who developed severe Covid during the trial, all were in the placebo group. The results also suggest that the vaccine is effective in the elderly and those of various ethnicities. Moderna said about 42% of participants were at risk of developing severe Covid-19 if they were infected because they were older or had comorbidities such as diabetes, obesity or high blood pressure.
Moderna’s interim analysis did not reveal any significant safety concerns, with most reactions being mild to moderate and of short duration. Among the side effects reported were pain at the injection site in 2.7% of the trial volunteers after the first vaccine. After the second, the most significant side effects included fatigue in 9.7%, muscle pain in 9%, and joint pain in 5%. Others had headaches, other pain, or redness at the injection site.
