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© Associated Press
Modern pharmaceutical company reported that its experimental vaccine was 94.5% effective in preventing COVID-19 based on interim data from a third phase of a clinical trial.
Moderna received $ 1 billion from the Donald Trump administration, although the Wall Street Journal and Reuters reported that it has not yet approved any vaccines in the United States and that disputes have arisen with suspected government scientists. that the biotech company has enough experience and staff to conduct large-scale testing among tens of thousands of volunteers.
Along with the vaccine from Pfizer Inc., which also reported 90% efficacy, and pending more safety data and regulatory review, the United States may have two vaccines approved for emergency use in December and up to 60 million doses. . Vaccine available from the end of the year.
Next year, the US government may have access to more than 1 billion doses from the two vaccine manufacturers alone – more than the 330 million people needed. Vaccines created with a new technology known as messenger RNA, or mRNA, are powerful new tools to fight the pandemic.
Moderna’s interim analysis was based on 95 infected people in the study who received a placebo or a vaccine. Of these, only five infections occurred in those who received the vaccine, which was given in two doses at 28-day intervals. A key advantage of Moderna’s vaccine is that it does not require ultra-cold storage like Pfizer’s, which makes it easy to spread.
Moderna expects it to be stable at standard temperatures of 2 to 8 degrees Celsius for 30 days and can be stored for up to 6 months at -20 degrees Celsius. Pfizer vaccine should be stored at -70 degrees Celsius. At standard temperatures in the refrigerator it can be stored for up to five days.
Data from the Moderna study of 30,000 participants also showed that the vaccine prevented cases of severe COVID-19, an unresolved problem in the Pfizer vaccine. Of the 95 cases in the modern process, 11 were severe and all 11 occurred among placebo volunteers.
Moderna, part of the US government’s Warp Speed program, expects to produce about 20 million doses of the vaccine for the United States this year, millions of which the company has already manufactured and is ready to ship if approved. from the FDA. “Assuming we get an emergency permit, we’ll be ready to ship it through Warp Speed in almost hours,” Hoge said, “so it can start rolling out immediately.”
Moderna has received nearly $ 1 billion in research and development funding from the United States government and has a $ 1.5 billion deal for 100 million doses.
The cases of the sick
The 95 cases of COVID-19 include several key groups that are at increased risk of serious illness, including 15 cases in adults 65 and older and 20 in participants of different racial groups. Most of the side effects are mild to moderate. However, a significant proportion of volunteers experienced more severe pain after taking the second dose, including about 10% who felt tired enough to interfere with daily activities, while another 9% had physical pain.
Most of these complaints are typically short-lived, the company said. Moderna’s data provides further validation of the concept of a promising but unproven mRNA that turns the human body into a “vaccine factory” by causing cells to produce certain viral proteins that the immune system sees as a threat and triggers a response. Moderna hopes to have enough data to obtain a permit in the United States next week and apply for emergency use in the coming weeks.
The US government has said that COVID-19 vaccines will be provided free of charge to Americans, whether they have health insurance, are uninsured, or are covered by government health programs like Medicare. Moderna also said it would use its data to find a solution in Europe and other regions.
Other countries, such as China and Russia, have already started vaccinating. Russia approved its COVID-19 Sputnik-V vaccine for home use in August before releasing data from large-scale trials. On November 11, he said his vaccine was 92% effective based on 20 infections in the large study.
The first reactions
“It will be much easier to transport and administer this vaccine than Pfizer’s. Preliminary evidence also suggests that it can prevent severe COVID-19. However, Moderna’s vaccine is more expensive and will have fewer doses available next year,” he said to Reuters Andrew Hill, Principal Investigator at the University of Liverpool “No vaccine company has enough supplies to protect everyone in need. We will need all available vaccines with greater than 90% efficiency to meet global demand.”
“The safety data looks promising. The side effects of the vaccine are the same as those seen with other adult vaccines, including the seasonal flu vaccine, which is given in many millions of doses each year,” said Eleanor Riley, Professor of Immunology at the University of Edinburgh. “It is important to know whether this vaccine, or any of the vaccines currently being tested, prevents disease transmission. Vaccines that prevent symptomatic disease are likely to reduce the duration and level of infection and thus reduce transmission However, we do not know if this effect will be severe enough to make a significant difference in the spread of the virus. “
