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CAMBRIDGE, Mass .: Moderna said Monday (Nov. 16) that its experimental vaccine was 94.5 percent effective in preventing COVID-19 based on interim data from a late-stage clinical trial, making it the second largest U.S. company. in a week to report results so far. exceed expectations.
Along with the Pfizer vaccine, which has also been shown to be more than 90 percent effective, and pending more safety data and regulatory review, the United States could have two vaccines licensed for emergency use in December with up to 60 million vaccine doses available by the end of the year.
Next year, the US government could have access to more than 1 billion doses from the two vaccine manufacturers alone, more than is needed for the country’s 330 million residents.
The vaccines, both built with new technology known as messenger RNA or mRNA, represent powerful new tools to fight a pandemic that has infected 54 million people worldwide and killed 1.3 million.
The news also comes at a time when COVID-19 cases are skyrocketing, hitting new records in the United States and pushing some European countries back into lockdowns.
“We are going to have a vaccine that can stop COVID-19,” Moderna president Stephen Hoge said in a telephone interview.
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Moderna’s interim analysis was based on 95 infections among trial participants who received a placebo or the vaccine. Of these, only five infections occurred in those who received the vaccine, which is given in two injections 28 days apart.
“This news from Moderna is tremendously exciting and greatly increases optimism that we will have a selection of good vaccines in the coming months,” said Peter Openshaw, professor of experimental medicine at Imperial College London.
“This latest press release is based on a study of 30,000 American adults, including many seniors or high-risk people. This gives us confidence that the results are relevant to people who are at higher risk for COVID-19.”
Moderna expects to have enough safety data required for the US authorization in the next week and the company expects to apply for the emergency use authorization (US) in the coming weeks.
SEVERE CASES
A key advantage of Moderna’s vaccine is that it does not require ultra-cold storage like Pfizer’s, making it easy to distribute. Moderna expects it to be stable at standard refrigerator temperatures of 2 to 8 degrees Celsius for 30 days and can be stored for up to six months at minus 20 degrees Celsius.
Pfizer’s vaccine should be shipped and stored at minus 70 degrees Celsius, the type of temperature typical of an Antarctic winter. It can be stored for up to five days at standard refrigerator temperatures or up to 15 days in an insulated shipping box.
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Data from Moderna’s trial of 30,000 participants also showed that the vaccine prevented severe COVID-19 cases, an issue that still remains with the Pfizer vaccine.
Of the 95 cases in Moderna’s trial, 11 were severe, and all 11 occurred among volunteers who received the placebo.
Moderna, part of the US government’s Operation 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. Submit if cleared by FDA.
“Assuming we get an emergency use authorization, we will be ready to ship through Warp Speed in almost hours,” Hoge said. “So it can start being distributed instantly.”
The 95 COVID-19 cases included several key groups that are at increased risk for severe disease, including 15 cases in adults 65 and older and 20 in participants from racially diverse groups.
“We will need much more data and a full report or publication to see if the benefit is consistent across all groups, especially the elderly, but this is definitely encouraging progress,” said Stephen Evans, professor of pharmacoepidemiology at the School of Hygiene and London Tropical Medicine. .
ROLLING REVIEW
Most of the side effects were mild to moderate. However, a significant proportion of volunteers experienced more severe aches and pains after taking the second dose, including about 10 percent who had fatigue severe enough to interfere with daily activities, while another 9 percent had body aches. serious.
Most of these complaints were generally short-lived, the company said.
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Their data provides further validation of the promising but previously untested mRNA platform that turns the human body into a vaccine factory by persuading cells to produce certain viral proteins that the immune system sees as a threat and against which it mount an answer.
The United States has the highest known number of COVID-19 cases and deaths with more than 11 million infections and nearly 250,000 deaths.
The Trump Administration has relied primarily on the development of vaccines and treatments in response to the pandemic. 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 United States government also has the option of another 400 million doses.
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The company expects to have between 500 million and 1 billion doses in 2021, split between its US and international manufacturing sites and depending in part on demand.
The US government has said that COVID-19 vaccines will be provided free to Americans, whether they have health insurance, are uninsured, or are covered by government health programs like Medicare.
Moderna also said it will use your data to seek authorization in Europe and other regions.
Europe’s health regulator said on Monday it had launched a real-time “continuous review” of Moderna’s vaccine, following similar reviews of vaccines from Pfizer and AstraZeneca.
Other countries like China and Russia have already started vaccinating. Russia licensed its COVID-19 “Sputnik-V” vaccine for home use in August before releasing data from large-scale trials. He said on November 11 that his vaccine was 92 percent effective based on 20 infections in his large trial.
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