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Moderna Inc said its experimental vaccine was 94.5% effective in preventing Covid-19 according to interim data from a late-stage clinical trial, becoming the second American company in a week to report results that far exceed expectations.
Along with the Pfizer Inc vaccine, which has also been shown to be more than 90% 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 on the rise, 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.
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 ° C to 8 ° C for 30 days and can be stored for up to 6 months at -20 ° C.
Pfizer’s vaccine should be shipped and stored at minus 70 degrees Celsius, the type of temperature typical of an Antarctic winter.
At standard refrigerator temperatures, it can be stored for up to five days.
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.”
Data details
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.
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 around 10% who had fatigue severe enough to interfere with daily activities, while another 9% had severe body aches.
Most of these complaints were generally short-lived, the company said.
Moderna’s 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. the ones that mount an answer.
Moderna expects to have enough safety data required for US authorization in the next week and the company expects to apply for emergency use authorization in the coming weeks.
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.
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.
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% effective based on 20 infections in his large trial.
Vaccine will not be enough to stop pandemic: WHO chief
The head of the World Health Organization has said that a vaccine alone would not stop the coronavirus pandemic.
There have been more than 54 million cases of Covid-19 since it broke out in China last year and more than 1.3 million people have died.
“A vaccine will complement the other tools we have, it will not replace them,” said CEO Tedros Adhanom Ghebreyesus. “A vaccine alone will not end the pandemic.”
WHO figures for Saturday showed 660,905 cases of coronavirus were reported to the UN health agency, setting a new record.
That number, and the 645,410 recorded on Friday, surpassed the previous daily record of 614,013 recorded on November 7.
Dr. Tedros said that supplies of the vaccine would initially be restricted, and that “healthcare workers, the elderly and other at-risk populations will receive priority.”
“Hopefully that will reduce the number of deaths and allow health systems to cope.”
But he warned: “That will still leave the virus with a lot of room to move. Surveillance will have to continue, people will still have to be examined, isolated and cared for, contacts will still have to be traced … and individuals will still need to be cared for.”
Earlier this month, Pfizer and BioNTech said their experimental vaccine was more than 90% effective.
Protection in patients was achieved seven days after the second of two doses and 28 days after the first, based on preliminary vaccine findings.
Pfizer and BioNTech plan to release the first doses in weeks, once they receive emergency use permits from pharmaceutical agencies. They hope to have 1.3 billion doses ready next year.
Pfizer has yet to release its full results, so it is unclear if its vaccine stops transmission of Covid-19, meaning it would be suitable for mass administration, or if it only prevents serious diseases, in which case it would be prioritized for the elderly and in-risk populations.
There are currently more than three dozen other Covid-19 candidate vaccines in development, 11 of which are in phase 3 or have completed their trials.
Meanwhile, Europe’s health regulator said it had started a real-time review of Moderna’s experimental vaccine for Covid-19, in the wake of similar review releases for vaccines from AstraZeneca and Pfizer.
The Human Medicines Committee of the European Medicines Agency has started a “continuous review” for Moderna’s mRNA-1273 vaccine candidate and has already begun evaluating the first batch of data, the regulator said.
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