Moderna Inc’s experimental vaccine was 94.5% effective in preventing Covid-19 based on interim data from a late-stage trial, the company said Monday, becoming the second U.S. pharmacist to report results that far exceed those. expectations.
Along with Pfizer Inc’s vaccine, which is also 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 doses of vaccine available this 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 developed with a new technology known as messenger RNA (mRNA), represent powerful 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, setting new records in the United States and pushing some European countries to re-block.
“We are going to have a vaccine that can stop Covid-19,” Moderna president Stephen Hoge said in a telephone interview.
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.
“Having more than one source of an effective vaccine will increase the global supply and hopefully help us all return to something close to normal sometime in 2021,” said Eleanor Riley, professor of immunology and infectious diseases at the University of Edinburgh. .
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.
The company’s shares, which have more than quadrupled this year, were up 15% in pre-market trading, while European stocks and Wall Street stock futures rose with the vaccine update. Reference futures for the S&P 500 rose 1.3%, pausing shortly before a new record, while the pan-European STOXX 600 hit late-February highs.
Pfizer shares fell 1.7% in premarket trading, while Britain’s AstraZeneca, which has yet to release any results from its late-stage vaccine trials, were 0.7% weaker.
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 normal refrigerator temperatures of 2 to 8 degrees Celsius (36 to 48 ° F) for 30 days and can be stored for up to 6 months at -20 ° C.
Pfizer’s vaccine should be shipped and stored at -70 ° C, the typical type of temperature for 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.
Data from Moderna’s trial that involved 30,000 volunteers also showed that the vaccine prevented cases of severe Covid-19, a question 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 U.S. government’s Operation Warp Speed program, expects to produce about 20 million doses for the United States this year, millions of which the company has already manufactured and is ready to ship if it gets clearance from the U.S. 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. .
One question with this vaccine, and all the others currently being tested, is whether they will stop the spread of Covid-19.
“Vaccines that prevent symptomatic disease are likely to reduce the duration and level of infectivity, and thus reduce transmission, but we do not yet know if this effect will be large enough to make a significant difference in the spread of the virus. within communities, “said Riley of the University of Edinburgh.
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 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, Moderna said.
“These effects are what we would expect with a vaccine that works and induces a good immune response,” said Peter Openshaw, professor of experimental medicine at Imperial College London.
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.
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 produce between 500 million and 1 billion doses in 2021, split between its US and international manufacturing sites, depending in part on demand.
Moderna also said it would use its 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 Sputnik-V Covid-19 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.
Along with Pfizer Inc’s vaccine, which is also 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 doses of vaccine available this 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 developed with a new technology known as messenger RNA (mRNA), represent powerful 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, setting new records in the United States and pushing some European countries to re-block.
“We are going to have a vaccine that can stop Covid-19,” Moderna president Stephen Hoge said in a telephone interview.
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.
“Having more than one source of an effective vaccine will increase the global supply and hopefully help us all return to something close to normal sometime in 2021,” said Eleanor Riley, professor of immunology and infectious diseases at the University of Edinburgh. .
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.
The company’s shares, which have more than quadrupled this year, were up 15% in pre-market trading, while European stocks and Wall Street stock futures rose with the vaccine update. Reference futures for the S&P 500 rose 1.3%, pausing shortly before a new record, while the pan-European STOXX 600 hit late-February highs.
Pfizer shares fell 1.7% in premarket trading, while Britain’s AstraZeneca, which has yet to release any results from its late-stage vaccine trials, were 0.7% weaker.
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 normal refrigerator temperatures of 2 to 8 degrees Celsius (36 to 48 ° F) for 30 days and can be stored for up to 6 months at -20 ° C.
Pfizer’s vaccine should be shipped and stored at -70 ° C, the typical type of temperature for 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.
Data from Moderna’s trial that involved 30,000 volunteers also showed that the vaccine prevented cases of severe Covid-19, a question 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 U.S. government’s Operation Warp Speed program, expects to produce about 20 million doses for the United States this year, millions of which the company has already manufactured and is ready to ship if it gets clearance from the U.S. 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. .
One question with this vaccine, and all the others currently being tested, is whether they will stop the spread of Covid-19.
“Vaccines that prevent symptomatic disease are likely to reduce the duration and level of infectivity, and thus reduce transmission, but we do not yet know if this effect will be large enough to make a significant difference in the spread of the virus. within communities, “said Riley of the University of Edinburgh.
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 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, Moderna said.
“These effects are what we would expect with a vaccine that works and induces a good immune response,” said Peter Openshaw, professor of experimental medicine at Imperial College London.
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.
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 produce between 500 million and 1 billion doses in 2021, split between its US and international manufacturing sites, depending in part on demand.
Moderna also said it would use its 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 Sputnik-V Covid-19 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.
.
