Based on interim evidence from a late-stage study, Moderna Inc's experimental vaccine is 94.5 percent successful in preventing Covid-19, the company said on Monday, becoming the second US drugmaker to announce findings that far exceed estimates.
Another biotech company in the U.S named Moderna has claimed that their moderna vaccine is 94.5 percent effective. After Pfizer, it’s the second vaccine in the U.S. The vaccines, both produced with modern messenger RNA (mRNA) technologies, are effective instruments for battling a pandemic that has affected 54 million people globally and killed 1.3 million people. In the next week or so, Moderna expects to have adequate safety data needed for US authorization and expects to apply for emergency usage authorization (EUA) in the coming weeks.
The United States may have two vaccines approved for emergency use in December, with as much as 60 million doses of vaccine available this year along with Pfizer Inc's vaccine, which is still more than 90pc effective, and awaiting more safety evidence and regulatory review.
The vaccines, both produced with modern messenger RNA (mRNA) technologies, are effective instruments for battling a pandemic that has affected 54 million people globally and killed 1.3 million people.
Unlike the Pfizer vaccine, the shot of Moderna can be kept at regular fridge temperatures, which should make it easier to administer, a vital consideration as cases of Covid-19 are soaring, breaking new levels in the US and moving back into lockdowns in several European countries.
The interim study of Moderna was focused on 95 infections among participants in the trial who obtained the vaccine or a placebo.
In volunteers who got the vaccine mRNA-1273, which is given in two shots 28 days apart, only five infections occurred.
“The vaccine is really the light at the end of the tunnel,” Dr Anthony Fauci, the top US infectious diseases expert said. He urged Americans not to let their guard down and to continue washing hands and being vigilant about social distancing.
In the next week or so, Moderna expects to have adequate safety data needed for US authorization and expects to apply for emergency usage authorization (EUA) in the coming weeks.
As European stocks and Wall Street futures rose, the company's shares, which have more than quadrupled this year, surged as much as 12pc to a record high.
Benchmark S&P 500 futures rose 1.3pc, stopping just short of a lifetime peak, while since March 5, the pan-European STOXX 600 has reached its highest.
Shares of Pfizer and its partner BioNTech dropped 2.6pc and 12.9pc, respectively, while AstraZeneca of Britain, which has yet to report any data from its late-stage vaccine trials, dropped 1.1pc at 1425 GMT.
The results from Moderna further confirm the exciting but previously unproven mRNA platform that converts the human body into a vaccine factory by coaxing cells to generate viral proteins that are seen as a threat and assault by the immune system.
Moderna expects the vaccine to be stable for 30 days at normal fridge temperatures of 2 to 8 degrees Celsius (36 to 48F) and can be kept at -20C for up to 6 months.
The Pfizer vaccine must be shipped and processed at a temperature of -70C, the average temperature of the Antarctic winter.
It can be kept at the normal refrigerator temperature for up to five days, or in a thermal shipping box for up to 15 days.
The Moderna trial results involving 30,000 volunteers also revealed that the vaccine stopped serious Covid-19 cases, a concern that still persists with the Pfizer vaccine.
Of the 95 cases in Moderna's trial, 11 were extreme and all 11 occurred among placebo-placed volunteers.
Moderna, part of the Operation Warp Speed programme of the US government plans this year to manufacture around 20 million doses for the US, millions of which the company has already produced and is ready to ship if it receives FDA approval.
“Assuming we get an emergency use authorisation, we'll be ready to ship through Warp Speed almost in hours,” Hoge said. “So it could start being distributed instantly.”
The 95 cases of Covid-19 involved several key groups at elevated risk of serious illness, including 15 cases in adults 65 years of age and older and 20 cases of participants of culturally mixed groups.
“We will need much more data and a full report or publication to see if the benefit is consistent across all groups, notably the elderly, but this is definitely encouraging progress,” said Stephen Evans, professor of pharmacoepidemiology, London School of Hygiene & Tropical Medicine.
“It is likely that vaccines that prevent symptomatic disease will reduce the duration and level of infectiousness, and thus reduce transmission, but we don't yet know if this effect will be large enough to make any meaningful difference to the spread of the virus within communities,” said Eleanor Riley, professor of immunology and infectious disease at the University of Edinburgh.
The bulk of side effects have been mild to moderate.
However after taking the second dose, a large number of participants experienced more extreme aches and pains, including about 10pc that had exhaustion severe enough to interfere with everyday tasks, while another 9pc had severe body aches. In general, most of these issues were short-lived, Moderna said.
“These effects are what we would expect with a vaccine that is working and inducing a good immune response,” said Peter Openshaw, professor of experimental medicine at Imperial College London.
The US government, faced with the largest number of cases of Covid-19 known in the world, may have access to more than one billion doses of Moderna and Pfizer next year more than necessary for the country's 330 million people.
In its reaction to the pandemic, the Trump Administration has focused primarily on the production of vaccines and therapies.
Moderna has secured almost $1 billion in US federal grants for research and development and has a $1.5 billion contract for 100 million doses. For another 400 million doses, the government has a choice.
In 2021, the organization plans to manufacture between 500 million and 1 billion doses, divided between its US and foreign production sites, partially based on demand.
On Monday, the European health authority said it had conducted a real-time 'rolling study' of Moderna's vaccine, as it did with Pfizer and AstraZeneca vaccines.
Even, Brussels said it was about securing doses in talks with Moderna.
Vaccinations have also started in other countries such as China and Russia. In August, before beginning large-scale trials, Russia approved the Sputnik-V Covid-19 vaccine for domestic use. It said on November 11 that in its large trial, its vaccine was 92pc successful based on 20 infections.