Modern Inc. said on Monday that the COVID-19 vaccine candidate had reached its main endpoint in the initial analysis of phase 3 test data, demonstrating 94.5% effectiveness, a far higher percentage than originally expected and triggering a wide-ranging market rally.
The news was shared in a statement and has not yet been published as a prepress or in a peer-reviewed medical journal. The company also said the vaccine could remain stable at refrigerated temperatures for longer than expected, which should facilitate distribution.
BofA analysts said the results were the best case scenario. “Today’s news is a clear victory for the global community,” they wrote in a note to customers. However, “additional data such as extended safety, durability, transmission rate and reduced hospitalizations are key data points that are still missing,”
The announcement comes a week after Pfizer Inc. PFE,
and partner BioNTech SE BNTX,
said their candidate for the COVID-19 vaccine had achieved 90% efficacy in a similar trial at a late stage, news that also sent the broader market and sectors destroyed by a pandemic significantly higher.
This is happening as the United States continues to record new cases of COVID-19 and hospitalizations, and as health systems in countries including Dakotas and Wisconsin are close to full hospital capacity. The United States leads the world in 11 million deaths and 246,224 deaths, according to data compiled by Johns Hopkins University. In any case, this is about one-fifth of the global total.
For full coverage of the MarketWatch pandemic, see:Up-to-date information on coronavirus
Cambridge, Massachusetts Moderna MRNA,
said it plans to apply for an emergency authorization to the US Food and Drug Administration for the mRNA-1273 vaccine in the coming weeks and expects it to be based on a final analysis of 151 cases and a median follow-up of more than two months. The FDA has said it will require a coronavirus vaccine to be at least 50% effective in order to gain approval.
The Phase 3 trial involved more than 30,000 participants in the United States and is conducted with the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, and the Biomedical Research and Development Authority, part of the Assistant Secretary’s Office of Preparation and Response. at the U.S. Department of Health and Human Services.
Read:BioNTech and Pfizer say their candidate for the COVID-19 vaccine is 90% effective, much higher than expected
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Modern stated that the main endpoint of the Phase 3 trial was based on the analysis of COVID-19 cases starting two weeks after the second dose of vaccine. The first analysis was based on 95 cases with 90 cases in the placebo group and five in the mRNA-1273 group.
The 95 cases were in adults aged 65 and over, with 20 participants identified as coming from different communities. Twelve were Hispanic or Latino, four were black or African American, three were Asian American, and one was a multiracial man. The inclusion of different patients in the studies is important because blacks and Asians are at greater statistical risk of contracting the virus and developing severe cases of COVID-19. The test did not reveal any significant safety concerns.
Both Moderna and Pfizer vaccines are based on RNA messenger technology, which uses a synthetic version of the virus to cause human cells to make copies of part of the virus and then trigger the immune system to respond. This technology is being developed to treat other serious diseases, including cancer, but an mRNA vaccine has not yet been approved.
Separately, Moderna said mRNA-1273 now remains stable at refrigerated temperatures for longer. In particular, the vaccine can remain stable at 2 degrees to 8 degrees Celsius (36 degrees to 46 degrees Fahrenheit), which is the temperature of a standard home refrigerator, for 30 days, extending from an earlier assessment of seven days.
In case you missed it:Moderna and Pfizer’s COVID-19 vaccine applicants require ultra-low temperatures, raising questions about storage, distribution
At negative 20 degrees Celsius (negative 4 degrees Fahrenheit), mRNA-1273 can remain stable for up to six months. It can remain stable at room temperature for up to 12 hours.
The vaccine will not require dilution or special handling, which means vaccination can be done in a number of settings, including pharmacies and doctor’s offices, Moderna said.
Like the Pfizer-BioNTech vaccine, two doses of Moderna are needed.
“We are pleased to provide these extended stability conditions for mRNA-1273 to regulators for approval,” said Moderna’s Chief Technical Officer for Quality Operations and Quality Juan Andres. “The ability to store our vaccine for up to six months in [-20 degrees Celsius] the inclusion of up to 30 days under normal conditions in the refrigerator after thawing is an important development and would allow for simpler distribution and more flexibility to facilitate larger-scale vaccination in the United States and other parts of the world. “
Medical experts warned last week that the Pfizer / BioNTech vaccine may be less effective in the real world than in the lab, according to MarketWatch’s Jaimy Lee.
“In the clinical trial, you choose the patients you like and follow them very closely,” said Mizuho Securities analyst Difey Yang. “In the real world, there are all ages and everyone has different health conditions.”
Shares of Moderna last rose 7.7% on the news and gained 392% during the year so far, while SPDR S&P Biotech ETF XBI,
has won 31% and the S&P 500 SPX,
has won 11%.