COVID-19 vaccine developed by Moderna, NIH is 94.5% effective, early data show
An interim review of phase 3 data showed that a COVID-19 vaccine codeveloped by Moderna Inc. and the NIH had an efficacy rate of 94.5% with no significant safety concerns, Moderna said.
The efficacy and safety data were reported by an NIH-appointed data safety monitoring board and were based on 95 cases of COVID-19, of which 90 occurred in the placebo group vs. five in the vaccine group. These included 11 cases of severe COVID-19 — all in the placebo group.
Based on the data, Moderna said it will submit the two-dose messenger RNA (mRNA) vaccine candidate — currently called mRNA-1273 — to the FDA for an emergency use authorization “in the coming weeks.”
The announcement was more good news for COVID-19 vaccine programs following Pfizer and BioNTech’s announcement last week that its mRNA vaccine candidate was shown to be more than 90% effective based on interim phase 3 data.
“Since the vaccines are very, very similar, we can conclude that repeating the experiment led to the same outcome, which increases confidence,” Florian Krammer, PhD, a professor of vaccinology at the Icahn School of Medicine at Mount Sinai in New York, told Healio.
Krammer said the results also mean “more vaccine doses will become available quicker.” Pfizer and BioNTech said last week that they expect to produce up to 50 million doses of their vaccine globally by the end of the year and up to 1.3 billion doses in 2021. Moderna said it would have approximately 20 million doses of its vaccine ready to ship in the United States by the end of 2020 and up to 1 billion doses available globally in 2021.
Moderna also said that new data indicate its vaccine remains stable for 30 days at 36°F to 46°F, “the temperature of a standard home or medical refrigerator.” That is weeks longer than an early estimate of 7 days, which could mitigate issues related to cold shipment and storage and make distribution easier, allowing the vaccine to be shipped a temperatures “commonly found in readily available pharmaceutical freezers and refrigerators,” Moderna Chief Technical Operations and Quality Officer Juan Andres said in a news release.
COVID-19 cases are surging globally. In the U.S., which is facing a significant third wave of the disease, there have been more than 11 million cases and 246,000 reported deaths, according to tracking by Johns Hopkins.
Experts have begun discussing who will receive a COVID-19 vaccine first when one is available, with all indications suggesting that health care workers, other essential workers, people with high-risk conditions and older patients will top the list. The Biden-Harris transition team has made the “effective, equitable” distribution of vaccines and treatments one of the seven goals of its plan to fight the virus.
Speaking at The Liver Meeting Digital Experience before the release of data from the Moderna-NIH vaccine, National Institute of Allergy and Infectious Diseases Director Anthony S. Fauci, MD, said he was excited by the early results from clinical trials of COVID-19 vaccine candidates.
“We now look at this with cautious optimism that by the end of this calendar year and well into 2021, we will be administering doses first to the highest priority and then ultimately to virtually everyone in the United States,” Fauci said.
Early data on the Moderna vaccine come from the COVE study, which enrolled more than 30,000 participants in the U.S. It was the first COVID-19 vaccine candidate given to people in the U.S., with injections starting in March. In addition to Moderna and the NIAID, the trial is also being conducted in collaboration with the Biomedical Advanced Research and Development Authority.
According to Moderna, the 95 COVID-19 cases included in the interim analysis included 15 adults aged 65 years or older, and 12 self-identified Hispanic or Latinx, four Black or African Americans, three Asian Americans and one multiracial participant.
Analysis of the primary endpoint, which was based on confirmed cases of COVID-19 starting 2 weeks after participants received a second dose of the vaccine,
“suggests a broadly consistent safety and efficacy profile across all evaluated subgroups,” the company said.
One remaining question is how long immunity from these vaccines will last. Krammer said “there is no reason to believe it will disappear quickly.”
“We will find out once time goes by,” he said.
Moderna previously released promising phase 1 data on its vaccine candidate in July. Participants in the phase 3 trial received 100 µg doses of the vaccine. An expansion of the phase 1 trial showed that adults aged 55 years or older did not need larger doses of the vaccine to achieve responses similar to those of younger adults.