Wednesday, September 22, 2021

EXCLUSIVE: Trial Results Show Moderna Vaccine Continued to Be Safe and Efficacious More Than Five Months After Second Dose

Good news regarding Covid-19 has been rather scarce of late. But results from a Phase 3 clinical trial published today in the New England Journal of Medicine show that more than five months post-second injection, the Moderna (mRNA-1273) vaccine’s efficacy did not wane. These findings dramatically demonstrate the high level of protection COVID-19 vaccines are continuing to give us.

On a personal note, as a cancer patient, two-time Moderna vaccine recipient and advocate for Covid-19 patients and cancer patients, I am pleased to learn the results of this study.  

“Overall, our results continue to demonstrate that vaccines work and work extremely well at preventing COVID-19,” Dr. Lindsay Baden, the trial's co-corresponding author, said in a press statement.

Baden, who works in the Division of Infectious Diseases at Brigham and Women’s Hospital, said that researchers are continuing to explore questions about duration of immunity following vaccination and the impact of variants. Snd the news is largely good. Even as we examine the possibility of waning immunity, Baden said, "We see evidence that the vaccine is still very protective."

The peer-reviewed NEJM paper details the findings.  Starting 14 days after the second dose of the Moderna vaccine, the vaccine efficacy was 93.2 percent for the prevention of COVID-19 compared to placebo.  Prevention of COVID-19 remained consistent across the follow-up period, with greater than 90 percent vaccine efficacy against disease observed four or more months after the second injection.

 

"Safety data were assessed continuously throughout the trial, including severe adverse events. The team solicited data on local and systemic adverse events seven days after each injection and collected data on unsolicited adverse events 28 days after each injection," the study noted. 

 

The frequency of other adverse events — including severe adverse events — were generally similar between the vaccine and placebo group, regardless of age. Vaccine efficacy was consistently high in subgroups, including participants who were 65 and older, 75 and older, those with comorbidities, different racial and ethnic groups, and different categories of occupational risk exposures. 

 

In secondary analyses, researchers also found substantial protection against asymptomatic infection.

“Overall, our results continue to demonstrate that vaccines work and work extremely well at preventing COVID-19,” said Baden. “We are continuing to explore questions about duration of immunity following vaccination and the impact of variants. But even as we examine the possibility of waning immunity, we see evidence that the vaccine is still very protective.”

The trial enrolled 30,415 participants; 15,209 were assigned to receive the mRNA- 1273 vaccine, and 15,206 to receive placebo. Vaccine efficacy in preventing Covid-19 illness was 93.2%. The efficacy in preventing severe disease was 98.2%. 

And vaccine efficacy was consistent across ethnic and racial groups, age groups, and participants with coexisting conditions. No safety concerns were identified.

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