Good news and bad news today.

By December 17, 2020Member News

First, the bad news. The U.S. continues to report new single-day records for daily incidence of new coronavirus cases with 194,610 reported on Friday. This is 36% more cases than the previous record, which was reported on the previous day. Since November 4, the average daily incidence has increased by 65%, and it appears to still be increasing exponentially. This surge is being called the “third wave,” and the reality is that for frontline healthcare workers, this is just the ever growing peak of a single wave that began in March. The U.S. never successfully contained the “first wave” so healthcare workers have not gotten a reprieve since the pandemic began. The upcoming Thanksgiving holidays is scaring public health leaders, in part fueled by a study that found a very high probability that at least one person will be carrying the coronavirus in holiday gatherings of 10 or more.

 

Now, the good news. Moderna Therapeutics issued a series of press releases over the past several days regarding the progress for the Phase 3 clinical trials for its candidate SARS-CoV-2 vaccine. Last week, Moderna announced that it identified enough cases among study participants—i.e., at least 53—to conduct the first interim analysis on the vaccine’s efficacy. The study completed enrollment of 30,000 participants in late October, and the primary metric is preventing symptomatic COVID-19 disease, with secondary aims of preventing severe disease and preventing infection. Last Friday, Moderna announced that Swiss regulatory officials began reviewing the trial’s safety and efficacy data to evaluate the possibility of authorizing its use in Switzerland. The review will occur on a rolling basis, as new data become available, as opposed to waiting until all data are collected, in hopes of accelerating the review process compared to traditional timelines. The most noteworthy news, however, was today’s announcement that interim analysis of the data indicates that the candidate vaccine could be nearly 95% effective. Like Pfizer’s announcement last week, this update was provided in a press release, and the actual data still need to be published and reviewed; however, the news is promising that multiple highly efficacious vaccines could be available in 2021. The Moderna interim analysis involved 95 participants with confirmed COVID-19 (90 of which were in the placebo group). Notably, 11 severe COVID-19 cases were reported among trial participants, and all were among the placebo group. Among the 95 cases, 15 are aged 65 years or older and 20 are racial or ethnic minorities—12 Hispanic or LatinX, 4 Black or African American, 3 Asian, and 1 multiracial. Moderna estimates the vaccine to be 94.5% efficacious based on the preliminary data, which would be comparable to the Pfizer vaccine. The vaccine also appears to have an acceptable safety profile, with no serious adverse events reported thus far.

 

Moderna also announced that the vaccine has demonstrated longer shelf life and greater stability at refrigeration temperatures than initially anticipated. According to the press release, “remains stable at 2° to 8°C (36° to 46°F)…for 30 days” and “at -20° C (-4°F) for up to six months.” The Moderna vaccine could be stored temporarily in standard refrigerators or freezers. Additionally, the Moderna vaccine can remain at room temperature for up to 12 hours and does not require onsite dilution or additional handling at the vaccination site, which could reduce the logistical burden required for mass vaccination. Both Pfizer and Moderna are expected to file for Emergency Use Authorization (EUA) with the FDA, and regulatory authorities in other countries. The news about both vaccine candidates has been received positively and with relief, especially as initial expectations about the efficacy of mRNA vaccines were somewhat low. Neither company has released the full interim analysis or the data analyzed in a journal, however, and the long-term safety and efficacy of these candidates remains to be assessed.  By the way, if you would like to participate in a COVID vaccine research trial you may contact Headlands Research.

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