From Moderna’s new press release:
Moderna Announces Primary Efficacy Analysis in Phase 3 COVE Study for Its COVID-19
Vaccine Candidate and Filing Today with U.S. FDA for Emergency Use Authorization
November 30, 2020 at 6:59 AM ESTPrimary efficacy analysis of the Phase 3 COVE study of mRNA-1273 involving 30,000 participants included 196 cases of COVID-19, of which 30 cases were severe
Vaccine efficacy against COVID-19 was 94.1%; vaccine efficacy against severe COVID-19 was 100% …
Moderna plans today to request EUA from the U.S. FDA, to apply for a conditional marketing authorization with the European Medicines Agency (EMA) and to progress with the rolling reviews, which have already been initiated with international regulatory agencies
FDA has told Company to expect VRBPAC meeting for mRNA-1273 likely on December 17, 2020 …
The primary endpoint of the Phase 3 COVE study is based on the analysis of COVID-19 cases confirmed and adjudicated starting two weeks following the second dose of vaccine. Vaccine efficacy has been demonstrated at the first interim analysis with a total of 95 cases based on the pre-specified success criterion on efficacy. Today’s primary analysis was based on 196 cases, of which 185 cases of COVID-19 were observed in the placebo group versus 11 cases observed in the mRNA-1273 group, resulting in a point estimate of vaccine efficacy of 94.1%. A secondary endpoint analyzed severe cases of COVID-19 and included 30 severe cases (as defined in the study protocol) in this analysis. All 30 cases occurred in the placebo group and none in the mRNA-1273 vaccinated group. There was one COVID-19-related death in the study to date, which occurred in the placebo group
So, out of about 15,000 people in the placebo group, 185 were infected and symptomatic (I believe Moderna and Pfizer haven’t been looking for asymptomatic cases while Astra-Zeneca has) over a few months, with 30 getting severe cases of COVID and one dying. It looks like case counts were slow to accumulate during the late summer/early fall lull between the second wave that hit the US sunbelt in July and the current third wave that started in the north central states with the coming of cold weather. But then the number of cases apparently doubled over the last few weeks as this third wave is now hitting hard.
In contrast, 11 in the vaccine arm came down with non-severe cases of symptomatic COVID.
A big unanswered question is whether these vaccines protect not only the recipients from severe symptoms, which they apparently do, quite well, but also protect the unvaccinated from being infected by vaccine recipients with no or only mild symptoms. If only the former, COVID would become Just The Flu, Bro for only the vaccinated, while it would continue to spread from the vaccinated to the unvaccinated. But, hopefully, if the vaccine also reduces infectiousness as well as severity, it can take a bite out of the pandemic’s spread fairly quickly.
Efficacy was consistent across age, race and ethnicity, and gender demographics. The 196 COVID-19 cases included 33 older adults (ages 65+) and 42 participants identifying as being from diverse communities (including 29 Hispanic or LatinX, 6 Black or African Americans, 4 Asian Americans and 3 multiracial participants).
I wish they would report how many of the 33 cases in 65+ volunteers were in the two arms. But, still, the worst case scenario of 11 in vaccine arm, 22 in the placebo arm is still pretty good.
My assumption is that they didn’t recruit volunteers who were both elderly and severely debilitated, the kind most likely to die in nursing homes. But it’s good news that it works at all in 65+.
The safety profile of the Phase 3 study of mRNA-1273 was previously described on November 16. A continuous review of safety data is ongoing and no new serious safety concerns have been identified by the Company. Based on prior analysis, the most common solicited adverse reactions included injection site pain, fatigue, myalgia, arthralgia, headache, and erythema/redness at the injection site. Solicited adverse reactions increased in frequency and severity in the mRNA-1273 group after the second dose.
Once again, some percentages would be useful.
The Company will submit data from the Phase 3 COVE study to a peer-reviewed publication.
… Additionally, Moderna announced that the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting to review the safety and efficacy data package for mRNA-1273 will likely be scheduled for Thursday, December 17. The Company expects that the U.S. Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) will make a recommendation on immunization priorities. The Company anticipates that the shipping of mRNA-1273 to designated distribution points throughout the U.S. will occur shortly after an Emergency Use Authorization is granted.
Moderna is working with the U.S. CDC, Operation Warp Speed and McKesson (NYSE: MCK), a COVID-19 vaccine distributor contracted by the U.S. government, as well as global stakeholders to be prepared for distribution of mRNA-1273, in the event that it receives an EUA and similar global authorizations and approvals. By the end of 2020, the Company expects to have approximately 20 million doses of mRNA-1273 available in the U.S.
So, 20 million doses at 2 doses each equals 10 million innoculees. Pfizer could supply an equivalent amount or more. Pfizer, which is a week ahead, is beginning to practice flying dry ice containers around the country to work the bugs out of distribution.
Keep in mind that this is a 2-shot regimen, so it is assumed it takes about a month for the vaccine to have full effect.
A big question is whether, following the Democrats’ and Prestige Media’s months of declaring that white people are out to get blacks, and the Democratic candidates’ anti-vaxx dogwhistling against Trump’s emphasis on rapid vaccine development, whether enough blacks will allow themselves to be vaccinated. From a late summer Kaiser survey:
