Top news, reports and insights for today:
- Daily headline summaries for Friday:
- CDC report shows that coronavirus epidemic is eroding Americans’ mental health. Forty one percent say they are grappling with mental health challenges (New York Magazine)
- U.K. study of 300,000 says being overweight raises the risk of severe COVID-19 by at least 40%. Obese people may be 70% more likely to end up in hospital if they catch the disease (Daily Mail)
- Face masks with valves or vents do not prevent spread of the coronavirus, CDC says (Washington Post)
- California ranks fifth in the world for COVID-19 cases, reaching almost 600,000 (Daily Mail, See Figure A)
- New U.S. COVID-19 cases are no longer dropping; deaths persistent at >1,100 a day
New U.S. daily COVID-19 cases are shown in Figure B below. Last week, 363,046 cases were added, a weekly total that is almost identical to what we have seen since early August. The decline in daily cases we saw starting around July 20th appears to have stopped. The 7-day moving average trend has flattened at over 50,000 a day. The trend in new daily case rates by states have worsened since last week (Figure C). Overall, fewer states are at or below the 5 cases per 100,000 per day and a number of states have seen new case rates rise. Accept for 8 in the Northeast, the only other U.S. state that is under control in the West, Midwest and South is Wyoming. In the West, 3 states are adding more than 20 new cases per 100,000 per day including California (+23), Idaho (+26), and Nevada (+24). The South continues to be the hardest hit region. States above 20 include Alabama (+24), Arkansas (+22), Florida (+31), Georgia (+32), Louisiana (+25), Mississippi (+27), Tennessee (+25), and Texas (+23). While no Midwest states are above 20 this week, new cases are rising fastest in that region. Weekly growth factors show 10% or more increases in weekly cases in Indiana, Michigan, and North Dakota. I expect the focus to shift in coming weeks to the Midwest as the epidemic finally slows in the hard-hit South.
U.S. deaths remain flat, averaging about 1,100 a day since August 1 (Figure D). Weekly deaths continue to rise in Arkansas, Georgia, Kentucky, Louisiana and North Carolina. Big jumps were also seen in Nevada, Oregon, Indiana, Kansas and Minnesota. For reasons that elude me, we are also seeing a rise in weekly deaths in several Northeast states including New Jersey and Pennsylvania, although numbers are small in 6 others.
What it means: The dog days of summer are here both in terms of weather and coronavirus. Overall, new cases and deaths remain stubbornly elevated. I expect the focus to shift in coming weeks to the Midwest as the epidemic finally slows in the hard-hit South.
- Vaccine update: 200 vaccines under study; Russia approves theirs but the world isn’t buying; concerns about minority representation in clinical trials; promising intermediate results from an inactivated virus vaccine from China
There has been a flurry of activity around the race to develop a safe and effective vaccine against the novel coronavirus. I’ve reviewed some of these developments and want to try to summarize the top things we learned this week. Below is a short list of key take-home points:
- The Washington Post is tracking over 200 vaccines in various stages of testing and development. Currently, their database shows that there are fifteen candidate vaccines in Phase 1 studies, three in phase 2 and seven candidates undergoing Phase 3 trials. At this time, there are no recognized approved vaccines against COVID-19. The Food and Drug Administration, which has the ultimate say on whether a vaccine has been proved safe and effective, says a vaccine for covid-19, the disease caused by the coronavirus, will need to prevent disease or decrease symptoms in at least 50 percent of those who receive it. The effectiveness of the flu vaccine ranges from 40 to 60 percent, according to the Centers for Disease Control and Prevention.
- The Russians are the first to have approved and licensed a vaccine before the end of the Phase 2 study and without even doing the harder phase 3 trial. Everyone agrees that this is a completely crazy path to take. The name of the vaccine (“Sputnik V”) may offer clues about what this is about. This week, Dr. Fauci was among many who said he doubts the Russian vaccine is safe. Despite widespread concerns, President Putin says one of his own daughters has received a dose (but he hasn’t said which one). Russian officials are promising to vaccinate millions within a month. A good article in ARS Technica explains why the Russian approach, while similar to that taken by other vaccine groups, has some really big risks. It’s very doubtful other countries will rush to adopt the Russian approach. That is a good thing.
- CNN reports that the US government has agreed to a $1.525 billion deal with Moderna for 100 million doses of its COVID-19 vaccine. The deal is one of several similar agreements that are part of Operation Warp Speed. The president announced the deal during a media briefing on Tuesday. This move should confuse people. I keep saying that proving a vaccine is safe and effective has to be done carefully and slowly. With this (and all candidate vaccines) we aren’t there yet. So why is the Trump administration picking a winner? It’s not clear at this point but Moderna is one of the companies actually manufacturing a vaccine on an “at risk” basis, meaning it’s being made before the clinical trials proving safety and effectiveness are complete. It is a very big risk. Moderna started their big Phase III clinical trial on July 27. Their plan is to enroll about 30,000 people who don’t have the virus. It’s not clear how well the trial is going now but the plan is to complete the two-shot protocol around the end of November. I am not holding my breath because recruitment almost always goes slower than expected. Regarding this deal (and so much of the vaccine story in this pandemic) we in uncharted waters moving at unbelievable speed.
- We know that COVID-19 has disproportionally caused death and suffering in minority populations. We also know that the clinical studies of the only medication shown to be effective (Remdesivir) was not adequately representative of minority study subjects. It is very important that clinical trials of vaccines include adequate numbers of minorities to assure we get the right answer to the safety and efficacy questions. An important perspective article this week in the New England Journal of Medicine addresses concern that the fast pace of vaccine studies hasn’t sufficiently addressed this need. NIH policies about the inclusion of minorities in trials can be reviewed here.
- This week, JAMA reports on a Phase 1 and 2 double-blind clinical trial of a new and promising type of vaccine from China. This report is an interim analysis of the data, meaning the trial is still ongoing, and final results aren’t in, but the trial included a pre-planned peak at the data to make sure the trial should continue. So far, it looks like the vaccine has been safe with adverse reactions occurring at expected rates. It also looks like the vaccine is getting a passing grade for stimulating an acceptable level of neutralizing antibodies. This is all promising news but we will still have to wait for the big phase 3 study to show it is safe and effective at preventing infection in a population. This particular study is important though because it is one of the first rigorous attempts to test a different kind of vaccine. Unlike the “traditional” vaccines being tested, this one is the first that tests the use of a whole inactivated SARS-CoV-2 virus to stimulate immunity. This kind of vaccine has been used for decades for other respiratory viruses. It’s technically a different approach than most U.S. firms are taking, but has the potential to be safer than other vaccines.