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Many important things happened related to COVID in the US this past week. Here are some of the good and some of the not-good developments, and their implications. First, here are some of the good: 1/x
J&J started large (60,000 person) phase 3 trial of its vaccine. Its 1 dose only, which distinguishes it. Safety + efficacy results by early 2021. Storage requirements (-20 C) are compatible w/ standard vaccine distribution approaches. Very good. 2/x https://www.fiercebiotech.com/biotech/j-j-starts-covid-19-vaccine-phase-3-eyes-early-2021-approval
This is more forward progress from Op Ward speed collaboration btwn gov & vaccine makers. Potentially invaluable for fight against COVID. Important to let trials and regulatory process proceed safely, so people don’t lose confidence in what could be most helpful tools. 3/x
Also good- FDA likely to issue new guidance (from senior FDA scientists) on requirements for COVID vax. Will say late stage trials should follow vax candidates for 2 mos before EUA issued. Calls for sponsors to present clear safety monitoring plans. 4/x https://www.nytimes.com/2020/09/22/health/covid-19-vaccine-fda-guidelines.html
Also good: New study identifies reason why children mnay do better than adults – found innate immune system responded more strongly to COVID than adults. Could help with clinical management and development of therapeutic approaches to reduce mortality. https://stm.sciencemag.org/content/early/2020/09/21/scitranslmed.abd5487 5/x
Also promising – Rapid Ag tests continue to move ahead. Will be cheaper, faster (results in minutes), much more available. Could be used to screen people in higher risk settings more frequently. Hopefully will include home antigen testing soon. 6/x https://www.usatoday.com/in-depth/news/health/2020/09/24/rapid-cheap-covid-tests-ready-but-regulatory-barriers-remain/5824882002/
One challenge is that we will need to figure out how to centrally collect data from Antigen tests – lab based and home testing - just as we track data on PCR tests, so we can track evolution of epidemic. 7/x
Also good – N.E. region has comparatively low incidence w/ many counties <5 cases/d per 100,000. Shows it's possible to achieve this level of control in US. Though regional numbers starting to climb. Successful states need to fight sliding backwards. https://covidtracking.com/data/charts/regional-cases 8/x
And validating to see yet another study showing value of physical distancing, masks, handwashing. We should all keep doing what is effective. Need clear and consistent public messaging. 9/x https://wwwnc.cdc.gov/eid/article/26/11/20-3003_article
Good because useful: a study showed lack of infectious SARS-CoV-2 in environmental samples in healthcare facilities. Underscored need to prioritize strong prevention measures that stop person-to-person and droplet transmission.10/x https://www.clinicalmicrobiologyandinfection.com/article/S1198-743X(20)30532-2/fulltext
Valuable to see CDC release metrics to guide school decisions. Even ~14 or > cases per day per 100,000 puts you in the highest risk of school transmission. For the US as a whole our number is 13 cases/day per 100,000 people. 11/x https://www.cdc.gov/coronavirus/2019-ncov/community/schools-childcare/indicators.html#thresholds
This means a lot of country is still in category of highest risk of transmission and needs to do more to slow the spread, esp as cold weather coming and people will be spending more time indoors. 12/x
On the not good side, here are some developments that will not help US get better control of COVID or which show some of the big challenges ahead: 13/x
FL gov announced end to limits on restaurants+bars and loosening mask requirements in the state, on a day when FL had 20% of US COVID deaths. Increases risk of widening transmission in the state. Hopefully he and his team will change their minds. https://www.orlandosentinel.com/politics/os-ne-desantis-florida-reopens-20200925-f3sr4wk5tncvvkhwr6ua4pereq-story.html 14/x
Also not good - White House badgered FDA about new guidance it's preparing for COVID vaccine trials, threatened to prevent FDA from issuing them. Another dangerous step in interfering in science process. They should stop and allow FDA to do its job of keeping Americans safe 15/x
Very concerning to see continued rise in cases in Midwest, reaching highest weekly average since COVID started. The region is leading alarming national rise in cases that has been happening for two weeks now. 32 states now with numbers on the rise. https://www.nytimes.com/interactive/2020/us/coronavirus-us-cases.html 16/x
Also alarming – more large political rallies. One this week in VA 4000 people standing shoulder to shoulder, many without mask. These rallies increase risk of spread and could be superspreading events. 17/x https://www.c-span.org/video/?476122-1/president-trump-holds-rally-newport-news-virginia
Do leaders know what risks they are posing for people in the audience? And for the communities where they live? Do attendees understand the risks they are taking for themselves and their families. These should be discontinued until pandemic under control. 18/x
And worrisome to see Europe experiencing sharp rise in COVID. After prolonged period when numbers were low. Shows this virus continues to pose risks to other highly developed countries. National responses will require consistency, persistence, strong public communication.19/x
And 1 final very sad marker of the pandemic. US passed 200,000 COVID fatalities. Despite the terrible milestone, there was no official moment of mourning or remembrance from White House for lives lost, >500,000 hospitalized. The country should take the time to do this. /end
