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April 20, 2022

One-Way Masking - After Federal Mask Mandate Removed

As a physician I was shocked that a Federal Judge from Florida revoked mask mandates for public transportation.  I live in the Northeast and each day follow the case numbers (which are an underestimate because of unreported positive home tests). We were at Low Risk on the CDC guide for my county (NY State and New York County), but Covid cases keep increasing and we are now at Intermediate Risk for infection.  Since Omicron BA.2 and its subvariants spread across our region, we passed 200 cases/100,000 total over 7 days (the CDC metric for intermediate risk).  Everyone is free to wear a mask if they choose, but what do we know about ONE-WAY MASKING. I reviewed recommendations from 3 sources, each with information from scientists I follow. 

MASKS:  Pick the best mask you can - K95, KN95, or KF94.  They filter out viral particles - both aerosoles and droplets. Neither surgical masks nor cloth masks are sufficient now.  Make sure there are no gaps - your glasses shouldn't fog up if the metal bridge inside the mask fits well across your nose.  Masks with 2 elastic bands that go over your head fit better if you can get them.  You will not be able to make INDOOR spaces risk free.  The possibility of getting infected depends on the infection rate and vaccination rate in the region, the number of people, and the ventilation.  In addition your risk factors: age, comorbidities, and immune status are equally important.  Being vaccinated, boosted, and wearing one of the mask types listed above will reduce your risk significantly but nothing in life is 100%.  See below for mask sources.  

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My Physician Son recommended VIDA as a reliable online source for us, since he and his coworkers keep track of the companies and masks they carry.  Wirecutter also has an online list of masks they vetted.  You won't be able to get a "fit test," like physicians and health care workers, but you can at least make sure that your glasses don't fog up, and that the mask moves in a little when you inhale and moves out a little when you exhale.

Face Masks – VIDA (shopvida.com)     https://shopvida.com/pages/face-masks

Where to Buy N95s, KN95s, and Surgical-Style Masks in 2022 | Reviews by Wirecutter (nytimes.com) 

  

April 16, 2022

Some Good News - as the Pandemic Continues

Scientists around the world are busy looking for drugs with activity against SARS-CoV.2.  This week Veru Biopharmaceuticals announced preliminary results for a drug developed for hospitalized patients with moderate to severe Covid-19.  150 patients were treated with SABIZABULIN or placebo for 21 days.  The drug was given as a single capsule daily for 21 days - along with the usual drugs given during the inflammatory phase of the respiratory "cytokine storm."  The primary end point of the study was death within 60 days.  The Independent Safety Monitoring Board did a scheduled interim review and found out that the 98 patients who received the drug had a death rate of 20% and the 52 patients that received placebo had a death rate of 45% (P=0.0029).  There were no safety issues seen in the 150 patients analyzed. 

Independent Safety Monitoring Boards are appointed during clinical trials and their job is to review data at a prespecified time.  The principal investigators of the trial don't see the data or break the code for which patients received drug vs placebo until the trial ends.  The Board can stop the trial for safety reasons or continue interim reviews which allows more patients to be enrolled and followed.  The Independent Safety Board stopped this clinical trial because the results were so remarkable that they didn't want any more patients to be enrolled and receive placebo.   See Below 

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The drug has both anti-inflammatory and antiviral properties.  The exact mechanism of action is too complicated for this quick note, but it is clear that the two-pronged approach can control the infection and reduce the debilitating inflammatory effects that lead to Acute Respiratory Distress Syndrome (ARDS) and death.  The company will submit a request to the FDA for an EUA.  This information was gathered from several reports and the data will be fully analyzed for the FDA and peer reviewed by additional scientists for publication.  WHO NAMES THESE DRUGS?

April 13, 2022

Covid Concern?

The Omicron BA.2 variant has now spread across the country and cases are increasing, especially in the Northeast.  No one knows whether the case counts are artificially low because of the number of Covid home tests used, and not reported.  Hospitalizations are also relatively low in the Northeast, and there should be some change in those numbers by now. Immunity may be up, due to vaccines and the earlier BA.1 Omicron surge that probably infected 45% of the US during the winter. 

Just when the BA.2 variant was spreading in the US, the society was opening up.  Masks were no longer required in many places, and vaccine mandates were changing.  It is hard for people, who really want this pandemic to be over, to determine what risk level for infection they are comfortable with.  Vaccines continue to prevent severe disease and death, but infection can still occur.  However even mild infections can be associated with long Covid, and based on recent studies cardiovascular disease, brain alterations on scans, and the development of diabetes.  All of these complications are being seen in Covid infected patients as long as a year after infection.  See Below 

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Most of the country has low community levels of infection today. US Covid cases are averaging 31,000 cases per day as of this past weekend - an increase of about 3% over the last few weeks.  The infection rates in NYC and DC are among the highest, but they are still incredibly low when compared to the first omicron surge.  As BA.2 spreads, the cases in NY state increased slowly from <10/100,000 population to 25/100,000 this week.  In contrast, the number of cases in NY state when Omicron BA.1 was increasing went up by at least 25/100,000 per day - peaking at 383cases/100,000 on 1/8/22.  The BA.2 variant is more transmissible, but the statistics aren't showing that yet.  Based on these statistics everyone is going to have to determine their own level of risk when we can't accurately predict the future or even the next month!

April 9, 2022

FDA Advisory Group Brainstorms Covid Vaccines

Do covid vaccines need to be adjusted to maintain vaccine efficacy and safety, and how can scientists anticipate possible mutations in time to modify existing vaccines?  Yesterday the FDA Scientific Advisory Board (VRBPAC) met virtually to discuss all aspects of Covid vaccine efficacy and development. Since the Wuhan strain was identified, variant strains developed - some like the beta and gamma variants spread locally and others like delta and omicron quickly spread across the world.  Fortunately the vaccine efficacy against severe disease and death is still above 80% and infections, hospitalizations, and deaths occur mostly in unvaccinated people.  Here are some of the issues under discussion.

1.   What is the best way to assess vaccine efficacy?  The gold standard is randomized, placebo-controlled clinical trials of thousands of volunteers - as was done in the original Covid vaccine clinical trials.  Antibodies can be measured in plasma from vaccinated subjects, but a "correlate of protection,"  i.e. that level of circulating antibodies that prevents infection, is not yet fully established.  Tests to measure memory B cells and effective T cells are too laborious for large clinical trials.

2.  The current vaccines still reduce hospitalizations and deaths, but like other viral vaccines they may not  prevent mild infection.  Is it even possible to prevent mild infections?   

See Below for 3. and 4.

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3.  Can a future variant be anticipated in time to modify the current vaccines?  Or should there be vaccines developed and mixed that will cover a broader range of possible mutations in the spike protein variants that already circulated.  Some of this is being done in anticipation of further mutations.

4.  Can modified vaccines be manufactured and delivered quickly enough to prevent Covid infections and spread?  Studies are already underway to develop modified vaccines.  Influenza vaccines are mixtures of vaccines to strains that are known to be circulating, and a new vaccine (a mixture of 3 or 4 virus strains are chosen and mixed).  Modified influenza vaccines are made twice each year - once for winter in the Northern Hemisphere and once for winter in the Southern Hemisphere.  This model would be near impossible now for Covid vaccines.   

April 6, 2022

Do At Home Covid Tests Expire?

Each At Home Covid Antigen Test has an expiration date on the package.  At the beginning the FDA approves the tests and sets the expiration dates on the box.  But it is important to know that the company may extend the expiration date on these newly developed tests because the Covid test stability was now observed for a longer period of time.  The expiration date may have been moved 3 months later or more, but not on your box! 

These tests were only developed during the pandemic, and they may have been "observed" in storage" for only several months after they were approved by the FDA and manufactured.  If the tests are stable over the next months, the expiration time can change.   But you can't tell what the new expiration date is for your box of 2 tests. It may be possible to get the information from the FDA, but there is a more practical way to see if your tests are still good.  If the CONTROL line on the test strip appears quickly, the test is fine to use. HomeAntigenTest.jpg

How should you store your extra test boxes?  Keep them at room temperature and dry.  Don't let them freeze or become heated.  Use the test boxes with the earliest expiration dates first.  Dr. Michael Minna, an expert in home test technology, thinks that most of these Covid tests will eventually have an expiration date after 18 to 24 months.    

REFERENCE: Do Home Covid Tests Expire? https://nyti.ms/3K9ZOt2