Tag Archives: FDA

A COVID Vaccine is Being Manufactured in Baltimore Now. But the Government Won’t Let You Have It.

The AstraZeneca COVID vaccine is being manufactured today at a plant in Baltimore. This vaccine has been show to be between 62% and 90% effective at preventing symptomatic COVID.

But despite those excellent results in trials in the UK, Brazil, India and South Africa, the US government plans to wait until an American trial is finished in April. This as 4,000 of our fellow citizens die daily.

We should do what the UK and other nations have done, rely on the data we have, and get this vaccine approved immediately. I propose we follow the counsel of economist Alex Tabarrok:

“The AZ vaccine should be given an EUA immediately and made available in pharmacies for anyone who wants it while continuing to prioritize Moderna and Pfizer for the elderly and essential workers.”

Alex Tabarrok, Marginal Revolution

I just wrote my Congressman and Senators to urge them to push for immediate FDA approval of this life saving medication, and I humbly request you do the same! Frankly, I am very frustrated with this situation. Maybe you are too!

If you like, you can use the text I used, below. You can find your Congressman’s contact info here and your Senator’s contact info here.

Dear X,

The AstraZeneca COVID vaccine is approved in the UK and other countries and has shown efficacy of 62-90%. With over 4,000 of our fellow Americans dying daily, I urge you in the strongest possible terms to push the FDA to authorize this lifesaving medication immediately.

Thank you for all the good work you do!

Sincerely,

X

Why a Cloth Mask Isn’t Enough…Plus the Lowest Price I’ve Ever Seen on FDA Approved KN95’s

Above: Me, an FDA Approved KN95, and a snowman.

I am starting to see more and more people on the street wearing N95, KN95 and surgical masks, rather than cloth ones. That makes me really happy, because I know they’re a lot more effective. With a more contagious COVID variant from the UK spreading here, we need all the protection we can get. And with that in mind, I did a little Googling last night.

The eminent Dr. Eric Topol encourages us to use better masks, like N95/KN95, to confront the new UK variant of COVID.

My supply of KN95 masks, which filter much better than a cloth mask (and likely much better than most surgical ones also), was running low. I found an incredible deal on an FDA approved KN95 mask by Powecom at, of all places, Office Depot!

I ordered 100 last night and they should be here by Friday, with free shipping. $1/each is unheardof. The lowest I’ve paid before is about $1.35. I was very pleased!

You can see that these masks are FDA approved by going here. Go to Appendix A: Authorized Imported, Non-NIOSH Approved Respirators Manufactured in China (Updated: October 15, 2020). Then, see the manufacturer name, Guangzhou Powecom Labor Insurance Supplies Co. LTD, in the list.

Happy hunting! I suggest ordering a larger quantity because this price is unusual.

The Pace of Vaccination is Increasing Rapidly

Take a look at the chart above…this is COVID vaccines administered daily (7 day moving average). We see a trend of rapid increase in the pace of vaccination. The numbers bounce around a bit from day to day, but I find this trend very encouraging along with the new federal policy to release 2nd doses and allow everyone over 65 to be vaccinated.

Vaccine Policy Just Changed in a Major Way

The federal government will now start sending out all available doses of the COVID vaccine, rather than holding some in reserve for second doses, per The Wall Street Journal. It will also recommend the vaccine be available to everyone over age 65.

Broader eligibility criteria have helped Israel vaccinate faster than any other country, and significant evidence has emerged for getting more people their first dose sooner. It’s great to see the government acting on this information.

I strongly suspect we are in a race between new, more contagious variants of COVID and the vaccines. Right now, as far as we know, those variants aren’t that common in the US. But if we follow the path of the UK, they could quickly become dominant, resulting in an unprecedented burden on hospitals. We need to use this time to vaccinate as quickly as possible and prevent such a catastrophe.

A New Strategy for Getting More People Vaccinated Faster

If the average benefit from a booster is only 5%,(increasing efficacy from 90 to 95%), then intuitively it seems logical that this dose is better used by giving it to another individual without any vaccination to increase their immunity from 0 to 90%.

A number of researchers have proposed getting first COVID vaccine doses to as many people as possible right away, instead of holding back vaccine to give as 2nd doses later. A new paper released today estimates that we could immunize everyone much more quickly given this approach.

Most of the protection comes from the first dose, so getting more first doses out should be able to protect more people than reserving doses so people can get a second one.

The clinical trials did not delay 2nd doses, so this approach is somewhat speculative. However, the paper shows that even if immune function drops off significantly with just one dose, getting more doses out faster leads to faster herd immunity.

This is being done in Canada and the UK. Former FDA Commissioner Scott Gottlieb favors it. It may be time to give this innovative approach a try in the United States.

I Just Bought These FDA Approved Surgical Masks for My Family

I just bought these high quality surgical masks from Taiwan.

I’ve heard scary stuff about poorly made masks that don’t do a good job protecting people. I’ve worn these KN95 masks for some time (also FDA approved) and found them very comfortable, but I think masks are like clothing: they fit different people differently.

Some in my family prefer the surgical style masks (the mostly blue disposable ones you see frequently). So last night, I made it my mission to find a high quality, FDA approved surgical mask.

I found out that a good surgical mask should be ASTM-rated. This is an international standard of how the mask performs:

  • Level 1: low barrier protection. General use for short procedures and exams that don’t involve aerosols, spray or fluids
  • Level 2: moderate barrier protection. For low to moderate levels of aerosols, spray and/or fluids
  • Level 3: maximum barrier protection. For heavy levels of aerosols, spray and/or fluids

Every mask I’ve ever seen in normal stores has no ASTM rating at all, which means they’re less protective. The masks I bought are ASTM Level 1.

The FDA-approved higher level masks I saw appeared to be available in very large lots designed for hospitals. Since no one in my family works in the medical field, I am thinking an ASTM Level 1 mask should suffice. If you guys know of a Level 3 mask available in smaller quantities, please leave that info in the comments.

The FDA publishes lists of approved surgical masks and respirators (like the KN95 I wear). You can see the masks I bought on that list below. If you match the model number on the FDA list to the model number on the Mocacare website, you’ll see it’s an exact match.

Consider these masks as a good alternative to a KN95 or to surgical masks that came from who-knows-where.

We’ve Had a Vaccine Since January 2020

I just found out that we’ve had a COVID vaccine since January 13, 2020, a mere two days after a brave Chinese scientist published the virus’ genetic sequence. In this superb article, David Wallace-Wells details how Moderna created its vaccine, which has proven highly effective in trials, in a single weekend.

What if we had made that vaccine available to anyone who wanted it, albeit with a major safety warning, in January? Tens, maybe even hundreds of thousands of lives might have been saved. We might also have been able to collect more safety data sooner, from those very volunteers.

In an insightful post, economist John Cochrane proposes such a system that would track those volunteers and thereby collect great safety data (see part 2 of his post). This could be done alongside the traditional clinical trials the FDA mandates, rather than in place of them.

Such a system would provide greater freedom, more data, and a chance to save lives. With thousands dying in the US alone per day, what are we waiting for?

Why I Am Confident the FDA Will Make the Right Decision on COVID Vaccines

Despite the speed at which COVID vaccines were developed, I am confident the FDA will only approve a safe and effective vaccine. In this interview with the eminent Dr. Eric Topol, FDA Commissioner Dr. Stephen Hahn explains that the decision will be made by career scientists at the FDA. It will not be made by politicians or political appointees, including Hahn himself.

Hahn and Topol note that these clinical trials are among the largest ever conducted. Any employee can raise concerns re. efficacy and safety.

And frankly, if a doctor with Topol’s track record is confident in the FDA’s decision making, that gives me enormous confidence as well.

The Best Discussion of COVID and Vaccines

Today, we are all thinking the same thing. Where are these vaccines? And are they safe? In this podcast, Dr. Peter Attia (Stanford Med, NIH, Johns Hopkins) interviews Dr. Paul Offitt (CHOP, vaccine expert, on the FDA committee that will approve any COVID vaccine). This is the best discussion I’ve heard on the topic.

Some things I got out of this episode:

  • Vaccines are coming soon
  • Many vaccines have good safety profiles
  • There are numerous vaccine candidates, with a variety of approaches. Our bets are spread, which gives me confidence something will work.

I listened to this episode at 0.7x speed, given the technical nature of the topic and the speed at which the guest speaks. Enjoy!

The FDA Approved Mask I Wear

With evidence indicating that cloth masks may be less effective than surgical/N95/KN95 masks, what type of mask should we choose? And how do we know that the one we’ve chosen is safe?

I’ve been wearing these KN95 masks for several weeks and have come to love them. They only touch your face at the edges, which I find more comfortable. The earloops are thick and cushioned, providing better comfort. And as someone who wears glasses, I find that these fog my glasses less than anything else I’ve tried, provided I fit the adjustable nose piece carefully.

I’ve done yoga classes in this mask and walked all over town in it, and I actually forget I’m wearing it sometimes. I never thought that would happen. I find myself handing these out to friends and family in the hopes it will protect them as well.

This mask is on the FDA approved list. Go to Appendix A: Authorized Imported, Non-NIOSH Approved Respirators Manufactured in China (Updated: October 15, 2020). Then, see the manufacturer name, Guangzhou Nan Qi Xing Non-Woven Co., Ltd. This gives me greater peace of mind that it will work as advertised.

If you’re ready to dive in and buy a box of 50 at a lower price, the link is here.

Stay safe and stay strong everyone!