FDA Removes N95 Respirators from Shortage List

I think it’s ironic that about the same time a PLOs One study and news articles came out announcing a new method using 8-inch rubber bands for improving the fit of the surgical mask to approximate that of the N95 respirator, the FDA removed the N95 respirator from the medical device shortage list. This is relevant to help protect people from infection with Covid-19 because even vaccinated older people are getting hospitalized with the Omicron variant of the virus.

I’m not saying that the new rubber band method to tighten the fit of the surgical mask is not an improvement. It might come in handy when there is another shortage of N95 respirators.

The method mainly targets health care professionals. It would be difficult to persuade everyone in the community to adopt the technique. It’s tough enough to get people to wear masks even in crowded buildings in high transmission areas.

This is despite the CDC study showing that the elderly population continue to be at high risk for hospitalization from Covid-19 despite being vaccinated with the initial series and one or more boosters.

I think it’s hard to achieve a good fit even with the N95 respirators. The free ones distributed by the Federal government early this year were not widely available and fit poorly because the straps were elastic (similar to rubber bands, only flimsier) and loosened quickly, even after using only 2 or 3 times. At least the ones I got did. Prior to retiring, I was never able to pass a Fit test at the hospital using that type of mask.

I think my surgical masks fit better than the N95 respirators, especially after using the knot and tuck method to get a tighter seal.

Now the newer rubber band method to get a better seal uses two large 8-inch rubber bands to make the mid-face portion of the mask fit closer to your face. It looks a little easier to do than the earlier 3 rubber band technique developed a couple of years ago. That one was even tested at the University of Iowa Hospitals and Clinics by emergency room health care professionals, resulting in a small published study (the “double eights mask brace”).

All of the rubber band mask braces techniques were a response to the shortage of N95 respirators. What’s interesting to me is that, as the authors of the PLOs One study point out, there is a fair amount of variability in how well the N95 mask fits. Differences in the shape of a person’s face can account for some of this.

And there’s no shortage of N95 respirators—for now, at least according to the FDA.

If a non-health care professional wanted to use a rubber band brace, it would take some practice to get a good seal. There’s a bit of a learning curve even for a pro.

I think it would be difficult to persuade the average person to get the rubber bands and the surgical mask out of a pocket or a purse and fiddle around to achieve a good fit if you’re just going to run into Wal Mart—where I could not find that the big 8-inch rubber bands are even in stock. They’re pretty much a “3-day shipping” kind of item and could cost as much as $20 a bag.

FDA Advisory Committee Approves Adding Omicron component to the Next Covid-19 Vaccine

On June 28, 2022 the FDA Vaccine and Related Biological Products Advisory Committee came to a majority “yes” vote to the question:

“Does the committee recommend inclusion of a SARS-CoV-2 Omicron component for COVID-19 booster vaccines in the United States?”

The meeting was recorded and is available for review.

FDA and CDC Endorse 2nd Vaccine Booster for Covid-19

On March 29, 2022, both the FDA and the CDC endorsed a 2nd Covid-19 booster vaccine dose. The FDA Advisory Committee on vaccines still has a meeting scheduled about vaccine boosters on April 6, 2022. Neither of the booster doses will be variant specific.

FDA Advisory Committee to Discuss Pfizer COVID-19 Vaccine for Children 5 Through 11 Years of Age

On October 26, 2021 the FDA Vaccines and Related Biological Products Advisory Committee will meet to discuss the extension of the Pfizer EUA for the COVID-19 vaccine for children 5 through 11 years of age. Some event materials are already available. The meeting is scheduled for at 8:30 AM-5:00 PM, ET.

FDA Authorizes COVID-19 Moderna and Janssen Boosters and Heterologous Boosting

The FDA just released a statement this afternoon announcing the extension of the EUA for COVID-19 boosting with Moderna and Janssen vaccine. The FDA also authorized heterologous boosting (mix and match).

FDA Advisory Meeting on Pfizer COVID-19 Vaccine Booster Announcement

The FDA announcement about the Advisory Committee meeting on the Pfizer COVID-19 vaccine booster for September 17, 2021 is here. The time will be 8:30 AM-3:45 PM ET (check your time zone provided on the FDA YouTube web page). Review materials (if available) will be posted at the FDA link provided in the announcement.

Update on COVID-19 Vaccine Boosters

The messaging on COVID-19 boosters is being clarified by the CDC and the FDA in separate announcements, posted September 1, 2021.

The CDC update is here. The FDA announcement is here. The FDA plans to hold a virtual meeting about the issue September 17, 2021 from 8:30 AM to 3:45 PM EST and it will be livestreamed on the agency’s YouTube channel. Background material will be made available to the public two days before the meeting.

“Those who are tardy do not get fruit cup.”

New FDA Warning Regarding association of Guillain-Barre Syndrome with J&J Covid-19 Vaccine

On July 13, 2021, the FDA issued a revision to the J&J COVID-19 vaccine fact sheets regarding the increased risk of Guillain-Barre Syndrome (GBS) with the vaccine. According to the announcement, the benefits still outweigh the risks for getting the vaccine and so far no causal association has been found. GBS is rare and has been associated with other vaccines, including the flu vaccine. GBS has not been associated with the mRNA vaccines, so far.

Update: CDC Emergency Meeting June 23-25, 2021 on COVID-19 Vaccine Safety Including Myocarditis

The CDC Advisory Committee on Immunization Practices (ACIP) emergency meeting is re-scheduled for June 23-25, 2021 to discuss COVID-19 vaccine safety including myocarditis after Vaccine Safety Technical Work Group assessment. You can find a webcast link and the draft of the working agenda details here. The Vaccines and Related Biological Products Advisory Committee report slide set summary as of May 31, 2021 is on slide 26. The American Academy of Pediatrics (AAP) news story is here.