CDC Identifies Preliminary Covid-19 Vaccine Safety Signal

The CDC announced that a prelimary Covid-19 Vaccine Safety signal has been identified in a recent update on their website:

“Following the availability and use of the updated (bivalent) COVID-19 vaccines, CDC’s Vaccine Safety Datalink (VSD), a near real-time surveillance system, met the statistical criteria to prompt additional investigation into whether there was a safety concern for ischemic stroke in people ages 65 and older who received the Pfizer-BioNTech COVID-19 Vaccine, Bivalent. Rapid-response investigation of the signal in the VSD raised a question of whether people 65 and older who have received the Pfizer-BioNTech COVID-19 Vaccine, Bivalent were more likely to have an ischemic stroke in the 21 days following vaccination compared with days 22-42 following vaccination.

This preliminary signal has not been identified with the Moderna COVID-19 Vaccine, Bivalent. There also may be other confounding factors contributing to the signal identified in the VSD that merit further investigation. Furthermore, it is important to note that, to date, no other safety systems have shown a similar signal and multiple subsequent analyses have not validated this signal:

  • A large study of updated (bivalent) vaccines (from Pfizer-BioNTech and Moderna) using the Centers for Medicare and Medicaid Services database revealed no increased risk of ischemic stroke
  • A preliminary study using the Veterans Affairs database did not indicate an increased risk of ischemic stroke following an updated (bivalent) vaccine
  • The Vaccine Adverse Event Reporting System (VAERS) managed by CDC and FDA has not seen an increase in reporting of ischemic strokes following the updated (bivalent) vaccine
  • Pfizer-BioNTech’s global safety database has not indicated a signal for ischemic stroke with the updated (bivalent) vaccine
  • Other countries have not observed an increased risk for ischemic stroke with updated (bivalent) vaccines”

The CDC says it’s “very unlikely  that the signal in VSD represents a true clinical risk…” The data and additional analyses will be discussed at the January 26, 2023 meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee.

No changes are recommended to the current Covid-19 vaccination practice:

“CDC continues to recommend that everyone ages 6 months of age and older stay up-to-date with COVID-19 vaccination; this includes individuals who are currently eligible to receive an updated (bivalent) vaccine. Staying up-to-date with vaccines is the most effective tool we have for reducing death, hospitalization, and severe disease from COVID-19, as has now been demonstrated in multiple studies conducted in the United States and other countries:

  • Data have shown an updated COVID-19 vaccine reduces the risk of hospitalization from COVID-19 by nearly 3-fold compared to those who were previously vaccinated but have not yet received the updated vaccine.
  • Data have shown that the updated COVID-19 vaccine also reduces the risk of death from COVID-19 by nearly 19-fold compared to those who are unvaccinated.
  • Other preliminary data from outside the U.S. have demonstrated more than 80% protection against severe disease and death from the bivalent vaccine compared to those who have not received the bivalent vaccine.

Overall safety data for the bivalent COVID-19 vaccines are available here.

Once again, no change is recommended in COVID-19 vaccination practice, which can be found here.”

FDA Authorizes Bivalent Covid-19 Vaccine Booster Dose Today

The FDA announced the EUA authorization this morning of the Moderna and Pfizer-BioNTech Bivalent Omicron Covid-19 Vaccine Booster Dose.

CDC-ACIP meeting starts tomorrow for evaluation of the booster doses.

CDC ACIP Meeting for September 1-2 on Bivalent Omicron Covid-19 Vaccine Boosters

The CDC ACIP have an agenda posted indicating that the advisory committee will discuss Covid-19 Bivalent Omicron vaccine candidates on September 1-2, 2022. A vote is scheduled on September 1, 2022.

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.

CDC Study of High-Contact & Surface Contamination in Household of Persons with Monkeypox Virus Infection

The CDC study, “High-Contact Object and Surface Contamination in a Household of Persons with Monkeypox Virus Infection-Utah June 2022″ was published as an early release on August 19, 2022 in the MMWR. See the link below for the full article.

Pfeiffer JA, Collingwood A, Rider LE, et al. High-Contact Object and Surface Contamination in a Household of Persons with Monkeypox Virus Infection — Utah, June 2022. MMWR Morb Mortal Wkly Rep. ePub: 19 August 2022. DOI:

Novavax Covid-19 Vaccine Gets CDC Green Light

The Novavax Covid-19 vaccine was approved by the CDC a few days ago. University of Iowa Health Care was one of the sites in the multi-site Phase 3 trial.

The vaccine is not based on mRNA technology; it uses a more traditional method similar to the flu vaccine, which is familiar to more people.

ACIP Meeting on Covid-19 Vaccines and Boosters Held on April 20, 2022

I got to listen to some of the presentations yesterday during the ACIP meeting on Covid-19 vaccines and boosters. My impression is that there seems to still be some discussion about what the most important goals of the vaccination program. Is it to prevent severe disease, hospitalization, and death? Or is it to prevent infection altogether?

It’s not lost on me that even mild infection with Covid-19 can lead to a chronic (“long haul”) syndrome. On the other hand, it doesn’t sound plausible that a vaccine to prevent infection would even be possible, given that so many people remain unvaccinated. That’s part of the context for the rise of variants that can lead to vaccine-resistant strains. That can lead to boosters and what some ACIP committee members are now afraid might lead to a new vogue term-“booster fatigue.”

Sena and I are now immunized as far as we can go, with 4 doses. We’re hoping for a new vaccine that is safe, effective against variants, and doesn’t involve boosting every few months.

We focus a lot on vaccines. But the other side of the risk of getting infected and sick are a part of host immunity. It gets weaker as we get older. It’s weak in those who are immunocompromised for other reasons, including things like underlying diseases and organ transplantation.

Looking at other ways to prevent disease with Covid-19, such as new medications that might counter the decline of the immune system as we age, and any other innovations are also important.

Second Covid Vaccine Booster Got Any Mojo?

Tomorrow’s April Fool’s Day and I thought I’d get this post up today so it wouldn’t get confused with a joke.

I’m genuinely a little confused about the FDA and CDC approval of the 2nd Covid vaccine booster. It’s almost like this vaccine is getting a mojo of some kind, at least with some experts.

Although I’m not keen on getting another jab, I’ll do it if there is reasonable evidence to support it. Not everyone on the FDA Advisory committee is for it. Dr. Paul Offit was quoted in a news story as saying, “We’re going to have to learn to live with mild disease at some point.” 

Dr. Offit is the director of the Vaccine Education Center at Children’s Hospital of Philadelphia. I’ve heard him speak at FDA Advisory Committee meetings during public Zoom meetings on the subject and I respect his opinion. He doesn’t think frequent boosting is a reasonable thing to do. I’m inclined to agree with his opinion that most people won’t do it anyway. I’m sure he’ll have more to say at the April 6 FDA Covid Vaccine Advisory Committee meeting.

I was not surprised to learn that of the 90 million Americans who got their initial Covid vaccine series, only about half got the first booster. What kind of mojo is that?

Even the Pfizer drug company CEO, Albert Bourla, says frequent boosting is impractical.

There is some serious doubt in my mind about the booster mojo. Sena says that it would be helpful if more local infectious disease experts would express their own opinions about the direction this vaccination strategy is going. She has a point.

Does the Covid vaccine booster have any mojo? What do you think?

Featured image picture credit: pixydotorg.

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