Tag: CDC

CDC Update on Covid-19 Variant BA.2.86

I saw a news item headline which mentioned Covid-19 Variant. BA.2.86. The CDC website tracking respiratory variants has a definitive update as of November 27, 2023:

“What to know about BA.2.86

  • The virus that causes COVID-19 is constantly changing over time. Sometimes these changes allow new variants to spread more quickly or effectively. If that occurs, the new variant may become more common relative to other variants that are circulating.
  • Since CDC’s first post on BA.2.86 in August 2023, the proportion of infections caused by BA.2.86 has slowly increased. In the CDC Nowcast posted Nov. 27, 2023, BA.2.86 is projected to account for 5-15% of currently circulating variants.
  • CDC projects BA.2.86 and its offshoots like JN.1 will continue to increase as a proportion of SARS-CoV-2 genomic sequences.
  • At this time, BA.2.86 does not appear to be driving increases in infections or hospitalizations in the United States.
  • CDC contributed to and agrees with the World Health Organization’s recent risk assessment about BA.2.86 suggesting that the public health risk posed by this variant is low compared with other circulating variants, based on available limited evidence.
  • Updated COVID-19 vaccines are expected to increase protection against BA.2.86, as they do for other variants.
  • As mentioned in previous updates, COVID-19 tests and treatments are expected to be effective against this variant, including its offshoot JN.1.
  • It is not possible at this time to know whether BA.2.86 infection produces different symptoms from other variants. In general, symptoms of COVID-19 tend to be similar across variants. The types of symptoms and how severe they are usually depend more on a person’s immunity than which variant causes the infection.
  • Regardless of what variants happen, CDC will continue to track them, working closely with partners around the world to understand how they are spreading and how they respond to vaccines and treatments.”

CDC on How to Get Flu, Covid-19, and RSV Vaccines

The latest update on how to get the respiratory viruses vaccines is updated on the CDC website. Highlights:

  • “f you have insurance, these vaccines should be free to you in most cases.
  • Adults without health insurance or adults whose insurance doesn’t cover all COVID-19 vaccine costs can get an updated COVID-19 vaccine for free through the Bridge Access Program.
  • Most children can get recommended vaccines for free through their family’s insurance or the Vaccines for Children (VFC) Program.
  • How COVID-19 vaccines are being distributed changed in September 2023 when these products moved to the commercial market, but there is still plenty of vaccine supply.
  • Flu, COVID-19, and RSV vaccines may be given at the same visit.”

CDC Recommends Updated COVID-19 Vaccine This Fall-Winter Season

The CDC has posted a press release announcing that it has recommended the updated COVID-19 vaccine for the fall/winter virus season.

CDC Update on SARS CoV-2 Variant BA.2.86

New update on the Covid-19 variant BA.2.86 as of Sept. 8, 2023. Highlights:

  • “The current increases in COVID-19 cases and hospitalizations in the United States are not being driven by BA.2.86 and instead are being caused by other predominantly circulating viruses.
  • Early research data from multiple labs are reassuring and show that existing antibodies work against the new BA.2.86 variant. These data are also encouraging because of what it may mean for the effectiveness of the 2023-2024 COVID-19 vaccine, which is currently under review. That’s because the vaccine is tailored to the currently circulating variants.
  • Since CDC’s initial risk assessment, BA.2.86 has been identified in additional countries from both human and wastewater specimens. The variant has been identified in nine U.S. states as of September 8, 2023, at 11:30 AM EDT— in people across Colorado, Delaware, Michigan, Ohio, Pennsylvania, Virginia, and Washington, as well as one additional human case that is being investigated. The variant has also been identified in wastewater samples in two states, New York and Ohio.
  • The U.S. SARS-CoV-2 Interagency Group (SIG) classified BA.2.86 as a Variant being Monitored (VBM) on September 1, 2023.”

CDC Update Today on Covid-19 Variant BA.2.86

Today’s update by the CDC on the Covid-19 variant BA.2.86 is at this link.

Highlights:

  • “The variant has been identified in at least four states in the United States in samples from either people or wastewater.
  • This variant is currently being studied in the laboratory to help understand how the immune system may interact with this virus.
  • The current increases in cases and hospitalizations in the United States are likely being driven by infections with XBB lineage viruses, not the new BA.2.86 variant.”

“CDC’s current assessment is that the updated COVID-19 vaccine, which will be available in mid-September, will likely be effective at reducing severe disease and hospitalization. Immune responses generated from prior infection also help protect against severe outcomes of COVID-19. There is currently no evidence that this variant is causing more severe illness. That assessment may change as additional scientific data are developed. CDC remains committed to releasing updates on trends and observations of this variant.”

“Immune Impacts:  Approximately 97% of the U.S. population has antibodies to SARS-CoV-2 from vaccination, previous infection, or both (hybrid immunity). Immune responses to vaccines and infections are complex and involve both humoral (antibodies) and cellular immunity. It is likely that the humoral and cellular immune responses will continue to provide protection against severe disease from this variant. Laboratories are currently working on measuring antibody neutralization of BA.2.86 as well as other immune responses. This is an area of ongoing scientific investigation.

Therapeutics: The assessment as to the impact of BA.2.86 on currently approved or authorized therapeutics is unchanged. Examination of the mutation profile of BA.2.86 suggests that currently available treatments like nirmatrelvir-ritonavir (Paxlovid), remdesivir (Veklury), and molnupiravir (Lagevrio) will be effective against this variant. This assessment is from the SARS-CoV-2 Interagency Group (SIG), which comprises experts from multiple United States government agencies. Monitoring is ongoing, and CDC will update this document as additional data on the impact of this variant on therapeutics become available.”

CDC Updated Recommendations for Covid-19 Vaccine Use

The Centers for Disease Control (CDC) held a Clinician Outreach and Communication Activity (COCA) meeting to discuss updated recommendations for Covid-19 vaccine use on May 11, 2023. You can view the YouTube recording of the meeting and view presentation slides at this link. The meeting was designed for clinicians.

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.