Coronavirus updates September 2022

[danusia]

Posted the other day in the August thread. I am adding it here where it belongs.

"

One shot per year? We really need to step up our game then​

Katelyn Jetelina Sep 7

Yesterday, the White House announced a new plan: one COVID-19 shot per year. The idea is this will decrease public confusion and increase booster uptake by aligning with the flu vaccine campaign. Reading between the lines, I think this is also a political signal to shift out of the SARS-CoV-2 emergency phase.
Will an annual shot plan work? Maybe. But there’s a lot that needs to align beforehand. And I certainly hope this doesn’t mean we are accepting our current state of affairs with vaccines.

Stars need to align​

The annual COVID-19 plan largely follows our flu model: evaluate circulating strains and update the vaccine before the flu season. This model works for the flu for three main reasons:

1. Flu is clearly seasonal. The predictability of the flu allows us to time vaccine recommendations so that vaccine companies can manufacturer and distribute by winter. A 6-month flu season also means that we really only need our flu to cover the winter months. In other words, the vaccine can wane, particularly among older populations.
2. Flu mutations have direction. As I have written before, the flu mutates in a ladder-like pattern. This allows us to “predict” the direction the flu may be mutating.
3. Flu has been around for decades, which has allowed us to develop and refine global surveillance systems to identify emerging strains.

SARS-CoV-2 is mutating 4 times faster than the flu. It’s not seasonal nor annual. It’s not mutating in a ladder like form. And we do not have global surveillance systems in place. We expect and hope that COVID-19 will eventually be like the flu but to assume that has already happened is premature. I also think it is a gamble, as the virus continues to surprise us. To pivot the public—again—is risky.
The fall bivalent vaccine is also our first attempt to apply the flu model to SARS-CoV-2. This is our pilot. And we really need to see how the pilot works in the “real world” before making sweeping declarations, like an annual shot. We need the data, the time, and the humility to tell. Let’s first get through winter.

Up our vaccine game​

The annual COVID-19 booster plan also means the White House has one goal: prevent severe disease and death. And our first generation vaccines can do this well. In fact, the first generation vaccines saved an estimated 20 million lives across the globe in one year.
However, we can and should do better. This does not mean boosting our way out of the pandemic, but it means leveraging innovation and science to develop next generation vaccines that last longer and/or prevent infection/transmission. This would have immense, positive ripple effects. It would slow transmission. It would slow viral mutations. It would slow morbidity (long COVID-19). It could sunset the pandemic.
Next generation vaccines include:

• Mucosal vaccines. Nasal and/or oral vaccines would provide more protection against infection and transmission (i.e., sterilizing immunity). Thirteen nasal vaccines are currently in development. These work very differently from our current vaccines, as they target “mucosal” immunity. Mucosal tissue is all over our body, including our nose and throats. In fact, it’s the largest component of our immune system and is one of the first defenses with the elements in the real world. By providing immunity there (instead of deep within our circulatory system) we can prevent infection in the first place. Clinical trial data is incredibly promising, especially when used as a booster (opposed to the primary series). This week, China approved the world’s first inhaled booster against COVID-19 called Convidecia Air.
• Pancoronavirus vaccines. The next best thing to sterilizing immunity would be a variant-proof vaccine that lasts longer. As I’ve written before, there are several in development, but the one winning the race is from the Walter Reed Army Institute of Research using “nanoparticle vaccine technology.” The vaccine presents a protein that looks like a soccer ball with many different faces. Each face presents instructions for a different part or version of a virus. We can include faces on it not just for SARS-CoV-2, but for other coronaviruses, too.
• Flu and COVID-19 combo vaccines. At the very least we need one vaccine that contains both the flu and COVID-19 vaccine formula. Earlier this year, Novavax released data on the Phase 1/2 clinical trial of its COVID-Influenza Combination Vaccine. Animal data showed this vaccine worked well, and currently 642 people aged 50-70 years old are in the Phase 1/2 clinical trial. If all goes well, a combo vaccine may be available by 2023 flu season. We need more options in case this one doesn’t make it through clinical trials.

These next generation vaccines are obtainable. We are well on our way, but this cannot be accomplished without investment from Congress. It costs an estimated $1 billion to develop and test a drug or vaccine from start to finish. And it takes risk, as not every vaccine makes it through clinical trials. Money will move mountains in science and research. But we need a push from the public, and a push from the administration. We need an Operation Warp Speed 2.0.

Bottom line​

The White House plans to have only one booster per year. This plan may (or may not) be a good one, as the stars would need to align for it to be effective. Regardless, next generation vaccines need to be a part of this conversation, as they are a critical solution for better health. We just need to fight for it.


"

So what do you do when the doctor says no mRNA vaccines for you as they did to my DD who came down with pericarditis after her booster? No one has an answer for her; not even the CDC.

 

[missy]

So what do you do when the doctor says no mRNA vaccines for you as they did to my DD who came down with pericarditis after her booster? No one has an answer for her; not even the CDC.

How about the other vaccine options?

Johnson and Johnson and Novavax?

COVID-19 Vaccination

COVID-19 vaccines protect against COVID-19. Get safety info and more.

www.cdc.gov

 

[Gloria27]

So what do you do when the doctor says no mRNA vaccines for you as they did to my DD who came down with pericarditis after her booster? No one has an answer for her; not even the CDC.

It seems you got your answer: more spike protein to the heart!

 

[Lookinagain]

@missy - I'm really grateful that DH and I didn't get it till now, when the variant we caught wasn't as toxic as the original strain, and only after we've both had multiple vaccinations. We've been *incredibly* careful - but once DH caught it, given how much day to day help I need from him due to my back, there was just no way I could stay right away from him. And down we both went.....

He caught it at a conference where he was hosting dinners for clients. I suspect the whole conference (some hundreds of people) ended up being a super spreader event. Why people think we've reached a point where we don't need masks is utterly beyond me. I'm still sanitizing my hands/arms/face multiple times a day, for Pete's sake....

@mrs-b I'm so sorry to hear that you are ill. Hopefully the anti viral will make you feel better soon. Please let me know if you two need anything. I can shop for you and drop things off. I know you don't want to eat right, but even ginger ale may help.

I too had a work conference just about two weeks ago. I stayed away from people and wore my mask most of the time, didn't sit during meetings but stood at the back of the room. I escaped Covid but at least two of my employees caught it there and I'm sure others from other operations did too. Other than myself, only one other person was wearing a mask. So the results were expected.

Anyway, please let me know if you need anything. I'm happy to help.

 

[missy]

Fall bivalent boosters: Science update​

Katelyn Jetelina Sep 28

​

The fall booster roll-out is well on its way. As of last Thursday, 4.35 million Americans have received their Pfizer/Moderna bivalent booster in the first three weeks of availability. (CDC numbers are updated every Thursday.) The new booster recommendation created an obvious uptick on the graph below of the daily number of COVID-19 vaccines administered.

There’s good and bad news about this number. Good news: This is higher than the initial booster uptake in the same time period last year. Potentially bad news: This is still really low uptake. In fact, it’s lower than what we see with the flu vaccine at this time. (For example, 13 million flu vaccines were administered by this time last year.) It’s only potentially bad news, though, because people may be waiting (and rightfully so) due to recent infections or boosters. Time will tell if we will get to optimal vaccine coverage for the winter. I still have hope.

The FDA and CDC authorized the bivalent boosters based on a number of data sources. This was necessary to get ahead of the virus, like we do with the flu vaccine each year. Our hope is that a bivalent booster will help in three distinct ways:

1. Greater protection against infection and transmission, by boosting our first line of defense—neutralizing antibodies;
2. Longer protection against infection and severe disease, even just by a few months. (Unfortunately, we are at the mercy of time to know whether this will happen, but we are hopeful given data from our bivalent Beta vaccine clinical trials);
3. Broader protection or the ability to create antibodies that “see” more virus parts and “attach” more strongly compared to the antibodies we have right now.

We have two new studies with promising data.

The first preprint solidifies #1 and #3. Before now, we’ve relied on mice datato show that bivalent BA.4/5 vaccine increased neutralizing antibodies. But, now we have data on humans. Scientists measured antibodies in individuals who had three mRNA vaccines and a BA.4/5 breakthrough infection. (This can act as a proxy for the BA.4/5 booster.) They found antibodies were very high and were high against all Omicron subvariants studied. In other words, the bivalent booster will enhance protection against Omicron, which will help prevent infection and transmission. This is not surprising, but reassuring.

​

The second preprint points to #3. This is a study we’ve all been waiting for. Scientists studied B-cells—our antibody factories—and, particularly, whether we could make new B-cells (update the factory line after seeing another variant). This is important to study to ensure we don’t have original antigenic sin. (If you haven’t already, read this previous post on original antigenic sin where I attempt to explain this concept.) The current study showed that while we do have imprinting (which is normal and expected), we do make new B-cells after an updated Omicron vaccine. In fact, the authors stated, “immunization with an antigenically distant spike can overcome the antigenic imprinting by the primary vaccination series.” This means that an updated booster will increase the diversity of our antibodies and that memory will be retained by our immune systems.

Limitations​

It’s important to note that, unfortunately, new subvariants of Omicron are already on the horizon with concerning mutations for antibody escape, like BA.2.75.2 or BQ.1.1. These new variants were not tested in the studies above. We’ve seen from another study that these new variants can substantially escape neutralizing antibodies from Coronavac (a Chinese vaccine using inactivated virus). But there are still a lot of unknowns: We don’t know how mRNA vaccines will hold up; we don’t know if these variants will take hold; and neutralizing antibodies are just one part of our complex immune system. Our safest bet is not through infection, but through vaccination. Our immune systems need updating and we need to be responsive to that, even if that updating is not perfect.

Bottom line​

Emerging evidence on bivalent vaccines is encouraging. Even with new subvariants on the horizon, they will help in one way or another. Be sure to get your booster this fall!

 

[missy]

NYT

The latest on shots​ ​

About 40,000 Americans died of Covid this summer. That toll means that Covid is continuing to kill many more people each day than vehicle crashes, gun violence, the flu or many other health threats.​

The situation is especially tragic because most of these Covid deaths could have been prevented — if only more Americans had received vaccine shots, including booster shots for older people and others with vulnerable health.​

Consider this data from King County, Wash., which includes Seattle and publishes some of the most detailed, up-to-date Covid statistics in the country:​

Chart shows the 30-day average from Aug. 22 to Sept. 21, 2022, in King County, Wash. | Source: Washington State Department of Health​

(The King County data is more current than the publicly available data from other places, but all of the numbers — from King County, other localities and the C.D.C. — are broadly similar.)​

As you can see, Covid is killing almost nobody under 50 and is hospitalizing very few people. The death and hospitalization rates also remain low among older people who are boosted. And in all of these groups, severe Covid illness is concentrated among people who have significant underlying medical problems.​

The main reason so many Americans are still dying from Covid is that vaccination and booster rates are not higher. Only about half of adults have received a booster shot, according to the Kaiser Family Foundation’s most recent poll. More than 20 percent have not received any vaccine shot.​

I know that there is still a lot of confusion about booster shots — including about the new version, known as a bivalent booster. Today’s newsletter will offer answers to some common questions.​

Do boosters matter?​ ​

Yes, boosters matter, as the charts above show. The biggest benefit is a reduction in severe illness among vulnerable people, as Jennifer Nuzzo, an epidemiologist at Brown University, told me. For that reason, anybody over 50 who has not yet received a booster shot in 2022 should consider getting one as soon as possible.​

(One exception: If you recently had Covid, you should wait several months before getting a booster, as my colleague Dani Blum explains.)​

The most effective way to reduce Covid deaths, however, does not involve boosters. It involves persuading more unvaccinated Americans to get their first shot. Their risks are far higher than the risks facing the unboosted. Unfortunately, public health officials acknowledge that they don’t know how to increase that number very much. About four-fifths of the unvaccinated — a group that is disproportionately Republican — say they will “definitely not” get a shot, according to Kaiser.​

Covid remains so deadly largely because millions of Americans have decided they would rather accept its risks than receive a vaccine shot.​

Do younger people need one?​ ​

Whether to get a booster shot is a closer call for healthy people under 50, many experts believe. Rates of severe Covid are already so low among this group that booster shots don’t seem to have a huge health benefit. Of course, the downsides of the shots also seem to be small, because research has consistently shown them to be safe.​

But getting a booster shot is not wholly without downsides. Some people are fearful of needles or prefer to avoid taking unnecessary medicines. Other people were sick for a day or two after getting an earlier Covid shot and would prefer not to repeat the experience. For hourly workers and single parents, a day in bed can also bring financial or logistical burdens, especially in a country without guaranteed sick leave or child care.​

For these reasons, many experts stop short of telling younger adults and children that they need to be boosted. “I’m not in the camp of saying if you’re under 50, you have to do it,” Andy Slavitt, a former Covid adviser to President Biden and former head of Medicare and Medicaid, told me. “Reasonable people could come out on different sides of it.” Similarly, Dr. Paul Sax, a leader of the infectious-disease division at Brigham and Women’s Hospital in Boston, said, “I don’t think it’s as clear for young healthy people as for older people to get the booster.”​

Still, if you’re a booster skeptic, I would encourage you to keep in mind that many of these same experts — including Sax and Slavitt — are encouraging the younger adults in their own families to get booster shots.​

Why? For one thing, the data suggests that a booster reduces a person’s chances of being infected with Covid, at least for a few months, and even a moderate Covid infection can keep somebody in bed for days. It can sometimes lead to longer-term symptoms, too. Perhaps most important, a younger person could infect an older person for whom Covid might be more severe.​

“You’re doing it for your family and your friends,” Dr. Ashish Jha, the White House’s Covid coordinator, told The Washington Post. The Biden administration has recently changed its guidance to recommend that all eligible people 12 and above receive a booster shot with one of the updated vaccines. Jha recently said that he expected a Covid shot to become an annual ritual, like a flu shot.​

In some cases, it may make sense for younger, healthy people to schedule their next Covid shot to line up with their risk of exposure to the virus, including the chance that they would infect a more vulnerable person. Nuzzo — who’s under 50, without underlying health conditions — told me that she was waiting to get her next booster until shortly before the holidays. “I do appreciate the temporary added benefit against infection and want to time that protection to correspond to when I am most likely to be exposed to Covid,” she said.​

I’m 49 and got my second booster — a bivalent booster, this time — a few weeks ago. I did not want to enter the colder fall weather without updated protection. But I understand why others, especially younger people, may decide to wait.​

What about new boosters?​ ​

Pfizer and Moderna began offering bivalent booster shots in September, designed to combat Omicron subvariants of the Covid virus. Tests in animals have suggested that the shots will do a better job preventing infections than earlier vaccine shots.​

So far, the real-world evidence is unclear. “The truth is,” Slavitt says, “we don’t know.” The situation will become clearer once the C.D.C. releases more data in coming weeks.​

But most people don’t need to worry too much about these fine differences. The new boosters, like the earlier versions, are likely to be extremely effective at preventing severe illness, scientists say. For people who are more vulnerable to severe Covid, either because of age or a health condition, the best advice has not changed: Stay up-to-date on your Covid boosters.​

 

[danusia]

How about the other vaccine options?

Johnson and Johnson and Novavax?

COVID-19 Vaccination

COVID-19 vaccines protect against COVID-19. Get safety info and more.

www.cdc.gov

She contacted the cardiologist regarding both and he is unsure based on the data he has been reviewing. It seems that he has a few patients he has been treating for myocarditis and pericarditis due to the vaccines.

 

[missy]

She contacted the cardiologist regarding both and he is unsure based on the data he has been reviewing. It seems that he has a few patients he has been treating for myocarditis and pericarditis due to the vaccines.

The mrna vaccines right? I don't believe that's a side effect with the other vaccines.

Myocarditis and Pericarditis After mRNA COVID-19 Vaccination

Learn about myocarditis and pericarditis after COVID-19 vaccination. CDC still recommends that everyone aged 5 years and older get vaccinated. (142)

www.cdc.gov

 

[Gloria27]

@danusia wonder how many of these injuries are actually reported.

Hope your DD will not have any long lasting issues.

 

[Lookinagain]

@danusia wonder how many of these injuries are actually reported.

Hope your DD will not have any long lasting issues.

Anyone with myocarditis and pericarditis would need medical treatment and the physicians would be required to report it.

 

[danusia]

Anyone with myocarditis and pericarditis would need medical treatment and the physicians would be required to report it.

You would think so. The only treatment she got was a wait and see and retested approach. 6 months after her booster her echo showed fluid around the heart was gone, but she still had rapid heartbeats. She told me that he said he did not know who to report it to. She gave him the info. She did report it directly herself giving (I think it was the CDC) doctor info and test results. She wanted to get in on record, because if she suffers any permanent or long lasting effects the government will re responsible based on the responses she received.

I mentioned this to my cardiologist and he said that her reaction to the booster was probably better than coming down with covid. He too said that he does not know who to report such reactions to the covid vaccine to. So what good are our doctors if they don't know what to do?!

 

[Lookinagain]

You would think so. The only treatment she got was a wait and see and retested approach. 6 months after her booster her echo showed fluid around the heart was gone, but she still had rapid heartbeats. She told me that he said he did not know who to report it to. She gave him the info. She did report it directly herself giving (I think it was the CDC) doctor info and test results. She wanted to get in on record, because if she suffers any permanent or long lasting effects the government will re responsible based on the responses she received.

I mentioned this to my cardiologist and he said that her reaction to the booster was probably better than coming down with covid. He too said that he does not know who to report such reactions to the covid vaccine to. So what good are our doctors if they don't know what to do?!

If the doctor administers vaccines they are required to report it to the CDC. Those two issues are both listed. Maybe the doctor she uses doesn't give the vaccine but whomever gave it to her would need to report her issues. I don't know about treating, but most people would go to the doctor for the issues and the doctor should know that whoever gave her the vax needed to report it.

The reporting requirements for COVID-19 vaccines are the same for those authorized under emergency use (EUA) or approved under a Biologics License Application (BLA). Healthcare providers who administer COVID-19 vaccines are required by FDA, and under the provider agreements for the CDC COVID-19 Vaccination Program, to report the following to VAERS:

• Vaccine administration errors, whether or not associated with an adverse event (AE).
  • If the incorrect mRNA COVID-19 vaccine product was inadvertently administered for a second dose in a 2-dose series, VAERS reporting is required.
  • If a different product from the primary series is inadvertently administered for the additional or booster (third dose), VAERS reporting is required.
  • VAERS reporting is not required for the following situations:
    • If a mixed series is given intentionally (e.g., due to hypersensitivity to a vaccine ingredient)
    • Mixing and matching of booster doses intentionally (as of October 21, 2021, mixing and matching of booster doses is allowed)
• Serious AEs regardless of whether the reporter thinks the vaccine caused the AE. Serious AEs per FDA are defined as:
  1. Death
  2. A life-threatening AE
  3. Inpatient hospitalization or prolongation of existing hospitalization
  4. A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions
  5. A congenital anomaly/birth defect
  6. An important medical event that based on appropriate medical judgement may jeopardize the individual and may require medical or surgical intervention to prevent one of the outcomes listed above
• Cases of myocarditis after a Pfizer-BioNTech, Moderna, or Novavax vaccine
• Cases of pericarditis after a Pfizer-BioNTech, Moderna, or Novavax vaccine
• Cases of Multisystem Inflammatory Syndrome in children and adults
• Cases of COVID-19 that result in hospitalization or death

 

[Gloria27]

If the doctor administers vaccines they are required to report it to the CDC. Those two issues are both listed. Maybe the doctor she uses doesn't give the vaccine but whomever gave it to her would need to report her issues.

What if your vaccine is administered by a nurse not a doctor and you got in one of those pop up places, standing in a queue? (assuming you guys had such pop-up/conversions in the US)

Then how do you know who was the person administering it and if they are just a nurse, how will you find them and make them report it?

 

[missy]

I posted this two years ago in the Coronavirus update thread.Reporting adverse effects FYI

Vaccine Adverse Event Reporting System (VAERS)

VAERS is a warning system used to monitor events after vaccination.

www.cdc.gov

Snip...

"
There are two ways to report an adverse event to VAERS: report online or report using a writable pdf form. If you need further assistance with reporting to VAERS, please email [email protected] or call 1-800-822-7967.

For healthcare providers – Under Emergency Use Authorization, FDA requires healthcare professionals to report to VAERS certain adverse events that occur after COVID-19 vaccination. CDC also encourages reporting of any medically important adverse event even if it isn’t clear if the vaccine caused the health problem.

Learn more about selected adverse events reported to VAERS.

"


In addition, you can report side effects to:

ModernaTX, Inc. at 1-866-MODERNA (1-866-663- 3762)

and Pfizer

Pfizer's COVID-19 Vaccine Side Effects & Adverse Events

Report an adverse event related to the Pfizer COVID-19 vaccine here.

covaes.pfizersafetyreporting.com

And if you google any of the vaccines this info and more readily appear.

 

[missy]

mRNA in breastmilk. That's okay. And more on COVID19 vaccines and pregnancy​

Katelyn Jetelina Sep 30

A ridiculous amount of misinformation has recently surfaced online regarding COVID-19 vaccinations, pregnancy, and breastfeeding. This is due to a number of bad players intentionally spreading false information as well as some solid players poorly writing tweets.

Regardless of what you see on social media, it is still strongly recommended that all pregnant and breastfeeding people get the COVID-19 vaccine.

I partnered with Dr. Viki Male, an immunologist and lecturer on pregnancy and reproductive immunology at Imperial College London. She updates a fantastic multi-page document with the latest evidence regarding pregnancy and COVID-19 vaccines. Here are answers to some questions circulating right now.

I am pregnant. What are the risks if I get COVID during pregnancy?​

There is evidence that COVID infection increases the risk of miscarriage (here, here), although not all studies have been able to find this (here, here). Preterm birth and stillbirth occur more often in pregnant patients with COVID-19, and their babies are more likely to be admitted to the neonatal unit. Pregnant patients with COVID-19 also more likely to need intensive care than COVID-19 patients who are not pregnant.

Can the COVID-19 vaccine cross the placenta?​

One study of 19 people who received the COVID vaccine during pregnancy could not detect any vaccine mRNA or spike protein in placenta or cord blood. Babies of vaccinated mothers do not have any anti-spike IgM (a type of antibody), indicating that the vaccines themselves do not cross the placenta. (You can see the data on this here, here, and here, and an explanation on the interpretation of the studies here).

A study of 48 placentas collected shortly after vaccination was unable to detect any spike protein or mRNA. Vaccination is also not associated with any placental abnormalities (here, here).

Is it safe to get the COVID vaccine during pregnancy?​

Yes. The safety of COVID vaccination during pregnancy is being monitored in a number of ways:

• Passive monitoring systems, such as Yellow Card in the UK and VAERS in the USA, collect information that doctors, patients, and their families report. Neither have detected adverse events occurring more often following COVID vaccination than they normally do in pregnancy.
• Twenty-seven studies have been conducted across eight countries and 316,470 people vaccinated during pregnancy and tracked outcomes of pregnancy. None of these studies have found any increased risk of miscarriage, preterm birth, stillbirth, or babies being born smaller than expected or with congenital abnormalities following COVID-19 vaccination. A meta-analysis pooling many of these studies found that COVID vaccination actually reduces the rate of stillbirth by 15%, presumably because it prevents stillbirths that occur because of COVID infection.
• Registry studies recruit people at vaccination, track the outcomes of their pregnancies, and compare the outcomes to those we normally see in pregnancy. No registry has found an increase risk of miscarriage, preterm birth, stillbirth, or babies needing intensive care or dying:
  • In the U.S., V-SAFE examined the outcomes for 5,096 people vaccinated in pregnancy and their babies. The first report found the rates of adverse events were the same as we normally see. A follow-up study looking at outcomes of people vaccinated before 20 weeks of pregnancy found no increased risk of miscarriage following vaccination. A second follow up of 1,634 births found that the rates of adverse events at birth remained normal.
  • In Canada, the BORN Ontario registry comprises 64,234 people vaccinated during pregnancy and showed no increased risk of stillbirth, preterm birth or babies being smaller than expected for their gestational age (here, here, here and here).
  • In Scotland, a study looked at 18,399 people vaccinated against COVID during pregnancy and found no increased risk of stillbirth, babies dying shortly after birth, or preterm birth following vaccination.
  • The Swiss COVI-PREG registry followed 1,012 people vaccinated during pregnancy and found no increased risk of miscarriage, preterm birth, stillbirth, or babies needing intensive care or dying.
  • A small registry study of 390 people vaccinated during pregnancy in Israel found no increased risk of miscarriage, preterm birth, babies being born smaller than expected or with congenital abnormalities, or needing intensive care.

Will being vaccinated while I am pregnant give my baby any protection against COVID once they are born?​

We have many reports showing that antibodies the body makes after vaccination (called IgG) do cross the placenta. Early reports suggest that vaccination in pregnancy is about 61% effective at protecting babies under 6 months old from hospitalization with COVID. Two more recent studies (here, here) found vaccination in pregnancy was 80% and 38% protective against hospitalization with Delta and Omicron, respectively, and 71% and 33% effective at protecting against infection.

I am breastfeeding. Should I get the vaccine if I am offered it?​

Yes. There is no known risk associated with non-live vaccines (i.e. mRNA vaccines) while breastfeeding. No safety signals have appeared in breastfeeding people or their babies.

Two studies looking for vaccine mRNA in breast milk have been unable to detect it (here and here). Three studies were able to detect it at very low levels. One study found mRNA at 2 parts per billion in 3 out of 10 milk donors. Another study found mRNA in 4 out of 31 milk donors at a maximum of 0.17 parts per billion, and the third study found mRNA in 3 out of 11 milk donors at a maximum of 0.011 parts per billion. You can read an explanation of what “parts per billion” means here, but the latest study means this is roughly equivalent to a single tear in an Olympic pool. (Note that mRNA is part of our everyday life, outside of vaccines. For example, it’s in meat we eat, and our stomach acid is strong enough to break it down.)

A study that looked for the chemical PEG, which is used to stabilize mRNA vaccines, in the breast milk of 13 people found that levels did not increase after vaccination. (Note that PEG is commonly found in many cosmetics, so was found in some milk samples from unvaccinated donors.)

Together, this means those who are breastfeeding do not need to “pump and dump” within 48 hours of vaccination.

A number of studies have shown antibodies get into breast milk at high concentrations. You can find them summarized in this systematic review. One of these studies found that antibodies could persist in breast milk for as long as 6 months after vaccination. There is also some evidence that T cells that respond to COVID-19 get into breast milk (here, here). These antibodies and T cells give your baby some protection against COVID19, although more research is being done to confirm this.

More questions​

For questions about COVID-19 vaccine safety before pregnancy, including questions about fertility and menstrual cycles, and answers to more questions about vaccines during and after pregnancy, be sure to check out this live document on the latest evidence. It’s updated in almost real time.

Bottom line​

The vaccines are safe and effective before pregnancy, during pregnancy, and after pregnancy. For both the parent and the baby. The new bivalent vaccine does not change this. Be sure to get your vaccine!

 

[dk168]

Second seasonal booster booked, don't know which version I am having and don't care.

Hong Kong apparently has eased the quarantine requirements according to my mum who is not vaccinated due to existing health concerns.

DK

 

[YadaYadaYada]

I’m not sure if this has been mentioned but here is information about compensation for Covid vaccine related injuries:

https://crsreports.congress.gov/product/pdf/LSB/LSB10584

Also worth reading:

COVID vaccine injury plaintiffs face long odds in U.S. compensation program

“I thought it would be impossible to deny me.”

www.reuters.com

 

[missy]

https://www.washingtonpost.com/health/2022/09/26/covid-questions-variants-long-covid/

The latest
After 2½ years of studies of a virus that has killed 6.5 million people globally, coronavirus enigmas still plague scientists and the public. My colleague Mark Johnson recently explored some of the most pressing questions such as “where did the virus come from, and why has it been so successful?” and “why do some people develop long covid?” in his latest piece.

The complexities of the virus have led researchers to publish more than 200,000 studies, which is four times more than the number of research papers written on the flu in the past century, Johnson reports.

The U.S. government has spent almost $4 trillion in its response to the pandemic.

New research shows that transplant patients treated with immunosuppressive drugs later tested positive for a coronavirus variant that is resistant to treatment.

According to findings from researchers at the NYU Grossman School of Medicine and NYU Long Island School of Medicine, two kidney transplant patients were treated with remdesivir after developing covid-19. They were readmitted to the hospital after developing symptoms including fatigue, cough and a fever, despite being vaccinated.

When doctors tested the patients, they identified a gene mutation that wasn't previously present and appeared only after the patients took the antiviral treatment. The mutation made the virus more resistant to remdesivir.

Remdesivir — developed initially to treat hepatitis C — is one of the few antiviral therapies approved by the Food and Drug Administration to treat hospitalized coronavirus patients.

“In the future, physicians might also screen for such mutations before making treatment decisions for their most vulnerable patients,” Adriana Heguy, one of the study authors, said in a statement.

 

[missy]

What Makes Some Infections Asymptomatic?

Judy Stone, MD
September 29, 2022

A young man is paralyzed from polio in New York. Yet all around him many others are carrying the polio virus in their gut but have no symptoms. What makes them different?
The famous Typhoid Mary was asymptomatic, although she carried Salmonella typhi in her gut for decades. She transmitted the bacteria to more than a hundred New Yorkers by inadvertently contaminating the food she prepared, and five of those people died. Why did she display no symptoms from the typhoid she carried and spread?
COVID-19 is still killing 3000 people per week in the US, and there are more than 400,000 cases per week. But 40% to 60% of COVID cases are estimated to be asymptomatic, and they're driving the infection because they're spreading silently. How do some people escape the pandemic while others quickly develop respiratory failure and die?
With typhoid, Denise Monack, PhD, chair of microbiology and immunology at Stanford University, told Medscape Medical News, "These microbes that have evolved to colonize parts of our body that normally are not colonized by bacteria...have an armament of — we call them virulence factors — that allow them to dampen immune responses or hide from our immune system. A classic example for typhi is that it has this capsule, a polysaccharide on the surface [of its cell wall], and it allows it to evade innate immune recognition."

Monack said typhi can evade complement (part of a complex with an antibody that triggers an inflammatory response) as well as immune cells and even replicate inside macrophages through other virulence factors. This ability to survive intracellularly distinguishes it from more common Gram-negative organisms, like E. coli or Klebsiella.

Dr Denise Monack
Monack also described recent research with human-derived gut organoids infected with poliovirus that show that infected cells sloughed off from the rest. In humans, they would be excreted and then ingested by other people. The goal of these microbes is to replicate "because otherwise, it's a dead end for the virus.... There's no intent to cause disease to kill both." And all else being equal, there is selection pressure for less virulence over time.

Dr Sten Vermund
Sten Vermund, MD, PhD, professor of public health and pediatrics at the Yale School of Medicine, told Medscape Medical News, "This range — asymptomatic, mild, severe, and life-threatening — is actually not that uncommon. That's true for flu. That's true for RSV [respiratory syncytial virus].... The ones that don't have that range are the exceptions — like rhinovirus."

Infectivity also varies with the virulence of the organism and with the health of the person. Generally, very young infants and the elderly are more susceptible to infections.


"Different organisms have different age predilections," said Vermund. "So, for influenza, typically, it's the very old and the very young who are at the highest risk."
On the other hand, Vermund continued, "For reasons that nobody understands, the Spanish Influenza of 1918-1919 had a predilection for middle-aged people and young adults. Less the elderly, less the infants, and we don't understand that! So, there are these age-related factors and the immunologic differences."
There is still much to understand about these immunologic differences, but we have learned some things about how some people can be infected with a normally virulent disease yet show no symptoms.
Some clues come from infants, who have had little or no exposure to pathogens and have an undeveloped immune system, but here is some of what we've learned.
"A baby is obviously born relatively immune-naive and is protected for many months through the passive antibody that has been gifted by the mother and then additional antibodies through breast milk," Vermund said. "But slowly, that infant generates immune responses that are much more mature...as the infant grows to 1 or 2 years of age."
That immune naïveté becomes especially dangerous when the infant or fetus develops one of the infections associated with the "TORCH syndrome." (TORCH is an acronym for Toxoplasmosis, Other Agents, Rubella, Cytomegalovirus, and Herpes Simplex.)
Vermund explained, "The worst is when you have the pregnant mother infected with these viruses that then infect the infant in utero before the infant has any real ability to mount an immune response."
Babies have an innate immune system, a nonspecific response that includes the skin and mucous membranes as physical barriers to infection. Chemical reactions also result in inflammation and activation of specialized scavenger cells to kill the invading organism. But babies have not yet developed the antigen-specific responses needed for adaptive immunity. Over months they produce T cells, which detect and destroy viruses and activate B cells. B cells make antibodies in response to a specific target, and they both neutralize the invader and signal to attract other cells to the immune response.
For the elderly, senescence of the immune system causes both the diminished response to vaccines and the reemergence of infections. Herpes zoster, for example, remains indolent and controlled for decades after someone is infected with the varicella virus before it emerges.

Dr William Moss
"Tuberculosis is a great example of pathogens that have a latency within the body," William Moss, MD, professor of epidemiology and executive director of the International Vaccine Access Center at Johns Hopkins University, told Medscape Medical News, "Latency is one kind of biological mechanism subverting the immune system. It's another mechanism by which a pathogen can infect someone and not cause symptoms [that] are largely mediated by our immune response."

Dr Vincent Racaniello
With COVID-19, "The No. 1 risk for severe COVID is age, and the No. 2 risk is not having a good interferon response," Vincent Racaniello, PhD, professor of virology at Columbia University, told Medscape Medical News.
"A really good response makes the infection asymptomatic," Racaniello continued. "[But] there's a subtlety here because if you have too much interferon, [you get flu-like symptoms]."

At the other extreme, a patient could experience a "cytokine storm" with the release of many proinflammatory cytokines, proteins like interferon and the interleukins. This overwhelming immune response accounts for many of the deaths from COVID — and may also explain the 1918 deaths from influenza.
Racaniello stressed that this type of balance is true for a variety of organisms and in a variety of settings. "People have studied bacteria in the gut, and it's quite clear that interferon immunity is important for regulating those bacteria so they don't overgrow and become pathogenic. We know that in an immunosuppressed host, they can cause a problem. So, there's got to be this balance. It's in part mediated by immune responses, I think, as well as what other viruses and bacteria are present."
Racaniello pointed out that we likely will never understand those details regarding polio, because there are too few cases to study. That's also true of other infections causing limited disease.

There's much that remains unknown about immunity and what makes some infections asymptomatic. One striking example is that of meningococcus. About 10% to 15% of adults carry meningococcus in their nasal passages and do not become sick. But occasionally, and for reasons unknown, when somebody new encounters the bacterium — often a young child or a teen or young adult — they may become critically ill within hours from meningitis or develop septic shock and die. Why is there such a range?
The researchers Medscape spoke with answered that question by emphasizing various aspects of the host-pathogen balance. How much is affected by environmental elements? How much by the host's genetics vs quirks in the pathogen's genetics? What about coinfections?
Vermund pointed to the microbiome, "I think the microbiome to be relevant. The respiratory microbiome might increase or decrease the pathogenic consequences of SARS-CoV2, RSV, or flu. There's a long way to go in our discipline before we sort this all out."
Racaniello agreed on the importance of the microbiome, "When you're born, you get a microbiome from your mom, and you have that for the rest of your life. I'm not sure that's an infection, right? That's part of your flora [and] there are mechanisms that allow people to coexist with these bacteria. In your gut, you have Clostridium, and it's only when you disturb the balance of the flora then those can overgrow and cause problems. So that tells us that part of the control is based on the community, the entire community, regulating members that could be otherwise problematic."
Moss pointed to T cell immunity, "T cell immunity probably plays a much bigger role in protecting against severe disease, but not [against] any symptoms. So, for individuals who are truly asymptomatic and infected, I think it's going to be local mucosal immunity at the site of initial viral infection that's going to be most strongly correlated."
Vermund turned back to inflammation as a critical unifying theme. "You would think that there are some fundamentals about inflammation that need to be sorted," he said. "What is it about the human immune response in which inflammatory dynamics are vital components that are functional? And why is it so frequently dysfunctional? Why does there exist the phenomenon of the cytokine storm where the immune response seems to be driving a pathogenic process? The whole field of autoimmunity, is an example. And then, of course, long-term consequences of infectious agents are also a component of this great mystery."
The bottom line, as always, is "more research is needed."
There is much we need to learn about why there is such a range of responses in humans from encounters with bacteria and viruses. As noted by Monack, Vermund, Moss, and Racaniello, there are many possible mechanisms contributing to those varied responses. Teasing out the relative contribution of each mechanism will require substantial further research.
Judy Stone, MD, is an infectious disease specialist and author of Resilience: One Family's Story of Hope and Triumph Over Evil and of Conducting Clinical Research, the essential guide to the topic. You can find her at drjudystone.com or on Twitter @drjudystone.

 

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Can Nasal Vaccines Change the Course of the Pandemic?​

— Blocking transmission is a noble goal, but there's not yet evidence mucosal vaccines can do that​

by Amanda D'Ambrosio, Enterprise & Investigative Writer, MedPage Today September 29, 2022

Mucosal vaccines against COVID-19 have potential to prevent even mild infections and stop transmission – a challenge current vaccines are unable to address. But it's too soon to declare these vaccines -- delivered nasally, orally, or transdermally -- the solution that could quash the pandemic, experts say.
It's still "early days" for these immunizations, said William Schaffner, MD, an infectious diseases physician at Vanderbilt University in Nashville, Tennessee. There is hope that intranasal vaccines will be able to cut transmission, but "it's more anticipated than demonstrated at the present time," he said.

He and other experts point to a lack of data on the efficacy of mucosal COVID vaccines in humans and many challenges ahead for development and evaluation of efficacy.
At least 12 nasal vaccine candidates for COVID are in development, four of which have reached phase III clinical trials.
The only approved intranasal vaccine of any type in the U.S. is FluMist, a live attenuated vaccine against influenza. Some countries, however, have already approved mucosal vaccines for COVID. Earlier this month, China approved an inhaled COVID-19 vaccine as a booster and India gave the green light to an intranasal vaccine for emergency use, both based on adenovirus vectors.
Reaching Sterilizing Immunity
Like most respiratory viruses, SARS-CoV-2 enters the body through mucous membranes such as the mouth, nose, and throat. After the virus makes contact on the mucosal surfaces, it multiplies, traveling from those entry points through the bloodstream to other parts of the body.

The idea is that mucosal vaccines could bolster immunity at these viral entry points, stopping the pathogen from implanting, multiplying, and transporting itself throughout the body.
"We know that if you can induce immunity in the nose, that often is much more effective in preventing infection," said Kathryn Edwards, MD, a professor of pediatrics and vaccine researcher also at Vanderbilt University. "It's an attractive hypothesis to think we could begin to make weakened COVID vaccines that might be able to stimulate local immunity and really prevent infection."
There's some evidence accruing that higher levels of mucosal immunity do just that. For example, a research letter published in the New England Journal of Medicine showed that triple-vaccinated healthcare workers with higher levels of anti-spike mucosal immunoglobulin A (IgA) had a reduced risk of a breakthrough infection with the Omicron variant (RR 0.35, 97.5% CI 0.11-0.91).
Current injectable vaccines, which help prevent progression to severe infection and death, do induce some level of mucosal immunity -- but at typically very low levels, experts noted.

"Current vaccine strategies are really effective and are great at preventing disease," said Benjamin Goldman-Israelow, MD, PhD, assistant professor of internal medicine and infectious diseases at Yale School of Medicine in New Haven, Connecticut.
"We do think that further immunization and further immunity within the respiratory tract has the potential to reduce transmission even more," he said in an interview. "Could that further dampen the pandemic? Could it further inhibit viral evolution and the emergence of variants? All those things, we think, are very important."
How Effective Are Nasal Vaccines?
Animal studies evaluating the efficacy of mucosal vaccines for COVID-19 suggest that these vaccines might do a better job at preventing infection.
Goldman-Israelow and colleagues tested intranasal vaccines in mice, showing that a nasally-delivered, unadjuvanted spike protein booster that was administered after an intramuscular mRNA shot induced mucosal immunity, both reducing viral load in the respiratory tract and preventing lethal illness.

Additionally, Ahmed Hassan, PhD, and colleagues at the University of Washington in St. Louis, found that a single-dose, adenovirus-vectored intranasal vaccine reduced risk of infection in rhesus macaques in both the upper and lower respiratory tracts.
A combination approach appeared promising in mouse-model research led by Matthias Tenbusch, PhD, of University Hospital Erlangen, Germany. An intranasal booster with adenoviral vectors induced high levels of mucosal IgA and lung-resident memory T cells, enhanced mucosal neutralization of SARS-CoV-2, and provided complete protection against infection in mice.
"Our data thus suggest that mucosal booster immunizations after mRNA priming is a promising approach to establish mucosal immunity in addition to systemic responses," Tenbusch's group wrote.
Biotech company Codagenix released phase I data on its live attenuated intranasal vaccine, CoviLiv, which showed a strong cellular immune and mucosal antibody response against Omicron BA.2.
However, there is still very little data describing the efficacy of intranasal vaccines in humans. Understanding how effective intranasal vaccines will be in preventing human infection and transmission will have to wait on phase III clinical trial results.

Obstacles to Development
Despite the promising premise, it won't be easy to assess clinical efficacy, said John Moore, PhD, professor of microbiology and immunology at the Weill Cornell School of Medicine in New York City.
Determining correlates of protection -- that is, how much of an immune response will prevent infection -- is challenging in a population that has been largely exposed to the virus, he told MedPage Today.
"It's a worthwhile concept, but it's going to be challenging to prove that it's better than what we already have," Moore said. He added that further research should also determine whether nasal vaccines will induce both mucosal and systemic immunity such that they could be used alone instead of only as a booster.
Additionally, it is difficult to produce a long-lasting and effective immune response with mucosal formulas. FluMist, for example, was discontinued for a period following recommendations from the CDC's Advisory Committee on Immunization Practices (ACIP), after it was shown to be less effective than injected flu vaccines in kids over several seasons. Now, the vaccine is recommended for young children but not for adults over age 49.

Gregory Poland, MD, a vaccine researcher at the Mayo Clinic in Rochester, Minnesota, added to the list of questions around these vaccines: What will durability and efficacy look like across age groups? Will the antibodies generated neutralize all the variants?
While intranasal vaccines for COVID are a potentially great answer for crowded environments, such as the military, college campuses or schools, Poland added: "Is it the answer for infants and older adults, the ones who actually are most likely to be hospitalized or die? Unlikely without some kind of scientific advance that hasn't yet happened."
Still, Poland said that finding a vaccine that could indeed block transmission could be crucial to the public health approach at this stage of the pandemic.
"I think that's really important if we can do it," he said, noting that at least 100,000 people will likely die of COVID each year at the rate the virus is spreading. "So yeah, blocking transmission? That would be a godsend."

• Amanda D'Ambrosio is a reporter on MedPage Today’s enterprise & investigative team. She covers obstetrics-gynecology and other clinical news, and writes features about the U.S. healthcare system