Dog Beach, Carmel
COVID VACCINE
-FLU VACCINE
-WEST NILE VIRUS
-UNITED HEALTH INSURANCE
-TRAVELAN
School has already started. That’s good news and bad news for families. The good news is that families are getting back into a routine. The bad news is kids are getting together and spreading germs. The “back to school special” I always called it. We have seen a late summer surge of Covid 19 as in previous summers. It is said to be milder this summer. Fewer people are being hospitalized, but there are still a lot of sick people out there. If you have cold symptoms, you might want to check to know what you have so you can be a little more careful not to spread it around. If it is mild, we usually just treat the symptoms, but if you are really sick, Paxlovid is an option. The shocking thing about Paxlovid is the price difference I hear being quoted depending on insurance. I’ve heard anywhere from $0 to $850! Here is a link to an old post on Paxlovid. Do I Need Paxlovid, Revisited? – Mark Thornton
FDA Approves Moderna’s New COVID Vaccine With Restricted Use
Here is the latest:
FDA Limits Approval For Updated COVID-19 Vaccines To Older Adults, High-Risk Patients
The New York Times (8/27, Jewett, Fortin) reports the FDA on Wednesday approved “updated Covid vaccines for the fall season and limited who can get the shots, the federal government’s most restrictive policy since the vaccines became available.” The agency “authorized the vaccines for people who are 65 and older, who are known to be more vulnerable to severe illness from Covid.” Meanwhile, adults will only be eligible for the vaccine “if they had at least one underlying medical condition that would put them at risk for severe disease. Healthy children under 18 could still receive the shots if a medical provider is consulted.” According to the Times, the action marks “the first fall/winter season that Covid shots were not widely recommended to most people and children.”
The AP (8/28, Perrone) adds that Pfizer’s COVID-19 vaccine “will no longer be available for any child under 5, because the FDA said it was revoking the shot’s emergency authorization for that age group. Parents will still be able to seek out shots from rival drugmaker Moderna, the other maker of mRNA vaccines, which has full FDA approval for children as young as 6 months. But the company’s Spikevax vaccine is only approved for children with at least one serious health problem.”
Reuters (8/27, Wingrove, Roy) reports that insurers usually follow recommendations from a CDC expert panel “that advises on who should take FDA-approved vaccines, but the panel has yet to weigh in on updated COVID shots.”
BOTTOM LINE: If you are over 65 and it’s been 6 months you can get another one. If you were hoping to avoid the summer surge, you are late. A “newish” vaccine should be in pharmacies in the next week or two. I say “newish” because it has some minor tweaks based on the latest variant but is very similar to the previous vaccine. Unless you are traveling this fall, I would probably wait to get it until a few weeks before Thanksgiving to avoid the winter surge. If you’ll be traveling before that, I would get it a few weeks before your trip. The Covid 19 virus has settled into a pattern of late summer and early winter peaks. If you are under 65 and want to get the vaccine to reduce your risk of getting sick, hospitalized or developing long Covid you will need to say that you have an underlying condition, such as hypertension, obesity, asthma, diabetes, heart disease, or compromised immune system. The vaccines are less effective than flu vaccines as far as reducing the risk of getting sick.
JUST WHEN YOU THOUGHT IT COULDN’T GET ANY WORSE!
CVS Holds Off on Offering Covid Vaccines in 16 States
The country’s largest pharmacy chain said it needed a C.D.C. panel to recommend the shots before it could offer them nationwide.
CVS, the country’s largest pharmacy chain, is currently not offering Covid vaccines in 16 states, including Florida, New York and Pennsylvania, even to people who meet newly restricted criteria from the Food and Drug Administration.
Amy Thibault, a spokeswoman for CVS, cited “the current regulatory environment” as the reason the vaccine was not available in those states, or in the District of Columbia, emphasizing that the list could change. Legal experts said that federal decisions were creating an extremely difficult situation for pharmacies to navigate.
In some states, pharmacists are forbidden to administer vaccines that are not recommended by the Advisory Committee on Immunization Practices, a Centers for Disease Control and Prevention panel.
Last year, the panel voted to recommend updated Covid vaccines in June. In 2023, it endorsed new Covid vaccines in September, just one day after the F.D.A. gave its approval.
But as of this Thursday, the panel was not scheduled to meet for another three weeks. And, after a slew of high-level resignations at the C.D.C., Senator Bill Cassidy — Republican of Louisiana and the chairman of the Senate’s health committee — has called for the meeting to be “indefinitely” postponed. That could mean many people’s access to shots remains hamstrung well into the fall, when infections from respiratory viruses normally spike.
CVS will make the vaccines available nationwide if the advisory panel recommends them, Ms. Thibault said. But since the panel hasn’t yet made a decision, the company is holding off in states where it believes its pharmacists need a C.D.C. endorsement.
Those states are Arizona, Colorado, Florida, Georgia, Kentucky, Louisiana, Maine, Massachusetts, Nevada, New Mexico, New York, North Carolina, Pennsylvania, Utah, Virginia and West Virginia, along with the District of Columbia.
Pharmacies have traditionally been a crucial access route to the Covid vaccine, accounting for a vast majority of shots given last year. The CVS move is a strong signal that federal decisions could reduce access more than the restrictions laid out on paper, and the confusion is likely to crop up at other pharmacies as well, legal experts said.
Walgreens, the nation’s second largest pharmacy chain, did not respond to requests for comment about the availability of Covid shots at its stores. But when a New York Times reporter tried to schedule vaccine appointments in all 50 states, the pharmacy’s website said patients would need a prescription in 16.
Experts are themselves divided on what pharmacies can do, but they agree that the choices are hard.
Whether last year’s C.D.C. recommendation still applies is ambiguous, said Richard Hughes IV, a vaccine lawyer who teaches at George Washington University Law School and worked for Moderna early in the pandemic. There is an argument that it does, and that pharmacists can administer the updated vaccines under it unless ACIP says otherwise, he said.
But Richard Dang, an associate professor of clinical pharmacy at the University of Southern California, said he believed the reformulated shots required a new recommendation.
In the states where Walgreens is requiring prescriptions, it appears to have judged that its pharmacists can perform the actual injections, but can’t determine the appropriateness of a vaccine for a particular patient. Those questions are legally separate, Mr. Hughes said.
Vaccine appointments also appeared unavailable at Walgreens in many states. That may, in part, reflect a supply issue, doctors said. But Walgreens’ note that patients need prescriptions in some states could signal confusion among pharmacists over whom they’re allowed to vaccinate.
Covid vaccination rates have fallen precipitously since the height of the pandemic. Just 23 percent of adults and 13 percent of children reported getting an updated Covid vaccine last season.
The fact that pharmacies are limiting access to vaccines when Covid infections are rising, as they do every summer, is “really unconscionable,” said Dr. Peter Chin-Hong, an infectious disease specialist at the University of California, San Francisco.
Making it more difficult to schedule a shot may discourage even more people from getting vaccinated, doctors said.
“It’s just raising more and more barriers,” Dr. Chin-Hong said. “It’s like an obstacle course.”
He added: “I don’t know anybody who’s not confused.”
Maggie Astor covers the intersection of health and politics for The Times.
Dani Blum is a health reporter for The Times.
CDC officials escorted from headquarters as chaos engulfs public health agency
NEW YORK — The nation’s top public health agency was left reeling and leaderless as the White House works to expel its handpicked director from the Centers for Disease Control and Prevention and three senior officials were escorted from its headquarters on Thursday.
The turmoil triggered rare bipartisan alarm as President Trump’s health secretary, Robert F. Kennedy Jr., tries to advance anti-vaccine policies that are contradicted by decades of scientific research.
The chaos comes weeks before a key advisory committee, which Kennedy has reshaped with vaccine skeptics, is expected to meet to issue new recommendations on immunizations.
Two Republican senators called for congressional oversight and some Democrats said Kennedy should be fired. He is scheduled to testify on Capitol Hill on Sept. 4.
No explanation given for CDC director’s ouster
Kennedy has not explained the decision to oust Susan Monarez as CDC director less than a month after she was sworn in, but warned that more turnover could be coming.
“There’s a lot of trouble at the CDC and it’s going to require getting rid of some people over the long term, in order for us to change the institutional culture,” Kennedy said at a news conference in Texas.
The White House has only said that Monarez was “not aligned with” Trump’s agenda. There is no word on when a replacement could be named.
Monarez’s lawyers said that she refused “to rubber-stamp unscientific, reckless directives and fire dedicated health experts.” She is fighting her dismissal, saying the decision must come directly from Trump, who nominated her in March.
The saga began Wednesday night with the administration’s announcement that Monarez would no longer lead the CDC. In response, three officials — Dr. Debra Houry, Dr. Demetre Daskalakis and Dr. Daniel Jernigan — resigned from senior roles at the agency.
Monarez tried to block political interference, departing CDC officials say
The officials returned to the office Thursday to collect their belongings, and staff members at the beleaguered agency had planned to gather in the afternoon to applaud them as they left the Atlanta campus. But their removal by security personnel earlier in the morning squelched those plans, according to current and former employees.
Houry and Daskalakis told the Associated Press that Monarez had tried to guard against political meddling in scientific research and health recommendations.
“We were going to see if she was able to weather the storm. And when she was not, we were done,” Houry said. She had been the agency’s deputy director and chief medical officer.
Daskalakis resigned as head of the National Center for Immunization and Respiratory Diseases and Jernigan from the National Center for Emerging and Zoonotic Infectious Diseases
If removed, Monarez will be the shortest-serving director since the CDC was founded in 1946, exacerbating a leadership vacuum that has persisted since Trump took office. He initially chose David Weldon, a former Florida congressman who is a doctor and vaccine skeptic, but yanked the nomination in March.
Monarez, a longtime government scientist, was tapped next to lead the $9.2-billion agency while she was serving as its interim director. But questions immediately emerged within Kennedy’s circle about her loyalty to the “Make America Healthy Again” movement, especially given her previous support of the COVID-19 vaccines that Kennedy has routinely criticized.
Vaccine panel changes prompt demands for new oversight
Kennedy rarely mentioned Monarez by name in the way he did other health agency leaders such as Mehmet Oz of the Centers for Medicare and Medicaid Services or Marty Makary of the Food and Drug Administration.
A flashpoint has been Kennedy’s handling of the CDC’s advisory vaccine committee, which he has tried to reshape since taking over the Department of Health and Human Services.
The panel is expected to meet next month, and Sen. Bill Cassidy (R-La.) said any recommendations issued then will be “lacking legitimacy.”
“Serious allegations have been made about the meeting agenda, membership and lack of scientific process being followed,” said Cassidy, who heads the Senate committee overseeing Kennedy’s department. He added that “these decisions directly impact children’s health and the meeting should not occur until significant oversight has been conducted.”
Cassidy, a doctor, provided crucial support for Kennedy’s nomination after saying Kennedy had assured him that he would not topple the nation’s childhood vaccination program.
The Advisory Committee on Immunization Practices is a group of outside experts who make recommendations to the CDC director on how to use vaccines. The recommendations are then adopted by doctors, school systems, health insurers and others.
Kennedy is a longtime leader in the anti-vaccine movement, and in June, he abruptly dismissed the entire panel, accusing members of being too closely aligned with manufacturers. He replaced them with a group that included several vaccine skeptics and then he shut the door to several doctors organizations that had long helped form vaccine recommendations.
Departing CDC officials worry science will be compromised
Houry and Daskalakis said Monarez had tried to make sure scientific safeguards were in place.
For example, she tried to replace the official who coordinated the panel’s meetings with someone who had more policy experience. Monarez also pushed to have slides and evidence reviews posted weeks before the committee’s meetings and have the sessions open to public comment, Houry said.
Department of Health officials nixed that and called Monarez to a meeting in Washington on Monday, Houry said.
Daskalakis described the situation as untenable.
“I came to the point personally where I think our science will be compromised, and that’s my line in the sand,” he said.
Stobbe, Seitz and Megerian write for the Associated Press. Seitz and Megerian reported from Washington.
FLU VACCINE:
We will start giving flu vaccinations after Labor Day. The optimal time to get on is in September to October. I try to get mine in October. If one gets it too early there is the concern that antibodies will drop by the time the flu rolls around in the winter months. Often, people want to get it right away. That’s not necessary. If you have an appointment this fall you can get it, then. We do like schedule appointments for these. As in previous years if you wear a short-sleeved shirt you can remain in your car and one of our staff will come out and give it to you. We usually give high dose vaccine to those 65 and older.
WEST NILE VIRUS
Even though it has been dry lately and there are fewer mosquitoes, I would still wear an insect repellant when spending time outdoors. Reported West Nile virus cases spiked by 132% between 2022 and 2023, according to the Centers for Disease Control and Prevention, with most occurring in the July-September period.
UNITED HEALTH CARE
Some patients received a letter saying that I was no longer covered on their health insurance. This happened because I didn’t respond to a email that they sent to an email address that hadn’t been used in 5 years. We finally got it straightened out. It was very frustrating to not be able to speak to a person and have to deal with a chat bot. When I asked if they would now send letters notifying patients that I was in network, this was the series of exchanges.
Now they have sent letters to Dr. Wallace’s patients. We think we have it straightened out but will have to wait and see. Our world is run by chatbots!
TRAVELAN
When I travel to developing countries, I drink bottled water and eat food that is cooked, avoiding raw fruits and vegetables. In addition to this I take a tablet or two of pepto bismol before each meal to reduce my risk oif traveler’s diarrhea. Traveler’s diarrhea or “Tourista” is a bacterial infection caused by enterotoxigenic E. coli. There is a product that I have recently been made aware of that that works in a different way to reduce risk. Here is some information on it.
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Antibody Action:
Travelan contains antibodies from the colostrum of cows that have been vaccinated against common bacteria that cause travelers’ diarrhea.
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Binds to Bacteria:
When you consume food or drinks contaminated with these bacteria, the antibodies in Travelan bind to the bacteria and their toxins.
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Neutralizes Pathogens:
This binding action neutralizes the pathogens, preventing them from attaching to the intestinal wall and causing symptoms.
- Travelan is a natural, gluten-free dietary supplement for adults.
- It is not recommended for children under the age of 6 unless directed by a healthcare professional.
Where to Buy
- Online from Amazon.com and other retailers.
- In the USA, at Passport Health Travel Clinics and some pharmacies.
- In Australia and Canada, at pharmacies and online.
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Hygiene:
Travelan is a supplement and should be used alongside good hygiene practices, such as washing hands, drinking bottled water, and eating only safely prepared food.
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Consult a Doctor:Always follow the directions on the label and consult a healthcare professional for advice, especially for children.
HAVE A HAPPY AND SAFE LABOR DAY!
Mark l. Thornton, M.D., F.A.C.P.
