What is holding up vaccines for children?

It is almost as if we are living in two countries: one that cannot wait to get kids vaccinated against a virus that is filling intensive care units with new cases daily and another that can’t be bothered. For parents who are reading the stories about an increasing number of pediatric COVID-19 cases, the question is: What is holding up Food and Drug Administration approval of vaccines for kids? 

Both Pfizer and Moderna are signing up children to take the shots in the drug trials but, as we certainly know by now, it takes several months of trials before the drug companies have enough data to show the FDA that the vaccines are safe and effective for that population. It appears that Pfizer will be ready first, if all goes well, with data likely available sometime in the fall, maybe September. That might put the decision in front of the FDA shortly after that. 

Moderna will be a bit behind, probably. If all goes well, the vaccines might be delivered to children under age 12 before the end of the year. 

But all of that is an estimate. And CNN quotes one expert who says even that timeline might be too optimistic:

“I can’t imagine that we’d be in a position to even consider how to use these vaccines until the very end of the calendar year of 2021, going into the first quarter of 2022,” said Dr. Buddy Creech, a pediatric infectious disease specialist at Vanderbilt University and one of the lead investigators for Moderna's pediatric Covid-19 vaccine. “I love that we’re riding the success of how quickly we were able to get a vaccine for adults, but we’ve just got to be patient.” 

Experts point out that while we await vaccines for children, the best thing we can do to protect kids from getting sick is for the teens and adults who can be safely vaccinated to do so right away. 

Why can’t we just use the same doses that we give adults and teens?

As Dr. Creech puts so clearly, “children are not just little adults.” Their immune systems are still developing and drug companies are trying to find out whether the children need two doses, or one, or something else. And it may also be that toddlers need something different from preteens or teenagers.

CNN reports:

Creech said finding the “Goldilocks dose” for young children takes time. Give too little and the child may not make enough of an immune response to the coronavirus. Then they’re getting a vaccine with the potential for side effects with little or no benefit. 

Remember that COVID-19 deaths among children are rare. And even when children are infected, they tend to have much less severe symptoms than older people, which is why the testing and approval process began with the most vulnerable senior population first.  

Trying to avoid ‘immune enhancement’

One other reason we need the FDA and drug companies not to rush into vaccinating young kids without enough data is to avoid something clinicians call “immune enhancement.” Immunologists have known about this danger for a long time — back to the 1960s — which, again, is why these drug trials have to move only at the pace of the data they produce.

A research paper in the National Academy of Sciences explains: 

Some animals or people who received the vaccine and were later exposed to the virus developed more severe disease than those who had not been vaccinated. The vaccine-primed immune system, in certain cases, seemed to launch a shoddy response to the natural infection. “That is something we want to avoid,” says Kanta Subbarao, director of the World Health Organization Collaborating Centre for Reference and Research on Influenza in Melbourne, Australia.

Why are zoo animals getting COVID-19 vaccines?

The Philadelphia Zoo says it will vaccinate a number of “at-risk” zoo animals against COVID-19. The Philadelphia Inquirer reports: 

The Philadelphia Zoo is gearing up to vaccinate its highest-risk animals with an experimental vaccine developed by Zoetis, a former subsidiary of Pfizer that develops drugs for animals. While animals are not a major concern for spreading the virus to humans, according to the Centers for Disease Control and Prevention, they may still get infected. Cases have been reported in some big cats and gorillas at zoos, household pets, and farmed minks, motivating zoos nationwide to help their animals build up immune defenses. 

Hundreds of zoos and animal farms will be getting the vaccine soon. Zoetis is donating 11,000 doses of the vaccine to about 70 zoos and other facilities in 27 states. 

Last year it appeared that there might be a need to vaccinate cats and dogs after experts found that the virus can be transmitted from human to pet but not from pet to human, at least that we know of. Testing showed cats are more likely to get infected by sick humans than dogs. 

Former Surgeon General says CDC should push people to mask up again — now

Former Surgeon General Jerome Adams, who was the surgeon general under President Donald Trump, says the Centers for Disease Control and Prevention should do an about-face and tell everyone, vaccinated and unvaccinated, to get their masks back on. The message came in a series of tweets. You can read the whole string here, but I will include the most direct advice:

The least vaccinated counties produce the highest number of COVID cases

The New York Times looks at the least vaccinated counties in America and compares that to the COVID-19 cases there. Surprise! Not.

Sometimes it is the little insight in these stories that touches the audience. The Times story includes a conversation with a woman who was deathly sick with COVID-19. She didn’t know if she would pull through and still, she said, she wouldn’t want the vaccine because she said it was “too new.” She spent 10 days with oxygen tubes pumping into her lungs.

Hospitals in the lowest vaccinated communities say they are increasingly seeing pregnant women showing up with COVID-19 and wind up in the ICU, risking their baby’s life.

More COVID-19 at the Olympics

COVID-19 keeps showing up in athletes arriving in Tokyo for the Olympics.

More members of the South African team tested positive yesterday. And U.S. tennis player Coco Gauff has tested positive for the coronavirus, so she is out, too.

Six British athletes are isolating in Tokyo because they were in close contact with another person who tested positive.

In order to discourage post-event celebrations, Olympic officials installed cardboard bedframes, which support the weight of one athlete but not two, if you know what I mean. They say it is to discourage close contact that might spread COVID-19. 

Monkeypox joins Murder Hornets as most interesting search words

A case of Monkeypox has been discovered in the United States for the first time in more than two decades. It showed up in a guy who arrived in Dallas after a trip to Nigeria. You may recall that Monkeypox was sort of the Murder Hornet of 2003 when it grabbed headlines after 47 people were infected. Scientists traced the outbreak to pet prairie dogs, which I always thought was a terrible disservice to monkeys. I mean, why couldn’t they call it Prairie Pox?

But Monkeypox is pretty serious stuff. It is related to smallpox and was first linked to lab monkeys in 1958 but can also spread to other critters, including squirrels, rats and mice. The CDC says:

The first human case of monkeypox was recorded in 1970 in the Democratic Republic of Congo during a period of intensified effort to eliminate smallpox. Since then, monkeypox has been reported in humans in other central and western African countries.

In Africa, the death rate among those with monkeypox ranges from 1 to 10%, with the highest rates among young children.

To this day, there is no cure for monkeypox.

And, I have to add this, just so we will have it on the record: “This case is not a reason for alarm and we do not expect any threat to the general public,” Dallas County Judge Clay Jenkins said in a press release. 

Telehealth becoming less available soon

Stat reports:

State-issued emergency declarations and insurer policies that were issued at the start of the Covid-19 pandemic and that were meant to encourage the use of telemedicine are being phased out across U.S. states, one by one. And as they fade away, rules that make telemedicine more complicated — and costly — are setting back in.

mHealthIntellegence summarizes what is happening in states that no longer consider the pandemic to be an emergency:

As a result, providers can no longer use audio-only telehealth platforms, such as the phone, to treat patients unless they’re on Medicare. They can’t prescribe controlled substances via telehealth for patients dealing with chronic pain or renew medical marijuana prescriptions via telehealth, and the frequency and length of telemental health services for Medicaid members will be reduced.

Stat says one effect of the phasing out of emergency telehealth rules is that doctors who have been talking with patients from different states will have to have a license for each state in which the patients they see reside. For example, “Mass General Brigham decided to end telemedicine appointments for patients in states where their providers are not licensed in anticipation of the lifting of temporary license allowances.” 

Ohio is one state that is continuing telehealth emergency coverage until mid-September. But others have or are soon letting the telehealth programs die off with the COVID-19 emergency order expirations. Other states have been even bolder in expanding telehealth beyond the pandemic. Idaho Gov. Brad Little signed an executive order making telehealth available beyond the pandemic.

“Our loosening of healthcare rules since March helped to increase the use of telehealth services, made licensing easier, and strengthened the capacity of our healthcare workforce — all necessary to help our citizens during the global pandemic,” he said. “We proved we could do it without compromising safety. Now it’s time to make those healthcare advances permanent moving forward.”

Connecticut Gov. Ned Lamont extended telehealth coverage for two years.

Kaiser Health says Medicare patients will also have fewer telehealth options when the federal pandemic emergency ends. Before the pandemic, Medicare-covered telehealth was limited to rural areas. Then the pandemic opened it to everyone. Now, it will revert back to the way it was, unless the government acts to make the pandemic-era changes permanent.

Under the pandemic-era rules, Medicare paid for office visits at the same rate as if the patient traveled to the doctor’s office. And in the last year, about one in four Medicare patients used telehealth. Patients who had the most chronic issues used it even more.

Telehealth was not very popular in the U.S. prior to the pandemic, but patient surveys show the attitude is changing rapidly.

Telehealth has proven to be especially useful for people seeking mental health care. A study recently published in the Journal of the American Medical Association says patients used the most telehealth services during the pandemic for psychiatric care, accounting for 61.7% of all telehealth visits in 2020.

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