Will parents let their young children be vaccinated? Plus, FDA gives Moderna vaccine full approval, a study that will be widely misreported, and more. Email not displaying correctly?
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** FDA to consider Pfizer vaccine for children under age 5
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A member of the medical staff talks to a little girl as she waits to get her first dose of the Pfizer-BioNTech COVID-19 at a vaccination center in Bucharest, Romania, Wednesday, Jan.26, 2022. (AP Photo/Andreea Alexandru)

Within weeks, there may be an approved COVID-19 vaccine for children ages 6 months to 5 years old. Pfizer-BioNTech announced it is ready to move forward with its two-dose vaccine for children under age 5 and has asked the Food and Drug Administration to consider approval ([link removed]) .

The FDA’s vaccine advisory committee will consider Pfizer’s drug trial data on Feb. 15. By now, you know the several-step process that follows: the FDA gives its full approval, then advisers from the Centers for Disease Control and Prevention look at the data and make recommendations for the full CDC to approve.

These committees usually move in lockstep, but not always. If the process goes smoothly, the vaccines could be available in early March.

The first round of Pfizer tests included three low-dose shots, but the FDA will consider a two-dose regimen for now ([link removed]) . The second dose would be administered about three weeks after the first dose. If the FDA eventually approves a three-dose vaccine for children, the third dose would likely come two months after the second one. But Pfizer may wait until sometime in March — when it has more data to show how a three-dose plan might stimulate immunity — to suggest that.

Pharmaceutical researchers have tried to discover the optimal dose for young children. In December, Pfizer-BioNTech said ([link removed]) its low dose shot didn’t produce enough of an immune response. That drug trial involved 3 micrograms of the vaccine, which is about one-tenth of the adult version of Pfizer’s vaccine. The data showed that that smaller dose produced an effective immune response for the smallest children, aged 6 months to two years old. But children aged 2 through 5 didn’t get the immune benefit that the drugmaker was looking for, so they went back to the lab to try other dosages.

A company statement late Tuesday said ([link removed]) :

Since the pandemic began, more than 10.6 million children have tested positive for COVID-19 in the U.S.,1 with children under 4 accounting for more than 1.6 million of those cases.

Further, reported COVID-19 cases and related hospitalization among children have spiked dramatically across the United States during the Omicron variant surge. For the week ending January 22, children under 4 accounted for 3.2% of the total hospitalizations due to COVID-19.2

If authorization is granted, the Pfizer-BioNTech COVID-19 Vaccine would be the first vaccine available to help protect children under 5 years of age from this disease, potentially including future emerging variants of concern.

The pediatric vaccine trials involved 4,500 children in the United States, Finland, Poland and Spain.

If the FDA approves this pediatric vaccine, it would be the third age-focused dosage to be approved. The CDC points out ([link removed]) :

Adolescents ages 12 years and older receive the same dose of Pfizer-BioNTech COVID-19 vaccine ([link removed]) as adults. Children ages 5 through 11 years receive an different dose of the Pfizer-BioNTech COVID-19 vaccine ([link removed]) . The Pfizer-BioNTech COVID-19 vaccine ([link removed]) for children ages 5 through 11 years has the same active ingredients as the vaccine given to adults and adolescents. However, the Pfizer-BioNTech vaccine for adults and adolescents cannot be used for children ages 5 through 11 years.

Omicron hit the youngest ([link removed]) Americans hard. A vaccine for children under age 5 would reach 19 million children.


** Will parents allow their young children to be vaccinated?
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Developing and approving a vaccine is hard enough but, it seems, convincing parents to allow their children to be vaccinated is even more difficult. Kaiser Family Foundation polling found:

* Nationally, more than a quarter (28.1%) of 5–11-year-olds had received at least one COVID-19 vaccine dose as of January 18, 2022. This represents just over 8 million of the approximately 28 million children in this age group in the United States. Just 18.8% of children have gotten two doses.
* The rate of vaccination among 5–11-year-olds reached its peak before Thanksgiving and then dropped steeply. Vaccination rates among 5–11-year-olds, as measured by first doses administered daily, rose sharply for the two-week period after the recommendation was first made on November 2, then dropped steeply.
* The share of children having received at least one COVID-19 vaccine dose ranged from 63.1% in Vermont to just 11.2% in Mississippi. The top ten states have vaccinated more than a third of 5–11-year-olds, with three states at more than 50%; the bottom ten states have vaccinated fewer than 20%. Eight of the ten states with the lowest vaccine coverage among 5–11-year-olds are in the South (South Carolina, Georgia, West Virginia, Oklahoma, Tennessee, Louisiana, Alabama, and Mississippi). (See all state data here ([link removed]) .)


** FDA gives Moderna vaccine full approval
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Vials of the Moderna COVID-19 vaccine being administered for local residents are placed in a tray at a vaccination center in the complex of the Tokyo Skytree, the tallest structure in Japan, Saturday, Jan. 22, 2022, in the Sumida ward of Tokyo. (AP Photo/Eugene Hoshiko)

I should mention that the FDA gave full approval ([link removed]) to Moderna’s COVID-19 vaccine, removing it from the emergency use authorization list. It is important for any drug to get that full designation if the drug is sold to users, not supplied by the government. Full approval is linked to a company’s ability to show their product is safe and effective and backed up with mountains of data.

Pfizer-BioNTech’s vaccine got the full approval designation in August 2021 ([link removed]) .


** A study that will be widely misreported
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I have already seen examples ([link removed]) of people using a new Johns Hopkins research paper ([link removed]) to bolster the notion that pandemic lockdowns did not work. ([link removed]) So I want to highlight some details from the study for you to consider.

This is a study of studies; the researchers started with 1,000 studies on the effect of lockdowns then narrowed it down to 34 studies to come up with a meta-analysis of what the body of evidence seems to say. And, the researchers say, “Overall, we conclude that lockdowns are not an effective way of reducing mortality rates during a pandemic, at least not during the first wave of the COVID-19 pandemic.”

The report found shelter-in-place orders did, however, reduce deaths ([link removed]) , just not as many as you might think. “Shelter-in-place orders (SIPOs) were also ineffective. They only reduced COVID-19 mortality by 2.9%.” That number includes some regions of the world that had strict shelter-in-place orders as well as Europe and the U.S., which had loose regulations.

The data seems to show that closing bars at the height of the pandemic may have saved lives.

But if you stopped reading there, you would miss important caveats.
* The study looks at COVID-19 deaths, not infections or hospitalizations.
* The study lumps countries with strict orders with those who had loose guidelines.
* “Ten studies consistently showed that it successfully reduced the incidence, onward transmission, and mortality rate of COVID-19”
* Many of the studies that the researchers found showed shelter-in-place orders did reduce mortality.
* However, closing nonessential businesses seems to have had some effect (reducing COVID-19 mortality by 10.6%), which is likely to be related to the closure of bars. Also, masks may reduce COVID-19 mortality, but there is only one study that examines universal mask mandates.
* The effect of border closures, school closures and limiting gatherings on COVID-19 mortality yields precision-weighted estimates of -0.1%, -4.4%, and 1.6%, respectively.
* “The ineffectiveness (of lockdowns) stemmed from individual changes in behavior: either non-compliance or behavior that mimicked lockdowns.” In other words, lockdowns that people choose are likely to be more effective than lockdowns imposed on them.
* “Mandating facemasks — an intervention that was not widely used in the spring of 2020, and in many countries was even discouraged — seems to have a large effect (-21.2%), but this conclusion is based on only two studies.” The researchers offered the notion that the biggest effect of wearing masks could be that they discourage people from socializing and spreading the virus.

My main point is this: This is one of those nuanced studies that is full of “on one hand, on the other hand” findings. You could cherry-pick any point of view from it that you wanted to emphasize.

My recommendation is to take this study in context with many others ([link removed]) that show opposite findings. The real finding may be that because states, locales and countries had wildly different definitions of what a stay-at-home order means, and people worldwide had wildly different rates of compliance with the orders, lumping them all together may not tell us much.


** Another misunderstood study about ivermectin
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Reuters caused a stir ([link removed]) when it mistakenly reported Tuesday that a Japanese study showed the anti-parasitic drug ivermectin to be “effective” against omicron in Phase III clinical trials, which are conducted in humans. While the drug may someday prove to have some value in treating COVID-19, this study didn’t say it is “effective.” The study, which was done in a Japanese lab and did not involve humans, found ivermectin had an “antiviral effect” against omicron and other coronavirus variants. And that is all the company, Kowa Co. Ltd., said about its findings.

For now, both the FDA and Merck ([link removed]) , which produces the drug, say there is not enough proof to recommend the drug for the treatment of COVID-19. That said, there are studies going on ([link removed]) to try to get a definitive answer about whether ivermectin has a role to play in countering the pandemic.


** The soaring price of farmland
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Farmland and ranches are seen on the outskirts of Cascade, Mont. on Friday, Oct. 15, 2021. (AP Photo/Iris Samuels)

The Associated Press produced a story ([link removed]) pointing out that it is not just housing prices that are rising fast during the pandemic. Farmland prices are rising even faster ([link removed]) :

While median existing-home prices ([link removed]) rose by 15.8% in the U.S. last year, farmland values went up about double that rate in places like Iowa.

“I’m definitely surprised by the magnitude,” said Wendong Zhang, an economist at Iowa State University who oversees an annual farmland value survey.

The rising values, especially in the Midwest, are due to high prices being paid for the key commodity crops of corn and soybeans, plentiful harvests in recent years coupled with low interest rates and optimism the good times ([link removed]) will continue.

Federal Reserve Banks in Chicago and Kansas City reported double-digit increases in Illinois, Wisconsin, Indiana, Missouri and Nebraska.

In Iowa, average farmland has risen from $7,559 an acre in 2020 to $9,751 an acre in 2021.

Nationally, farmland was up an average of 7% but that doesn’t include the last half of 2021, when prices really took off in many areas.

Farmland prices have even climbed in California despite concerns about persistent drought ([link removed]) . In 2021, the average prices of $10,900 an acre was up 9% from 2020.

The website AcreTrader ([link removed]) can give you an idea of how much farmland prices have risen near you.

The U.S. Department of Agriculture also produced annual price reports. Here is the latest:
[link removed]
(USDA)

The USDA survey also has state-by-state data ([link removed]) listed for the last several years. You will see different surveys according to the way the land is used (crops, pasture, irrigated and nonirrigated). It is interesting that the value of farm buildings, like barns, didn’t rise the way that land did.
[link removed]
(USDA)


** Traffic deaths keep rising. Why are we driving so recklessly?
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Something is causing us to crash into each other more often. The Department of Transportation says from January to September last year, traffic fatalities rose 12% year over year (2020-2021) ([link removed]) which is the biggest rise the DOT has recorded since it began keeping records in 1975. (The increase was both an increase in percentages and in total fatalities.See the data tables here ([link removed]) .)

The increase in traffic deaths was highest in the West and South, but 10 states saw a drop in traffic fatalities.

(National Highway Transportation Safety Administration)
(National Highway Transportation Safety Administration)

The DOT hopes President Joe Biden’s infrastructure bill will pay for bike lanes, clearer crosswalks, better lighting and maybe speed cameras.

Since the start of the pandemic, the DOT said people have been driving faster, partly because there were fewer cars on the highways. And for reasons they cannot explain, more people ignored seatbelts.

We’ll be back tomorrow with a new edition of Covering COVID-19. Are you subscribed? Sign up here ([link removed]) to get it delivered right to your inbox.
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