Colorado woman, 56, who won’t get vaccinated denied transplant


Honolulu Star-Advertiser 08 October, 2021 - 05:30pm 2 views

Another Pfizer study from Israel showed neutralizing antibodies waning dramatically after 6 months.

But Pfizer's protection against severe disease and death is still well over 90% for at least 6 months.

People who get Pfizer's two-shot vaccine may still catch COVID-19 in the months after they are fully vaccinated - though those infections may be so mild they fly entirely under the radar.

Two new studies, published in the New England Journal of Medicine on Wednesday, show that Pfizer's mRNA shots still remain effective in guarding against hospitalization and death for at least six months, though protection against milder disease as well as antibody levels can fall - or at least they did in the face of the Beta and Delta variants.

The new findings affirm what Pfizer, Moderna, and the Centers for Disease Control and Prevention have indicated in recent weeks - that the mRNA vaccines' ability to protect the body from coronavirus infection may wane over time, meriting a third shot.

In the first study, researchers in Qatar (a highly inoculated country with more than 82% of people fully vaccinated) investigated more than 900,000 PCR tests of people vaccinated with Pfizer (the most popular shot there), and found that their protection against any infection started to decrease markedly about four months after their second jab.

The researchers found that Pfizer's protection against infection was "negligible" just after a first dose, rising to 36.8% three weeks later. When people then received their second shot, their vaccine protection jumped to 77.5% within about four weeks, and protection against "any severe, critical, or fatal case of COVID-19 increased rapidly," the researchers said, reaching 96% or higher in the first two months that people were fully vaccinated.

That strong protection against the worst things COVID-19 can do to a person persisted for at least half a year.

"No evidence was found for an appreciable waning of protection against hospitalization and death, which remained robust - generally at 90% or higher - for 6 months after the second dose," the researchers said.

Meanwhile, Pfizer's protection against milder and more negligible COVID-19 infections declined.

After people had been fully vaccinated for about five to seven months, the researchers observed Pfizer's vaccine effectiveness hovering around 20%, though only about a third of those infections were diagnosed "on the basis of symptoms," suggesting that many of them were silent, asymptomatic infections.

"Protection against asymptomatic infection diminished more quickly than that against symptomatic infection, as would be expected in a vaccine that prevents symptoms," the researchers said. "These findings suggest that a large proportion of the vaccinated population could lose its protection against infection in the coming months."

Other research from Qatar suggests that breakthough infections are less infectious than those in unvaccinated individuals, making them less likely to spread.

The second NEJM study, conducted in Israel, looked at 4,868 healthcare workers who'd been fully vaccinated with Pfizer's vaccine. It reported that their neutralizing antibodies to COVID-19 are "substantially" lowered by six months after receiving their second dose of Pfizer's vaccine - a trend that's especially true for men, people over age 65, and people with weakened immune systems.

Even so, only 20 of those healthcare workers had breakthrough infections during the study period, suggesting, again, that vaccine protection remains robust for many months after people get jabbed.

It's normal for neutralizing antibodies to decline after vaccination, and neutralizing antibodies are not the only element of immune response that protects us from reinfection, but vaccines for other conditions such as mumps, measles, and rubella only show small decreases of about 5% to 10% each year in neutralizing antibody levels, the researchers said.

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What parents should know about Pfizer's COVID-19 vaccine for kids

Business Insider 09 October, 2021 - 08:20am

"With new cases in children in the US continuing to be at a high level, this submission is an important step in our ongoing effort against COVID-19," Pfizer wrote on Twitter.

The FDA has tentatively scheduled a meeting on October 26 to review Pfizer's request.

While adults and teenagers have been benefitting from vaccine protection for months, young kids have had few options beyond masks and social distancing in the face of the Delta variant and while returning to school in person. 

"Delta has made COVID a pediatric problem," said Dr. Andrew Pavia, pediatric infectious disease specialist at the University of Utah. 

But if all goes well and the government green-lights Pfizer's shot, here's what parents will need to know.

Pavia has served on advisory groups that review and suggest improvements to the US vaccine safety system — "I've been under the hood," he said. 

The COVID-19 vaccine, he added, "isn't brand new — this isn't understudied."

So far, Pfizer's vaccine has been administered to more than 230 million Americans and has proven safe in teenagers, Pavia explained. Another factor that should reassure parents is that the US has a robust reporting system for detecting vaccine safety issues and side effects. 

"It's been able to detect very rare side effects very effectively," Pavia said. He gave the example of myocarditis, inflammation of the heart muscle.

"Myocarditis in women occurs with a frequency of about two to five per million, and our safety systems are good enough to pick something up that's that rare," Pavia said.

Dr. Simon Li, too, has peered behind the curtain. He's a principal investigator helping run the vaccine study on kids in New Jersey alongside Pfizer, and an associate professor of pediatrics at Rutgers.

"The studies that are being done have been extremely, extremely cautious and careful and very well run," Li said.

Li's own kids are 4, 8, and 10, so not old enough to get the shots yet. The only reason he hasn't enrolled then in a vaccine study, he said, is that his role with Pfizer prohibits him from doing so.

"When it comes out, I'll be first in line" Li said of vaccinating his children.

Not exactly. The kids' vaccine is a two-shot formula, but it comes in smaller doses. Pfizer gave 30-milligram doses to adults, but 5- to 11-year-olds are receiving less than half of that. 

Li likened the process to the comparatively small doses of other medicines, like Tylenol, that we give children. Children don't need the same dosage because they are smaller than adults and because their bodies process drugs differently. 

"It's size and their ability to break down and react," Li said.

Some doctors say that taking pain medication to dim potential vaccine side effects isn't a big deal. But other experts and the CDC recommend against taking it, since "it is not known how these medications might affect how well the vaccine works." (A caveat: If your child takes regular medication for another reason, they should maintain their normal routine.)

Side effects are a sign that your body is learning how to respond to the virus and building immunity. While there's not research pain medicine would interrupt that process, the CDC is erring on the side of caution.

Once his kids can get the shots, Li said, "I will not be giving them anything — I want them to have that full immune reaction to build immunity against the virus."

There is not yet data on how well Moderna's vaccine works among children, but real-world study published in the New England Journal of Medicine last month found that among adults, Pfizer's vaccine had an efficacy rate of 88.8%, compared to Moderna's 96.3%. 

Li says the difference is tiny compared to the risk of leaving your child unvaccinated for weeks or months while Moderna seeks FDA authorization. So it's best not to wait.

"I would advise them to get vaccinated as soon as they can. Those differences are so small. That's just silly," he said.

Nearly 5.9 million children have tested positive for the virus since the start of the pandemic, according to the American Academy of Pediatrics. COVID-19 deaths among children are uncommon — the CDC has recorded 650 so far. But there have been 5,217 cases of multisystem inflammatory syndrome in children, a rare but serious condition associated with COVID-19 in which body parts like the heart, lungs, brain, or other organs become inflamed.

Call your pediatrician if your child has any issue — "they'll be ready," Li said.

Most pediatricians are by now well-versed in the vaccine and its side effects. They are also required to report any clinically significant side effects to the Vaccine Adverse Event Reporting System, an early warning system run by the CDC and FDA.

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