Title: Flu Shots Lag in States With Low COVID Vaccine Uptake
Category: Health News
Created: 6/16/2022 12:00:00 AM
Last Editorial Review: 6/16/2022 12:00:00 AM

Texas AG Paxton says Pfizer might have lied about efficacy of COVID vaccine, could be 1% effective | 6 Dec 2023 | GOP Texas Attorney General Ken Paxton says that he believes that pharmaceutical company Pfizer may have lied about the efficacy of the COVID-19 vaccine and the effectiveness could be as low as one […]

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A teen gets a dose of Pfizer's COVID-19 vaccine at Holtz Children's Hospital in Miami on May 18. Nearly 7 million U.S. teens and pre-teens (ages 12 through 17) have received at least one dose of a COVID-19 vaccine, so far, the CDC says.; Credit: Eva Marie Uzcategui/Bloomberg via Getty Images

Joanne Silberner | NPR

It's been a little more than a month since adolescents as young as 12 became eligible in the United States to receive the Pfizer vaccine against COVID-19, and nearly all reports have been positive: The vaccine is very effective in this age group, and the vast majority of kids experience mild side effects, if any — the same sore arm or mild flu-like symptoms seen among adults who get the shot.

The Centers for Disease Control and Prevention has recommended that everyone 12-years-old and older get vaccinated against COVID-19, and the rollout is well underway: According to the CDC, nearly 7 million U.S. teens and pre-teens (ages 12 through 17) have received at least one dose of a COVID-19 vaccine, so far.

Still, soon after the FDA authorized the use of Pfizer's vaccine in young people, federal agencies began receiving reports of mild chest pain or other signs of possible heart inflammation (known as myocarditis) in a very small percentage of recently vaccinated teens.

CDC director Rochelle Walensky said at a White House briefing Friday that there have been more than 300 cases of heart inflammation reported among more than 20 million teens and young adults who have received one of the vaccines made by Moderna or Pfizer. She said that in the "vast majority" of cases, the inflammation went away.

An expert advisory committee to the health agency is expected to review the cases in more depth at a meeting Friday.

So, in the meantime, should parents of teens hesitate to have their kids vaccinated against COVID-19? Vaccine experts and the American Academy of Pediatrics say no, don't hesitate. It's good for doctors and patients to be aware that there might be a connection between the mRNA vaccines and heart inflammation, and to report to their pediatrician anything they see in that first week after vaccination. But it is also important, the CDC notes, to recognize that even if this does turn out to be an extremely rare side effect of the vaccine, "most patients who received care responded well to medicine and rest and quickly felt better." And the serious risks of COVID -19 — even for young healthy people — outweigh the risks of any possible side effects from the vaccine. Here are some questions you may have, and what's known:

What exactly is myocarditis?

Myocarditis is an inflammation of the heart muscle, and pericarditis, also being investigated, is an inflammation of the sac around the heart.

Long before the pandemic, thousands of cases of myocarditis were diagnosed in the U.S. and around the world each year, often triggered by the body's immune response to infections. SARS-CoV-2 can trigger it, and so can cold viruses, and staph and strep and HIV. Other causes include toxins and allergies.

Symptoms include chest pain and shortness of breath. It's often mild enough to go unnoticed, but a full-blown case in adults can cause arrhythmias and heart failure that require careful treatment with multiple medications, and several months of strict rest. In a case study of seven teenagers who got myocarditis following vaccination published last week in the journal Pediatrics, all seven got better after routine treatment with anti-inflammatory drugs.

Pediatric cardiologist Dr. Stuart Berger of the Northwestern University Feinberg School of Medicine, a spokesperson for the American Academy of Pediatrics, says vaccine-related myocarditis in teens is not all that worrisome. "Although they appear with some symptoms of chest pain, and maybe some findings on EKGs, all of the cases we've seen have been on the mild end of the spectrum," he says.

So, what's the concern?

Several hundred reports about the inflammation have been filed with the federal government's Vaccine Adverse Event Reporting System (VAERS); that's a repository of reports sent in by health professionals and patients about any health events they spot in the hours or days after vaccinations. Many of the events reported turn out to be coincidental — not caused by a vaccine. The database is just meant as a starting point for further investigation and not proof of cause and effect. But as NPR's Geoff Brumfiel noted this week, "when millions of people are vaccinated within a short period, the total number of these reported events can look big."

That said, anecdotes reported by doctors in medical journals and reports to VAERS suggest that both of the mRNA vaccines authorized for use in the U.S. — the Pfizer and Moderna vaccines — might slightly increase the incidence of myocarditis in young people. In 2003, a report in the New England Journal of Medicine estimated the background incidence of myocarditis to be 1.13 cases in 100,000 children per year.

Paul Offit, professor of pediatrics at the Children's Hospital of Philadelphia and a member of a Food and Drug Administration vaccine advisory committee says there likely is a causal link between the heart inflammation some doctors are seeing in these teens and the second dose of vaccine. "I think it's real," he says, but hastens to add that the effect is exceedingly small – based on the data collected so far, maybe one in 50,000 vaccinees between the ages of 16 and 39. "And the good news is at least so far it looks to be transient and self-resolving."

Still, maybe I should wait to get my teen vaccinated and see how this plays out?

Uhm, no, according to several vaccine experts contacted by NPR. And this is where a little math comes in handy.

"Take a stadium full of 100,000 people between the ages of 16 and 39, which is the subset that appears to be at greater risk," Offit says. "Vaccinate all of them, and two might get myocarditis." But if you don't vaccinate any of the 100,000, he estimates that about 1,300 would eventually get COVID-19. And those numbers are likely to increase this winter.

About one in 1,000 children who get COVID-19 have gone on to develop a condition called MIS-C (multisystem inflammatory syndrome in children), says Offit, and most of those kids have had some level of myocarditis. In addition, the new coronavirus has directly caused myocarditis in some children and adults. Which of the two stadiums in Offit's metaphor would have more cases of myocarditis — the vaccinated children or unvaccinated kids — is not known precisely. But Offit says he suspects it would be the unvaccinated group. And there's no doubt that 1,000 unvaccinated children would suffer more COVID-19-related illnesses. "A choice not to get a vaccine is not a choice to avoid myocarditis," he says. "It's a choice to take a different risk — and I would argue a more serious one" — of developing a bad case of COVID-19 or long-COVID or COVID-caused myocarditis.

Are the experts advising their own kids in this age group to get vaccinated?

Yes. "I understand people having concerns," says Dr. Judith Guzman-Cottrill. She's a parent and professor of pediatric infectious diseases at the Oregon Health and Science University, as well as the senior author on a small study that came out this month in the journal Pediatrics. In the report, Guzman-Cottrill and her colleagues analyzed the cases of seven boys around the country who developed myocarditis within four days of receiving the Pfizer-BioNTech vaccine.

She and her family recently faced the vaccination decision for her own 13-year-old daughter — and said a whole-hearted yes to the shot.

Guzman-Cottrill suspects there may turn out to be a slightly increased risk of heart inflammation from vaccination in young people, but she and her co-authors note in the Pediatrics report that a direct cause-and-effect connection — even in these seven cases — has yet to be established. And she's impressed that despite the millions of doses that have so far been delivered to teens, no clear and serious post-vaccination problems have shown up. "The emergency departments and urgent care clinics are not filled with teenagers complaining of chest pain," she says.

She's treated unvaccinated teens who developed severe myocarditis from an infection with the COVID-19 virus, and others who developed COVID-19 pneumonia and respiratory failure. Seeing those teens struggle — teens who lacked the powerful immune protection the vaccine provides — was enough for her to suggest vaccination to her daughter, who got her second vaccination earlier this week.

"She saw it as a pathway back to a normal post pandemic life," Guzman-Cottrill says.

And that's where public health comes in. "We really need a highly vaccinated student body when kids return to the classroom this fall," says Guzman-Cottrill, "so we don't see surges in COVID-19 cases."

Joanne Silberner, a former health policy correspondent for NPR, is a freelance journalist living in Seattle.

Copyright 2021 NPR. To see more, visit https://www.npr.org.

This content is from Southern California Public Radio. View the original story at SCPR.org.

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Source: Streetwise Reports   04/22/2020

The ways in which Moderna is to use the funds are explained and an update on its coronavirus vaccine is provided in a ROTH Capital Partners report.

In an April 19 research note, ROTH Capital Partners analyst Yasmeen Rahimi reported that the Biomedical Advanced Research and Development Authority (BARDA) awarded Moderna Inc. (MRNA:NASDAQ) $483 million in funding, in part for development of its COVID-19 vaccine, mRNA-1273.

Rahimi discussed how Massachusetts-based Moderna will use the funds, which will be provided in tranches to reach certain milestones.

Half of the $483 million award will be used to help cover clinical development costs of mRNA-1273, from trial operations to the filing of a biologics license application.

Currently, the vaccine is in Phase 1 in the clinic. Recently, the biopharma decided to add to the study a cohort of patients aged 51 years and up, which "will be key for demonstrating mRNA-1273's safety and immunogenicity in this vulnerable population," Rahimi noted.

The analyst explained that for mRNA-1273 to advance to Phase 2, the results from Phase 1 must be optimal. The data must demonstrate the vaccine is safe and tolerable. They must show that the vaccine produced a sufficient number of neutralizing antibodies, crucial for stopping viral replication and proving the vaccine's method of action. Phase 1 safety data from the group aged 18–55 years are expected in spring followed by immunogenicity results, likely in mid-July or early August.

Rahimi relayed that as soon as safety data are available, Moderna plans to launch a Phase 2 study of mRNA-1273 rather than wait for the remaining results to become available, according to CEO Stéphane Bancel.

"Pending favorable safety data from Phase 1, we point out that a potential Phase 2 study would enroll hundreds of patients, and that the BARDA funding could potentially allow Moderna to pursue trials in patient populations who are at greater risk, such as patients who have underlying comorbidities, those who are overweight and patients with cancer," commented Rahimi.

Moderna will spend the second half of the $483 million BARDA funding on the engineering and optimization work required to scale up the manufacturing of its messenger RNA (mRNA).

"With the current focus on SARS-CoV-2 and mRNA-1273, Moderna was now able to present BARDA its strategic plans (amount, time and people) of how to be ready for commercial launch," wrote Rahimi. "This preparation was likely helpful in expediting discussions with BARDA and awarding of the grant."

Also regarding mRNA production, Ginkgo Bioworks, a company with expertise in organism biology and genetically engineering bacteria to replace certain industrial applications, is helping Moderna optimize certain parts of the process.

Rahimi, who is closely tracking COVID-19 data, highlighted that April 18 was the first day in five on which the daily death tally, 1,867, was less than that predicted by Dr. Christopher Murray's model, 2,194.

ROTH has a Buy rating on Moderna.

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( Companies Mentioned: MRNA:NASDAQ, )

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