A new antiviral pill shows promise, as do vaccine mandates

https://mailchi.mp/a2cd96a48c9b/the-weekly-gist-october-1-2021?e=d1e747d2d8

Everything we know about the covid-19 coronavirus

Two pieces of hopeful news on the COVID front this week.

First, pharmaceutical manufacturer Merck announced this morning that molnupiravir, the oral antiviral drug it developed along with Ridgeback Biotherapeutics, reduced hospitalizations among newly diagnosed COVID patients by 50 percent. A five-day course of the drug was so successful in Merck’s clinical study that an independent monitoring group recommended halting the study and submitting the pill to the Food and Drug Administration (FDA) for emergency use authorization. Molnupiravir is activated by metabolism, and upon entering human cells, is converted into RNA-like building blocks, causing mutations in the COVID virus’s RNA genome and interfering with its replication. For that reason, the drug is unlikely to be prescribed during pregnancy, but otherwise the therapy seems to hold great promise in adding to the limited armamentarium available to fight the pandemic. One possible concern: the drug’s price tag. The federal government has agreed to purchase 1.7M courses of the drug at $700 per course, and with most insurance companies having returned to normal cost-sharing for COVID treatments, the drug may be out of reach for some patients. Still, a major clinical development to be celebrated, and more to come as Merck’s drug is vetted by the FDA.
 
At $20 to $40 per dose, with costs fully absorbed by the federal government, and remarkable effectiveness at preventing severe disease, hospitalizations, and deaths, vaccines remain far and away our best frontline weapon for fighting the COVID pandemic. Promising, then, that the much-debated vaccine mandates have begun to demonstrate success in increasing vaccination rates, even among those who have thus far resisted getting the shot.

Despite concerns about massive staffing shortages among hospitals resulting from the implementation of its mandate, the state of New York found that 92 percent of healthcare workers had been vaccinated by Monday, when the mandate went into effect. That was a 10-percentage-point increase from a week earlier, holding promise that the Biden administration’s planned federal mandate for healthcare workers could have the desired effect.

California’s mandate for healthcare workers went into effect yesterday, and was credited with boosting vaccination rates to 90 percent at many of the state’s health systems. Among private employers considering mandates, the experience of United Airlines may also be instructive: its employee mandate led to the vaccination of more than 99 percent of its workers, resulting in the termination of only 700 of its 67,000 employees. Of course, everyone prefers carrots to sticks, but sweepstakes and bonuses have only gotten so far in encouraging people to get vaccinated—now it appears mandates have a useful role to play as well.

With 56 percent of the population fully vaccinated, the US now ranks 43rd among nations, just ahead of Saudi Arabia and far behind most of Europe. In the next few days we’ll reach the grim milestone of 700,000 COVID deaths in this country—anything that helps stop that number from growing further should be welcome news.

FDA just fully approved the Pfizer vaccine. Here’s what it means for you.

What full FDA approval means for Covid-19 vaccines: Pfizer, Moderna, and  Johnson & Johnson - Vox

FDA on Monday issued its full approval for the Pfizer-BioNTech vaccine, making it the first Covid-19 vaccine to receive approval from the agency.

Up until now, the vaccine—which FDA said will be marketed under the brand name Comirnaty—was authorized for use under an emergency use authorization (EUA). Now, however, the vaccine is fully approved for the prevention of Covid-19 in individuals ages 16 and older.

FDA said the vaccine will remain available under an EUA for individuals ages 12 to 15. A third dose of the vaccine is also still available under the EUA for certain immunocompromised individuals.

Peter Marks, director of FDA’s Center for Biologics Evaluation and Research, said FDA “evaluated scientific data and information included in hundreds of thousands of pages, conducted our own analyses of Comirnaty’s safety and effectiveness, and performed a detailed assessment of the manufacturing process, including inspections of the manufacturing facilities.”

“The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S.,” Marks added.

What does FDA’s approval mean for you?

This new FDA approval, new guidance from the federal government, and new regulations from schools and private business have the potential to shift the posture of the currently unvaccinated. Today, just over 70% of American adults have had at least one dose Covid-19 vaccines. The question now is, how far can we get? The answer is up to you.

It may feel like decisions about the treatment and prevention of Covid-19 are out of your control. And while federal agencies and private businesses are making decisions quickly, every one of you has a vital role to play in this next phase of the pandemic. But there are three constituencies I want to speak to directly.

Employers

Many employers have been hesitant to come down hard on vaccine mandates or implementing clear consequences for the unvaccinated (such as submitting to weekly tests). Much of that fear had to do with the fact that vaccines were only approved for emergency use. Today’s announcement of the full approval of the Pfizer-BioNTech vaccine should offer many employers enough comfort to move forward with vaccine mandates. In fact, on the heels of announcing full approval, New York City announced that it would require all education staff to be vaccinated. I expect to see more employers inside and outside of health care following suit. If you are still questioning whether a vaccine mandate is appropriate, we recommend asking yourselves these five questions:

  1. Are you complying with federal and state guidance?
  2. Is a Covid-19 vaccine mandate the best way to achieve your goals?
  3. How will you manage individuals who have legitimate exemptions if you impose a Covid-19 vaccine mandate?
  4. How will you collect ‘proof of vaccination’?
  5. How will you address workforce retention concerns?

Provider executives

Since the start of the Covid-19 crisis, we’ve recommended that providers adopt a single source of truth mentality to combat misinformation associated with the virus, it’s treatment, and concerns over vaccination. Today, vaccine skepticism is largely why adults continue to pass on their shot, and while the FDA’s full approval of the Pfizer-BioNTech vaccine isn’t going to appease all of their fears, full approval really does matter to some vaccine hesitant patients, at least according to polling from the Kaiser Family Foundation.

Your job is to identify those patients, offer custom outreach that shares the good news of full approval, and direct patients to the right next steps. The more customized the communication can be, the better. But there are some common principles everyone can take when developing strong Covid-19 vaccine communication strategies. In fact, we’ve built a readiness assessment for this purpose. And while this readiness assessment was built for initial rollout, the questions within should continue to guide your organization in addressing key factors such as patient navigation, equity in vaccine access, public health messaging, and vaccine hesitancy and mistrust.

The best communication strategy generates action—action for the patient (e.g., making an appointment for their first dose) but also action steps for frontline providers. Leaders must make sure that their staff is equipped to recognize vaccine hesitancy vs. skepticism, which is rooted in misinformation. Leaders must train staff to listen to personal narratives and not merely default to scientific facts, and leaders must make sure clinicians feel equipped to ease potential patient concerns.

Frontline clinicians

Doctors must also be equipped to handle individual conversations with patients and discuss what this full approval means. Since patients typically turn to their doctors as a top, trusted source of insight, frontline clinicians are more important than ever in driving vaccine confidence. Yet in a recent poll from SymphonyRM, 41% of patients lost trust in their doctors amid the pandemic—and among those individuals, just over half noted it was because their provider rarely or never communicated with them about Covid-19. To regain trust and communicate the importance of the full approval, frontline clinicians should be prepared to proactively communicate and answer the following questions: 

  1. How does full approval differ from an emergency use authorization? Under what conditions is a full approval granted?
  2. Why did the FDA decide to grant this approval? What data or evidence led to their increased confidence in the vaccine?
  3. How should patients view this approval? What concerns, fears, or questions about the vaccine should this approval counter?
  4. How might this full approval lead to increased mandates or pushes for vaccination, and what does that mean for patients?   

Doctors should also continue to be prepared to answer any skepticism or misinformation about the full approval, which may come up during these discussions. In a July poll from KFF, 34% of unvaccinated adults were not at all confident about the safety of Covid vaccines, and 31% were not too confident. Today’s full approval should be used as an opportunity to help increase patient confidence in the safety of the vaccine.

The best defense we have against this virus is vaccination, and full approval of the Pfizer-BioNTech vaccine gives employers, providers, and frontline clinicians the shot in the arm they need to keep motivating Americans to get vaccinated (pun intended). It’s up to you to capitalize on the momentum of the FDA announcement, whether through your own vaccine regulations or through direct communication to the “watchful waiters” who have been waiting for this moment to get vaccinated. 

Driven by the Delta Variant, the Fourth Wave of COVID-19 in the U.S. Could Be Worse Than the Third. In Some States, It Already Is

Why the delta variant is hitting kids hard in the U.S. and how we can  prevent that in Canada | CBC News

Just a month ago, even as signs of a fourth wave of COVID-19 infections in the U.S. were blossoming in the lower Midwest, the memory of a long, miserable winter kept us warm. Even places with burgeoning case rates were far below their catastrophic peaks over the holidays, when a combination of cold weather and defiant travelers contributed to a third wave in infections and deaths that drowned out the previous two spikes in April and July of 2020.

This is regrettably no longer the case. In four states—Hawaii, Louisiana, Mississippi and Florida—the current number of daily new COVID-19 infections, averaged across seven days, has surpassed that winter peak, even with a substantial percentage of the population having received a complete dosage of the COVID-19 vaccine (though not nearly as many as public officials would prefer).

Hawaii is something of an anomaly, as its winter peak was not nearly as high as in colder, more accessible regions. But several other states threaten to join this quartet in the near future. Oregon’s daily rate of new infections is at 36.5 per 100,000 residents, or 99% of the peak value on Dec. 3, 2020. Nationwide, the rate is 37.7, just under 50% of the winter peak of 76.5.

While plenty of states remain far below the winter peaks, as the Delta variant tears across the country, we can expect more and more states to experience a fourth wave that crests higher than the third, even as new outbreaks are inspiring more vaccine holdouts to hold out their biceps and breakthrough infections, while frightening and non-trivial, remain reasonably rare.

What is perhaps most sobering about this surge is that COVID-19-related deaths, which typically lag behind case surges by about two weeks, are starting to rise again. No state has yet surpassed the winter peak in deaths, but at 65%, Louisiana very well may. That figure is still 15% nationwide, well below the Jan. 13, 2021 peak of 1.04 fatalities per 100,000 people. It is currently at 0.16.

When it comes to the pandemic, no one wants to sound like Chicken Little. The sky might not be falling. But neither is the national case rate, or the number of people dying.

Encouraging hospitals to implement vaccine mandates

https://mailchi.mp/b5daf4456328/the-weekly-gist-july-23-2021?e=d1e747d2d8

Bills to Block Mandatory Worker Vaccines Falter in the States | The Pew  Charitable Trusts

With the Delta variant now accounting for more than 83 percent of all new COVID cases in the US, daily new case counts more than quadrupling across the month of July, and hospitalizations—particularly in states with low vaccination rates—beginning to climb significantly, we appear to have entered a new and uncertain phase of the pandemic, now being dubbed a “pandemic of the unvaccinated”.

Welcome news, then, that this week the American Hospital Association (AHA) publicly encouraged its members to put in place vaccine mandates for their employees. While several large health systems have taken the lead in implementing vaccine mandates, including Trinity Health, the Livonia, MI-based Catholic system that operates hospitals across 22 states, Phoenix, AZ-based Banner Health, Houston Methodist in Texas, and the academic giant NewYork-Presbyterian, others have been more reticent to compel employees to get vaccinated, citing concerns over employee privacy and the potential for workforce backlash.

The New York Times reports that a quarter of all hospital employees remain unvaccinated nationwide, with many facilities reporting that more than half of their healthcare workers have not gotten the COVID vaccine. In our discussions with health system executives, one consideration frequently cited is the desire for full Food and Drug Administration (FDA) approval of the new vaccines before mandates are put in place.

In a CNN town hall meeting this week, President Biden suggested that approval could come as soon as the end of August, although other reports point to likely approval much later, potentially not until January of next year. Facing a new variant of the virus that is much more transmissible and possibly more virulent than earlier strains, hospitals—and their patients—can’t afford to wait that long. 

For safety’s sake, hospitals should quickly put in place vaccine mandates, with appropriate exceptions.

More than 99% of US Covid-19 deaths are among unvaccinated patients

Almost All of the Current COVID-19 Deaths Are Among Those Unvaccinated

As the delta variant of the coronavirus spreads, especially among the unvaccinated, the Biden administration is gearing up for a new push to vaccinate the so-called “movable middle”—and some public health experts say FDA could advance that goal by fully approving Covid-19 vaccines.

Analysis reveals toll of US Covid-19 deaths among unvaccinated patients

According to an analysis by the Associated Press, nearly all recent Covid-19 deaths have occurred in unvaccinated individuals.

The AP analysis is based on data from CDC, although CDC has not itself released estimates of the share of Covid-19 deaths among unvaccinated patients.

According to the AP analysis, just 0.8% of Covid-19 deaths in May were among the fully vaccinated. Meanwhile, the share of hospitalized patients who were fully vaccinated was just 0.1% in May, with fewer than 1,200 fully vaccinated people hospitalized out of more than 853,000 hospitalizations.

Meanwhile, according to CDC, 54% of the U.S. population, including 66% of American adults, have received at least one dose of a Covid-19 vaccine, while 46.1% of the total population and 56.8% of American adults have received all required doses.

MedPAC: Overhaul MA payments and streamline CMMI models

Two influential advisory groups sent recommendations to Congress calling for a revamp of how health plans are paid in the lucrative Medicare Advantage program, culling how many models CMS tests and curbing high-cost drug approvals.

By many measures, the MA program has been thriving. Enrollment and participation has continued to grow, and in 2021, MA plans’ bids to provide the Medicare benefit declined to a record low: Just 87% of comparable fee-for-service spending in their markets.

But despite that relative efficiency, MA contracting isn’t saving Medicare moneyactually, in the 35 years Medicare managed care has been active, it’s never resulted in net savings for the cash-strapped program, James Mathews, executive director of the Medicare Payment Advisory Commission, told reporters in a Tuesday briefing.

MedPAC estimates Medicare actually spends 4% more per capita for beneficiaries in MA plans than those in FFS under the existing benchmark policy.

To save money, Medicare could change how the benchmark, the maximum payment amount for plans, is adjusted for geographic variation, MedPAC said.

Under current policy, Medicare pays MA plans more if they cover an area with lower FFS spending, despite most plans bidding below FFS in these areas. At the same time, plans in areas where FFS spending is higher bid at a lower level relative to their benchmark, and wind up getting higher rebates — the difference between the bid and the benchmark — as a result.

“Because the rebate dollars must be used to provide extra benefits, large rebates result in plans offering a disproportionate level of extra benefits,” MedPAC wrote in its annual report to Congress. “Moreover, as MA rebates increase, a smaller share of those rebates is used for cost-sharing and premium reductions — benefits that have more transparent value and provide an affordable alternative to Medigap coverage.”

The group recommended rebalancing the MA benchmark policy to use a relatively equal blend of per-capita FFS spending in a local area and standardized national FFS spending, which would reduce variation in local benchmarks, and use a rebate of at least 75%. Currently, a plan’s rebate depends on its star rating, and ranges from 65% to 70%.

MedPAC also suggested a discount rate of at least 2% to reduce local and national blended spending amounts.

The group’s simulations suggest the changes would have minimal impact on plan participation or MA enrollees, but could lead to savings in Medicare of about 2 percentage points, relative to current policy.

Finding savings in Medicare, even small ones, is integral for the program’s future, policy experts say. The Congressional Budget Office expects the trust fund that finances Medicare’s hospital benefit will become insolvent by 2024, as — despite perennial warnings from watchdogs and budget hawks — lawmakers have kicked the can on the insurance program’s snowballing deficit for years.

Fewer and more targeted alternative payment models

MedPAC also recommended CMS streamline its portfolio of alternative payment models, implementing a smaller and more targeted suite of the temporary demonstrations designed to work together.

CMS is already undergoing a review of the models, meant to inject more value into healthcare payments, following calls from legislators for more oversight in the program. The agency doesn’t have the most stellar track record: Of the 54 models its Center for Medicare and Medicaid Innovation has trialed since it was launched a decade ago, just four have been permanently encoded in Medicare.

New CMMI head Elizabeth Fowler said earlier this month the agency will likely enact more mandatory models to force the shift toward value, as the ongoing review has resulted in more conscious choices about where it should invest.

In its report, MedPAC pointed out many of CMMI’s models generated gross savings for Medicare, before performance bonuses to providers were shelled out. That suggests the models have the power to change provider practice patterns, but their effects are tricky to measure. Many providers are in multiple models at once, and the same beneficiaries can be shared across models, too.

Additionally, some models set up conflicting incentives. Mathews gave the example of accountable care organizations participating in one model to reduce spending on behalf of an assigned population relative to a benchmark, but its provider participants could also be in certain bundled models with incentives to keep the cost of care per episode low — but not reduce the overall number of episodes themselves.

“The risk of these kinds of inconsistent incentives would be minimized again if the models were developed in a manner where they would work together at the outset,” Mathews said. MedPAC doesn’t have guidance on a specific target number of alternative models, but said it should be a smaller and more strategic number.

Curbing high-cost drugs in Medicaid

Another advisory board, on the Medicaid safety-net insurance program, also released its annual report on Tuesday, recommending Congress mitigate the effect of pricey specialty drugs on state Medicaid programs.

High-cost specialty drugs are increasingly driving Medicaid spending and creating financial pressure on states. The Medicaid and CHIP Payment and Access Commission (MACPAC) didn’t recommend Congress change the requirement that Medicaid cover the drugs, but recommended legislators look into increasing the minimum rebate percentage on drugs approved by the Food and Drug Administration through the accelerated approval pathway, until the clinical benefit of the drugs is verified.

The accelerated approval pathway, which can be used for a drug for a serious or life-threatening illness that provides a therapeutic advantage over existing treatments, allows drugs to come to market more quickly. States have aired concerns about paying high list prices for such drugs when they don’t have a verified clinical benefit.

That pathway has faced growing scrutiny in recent days in the wake of the FDA’s high-profile and controversial approval of Biogen’s aducanumab for Alzheimer’s disease.

Several advisors to the FDA have resigned over the decision, as it’s unclear if aducanumab actually has a clinical benefit. What aducanumab does have is an estimated price tag of $56,000 a year, which could place severe stress on taxpayer-funded insurance programs like Medicare and Medicaid if widely prescribed.

MEDPAC also recommended an increase in the additional inflationary rebate on drugs that receive approval from the FDA under the accelerated approval pathway if the manufacturer hasn’t completed the postmarketing confirmatory trial after a specified number of years. Once a drug receives traditional approval, the inflationary rebate would revert back to the standard amounts.

The recommendations would only apply to the price Medicaid pays for the drug and doesn’t change the program’s obligation to cover it.

Should hospitals mandate the COVID vaccine for employees?

What the COVID-19 vaccine means for your workforce

As we’ve talked to health system executives about the challenges of rolling out COVID vaccines in their communities, one topic keeps coming up: how difficult it’s been to get hospitals’ own workers fully vaccinated. One system told us recently that only 55 percent of their frontline caregivers have opted to get vaccinated, despite early and easy availability, and ongoing encouragement from the hospital’s leaders.

Healthcare workers, it turns out, are just like the general population, bringing the same diversity of perspectives and concerns about vaccination to work with them from their own communities. Vaccine hesitancy is not a new issue for hospital staffers; getting the workforce to take the flu vaccine is an annual struggle for many hospitals.

But given the risks of COVID-19, why not just mandate that hospital employees get the vaccine, as other employers have started to do? We commonly hear two concerns.

One is a labor relations worry: will mandating vaccination cause workers to quit, or make it harder to hire staff in an already difficult market for talent? And given growing concerns about unionization of healthcare workers, will mandatory vaccination become a flashpoint issue?

The second concern is medical liability: can we force workers to get a vaccine that hasn’t been fully approved by the FDA? Would that expose the hospital to legal challenges down the road, if there turn out to be long-term complications from the vaccine?

Our own view is that the first concern is overblown—we suspect vaccine mandates are going to become more and more common as the economy reopens. As to the second, we’re more sympathetic. But once the FDA does grant full approval for the vaccines, we’d hope hospitals will get tougher about vaccine mandates (with the necessary exemptions for health, religious, and other concerns).

At the end of the day, hospitals are in the patient care business, and they should view vaccine mandates—whether for COVID or for influenza—as a patient safety issue, not a workforce engagement issue.

FDA authorizes Pfizer coronavirus vaccine for adolescents 12 to 15 years old

https://www.washingtonpost.com/health/2021/05/10/coronavirus-vaccine-for-kids/?fbclid=IwAR0RKJNrlP3TiTDrvPuczKSHIPmTRds8kdAepwOCSqlrzdDHgGcm9vlBYk8

FDA authorizes Pfizer COVID-19 vaccine in adolescents 12 and up

The Food and Drug Administration cleared the first coronavirus vaccine for emergency use in children as young as 12 on Monday, expanding access to the Pfizer-BioNTech shot to adolescents ahead of the next school year and marking another milestone in the nation’s battle with the virus.

The decision that the two-shot regimen is safe and effective for younger adolescents had been highly anticipated by many parents and pediatricians, particularly with the growing gap between what vaccinated and unvaccinated people may do safely. Evidence suggests that schools can function at low risk with prevention measures, such as masks and social distancing. But vaccines are poised to increase confidence in resuming in-person activities and are regarded as pivotal to returning to normalcy.

“Adolescents, especially, have suffered tremendously from the covid pandemic. Even though they’re less likely than adults to be hospitalized or have severe illness, their lives really have been curtailed in many parts of the country,” said Kawsar R. Talaat, an assistant professor of international health at the Johns Hopkins Bloomberg School of Public Health. “A vaccine gives them an extra layer of protection and allows them to go back to being kids.”

Expert advisers to the Centers for Disease Control and Prevention are scheduled to meet Wednesday to recommend how the vaccine should be used in that age group, and the vaccine can be administered as soon as the CDC director signs off on the recommendation.

In a news briefing Monday evening after the announcement, FDA officials said the Pfizer authorization for 12- to 15-year-olds was a straightforward decision because the data showed that the vaccine was safe and that the response to the vaccine was even better than among the 18- to 25-year-olds who got the shots.

Children rarely suffer serious bouts of covid-19, the illness caused by the coronavirus. But there is no way to predict the few who will become dangerously sick or develop a rare, dangerous inflammatory syndrome. Out of more than 581,000 covid-19 deaths in the United States, about 300 have been people under 18 — a tiny fraction of the total. But that exceeds the number of children who die in a bad flu season.

Children appear to be less efficient at spreading the virus, although their role in transmission is still not fully understood — another reason for pediatric vaccinations.

Clinicians also worry that with a new virus with many unknowns, the possibility exists for long-term impacts of infection, even from the mild or asymptomatic courses of illness common among children.

The Pfizer-BioNTech vaccine, already authorized for adolescents 16 and older, was the first to be tested in younger adolescents. The FDA’s decision will provide a potential path for other vaccine-makers to follow, most of which have launched or plan to initiate trials of their vaccines in teenagers and younger children.

The agency based its authorization on a trial of nearly 2,300 adolescents between 12 and 15 years old, half of whom received the same two-shot regimen shown effective and safe in adults. Researchers took blood samples and measured antibody levels triggered by the shots and foundstronger immune responses in the teens than those found in young adults. There were 16 cases of covid-19 in the trial, all of them among adolescents who received a placebo, suggesting the regimen offered similar protection to younger recipients as it does to adults.

Robert W. Frenck Jr., the researcher who led the adolescent trial at Cincinnati Children’s Hospital Medical Center, said the study was designed to test whether it triggered immune responses, not whether it prevented disease. But because of the number of children who became ill in the placebo arm of the trial, it also became evident the vaccine offered robust protection.

“That really points out how much covid there is in the adolescent community,” Frenck said.

The data has not been published or peer-reviewed, but Kathryn M. Edwards, a pediatric infectious-disease specialist at Vanderbilt University Medical Center, said the results announced by Pfizer were “pretty exciting — it looked very effective and the immune responses were really good.”

Edwards said she is comfortable the benefits of vaccinations are clear among teens, noting that while children, in general, are at lower risk of severe covid-19 than adults, older adolescents seem to be more like adults in their risk for covid-19 than the very youngest children.

Audrey Baker, 15, and Sam Baker, 12, rolled up their sleeves for shots in the Pfizer-BioNTech trial at Cincinnati Children’s Hospital Medical Center. Audrey said she had no hesitation about signing up, and misses little things about how life used to be — eating out in restaurants and seeing family.

“I just trusted the science,” Audrey said. “I knew it was tested in adults. I was really just joining, hoping that maybe I could get vaccinated and help out science.”

Sam said he was more hesitant, in part because participating meant many follow-up lab tests. But he decided to do it and thinks he may have gotten the vaccine in the trial because he developed a headache and fever after his second dose.

Their mother, Rachel Baker, said she felt relief because of Sam’s symptoms.

The biggest benefit has been that I feel a weight off my shoulders,” Rachel said. “We haven’t changed how we do anything. … We’re still masking, we’re still social distancing, but we’re a bit calmer about it all.”

H. Cody Meissner, a pediatrician at Tufts Medical Center and a member of an external advisory committee to the FDA, said he thinks a pediatric vaccine is needed. But he said he would like to see more safety data because the messenger RNA technology at the core of vaccines from Pfizer-BioNTech and the biotechnology company Moderna does not have a long, established safety record, and its first large-scale use began in December.

Meissner abstained from the December vote that overwhelmingly recommended authorization of the Pfizer-BioNTech vaccine for people 16 and older, because he thought the vaccine should be authorized in people 18 and older.

“For those who are eager to get it, it’s important for them to understand that this is very rarely a severe disease in young adolescents, number one, and this is an entirely new vaccine,” Meissner said. “I just don’t want people to get too swept up in fear of hospitalization and death from covid-19 for the first few decades of life.”

But many other physicians take comfort knowing that 250 million shots of messenger RNA vaccine have been given in the United States alone. Serious side effects, such as a risk of anaphylaxis, are extremely rare. Because the trial in teens was an “immune bridging” trial designed to test whether the vaccine triggered immune responses similar to those in adults, researchers did not need to recruit tens of thousands of people to see if those who received a vaccine were protected against illness. The immune bridging technique is commonly used to expand access to vaccines that have been proved effective and safe to adolescents or other populations.

The expansion of eligibility to children will probably ignite debates in families about when to get vaccinated, and among policymakers about whether it should be required.

Dorit Reiss, a law professor focused on vaccine policy at the University of California Hastings College of Law, said she thinks it is unlikely children will be mandated to receive a coronavirus shot until the vaccines win full approval and not just emergency use authorization.

She predicted that acceptance of the vaccine will evolve as more children are vaccinated and depend on the state of the pandemic. She noted that when vaccines are introduced, the rollout often starts slowly before accelerating.

“Nervousness about a new vaccine is normal, especially when it’s for kids,” Reiss said. “Parents that are nervous now might feel different in a few months, once their friends’ kids have gotten vaccinated. And the views of the kids are also going to matter — if teens are going to think this is going to make their lives easier.”

Opening up vaccinations to children may sharpen a debate unfolding globally about the equity of vaccine access. Talaat said that while she can’t wait for her kids to have access to a vaccine, she is troubled by the global inequities as high-risk front-line workers or older people still don’t have access to vaccines in countries where the coronavirus is out of control.

Moderna announced Thursday that an initial analysis of its teen trial found its vaccine was 96 percent effective among participants who received at least one dose. Moderna is in discussions with regulators about the data. Pfizer-BioNTech and Moderna are testing their vaccines in children as young as infants. Johnson & Johnson is planning pediatric trials of its single-shot vaccine.

Trials in younger children are expected to take longer, because researchers must step down gradually in age and determine a safe and effective dose. William Gruber, senior vice president of vaccine clinical research and development at Pfizer, said data from tests in children as young as 2 years old may be available by September or October, with data on children as young as 6 months possible by the end of the year.

Within each age category, a separate risk-benefit assessment may take place. In the youngest children, given the low risk from the coronavirus, side effects may figure more prominently into the analysis, for example. Researchers may end up choosing a lower dose of vaccine. The understanding of children’s role in transmission may also evolve and help guide vaccine use and public policy.

“We are proceeding carefully, cautiously,” Edwards said. “We’re using the same rigid guidelines we use in all vaccines, and we take this very seriously. I think as time goes on and more information becomes available, some of the questions may be easier to address.”

Cartoon – Anti-Vaccine or Pro-Disease?

Vaccine hesitancy among the top 10 global health threats