Is the Pfizer-BioNTech coronavirus vaccine safe for children ages 5 to 11? Does it work? Does every child need it?
The Food and Drug Administration on Friday authorized the vaccine for emergency use in those age groups, following a near-unanimous recommendation from its advisers last week. On Tuesday, a similar committee advising the Centers for Disease Control and Prevention is meeting to have its say. (The meeting is streaming here.)
If, as expected, the advisers recommend the vaccine and the agency’s director, Dr. Rochelle Walensky, signs off, the decision would most likely ease the worries of millions of parents and buttress the United States’ defenses against the virus before winter arrives.
Dr. Walensky made a brief appearance as the meeting began, noting that the day was “one that many of us have been very eager to see.”
Still, she cautioned that vaccinating children is just one important piece to the puzzle. “It is important that we also continue to vaccinate as many adults as possible to provide protection to children in the community,” she said, including those children younger than age 5 who are not yet eligible for vaccination.
Inoculations for children ages 5 through 11 could begin this week. Anticipating the agency’s decision, the Biden administration has enlisted more than 20,000 pediatricians, family doctors and pharmacies to administer the vaccines.
About 15 million doses are already being packed with dry ice, loaded into small specialized containers and shipped via airplanes and trucks to vaccination sites across the country, federal officials said on Monday. Several million pediatric doses should be available in the next few days, but the vaccination program for the age group will only start “running at full strength” in the second week of November, said Jeffrey D. Zients, the administration’s pandemic response coordinator.
The younger children will receive one-third of the dose authorized for those 12 and older, delivered by smaller needles and stored in smaller vials to avoid a mix-up with adult doses.
The C.D.C.’s guidelines for the vaccine’s use are not legally binding, but heavily influence the medical community’s practice. An endorsement would be timely, as Americans begin to plan for the winter holidays.
Although cases in the United States have been falling steadily for weeks, experts warn that indoor family gatherings during the Thanksgiving and Christmas holidays may send the rates soaring again, even if not to the horrific highs of last year. Airlines are preparing for what may be the busiest travel season since the start of the pandemic.
Vaccinations would ease the minds of many parents who are anxious to protect their young children and frustrated by frequent school shutdowns and quarantines. Outbreaks of the coronavirus forced 2,000 schools to close between early August and October. Every million doses given to children aged 5 to 11 would prevent about 58,000 cases and 226 hospitalizations in that age group, according to a C.D.C. estimate.
Still, many parents are hesitant to immunize their children, citing concerns about long-term safety of the vaccine or because they fear that the vaccine is more harmful than Covid-19.
About three in 10 parents say they will definitely not get the vaccine for their 5- to 11-year-old children, according to the most recent poll by the Kaiser Family Foundation. A similar percentage of parents said that they would immunize their children “right away,” a figure that has barely budged since similar polls in July and September.
Before the F.D.A. advisers met last week, they were bombarded by thousands of emails spouting misinformation about the vaccine and asking the experts to vote against it. One common objection to the vaccine holds that children rarely get sick from the virus, and the vaccine’s potential harms may outweigh its benefits.
But while children are much less likely than adults to become seriously ill from the virus, their risk is not zero. Many children were infected with the coronavirus in the most recent surge, and children ages 5 through 11 accounted for nearly 11 percent of all cases the week of Oct. 10, according to data collected by the C.D.C.
Since the beginning of the pandemic, more than 8,300 children ages 5 to 11 have been hospitalized with Covid, and at least 94 have died. (Some provisional estimates are higher — at least 170 deaths.) About one-third of the hospitalized children were sick enough to be admitted to intensive care units.
Experts on the C.D.C. panel spent a significant portion of their time deliberating a rare side effect called myocarditis, inflammation of the heart. The risk is highest in males 16 to 29 years, but even in that group, a majority recover quickly. The risk appears to decline in children 12 to 15, and is expected to be even lower in younger children, experts said at the meeting. Covid is far more likely to cause myocarditis, and a more severe version of it, studies have shown.
The C.D.C. has not definitively linked any deaths from myocarditis to vaccination, said Dr. Matthew Oster, a C.D.C. scientist who presented myocarditis data at the meeting. “Getting Covid I think is much riskier to the heart than this vaccine, no matter what age or sex,” he said.
An expert advisory committee to the Centers for Disease Control and Prevention meets on Tuesday to consider whether to vote to recommend Pfizer-BioNTech’s coronavirus vaccine for use in children 5 to 11.
Last week the Food and Drug Administration decided to authorize the vaccine for that age group. Then there are steps at the C.D.C. and at the state level before the 28 million children in the age group could get shots.
Here’s what needs to happen first.
At the C.D.C.
The panel, a group of independent experts called the Advisory Committee on Immunization Practices, considers the F.D.A.’s decision and makes recommendations.
The C.D.C. contemplates the panel’s suggestions, which the agency usually follows.
The C.D.C., which is led by Dr. Rochelle P. Walensky, weighs in with final guidance, which influences how entities like states, hospitals and doctors’ offices distribute vaccines. In September, Dr. Walensky ignored the C.D.C. panel’s advice and recommended booster shots of Pfizer’s vaccine for frontline workers, aligning her agency’s guidance with the F.D.A.’s authorization.
In the states
State health authorities typically adopt the C.D.C.’s guidance, though it is not binding.
Pediatric doses will begin to become available once the regulatory process is done, but the vaccination program will only reach full strength next week, Jeffrey D. Zients, the White House’s pandemic response coordinator, said on Monday.
With its coronavirus vaccine on track this year to generate the biggest single-year sales ever for a medical product, Pfizer on Tuesday disclosed revenue projections indicating that the shot will likely beat that record or come close in 2022.
The company said while reporting its third quarter earnings that it expects its vaccine to bring in $36 billion in revenue this year. Pfizer said it has already reached supply deals worth $29 billion in revenue for its vaccine next year, covering 1.7 billion shots it has already committed to countries around the world. Billions more in sales are likely to come as the company reaches more deals to sell to governments the four billion shots it expects to produce next year.
The company’s chief executive, Dr. Albert Bourla, told analysts on Tuesday that most of the company’s negotiations are with high- and upper-middle-income countries. He said he was concerned that poorer countries and their proxies were not lining up to place orders. “I don’t want to reach a level that again the low- and middle-income countries will be behind in their deliveries because they didn’t place their orders,” he said.
Pfizer says it is selling shots for poorer countries at discounted prices, but many of the world’s poorest countries cannot afford to buy doses directly. They have depended on donations from the United States and other wealthy countries, and on supply from Covax, the United Nations program to vaccinate the globe.
There remain stark differences in vaccine access: Worldwide, about 75 percent of all shots that have gone into arms have been administered in high- and upper-middle-income countries, according to the Our World in Data project at the University of Oxford. Only 0.6 percent of doses have been administered in low-income countries.
The enormous sales figures will translate into billions in profits for Pfizer. The company, which must split its vaccine revenue with development partner BioNTech, said that it expects its profit margins on the vaccine will be in the high 20 percent range next year, the same margin it projected this year.
The doses that will be delivered next year include booster shots, mostly for wealthier countries, and primary immunizations, with an emphasis on second doses, for poorer countries.
A small chunk of the doses will be given to children. The company won authorization last week for its vaccine to be given in the United States to children between the ages of 5 and 11. An advisory panel to the Centers for Disease Control and Prevention is meeting Tuesday regarding pediatric doses for that age group and it is expected to make recommendations to the agency about how the vaccine should be used. If the director signs off, children could begin receiving it this week.
Pfizer expects to have initial data from its studies evaluating its vaccine in children between the ages of 2 and 4 by the end of December and in children between the ages of six months and 1 by the end of March, the company’s research chief, Dr. Mikael Dolsten, told analysts on Tuesday.
Pfizer could get another revenue boost next year from an antiviral pill it is developing for high-risk Covid patients early in their infections. Results are expected within the next few months from a key clinical trial evaluating whether the drug can cut the risk of hospitalizations and death.
A Pfizer executive, Angela Hwang, said the company sees a market of up to 150 million people for the pill. She called it a “durable opportunity,” saying that governments may be interested in stockpiling the drug.
A rival pill from Merck, known as molnupiravir, has already been shown to halve the risk of hospitalization in similar patients. Merck said last week that it expects molnupiravir to generate between $5 and $7 billion in revenue globally through the end of next year.
American officials on Tuesday warned that the reopening of international land borders next week could lead to longer wait times at ports of entry and asked that travelers have their travel and vaccine documents readily available for border officials.
On Monday, U.S. land borders will reopen to authorized adults who can show proof that they are fully vaccinated against the coronavirus. Unvaccinated children under 18 will be allowed in if they are traveling with a fully vaccinated adult, officials said on Tuesday.
This applies to travelers crossing at official ports of entry, as well as those arriving by passenger train. Officials said it did not matter if the proof of vaccination was in a language other than English.
The long-awaited reopening on Nov. 8 comes just ahead of the holiday season, clearing the way for tourists and other nonessential travelers after about 19 months of border closures during the pandemic. It follows a recent decision by the Biden administration to reopen the country to vaccinated foreigners traveling by air. While a negative coronavirus test is required to enter the country by air, that will not be the case for crossing land borders. The border has been open to essential travel for legal trade, emergency response and medical reasons.
The United States saw a record number of illegal border crossings in the past 12 months, which officials blame, in part, on misinformation spread by smuggling networks to vulnerable migrants, telling them incorrectly that American borders were open.
Border officials reiterated on Tuesday that authorities continue to expel migrants who cross the border illegally, authorized under the public health rule that was put in place at the beginning of the pandemic.
“Any foreign national attempting to enter the United States other than at a lawful port of entry or without proper documents will be subject to border restrictions, including expulsions,” said Matthew Davies, the executive director of admissibility and passenger programs at Customs and Border Protection.
The proof of vaccination can be electronic or on paper, officials said, but the vaccine has to be one cleared by U.S. regulators or for emergency use by the World Health Organization.
A fair number of Mexican people have been vaccinated with drugs that do not have W.H.O. authorization, like Sputnik V, developed in Russia, or the CanSino vaccine from China.
Reopening the country to vaccinated air and land travelers has been a welcome development for businesses, many of which have suffered because of the pandemic-driven closures.
In 2019, more than half of the 20.7 million people who visited the United States from Canada traveled across land borders, according to the U.S. Travel Association, a trade group. And more than 15 million people traveled to the United States across the land border with Mexico.
Canada reopened its land borders in August, and Mexico’s never closed.
The official daily death toll from the coronavirus in Russia hit a record of 1,178 on Tuesday as the authorities urged the public to get vaccinated and signaled that a partial lockdown could be extended in some regions.
Russia is in the middle of a vicious fourth wave of the coronavirus, which is wreaking havoc in a population that is largely unvaccinated and distrustful of government interventions to slow the spread. The police have opened 503 criminal investigations into the distribution of fake vaccine certificates since July and have shut down more than 2,000 websites peddling them, the Interior Ministry said on Tuesday.
President Vladimir V. Putin has declared this week to be a “nonworking” period, with nonessential workers encouraged to stay home and employers encouraged to pay them at least the minimum wage to do so. In some regions, including Moscow, restaurants, bars and other businesses are closed. There were signals that the restrictions might extend beyond seven days, but the Kremlin said on Tuesday that no official decisions had been confirmed.
Nonetheless, Anna Popova, a senior health official, said on Monday, “The effect from the measures being taken, and the ones that have been taken, will not come immediately.”
“It is likely that more time will be needed,” she added.
Russia’s coronavirus task force has been reporting more than 1,000 daily deaths since mid-October, for a total of 240,871 since the pandemic’s beginning, though those numbers undercount the true toll. The government’s statistics agency, which provides its own monthly figures, said last week that it had recorded at least 44,265 coronavirus deaths in September, and some 462,000 in total.
Less than half of Russian adults are vaccinated, according to the official statistics, a figure that may be difficult to lift, considering that 45 percent have no plans to get a shot, according to the independent polling center Levada. Analysts say that mixed government messaging and public distrust are to blame — the Russian vaccine Sputnik V has been widely available for months.
A mass text message sent out by the Moscow city government on Tuesday said, “You can protect your close ones by signing them up for a vaccine.” It noted that one out of every nine people older than 60 who contracted Covid was dying and that vaccinated people were eligible to receive a cash prize of 10,000 rubles, or about $140.
China has called on families and local governments to stock up on daily necessities as the country enforces stringent restrictions intended to curb a number of Covid outbreaks.
The Chinese Ministry of Commerce issued the guidance in a statement on Monday. The Economic Daily, a Communist Party-backed newspaper, said that the directives were an effort by the government to prepare the public for Covid lockdowns in the prelude to winter.
China has enforced a “zero Covid” policy that includes widespread testing and lockdowns to stamp out any small resurgence of the coronavirus. The country is battling several Covid-19 outbreaks.
Pan Chenjun, an agriculture analyst at the Dutch lender Rabobank, said, “The directive to stock up on necessities is mainly about warning residents to prepare for any quarantine if Covid cases occur in their community.”
Extreme weather events in recent months, including flooding, have ruined crops and disrupted food chain supplies in parts of the country, Ms. Pan added.
As a consequence, the cost of certain foods, such as vegetables, has soared. Some vegetables, like spinach, have doubled in price, in some cases costing as much as meat does, according to one local report.
Some residents have taken to social media in recent days to complain about the skyrocketing prices.
One commenter on the Chinese platform Weibo described the shock of being told the price of tomatoes during a recent trip to the market. “I thought I had a hearing problem,” the person wrote.
When the Biden administration announced that vaccinated foreign travelers would be allowed to enter the United States starting Nov. 8, it was as though a starting gun had been fired.
Skyscanner, a travel booking site, saw an 800 percent spike in bookings the day after the announcement. The week after the administration confirmed the date travelers could arrive, Expedia, the online booking site, saw a 28 percent increase in searches for U.S. hotels from Britain and a 24 percent increase from France.
And even domestic tourism seems poised for a lift. Experts said that the U.S. reopening to those coming from overseas signaled to American travelers that they could leave their homes this coming holiday season, too. Searches for outbound international travel on the booking application Hopper, for instance, increased by 24 percent since the announcement, the highest uptick since the spring.
Though the travel industry continues to face staffing and regulatory challenges, the process of traveling is becoming smoother. Coronavirus tests needed before foreign flights are easier to book, and the process for checking documents at airports has been streamlined. But most important, travelers are becoming accustomed to the uncertainties of pandemic travel, planning for it rather than dreading it.
Federal regulators are reviewing data on the link between Moderna’s coronavirus vaccine and a rare heart problem in adolescents, the company announced on Sunday. That side effect — myocarditis, an inflammation of the heart muscle — has also worried advisers to federal agencies in deliberations regarding use of the Pfizer-BioNTech vaccine in younger children and teenagers.
Scientists advising the Centers for Disease Control and Prevention will review the latest data on the condition at a meeting on Tuesday before deciding whether to recommend the Pfizer-BioNTech vaccine for younger children.
So how common is myocarditis? And should parents be concerned about vaccinating their children?
Absolutely not, said several experts familiar with the recent studies. While the vaccines made by Pfizer-BioNTech and Moderna do seem to be associated with an increased risk of myocarditis, the absolute risk remains very small. Most cases are mild and resolve quickly.
Myocarditis generally results from infection with a virus or bacteria, and causes symptoms like rapid or irregular heartbeat, chest pain and shortness of breath. Globally, about 10 to 20 people out of every 100,000 develop myocarditis each year, but many others have mild symptoms and may never be diagnosed.
Since the start of the coronavirus pandemic, tens of thousands of U.S. children have been hospitalized with Covid-19, and 657 have died, according to data collected by the C.D.C.
Some children who are infected with the coronavirus may go on to develop long Covid, remaining ill for months after the initial infection is gone, or multisystem inflammatory syndrome, which has affected at least 5,200 children in the United States.
The myocarditis linked to the vaccines is far less frequent and severe compared with that observed in patients with Covid, and it does not seem to cause lasting harm, said Dr. James de Lemos, a cardiologist at the University of Texas Southwestern Medical Center in Dallas.
The coronavirus can infect cardiac muscle, as well as the lining of blood vessels, putting the heart and other organs at risk of long-term damage. The virus can also weaken the heart enough to require a transplant, and even cause lethal damage.
In addition to the big, juicy turkey on the table, there’s also an elephant lurking in the room this Thanksgiving: the vaccination status of your guests.
It’s a tricky thing to talk about. Do you ask your aunt if she received the Covid vaccine after she R.S.V.P.s? What if she says no? Do you endure another scaled-back celebration, like last year? Or should you serve up a bunch of precautions?
According to a Marist Poll published in September, most Americans (nearly 80 percent) say they have gotten or will get a Covid vaccine, but nearly 20 percent still say they do not intend to be vaccinated.
That doesn’t sit well with some of the people who have already rolled up their sleeves. A recent Harris Poll found that half of the more than 1,400 vaccinated respondents were either “extremely” or “considerably” hesitant to spend the holidays with unvaccinated family members or friends.
For some, the risk of celebrating with unvaccinated friends and relatives just isn’t worth it. But if you’re open to gathering with a mixed vaccination status group, there are ways to do it cautiously, experts say.
“Be not afraid, but be reasonable,” said Dr. Juan C. Salazar, a pediatric infectious diseases specialist and physician-in-chief of Connecticut Children’s in Hartford, Conn. You can still get together, he said, but each family will need to ask one crucial question: “What is the likelihood that we will get very sick from Covid-19?”
If you’re uncertain of how to proceed (or whether you ought to gather at all) we asked several experts for ideas on how to make Thanksgiving safer for everyone.
Start by calling your unvaccinated family members and soliciting their ideas on how to gather safely, said Daniel L. Shapiro, an associate professor of psychology at Harvard Medical School and the author of “Negotiating the Nonnegotiable: How to Resolve Your Most Emotionally Charged Conflicts.”
Ask: “What’s your advice on how we can make sure everyone feels safe and comfortable when we get together?” he suggested. Then come up with some ideas. Perhaps you suggest that there should be mandatory testing right before dinner, or that you should gather outside, near a patio heater.
Kristy Swanson, an actress who is a vocal vaccine skeptic and critic of Dr. Anthony Fauci, has been hospitalized with virus-related pneumonia in New Jersey, she said.
The actress, who is best known for playing the titular character in the 1992 film “Buffy the Vampire Slayer,” was taken by ambulance on Sunday to Virtua Memorial Hospital in Mount Holly, N.J., she said on Twitter on Monday. She said she had pneumonia and was being treated with oxygen, blood thinners and baricitinib, an arthritis drug that the Food and Drug Administration in July granted emergency authorization to treat Covid.
She said on Monday that she was “in good spirits” but was receiving treatments “so I don’t clot.”
“I was just at the tail end of my Covid diagnosis when it jumped into my lungs,” she said on Twitter.
Although it was not clear if Ms. Swanson, 51, has received a Covid vaccine, she has frequently criticized proponents of the vaccine. In September, she said on Twitter, alongside an article about Covid, that “it behaves just like the flu.”
Every year there is a new strain of the flu and “a new vaccine comes out for it,” she said. “That’s exactly what this whole thing is, except this time they want to mandate vaccines so they can make mo-money.”
On Monday afternoon, she said on Twitter: “Fact Check: I have NEVER said I am anti-vax.”
Ms. Swanson has been a vocal supporter of President Donald Trump and met him in the Oval Office in February last year. She has directed several critical tweets at Dr. Fauci, the top U.S. infectious disease official.
Coronavirus vaccines were significantly less effective in protecting people with weakened immune systems than they were for other people, the Centers for Disease Control and Prevention reported on Tuesday, buttressing the agency’s call for immunocompromised adults to receive third or fourth doses of vaccines.
Two doses of either the Pfizer-BioNTech or Moderna vaccines were 77 percent effective against Covid-related hospitalization for immunocompromised people. That was a significant degree of protection, the agency said, but far lower than the shots’ benefit to people without immune deficiencies: In those people, the agency said, the vaccines were 90 percent effective against Covid hospitalizations.
The Moderna vaccine also offered more protection to people with weakened immune systems than did the Pfizer shot, mirroring results seen across American adults. And certain people with immune deficiencies — especially organ or stem cell transplant recipients, who often take drugs to suppress their immune systems and prevent rejection of the transplant — showed weaker responses to Covid vaccines than other categories of immunocompromised people did.
The study did not examine recipients of the Johnson & Johnson vaccine.
To help immunocompromised people mount a more aggressive immune response, the C.D.C. suggests that they be given three doses of Pfizer or Moderna vaccines, plus an additional booster shot six months after the third dose. In addition, the agency’s scientists wrote, they should take precautions like wearing masks, and be considered for treatments like monoclonal antibody therapy as early as possible after a Covid diagnosis.
The study released on Tuesday used a circuitous experimental design. The researchers examined roughly 20,000 immunocompromised adults and 70,000 people without immune deficiencies hospitalized this year with Covid-like illness. Of the immunocompromised patients in the study, 43 percent were fully vaccinated. Of the other participants, 53 percent were vaccinated.
The researchers then determined how many of those hospitalized patients were indeed infected with the coronavirus, and compared the odds of a positive test results between fully vaccinated and unvaccinated patients.
The immunocompromised patients included those with cancer, inflammatory disorders, organ or stem cell transplants and other immune deficiencies.
The study’s authors cautioned that there could have been cases in which patients were misclassified as immunocompromised, and that there could have been biases in which patients sought out coronavirus tests.