CDC Recommends New Covid Boosters

By Arthur Allen, KFF Health News

Everyone over the age of 6 months should get the latest covid-19 booster, a federal expert panel recommended Tuesday after hearing an estimate that universal vaccination could prevent 100,000 more hospitalizations each year than if only the elderly were vaccinated.

The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted 13-1 for the motion after months of debate about whether to limit its recommendation to high-risk groups. A day earlier, the FDA approved the new booster, stating it was safe and effective at protecting against the covid variants currently circulating in the U.S.

After the last booster was released, in 2022, only 17% of the U.S. population got it — compared with the roughly half of the nation who got the first booster after it became available in fall 2021. Broader uptake was hurt by pandemic weariness and evidence the shots don’t always prevent covid infections. But those who did get the shot were far less likely to get very sick or die, according to data presented at Tuesday’s meeting.

The virus sometimes causes severe illness even in those without underlying conditions, causing more deaths in children than other vaccine-preventable diseases, as chickenpox did before vaccines against those pathogens were universally recommended.

The number of hospitalized patients with covid has ticked up modestly in recent weeks, CDC data shows, and infectious disease experts anticipate a surge in the late fall and winter.

The shots are made by Moderna and by Pfizer and its German partner, BioNTech, which have decided to charge up to $130 a shot. They have launched national marketing campaigns to encourage vaccination. The advisory committee deferred a decision on a third booster, produced by Novavax, because the FDA hasn’t yet approved it. Here’s what to know:

Who Should Get a Booster Shot?

The CDC advises that everyone over 6 months old should, for the broader benefit of all. Those at highest risk of serious disease include babies and toddlers, the elderly, pregnant women, and people with chronic health conditions including obesity. The risks are lower — though not zero — for everyone else. The vaccines, we’ve learned, tend to prevent infection in most people for only a few months. But they do a good job of preventing hospitalization and death, and by at least diminishing infections they may slow spread of the disease to the vulnerable, whose immune systems may be too weak to generate a good response to the vaccine.

Pablo Sánchez, a pediatrics professor at The Ohio State University who was the lone dissenter on the CDC panel, said he was worried the boosters hadn’t been tested enough, especially in kids. The vaccine strain in the new boosters was approved only in June, so nearly all the tests were done in mice or monkeys. However, nearly identical vaccines have been given safely to billions of people worldwide.

When Should You Get It?

The vaccine makers say they’ll begin rolling out the vaccine this week. If you’re in a high-risk group and haven’t been vaccinated or been sick with covid in the past two months, you could get it right away, says John Moore, an immunology expert at Weill Cornell Medical College. If you plan to travel this holiday season, as he does, Moore said, it would make sense to push your shot to late October or early November, to maximize the period in which protection induced by the vaccine is still high.

Who Pays For It?

When the ACIP recommends a vaccine for children, the government is legally obligated to guarantee kids free coverage, and the same holds for commercial insurance coverage of adult vaccines.

For the 25 to 30 million uninsured adults, the federal government created the Bridge Access Program. It will pay for rural and community health centers, as well as Walgreens, CVS, and some independent pharmacies, to provide covid shots for free. Manufacturers have agreed to donate some of the doses, CDC officials said.

Will New Booster Work Against Current Variants?

It should. More than 90% of currently circulating strains are closely related to the variant selected for the booster earlier this year, and studies showed the vaccines produced ample antibodies against most of them. The shots also appeared to produce a good immune response against a divergent strain that initially worried people, called BA.2.86. That strain represents fewer than 1% of cases currently. Moore calls it a “nothingburger.”

Why Are People Still Skeptical About Vaccines?

Experience with the covid vaccines has shown that their protection against hospitalization and death lasts longer than their protection against illness, which wanes relatively quickly, and this has created widespread skepticism.

Most people in the U.S. have been ill with covid and most have been vaccinated at least once, which together are generally enough to prevent grave illness, if not infection — in most people. Many doctors think the focus should be on vaccinating those truly at risk.

What About Getting Other Vaccines?

People tend to get sick in the late fall because they’re inside more and may be traveling and gathering in large family groups. This fall, for the first time, there’s a vaccine — for older adults — against respiratory syncytial virus. Kathryn Edwards, a 75-year-old Vanderbilt University pediatrician, plans to get all three shots but “probably won’t get them all together,” she said.

Covid “can have a punch” and some of the RSV vaccines and the flu shot that’s recommended for people 65 and older also can cause sore arms and, sometimes, fever or other symptoms. A hint emerged from data earlier this year that people who got flu and covid shots together might be at slightly higher risk of stroke. That linkage seems to have faded after further study, but it still might be safer not to get them together.

Pfizer and Moderna are both testing combination vaccines, with the first flu-covid shot to be available as early as next year. Although Pfizer’s shot has been approved in the European Union, Japan, and South Korea, and Moderna has won approval in Japan and Canada. Rollouts will start in the U.S. and other countries this week.

Unlike in earlier periods of the pandemic, mandates for the booster are unlikely. But “it’s important for people to have access to the vaccine if they want it,” said panel member Beth Bell, a professor of public health at the University of Washington.

“Having said that, it’s clear the risk is not equal, and the messaging needs to clarify that a lot of older people and people with underlying conditions are dying, and they really need to get a booster,” she said.

ACIP member Sarah Long, a pediatrician at Children’s Hospital of Philadelphia, voted for a universal recommendation but said she worried it was not enough. “I think we’ll recommend it and nobody will get it,” she said. “The people who need it most won’t get it.”

KFF Health News is a national newsroom that produces in-depth journalism about health issues.

Is Another Covid Spike Coming? 6 Tips to Help You Stay Safe

By Celine Gounder, Kaiser Health News

The emergence last year of the highly transmissible omicron variant of the covid-19 virus caught many people by surprise, and led to a surge in cases that overwhelmed hospitals and drove up fatalities. Now we’re learning that omicron is mutating further to better evade the immune system.

Omicron-specific vaccines were authorized by the FDA in August and are recommended by U.S. health officials for anyone 5 or older. Yet only half of adults in the United States have heard much about these booster shots, according to a recent Kaiser Family Foundation poll, and only a third say they’ve gotten one or plan to get one as soon as possible. In 2020 and 2021, covid cases spiked in the U.S. between November and February.

Although we don’t know for sure that we’ll see another surge this winter, here’s what you should know about covid and the updated boosters to prepare.

1. Do I need a covid booster shot this fall?

If you’ve completed a primary vaccination series and are 50 or older, or if your immune system is compromised, get a covid booster shot as soon as possible. Forty percent of deaths are occurring among people 85 and older and almost 90% among people 65 and over. Although people of all ages are being hospitalized from covid, those hospitalizations are also skewing older.

Unvaccinated people, while in the minority in the U.S., are still at the highest risk of dying from covid. It’s not too late to get vaccinated ahead of this winter season. The United Kingdom, whose covid waves have presaged those in the United States by about a month, is beginning to see another increase in cases.

If you’ve already received three or more covid shots, you’re 12 to 49 years old, and you’re not immunocompromised, your risk of hospitalization and death from the disease is significantly reduced and additional boosters are not likely to add much protection.

However, getting a booster shot provides a “honeymoon” period for a couple of months after vaccination, during which you’re less likely to get infected and thus less likely to transmit the virus to others. If you’ll be seeing older, immunocompromised, or otherwise vulnerable family and friends over the winter holidays, you might want to get a booster two to four weeks in advance to better shield them against covid.

You may have other reasons for wanting to avoid infection, like not wanting to have to stay home from work because you or your child is sick with covid. Even if you aren’t hospitalized from covid, it can be costly to lose wages or arrange for backup child care.

One major caveat to these recommendations: You should wait four to six months after your last covid infection or vaccination before getting another shot. A dose administered too soon will be less effective because antibodies from the previous infection or vaccination will still be circulating in your blood and will prevent your immune cells from seeing and responding to vaccination.

2. Do kids need to be vaccinated even if they’ve had covid?

Although children are at lower risk for severe covid than are adults, the stakes for kids are higher than many diseases already recognized as dangerous. Their risk shouldn’t be measured against the risk that covid poses to other age groups but against the risk they face from other preventable diseases.

In the first two years of the pandemic, covid was the fourth- or fifth-leading cause of death in every five-year age bracket from birth to 19, killing almost 1,500 children and teenagers. Other vaccine-preventable diseases like chickenpox, rubella, and rotavirus killed an average of about 20-50 children and teens a year before vaccines became available. By that measure, vaccinating kids against covid is a slam-dunk.

Children who have had covid also benefit from vaccination. The vaccine reduces their risk of hospitalization and missing days of school, when parents might need to stay home with them.

But it’s precisely because the stakes are higher for kids that many parents are anxious about getting their children vaccinated. As recently as July, just after the FDA authorized covid vaccines for children as young as 6 months, a KFF poll found that over half of parents of children under age 5 said they thought vaccines posed a greater risk to the health of their child than getting the disease. And in the most recent poll, half said they had no plans to get their children vaccinated. Covid vaccination rates range from 61% among children ages 12 to 17 to 2% among kids younger than 2.

Similar to influenza, covid is most deadly for the very youngest and oldest. At especially high risk are infants. They’re unlikely to have immunity from infection, and a small share have been vaccinated. Unless their mothers were vaccinated during pregnancy or got covid during pregnancy — the latter of which poses a high risk of death for the mother and of preterm birth for the baby — infants are probably not getting protective antibodies against covid through breast milk. And because infants have small airways and weaker coughs, they’re more likely to have trouble breathing with any respiratory infection, even one less deadly than covid.

3. Will I need a covid shot every year?

It depends on the targets set by public health officials whether covid becomes a seasonal virus like the flu, and how much the virus continues to mutate and evade humanity’s immune defenses.

If the goal of vaccination is to prevent severe disease, hospitalization, and death, then many people will be well protected after their primary vaccination series and may not need additional shots. Public health officials might strongly recommend boosters for older and immunocompromised people while leaving the choice of whether to get boosted to those with lower risk. If the goal of vaccination is to prevent infection and transmission, then repeat boosters will be needed after completing the primary vaccination series and as often as a couple of times a year.

Influenza is a seasonal virus causing infections and disease generally in the winter, but scientists don’t know whether covid will settle into a similar, predictable pattern. In the first three years of the pandemic, the United States has experienced waves of infection in summer. But if the covid virus were to become a wintertime virus, public health officials might recommend yearly boosters. The Centers for Disease Control and Prevention recommends that people 6 months and older get a flu shot every year with very rare exceptions. However, as with the flu, public health officials might still place a special emphasis on vaccinating high-risk people against covid.

And the more the virus mutates, the more often public health officials may recommend boosting to overcome a new variant’s immune evasion. Unfortunately, this year’s updated omicron booster doesn’t appear to provide significantly better protection than the original boosters. Scientists are working on variant-proof vaccines that could retain their potency in the face of new variants.

4. Are more covid variants on the way?

The omicron variant has burst into an alphabet soup of subvariants. The BA.5 variant that surfaced earlier this year remains the dominant variant in the U.S., but the BA.4.6 omicron subvariant may be poised to become dominant in the United States. It now accounts for 14% of cases and is rising. The BA.4.6 omicron subvariant is better than BA.5 at dodging people’s immune defenses from both prior infection and vaccination.

In other parts of the world, BA.4.6 has been overtaken by BA.2.75 and BF.7 (a descendant of BA.5), which respectively account for fewer than 2% and 5% of covid cases in the U.S. The BA.2.75.2 omicron subvariant drove a wave of infections in South Asia in July and August. Although the U.S. hasn’t yet seen much in the way of another variant descended from BA.5 — BQ.1.1 — it is rising quickly in other countries like the U.K., Belgium, and Denmark. The BA.2.75.2 and BQ.1.1 variants may be the most immune-evasive omicron subvariants to date.

BA.4.6, BA.2.75.2, and BQ.1.1 all evade Evusheld, the monoclonal antibody used to prevent covid in immunocompromised people who don’t respond as well to vaccination. Although another medication, bebtelovimab, remains active in treating covid from BA.4.6 and BA.2.75.2, it’s ineffective against BQ.1.1. Many scientists are worried that Evusheld will become useless by November or December. This is concerning because the pipeline for new antiviral pills and monoclonal antibodies to treat covid is running dry without a guaranteed purchaser to ensure a market. In the past, the federal government guaranteed it would buy vaccines in bulk, but funding for that program has not been extended by Congress.

Other omicron subvariants on the horizon include BJ.1, BA.2.3.20, BN.1, and XBB, all descendants of BA.2.

It’s hard to predict whether an omicron subvariant or yet another variant will come to dominate this winter and whether hospitalizations and deaths will again surge in the U.S. Vaccination rates and experience with prior infections vary around the world and even within the United States, which means that the different versions of omicron are duking it out on different playing fields.

While this might all sound grim, it’s important to remember that covid booster shots can help overcome immune evasion by the predominant omicron subvariants.

5. What about long covid?

Getting vaccinated does reduce the risk of getting long covid, but it’s unclear by how much. Researchers don’t know if the only way to prevent long covid is to prevent infection.

Although vaccines may curb the risk of infection, few vaccines prevent all or almost all infections. Additional measures — such as improving indoor air quality and donning masks — would be needed to reduce the risk of infection. It’s also not yet known whether prompt treatment with currently available monoclonal antibodies and antiviral drugs like Paxlovid reduces the risk of developing long covid.

6. Do I need a flu shot, too?

The CDC recommends that anyone 6 months of age or older get an annual flu shot. The ideal timing is late October or early November, before the winter holidays and before influenza typically starts spreading in the U.S. Like covid shots, flu shots provide only a couple of months of immunity against infection and transmission, but an early flu shot is better than no flu shot. Influenza is already circulating in some parts of the United States.

It’s especially important for people 65 or older, pregnant women, people with chronic medical conditions, and children under 5 to get their yearly flu shots because they’re at highest risk of hospitalization and death. Although younger people might be at lower risk for severe flu, they can act as vectors for transmission of influenza to higher-risk people in the community.

High-dose flu vaccines and “adjuvanted” flu vaccines are recommended for people 65 and older. Adjuvants strengthen the immune response to a vaccine. It is safe to get vaccinated for covid and the flu at the same time, but you might experience more side effects like fevers, headache, or body aches.

Kaiser Health News is a national newsroom that produces in-depth journalism about health issues.

Covid’s New Wave: Get Another Booster Shot or Wait?

By Sam Whitehead and Arthur Allen, Kaiser Health News

Gwyneth Paige didn’t want to get vaccinated against covid-19 at first. With her health issues — hypertension, fibromyalgia, asthma — she wanted to see how other people fared after the shots. Then her mother got colon cancer.

“At that point, I didn’t care if the vaccine killed me,” she said. “To be with my mother throughout her journey, I had to have the vaccination.”

Paige, who is 56 and lives in Detroit, has received three doses. That leaves her one booster short of federal health recommendations.

Like Paige, who said she doesn’t currently plan to get another booster, some Americans seem comfortable with the protection of three shots. But others may wonder what to do: Boost again now with one of the original vaccines, or wait months for promised new formulations tailored to the latest, highly contagious omicron subvariants, BA.4 and BA.5?

The rapidly mutating virus has created a conundrum for the public and a communications challenge for health officials.

“What we’re seeing now is a little bit of an information void that is not helping people make the right decision,” said Dr. Carlos del Rio, a professor of infectious diseases at the Emory University School of Medicine.

Del Rio said the public isn’t hearing enough about the vaccines’ value in preventing severe disease, even if they don’t stop all infections. Each new covid variant also forces health officials to tweak their messaging, del Rio said, which can add to public mistrust.

About 70% of Americans age 50 and older who got a first booster shot — and nearly as many of those 65 and older — haven’t received their second covid booster dose, according to data from the Centers for Disease Control and Prevention. The agency currently recommends two booster shots after a primary vaccine series for adults 50 and older and for younger people with compromised immune systems. Last week, multiple news outlets reported that the Biden administration was working on a plan to allow all adults to get second covid boosters.

Officials are worried about the surge of BA.4 and BA.5, which spread easily and can escape immune protection from vaccination or prior infection. A recent study published in Nature found BA.5 was four times as resistant to the currently available mRNA vaccines as earlier omicron subvariants.

Mixed Messages

Consistent messaging has been complicated by the different views of leading vaccine scientists. Although physicians like del Rio and Dr. Peter Hotez of Baylor College of Medicine see the value in getting a second booster, Dr. Paul Offit, a member of the FDA’s vaccine advisory committee, is skeptical it’s needed by anyone but seniors and people who are immunocompromised.

“When experts have different views based on the same science, why are we surprised that getting the message right is confusing?” said Dr. Bruce Gellin, chief of global public health strategy at the Rockefeller Foundation and Offit’s colleague on the FDA panel.

Janet Perrin, 70, of Houston hasn’t gotten her second booster for scheduling and convenience reasons and said she’ll look for information about a variant-targeted dose from sources she trusts on social media. “I haven’t found a consistent guiding voice from the CDC,” she said, and the agency’s statements sound like “a political word salad.”

On July 12, the Biden administration released its plan to manage the BA.5 subvariant, which it warned would have the greatest impact in the parts of the country with lower vaccine coverage. The strategy includes making it easier for people to access testing, vaccines and boosters, and covid antiviral treatments.

During the first White House covid briefing in nearly three weeks, the message from top federal health officials was clear: Don’t wait for an omicron-tailored shot. “There are many people who are at high risk right now, and waiting until October, November for their boost — when in fact their risk is in the moment — is not a good plan,” said Dr. Rochelle Walensky, head of the CDC.

With worries about the BA.5 subvariant growing, the FDA on June 30 recommended that drugmakers Pfizer-BioNTech and Moderna get to work producing a new, bivalent vaccine that combines the current version with a formulation that targets the new strains.

The companies both say they can make available for the U.S. millions of doses of the reformulated shots in October. Experts think that deadline could slip by a few months given the unexpected hitches that plague vaccine manufacturing.

“I think that we have all been asking that same question,” said Dr. Kathryn Edwards, scientific director of the Vanderbilt Vaccine Research Program. “What’s the benefit of getting another booster now when what will be coming out in the fall is a bivalent vaccine and you will be getting BA.4/5, which is currently circulating?”

“There are many people who are at high risk right now, and waiting until October, November for their boost — when in fact their risk is in the moment — is not a good plan. ”

— Dr. Rochelle Walensky, CDC.Director

The FDA on July 13 authorized a fourth covid vaccine, made by Novavax, but only for people who haven’t been vaccinated yet. Many scientists thought the Novavax shot could be an effective booster for people previously vaccinated with mRNA shots from Pfizer-BioNTech and Moderna because its unique design could broaden the immune response to coronaviruses. Unfortunately, few studies have assessed mix-and-match vaccination approaches, said Gellin, of the Rockefeller Foundation.

Edwards and her husband got covid in January. She received a second booster last month, but only because she thought it might be required for a Canadian business trip. Otherwise, she said, she felt a fourth shot was kind of a waste, though not particularly risky. She told her husband — a healthy septuagenarian — to wait for the BA.4/5 version.

People at very high risk for covid complications might want to go ahead and get a fourth dose, Edwards said, with the hope that it will temporarily prevent severe disease “while you wait for BA.4/5.”

The omicron vaccines will contain components that target the original strain of the virus because the first vaccine formulations are known to prevent serious illness and death even in people infected with omicron.

Those components will also help keep the earlier strains of the virus in check, said Dr. David Brett-Major, an infectious disease specialist at the University of Nebraska Medical Center. That’s important, he said, because too much tailoring of vaccines to fight emerging variants could allow older strains of the coronavirus to resurface.

Brett-Major said messages about the value of the tailored shots will need to come from trusted, local sources — not just top federal health officials.

“Access happens locally,” he said. “If your local systems are not messaging and promoting and enabling access, it’s really problematic.”

Although some Americans are pondering when, or whether, to get their second boosters, many people tuned out the pandemic long ago, putting them at risk during the current wave, experts said.

Dr. Georges Benjamin, executive director of the American Public Health Association, said he doesn’t expect to see the public’s level of interest in the vaccine change much even as new boosters are released and eligibility expands. Parts of the country with high vaccine coverage will remain relatively insulated from new variants that emerge, he said, while regions with low vaccine acceptance could be set for a “rude awakening.”

Even scientists are at a bit of a loss for how to effectively adapt to an ever-changing virus.

“Nothing is simple with covid, is it? It’s just whack-a-mole,” said Edwards. “This morning I read about a new variant in India. Maybe it’ll be a nothingburger, but — who knows? — maybe something big, and then we’ll wonder, ‘Why did we change the vaccine strain to BA.4/5?’”

Kaiser Health News is a national newsroom that produces in-depth journalism about health issues.

If Covid Vaccines Are So Effective, Why Do I Need a Booster Shot?

By Julie Appleby, Kaiser Health News

The politicization of covid vaccines — and just about everything else having to do with the pandemic — has led to confusion, if not utter fatigue.

And some posts circulating on social media — like this slickly edited piece on YouTube — seem to build on these feelings, attempting to cast doubt on the effectiveness of the vaccines.

The video intersperses comments from White House medical adviser Dr. Anthony Fauci extolling their protectiveness with screenshots of news headlines, starting with those citing 100% effectiveness, then moving through others reporting sharply lower percentages. Set to the rapidly increasing tempo of the orchestral piece “In the Hall of the Mountain King,” the video ends with headlines about drug company profits.

But slowing the video to parse the headlines reveals more complexity. Some are reporting on studies that looked only at infection rates; others, more serious outcomes, including hospitalization and death. Some are about vaccines not offered in the U.S. In short, the video fosters misperceptions by mixing together dissimilar data points and leaving out key details.

Still, one can’t help but wonder what’s really going on with effectiveness — and is any of it a surprise?

If you don’t read any further, know this: No vaccine is 100% effective against any disease. The covid shots are no exception. Effectiveness in preventing infection — defined as a positive test result — appears in some studies to wane sharply the more time that goes by after completing the one- or two-shot regimen.

But on key measures — prevention of serious illness, hospitalization and death — real-world studies from the U.S. and abroad generally show protection weakening slightly, particularly in older or sicker people, but remaining strong overall, even with the rise of the more infectious delta variant of the covid virus.

The bottom line? Getting vaccinated with any of the three vaccines available in the U.S. reduces the chance of getting infected in the first place, and significantly cuts the risk of hospitalization or death if you do contract covid-19. The Centers for Disease Control and Prevention recently published a study showing fully vaccinated people were more than 10 times less likely to die or be hospitalized than the unvaccinated.

“When it comes to what matters, vaccines hold up really well,” said Dr. Amesh Adalja, an infectious-disease physician and senior scholar at the Johns Hopkins Center for Health Security. “They were designed to tame the virus.”

What do “efficacy” and “effectiveness” really mean?

Before a drug or vaccine is greenlighted by federal regulators, it is tested on volunteers randomly assigned to get either the product or a placebo. Then researchers compare how the groups fare. In the case of a vaccine, they look at how well it prevents infection, and whether it protects against serious illness, hospitalization or death. Those clinical trial results are often referred to as efficacy measures.

In the real world, however, a drug or vaccine’s performance is affected by numerous factors, including a much larger population receiving it, some of whom have underlying conditions or socioeconomic circumstances different from those in the clinical trial. That real-world performance measure is called effectiveness.

When authorized for emergency use following clinical trials, both the Pfizer-BioNTech and Moderna two-dose vaccines reported efficacy against symptomatic illness in the mid-90% range. The Johnson & Johnson single-dose shot — which was tested later, when there were more variants — reported overall efficacy in the high 60% range.

So, all three vaccines exceeded the 50% threshold health officials sought as a minimum for efficacy. Keep in mind, also, that the annual influenza vaccine’s real-world effectiveness is often 40% to 50%.

Another point: 95% effectiveness doesn’t mean 95% of vaccinated people will never get infected. What it means is that a fully vaccinated person exposed to the virus faces only 5% of the risk of infection compared with an unvaccinated person.

Have the effectiveness numbers changed?

Yes, decline in effectiveness against infection is seen in some studies. A few have also raised concerns that protection against serious illness may also be diminished, particularly in older people and patients with underlying medical conditions.

Reasons for the decline vary. First, when the vaccines were authorized, much of the U.S. was under tighter pandemic-related stay-at-home rules. Nearly a year later, restrictions — including mask rules — have loosened in many areas. More people are traveling and going into situations they would have avoided a year ago. So, exposure to the virus is higher.

Some studies from the U.S. and abroad show that time elapsed since vaccination also plays a role. The Lancet recently published a study of more than 3.4 million Kaiser Permanente members, both vaccinated and not, reviewing the effectiveness of the Pfizer vaccine. It showed an overall average 73% effectiveness against infection during the six months after inoculations, and an overall 90% effectiveness against hospitalization.

But protection against infection declined from 88% in the month after full vaccination to 47% at five to six months. Time since vaccination played a larger role than any changes in the virus itself, the researchers concluded.

“It shows vaccines are highly effective over time against severe outcomes,” said lead author Sara Tartof, an epidemiologist with the Department of Research and Evaluation for Kaiser Permanente Southern California. “Against infection, it does decline over time, something that is not unexpected. We have boosters for many other vaccines.”

The virus, too, has mutated.

“Along came delta,” said Dr. William Schaffner, a professor of preventive medicine at Vanderbilt University School of Medicine. “Because this virus was so highly contagious, it changed the outcomes slightly.”

And some vaccinated people can fall seriously ill with covid, or even die, especially if they have an underlying medical problem, as was the case with Gen. Colin Powell. He died of covid complications even though he was fully vaccinated — likely because he also had a blood cancer called multiple myeloma, which can lower the body’s response to an invading virus as well as to vaccination.

Why are they recommending booster shots?

Most scientists, researchers and physicians say the vaccines are working remarkably well, especially at preventing serious illness or death. But it’s not unusual to need more than one dose.

Vaccines for shingles and measles both require two shots, while people need to be revaccinated against tetanus every 10 years. Because influenza varies each year, flu shots are annual.

Immune response is often better when vaccines are spaced apart by a few months. But during the rollout of the covid vaccines, so many people were falling ill and dying of covid each day that the Food and Drug Administration and CDC decided not to delay, but to authorize the first and second doses within about a month of each other.

“We learn as we go along,” said Schaffner. “It was always anticipated there might have to be follow-up doses.”

Now, the recommendations call for a second dose for anyone who received a J&J shot at least two months prior. For those who received the two-dose Pfizer or Moderna vaccine, the recommendation is to wait six months after the second dose to get a booster, which is currently recommended for those who are 65 and older; have any of a variety of underlying health conditions; live in congregate settings, such as nursing homes; or have jobs that put them at higher risk. The booster recommendations may expand in the coming months.

Kaiser Health News is a national newsroom that produces in-depth journalism about health issues.

Experts Debate Need for Covid Booster Shots

By Rachana Pradhan, Kaiser Health News

The Biden administration’s plans to make covid-19 booster shots available next month has drawn a collective scream of protest from the scientific community.

As some scientists see it, the announcement is rash and based on weak evidence, and they worry it could undercut confidence in vaccines with no clear benefit of controlling the pandemic. Meanwhile, more information is needed on potential side effects or adverse effects from a booster shot, they say.

Perhaps even worse, the announcement has fueled deeper confusion about what Americans need to do to protect themselves from covid.

“I think we’ve scared people,” said Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia and an adviser to the National Institutes of Health and the Food and Drug Administration.

“We sent a terrible message,” he said. “We just sent a message out there that people who consider themselves fully vaccinated were not fully vaccinated. And that’s the wrong message, because you are protected against serious illness.”

As of Thursday, 51% of the U.S. population was fully vaccinated, Centers for Disease Control and Prevention data shows. Biden administration officials ― citing data from Israel, a study from the Mayo Clinic that is not yet peer-reviewed and new CDC studies ― say it’s necessary to plan for boosters to prevent a worsening of the pandemic as the delta variant powers a surge in cases and overwhelms hospital intensive care units.

In essence, officials are caught between a rock and a hard place ― trying to be prepared while simultaneously not undermining messaging about how well the existing vaccines work.

Virus Unpredictable

Officials must weigh two unknowns: the risks of moving ahead aggressively with booster shots versus the risks of waiting to learn much more about the virus and the power of the vaccines. The government’s normal path to regulatory approval is, by design, slow and deliberate. The virus has its own schedule, fast and unpredictable.

“Arguably, I think that the federal government is simply trying to stay ahead of the curve,” said Dr. Joshua Barocas, associate professor of medicine at the University of Colorado. But, he said, “I have not seen robust data yet to suggest that it is better to boost Americans who have gotten two vaccines than invest resources and time in getting unvaccinated people across the world vaccinated.”

Beginning in late September, boosters would be made available to adults (age 18 and up) eight months after they received the second dose of a Pfizer-BioNTech or Moderna covid vaccine, President Joe Biden said. But his plan comes with big caveats: It does not yet have the blessing of a CDC advisory panel, and the FDA has not authorized boosters for all adults.

The urgent question is whether the vaccines are losing their power against covid.

“We are concerned that this pattern of decline we are seeing will continue in the months ahead, which could lead to reduced protection against severe disease, hospitalization and death,” Surgeon General Vivek Murthy said.

But many scientists and public health experts say the data doesn’t demonstrate a clear benefit to the public in making booster shots widely available, and the Biden administration’s message confuses people about what the covid vaccines were designed to do.

“They’re not a force field. They don’t repel the virus from your body. They train your immune system to respond when you become infected … with the goal of keeping you out of the hospital,” said Jennifer Nuzzo, an epidemiologist and associate professor at the Johns Hopkins Bloomberg School of Public Health.

Meanwhile, questions abound. Will boosters for fully vaccinated adults make the virus less transmissible ― that is, slower or less likely to spread to others?

“I certainly hope that’s the case … but the bottom line, with full transparency, we don’t know that right now,” Dr. Anthony Fauci, Biden’s chief medical adviser, said Wednesday.

What about side effects? “It would be nice to understand what side effects people have after their third dose,” Nuzzo said.

“We don’t have any reason to believe, based on the safety profile of the vaccine itself, that we’re going to see significant adverse events with booster shots,” Barocas said. However, those things are “just now being studied.”

The concerns are real. While serious side effects from covid vaccines have been rare, some have caused alarm ― including mRNA vaccines being linked to cases of myocarditis, or inflammation of the heart.

“At the individual level, we need to know the side effect profile of a 3rd dose, especially in younger people. Until now, the benefits of vaccination have far outweighed the potential side effects,” Dr. Jeremy Faust, an emergency medicine physician at Brigham and Women’s Hospital in Boston, wrote in a blog post outlining why he was skeptical about a plan to give boosters to everyone.

Vaccines Still Effective

Even in light of the new CDC studies published Wednesday, experts say one thing is clear: The vaccines still work very well at what they were meant to do, which is to protect people against the worst outcomes of getting infected with the virus.

One study, relying on data from 21 hospitals in 18 states, found no significant change in the vaccines’ effectiveness against hospitalization between March and July, which coincides with delta becoming the prevalent covid strain. Another, using data from New York, also found the vaccines highly effective in preventing hospitalization, even as there was a decline in effectiveness against new infections. The third, evaluating the Pfizer and Moderna vaccines in nursing home residents, saw a drop in how effective they were at preventing infection ― but the research didn’t distinguish between symptomatic and asymptomatic cases.

“It’s like we’re engaged in friendly fire against these vaccines,” Nuzzo said. “What are we trying to do here? Are we just trying to reduce overall transmission? Because there’s no evidence that this is going to do it.”

Fauci, in outlining the case for boosters, highlighted data showing that antibody levels decline over time and higher levels of antibodies are associated with higher vaccine efficacy. But antibodies are only one component of the body’s defense mechanisms against a covid infection.

When the antibodies decrease, the body compensates with a cellular immune response. “A person who has lost antibodies isn’t necessarily completely susceptible to infection, because that person has T-cell immunity that we can’t measure easily,” said Dr. Cody Meissner, a specialist in pediatric infectious diseases who sits on the FDA’s vaccine advisory panel.

John Wherry, director of the Penn Institute of Immunology at the University of Pennsylvania, recently published a study finding that the mRNA vaccines provoked a strong response by the immune system’s T cells, which researchers said could be a more durable source of protection. Wherry is working on a second study based on six months of data.

“We’re seeing very good durability for at least some components of the non-antibody responses generated by the vaccines,” he said.

For protection against serious disease, “really all you need is immunological memory, and these vaccines induce immunological memory and immunological memory tends to be longer-lived,” Offit said. Federal scientists also are studying T-cell response, Fauci said.

FDA Approval Needed

Pfizer and Moderna have said they think boosters for covid will be necessary. But it’s up to the government to authorize them. Federal officials say they are sifting through new data from the companies and elsewhere as it becomes available.

There’s not a deep playbook for this: Emergency use authorization, or EUA, of vaccines has been sparingly used. The FDA has already amended Pfizer’s prior EUA clearance twice, first in May to expand the vaccines to adolescents 12 to 15 years old and, again, this month to allow immunocompromised people to obtain a third dose. The FDA did not respond to questions about the process for authorizing widespread booster shots.

Pfizer announced in July that it expects $33.5 billion in covid vaccine revenue this year. Its stock has risen 33% this year, closing at $48.80 Thursday. Moderna reported sales of $5.9 billion through June 30 for 302 million doses of its vaccine. The company’s stock has skyrocketed 236% year-to-date, closing at $375.53 Thursday.

In applying for emergency authorization, the FDA requires vaccine manufacturers to submit clinical efficacy data and all safety data from phase 1 and phase 2 clinical trials as well as two months of safety data from phase 3 studies. For full approval, the FDA requires manufacturers to submit six months of data.

Pfizer this week announced it has submitted phase 1 clinical trial data to the FDA as part of an evaluation for future approval of a third dose. The company said phase 3 results are “expected shortly.”

Pfizer said its preliminary trial results showed a third dose was safe and increased antibody levels against the original virus and the delta variant. Moderna found a third dose had safety results similar to a second dose and produced a strong antibody response. 

Typically, any distribution of shots would occur after the CDC’s Advisory Committee on Immunization Practices also developed recommendations. But with the Biden administration’s announcement about boosters, public health experts worry the message suggests the outcome is preordained.

“They have completely and unfairly jammed FDA and ACIP. They’ve left them no choice. If there’s no booster program, FDA gets blamed and that’s not appropriate,” said Dr. Nicole Lurie, a former senior Health and Human Services official in the Obama administration and U.S. director of the Coalition for Epidemic Preparedness Innovations, the global epidemic vaccines partnership.

Kaiser Health News is a national health policy news service. It is an editorially independent program of the Kaiser Family Foundation, which is not affiliated with Kaiser Permanente.