Health Misinformation Rampant on Social Media

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By Dr. Monica Wang, Boston University

The global anti-vaccine movement and vaccine hesitancy that accelerated during the COVID-19 pandemic show no signs of abating.

According to a survey of U.S. adults, Americans in October 2023 were less likely to view approved vaccines as safe than they were in April 2021. As vaccine confidence falls, health misinformation continues to spread like wildfire on social media and in real life.

I am a public health expert in health misinformation, science communication and health behavior change.

In my view, we cannot underestimate the dangers of health misinformation and the need to understand why it spreads and what we can do about it. Health misinformation is defined as any health-related claim that is false based on current scientific consensus.

False Claims About Vaccines

Vaccines are the No. 1 topic of misleading health claims. Some common myths about vaccines include:

High Cost of Misinformation

Beliefs in such myths have come at the highest cost.

An estimated 319,000 COVID-19 deaths that occurred between January 2021 and April 2022 in the U.S. could have been prevented if those individuals had been vaccinated, according to a data dashboard from the Brown University School of Public Health. Misinformation and disinformation about COVID-19 vaccines alone have cost the U.S. economy an estimated US$50 million to $300 million per day in direct costs from hospitalizations, long-term illness, lives lost and economic losses from missed work.

Though vaccine myths and misunderstandings tend to dominate conversations about health, there is an abundance of misinformation on social media surrounding diets and eating disorders, smoking or substance use, chronic diseases and medical treatments.

My team’s research and that of others show that social media platforms have become go-to sources for health information, especially among adolescents and young adults. However, many people are not equipped to maneuver the maze of health misinformation.

For example, an analysis of Instagram and TikTok posts from 2022 to 2023 by The Washington Post and the nonprofit news site The Examination found that the food, beverage and dietary supplement industries paid dozens of registered dietitian influencers to post content promoting diet soda, sugar and supplements, reaching millions of viewers. The dietitians’ relationships with the food industry were not always made clear to viewers.

Studies show that health misinformation spread on social media results in fewer people getting vaccinated and can also increase the risk of other health dangers such as disordered eating and unsafe sex practices and sexually transmitted infections. Health misinformation has even bled over into animal health, with a 2023 study finding that 53% of dog owners surveyed in a nationally representative sample report being skeptical of pet vaccines.

Declining Trust

One major reason behind the spread of health misinformation is declining trust in science and government. Rising political polarization, coupled with historical medical mistrust among communities that have experienced and continue to experience unequal health care treatment, exacerbates preexisting divides.

The lack of trust is both fueled and reinforced by the way misinformation can spread today. Social media platforms allow people to form information silos with ease; you can curate your networks and your feed by unfollowing or muting contradictory views from your own and liking and sharing content that aligns with your existing beliefs and value systems.

By tailoring content based on past interactions, social media algorithms can unintentionally limit your exposure to diverse perspectives and generate a fragmented and incomplete understanding of information. Even more concerning, a study of misinformation spread on Twitter analyzing data from 2006 to 2017 found that falsehoods were 70% more likely to be shared than the truth and spread “further, faster, deeper and more broadly than the truth” across all categories of information.

The average kindergarten student sees about 70 media messages every day. By the time they’re in high school, teens spend more than a third of their day using media.

How to Identify Misinformation

The lack of robust and standardized regulation of misinformation content on social media places the difficult task of discerning what is true or false information on individual users. We scientists and research entities can also do better in communicating our science and rebuilding trust, as my colleague and I have previously written. I also provide peer-reviewed recommendations for the important roles that parents/caregivers, policymakers and social media companies can play.

Below are some steps that consumers can take to identify and prevent health misinformation spread:

  • Check the source. Determine the credibility of the health information by checking if the source is a reputable organization or agency such as the World Health Organization, the National Institutes of Health or the Centers for Disease Control and Prevention. Other credible sources include an established medical or scientific institution or a peer-reviewed study in an academic journal. Be cautious of information that comes from unknown or biased sources.

  • Examine author credentials. Look for qualifications, expertise and relevant professional affiliations for the author or authors presenting the information. Be wary if author information is missing or difficult to verify.

  • Pay attention to the date. Scientific knowledge by design is meant to evolve as new evidence emerges. Outdated information may not be the most accurate. Look for recent data and updates that contextualize findings within the broader field.

  • Cross-reference to determine scientific consensus. Cross-reference information across multiple reliable sources. Strong consensus across experts and multiple scientific studies supports the validity of health information. If a health claim on social media contradicts widely accepted scientific consensus and stems from unknown or unreputable sources, it is likely unreliable.

  • Question sensational claims. Misleading health information often uses sensational language designed to provoke strong emotions to grab attention. Phrases like “miracle cure,” “secret remedy” or “guaranteed results” may signal exaggeration. Be alert for potential conflicts of interest and sponsored content.

  • Weigh scientific evidence over individual anecdotes. Prioritize information grounded in scientific studies that have undergone rigorous research methods, such as randomized controlled trials, peer review and validation. When done well with representative samples, the scientific process provides a reliable foundation for health recommendations compared to individual anecdotes. Though personal stories can be compelling, they should not be the sole basis for health decisions.

  • Talk with a health care professional. If health information is confusing or contradictory, seek guidance from trusted health care providers who can offer personalized advice based on their expertise and individual health needs.

  • When in doubt, don’t share. Sharing health claims without validity or verification contributes to misinformation spread and preventable harm.

All of us can play a part in responsibly consuming and sharing information so that the spread of the truth outpaces the false.

Monica Wang, ScD, is an Associate Professor of Community Health Sciences at the Boston University School of Public Health and an Adjunct Associate Professor of Health Policy and Management at the Harvard T.H. Chan School of Public Health. She receives funding from the National Institutes of Health.

This article originally appeared in The Conversation and is republished with permission.

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

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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.

Do Infections or Vaccines Provide Better Covid Immunity?

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By Arthur Allen, Kaiser Health News

Dr. Aaron Kheriaty, a University of California-Irvine psychiatry professor, felt he didn’t need to be vaccinated against covid because he’d fallen ill with the disease in July 2020.

So, in August, he sued to stop the university system’s vaccination mandate, saying “natural” immunity had given him and millions of others better protection than any vaccine could.

A judge on Sept. 28 dismissed Kheriaty’s request for an injunction against the university over its mandate, which took effect Sept. 3. While Kheriaty intends to pursue the case further, legal experts doubt that his and similar lawsuits filed around the country will ultimately succeed.

That said, evidence is growing that contracting SARS-CoV-2, the virus that causes covid-19, is generally as effective as vaccination at stimulating your immune system to prevent the disease. Yet federal officials have been reluctant to recognize any equivalency, citing the wide variation in covid patients’ immune response to infection.

Like many disputes during the covid pandemic, the uncertain value of a prior infection has prompted legal challenges, marketing offers and political grandstanding, even as scientists quietly work in the background to sort out the facts.

For decades, doctors have used blood tests to determine whether people are protected against infectious diseases. Pregnant mothers are tested for antibodies to rubella to help ensure their fetuses won’t be infected with the rubella virus, which causes devastating birth defects. Hospital workers are screened for measles and chickenpox antibodies to prevent the spread of those diseases. But immunity to covid seems trickier to discern than those diseases.

The Food and Drug Administration has authorized the use of covid antibody tests, which can cost about $70, to detect a past infection. Some tests can distinguish whether the antibodies came from an infection or a vaccine. But neither the FDA nor the Centers for Disease Control and Prevention recommend using the tests to assess whether you’re, in fact, immune to covid. For that, the tests are essentially useless because there’s no agreement on the amount or types of antibodies that would signal protection from the disease.

“We don’t yet have full understanding of what the presence of antibodies tells us about immunity,” said Kelly Wroblewski, director of infectious diseases at the Association of Public Health Laboratories.

‘Natural Immunity’

By the same token, experts disagree on how much protection an infection delivers.

In the absence of certainty and as vaccination mandates are levied across the country, lawsuits seek to press the issue. Individuals who claim that vaccination mandates violate their civil liberties argue that infection-acquired immunity protects them. In Los Angeles, six police officers have sued the city, claiming they have natural immunity.

In August, law professor Todd Zywicki alleged that George Mason University’s vaccine mandate violated his constitutional rights given he has natural immunity. He cited a number of antibody tests and an immunologist’s medical opinion that it was “medically unnecessary” for him to be vaccinated. Zywicki dropped the lawsuit after the university granted him a medical exemption, which it claims was unrelated to the suit.

Republican legislators have joined the crusade. The GOP Doctors Caucus, which consists of Republican physicians in Congress, has urged people leery of vaccination to instead seek an antibody test, contradicting CDC and FDA recommendations. In Kentucky, the state Senate passed a resolution granting equal immunity status to those who show proof of vaccination or a positive antibody test.

Hospitals were among the first institutions to impose vaccine mandates on their front-line workers because of the danger of them spreading the disease to vulnerable patients. Few have offered exemptions from vaccination to those previously infected. But there are exceptions.

Two Pennsylvania hospital systems allow clinical staff members to defer vaccination for a year after testing positive for covid. Another, in Michigan, allows employees to opt out of vaccination if they present evidence of previous infection and a positive antibody test in the previous three months. In these cases, the systems indicated they were keen to avoid staffing shortages that could result from the departure of vaccine-shunning nurses.

For Kheriaty, the question is simple. “The research on natural immunity is quite definitive now,” he told KHN. “It’s better than immunity conferred by vaccines.” But such categorical statements are clearly not shared by most in the scientific community.

Dr. Arthur Reingold, an epidemiologist at UC-Berkeley, and Shane Crotty, a virologist at the respected La Jolla Institute for Immunology in San Diego, gave expert witness testimony in Kheriaty’s lawsuit, saying the extent of immunity from reinfection, especially against newer variants of covid, is unknown. They noted that vaccination gives a huge immunity boost to people who’ve been ill previously.

Yet not all of those pushing for recognition of past infection are vaccine critics or torchbearers of the anti-vaccine movement.

Dr. Jeffrey Klausner, clinical professor of population and public health sciences at the University of Southern California, co-authored an analysis published last week that showed infection generally protects for 10 months or more. “From the public health perspective, denying jobs and access and travel to people who have recovered from infection doesn’t make sense,” he said.

In his testimony against Kheriaty’s case for “natural” immunity to covid, Crotty cited studies of the massive covid outbreak that swept through Manaus, Brazil, early this year that involved the gamma variant of the virus. One of the studies estimated, based on tests of blood donations, that three-quarters of the city’s population had already been infected before gamma’s arrival. That suggested that previous infection might not protect against new variants. But Klausner and others suspect the rate of prior infection presented in the study was a gross overestimate.

A large August study from Israel, which showed better protection from infection than from vaccination, may help turn the tide toward acceptance of prior infection, Klausner said. “Everyone is just waiting for Fauci to say, ‘Prior infection provides protection,’” he said.

When Dr. Anthony Fauci, the top federal expert on infectious diseases, was asked during a CNN interview last month whether infected people were as well protected as those who’ve been vaccinated, he hedged. “There could be an argument” that they are, he said. Fauci did not immediately respond to a KHN request for further comment.

CDC spokesperson Kristen Nordlund said in an email that “current evidence” shows wide variation in antibody responses after covid infection. “We hope to have some additional information on the protectiveness of vaccine immunity compared to natural immunity in the coming weeks.”

A “monumental effort” is underway to determine what level of antibodies is protective, said Dr. Robert Seder, chief of the cellular immunology section at the National Institute of Allergy and Infectious Diseases. Recent studies have taken a stab at a number.

Antibody tests will never provide a yes-or-no answer on covid protection, said Dr. George Siber, a vaccine industry consultant and co-author of one of the papers. “But there are people who are not going to be immunized. Trying to predict who is at low risk is a worthy undertaking.”

This story was produced by Kaiser Health News, which publishes California Healthline, an editorially independent service of the California Health Care Foundation.

Experts Debate Need for Covid Booster Shots

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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.

More Data Needed on Covid Vaccine Safety for High-Risk People

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By Roger Chriss, PNN Columnist

The Covid-19 vaccine rollout in the U.S. hasn’t been so smooth or fast. Fortunately, however, the vaccines are proving to be generally very safe. But there have been some serious allergic reactions associated with the vaccines. And in a few tragic cases, there have been deaths.

As a result, it is worth looking closely at what is now known about vaccine safety, in particular for high-risk people such as the elderly and those with compromised immune systems.

On January 3, Florida physician Gregory Michael died 18 days after receiving the first dose of Pfizer's vaccine. He was an otherwise healthy adult who developed acute thrombocytopenia, a severe shortage of platelets, soon after being vaccinated. Michael ultimately died of a brain hemorrhage after a two-week effort to raise his platelet count.

This is the only known case of a platelet crisis after vaccination, but it’s not yet clear if the two are connected. Work to understand what happened is ongoing.

“I don’t know what this is. We’ll keep our eyes open and see if it happens to anybody else,” vaccine expert Paul Offit, MD, told The New York Times.

The Platelet Disorder Support Association released a statement calling Michael’s death “tragic and concerning,” but said patients with immune thrombocytopenic purpura (ITP) “should not be hesitant to be vaccinated.”

“The relationship between the occurrence of severe thrombocytopenia and the vaccination, if any, is uncertain. To our knowledge, this is the first such event reported after over 5 million such vaccinations. Based on the available data, the benefit to risk ratio strongly favors vaccination of all adults, including those with ITP,” the statement said.

There have been a few other deaths worldwide. The Jerusalem Post reported in December on the death of an 88-year-old man who died just hours after being vaccinated, and a 75-year-old who died of a heart attack shortly after getting a shot. Both cases are seen as coincidental and no further deaths have been reported as Israel continues to vaccinate its population.

Norway, however, has seen 29 elderly people die after being vaccinated, all of them over the age of 75. The deaths prompted Norway to suggest that Covid-19 vaccines may be too risky for the very old and terminally ill.

“For those with the most severe frailty, even relatively mild vaccine side effects can have serious consequences. For those who have a very short remaining life span anyway, the benefit of the vaccine may be marginal or irrelevant,” the Norwegian Institute of Public Health said in a statement.

Information about vaccine safety for higher-risk populations is not easy to get at present. For instance, there is as yet no clinical data on what vaccine risks may exist for women who are pregnant or lactating. Without that data, STAT News says “it’s impossible for any organization or expert to say with absolute certainty that there are no risks.”

As of today, over 60 million doses of vaccine have been given worldwide and nearly 20 million in the U.S. Based on the small number of severe adverse events seen so far, this means that the vaccines are extremely safe for the vast majority of people.

Norway and Israel are reporting side effects and outcomes faster than most other nations. Consequently, the recent deaths may be nothing more than an artifact of good public health statistics offering a complete picture of all risks.

But precautions for people who are elderly, frail or otherwise high risk may turn out to be justified. As more data from vaccination efforts worldwide comes in, the risks will be better understood.

Roger Chriss suffers from Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society. Roger is a technical consultant in Washington state, where he specializes in mathematics and research.

COVID Vaccines Appear Safe and Effective, But Key Questions Remain

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By Bernard J. Wolfson, Kaiser Heralth News

The recent rollout of two newly authorized COVID-19 vaccines is a bright ray of hope at the pandemic’s darkest hour.

We now have a path that can lead us to happier times — even as we watch and suffer from the horrible onslaught of new infections, hospitalizations and deaths that mark the end of this regrettable year.

Health care workers and nursing home residents have already begun to get shots in the first phase of the rollout. Vaccinations should start to be available to the general public sometime in the first few months of next year.

The two vaccines — one developed by Pfizer and BioNTech, the other by Moderna — use the same novel genetic approach. Their development in under a year, shattering all records, is a marvel of science. It’s also a cause for concern for millions of Americans who fear the uncertainty of an unknown technology.

The clinical trial data for the Pfizer and Moderna vaccines show that when both shots of the dual-injection immunization are taken, three weeks to a month apart, they are about 95% effective — at least at preventing severe COVID illness.

However, “a vaccine that remains in the vial is 0% effective no matter what the data show,” says Dr. Walter Orenstein, a professor of infectious diseases at the Emory University School of Medicine in Atlanta and associate director of the Emory Vaccine Center.

Hence, the imperative of persuading millions of people, across racial, cultural, religious, political and generational lines, to get immunized when a vaccine becomes available to them. A survey published this month showed 45% of respondents are taking a wait-and-see approach to vaccination.

Because the vaccines were developed under duress as the coronavirus exacted its deadly toll, the premium was on speed — “warp speed.” So although the number of people in the COVID-19 trials is as large as or larger than in previous vaccine trials, some key questions won’t be answered until millions more are vaccinated.

For example, we don’t know to what extent the vaccines will keep us from transmitting or contracting the virus. We don’t know whether irreversible side effects might emerge, or who is at higher risk from them. And we don’t know whether we’ll need to get vaccinated every year, every three years, or never again.

Skepticism about the vaccines reside in many quarters, including among African Americans, many of whom have a long-standing mistrust of the medical world; the vocal “anti-vaxxers”; and people of all stripes with perfectly understandable doubts. Not to mention communities with language barriers and immigrants without documents, who may fear coming forward.

Here are answers to some questions you might be asking yourself about the new vaccines:

Q: How can I be sure they’re safe?

There’s no ironclad guarantee. But the federal Food and Drug Administration, in authorizing the Moderna and Pfizer vaccines, determined that their benefits outweighed their risks.

The side effects observed in trial participants were common to other vaccines: pain at the injection site, fatigue, headache, muscle pain and chills.

“Those are minor side effects, and the benefit is not dying from this disease,” says Dr. George Rutherford, a professor of epidemiology at the University of California-San Francisco.

Saturday, the Centers for Disease Control and Prevention reported six cases of anaphylactic allergic reaction in the first 272,000 people who got the Pfizer vaccine outside the clinical trials. This has led the CDC to recommend that people receiving the vaccine be observed for up to 30 minutes afterward. It’s possible other unexpected adverse effects could pop up down the road.

“The chances are low, but they are not zero,” says Orenstein. There’s not enough data yet to know if the vaccines pose an elevated risk to pregnant or lactating women, for example, or to immunocompromised people, such as those with HIV. And we know very little about the effects in children, who were not in the initial trials and for whom the vaccines are not authorized.

Q: Why should my family and I take it?

First of all, because you will protect yourselves from the possibility of severe illness or even death. Also, by getting vaccinated you will be doing your part to achieve a vaccination rate high enough to end the pandemic. Nobody knows exactly what percentage of the population needs to get inoculated for that to happen, but infectious disease experts put the number somewhere between 60% and 70% — perhaps even a little higher. Think of it as a civic duty to get your shots.

Q: So, when can I get mine?

It depends on your health status, age and work. In the first phase, already underway, health care workers and nursing home residents are getting vaccinated. The 40 million Moderna and Pfizer doses expected to be available by year’s end should immunize most of them.

Next in line are people 75 and older and essential workers in various public-facing jobs. They will be followed by people ages 65-74 and those under 65 with certain medical conditions that put them at high risk. Enough vaccine could be available for the rest of the population by late spring, but summer or even fall is more likely. Already, some distribution bottlenecks have developed.

On the bright side, two other vaccines — one from Johnson & Johnson, the other from AstraZeneca and Oxford University — could win FDA authorization early next year, significantly increasing the supply.

Q: Once I’m vaccinated, can I finally stop wearing a mask and physical distancing?

No. Especially not early on, before a lot of people have been vaccinated. One reason for that is self-protection. The Moderna and Pfizer vaccines are 95% effective, but that means you still have a 5% chance of falling ill if you are exposed to someone who hasn’t been vaccinated — or who has been but is still transmitting the virus.

Another reason is to protect others, since you could be the one shedding virus despite the vaccination.

Q: I’ve already had COVID-19, so I don’t need the vaccine, right?

We don’t know for sure how long exposure to the virus protects you from reinfection. Protection probably lasts at least a few months, but public health experts say it’s a good idea to get vaccinated when your turn comes up — especially if it’s been many months since you tested positive.

Q: How long before our lives get back to normal?

“If everything goes well, next Thanksgiving might be near normal, and we might be getting close to that by the summer,” says Dr. William Schaffner, a professor of infectious diseases at the Vanderbilt University School of Medicine in Nashville, Tennessee. ”But there would have to be substantial acceptance of the vaccine and data showing the virus moving in a downward direction.”

This story was produced by Kaiser Health News, which publishes California Healthline, an editorially independent service of the California Health Care Foundation.