Senior Master Sgt. Vincent De Groot/Air National Guard

The White House Says Boosters for All. Here’s What You Need to Know.

Federal officials are preparing to offer those who received Pfizer or Moderna covid vaccines a third dose in September. But the FDA and CDC are still reviewing the data for final clearance.

The Biden administration announced plans Wednesday to offer boosters to all U.S. adults as soon as next month, saying that recent data, including some made available only in the past few days, played a role in that decision.

“If you wait for something bad to happen before you respond to it, you find yourselves considerably behind,” Dr. Anthony Fauci said during a White House briefing. “You want to stay ahead of the virus.”

White House officials emphasized that the rollout of boosters was pending review of evidence by officials at the Food and Drug Administration as well as the advisory committee to the Centers for Disease Control and Prevention.

The rollout would begin the week of Sept. 20. U.S. residents 18 and older who received the Moderna or Pfizer-BioNTech vaccines would be eligible for a third shot eight months after their second dose. The timing would mean that health care workers, long-term care residents and older residents would be first in line for boosters.

“If you are fully vaccinated, you still have a high degree of protection from the worst outcomes — we are not recommending you go out and get a booster today,” U.S. Surgeon General Vivek Murthy said. Johnson & Johnson vaccines were not distributed until March and a plan for those booster shots will come later, officials said.

Political and corporate pressure to offer a booster to U.S. citizens has been mounting over the summer months, as the highly contagious delta variant has spread nationally and filled hospital beds. On Wednesday, Biden officials offered slides filled with charts of recent data, talked about antibody response, and noted that research showing waning vaccine strength in Israel played a key role in their decision as did a study from Mayo Clinic that is not yet peer-reviewed.

“Stick to the advice from the CDC and the FDA, because they are doing their very best to ensure maximum protection and safety,” said Dr. Cody Meissner, a specialist in pediatric infectious diseases who sits on the FDA’s vaccine advisory panel. “People have to be very careful about statements that come from Big Pharma. They have a very different goal.”

Dr. Sadiya Khan, an epidemiologist and cardiologist at Northwestern University’s Feinberg School of Medicine, said that taking any medication has risks and that adding an additional dose of vaccine might cause unnecessary side effects. “What we need is data,” she said.

There was no discussion Wednesday of any potential side effects of a third dose.

So what do we know about whether healthy, fully vaccinated people should get a booster? Here are answers to seven key questions.

1. What evidence are vaccine makers giving federal regulators to support the idea that an additional shot is needed?

It’s unclear how the booster may be authorized by regulators. On Tuesday, FDA spokesperson Abby Capobianco said federal agencies are reviewing laboratory and clinical trial data as well as data from the real world. Some data will come from specific pharmaceutical companies, but the agency’s analysis “does not rely on those data exclusively,” she said.

The companies, for their part, are racing to produce data. On Monday, Pfizer and BioNTech submitted initial but promising results from a phase 1 study of the safety and immune response from a booster dose given at least six months after the second dose. Late-stage trial results that evaluate the effectiveness of a third dose are “expected shortly,” Pfizer spokesperson Jerica Pitts confirmed this week.

Moderna President Stephen Hoge said during his company’s earnings call this month that a third dose is “likely to be necessary” this fall because of the highly contagious delta variant. Moderna spokesperson Ray Jordan said Tuesday the company is in talks with regulators but hasn’t provided an estimated timeline.

Johnson & Johnson, whose vaccine is administered in a single shot, hopes to share results soon from a late-stage clinical trial studying the safety and efficacy of a two-dose regimen in 30,000 adults. The study is looking at “potential incremental benefits” with a second dose, company spokesperson Richard Ferreira wrote in a Tuesday email.

2. Why might healthy people not need a booster yet?

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 FDA, said current federal guidance does not recommend a booster and there’s no “science-based” reason to get an additional shot at this time — even after receiving the J&J vaccine.

The current mRNA vaccines work by inducing a certain level of neutralizing, virus-specific antibodies with the first dose. Then the second dose brings on an exponential increase in the measurable level of specific neutralizing antibodies — and, more important, there’s evidence that the second dose of mRNA vaccine also gives cellular immunity, Offit said.

“That predicts relatively longer-term protection against severe critical disease,” he said. A single dose of the J&J vaccine — which uses a different technology, called an adenovirus vector — has been shown to provide the equivalent response to the second dose of an mRNA vaccine, he said.

3. How do the three vaccines authorized in the U.S. compare?

A recent preprint — a paper that has not been peer-reviewed — from the Mayo Clinic suggests that the Moderna vaccine may be more protective against the delta variant than the Pfizer-BioNTech vaccine. However, that research is based on examining the vaccination history of thousands of people who got covid, rather than a direct comparison of the vaccines, said Dr. Catherine Blish, a specialist in infectious diseases at Stanford Medicine.

“I would be hesitant to alter any practices or change behavior in any way based on that data,” she said.

The Moderna and Pfizer-BioNTech vaccines are administered differently, which could factor into how much mRNA the body receives to code into protein, said Dr. Monica Gandhi, a specialist in infectious diseases at the University of California-San Francisco. Moderna’s dosing is two shots of 100 micrograms delivered four weeks apart, while the Pfizer-BioNTech vaccine’s two 30-microgram doses are delivered three weeks apart.

At the end of July, Pfizer and BioNTech announced findings that four to six months after a second dose their vaccine’s efficacy dropped from a peak of 96% to about 84%. With its own data of fading efficacy, the Israeli government launched a vaccination campaign this month encouraging more than 1 million residents over age 50 to get a third shot.

As for J&J’s one-shot vaccine, there’s no evidence that recipients are being hospitalized with breakthrough infections at a higher rate than if they had received other vaccines, said Dr. Amesh Adalja, a specialist in infectious diseases at Johns Hopkins Center for Health Security.

4. Could a booster harm a healthy, fully vaccinated person?

It’s unclear. Offit said he believes a booster is safe and may well become important — but “it’s just not where we should be in this country right now.” The best defense against delta and other variants, he said, is to first vaccinate as many people as possible.

Others, though, said the available research signaled that caution is warranted. During a media briefing reported by Reuters last month, Jay Butler, the CDC’s deputy director for infectious diseases, said the agency was “keenly interested in knowing whether or not a third dose may be associated with any higher risk of adverse reactions, particularly some of those more severe — although very rare — side effects.”

The CDC did not respond to questions this week about its stance on potential risks. There have been reports of blood clots and allergic reactions after regular dosing. Khan, at Northwestern, said she is also concerned about reports of myocarditis, inflammation of the heart — which is more common after the second shot than the first. She said it’s not clear that the benefit of taking a booster would outweigh the risk for young, healthy people.

5. Would a booster limit a vaccinated person’s ability to spread the virus?

Dr. William Moss, a professor of epidemiology at Johns Hopkins’ Bloomberg School of Public Health, explained that the immune protection conferred by vaccines operates along a spectrum, from severely limiting initial virus replication to preventing widespread virus dissemination and replication within our bodies.

“Booster doses, by increasing antibody levels and enhancing other components of our immune responses, make it more likely virus replication will be rapidly prevented,” Moss said. “This then makes it less likely a vaccinated individual will be able to transmit the virus.”

Moss also said there are potential benefits to combinations of vaccines like those being administered in San Francisco and some European countries. German Chancellor Angela Merkel boosted her adenovirus-vectored AstraZeneca shot with Moderna in June.

Another possible step for pharmaceutical companies is to reformulate their covid vaccines to more closely match newer variants. Pfizer has announced it could do so within 100 days of the discovery of a variant.

Hopefully, the regulatory process could be expedited for such reformulated vaccines, said Moss, who works within Johns Hopkins’ International Vaccine Access Center.

6. Would we have to pay for the booster dose, or would it be free, like the previous shots?

It will be free regardless of immigration or health insurance status, according to White House officials. No identification or insurance will be required.

In July, White House press secretary Jen Psaki announced that the federal government bought an additional 200 million doses of the Pfizer-BioNTech vaccine for inoculating children under 12 and for possible boosters.

7. Is there a future in which we take an annual covid shot?

Dr. Vincent Rajkumar, a hematologist at the Mayo Clinic who studies cancers involving the immune system, said a year ago he believed immune responses to covid may be similar to those of the measles, which create “a very long memory that protects us.”

Then covid mutated. “India changed everything for me,” he said, referring to its massive second wave after delta was discovered. Many of those who were infected had already had covid, he said.

Rajkumar now believes “we might need annual boosters — and it would be nice if such boosters can be combined with the flu vaccine.”

Subscribe to KHN's free Morning Briefing.

X
This website uses cookies to enhance user experience and to analyze performance and traffic on our website. We also share information about your use of our site with our social media, advertising and analytics partners. Learn More / Do Not Sell My Personal Information
Accept Cookies
X
Cookie Preferences Cookie List

Do Not Sell My Personal Information

When you visit our website, we store cookies on your browser to collect information. The information collected might relate to you, your preferences or your device, and is mostly used to make the site work as you expect it to and to provide a more personalized web experience. However, you can choose not to allow certain types of cookies, which may impact your experience of the site and the services we are able to offer. Click on the different category headings to find out more and change our default settings according to your preference. You cannot opt-out of our First Party Strictly Necessary Cookies as they are deployed in order to ensure the proper functioning of our website (such as prompting the cookie banner and remembering your settings, to log into your account, to redirect you when you log out, etc.). For more information about the First and Third Party Cookies used please follow this link.

Allow All Cookies

Manage Consent Preferences

Strictly Necessary Cookies - Always Active

We do not allow you to opt-out of our certain cookies, as they are necessary to ensure the proper functioning of our website (such as prompting our cookie banner and remembering your privacy choices) and/or to monitor site performance. These cookies are not used in a way that constitutes a “sale” of your data under the CCPA. You can set your browser to block or alert you about these cookies, but some parts of the site will not work as intended if you do so. You can usually find these settings in the Options or Preferences menu of your browser. Visit www.allaboutcookies.org to learn more.

Sale of Personal Data, Targeting & Social Media Cookies

Under the California Consumer Privacy Act, you have the right to opt-out of the sale of your personal information to third parties. These cookies collect information for analytics and to personalize your experience with targeted ads. You may exercise your right to opt out of the sale of personal information by using this toggle switch. If you opt out we will not be able to offer you personalised ads and will not hand over your personal information to any third parties. Additionally, you may contact our legal department for further clarification about your rights as a California consumer by using this Exercise My Rights link

If you have enabled privacy controls on your browser (such as a plugin), we have to take that as a valid request to opt-out. Therefore we would not be able to track your activity through the web. This may affect our ability to personalize ads according to your preferences.

Targeting cookies may be set through our site by our advertising partners. They may be used by those companies to build a profile of your interests and show you relevant adverts on other sites. They do not store directly personal information, but are based on uniquely identifying your browser and internet device. If you do not allow these cookies, you will experience less targeted advertising.

Social media cookies are set by a range of social media services that we have added to the site to enable you to share our content with your friends and networks. They are capable of tracking your browser across other sites and building up a profile of your interests. This may impact the content and messages you see on other websites you visit. If you do not allow these cookies you may not be able to use or see these sharing tools.

If you want to opt out of all of our lead reports and lists, please submit a privacy request at our Do Not Sell page.

Save Settings
Cookie Preferences Cookie List

Cookie List

A cookie is a small piece of data (text file) that a website – when visited by a user – asks your browser to store on your device in order to remember information about you, such as your language preference or login information. Those cookies are set by us and called first-party cookies. We also use third-party cookies – which are cookies from a domain different than the domain of the website you are visiting – for our advertising and marketing efforts. More specifically, we use cookies and other tracking technologies for the following purposes:

Strictly Necessary Cookies

We do not allow you to opt-out of our certain cookies, as they are necessary to ensure the proper functioning of our website (such as prompting our cookie banner and remembering your privacy choices) and/or to monitor site performance. These cookies are not used in a way that constitutes a “sale” of your data under the CCPA. You can set your browser to block or alert you about these cookies, but some parts of the site will not work as intended if you do so. You can usually find these settings in the Options or Preferences menu of your browser. Visit www.allaboutcookies.org to learn more.

Functional Cookies

We do not allow you to opt-out of our certain cookies, as they are necessary to ensure the proper functioning of our website (such as prompting our cookie banner and remembering your privacy choices) and/or to monitor site performance. These cookies are not used in a way that constitutes a “sale” of your data under the CCPA. You can set your browser to block or alert you about these cookies, but some parts of the site will not work as intended if you do so. You can usually find these settings in the Options or Preferences menu of your browser. Visit www.allaboutcookies.org to learn more.

Performance Cookies

We do not allow you to opt-out of our certain cookies, as they are necessary to ensure the proper functioning of our website (such as prompting our cookie banner and remembering your privacy choices) and/or to monitor site performance. These cookies are not used in a way that constitutes a “sale” of your data under the CCPA. You can set your browser to block or alert you about these cookies, but some parts of the site will not work as intended if you do so. You can usually find these settings in the Options or Preferences menu of your browser. Visit www.allaboutcookies.org to learn more.

Sale of Personal Data

We also use cookies to personalize your experience on our websites, including by determining the most relevant content and advertisements to show you, and to monitor site traffic and performance, so that we may improve our websites and your experience. You may opt out of our use of such cookies (and the associated “sale” of your Personal Information) by using this toggle switch. You will still see some advertising, regardless of your selection. Because we do not track you across different devices, browsers and GEMG properties, your selection will take effect only on this browser, this device and this website.

Social Media Cookies

We also use cookies to personalize your experience on our websites, including by determining the most relevant content and advertisements to show you, and to monitor site traffic and performance, so that we may improve our websites and your experience. You may opt out of our use of such cookies (and the associated “sale” of your Personal Information) by using this toggle switch. You will still see some advertising, regardless of your selection. Because we do not track you across different devices, browsers and GEMG properties, your selection will take effect only on this browser, this device and this website.

Targeting Cookies

We also use cookies to personalize your experience on our websites, including by determining the most relevant content and advertisements to show you, and to monitor site traffic and performance, so that we may improve our websites and your experience. You may opt out of our use of such cookies (and the associated “sale” of your Personal Information) by using this toggle switch. You will still see some advertising, regardless of your selection. Because we do not track you across different devices, browsers and GEMG properties, your selection will take effect only on this browser, this device and this website.